- Trials with a EudraCT protocol (1,205)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (9,325)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: High-fluoride toothpaste and no post-brushing water rinsing on enamel demineralization using an in-sit caries model with orthodontic bands2010-AlMulla |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 2010-AlMulla-high-fluoride toothpaste and no post-brushing water rinsing on enamel demineralization using an in-sit caries model with orthodontic b... |
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Document reference: 49098 |
Study title: Bone scintigraphy in calcific discitis of childhood. Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med. 1990 Feb;31(2):234-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48843 |
Study title: K.E.E.P.E.R. (KEPPRA(R) EPILEPSY EVALUATION OF PATIENT TIME TO RESPONSE). A PHASE IV, OPEN-LABEL, MULTI-CENTER, COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF LEVETIRACETAM AS ADD-ON THERAPY IN ADULT PATIENTS WITH TREATMENT-RESISTANT, PARTIAL-ONSET EPILEPSY. |
Active substance: levetiracetam |
Study summary document link (including results): N01030 - Levetiracetam - RRCE02E1301.pdf |
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Document reference: 31147 |
Study title: Hepatopulmonary syndrome: a prospective study of relationships between severity of liver disease, PaO(2) response to 100% oxygen, and brain uptake after (99m)Tc MAA lung scanning. Chest. 2000 Sep;118(3):615-24. Krowka MJ 2000 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48803 |
Study title: Irreversible long-term pulmonary functional impairments after adenovirus type-7 pneumonia: assessment with xenon-133 ventilation and Tc-99m MAA perfusion studies. Eur Radiol. 2000;10(9):1411-5. Suga K 2000 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48802 |
Study title: Late pulmonary scintigraphic defects after uneventful recovery from focal pneumonia in children: comparison with initial radiograph. Med Sci. 2002 Jul;18(7):334-9. Kaohsiung J 2002 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48798 |
Study title: Gastric uptake of Tc-99m MDP in a child treated with isotretinoin.Franco A, Hampton WR, Greenspan BS, Holm AL, O'Mara RE. Clin Nucl Med 1993 18(6):510-1. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48723 |
Study title: Acute asthma management of children in the emergency department. |
Active substance: IPRATROPIUM |
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Document reference: 30563 |
Study title: AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di tonsillectomia. Osservazioni clinico-statistich su 91 casi. SO Minerva otorinolaringologica, {Minerva-Otorinolaringol}, Sep-Oct 1971, vol. 21, no. 5, p. 191-5, ISSN: 0026-4938. AU Fior-R. YR 1971.AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di... |
Active substance: CYPROHEPTADINE |
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Document reference: 25204 |
Study title: Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV. |
Active substance: DACTINOMYCIN |
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Document reference: 25301 |
Study title: Efficacy and morbidity of Daunomycin (NSC-82151) added to vincristine (NSC-67574) and Prednisone (NSC-10023) for remission induction of childhood acute lymphocytic leukemia - Verzosa, M., Fite, A. - 1971 (Cancer Chemotherapy Reports Part.1 Vol. 55 n°1, 79-82) - Publication in the dos. Allemand jan 1981 - Efficacy and morbidity of Daunomycin (NSC-82151) added to vincristine (NSC-67574) and Prednisone (NSC-10023) for remission induction of childhood acute lymphocytic leukemia - Verzosa, M., Fite, A. - 1971 (Cancer Chemotherapy Reports Part.1 Vol. 55 n°1, 79-82) - Publication in the dos. Allemand jan 1981 - |
Active substance: DAUNORUBICIN |
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Document reference: 25617 |
Study title: Paul IM et al. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther 2004; 26(9):1508-1514 |
Active substance: Dextromethorphan + GUAFENESIN |
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Document reference: 25913 |
Study title: Double-blind, eight-month extension study to collect durability of efficacy data and additional safety data in patients with juvenile rheumatoid arthritis completing the double-blind comparison study HWA486/3503 of leflunomide versus methotrexate |
Active substance: LEFLUNOMIDE |
Study summary document link (including results): Leflunomide-Study 3.pdf |
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Document reference: 47350 |
Study title: Efficacy and safety of leflunomide versus methotrexate in the treatment of pediatric patients with juvenile rheumatoid arthritis (JRA) |
Active substance: LEFLUNOMIDE |
Study summary document link (including results): Leflunomide-Study 2.pdf |
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Document reference: 47349 |
Study title: Compatibility of Lomaherpan Cream in children with herpes simplex labialis 1995 |
Active substance: Lemon balm dry extract |
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Document reference: 40047 |
Study title: Q Clinical impact of fluorine-18fluorodeoxyglucose positron emission tomography in cancer patients. A comparative study between dedicated camera and dual-head coincidence gamma camera.JNucl Med Mol Imaging. 2006 Mar;50(1):68-77. Andrieux A 2006 |
Active substance: SteriPET |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48624 |
Study title: Rigacci L, Castagnoli A, Dini C, Carpaneto A, Matteini M, Alterini R. FDG-positron emission tomography in post treatment evaluation of residual mass in Hodgkin's lymphoma: long-term results. [rigacci-2005]Oncol Rep. 2005 Nov;14(5):1209-14. 18. Rigacci L 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48692 |
Study title: Rixham PA, Roberts G. The new EANM paediatric dosage card : how does it affect UK centres working under the ARSAC guidelines? [rixham-2009]Nucl Med Comm 2009; 319 – 321. Rixham PA 2009 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48694 |
Study title: Shulkin BL, Hutchinson RJ, Castle VP, Yanik GA, Shapiro B, Sisson JC.. Neuroblastoma: positron emission tomography with 2-[fluorine-18]-fluoro-2-deoxy-D-glucose compared with metaiodobenzylguanidine scintigraphy. [shulkin-1996]Radiology. 1996 Jun;199(3):743-50. Shulkin BL 1996 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48697 |
Study title: Long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients1994-boyd |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1994-boyd - long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients.pdf |
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Document reference: 49157 |
Study title: Prevention of caries progress in xerostomic patients by topical fluoride applicationsMarkitziu 1982 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Markitziu 1982 Prevention of caries progress.pdf |
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Document reference: 49171 |
Study title: Role of buclizine hydrochloride in promoting weight gain in children |
Active substance: Buclizine |
Study summary document link (including results): DE81G307P - Buclizine hydrochloride.pdf |
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Document reference: 42007 |
Study title: A comparison of iohexol and diatrizoate-meglumine in children undergoing cardiac catheterization. Investigative radiology (1991), 26(7), 665-70 Pelech AN 1991 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48863 |
Study title: A) Open non-comparative pilot study B) randomized, double-blind, parallel study using Amipaque (metrizamide) 300 mgI/ml as comparison in pediatric urography to assess the safety, tolerability and image effectiveness of iohexol 300 mgI/ml firstly in an open study and later compared to Amipaque 300 mgI/ml.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48887 |
Study title: Impact of ibuprofen administration on renal drug clearance in the first weeks of life. |
Active substance: INDOMETHACIN |
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Document reference: 29913 |
Study title: A comparative study to compare the effects of BDP and BUD of symptoms, peak-flow diaries. Lung function and hypothalamic-adrenal function |
Active substance: BUDESONIDE |
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Document reference: 48892 |
Study title: Comparison of the risk of nocturnal hypoglycemia in adolescents with type 1 diabetes mellitus given either HOE901 with lispro or NPH insulin with regular human insulin, as multiple injection regimens |
Active substance: INSULIN GLARGINE |
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Document reference: 47341 |
Study title: Morning Lantus® (insulin glargine [rDNA origin] injection) vs. intermediateacting insulin twice daily as basal insulin in a multiple daily injection regimen with Humalog® (insulin lispro injection [rDNA Origin]) in pediatrics with type 1 diabetes mellitus: an activeontrolled, open, randomized, gender-stratified, two arm, parallel-group study. |
Active substance: INSULIN GLARGINE |
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Document reference: 47342 |
Study title: Multicenter, open, uncontrolled clinical extension trial of HOE901 in type 1 diabetic children previously participating in study HOE901/3003. |
Active substance: INSULIN GLARGINE |
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Document reference: 47340 |
Study title: Lai C.L. Open, pilot (phase II) study comparing patients treated with interferon alfa-2a with an untreated control group, in chinese chidren with chronic hepatitis B (Protocol 0-10002); 30th May 1988 (Leitz G.J., Rochefort E., Ryff J.C.) |
Active substance: INTERFERON ALPHA (2A) |
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Document reference: 30188 |
Study title: V. Carreno M.D. Open, single centre pilot (phase II) study comparing patients treated with interferon alfa-2a with an untreated control group in children with chronic hepatitis B (Protocol 0-10002); 30th May 1988 (Leitz G.J., Rochefort E., Ryff J.C.) |
Active substance: INTERFERON ALPHA (2A) |
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Document reference: 30189 |
Study title: Treatment of Early Onset Mulitple Sclerosis with Suboptimal Dose of Interferon Beta-1a (Pakdaman et al) |
Active substance: Interferon beta-1a |
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Document reference: 41483 |
Study title: 107.162, 107.235 - A Population pharmacokinetic analysis for meloxicam in pediatric juvenile rheumatoid arthritis patients – A combined analysis of pharmacokinetic data obtained in studies 107.162 and 107.235 |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30200 |
Study title: Bastiaannet E, Oyen WJ, Meijer S, Hoekstra OS, Wobbes T, Jager PL, et al.. Impact of 18F] fluorodeoxyglucose positron emission tomography on surgical management of melanoma patients. [bastiaannet-2006]Br J Surg. 2006 Feb;93(2):243-9. Bastiaannet E 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48631 |
Study title: Boellaard R, Oyen WJ, Hoekstra CJ, Hoekstra OS, Visser EP, Willemsen AT, Arends B, Verzijlbergen FJ, Zijlstra J, Paans AM, Comans EF,. The Netherlands protocol for standardisation and quantification of FDG whole body PET studies in multi-centre trials. [boellaard-2008]Pruim J Eur J Nucl Med Mol Imaging 2008 12:2320–2333. Boellaard R 2008 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48633 |
Study title: Brenner W, Friedrich RE, Gawad KA, Hagel C, von Deimling A, de Wit M, et al.. Epub 2006 Jan 11. Prognostic relevance of FDG PET in patients with neurofibromatosis type-1 and malignant peripheral nerve sheath tumours. [brenner-2006]Eur J Nucl Med Mol Imaging. 2006 Apr;33(4):428-32. Brenner W 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48635 |
Study title: Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437 |
Active substance: IODINE |
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Document reference: 30245 |
Study title: Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56)Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56) |
Active substance: IODINE |
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Document reference: 30327 |
Study title: Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. ; Kitahara-S. Journal of Pediatric Surgery, 1995, Vol/Iss/Pg. 30/12 (1709-1712)Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. ; Kitahara-S. Journal of Pediatric Surgery, 1995, Vol/Iss/Pg. 30/12 (1709-1712) |
Active substance: IODINE |
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Document reference: 30328 |
Study title: A study of clinical utility of a sustained release injection of leuprorelin acetate in the treatment of patients with central precocious puberty |
Active substance: LEUPRORELIN |
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Document reference: 31051 |
Study title: Clinical trial to evaluate efficacy and tolerability of subcutaneously administered leuprorelin acetate as a 1-month depot in a weight-dependent dosage in female patients with central precocious puberty + Biometrical report- interim results on bone metabolism |
Active substance: LEUPRORELIN |
Study summary document link (including results): 2011-08-11 Leuprorelin EC08(128)_EC108 Synopsis.pdf |
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Document reference: 31043 |
Study title: Prevention of decalcification in orthodontic patients by daily self treatment with 0.4 percent SnF2 gel1979-shannon |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1979-shannon - prevention of decalcification in orthodontic patients by daily self treatment with 0.4 percent SnF2 gel.pdf |
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Document reference: 49154 |
Study title: Stannous fluoride versus sodium fluoride in preventive treatment of orthodontic patients1977-shannon |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1977-shannon - stannous fluoride versus sodium fluoride in preventive treatment of orthodontic patients.pdf |
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Document reference: 49153 |
Study title: Rovamycine (Spiramycine) RP5337 - Etude clinique nationale de la rovamycine sirop pediatrique |
Active substance: SPIRAMYCIN |
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Document reference: 42590 |
Study title: 137163 - To study the effect duration of two different doses of IFN-gamma in patients with chronic granulomatous disease (CGD) on functional responses of neutrophils (PMN). |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30193 |
Study title: 137177 - The immunomodulatory impact of Imukin (IFNgamma-1b) on clinical and laboratory data in the treatment of atopic dermatitis. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30194 |
Study title: A phase III randomized, controlled open label trial of actimmune (Interferon gamma-1b, rIFN-alpha1b) in patients with severe, congenital (malignant) osteopetrosis. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30205 |
Study title: An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30191 |
Study title: EBI 4.20,IP 137.3,137.3 - Interferon gamma-1b (IF-RC 1001 XX G): Safety, Efficacy and Pharmacokinetics of 0.1 mg/sqm, 0.25 mg/sqm and 0.5 mg/sqm Interferon gamma-1b for 2 or more Weeks Subcutaneaously Administered to Patients with Lymphomas, Plasmocytomas and Solid Tumors. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30199 |
Study title: I0016g(A),CH 9903,137.41 - An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30196 |
Study title: I0286n - Post marketing surveillance study of Actimmune (recombinant human interferon gamma-Ib) in patients with chronic granulomatous disease. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30195 |
Study title: I0681s - A phase III randomized, controlled open label trial of actimmune (Interferon gamma-1b, rIFN-alpha1b) in patients with severe, congenital (malignant) osteopetrosis. |
Active substance: INTERFERON GAMMA (1B) |
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Document reference: 30197 |
Study title: Benefit of fluoroscopically guided intraarticular, long-acting corticosteroid injection for subtalar arthritis in juvenile idiopathic arthritis.; CAHILL AM; Pediatr. Radiol.; 2007 vol.37 p544 548Benefit of fluoroscopically guided intraarticular, long-acting corticosteroid injection for subtalar arthritis in juvenile idiopathic arthritis.; CAHILL AM; Pediatr. Radiol.; 2007 vol.37 p544 548 |
Active substance: IOVERSOL |
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Document reference: 30397 |
Study title: Blunt trauma in intoxicated patients: is computed tomography of the abdomen always necessary?; MAVRIDIS SP; South. Med. J.; 2000 vol.93 n.4 p.403 405Blunt trauma in intoxicated patients: is computed tomography of the abdomen always necessary?; MAVRIDIS SP; South. Med. J.; 2000 vol.93 n.4 p.403 405 |
Active substance: IOVERSOL |
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Document reference: 30398 |
Study title: Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730)Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730) |
Active substance: IODINE |
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Document reference: 30250 |
Study title: Etude de deux foyers d’endémie goitreuse au Niger : Belley-Koira et Tiguey-Tallawal; R. Aquaron. Annales d’Endocrinologie (Paris) 1990, 51, 231-240Etude de deux foyers d’endémie goitreuse au Niger : Belley-Koira et Tiguey-Tallawal; R. Aquaron. Annales d’Endocrinologie (Paris) 1990, 51, 231-240 |
Active substance: IODINE |
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Document reference: 30252 |
Study title: Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39)Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39) |
Active substance: IODINE |
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Document reference: 30253 |
Study title: Hepatocellular carcinoma after transcatheter hepatic arterial embolization: A histopathologic study of 84 resected cases. Higuchi-T. Cancer , 1994, Vol/Iss/Pg. 73/9 (2259-2267)Hepatocellular carcinoma after transcatheter hepatic arterial embolization: A histopathologic study of 84 resected cases. Higuchi-T. Cancer , 1994, Vol/Iss/Pg. 73/9 (2259-2267) |
Active substance: IODINE |
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Document reference: 30258 |
Study title: Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321)Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321) |
Active substance: IODINE |
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Document reference: 30259 |
Study title: Hepatocellular carcinoma outcomes based on indicated treatment strategy. ; Rose-A-T. American Surgeon, 1998, Vol/Iss/Pg. 64/12 (1128-1135)Hepatocellular carcinoma outcomes based on indicated treatment strategy. ; Rose-A-T. American Surgeon, 1998, Vol/Iss/Pg. 64/12 (1128-1135) |
Active substance: IODINE |
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Document reference: 30260 |
Study title: "Randomised, multi-centric, open-label, comparative clinical trial in patients; Duration: Treatment was 3 weeks." Baudon JJ 1995 |
Active substance: Lactitol |
Study summary document link (including results): Importal_Baudon JJ_1995-OK.xls |
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Document reference: 48154 |
Study title: Tuomilehto H, et all. Comparison of intravenous and oral ketoprofen for postoperative pain after adenoidectomy in children. Br J Anaesth. 2000 Aug;85(2):224-7. Tuomilehto H, et all. Comparison of intravenous and oral ketoprofen for postoperative pain after adenoidectomy in children. Br J Anaesth. 2000 Aug;85(2):224-7. |
Active substance: LACTITOL |
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Document reference: 30989 |
Study title: Huttenlocher, P:. Subacute Sclerosing Panencephalitis, 2nd Inti. Symp. SSPE, 1985:176-184. Follow-up of SSPE Patients on Long- Term Therapy with InosiplexHuttenlocher, P:. Subacute Sclerosing Panencephalitis, 2nd Inti. Symp. SSPE, 1985:176-184. Follow-up of SSPE Patients on Long- Term Therapy with Inosiplex |
Active substance: INOSINE |
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Document reference: 30124 |
Study title: Ink J, Andres FJ, Antonini GM, Scarpiello V, Stefano JC, Coronel N, Genoves MH, Spataro R, Natelli C, Buey O, Ink RL, Goijman I, Pernas N, Andres RJ, Sumay OR, Casal I, Cudemo OLa Prensa Medica Argentina; January 8, 1971; 45(57):2050-2064. NPT10.381 Antiviral AgentInk J, Andres FJ, Antonini GM, Scarpiello V, Stefano JC, Coronel N, Genoves MH, Spataro R, Natelli C, Buey O, Ink RL, Goijman I, Pernas N, Andres RJ, Sumay OR, Casal I, Cudemo OLa Prensa Medica Argentina; January 8, 1971; 45(57):2050-2064. NPT10.381 Antiviral Agent |
Active substance: INOSINE |
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Document reference: 30125 |
Study title: The role and limitation of living donor liver transplantation for hepatocellular carcinoma. ; Lo-C-M. Liver Transplantation, 2004, Vol/Iss/Pg. 10/3 (440-447)The role and limitation of living donor liver transplantation for hepatocellular carcinoma. ; Lo-C-M. Liver Transplantation, 2004, Vol/Iss/Pg. 10/3 (440-447) |
Active substance: IODINE |
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Document reference: 30333 |
Study title: Transarterial chemoembolization in the treatment of hepatoblastoma in children.; Vogl-T-J. European Radiology, 2006, Vol/Iss/Pg. 16/6 (1393-1396) Transarterial chemoembolization in the treatment of hepatoblastoma in children.; Vogl-T-J. European Radiology, 2006, Vol/Iss/Pg. 16/6 (1393-1396) |
Active substance: IODINE |
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Document reference: 30337 |
Study title: Transcatheter arterial chemoembolization in the treatment of hepatoblastoma. ; Oue-T. Journal of Pediatric Surgery, 1998, Vol/Iss/Pg. 33/12 (1771-1775)Transcatheter arterial chemoembolization in the treatment of hepatoblastoma. ; Oue-T. Journal of Pediatric Surgery, 1998, Vol/Iss/Pg. 33/12 (1771-1775) |
Active substance: IODINE |
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Document reference: 30339 |
Study title: Osteoma: a diagnoiss for radicular pain of extremities.Ebrahimzadeh MH, Ahmadzadeh-Chabock H, Ebrahimzadeh AR. Osteoid Orthopedics 2009; 32(11):821. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48718 |
Study title: Potentially misleading bone scan findings in patients with hepatoblastoma.Archer D, Babyn P, Gilday D, Greenberg MA. Clin Nucl Med 1993 Dec;18(12):1026-31 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48529 |
Study title: Publication 53: Radiation dose to patients from radiopharmaceuticalsICRP (lnternation Commission on Radiological Protection). Pergamon Press 1987 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48489 |
Study title: Publication 80: Radiation dose to patients from radiopharmaceuticalsICRP (lnternation Commission on Radiological Protection). Addendum to ICRP Publication 53. Pergamon Press 1998 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48490 |
Study title: Publication of result-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’) Amerscan Medronate ra.gehealthcare@ge.com |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48833 |
Study title: Pyogenic sacroiliitis - a comparison between paediatric and adult patientsWu M-S, Chang S-S, Lee S-H, Lee C-C. Rheumatology 2007;46:1684-7 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48765 |
Study title: Contrast media use in paediatrics; BABYN PS; Adv. X Ray Contrast; 1993 vol.1 p.74 85Contrast media use in paediatrics; BABYN PS; Adv. X Ray Contrast; 1993 vol.1 p.74 85 |
Active substance: IOVERSOL |
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Document reference: 30405 |
Study title: CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736 |
Active substance: IOVERSOL |
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Document reference: 30408 |
Study title: Double Blind, parallel group study to compare the efficacy and safety of Ioversol 350 and Iohexol 350 in Pediatric Patients undergoing Angiocardiography |
Active substance: IOVERSOL |
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Document reference: 30392 |
Study title: Comparative evaluation of iohexol and inulin clearance for glomerular filtration rate determinations Acta paediatrica (1994), 83(4), 418-22 Lindblad HG 1994 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48859 |
Study title: Comparison of intravenous contrast agents for CT studies in children Acta radiologica (Stockholm, Sweden : 1987) (1992), 33(6), 592-5 Cohen MD 1987 |
Active substance: IOHEXOL |
Study summary document link (including results): Cohen MD 1987.pdf |
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Document reference: 48868 |
Study title: A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9.A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9. |
Active substance: LACTULOSE |
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Document reference: 30997 |
Study title: A DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY OF LACTULOSE IN THE TREATMENT OF ENCOPRESIS IN CHILDREN WITH CHRONIC CONSTIPATION |
Active substance: LACTULOSE |
Study summary document link (including results): Lactulose-RH105.0101.pdf |
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Document reference: 31005 |
Study title: A pilot, open, parallel group study of the effect of lactulose on stool bacterial composition in children suffering from cystic fibrosis (antibiotic-treated and untreated) and healthy childrenConstipation in childood: a controlled comparison between lactulose and standardized senna.; Perkin J.M. - Current Medical Research and Opinion, 1977; 4(8): 540-543 |
Active substance: LACTULOSE |
Study summary document link (including results): lactulose-s1053101.pdf |
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Document reference: 30991 |
Study title: An open, group comparative study with Duphalac syrup versus lactulose crystalline in constipated children |
Active substance: LACTULOSE |
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Document reference: 30990 |
Study title: An open, randomized group comparative study with lactulose syrup (Duphalac~ versus lactulose crystalline in constipated children. |
Active substance: LACTULOSE |
Study summary document link (including results): Lactulose-H.105.910NL.pdf |
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Document reference: 31006 |
Study title: Clinical efficacy of duphalac in the treatment of functional constipations. Shevtsov SA. Eksp Klin Gastroenterol. 2005;(6):58-60.Clinical efficacy of duphalac in the treatment of functional constipations. Shevtsov SA. Eksp Klin Gastroenterol. 2005;(6):58-60. |
Active substance: LACTULOSE |
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Document reference: 30994 |
Study title: Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Gremse DA, Hixon J, Crutchfield A. Clin Pediatr (Phila). 2002 May;41(4):225-9.Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Gremse DA, Hixon J, Crutchfield A. Clin Pediatr (Phila). 2002 May;41(4):225-9. |
Active substance: LACTULOSE |
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Document reference: 30999 |
Study title: Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, François-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):625-33.Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, ... |
Active substance: LACTULOSE |
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Document reference: 30996 |
Study title: Effects of early enteral feeding on the prevention of enterogenic infection in severely burned patients. Peng YZ, Yuan ZQ, Xiao GX. Burns. 2001 Mar;27(2):145-9.Effects of early enteral feeding on the prevention of enterogenic infection in severely burned patients. Peng YZ, Yuan ZQ, Xiao GX. Burns. 2001 Mar;27(2):145-9. |
Active substance: LACTULOSE |
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Document reference: 31002 |
Study title: Clinical Implications of Different Image Reconstruction Parameters for Interpretation of Whole-Body PET Studies in Cancer Patients.J Nucl Med 2004; 45:559–566. Heiko Scho¨der, MD1; Yusuf E. Erdi, DSc2; Kenneth Chao, BS1; Mithat Gonen, PhD3; Steven M. Larson, MD1; and Henry W.D. Yeung, MD1. |
Active substance: Steripet |
Study summary document link (including results): schulte-1999.pdf |
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Document reference: 48746 |
Study title: rG-CSF injection. Protocol for double blind controlled clinical trial. Bone Marow Transplantation - by The Japanese rG-CSF clinical study group. |
Active substance: LENOGRASTIM |
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Document reference: 31036 |
Study title: rG-CSF injection. Protocol for phase II clinical trial. Bone Marow Transplantation - by The Japanese rG-CSF clinical study group. |
Active substance: LENOGRASTIM |
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Document reference: 31037 |
Study title: Nonspecific osteomyelitis in childhood and adolescence. The contribution of imaging diagnosisUrso S, Pacciani E, Fariello G, Colajacomo M, Fassari FM, Randisi F, et al. Radiol Med 1995 Sep;90(3):212-8 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48763 |
Study title: Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females.Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Angle Ortho 2006;76:759-67. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48568 |
Study title: Wu PS, Chiu NT, Lee BF, Yao WJ, W Chen HH. Clinical significance of solitary rib hot spots on bone scans in patients with extraskeletal cancer: correlation with other clinical manifestations. Clin Nucl Med. 2002 Aug;27(8):567-71. Wu PS, Chiu NT, Lee BF, Yao WJ, W Chen HH. Clinical significance of solitary rib hot spots on bone scans in patients with extraskeletal cancer: correlation with other clinical manifestations. Clin Nucl Med. 2002 Aug;27(8):567-71. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43444 |
Study title: Kokyu To Junkan. 1989 Sep;37(9):1003-7. [Significance of decreased washout rate in hypertrophic cardiomyopathy by exercise Tl-201 myocardial scintigraphy] [Article in Japanese] Inoue S, Nezuo S, Tadaoka S, Hasegawa K, Kawahara Y, Kakumae S, Nakamura T,Kokyu To Junkan. 1989 Sep;37(9):1003-7. [Significance of decreased washout rate in hypertrophic cardiomyopathy by exercise Tl-201 myocardial scintigraphy] [Article in Japanese] Inoue S, Nezuo S, Tadaoka S, Hasegawa K, Kawahara Y, Kakumae S, Nakamura T, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44656 |
Study title: Radionuclide imaging in bilateral os trigonum syndrome in a young athlete. Minoves M, Company A, Ardevol J, Matas RB, Costansa JM, Setoain J, Domenech-Torné FM. Clin Nucl Med. 2001 Mar;26(3):237-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43458 |
Study title: Radionuclide imaging in the evaluation of osteomyelitis and septic arthritis.Kim EE, Haynie TP, Lowry PA, Harle TS. Crit Rev Diagn Imaging 1989; 29(3):257-305 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48751 |
Study title: Tc-99m MDP, thallium- 201 chloride and Tc-99m MAG3 renal uptake in subacute and chronic radiation nephritis compared.Degirmenci B, Uysal K, Bekis R, Cetingoz R, Kaya GC, Durak H. Ann Nucl Med 2001 Oct;15(5):447-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48599 |
Study title: Natural history and distribution of bone and bone marrow infarction in sickle hemoglobinopathiesKim SK. Miller JH. J Nucl Med 2002 Jul;43(7):896-900 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48493 |
Study title: COMPARISON OF INTRAVENOUS CONTRAST AGENTS FOR CT STUDIES IN CHILDRENM.D. CoHEN, E. HERMAN, D. HERRON, S. J. WHITE and J. A. SMITH Acta Radiol. 1992 Nov;33(6):592-5. |
Active substance: IOHEXOL |
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Document reference: 48851 |
Study title: Comparison of low-osmolar contrast media in paediatric cardiac angiography. The British journal of radiology (1987), 60(710), 133-5 Rubin CME 1987 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48865 |
Study title: Comparison of iohexol with barium in gastrointestinal studies of infants and children Am J Roentgenol. 1991 Feb; 156(2): 345-50 Cohen MD 1991 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48855 |
Study title: Experiences with iohexol (Omnipaque) at urography Pediatr Radio! (1987) 17: 491-492 Fjelldal A 1987 Pediatr Radio! (1987) 17: 491-492 Fjelldal A 1987 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48867 |
Study title: Phase 1 Pilot Trial of Interferon alfa-2a in Children with Japanese Viral Encephalitis |
Active substance: INTERFERON ALPHA (2A) |
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Document reference: 30187 |
Study title: HyRhabdomyolysis after intraoperative myelography Paediatr Anaesth 2004 Jun; 14(6):509-13 Canbay O 2004 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48853 |
Study title: Hypothyroidism in neonates post-iodinated contrast media: a systematic review. Acta Paediatrica (Oxford, United Kingdom) (2009), 98(10), 1568-1574 Ahmet A 2009 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48852 |
Study title: Iohexol for contrast enhancement of bowel in paediatric abdominal CT. Acta Radiol. 1990 Nov; 31(6): 601-4 Smevik B 1990 |
Active substance: IOHEXOL |
Study summary document link (including results): Smevik B 1990.pdf |
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Document reference: 48870 |
Study title: Iohexol in paediatric myelography. An open non-comparative trial Neuroradiology (1986), 28(1), 65-8 Kendall B 1986 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48858 |
Study title: Myelography with iohexol (Omnipaque); a clinical report with special reference to the adverse effects. Neuroradiology. 1988; 30(2):169-74 Skalpe IO 1988 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48866 |
Study title: Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. The Central African journal of medicine (1996), 42(7), 192-5. Ndosi BN 1996 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48862 |
Study title: Open, non-comparative study in angiocardiography in children, Angiocardiography: evaluate safety, tolerance and the radiographic properties of of iohexol in pediatric use. Systolic blood pressure, ECG parameters, body temperature, visualization and adverse reactions were recorded.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48882 |
Study title: Clinical Performance of PET/CT in Evaluation of Cancer: Additional Value for Diagnostic Imaging and Patient ManagementRachel Bar-Shalom, MD1; Nikolai Yefremov, MD1; Ludmila Guralnik, MD2; Diana Gaitini, MD2,3; Alex Frenkel, DSc1; Abraham Kuten, MD3,4; Hernan Altman, MBA5; Zohar Keidar, MD, PhD1; and Ora Israel, MD1,3. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 44 • No. 8 • August 2003 |
Active substance: Steripet |
Study summary document link (including results): bar-shalom-2003.pdf |
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Document reference: 48623 |
Study title: Clinical Usefulness of 18F-FDG PET in Nasopharyngeal Carcinoma Patients with Questionable MRI Findings for Recurrence Biomedicine & Pharmacotherapy 60 (2006) 593–606. C. Nannia, D. Rubellob,*, P. Castelluccia, M. Farsada, R. Franchia, L. Rampinb M.D. Grossc, A. Al-Nahhasd, S. Fantia |
Active substance: Steripet |
Study summary document link (including results): ng-2004-b.pdf |
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Document reference: 48739 |
Study title: Comparison of 18F-FDG and 11C-Methionine for PET-Guided Stereotactic Brain Biopsy of GliomasJ Nucl Med 2004; 45:1293–1298. Benoit Pirotte, MD1; Serge Goldman, MD, PhD2; Nicolas Massager, MD1; Philippe David, MD3; David Wikler, MS1; Arlette Vandesteene, MD, PhD4; Isabelle Salmon, MD, PhD5; Jacques Brotchi, MD, PhD1; and Marc Levivier, MD, PhD1 |
Active substance: Steripet |
Study summary document link (including results): pirotte-2004.pdf |
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Document reference: 48742 |
Study title: Dietlein M, Krug B, Groth W, Smolarz K, Scheidhauer K, Psaras T, et al.. Positron emission tomography using 18Ffluorodeoxyglucose in advanced stages of malignant melanoma: a comparison of ultrasonographic and radiological methods of diagnosis. [dietlein-1999]Nucl Med Commun. 1999 Mar;20(3):255-61. Dietlein M 1999 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48640 |
Study title: Dizendorf EV, Baumert BG, von Schulthess GK, Lütolf UM, Steinert HC.. Impact of whole-body 18F-FDG PET on staging and managing patients for radiation therapy. [dizendorf-2003]J Nucl Med. 2003 Jan;44(1):24-9. Dizendorf EV 2003 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48641 |
Study title: Effect of Whole-Body 18F-FDG PET Imaging on Clinical Staging and Management of Patients with Malignant LymphomaJ Nucl Med 2001; 42:1139–1143. Heiko Scho¨der, Joubin Meta, Cecilia Yap, Maryam Ariannejad, Jyotsna Rao, Michael E. Phelps, Peter E. Valk, Jim Sayre, and Johannes Czernin |
Active substance: Steripet |
Study summary document link (including results): schoder-2001.pdf |
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Document reference: 48745 |
Study title: Treatment of IDJWI Island endemic goiter by iodized oil; F. Delange. In. Endemic goiter. J.B Stanbury Ed. Pan American Health Organization. Scientific publication n° 193 : 118-131, 1968Treatment of IDJWI Island endemic goiter by iodized oil; F. Delange. In. Endemic goiter. J.B Stanbury Ed. Pan American Health Organization. Scientific publication n° 193 : 118-131, 1968 |
Active substance: IODINE |
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Document reference: 30341 |
Study title: Uptake of Lipiodol(trademark) -cytotoxic conjugates by hepatoblastoma cells. ;Towu-E. British Journal of Surgery, 2002, Vol/Iss/Pg. 89/4 (437-441)Uptake of Lipiodol(trademark) -cytotoxic conjugates by hepatoblastoma cells. ;Towu-E. British Journal of Surgery, 2002, Vol/Iss/Pg. 89/4 (437-441) |
Active substance: IODINE |
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Document reference: 30343 |
Study title: Use of lipiodol, an iodinated oil preparation, in regions with moderate iodine deficiency. ; Sviridenko-Yu-N. Problemy Endokrinologii, 1995, Vol/Iss/Pg. 41/6 (8-11)Use of lipiodol, an iodinated oil preparation, in regions with moderate iodine deficiency. ; Sviridenko-Yu-N. Problemy Endokrinologii, 1995, Vol/Iss/Pg. 41/6 (8-11) |
Active substance: IODINE |
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Document reference: 30344 |
Study title: A bi-centre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 150 mg I/ml and 270 mg I/ml and iohexal (Omnipaque) 140 mg I/ml and 300 mg I/ml Report DXC064 (date Jun 1999) |
Active substance: IODIXANOL |
Study summary document link (including results): DXC064 Redacted.pdf |
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Document reference: 48211 |
Study title: A comparison of iopromide and iopamidol in CT scanning of pediatric patientsJ Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J. |
Active substance: IODIXANOL |
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Document reference: 30380 |
Study title: A PHASE IV, OPEN-LABEL, MULTI-CENTER COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF KEPPRA. AS ADJUNCTIVE THERAPY IN ADULT PATIENTS WITH UNCONTROLLED PARTIAL EPILEPSY. S.K.A.T.E. : SAFETY OF KEPPRA. AS ADJUNCTIVE THERAPY IN EPILEPSY. |
Active substance: levetiracetam |
Study summary document link (including results): N01031 - Levetiracetam - RRCE04G2602.pdf |
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Document reference: 41540 |
Study title: ANWENDUNG DER IN DEUTSCHLAND ZUGELASSENEN KEPPRA(R) - TABLETTEN ALS ZUSATZBEHANDLUNG BEI ERWACHSENEN PATIENTEN MIT FOKALEN EPILEPSIEN. |
Active substance: levetiracetam |
Study summary document link (including results): ARVD02L1406 - Levetiracetam.pdf |
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Document reference: 41539 |
Study title: BRIDGING STUDY OF L059 (LEVETIRACETAM) IN PATIENTS WITH EPILEPSY BY DOUBLE BLIND METHOD. |
Active substance: levetiracetam |
Study summary document link (including results): N165 - Levetiracetam - RRCE04C3001.pdf |
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Document reference: 41541 |
Study title: A study to compare the efficacy and safety of 0.0625% Levobupivacaine, 1 IJg.mr1 fentanyl, 0.0625% levobupivacaine plus1 IJg.mr1 fentanyl and 0.125% Levobupivacaine when administered as an extradural infusion in paediatric patients undergoing elective abdominal or urological surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30716.pdf |
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Document reference: 47651 |
Study title: Reflex sympathetic dystrophy associated with deep peroneal nerve entrapment.Para no E. Pavone V. Greco F. Majorana M. Trifiletti RR. Brain Dev 1998 Mar;20(2):80-2 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48509 |
Study title: Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44556 |
Study title: Technetium-99 m-MDP scintigraphy and long-term follow-up of musculoskeletal sarcoma reconstructed with pasteurized autologous bone graft.Ahmed AR. Arch Orthop Trauma Surg 2009;129:475-482 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48524 |
Study title: Thallium-201 scintigraphy in childhood osteosarcoma: Comparison with Technituim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response.Ilhan IE, Gulin V, Berberoglu S, Kapucuoglu N, Cila A, Eke S. Quantitative Hematol Oncol 2005;22(2):153-62 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48725 |
Study title: Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yieldBarai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. J Postgrad Med 2004a Jul-Sep;50(3):180-3; discussion 183-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48562 |
Study title: The role of 99Tcmsestamibi scintigraphy in the staging and prediction of the therapeutic response of stage IV neuroblastoma: comparison with 131I-MIBG and 99Tcm-MDP scintigraphy.Burak Z, Yuksel DA, Cetingul N, Kantar M, Ozkilic H, Moretti JL. Nucl Med Comm 1999; 20(11):991-1000. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48586 |
Study title: The role of ultrasound and isotope scanning in the management of irritable hipsGopakumar TS. Vaishya R. Klenerman L. Carty H. Eur J Radiol 1992 Sep;15(2):113-7 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48484 |
Study title: Open, non-comparative study in the GI tract in children and infants to evaluate the suitability/tolerability of iohexol in the GI tract in infants/children by monitoring patient reactions, taste acceptance and visualization.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48885 |
Study title: Open, non-comparative study Myelography study: evaluate safety, tolerance and image quality of iohexol in pediatric use.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48884 |
Study title: Open, non-comparative study to evaluate the suitability/tolerability of iohexol in abdominal CT in infants/children by monitoring patient reactions, taste acceptance and image qualityApplicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48886 |
Study title: Paediatric angiocardiography with iohexol Invest Radiol 1985 Jan-Feb; 20(1 Suppl): S75-8 Carlsson EC 1985 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48854 |
Study title: Paediatric myelography with iohexol Paediatric radiology (1992), 22(4), 290-2. Fjelldal et al. Experiences with iohexol (Omnipaque) at urography Paediatric radiology (1987), 17(6), 491-2 Dube LJ 1987 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48857 |
Study title: Randomized double-blind, parallel study(open two-group comparison on consecutive patients) in pediatric angiography. Angiocardiography: the aim of the study was to compare iohexol to the best tolerated contrast medium in angiocardiography at present approved for routing use.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48883 |
Study title: Randomized, single-blind, parallel study in pediatric urography to study the safety, tolerance and radiographic properties of iohexol 300 mg I/ml compared to a conventional ionic CM, Urografin 290 mg I/ml, in pediatric urography.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48880 |
Study title: The use of low osmolality water soluble (LOWS) contrast media in the paediatric gastro-intestinal tract. A report of 115 examinations Paediatric radiology (1986), 16(1), 47-52 Ratcliffe JF 1986 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48864 |
Study title: Interferon gamma-1b (IF-RC 1001 XX G): Safety, Efficacy and Pharmaco- kinetics of 0.1 mg/sqm, 0.25 mg/sqm and 0.5 mg/sqm Interferon gamma-1b for 2 or more Weeks Sub- cutaneaously Administered to Patients with Lympho- mas, Plasmo- cytomas and Solid Tumors. |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30201 |
Study title: Post marketing surveillance study of Actimmune (recombinant human interferon gamma-Ib) in patients with chronic granulomatous disease. |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30190 |
Study title: The immunomodulatory impact of Imukin (IFNgamma-1b) on clinical and laboratory data in the treatment of atopic dermatitis. |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30204 |
Study title: Franzius C, Daldrup-Link HE, Wagner-Bohn A, Sciuk J, Heindel WL, Jurgens H, et al.. FDG-PET for detection of recurrences from malignant primary bone tumors: comparison with conventional imaging. [franzius-2002]Franzius C 2002. Ann Oncol. 2002 Jan;13(1):157-60 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48645 |
Study title: Franzius C, Schober O.. Assessment of therapy response by FDG PET in pediatric patients. [franzius-2003]Q J Nucl Med. 2003 Mar;47(1):41-5. Franzius C 2003 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48646 |
Study title: Friedberg JW, Fischman A, Neuberg D, Kim H, Takvorian T, Ng AK, et al.. FDG-PET is superior to gallium scintigraphy in staging and more sensitive in the follow-up of patients with de novo Hodgkin lymphoma: a blinded comparison. [friedberg-2004]Leuk Lymphoma. 2004 Jan;45(1):85-92. Friedberg JW 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48650 |
Study title: Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH.. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. [gaillard-1995]Neurology. 1995 Jan;45(1):123-6. Gaillard WD 1995 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48653 |
Study title: Hypothyroid patients showing shortened responsiveness to oral iodized oil have paradoxically low serum thyroglobulin and low thyroid reserve. Thyroglobulin/thyrotropin ratio as a measure of thyroid damage. ;Contempre-B. European Journal of Endocrinology, 1996, Vol/Iss /Pg. 134/3 (342-351)Hypothyroid patients showing shortened responsiveness to oral iodized oil have paradoxically low serum thyroglobulin and low thyroid reserve. Thyroglobulin/thyrotropin ratio as a measure of thyroid damage. ;Contempre-B. European Journal of Endocrinology, 1996, Vol/Iss /Pg. 134/3 (342-351) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30261 |
Study title: effects of self-applied topical fluoride preparations in orthodontic patients2000-alexander |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 2000-alexander-effects of self-applied topical fluoride preparations in orthodontic patients.pdf |
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Document reference: 49096 |
Study title: A 48-month survival analysis comparing sealant (Delton) with fluoride varnish (Duraphat) in 6-8 year old children1997-bravo |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1996-bravo-Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial.pdf |
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Document reference: 49122 |
Study title: A home care program of chemical preventive dentistry for orthodontic patients1973-landry |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1973-landry-a home care program of chemical preventive dentistry for orthodontic patients.pdf |
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Document reference: 49151 |
Study title: A three year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children1987-Lu, Journal of dentistry for children, July-August 1987 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1987-Lu-a three year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children.pdf |
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Document reference: 49083 |
Study title: Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients.Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Clin Nucl Med 1997 Aug;22(8):532-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48567 |
Study title: Use of 99m-Tc-MDP Spect for assessment of mandibular growth: development of normal values.Fahey FH, Abramson ZR, Padwa BL, Zimmerman RE, Zurakowski D, Nissenbaum M, et al. Eur J Nucl Med Mol Imaging 2010;37:1002-10. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48722 |
Study title: International Commission on Radiological Protection, Radiation Dose to Patients from RadiopharmaceuticalsICRP Pergamon Press 1998) - Publication 80 |
Active substance: Iobenguane |
Study summary document link (including results): ICPR-1998.pdf |
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Document reference: 48116 |
Study title: A case of postoperative recurrence of fibrolamellar hepatocellular carcinoma with increased vitamin B(12) binding capacity in a young Japanese female. ; Kanai-T. Japanese Journal of Clinical Oncology, 01 JUN 2004, Vol/Iss/Pg. 34/6 (346-351)A case of postoperative recurrence of fibrolamellar hepatocellular carcinoma with increased vitamin B(12) binding capacity in a young Japanese female. ; Kanai-T. Japanese Journal of Clinical Oncology, 01 JUN 2004, Vol/Iss/Pg. 34/6 (346-351) |
Active substance: IOBITRITOL |
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Document reference: 30213 |
Study title: Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361 |
Active substance: IOBITRITOL |
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Document reference: 30210 |
Study title: Results of the Safety and Efficiency of Iobitridol in more than 61,000 Patients; Petersein J. et al. / Eur Radiol (2003) 13: 2006-2011Results of the Safety and Efficiency of Iobitridol in more than 61,000 Patients; Petersein J. et al. / Eur Radiol (2003) 13: 2006-2011 |
Active substance: IOBITRITOL |
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Document reference: 30209 |
Study title: Safety of iobitridol in the general population and at-risk patients; Hammerstingl RM et al; Eur. Radiol.; 2006 vol.16 n.6 p.1288 1297Safety of iobitridol in the general population and at-risk patients; Hammerstingl RM et al; Eur. Radiol.; 2006 vol.16 n.6 p.1288 1297 |
Active substance: IOBITRITOL |
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Document reference: 30208 |
Study title: A case of undifferentiated sarcoma of the liver in which chemo- embolization with cisplatin-lipiodol suspension was effective. ; Araki-T. Japanese Journal of Clinical Radiology, 1994, Vol /Iss/Pg. 39/3 (419-422)A case of undifferentiated sarcoma of the liver in which chemo- embolization with cisplatin-lipiodol suspension was effective. ; Araki-T. Japanese Journal of Clinical Radiology, 1994, Vol /Iss/Pg. 39/3 (419-422) |
Active substance: IODINE |
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Document reference: 30214 |
Study title: Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283 |
Active substance: IOVERSOL |
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Document reference: 30409 |
Study title: Extrahepatic metastases of hepatocellular carcinoma; KATYAL S; Radiology; 2000 vol.216 p.698 703Extrahepatic metastases of hepatocellular carcinoma; KATYAL S; Radiology; 2000 vol.216 p.698 703 |
Active substance: IOVERSOL |
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Document reference: 30411 |
Study title: Intraarterial chemotherapy with Lipiodol for initially unresectable hepatoblastomas in children. ;Ogita-S. Regional Cancer Treatment, 1992, Vol/Iss/Pg. 5/3-4 (106-109)Intraarterial chemotherapy with Lipiodol for initially unresectable hepatoblastomas in children. ;Ogita-S. Regional Cancer Treatment, 1992, Vol/Iss/Pg. 5/3-4 (106-109) |
Active substance: IODINE |
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Document reference: 30267 |
Study title: Intrahepatic Arterial Injections of Cisplatin-Phosphatidylcholine-Lipiodol Suspension in Two Unresectable Hepatoblastoma Cases;Kohji Sue. Medical and Pediatric Oncology 17:496-500 (1989)Intrahepatic Arterial Injections of Cisplatin-Phosphatidylcholine-Lipiodol Suspension in Two Unresectable Hepatoblastoma Cases;Kohji Sue. Medical and Pediatric Oncology 17:496-500 (1989) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30268 |
Study title: Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135)Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30271 |
Study title: Fukuyama Y, Nihei K, Matsumoto S, Ebina T, Kamoshita S, Sato T et al. Brain and Development. 1987; 9(3):270-282. Clinical effects of MND-19 (inosiplexl on subacute sclerosing panencephalitis: a multi-institutional collaborative study.Fukuyama Y, Nihei K, Matsumoto S, Ebina T, Kamoshita S, Sato T et al. Brain and Development. 1987; 9(3):270-282. Clinical effects of MND-19 (inosiplexl on subacute sclerosing panencephalitis: a multi-institutional collaborative study. |
Active substance: INOSINE |
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Document reference: 30104 |
Study title: Gallais H, Kadio A, Odehouri K, Moreau J, Bertrand EDBulletin of the Society of Exotic Pathology. September- October, 1981; 74(5):553-561. . Effect of Isoprinosine in tropical measles: double-blind study (200 cases)Gallais H, Kadio A, Odehouri K, Moreau J, Bertrand EDBulletin of the Society of Exotic Pathology. September- October, 1981; 74(5):553-561. . Effect of Isoprinosine in tropical measles: double-blind study (200 cases) |
Active substance: INOSINE |
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Document reference: 30106 |
Study title: Gallet J-P. Bulletin Officiel du Ministere de la Sante [Official gazette of the Ministry ofHealth, Paris]. June 3, 1986; 86(19): 1-12. Expert Clinician in Pediatrics report. Endorsement report concerning double-blind study of Isoprinosine and a placebo for the treatment of severe or complicated measles Gallet J-P. Bulletin Officiel du Ministere de la Sante [Official gazette of the Ministry ofHealth, Paris]. June 3, 1986; 86(19): 1-12. Expert Clinician in Pediatrics report. Endorsement report concerning double-blind study of Isoprinosine and a placebo for the treatment of severe or complicated measles |
Active substance: INOSINE |
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Document reference: 30107 |
Study title: Shoulder Pain in a young break-dancer evaluated with bone scintigraphy.Khoury JJ, Laberant N, Jerushalmi J. Clin Nucl Med 2009;34:916-7 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48750 |
Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Moilanen et al. |
Active substance: testa triticum |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Testa triticum tricum_1.xlsx |
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Document reference: 49079 |
Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Moilanen et al. |
Active substance: testa triticum |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Testa triticum tricum_1.xlsx |
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Document reference: 49080 |
Study title: Skeletal scintigraphy of young patients with low-back pain and a lumbosacral transitional vertebra. Connolly LP, d'Hemecourt PA, Connolly SA, Drubach LA, Micheli LJ, Treves ST. J Nucl Med. 2003 Jun;44(6):909-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48842 |
Study title: Small rounded B-cell lymphoma of bone presented by limp, with a positive multifocal 99mTC MDP bone scintigraphy pattern and a negative 99mTc HMPAO-labled leukocytes studyPerez RH, Farto JCA, Arias IA, Regi AR, Vazquez JMP. J Pediatr Hematol Oncol 2008:30:443-446 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48753 |
Study title: Prediction of myocutaneous adverse side effect due to intra-arterial chemotherapy by intra-arterial (99m)Tc-macroaggregated albumin administration in patients with bone and soft-tissue tumors. J Nucl Med. 2002 Nov;43(11):1452-6. Taki J 2002 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48797 |
Study title: Prevalence of deep venous thrombosis in the lower limbs and the pelvis and pulmonary embolism in patients with positive antiphospholipid antibodies. Ann Nucl Med. 2001 Dec;15(6):495-7. Kinuya K 2001 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48799 |
Study title: Oral contrast agents for CT of abdominal trauma in pediatric patients : a comparison of dilute hypaque and water; HALSTED MJ; AJR; 2004 vol.182 p.1555 1559Oral contrast agents for CT of abdominal trauma in pediatric patients : a comparison of dilute hypaque and water; HALSTED MJ; AJR; 2004 vol.182 p.1555 1559 |
Active substance: IOVERSOL |
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Document reference: 30421 |
Study title: A controlled clinical comparison of nasal decongestants in acute rhinitis.Curr Ther Res 1966; 8: 91-3, Haines HL., 1966 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48916 |
Study title: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel W, Taminiau J, Benninga M. Gut. 2004 Nov;53(11):1590-4.PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel W, Taminiau J, Benninga M. Gut. 2004 Nov;53(11):1590-4. |
Active substance: LACTULOSE |
Study summary document link (including results): |
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Document reference: 30998 |
Study title: Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.Rendeli C, Ausili E, Tabacco F, Focarelli B, Pantanella A, Di Rocco C, Genovese O, Fundarò C. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1259-65.Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.Rendeli C, Ausili E, Tabacco F, Focarelli B, Pantanella A, Di Rocco C, Genovese O, Fundarò C. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1259-65. |
Active substance: LACTULOSE |
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Document reference: 30995 |
Study title: The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7.The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7. |
Active substance: LACTULOSE |
Study summary document link (including results): |
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Document reference: 31000 |
Study title: A Multi-Center, Double-blind, Placebo-controlled, Parallel Evaluation of LAMICTAL as Add-on Therapy with Valproic Acid for the Treatment of Generalized Seizures in Paediatric and Adult Patients. |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Study SCAA3001-Lamotrigine.xls |
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Document reference: 31009 |
Study title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures [Data from the Open-label Continuation Phase] |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Lamotrigine-Lamotrigine-LAM40097-ICHE3.pdf |
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Document reference: 31007 |
Study title: A multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of lamotrigine in subjects with neuropathic pain and inadequate pain relief with gabapentin, tricyclic antidepressants or non-narcotic analgesics. |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Lamotrigine-Lamotrigine-NPP30010-ICHE3.pdf |
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Document reference: 31008 |
Study title: Lamotrigine: a single-blind dose-ranging study in patients with epilepsy. |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Lamotrigine-Lamotrigine-UK25-ICHE3.pdf |
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Document reference: 31010 |
Study title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY: 16-WEEK EVALUATION OF THE EFFICACY AND SAFETY OF LEVETIRACETAM (LEV) AS ADD-ON THERAPY IN ADULTS AND ADOLESCENTS OLDER THAN 16 YEARS SUFFERING FROM PARTIAL SEIZURES. |
Active substance: levetiracetam |
Study summary document link (including results): N01102 - Levetiracetam - RRCE05F1502.pdf |
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Document reference: 41537 |
Study title: A KOREAN OPEN-LABEL, MULTI-CENTER, COMMUNITY-BASED TRIAL ASSESSING THE EFFICACY AND SAFETY OF LEVETIRACETAM AS ADJUNCTIVE THERAPY IN ADULT SUBJECTS WITH UNCONTROLLED PARTIAL EPILEPSY FOR BRIDGING PURPOSE WITH A SIMILAR STUDY ON CAUCASIAN EPILEPTIC SUBJECTS. |
Active substance: levetiracetam |
Study summary document link (including results): N01099 - Levetiracetam - RRCE05B2803.pdf |
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Document reference: 41536 |
Study title: Caries inhibition of mixed NaF-Na2PO3F dentifrices containing 1000 and 2500 ppmF1988-Ripa- JADA Volume 116, January 1988 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1988-Ripa-caries inhibition of mixed NaF-Na2PO3F dentifrices containing 1000 and 2500 ppmF.pdf |
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Document reference: 49084 |
Study title: Caries preventive effect of fluoride varnish application performed two or four times a year1990-seppa |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1990-seppa-Caries preventive effect of fluoride varnish application performed two or four times a year.pdf |
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Document reference: 49115 |
Study title: Pulmonary scintigraphic findings in children with pectus excavatum by the comparison of chest radiograph indices. Clin Nucl Med. 1992 Nov;17(11):874-6 Kao CH 1992 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48820 |
Study title: Guidelines for paediatric bone scanning with 99mTc-labelled radiopharmaceuticals and 18F-fluoride. Stauss J, Hahn K, Mann M, De Palma D. Eur J Nucl Med Mol Imaging. (8 pages) Published online: www.eanm.org/scientific_info/guidelines/EJNMMI_Bone_Scintigraphy_in_Children.pdf |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48759 |
Study title: Renal uptake on lung perfusion scintigraphy in a patient with primary pulmonary hypertension. Clin Nucl Med. 2005 May;30(5):329-30. Kaya M 2005 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48792 |
Study title: Reversed intrapulmonary right-to-left shunt after banding of the patent ductus venosus. Clin Nucl Med. 2003 Oct;28(10):827-33. Suga K 2003 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48795 |
Study title: Spontaneous abrupt changes in the distribution of ventilation: a cause for apparent mismatching on ventilation/perfusion scintigraphy. Br J Radiol. 1989 Jun;62(738):536-43. Peters AM 1989 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48825 |
Study title: Tc-99m MAA perfusion lung scanning in hepatopulmonary syndrome. Clin Nucl Med. 1999 Aug;24(8):616-7. Nishiyama Y 1999 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48808 |
Study title: Chapter 7: Radionuclide techniques. In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA.Schneider R. Elsevier Saunders; 2005:86-117 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48515 |
Study title: Clinical note: Double-blind comparison of the duration of effect of oxymetazoline and phenylephrine in children..Ann Allergy 1966; 24: 250-1, Neidorff AH., 1966 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48919 |
Study title: En klinisk prövning av näsdroppar för spädbarn. (Clinical trials of nosedrops for infants).Z Allg Med 1974; 11: 535-7, Rüggeberg F., 1974 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48926 |
Study title: Evaluation of oxymetazoline paediatric in the treatment of congestion.J Matern Child Health 1976; 1: 32-3, Cannon NL., Dalgleisch J., Franks HL. et al., 1976 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48920 |
Study title: Compare the effect of treatment with penicillin V in children with AOM for 5 and 10 days respectively and to investigate whether a higher dose of penicillin V is associated with a beneficial result.Ingvarsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_11.xlsx |
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Document reference: 49042 |
Study title: Gaillard WD. Ment Retard Dev Disabil Res. Structural and functional imaging in children with partial epilepsy. [gaillard-2000]Rev. 2000;6(3):220-6. Gaillard WD 2000 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48654 |
Study title: Holm S, Borgwardt L, Loft A, Graff J, Law I, Højgaard L. Paediatric doses – a critical appraisal of the EANM paediatric dosage card. [holm-2007]Eur J Nucl Med Mol Imaging 2007; 34 : 1713 - 1718. Holm S 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48659 |
Study title: Hutchings M, Mikhaeel NG, Fields PA, Nunan T, Timothy AR.. Epub 2005 Jun 6. Prognostic value of interim FDG-PET after two or three cycles of chemotherapy in Hodgkin lymphoma. [hutchings-2005]Ann Oncol. 2005 Jul;16(7):1160-8. Hutchings M 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48661 |
Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFOXITIN/DOXYCYCLINE OR CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
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Document reference: 42626 |
Study title: Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse1987-seppa, Caries Res. 1987:21: 375-379 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1987-seppa-Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse.pdf |
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Document reference: 49114 |
Study title: Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420)Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420) |
Active substance: IODINE |
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Document reference: 30304 |
Study title: Preliminary experience with arterial chemoembolization for hepatoblastoma and hepatocellular carcinoma in children. ;Czauderna-P. Pediatric Blood and Cancer, 2006, Vol/Iss/Pg. 46/7 (825-828)Preliminary experience with arterial chemoembolization for hepatoblastoma and hepatocellular carcinoma in children. ;Czauderna-P. Pediatric Blood and Cancer, 2006, Vol/Iss/Pg. 46/7 (825-828) |
Active substance: IODINE |
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Document reference: 30306 |
Study title: Preoperative Chemoembolization for Hepatocellular Carcinoma.02/12/2010Mario Morino. Journal of Surgical Oncology Supplement 3:91-93 (1993)Preoperative Chemoembolization for Hepatocellular Carcinoma.02/12/2010Mario Morino. Journal of Surgical Oncology Supplement 3:91-93 (1993) |
Active substance: IODINE |
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Document reference: 30307 |
Study title: Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630)Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630) |
Active substance: IODINE |
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Document reference: 30308 |
Study title: Preoperative Porgal Vein Embolization for Extension of Hepatectomy Indications.;Thierry de Baere. Hepatology Vol. 24, No. 6, 1996.Preoperative Porgal Vein Embolization for Extension of Hepatectomy Indications.;Thierry de Baere. Hepatology Vol. 24, No. 6, 1996. |
Active substance: IODINE |
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Document reference: 30309 |
Study title: Preparation of two dosage forms containing antitumor prostaglandin and their antitumor effect in vitro and in vivo: Lipiodol solution for I.A. administration and lipid microspheres for I.P. or I.V. administration.;Fukushima Shoji. Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation and Radiation Injury 2, Edited by K.V. Honn et al., Plenum Press, New York 1997Preparation of two dosage forms containing antitumor prostaglandin and their antitumor effect in vitro and in vivo: Lipiodol solution for I.A. administration and lipid microspheres for I.P. or I.V. administration.;Fukushima Shoji. Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation and Radiation Injury 2, Edited by K.V. Honn et al., Plenum Press, New York 1997 |
Active substance: IODINE |
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Document reference: 30310 |
Study title: Cherubism: diagnostic imaging and review of the literature in JapanHitomi G. Nishide N. Mitsui K. Ora l Surg Oral Med Oral Pathol Oral Radial Endod 1996 May;81(5):623-8 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48487 |
Study title: Use of macroaggregated albumin lung perfusion scan to diagnose hepatopulmonary syndrome: a new approach. Gastroenterology. 1998 Feb;114(2):305-10. Abrams GA 1998 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48812 |
Study title: Double-blinded, Randomized parallel groups design trial, the primary objective of the study was to evaluate the taste of two formulations of phenoxymethylpenicillin suspension in children. The secondary objectives were to study age-related differences in taste perception, to evaluate the acceptability of the suspensions, and to determine patient compliance.Bagger-Sjöbäck et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_12.xlsx |
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Document reference: 49043 |
Study title: Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893)Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893) |
Active substance: IODINE |
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Document reference: 30217 |
Study title: Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801)Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801) |
Active substance: IODINE |
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Document reference: 30218 |
Study title: Koga H, Sasaki M, Kuwabara Y, Nakagawa M, Hayashi K, Kaneko K, et al.. Lesion detectability of a gamma camera based coincidence system with FDG in patients with malignant tumors: a comparison with dedicated positron emission tomography. [koga-2004]Ann Nucl Med. 2004 Apr;18(2):131-6. Koga H 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48669 |
Study title: Kostakoglu L, Leonard JP, Kuji I, Coleman M, Vallabhajosula S, Goldsmith SJ.. Comparison of fluorine-18 fluorodeoxyglucose positron emission tomography and Ga-67 scintigraphy in evaluation of lymphoma. [kostakaglu-2002]Cancer. 2002 Feb 15;94(4):879-88. Kostakoglu L 2002 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48670 |
Study title: Lamusuo S, Ruottinen HM, Knuuti J, Härkönen R, Ruotsalainen U, Bergman J, et al.. Comparison of [18F]FDGPET, [99mTc]-HMPAO-SPECT, and [123I]-iomazenil-SPECT in localising the epileptogenic cortex. [lamusuo-1997]J Neurol Neurosurg Psychiatry. 1997 Dec;63(6):743-8. Lamusuo S 1997 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48672 |
Study title: Lassmann M, Biassoni L, Monsieurs M, Franzius C, Jacobs F, EANM Dosimetry and Paediatrics Committees.. The new EANM paediatric dosage card. [lassman-2007]Eur J Nucl Med Mol Imaging 2007; 34:796–798. Lassmann M 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48673 |
Study title: Galli V, Canonaco F, Rozzi N.(1980) Clinica Pediatrica.; 62:1-11. Therapy with methisoprinol in pediatric pathologiesGalli V, Canonaco F, Rozzi N.(1980) Clinica Pediatrica.; 62:1-11. Therapy with methisoprinol in pediatric pathologies |
Active substance: INOSINE |
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Document reference: 30109 |
Study title: Gascon G, Yamani S, Crowell J, Stigsby B, Nester M, Kanaan I, Jallu A. Brain Dev. 1993 Sep-Oct;15(5):346-55. Combined oral isoprinosine-intraventricular alpha-interferon therapy for subacute sclerosing panencephalitis.Gascon G, Yamani S, Crowell J, Stigsby B, Nester M, Kanaan I, Jallu A. Brain Dev. 1993 Sep-Oct;15(5):346-55. Combined oral isoprinosine-intraventricular alpha-interferon therapy for subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30110 |
Study title: Gascon GG, Yamani S, Cafege A, Flock L, al-Sedairy S, Parhar RS, Crowell J, Nester M, Kanaan I, Jallu MA. Ann Neurol. 1991 Aug;30(2):227-8. Treatment of subacute sclerosing panencephalitis with alpha interferon.Gascon GG, Yamani S, Cafege A, Flock L, al-Sedairy S, Parhar RS, Crowell J, Nester M, Kanaan I, Jallu MA. Ann Neurol. 1991 Aug;30(2):227-8. Treatment of subacute sclerosing panencephalitis with alpha interferon. |
Active substance: INOSINE |
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Document reference: 30111 |
Study title: Ginsberg T. Third Int Symposium on SSPE, India 30-31 Oct 1989. Isoprinosine in subacute sclerosing panencephalitis: Confirmation and extension of beneficial clinical results in the US and Canada by a recent study in Japan.Ginsberg T. Third Int Symposium on SSPE, India 30-31 Oct 1989. Isoprinosine in subacute sclerosing panencephalitis: Confirmation and extension of beneficial clinical results in the US and Canada by a recent study in Japan. |
Active substance: INOSINE |
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Document reference: 30113 |
Study title: Grasso E. (1979) Isoprinosina; April 28,; Rome, Italy; 87-93. Isoprinosina treatment in viral mononucleosis and epidemic parotitis [in English]. Presented at del Convegno Internazionale sullaGrasso E. (1979) Isoprinosina; April 28,; Rome, Italy; 87-93. Isoprinosina treatment in viral mononucleosis and epidemic parotitis [in English]. Presented at del Convegno Internazionale sulla |
Active substance: INOSINE |
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Document reference: 30114 |
Study title: Randomized clinical trial comparing different iodine interventions in school children. ; Zhao-J. Public Health Nutrition, 1999, Vol/Iss/Pg. 2/2 (173-178)Randomized clinical trial comparing different iodine interventions in school children. ; Zhao-J. Public Health Nutrition, 1999, Vol/Iss/Pg. 2/2 (173-178) |
Active substance: IODINE |
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Document reference: 30320 |
Study title: Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795).Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795). |
Active substance: IODINE |
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Document reference: 30321 |
Study title: Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S.Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S. |
Active substance: IODINE |
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Document reference: 30322 |
Study title: Comparison of bone and gallium-67 imaging in heroin users' arthritis.Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. J Nucl Med 1985 Dec;26(12):1377-81. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48572 |
Study title: Comparison of planar scintigraphy alone and with SPECT for the initial evaluation of femoral neck stress fracture.Bryant LR, Song WS, Banks KP, Bui-Mansfield LT, Bradley YC. AJR 2008;191:1010-1015. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48584 |
Study title: Hip pain in an 18-year-old manRajaram A, Tamurian RM, Reith JD, Bush CH. Clin Orthop Relat Res 2008;466:248-54 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48754 |
Study title: A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip.Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, et al. Clin Pediatr 1988 Apr;27(4):175-81. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48527 |
Study title: A report of two cases of brucellar sacroiliitis without systematic manifestations in GreeceThoma S, Patsiogiannis N, Dempegiotis P, Filiopoulos K. J Pediatr Orthop 2009 29:375-79 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48761 |
Study title: DECREASED TRACER UPTAKE IN BONE TISSUE IN PAEDIATRIC REFLEX SYMPATHETIC DYSTROPHYX. Le Loet, J. Lefort, A. Daragon, B. Derumeaux, P. Deshayes Rheumatology Department, La Prévotière, Hôpital de Bois Guillaume, BP 100, F 76230 Bois Guillaume |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48845 |
Study title: Äthiopathogenese und Therapie der Jodmangelstruma, Gärtner, R.; Z. ärtzl. Fortbildung 89, 27-31, 1995Äthiopathogenese und Therapie der Jodmangelstruma, Gärtner, R.; Z. ärtzl. Fortbildung 89, 27-31, 1995 |
Active substance: IODINE |
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Document reference: 30220 |
Study title: Combined fibrolamellar carcinoma and cholangiocarcinoma exhibiting biphenotypic antigen expression: a case report; K. Tanaka. J Clin Pathol 2005;58:884-887.Combined fibrolamellar carcinoma and cholangiocarcinoma exhibiting biphenotypic antigen expression: a case report; K. Tanaka. J Clin Pathol 2005;58:884-887. |
Active substance: IODINE |
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Document reference: 30225 |
Study title: Pediatric hepatic CT : an injection protocol;ROCHE KJ; Pediatr. Radiol.; 1996 vol.26 p.502 507Pediatric hepatic CT : an injection protocol;ROCHE KJ; Pediatr. Radiol.; 1996 vol.26 p.502 507 |
Active substance: IOVERSOL |
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Document reference: 30422 |
Study title: Iodized oil in the prophylaxis of endemic goiter in Argentina;Tomas Watanabe. Reprint from Endemic Goiter and cretinism: continuing threats to world health PAHO scientific publication 292, 1974: 231-240 Iodized oil in the prophylaxis of endemic goiter in Argentina;Tomas Watanabe. Reprint from Endemic Goiter and cretinism: continuing threats to world health PAHO scientific publication 292, 1974: 231-240 |
Active substance: IODINE |
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Document reference: 30276 |
Study title: J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH. J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH. |
Active substance: IODINE |
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Document reference: 30345 |
Study title: J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. |
Active substance: IODINE |
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Document reference: 30346 |
Study title: Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma? ; Ngan-H. British Journal of Radiology, 1990, Vol/Iss/Pg. 63/754 (771-775)Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma? ; Ngan-H. British Journal of Radiology, 1990, Vol/Iss/Pg. 63/754 (771-775) |
Active substance: IODINE |
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Document reference: 30281 |
Study title: Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series. ; Lucena-de-la-Poza-J-L. Transplantation Proceedings, 2002, Vol/Iss/Pg. 34/1 (260-261)Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series. ; Lucena-de-la-Poza-J-L. Transplantation Proceedings, 2002, Vol/Iss/Pg. 34/1 (260-261) |
Active substance: IODINE |
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Document reference: 30282 |
Study title: Clinical evaluations on the biocompatibility- Valutazioni cliniche sulla biocompatibilitaGatto 1989 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Gatto 1989 Valutazioni cliniche sulla biocompatibilita.pdf |
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Document reference: 49167 |
Study title: Comments on the biocompatibility - Osservazioni sulla biocompatibilitaGallusi 1988 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Gallusi 1988 Osservazioni sulla biocompatibilita.pdf |
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Document reference: 49165 |
Study title: Comparision of a single application of stannous fluoride with a single application of sodium fluoride or two applications of stannous fluoride1961-Mercer |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1961-Mercer-Comparision of a single application of stannous fluoride with a single application of sodium fluoride or two applications of stannous f... |
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Document reference: 49141 |
Study title: Comparision of three self applied topical fluoride preparationsfor control of decalcification1993-boyd |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1993-boyd - comparision of three self applied topical fluoride preparationsfor control of decalcification.pdf |
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Document reference: 49156 |
Study title: Comparison of three prevention programs -Vergleich dreier Prophylaxe ProgrammeBüttner 1987 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Büttner 1987 Vergleich dreier Prophylaxe Programme.pdf |
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Document reference: 49159 |
Study title: Han CY, Lin HF, Shin PY, Liu CK, Liu CS. Kaohsiung J Med Sci. 2003 Aug;19(8):416-20. Combined interferon-alpha and inosiplex treatment of subacute sclerosing panencephalitis: a case report Han CY, Lin HF, Shin PY, Liu CK, Liu CS. Kaohsiung J Med Sci. 2003 Aug;19(8):416-20. Combined interferon-alpha and inosiplex treatment of subacute sclerosing panencephalitis: a case report |
Active substance: INOSINE |
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Document reference: 30118 |
Study title: Himawan T, Kho LKAbstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 64. Experiences in the treatment of dengue hemorrhagic fever with Isoprinosine.Himawan T, Kho LKAbstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 64. Experiences in the treatment of dengue hemorrhagic fever with Isoprinosine. |
Active substance: INOSINE |
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Document reference: 30119 |
Study title: Horiguchi Y, Ohya T. No To Hattatsu. 1995 May;27(3):231-7. Successful treatment of subacute sclerosing panencephalitis with long-term intrathecal large dose of alpha-interferon--a case reportHoriguchi Y, Ohya T. No To Hattatsu. 1995 May;27(3):231-7. Successful treatment of subacute sclerosing panencephalitis with long-term intrathecal large dose of alpha-interferon--a case report |
Active substance: INOSINE |
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Document reference: 30120 |
Study title: Hosoya M, Shigeta S et alAntimicrob Agents Chemother Mar 2001;45(3):943-5. High-dose intravenous ribavirin therapy for subacute sclerosing panencephalitis.Hosoya M, Shigeta S et alAntimicrob Agents Chemother Mar 2001;45(3):943-5. High-dose intravenous ribavirin therapy for subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30121 |
Study title: Hypertrophic osteoarthropathy in a child with follicular bronchiolitis.Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Clin Nucl Med 1995 Jan;20(1):49- 51. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48574 |
Study title: Diffuse hepatic uptake of technetium-99m methylene diphosphonate in a patient receiving high dose methotrexate.Flynn BM. Treves ST. J Nucl Med 1987 Apr;28(4):532-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48482 |
Study title: Does I- 131-MIBG underestimate skeletal disease burden in neuroblastoma?Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. J Postgrad Med 2004b Oct-Dec;50(4):257-61. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48563 |
Study title: Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia.Batte WG Jr., Yeh SD, Rosenblum MK, Larson SM. Clin Nucl Med 1991 Jun;16(6):421-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48566 |
Study title: Intraoperative radionuclide detection in the treatment of paediatric osteoid osteoma.M. Lacheretz, B. Herbaux, C. Hossein-Foucher, P. Lecouffe, M. Richir. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48844 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44191 |
Study title: Bandopadhyaya G. Malhotra A. Soft tissue uptake of Tc99m-MDP in acute lymphoblastic leukemia.Marwah A. Kumar R. Dasan J B. Choudhury S. Bandopadhyaya G. Malhotra A. Cl in Imaging 2002 May-Jun;26(3):206-8 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48505 |
Study title: Vergleichende Doppel-Blindprüfung zwischen Neseril™, einem neuen Nasentropfenpräparat, und Ephedrin. (Comparative double-blind trial between Neseril™ (Nasivin), a new nasal-drop formulation, and ephedrine).Särtryck ur Svenska Läkartidningen 1964; 61: 3204-13, Thulin A, Walther BW., 1964 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48917 |
Study title: A study to test the efficacy of E45 Cream on nappy rash |
Active substance: LANOLIN SOFT PARAFFIN AND FAT PRODUCTS |
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Document reference: 31012 |
Study title: Efficacy and tolerability of lactitol solution versus lactulose syrup in patients (children) suffering from chronic functional constipation. Investigator: Dr. Med. A.C. Douwes Report date: 04.11.1996 |
Active substance: LANREOTIDE |
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Document reference: 31014 |
Study title: Evaluation of the efficacy and safety of Somatuline sustained release form in adolescent with constitutive tall stature |
Active substance: LANREOTIDE |
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Document reference: 31013 |
Study title: A double blind, multi-centre, randomised, placebo-controlled study to assess the efficacy,tolerability and compliance profile of a triple therapy regimen (lansoprazole, amoxicilline and tinidazole) in comparison with the standard double therapy (amoxicilline and tinidazole), given for one week to children with Hpylori gastritis. |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_HP-AG-97-01-EC428-Synopsis.pdf |
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Document reference: 47614 |
Study title: A phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in neonates with clinically-evident GERD |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_c03-042-synopsis.pdf |
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Document reference: 47606 |
Study title: A Phase II, open-label, parallel group, 8-12 weeks study to assess the safety and efficacy of once daily administration of lansoprazole 15 mg or 30 mg in male and female adolescents aged 12 to 17 years with GERD including non-erosive GERD and erosive oesophagitis. |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_M00-158-Synopsis.pdf |
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Document reference: 47613 |
Study title: A phase II, two-centre, open-label study in patients aged 3 months to 13 years with endoscopically-proven reflux oesophagitis. |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_AG-II-95-028-Synopsis.pdf |
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Document reference: 47610 |
Study title: Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900)Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900) |
Active substance: IODINE |
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Document reference: 30314 |
Study title: Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650)Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650) |
Active substance: IODINE |
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Document reference: 30315 |
Study title: Pulmonary lipiodol embolism during transcatheter arterial chemoembolization for hepatoblastoma under general anaesthesia. Yamaura-K. European Journal of Anaesthesiology 2000, Vol /Iss/Pg. 17/11 (704-708)Pulmonary lipiodol embolism during transcatheter arterial chemoembolization for hepatoblastoma under general anaesthesia. Yamaura-K. European Journal of Anaesthesiology 2000, Vol /Iss/Pg. 17/11 (704-708) |
Active substance: IODINE |
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Document reference: 30317 |
Study title: A multicenter European randomized parallel-group phase III study to evaluate safety and efficacy of rHuG-CSF (lenograstim) in the first 12 weeks of the treatment of de novo severe aplastic anemia - 1998 (Blood, 92 (10) suppl 1 : abs 1551, p 376 a) |
Active substance: LENOGRASTIM |
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Document reference: 31028 |
Study title: A multicenter non-randomized open-label dose-escalating phase I-II study (pharmakokinetic and dose-ranging) of intravenous or subcutaneous administration of rG-CSF for a maximum of 21 days to reduce duration of neutropenia in children having received COPAdM1 and / or COPAdM2 chemotherapy course for advanced lymphoma |
Active substance: LENOGRASTIM |
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Document reference: 31029 |
Study title: A Phase III multicenter, double blind, randomized, parallel-group, vehicle controlled study to evaluate the safety and efficacy of 5µg/kg/day recombinant Granulocyte Colony Stimulating Factor (rHuG-CSF) in the treatment of patients who have undergone bone marrow transplantation (BMT). |
Active substance: LENOGRASTIM |
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Document reference: 31030 |
Study title: An open label, multicenter study to evaluate the pharmacokinetics of 5uG / KG / day of recombinant granulocyte colony stimulating factor (rHuG-CSF) in the treatment of pediatric patients who have undergone bone marrow transplantation (BMT) - No author - No date - Clinical study documentation GHBA 271 study - Vol. 6 - |
Active substance: LENOGRASTIM |
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Document reference: 31031 |
Study title: Antilymphocyte globulin, cyclosporine, prednisolone, and granulocyte colony-stimulating factor for severe aplastic anemia: an update of the GITMO / EBMT study on 100 patients. European Group for Blood and Marrow Transplantation (EBMT) Working party on Severe Aplastic Anemia and the Gruppo Italiano Trapianti di Midolio Osseo (GITMO). - Bacigalupo A. et al - 2000 (Blood 95: 1931 - 1931) - Publication - Ref17 of Clinical Expert Report - |
Active substance: LENOGRASTIM |
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Document reference: 31032 |
Study title: Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology - Patte C. et al - 2002 (J Clin Oncol. Jan 15;20(2):441-8)Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology - Patte C. et al - 2002 (J Clin Oncol. Jan 15;20(2):441-8) |
Active substance: LENOGRASTIM |
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Document reference: 31039 |
Study title: Isotope bone scans in the assessment of children with hip pain or limp.Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Pediatr Radiol 1985;15(5):319-23. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48576 |
Study title: 99Tcm-MAA lung scintigraphy in patients with Behçet's disease: its value and correlation with clinical course and other diagnostic modalities. Nucl Med Commun. 2000 Feb;21(2):171-9. Caglar M 2000 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48804 |
Study title: Acute paraquat intoxication: using nuclear pulmonary studies to predict patient outcome. Chest. 1999 Sep;116(3):709-14. Kao CH 1999 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48806 |
Study title: Aspiration of nasal secretions into the lungs in patients with acute sinonasal infections. Laryngoscope. 2000 Jan;110(1):107-10. Ozagar A 2000 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48805 |
Study title: Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma.Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, et al. Ann Nucl Med 2005 Feb;19(1):35-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48521 |
Study title: Bilateral pulmonary artery aneurysms in a patient with Behcet syndrome: evaluation with radionuclide angiography and V/Q lung scanning. Clin Nucl Med. 1998 Nov;23(11):735-8. Basoglu T 1998 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48811 |
Study title: Clinical studies of alveolar-capillary permeability using technetium-99m DTPA aerosol. Ann Nucl Med. 1995 Nov;9(4):171-8. Sundram FX 1995 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48816 |
Study title: Correlation of diagnostic imaging and subsequent autopsy findings in patients with pulmonary embolism. Patriquin L, Khorasani R, Polak JF. AJR Am J Roentgenol. 1998 Aug;171(2):347-9 Comment in: AJR Am J Roentgenol. 1998 Aug;171(2):293. AJR Am J Roentgenol. 1999 Jun;172(6):1691-3. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48244 |
Study title: Evaluate in children the taste of two different phenoxymethylpenicillins, one containing aspartame.Norstedt |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_13.xlsx |
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Document reference: 49044 |
Study title: "Infantile anorexia treated with degreased whole bone substance", Vidal Perez Fernandez, Medicina, 1969, 49 : 169-171"Infantile anorexia treated with degreased whole bone substance", Vidal Perez Fernandez, Medicina, 1969, 49 : 169-171 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr1.xls |
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Document reference: 47590 |
Study title: Open-label, single-arm, multicenter study to evaluate the efficacy and tolerability of Creon for children in infants with pancreatic exocrine insufficiency caused by cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S248-3003.pdf |
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Document reference: 47673 |
Study title: Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8 Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33636 |
Study title: Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5)Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5) |
Active substance: NIFUROXAZIDE |
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Document reference: 47064 |
Study title: Phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in infants with clinically-evident GERD |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_c03-043-synopsis.pdf |
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Document reference: 47608 |
Study title: Assessment of the efficacy and safety of Somatuline sustained release form in adolescent with constitutive tall stature |
Active substance: LARATADINE |
Study summary document link (including results): |
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Document reference: 31020 |
Study title: Lee JK, Liu RS, Shiang HR, Pan DH.. Usefulness of semiquantitative FDG-PET in the prediction of brain tumor treatment response to gamma knife radiosurgery. [lee-2003]J Comput Assist Tomogr. 2003 Jul-Aug;27(4):525-9. Lee JK 2003 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48674 |
Study title: Modafinil-induced hippocampal activation in narcolepsyNeuroscience Letters 422 (2007) 91–96. Yu Kyeong Kima, In-Young Yoon b,∗, Yoon-Kyung Shin b, Sang Soo Choa, Sang Eun Kima. |
Active substance: Steripet |
Study summary document link (including results): kim-2007.pdf |
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Document reference: 48735 |
Study title: Natsume J, Kumakura Y, Bernasconi N, Soucy JP, Nakai A, Rosa P, et al.. Alpha-[11C] methyl-L-tryptophan and glucose metabolism in patients with temporal lobe epilepsy. [natsume-2003]Neurology. 2003 Mar 11;60(5):756-61. Natsume J 2003 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48681 |
Study title: Control of decalcification in orthodontic patients by daily self administered application of a water free 0.4 percent stannous fluoride gel1974-stratemann |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1974-stratemann - control of decalcification in orthodontic patients by daily self administered application of a water free 0.4 percent stannous fl... |
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Document reference: 49152 |
Study title: The caries inhibitory effect of a fluoride gel (PreviDent) ina self-brushing home based programm for shoolchildren1994-DePaola |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1994-DePaola-the caries inhibitory effect of a fluoride gel (PreviDent) ina self-brushing home based programm for shoolchildren.pdf |
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Document reference: 49095 |
Study title: The caries prophylactic effect of Fluorlack after years of use in paediatric/adolescent dental care: Karies prophylaktische Wirkung von Fluorlack nach mehrjahriger Anwendung in der Jugendzahnpflege1978-leiser |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1978-leiser-Karies prophylaktische Wirkung von Fluorlack nach mehrjahriger Anwendung in der Jugendzahnpflege.pdf |
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Document reference: 49104 |
Study title: The clinical anticariogenic effectiveness of supplementary fluoride vitamin preparations - result at the end of four yearsDavid K. Hennon, Georg K Stookey, Joseph C Muhler 1967. Journal of dentistry for children. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1967-hennon-Ciinical Anticariogenic Effectivenoss of Supplementary Fluoride-Vitamin Preparations-Results at the end of four years.pdf |
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Document reference: 48785 |
Study title: Correlation of pulmonary 99mTc-DTPA ventilation and 99mTc-MAA perfusion scans with pulmonary function tests in asymptomatic asthmatic children. Nucl Med Commun. 2003 Jul;24(7):819-24. Dai ZK 2003 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48796 |
Study title: Diffusing capacity is not measurably affected by routine lung perfusion scanning.Morris T A 1988, J Nucl Med. 1988 Jul;29(7):1268-71. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Morris 1988.pdf |
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Document reference: 48789 |
Study title: Bone imaging for lower extremity pain in athletes.Brill DR. Clin Nucl Med 1983 Mar;8(3):101-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48579 |
Study title: The Therapeutic Efficacy of Human Insulin (recombinant DNA) in Patients with Insulin-dependent Diabetes Mellitus: A Comparative Study with Purified Porcine Insulin |
Active substance: INSULIN (HUMAN) |
Study summary document link (including results): |
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Document reference: 30182 |
Study title: Use of Biosynthetic Human Insulin (BHI), Mixed Beef-Pork (MBP) or Purified Pork (PPI), NPH or Lente Alone, or in Combination with Neutral Regular Insulin in Type I and Type II Diabetic Patients |
Active substance: INSULIN (HUMAN) |
Study summary document link (including results): Human insulin - B5K-MC-IBAL redacted CSR.PDF |
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Document reference: 30185 |
Study title: A 24-week, randomised, multi-centre, open-labelled, parallel-group trial to investigate the safety of NN304 (insulin detemir) and Neutral protamine hagedorn (NPH) human insulin in children with type 1 diabetes on a basal-bolus regimen |
Active substance: insulin detemir |
Study summary document link (including results): NN304-1604 ICTR Synopsis.pdf |
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Document reference: 47337 |
Study title: A 32 Week, Open-labelled, Randomised, Cross-over Trial comparing Efficacy and Safety of Insulin Detemir and Insulin Semilente, both administered at bedtime, in Children, Adolescents and Young Adults with Type 1 Diabetes on Basal-Bolus Regimen, LPLV November 2005 |
Active substance: insulin detemir |
Study summary document link (including results): NN304-1630-synopsis.pdf |
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Document reference: 41576 |
Study title: Fone-scan-like pattern with 99TcM(V)-DMSA scintigraphy in patients with osteomalacia and primary hyperparathyroidism.Akbunar AT, Orhan B, Alper E. Nucl Med Commun 2000;21:181-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48525 |
Study title: "Oxybutynin Chlorhydrate for the Treatment of Urinary Incontinence and Hyperactive Bladder in Children. - Aubert D et al. - Ann Pediatr (Paris). 1986 (33 (7): 629-634) - Publication in UK registration file -" "Oxybutynin Chlorhydrate for the Treatment of Urinary Incontinence and Hyperactive Bladder in Children. - Aubert D et al. - Ann Pediatr (Paris). 1986 (33 (7): 629-634) - Publication in UK registration file -" |
Active substance: OXYBUTYNIN |
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Document reference: 32987 |
Study title: The comparative antipyretic efffect of N-acetyl-P-aminophenol and acetylsalicylic acid" - Margaret T. Colgan and A.A. Mitz, Houston, Texas, USA - The Journal of PediatricsThe comparative antipyretic efffect of N-acetyl-P-aminophenol and acetylsalicylic acid" - Margaret T. Colgan and A.A. Mitz, Houston, Texas, USA - The Journal of Pediatrics |
Active substance: PARACETAMOL |
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Document reference: 45755 |
Study title: Diffuse lymphatic dysplasia with hepatic oil embolism. Tatezawa-T. American Journal of Roentgenology, 1978, Vol/Iss/Pg. 131/5 (898-900)Diffuse lymphatic dysplasia with hepatic oil embolism. Tatezawa-T. American Journal of Roentgenology, 1978, Vol/Iss/Pg. 131/5 (898-900) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30230 |
Study title: Effect of intestinal parasite treatment on the efficacy of oral iodized oil for correcting iodine deficiency in schoolchildren. ; Furnee-C-A. American Journal of Clinical Nutrition, 1997, Vol/Iss /Pg. 66/6 (1422-1427)Effect of intestinal parasite treatment on the efficacy of oral iodized oil for correcting iodine deficiency in schoolchildren. ; Furnee-C-A. American Journal of Clinical Nutrition, 1997, Vol/Iss /Pg. 66/6 (1422-1427) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30232 |
Study title: Naumann R, Beuthien-Baumann B, Reiß A, Schulze J, Hänel A, Bredow J, et al.. Substantial impact of FDG PET imaging on the therapy decision in patients with early-stage Hodgkin's lymphoma. [naumann-2004]BrJ Cancer. 2004 Feb 9;90(3):620-5. Naumann R 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48682 |
Study title: Ng SH, Chang JT, Chan SC, Ko SF, Wang HM, Liao CT, et al.. Epub 2004 Mar 9. Nodal metastases of nasopharyngeal carcinoma: patterns of disease on MRI and FDG PET. [ng-2004-a]Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1073-80. Ng SH 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48684 |
Study title: Novak L, Emri M, Molnar P, Balkay L, Lengyel Z. Subcortical [18F]fluorodeoxyglucose uptake in lesional epilepsy in patients with intracranial tumour. [novak-2004]Tron L. Nucl Med Commun. 2004 Feb;25(2):123-8. Novak L 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48685 |
Study title: Nuclear Medicine in Pediatric Neurology and Neurosurgery: Epilepsy and Brain Tumors.Semin Nucl Med 37:357-381. Shekhar Patil, MD,* Lorenzo Biassoni, MD,† and Lise Borgwardt, MD, PhD |
Active substance: Steripet |
Study summary document link (including results): patil-2007.pdf |
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Document reference: 48741 |
Study title: Papathanassiou D, Becker S, Amir R, Menéroux B, Liehn JC.. Epub 2005 Aug 31. Respiratory motion artefact n the liver dome on FDG PET/CT: comparison of attenuation correction with CT and a caesium external source. [papathanassiou-2005]Eur J Nucl Med Mol Imaging. 2005 Dec;32(12):1422-8. Papathanassiou D 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48688 |
Study title: Picardi M, De Renzo A, Pane F, Nicolai E, Pacelli R, Salvatore M, et al.. Randomized comparison of consolidation radiation versus observation in bulky Hodgkin's lymphoma with post-chemotherapy negative positron emission tomography scans. [picardi-2007]Leuk Lymphoma. 2007 Sep;48(9):1721-7. Picardi M 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48689 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44113 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44190 |
Study title: So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9. So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43490 |
Study title: Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35. Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43948 |
Study title: Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available. Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44126 |
Study title: Ultrasonic signs of pelvic osteomyelitis in children. Mah ET, LeQuesne GW, Gent RJ, Paterson DC. Pediatr Radiol. 1994;24(7):484-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43639 |
Study title: Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31. Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43524 |
Study title: Raymond J, Dumas JM, Lisbona R. Nuclear imaging as a screening test for patients referred for intraarticular facet block. J Can Assoc Radiol. 1984 Sep;35(3):291-2. Raymond J, Dumas JM, Lisbona R. Nuclear imaging as a screening test for patients referred for intraarticular facet block. J Can Assoc Radiol. 1984 Sep;35(3):291-2. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43984 |
Study title: Reddy MS, Palcanis KG, Barnett ML, Haigh S, Charles CH, Jeffcoat MK. Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis. J Clin Periodontol. 1993 Oct;20(9):635-40. Reddy MS, Palcanis KG, Barnett ML, Haigh S, Charles CH, Jeffcoat MK. Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis. J Clin Periodontol. 1993 Oct;20(9):635-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43649 |
Study title: [Metastatic calcifications detected by Tc-99m MDP bone scanning in patients with hypercalcemia: case report] Japanese. Sugita R, Nakamura M, Sakamoto K, Watabe N. Rinsho Hoshasen. 1990 Mar;35(3):419-22. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43766 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44228 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44275 |
Study title: Prolonged low-back pain in young athletes: a prospective case series study of findings and prognosis. Kujala UM, Kinnunen J, Helenius P, Orava S, Taavitsainen M, Karaharju E. Eur Spine J. 1999;8(6):480-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43496 |
Study title: A randomized, double-blind, double dummy, parallel group comparison of fluticasone propionate inhalation powder (50mcg BID) via DiskusTM with oral montelukast (5mg QD) chewable tablets in children 6–12 years of age with persistent asthma |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FPD40013-ICHE3.pdf |
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Document reference: 28428 |
Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate 50 or 100mcg BID via the Multi-Dose Powder Inhaler, Fluticasone Propionate 50 or 100mcg BID via the Diskhaler and Placebo in Subjects Aged 4 to 11 Years with Chronic Asthma |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLTA2006-ICHE3.pdf |
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Document reference: 28423 |
Study title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 12-Week Trial of Inhaled Fluticasone Propionate 88mcg BID versus Placebo in Propellant GR106642X in Pediatric Subjects 4 to 11 Years of Age With Asthma |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FAP30010-ICHE3.pdf |
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Document reference: 28391 |
Study title: A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNS30003-ICHE3.pdf |
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Document reference: 28368 |
Study title: A Randomized, Open-Label, 2-Way Crossover, Repeat-Dose Study in Pediatric Subjects with Asthma, Age 4-11 Years, to Compare Systemic Exposure of Fluticasone Propionate 2x44mcg Following Administration by Metered-Dose Inhalers Containing Hydrofluoroalkane or Chlorofluorocarbon Propellants |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FAP10006-ICHE3.pdf |
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Document reference: 28417 |
Study title: A Randomized, Open-Label, 2-Way Crossover, Repeat-Dose Study in Pediatric Subjects with Asthma, Age 4-11 Years, to Compare Systemic Exposure of Fluticasone Propionate 2x44mcg Following Administration by Metered-Dose Inhalers Containing Hydrofluoroalkane or Chlorofluorocarbon Propellants |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FAP10006-ICHE3.pdf |
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Document reference: 28441 |
Study title: A single centre, randomised, double blind, cross over study to investigate longitudinal growth using knemometry in children with seasonal and perennial rhinitis during treatment with fluticasone propionate aqueous nasal spray (FPANS) 100mcg/day and placebo. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40181-ICHE3.pdf |
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Document reference: 28415 |
Study title: Comparison of fluticasone powder 1mg/day to budesonide powder 1mg/day in deterioration of severe asthma in children: a double-blind, randomised, multicentre study with parallel groups. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone -Propionate-FLPB0145-ICHE3.pdf |
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Document reference: 28404 |
Study title: Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41. Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44245 |
Study title: Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available. Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43437 |
Study title: ICRP (lnternation Commission on Radiological Protection). Publication 53: Radiation dose to patients from radiopharmaceuticals.ICRP (lnternation Commission on Radiological Protection). Publication 53: Radiation dose to patients from radiopharmaceuticals. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 47920 |
Study title: ICRP Publication 80: Radiation dose to patients from radiopharmaceuticals (Addendum to ICRP Publication 53)..ICRP Publication 80: Radiation dose to patients from radiopharmaceuticals (Addendum to ICRP Publication 53).. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 47921 |
Study title: Ikawa G, dos Santos PA, Yamaguchi KT, Stroh-Recor C, Ibello R. Frostbite and bone scanning: the use of 99m-labeled phosphates in demarcating the line of viability in frostbite victims. Orthopedics. 1986 Sep;9(9):1257-61. Ikawa G, dos Santos PA, Yamaguchi KT, Stroh-Recor C, Ibello R. Frostbite and bone scanning: the use of 99m-labeled phosphates in demarcating the line of viability in frostbite victims. Orthopedics. 1986 Sep;9(9):1257-61. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43897 |
Study title: A follow-up study using iodine-131 metaiodobenzylguanidine imaging in a patient with neuroblastoma. Ikekubo K, Habuchi Y, Jeong S, Yamaguchi H, Saiki Y, Ito H, Hino M, Higa T. Clin Nucl Med. 1986 Nov;11(11):777-80. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43888 |
Study title: Miraglia del Giudice et al On the use of an extemporary combination of ambroxol and beclometasone dipropionate by aerosol in childhood allergic asthma. Comparative measurements. Riv.Pat.Clin.Tuberc.Pneumol.1985,56,37-48RivPatClinTub Pneumol 1985, Miraglia del Giudice. RivPatClinTub Pneumol 1985, Miraglia del Giudice |
Active substance: AMBROXOL |
Study summary document link (including results): RivPatClinTub Pneumol 1985, Miraglia del Giudice.pdf |
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Document reference: 48875 |
Study title: Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German. Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43891 |
Study title: Quantitative sacroiliac joint scintigraphy in normal subjects and patients with sacroiliitis. Kaçar G, Kaçar C, Karayalçin B, Güngör F, Tuncer T, Erkiliç M. Ann Nucl Med. 1998 Jun;12(3):169-73. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43530 |
Study title: Evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate the short term efficiacy in the treatment of acute otitis media. The study was comparative against amoxycillin suspension.Bagger-Sjöbäck et al. (1986-11-28) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_19.xlsx |
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Document reference: 49018 |
Study title: Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available. Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43528 |
Study title: Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6. Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44042 |
Study title: Nishiyama Y, Yamamoto Y, Yokoe K, Kawaguchi Y, Toyama Y, Satoh K, Ohkawa M. A comparative study of 201Tl scintigraphy and three-phase bone scintigraphy following therapy in patients with bone and soft-tissue tumors. Ann Nucl Med. 2004 May;18(3):235-41. Nishiyama Y, Yamamoto Y, Yokoe K, Kawaguchi Y, Toyama Y, Satoh K, Ohkawa M. A comparative study of 201Tl scintigraphy and three-phase bone scintigraphy following therapy in patients with bone and soft-tissue tumors. Ann Nucl Med. 2004 May;18(3):235-41. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43402 |
Study title: Isotope scanning with Tc99m-MDP of the spine and the costosternal junctions of patients with idiopathic scoliosis. Normelli H, Lewander R. Acta Radiol Diagn (Stockh). 1985 Jul-Aug;26(4):397-401. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43936 |
Study title: "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. " "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. " |
Active substance: FOMEPIZOLE |
Study summary document link (including results): |
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Document reference: 28468 |
Study title: A 12 month multi-center, randomized, dbdd trial to examine the long-term tolerability of formoterol 1mg via the mddpi, both as b.i.d maintenance therapy and as on-demand-use on top of maintenane, in patients with persistent asthma. |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47791 |
Study title: A 12 week randomized, double-blind, double-dummy, placebo controlled, parallel group study in adolescents and adults with persistent asthma comparing the safety and efficacy of two doses of formoterol fumarate b.i.d. administered from the multi-dose powder |
Active substance: FORMOTEROL |
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Document reference: 47792 |
Study title: A 12-month comparison of Oxis® (formoterol) Turbuhaler® and Bricanyl® (terbutaline)Turbuhaler both used as needed in subjects with asthma not using anti-inflammatory treatment |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0716 Study Synopsis.pdf |
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Document reference: 47793 |
Study title: A 12-month comparison of Oxis® (formoterol) Turbuhaler® and Bricanyl®(terbutaline) Turbuhaler® both used as needed in patients with asthma on anti-inflammatory treatment |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0714 Study Synopsis.pdf |
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Document reference: 47794 |
Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety and efficacy of Formoterol fumarate (10 µg b.i.d.) delivered by the multi-dose dry powder inhaler (MDDPI) versus place |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258F2302 Art45 listing 2011.xls |
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Document reference: 47795 |
Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety, efficacy, and pharmacokinetics of Foradil (formoterol fumarate) (10 mg bid) delivered by the multi-dose dry powder in |
Active substance: FORMOTEROL |
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Document reference: 47796 |
Study title: Efficacy and tolerability of four single doses of formoterol Turbuhaler compared to salmeterol Diskhaler 50μg and placebo in children with bronchial asthma. |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0002 Study Synopsis.pdf |
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Document reference: 47840 |
Study title: Intenzo C, Kim S, Millin J, Park C. Scintigraphic patterns of the reflex sympathetic dystrophy syndrome of the lower extremities. Clin Nucl Med. 1989 Sep;14(9):657-61. Intenzo C, Kim S, Millin J, Park C. Scintigraphic patterns of the reflex sympathetic dystrophy syndrome of the lower extremities. Clin Nucl Med. 1989 Sep;14(9):657-61. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43780 |
Study title: Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available. Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43952 |
Study title: Uno K, Uchida Y, Sakata S, Minoshima S, Okada J, Yoshikawa K, Arimizu N, Karikomi M, Kitakata Y, Suzuki Y. [Visualization of the female breast in bone scintigraphy] Kaku Igaku. 1992 Oct;29(10):1201-6. Japanese. Uno K, Uchida Y, Sakata S, Minoshima S, Okada J, Yoshikawa K, Arimizu N, Karikomi M, Kitakata Y, Suzuki Y. [Visualization of the female breast in bone scintigraphy] Kaku Igaku. 1992 Oct;29(10):1201-6. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43685 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43732 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44173 |
Study title: Kao PF, Tzen KY, Chang LY, You DL, Yang JY. 99Tcm-MDP scintigraphy in high-voltage electrical burn patients. Nucl Med Commun. 1997 Sep;18(9):846-52. Erratum in: Nucl Med Commun 1998 Jan;19(1):90. Kao PF, Tzen KY, Chang LY, You DL, Yang JY. 99Tcm-MDP scintigraphy in high-voltage electrical burn patients. Nucl Med Commun. 1997 Sep;18(9):846-52. Erratum in: Nucl Med Commun 1998 Jan;19(1):90. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43541 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc |
Study summary document link (including results): |
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Document reference: 41432 |
Study title: Double blind, controlled trial testing the immunogenicity and side effects of parenteral Vi polysaccharide typhoid vaccine in Indonesian children and adults |
Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
Study summary document link (including results): |
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Document reference: 21216 |
Study title: Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi |
Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
Study summary document link (including results): |
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Document reference: 41447 |
Study title: ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE VS. MEBENDAZOLE IN PATIENTS WITH ASCARIASIS. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf |
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Document reference: 46148 |
Study title: EFFICACY AND SAFETY OF OXANTEL-PYRANTEL PAMOATE TAB. AGAINST MULTIPLE INTESTINAL HELNINTHIC/NEMATODE INFECTIONS WITH TRICHURIS TRICHURIA. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): |
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Document reference: 46146 |
Study title: EFFICACY AND SAFETY OF OXANTEL/PYRANTEL PAMOATE TABLET AGAINST MULTIPLE INTESTINAL HELMINTHIC/NEMATODE INFECTIONS WITH TRICHURIS TRICHURIA. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): |
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Document reference: 46145 |
Study title: O'Duffy EK, Clunie GP, Gacinovic S, Edwards JC, Bomanji JB, Ell PJ. Foot pain: specific indications for scintigraphy. Br J Rheumatol. 1998 Apr;37(4):442-7. O'Duffy EK, Clunie GP, Gacinovic S, Edwards JC, Bomanji JB, Ell PJ. Foot pain: specific indications for scintigraphy. Br J Rheumatol. 1998 Apr;37(4):442-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43533 |
Study title: Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available. Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43449 |
Study title: Hersek N, Canay S, Caner B, Ulutuncel N. Bone SPECT imaging of patients with internal derangement of temporomandibular joint before and after splint therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Nov;94(5):576-80. Hersek N, Canay S, Caner B, Ulutuncel N. Bone SPECT imaging of patients with internal derangement of temporomandibular joint before and after splint therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Nov;94(5):576-80. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43431 |
Study title: Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available. Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43450 |
Study title: Cherubism: diagnostic imaging and review of the literature in Japan. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):623-8. Review. Hitomi G, Nishide N, Mitsui K. Cherubism: diagnostic imaging and review of the literature in Japan. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):623-8. Review. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43567 |
Study title: INFLUENCE ON BRONCHIAL HYPERRESPONSIVENESS USING A LONG ACTING (FORMOTEROL) AND A SHORT ACTING (SALBUTAMOL) BETA-2 SYMPATHOMIMETIC IN CHILDREN WITH BRONCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): |
View full study record |
Document reference: 45268 |
Study title: INFLUENCE ON BRONCHIAL HYPERRESPONSIVENESS USING A LONG ACTING (FORMOTEROL) AND A SHORT ACTING (SALBUTAMOL) BETA-2 SYMPATHOMIMETIC IN CHILDREN WITH BRONCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DFORD2 Art45 listing 2011.xls |
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Document reference: 47845 |
Study title: Investigation on the safety and efficacy of miflonide together with foradil in patients with moderate to severe asthma bronchiale which is not adequately controlled by other inhalative combinations of long-acting beta 2-agonists and corticosteroids. |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 45269 |
Study title: Investigation on the safety and efficacy of miflonide together with foradil in patients with moderate to severe asthma bronchiale which is not adequately controlled by other inhalative combinations of long-acting beta 2-agonists and corticosteroids. |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258DDE03 Art45 listing 2011.xls |
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Document reference: 47846 |
Study title: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 45270 |
Study title: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 BA-RP1 Art45 listing 2011.xls |
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Document reference: 47847 |
Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA) |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 45271 |
Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA) |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 SP PD2 Art45 listing 2011.xls |
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Document reference: 47848 |
Study title: Report on an Open Cross-Over Comparison of Flurbiprofen and Naproxen in Juvenile Spondylitis, Definite and Probable |
Active substance: FLURBIPROFEN |
Study summary document link (including results): Flurbiprofen-M84-121.pdf |
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Document reference: 47461 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44220 |
Study title: A "harness" distribution pattern on pediatric Ga-67 scintigraphy. Lewis GW, Mansberg R, Howman-Giles R. Clin Nucl Med. 1999 Jul;24(7):527-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43505 |
Study title: Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available. Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43480 |
Study title: Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available. Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44135 |
Study title: Open comparative trial to evaluate the effectiveness of gonorrhae in males.Fluker |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_9.xlsx |
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Document reference: 48999 |
Study title: Open parallell group to evalutate the efficacy for 2 different dose regimens for untreated maxillar sinuitis.Sydow et al. |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_13.xlsx |
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Document reference: 48998 |
Study title: TO ASSESS THE COMPARATIVE ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE AND MEBENDAZOLE IN ENTEROBIASIS AND ASCARIASIS. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf |
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Document reference: 46149 |
Study title: TO ASSESS THE EFFECT OF QUARTERLY TREATMENTS OVER A PERIOD OF ONE YEAR ON THE PREVALENCE OF ASCARIASIS, ANCYLOSTOMIASIS AND ENTEROBIASIS IN A RESIDENTIAL INSTITUTE FOR CHILDREN. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): |
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Document reference: 46151 |
Study title: TO ESTIMATE THE PERCENTAGE OF AT-RISK FAMILIES IN A HIGH-PREVALENCE AREA HAVING TWO OR MORE MEMBERS WITH ROUND-WORM HOOKWORM INFECTION. "AT-RISK" FAMILIES HAS ONE MEMBER INFECTED. "AFFECTED" FAMILIES HAS 2 OR MORE INFECTED MEMBERS. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): PRT-II-85-002 EMEA Pediatric Web Synopsis.pdf |
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Document reference: 46150 |
Study title: Afifi AK, Bell WE: Tests for juvenile myastenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 8, 403 – 411 (1993) Afifi AK, Bell WE: Tests for juvenile myastenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 8, 403 – 411 (1993) |
Active substance: PYRIDOSTIGMINE |
Study summary document link (including results): |
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Document reference: 35224 |
Study title: Afifi AK, Bell WE. Tests for juvenile myasthenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 1993;8:403-11.Afifi AK, Bell WE. Tests for juvenile myasthenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 1993;8:403-11. |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35228 |
Study title: Alhalel A et al. Ocular effects of hyoscine in double dose transdermal administration and its reversal by low dose pyridostigmine. Aviat Space Environ Med. 1995 Nov;66(11):1037-40Alhalel A et al. Ocular effects of hyoscine in double dose transdermal administration and its reversal by low dose pyridostigmine. Aviat Space Environ Med. 1995 Nov;66(11):1037-40 |
Active substance: PYRIDOSTIGMINE |
Study summary document link (including results): |
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Document reference: 35198 |
Study title: A Multicenter Safety Study of SR29142 in Cancer Patients (LTS3025). |
Active substance: rasburicase |
Study summary document link (including results): |
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Document reference: 47279 |
Study title: A Phase II, Open-Label, Multicenter Study of SR29142 as a Uricolytic Therapy for the Prophylaxis and Treatment of Hyperuricemia in Patients With Leukemias or Lymphomas (ACT2511) |
Active substance: rasburicase |
Study summary document link (including results): |
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Document reference: 47275 |
Study title: A Phase II, Open-Label, Multicenter Study of SR29142 as a Uricolytic Therapy for the Prophylaxis and Treatment of Hyperuricemia in Patients with Leukemias or Lymphomas (ACT2694) |
Active substance: rasburicase |
Study summary document link (including results): |
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Document reference: 47276 |
Study title: An open-label, randomized, multicenter comparison of SR29142 versus allopurinol for the prophylaxis and treatment of hyperuricemia in pediatric patients with leukemia or lymphoma (EFC2975) |
Active substance: rasburicase |
Study summary document link (including results): |
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Document reference: 47277 |
Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43847 |
Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44180 |
Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44227 |
Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44274 |
Study title: Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21. Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43605 |
Study title: Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2. Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43957 |
Study title: Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available. Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44023 |
Study title: Reflex sympathetic dystrophy associated with deep peroneal nerve entrapment. Parano E, Pavone V, Greco F, Majorana M, Trifiletti RR. Brain Dev. 1998 Mar;20(2):80-2. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43534 |
Study title: Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available. Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44106 |
Study title: Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available. Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43669 |
Study title: Early scintigraphic findings of occult femoral and tibial fractures in infants. Park HM, Kernek CB, Robb JA. Clin Nucl Med. 1988 Apr;13(4):271-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43819 |
Study title: Scintigraphic evaluation of extremity pain in children: its efficacy and pitfalls. Park HM, Rothschild PA, Kernek CB. AJR Am J Roentgenol. 1985 Nov;145(5):1079-84. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43930 |
Study title: Open single centertrial to evaluate efficacy and safety of amoxicillin for treatment of UTIParsons et al |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_11.xlsx |
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Document reference: 48995 |
Study title: Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available. Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43773 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43774 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44176 |
Study title: Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available. Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44120 |
Study title: [Algodystrophy, a little known disease in children. General review apropos of 4 cases] French. Labenne M, Bertrand AM, Wendling D, Onimus M, Laurain JM, Amsallem D. Ann Pediatr (Paris). 1987 Oct;34(8):603-8. Review. French. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43850 |
Study title: FLU9705: a multi-centre, parallel group, randomised, double-blind study to investigate the efficacy of fluticasone propionate 100 mcg MDI bd versus placebo MDI bd both via Babyhaler™ spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 months study period. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS40256-ICHE3.pdf |
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Document reference: 28395 |
Study title: Nebulised Fluticasone propionate in an upper respiratory tract inflammatory disorder (rhinopharyngitis): a multicentre, randomised, blinded, parallel group study of the efficacy and safety of nebulised fluticasone propionate 0.5mg daily compared with nebulised beclomethasone dipropionate 0.8mg daily in children suffering from acute rhinopharyngitis. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLIC09-ICHE3.pdf |
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Document reference: 28422 |
Study title: Prevention of Otitis media in children." 6) "A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients." |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40083-ICHE3.pdf |
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Document reference: 28367 |
Study title: Report on a multicentre, randomised, double-blind, parallel-group clinical trial to compare the efficacy and safety of the dry powder formulation of fluticasone proprionate (FP) 200μg/day with fluticasone proprionate 400μg/day administered for 6 weeks from a multidose powder device (Diskus™) to paediatric patients with chronic asthma. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLTB3051-ICHE3.pdf |
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Document reference: 28380 |
Study title: Systemic exposure of the fluticasone propionate from the hydrofluoroalkane propellant formulation via the metered-dose inhaler with and without a spacer in pediatric subjects 4 to 11 years of age with asthma. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FAP19058-ICHE3.pdf |
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Document reference: 28418 |
Study title: A multi-centre, randomised, open-label, parallel group clinical trial to assess the efficacy and safety of Salmeterol/Fluticasone Propionate combination product (2x 25/125μg/actuation, bd) via a hydrofluoroalkane metereddose inhaler compared with Salmeterol/Fluticasone Propionate Accuhaler™ (50/250μg bd) in adult Chinese patients with mild to moderate asthma. |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30021-ICHE3.pdf |
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Document reference: 28452 |
Study title: A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children (aged 5-12, inclusive) with persistent asthma evaluating the safety, efficacy and pharmacokinetics of Foradil (formoterol fumarate) 10 mg bid delivered b |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 0604 Art45 listing 2011.xls |
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Document reference: 47797 |
Study title: Paulsen HU, Rabøl A, Sørensen SS. Bone scintigraphy of human temporomandibular joints during Herbst treatment: a case report. Eur J Orthod. 1998 Aug;20(4):369-74. Paulsen HU, Rabøl A, Sørensen SS. Bone scintigraphy of human temporomandibular joints during Herbst treatment: a case report. Eur J Orthod. 1998 Aug;20(4):369-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43525 |
Study title: Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available. Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43884 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44118 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44238 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44285 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44086 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44187 |
Study title: Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44124 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44223 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44270 |
Study title: O'Reilly RJ, Cook DJ, Gaffney RD, Angel KR, Paterson DC. Can serial scintigraphic studies detect delayed fracture union in man? Clin Orthop Relat Res. 1981 Oct;(160):227-32. O'Reilly RJ, Cook DJ, Gaffney RD, Angel KR, Paterson DC. Can serial scintigraphic studies detect delayed fracture union in man? Clin Orthop Relat Res. 1981 Oct;(160):227-32. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44110 |
Study title: Review of spondylolisthesis and spondylolysis in paediatric practice. Oakley RH, Carty H. Br J Radiol. 1984 Oct;57(682):877-85. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43981 |
Study title: Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43400 |
Study title: A 3-week, multicenter study investigating patient use and functionality of the Foradil Certihaler device in patients with asthma. |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258F2309 Art45 listing 2011.xls |
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Document reference: 47799 |
Study title: A 3-week, open-label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in patients with Asthma. |
Active substance: FORMOTEROL |
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Document reference: 47801 |
Study title: A 6 months comparison of the safety and efficacy profiles of OXIS (formoterol) Turbuhaler as needed and BRICANYL (terbutaline) Turbuhaler as needed in children with asthma on anti-inflammatory treatment. |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0695 Study Synopsis.pdf |
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Document reference: 47802 |
Study title: A NEW BRONCHODILATOR, IN THE PEDIATRIC PATIENTS WITH NON-ASTHMATIC RESPIRATORY DISORDERS. |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 YBDG 5-4 Art45 listing 2011.xls |
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Document reference: 47804 |
Study title: A RANDOMISED, DOUBLE-BLIND, CROSS-OVER, MULTI-CENTRE STUDY COMPARING THE EFFICACY AND TOLERABILITY OF FORMOTEROL 12 UG INHALED TWICE DAILY WITH SALBUTAMOL 100 UG INHALED FOUR TIMES DAILY IN THE TREATMENT OF ASTHMA IN CHILDREN |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 NBG 8937 Art45 Listing.xls |
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Document reference: 47805 |
Study title: A randomized double-blind, cross-over comparison of inhaled formoterol 12 ug and salbutamol 200 ug in children with exercise induced asthma |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 FO-DK1Art45 listing 2011.xls |
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Document reference: 47807 |
Study title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIPLE DOSE (1 WEEK) FINDING, MULTICENTER, CROSSOVER STUDY IN CHILDREN AGED 5 TO 12 WITH PERSISTENT ASTHMA COMPARING 4 DOSES (5, 10, 15 AND 30 UG) OF FORMOTEROL BID ADMINISTERED FROM THE MULTIPLE DOSE DRY |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 0602 Art45 listing 2011.xls |
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Document reference: 47808 |
Study title: MULTI-CENTRE, OPEN LABEL, NON COMPARATIVE STUDY OF MULTIPLEDOSES OF 12 MYG FORMOTEROL METERED DOSE AEROSOL IN CHILDREN WITH BROCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 BA-RP1F Art45 listing 2011.xls |
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Document reference: 47849 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44234 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44281 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44267 |
Study title: [Nonspecific osteomyelitis in childhood and adolescence. The contribution of imaging diagnosis] Italian. Urso S, Pacciani E, Fariello G, Colajacomo M, Fassari FM, Randisi F, Certo A, Liberatore M, Pagnotta G. Radiol Med (Torino). 1995 Sep;90(3):212-8. Italian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43589 |
Study title: Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27. Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43736 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44237 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44284 |
Study title: Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43968 |
Study title: Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44063 |
Study title: Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9. Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43988 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44107 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44188 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44235 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44282 |
Study title: Open-label, multi-center, non-controlled follow-up study over 3 months on the safety of Formoterol Easyhaler in approximately 35 asthmatic pediatric patients initially treated in study |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47855 |
Study title: Open, 12-month, follow-up of a 3-month, comparative, multi-centre, double-blind trial to assess the long-term tolerability and efficacy of formoterol 12 ug dry powder capsules in children with reversible obstructive airways diseases |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DP-PD2F Art45 listing 2011.xls |
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Document reference: 47853 |
Study title: Open, multi-center, randomized, two fold crossover safety study comparing Formoterol Easyhaler vs. Foradil Aerolizer over a treatment period comprising two times 3-months in 70 asthmatic pediatric patients. |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47854 |
Study title: PLACEBO-CONTROLLED, COMPARATIVE, SINGLE-CENTER, DOUBLE-BLIND, WITHIN-PATIENT, TRIAL TO COMPARE THE MAGNITUDE AND DURATION OF PROTECTION AGAINST EXERCISE-INDUCED BRONCHOCONSTRICTION OF INHALED FORMOTEROL DRY POWDER CAPSULES 12 UG WITH THAT OF SALBUTAMOL DR |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DPPD3 Art45 listing 2011.xls |
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Document reference: 47856 |
Study title: PLACEBO-CONTROLLED, COMPARATIVE, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL TO COMPARE THE EXTENT AND DURATION OF PROTECTION AGAINST EXERCISE-INDUCED BRONCHOCONSTRICTION OF 12 UG INHALED FORMOTEROL AEROSOL WITH THAT OF 200 UG INHALED SALBUTAMOL AER |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 SP PD4 Art45 listing 2011.xls |
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Document reference: 47857 |
Study title: PLACEBO-CONTROLLED, DOSE-FINDING, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL OF DIFFERENT DOSES OF INHALED FORMOTEROL DRY POWDER (6, 12, 24 UG) AND 400 UG INHALED SALBUTAMOL DRY POWDER IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DP-PD6 Art45 listing 2011.xls |
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Document reference: 47858 |
Study title: PREVENTIVE EFFECT AND TOLERABILITY OF FORMOTEROL COMPARED WITH THAT OF SALBUTAMOL IN CHILDREN WITH EXERCISE-INDUCED ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47860 |
Study title: Protective effect of single doses of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses 6μg and 12μg, respectively) compared with terbutaline Turbuhelr 0.5mg and placebo in children with exercise-induced bronchoconstriction (EIB). |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0149 Study Synopsis.pdf |
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Document reference: 47861 |
Study title: Hypertrophic pulmonary osteoarthropathy in nasopharyngeal carcinoma: an early sign of pulmonary metastasis. Liu RS, Chen YK, Yen SH, Chu YK, Chu LS, Chen KY, Yeh SH. Nucl Med Commun. 1995 Sep;16(9):785-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43591 |
Study title: Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German. Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43695 |
Study title: The technetium phosphate bone scan in the diagnosis of osteomyelitis in childhood. Howie DW, Savage JP, Wilson TG, Paterson D. J Bone Joint Surg Am. 1983 Apr;65(4):431-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44041 |
Study title: [Osteomyelitis in children: sometimes hard to recognize] Dutch. te Pas AB, Feith SW, Wit JM. Ned Tijdschr Geneeskd. 2002 Aug 17;146(33):1547-50. Dutch. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43438 |
Study title: Rectus femoris muscle bone-image uptake in a sprinter. Telepak RJ, Hartshorne MF, Bauman JM, Cawthon MA. Clin Nucl Med. 1986 May;11(5):365. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43911 |
Study title: Intense gallbladder uptake associated with chemotherapy. An unusual finding in pediatric skeletal scintigraphy. Lowry PA, Carstens C. Clin Nucl Med. 1995 Nov;20(11):976-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43579 |
Study title: Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34. Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43659 |
Study title: Clinical impact and prognostic value of metaiodobenzylguanidine imaging in children with metastatic neuroblastoma. Perel Y, Conway J, Kletzel M, Goldman J, Weiss S, Feyler A, Cohn SL. J Pediatr Hematol Oncol. 1999 Jan-Feb;21(1):13-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43514 |
Study title: Comparison of radiographic and radionuclide skeletal surveys in battered children. Pickett WJ, Faleski EJ, Chacko A, Jarrett RV. South Med J. 1983 Feb;76(2):207-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44049 |
Study title: A Double-blind, Placebo-controlled trial: comparison of the clinical and bacteriological effectiveness of ampicillin and a placebo.Nelson et al. (Ann NY Acad Sci 145 1967) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_6.xlsx |
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Document reference: 49006 |
Study title: A prospective study of rash incidence in 532 patients treated with Amipicillin intravenously is reported.Scioli et al. (Boll 1st Sieroter Milan 1983;62;287-91) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_1.xlsx |
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Document reference: 49000 |
Study title: A reassessment of bone scintigraphy and commonly tested pretreatment biochemical parameters in newly diagnosed osteosarcoma. Stokkel MP, Linthorst MF, Borm JJ, Taminiau AH, Pauwels EK. J Cancer Res Clin Oncol. 2002 Jul;128(7):393-9. Epub 2002 Jun 13. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43446 |
Study title: Strömqvist B, Brismar J, Hansson LI, Palmer J. Technetium-99m-methylenediphosphonate scintimetry after femoral neck fracture. A three-year follow-up study. Clin Orthop Relat Res. 1984 Jan-Feb;(182):177-89. Strömqvist B, Brismar J, Hansson LI, Palmer J. Technetium-99m-methylenediphosphonate scintimetry after femoral neck fracture. A three-year follow-up study. Clin Orthop Relat Res. 1984 Jan-Feb;(182):177-89. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44018 |
Study title: Kobayashi H, Tanaka K, Sakuma S. [99mTc-MDP abnormal uptake in the femur shaft in hemi-lateral hip joint disorders] Kaku Igaku. 1990 Aug;27(8):833-40. Japanese. Kobayashi H, Tanaka K, Sakuma S. [99mTc-MDP abnormal uptake in the femur shaft in hemi-lateral hip joint disorders] Kaku Igaku. 1990 Aug;27(8):833-40. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43756 |
Study title: [The early diagnosis of Perthes disease: the value of bone scintigraphy and magnetic resonance imaging in comparison with x-ray findings] German. Theissen P, Rütt J, Linden A, Smolarz K, Voth E, Schicha H. Nuklearmedizin. 1991 Dec;30(6):265-71. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43717 |
Study title: Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43677 |
Study title: Routine bone scintigraphy is of limited value in the clinical assessment of untreated patients with Hodgkin's disease. Landgren O, Axdorph U, Jacobsson H, Johansson B, Grimfors G, Björkholm M. Med Oncol. 2000 Aug;17(3):174-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43478 |
Study title: The painful accessory navicular. Lawson JP, Ogden JA, Sella E, Barwick KW. Skeletal Radiol. 1984;12(4):250-62. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44012 |
Study title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4-11 years with asthma |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40012-ICHE3.pdf |
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Document reference: 28443 |
Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100314-ICHE3.pdf |
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Document reference: 28454 |
Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100316-ICHE3.pdf |
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Document reference: 47594 |
Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with Seretide(tm) 50/100mcg |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM3802-ICHE3.pdf |
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Document reference: 28442 |
Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”) |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30018-ICHE3.pdf |
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Document reference: 28451 |
Study title: Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric) |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-ADERE-PEDIATRIC-1-ICHE3.pdf |
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Document reference: 28444 |
Study title: Randomised, double-blind, comparator study to demonstrate the superiority of salmeterol/fluticasone propionate combination DISKUS™ 50/100mcg bd over fluticasone propionate DISKUS™/ACCUHALER™ 200mcg bd with respect to airway physiology in asthmatic children treated for 6 weeks. |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40100-ICHE3.pdf |
View full study record |
Document reference: 28447 |
Study title: Bone scan in diagnosis of lymphoma with extensive bone marrow necrosis--a case report. Jain D, Pattari S, Rajesh LS, Varma N, Mittal BR. Indian J Pathol Microbiol. 2004 Jul;47(3):394-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43381 |
Study title: A Single-blinded, Randomized trial to evaluate the efficacy and safety of 125 mg ampicillin suppositories in the treatment of acute respiratory tract infections in pediatric patients using ampicillin dry syrup as control.Nishimura et al. (1983-05-04) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_22.xlsx |
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Document reference: 49021 |
Study title: Clarify the effects of age, dosage, and route of administration on ampicillin-associated diarrhea in pediatric patients.Phillips et al. (PEDIATRICS Vol. 58 No. 6 Dec. 1976) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_5.xlsx |
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Document reference: 49004 |
Study title: Compare ampicillin and choramphenicol, both being given by the parenteral route in the therapyt of typhoid fever.Kaye et al. (Annals Ney York Academy of Sciences 145, 1967) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_3.xlsx |
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Document reference: 49002 |
Study title: Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available. Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43973 |
Study title: Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7. Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43650 |
Study title: Tc-99m nanocolloid and Tc-99m MDP three-phase bone imaging in osteomyelitis and septic arthritis. A comparative study. Mudun A, Unal S, Aktay R, Akmehmet S, Cantez S. Clin Nucl Med. 1995 Sep;20(9):772-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43587 |
Study title: Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese. Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43793 |
Study title: Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43668 |
Study title: Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43506 |
Study title: A randomized, multicenter, placebo-controlled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24 µg b.i.d. and 12 µg b.i.d. formoterol, double-blind, and 12 µg b.i.d. formoterol with additio |
Active substance: FORMOTEROL |
Study summary document link (including results): |
View full study record |
Document reference: 47810 |
Study title: A SINGLE CENTRE, DOUBLE-BLIND, WITHIN-PATIENT COMPARATIVE TRIAL WITH CUMULATIVE DOSES OF FORMOTEROL AND SALBUTAMOL METERED DOSE AEROSOLS IN CHILDREN WITH ASTHMA.INTEGRATED STUDY REPORT (CLINICAL AND STATISTICAL) |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 GS 19 Art45 listing 2011.xls |
View full study record |
Document reference: 47812 |
Study title: A single dose study evaluating peak inspiratory flow rate and forced inspiratory vital capacity in children and adults with asthma of differing severity after administration of a placebo capsule for inhalation when using the aerolizer device |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 0061 Art45 listing 2011.xls |
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Document reference: 47813 |
Study title: A single dose, randomised, double blind, double dummy, placebo controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of FormoterolHFA pMDI 12 mcg per actuation administered by means of a "spacer"device (AeroCha |
Active substance: FORMOTEROL |
Study summary document link (including results): |
View full study record |
Document reference: 47814 |
Study title: A Single Dose, Randomized, Double-Blind, Double-Dummy, 4-way Crossover Trial Comparing 12 mcg and 24 mcg of Foradil Aerolizer, 180 mcg Albuterol Metered-Dose Inhaler (MDI) Versus Placebo in the Prevention of Exercise-Induced Bronchospasm in Pediatric Pati |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258D 0402 Art45 listing 2011.xls |
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Document reference: 47815 |
Study title: A SINGLE-CENTRE, DOUBLE-BLIND STUDY COMPARING FORMOTEROL AND SALBUTAMOL DRY POWDER CAPSULES FOR INHALATION WITH REGARD TO DURATION OF BRONCHODILATORY EFFECT, ASTHMA SYMPTOMS, ADVERSE REACTIONS, AND PREFERENCE IN THE TREATMENT OF CHILDREN WITH ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DP PD5 Art45 listing 2011.xls |
View full study record |
Document reference: 47816 |
Study title: A six months, randomised, open, parallel group, multicentre study to examine efficacy and safety of as needed versus maintenance use of Oxis® Turbuhaler® (formoterol) 9 μg in subjects well controlled on maintenance treatment with inhaled corticosteroids a |
Active substance: FORMOTEROL |
Study summary document link (including results): SD-037-0739 Study Synopsis.pdf |
View full study record |
Document reference: 47817 |
Study title: A three month, double blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 mcg twice daily of Formoterol-HFA and 12 mcg twice daily of Formoterol-DPI (Foradil Aerolizer) in childrem with persistent asthma |
Active substance: FORMOTEROL |
Study summary document link (including results): |
View full study record |
Document reference: 47818 |
Study title: A twelve-month, double-blind, between-patient, placebo-controlled trial comparing the safety, tolerability and efficacy of 12 ug and 25 ug twice daily formoterol dry powder capsules for inhalation delivered by a single -dose inhaler (aeroliser) in childre |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 2702049 Art45 listing 2011.xls |
View full study record |
Document reference: 47819 |
Study title: A twelve-week, double-blind, parallel group trial comparing the safety, tolerability and efficacy of formoterol dry powder capsules for inhalation delivered by a single-dose inhaler versus albuterol metered-dose inhaler (mdi) versus placebo in patients wi |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258D0040 Art45 listing 2011.xls |
View full study record |
Document reference: 47820 |
Study title: A twelve-week, double-blind, parallel group trial comparing the safety, tolerability and efficacy of formoterol dry powder capsules for inhalation delivered by a single-dose inhaler versus albuterol metered-dose inhaler (mdi) versus placebo in patients wi |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258D0041 Art45 listing 2011.xls |
View full study record |
Document reference: 47821 |
Study title: Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8. Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43808 |
Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43731 |
Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44172 |
Study title: Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43750 |
Study title: Hanna SL, Fletcher BD, Fairclough DL, Jenkins JH 3rd, Le AH. Magnetic resonance imaging of disseminated bone marrow disease in patients treated for malignancy. Skeletal Radiol. 1991;20(2):79-84. Hanna SL, Fletcher BD, Fairclough DL, Jenkins JH 3rd, Le AH. Magnetic resonance imaging of disseminated bone marrow disease in patients treated for malignancy. Skeletal Radiol. 1991;20(2):79-84. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43749 |
Study title: Study the antibacterial and clinical efficacy of ampicillin as well as of its side-effects in comparison with penicillin V, our hitherto best peroral penicillin for scarlet fever therapy.Ström (Acta Paediatr Scand. 1968 Jul;57(4):285-8) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_31.xlsx |
View full study record |
Document reference: 49030 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate short term efficacy in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Bagger-Sjöbäck et al. (1987-07-22) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_24.xlsx |
View full study record |
Document reference: 49023 |
Study title: Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44091 |
Study title: Partial growth plate closure: apex view on bone scan. Howman-Giles R, Trochei M, Yeates K, Middleton R, Barrett I, Scougall J, Whiteway D. J Pediatr Orthop. 1985 Jan-Feb;5(1):109-11. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43970 |
Study title: Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4 |
Active substance: AMPICILLIN AND CLOXACILLIN |
Study summary document link (including results): |
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Document reference: 46646 |
Study title: SINGLE-CENTRE, DOUBLE-BLIND WITHIN-PATIENT COMPARISON OF THE PROTECTIVE EFFECT OF INHALED PLACEBO, SALBUTAMOL (200 MCG), AND FORMOTEROL (12 AND 24 MCG) ON METHACHOLINE-INDUCED BRONCHOCONSTRICTION IN CHILDREN WITH BRONCHIAL ASTHMA |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 BA-EP1 Art45 listing 2011.xls |
View full study record |
Document reference: 47864 |
Study title: STATISTICAL REPORT ON AN OPEN, NON-COMPARATIVE STUDY WITH FORMOTEROL-METERED DOSE AEROSOL (2 X DAILY 12 MCG) IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE DISEASES OF THE RESPIRATORY TRACT |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DFORC5 Art45 listing 2011.xls |
View full study record |
Document reference: 47866 |
Study title: TO COMPARE THE BRONCHODILATOR EFFICACY, DURATION OF EFFECT,AND SYSTEMIC TOLERABILITY OF SINGLE INHALED DOSES OF FORMOTEROL, SALBUTAMOL ANF PLACEBO IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ASTHMA). CLINICAL TRIAL SUMMARY AND REPORT |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 DFORC4 Art45 listing 2011.xls |
View full study record |
Document reference: 47869 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43828 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44179 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44226 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44273 |
Study title: Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese. Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43944 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate efficacy of a twice daily dosage regimen in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_26.xlsx |
View full study record |
Document reference: 49025 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_27.xlsx |
View full study record |
Document reference: 49026 |
Study title: Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800. Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43759 |
Study title: Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available. Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43870 |
Study title: Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10. Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43393 |
Study title: A double blind, double dummy, crossover study to compare the systemic pharmacodynamic effects and safety of inhaled fluticasone propionate Nebules™ 1mg bd with oral prednisolone administered for 7 days to children aged 4 to 16 years with asthma |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLTB3055-ICHE3.pdf |
View full study record |
Document reference: 28421 |
Study title: A Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Study to Compare the Potential Short-Term Growth Effect of Fluticasone Propionate Aqueous Nasal Spray, Beclomethasone Dipropionate Aqueous Nasal Spray, and Placebo in Adolescents with Perennial Allergic Rhinitis. |
Active substance: FLUTICASONE |
Study summary document link (including results): Study FNM40007-Fluticasone_Flixonase.xls |
View full study record |
Document reference: 28365 |
Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate given once- versus twice-daily versus placebo for two weeks in adolescent patients with seasonal allergic rhinitis |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLN-305-ICHE3.pdf |
View full study record |
Document reference: 28407 |
Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate given once daily versus placebo for two weeks in pediatric patients with seasonal allergic rhinitis |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLN-320-ICHE3.pdf |
View full study record |
Document reference: 28408 |
Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate versus placebo for four weeks in pediatric patients with seasonal allergic rhinitis |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM30008-ICHE3.pdf |
View full study record |
Document reference: 28409 |
Study title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Assess the Potential Growth Effects of a One-Year Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) Versus Placebo in Prepubescent, Pediatric Subjects with Perennial Allergic Rhinitis |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40017-ICHE3.pdf |
View full study record |
Document reference: 28414 |
Study title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in ≥2 and <4 Year Old Subjects with Allergic Rhinitis. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40183-ICHE3.pdf |
View full study record |
Document reference: 28416 |
Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of fluticasone propionate 400μg daily with budesonide 400μg daily in children with asthma. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS30037-ICHE3.pdf |
View full study record |
Document reference: 28426 |
Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to determine the clinical equivalence between fluticasone propionate 100μg twice daily delivered via a multidose powder inhaler (MDPI) and the Diskhaler™ in adult and paediatric patients with reversible airways disease. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-propionate-FMDT02-ICHE3.pdf |
View full study record |
Document reference: 28424 |
Study title: Effect of the combination of ipratropium bromide and fenoterol (berodual) in patients with asthmatic crises comparative study with fenoterol (Berotec). |
Active substance: IPRATROPIUM |
Study summary document link (including results): |
View full study record |
Document reference: 30682 |
Study title: Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31. Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44261 |
Study title: Compare the achieved ampicillin concentrations in CSF following intravenous and intramuscular routes of administration, and to correlate the clinical and laboratory responses in patients treated by the two routes.Wilson et al. (AM J Dis Child/Vol 129, Feb 1975) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_4.xlsx |
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Document reference: 49003 |
Study title: Compare the tolerability of Ampicillin, Amoxicillin and Trimethoprim-Sulfamethoxazole in children with otitis media.Feder (Antimicrobial agents and chemotherapy, Mar. 1982. p. 426-427) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_29.xlsx |
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Document reference: 49028 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44084 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44186 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44233 |
Study title: Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14. Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43655 |
Study title: Left distal femoral diaphysis metaphyseal injury in a 13-year-old patient.Delgado Garcia M, Mitjavila Casanovas M, Balsa Breton MA, Castillejos Rodriguez L, Alonso Garcia P, Canamaque Garcia L, et al. Rev Esp Med Nucl 2000 Sep;19{5):356-60. [in Spanish] |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48474 |
Study title: Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60. Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43694 |
Study title: False positive bone scan secondary to sympathectomy following resection of a ganglioneuroblastoma or affect of unilateral sympathectomy of bone scan in the pediatric patient. Haggstrom JA, Brown JC. Nebr Med J. 1988 Mar;73(3):67-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43823 |
Study title: Skeletal scintigraphy of young patients with low-back pain and a lumbosacral transitional vertebra. Connolly LP, d'Hemecourt PA, Connolly SA, Drubach LA, Micheli U, Treves ST. J Nucl Med 2003 Jun;44{6):909-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48473 |
Study title: Magnetic resonance imaging in children with acute hip pain. Ranner G, Ebner F, Fotter R, Linhart W, Justich E. Pediatr Radiol. 1989;20(1-2):67-71. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43799 |
Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44219 |
Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44266 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44280 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43855 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44181 |
Study title: Nakayama T, Saitoh Y, Yatabe K, Sueishi M, Kawai M. [Diagnosis of inflammatory myopathy; usefulness of 99mTc MDP scintigraphy and muscle MRI for determination of affected sites] Rinsho Shinkeigaku. 1999 Nov;39(11):1114-7. Japanese. Nakayama T, Saitoh Y, Yatabe K, Sueishi M, Kawai M. [Diagnosis of inflammatory myopathy; usefulness of 99mTc MDP scintigraphy and muscle MRI for determination of affected sites] Rinsho Shinkeigaku. 1999 Nov;39(11):1114-7. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43492 |
Study title: Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44278 |
Study title: Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available. Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43867 |
Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43404 |
Study title: Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43386 |
Study title: Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available. Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44075 |
Study title: Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available. Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43979 |
Study title: Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43967 |
Study title: Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63. |
Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 29053 |
Study title: Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). |
Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 29054 |
Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308. |
Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL |
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Document reference: 29062 |
Study title: Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63. |
Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL |
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Document reference: 29064 |
Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age. |
Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
Study summary document link (including results): |
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Document reference: 41159 |
Study title: Natural history and distribution of bone and bone marrow infarction in sickle hemoglobinopathies. Kim SK, Miller JH. J Nucl Med. 2002 Jul;43(7):896-900. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43447 |
Study title: Comparison of whole-body STIR-MRI and 99mTc-methylene-diphosphonate scintigraphy in children with suspected multifocal bone lesions. Mentzel HJ, Kentouche K, Sauner D, Fleischmann C, Vogt S, Gottschild D, Zintl F, Kaiser WA. Eur Radiol. 2004 Dec;14(12):2297-302. Epub 2004 Jul 9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43401 |
Study title: Merkel KD, Brown ML, Dewanjee MK, Fitzgerald RH Jr. Comparison of indium-labeled-leukocyte imaging with sequential technetium-gallium scanning in the diagnosis of low-grade musculoskeletal sepsis. A prospective study. Merkel KD, Brown ML, Dewanjee MK, Fitzgerald RH Jr. Comparison of indium-labeled-leukocyte imaging with sequential technetium-gallium scanning in the diagnosis of low-grade musculoskeletal sepsis. A prospective study. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43951 |
Study title: comparative single blind parallell clinical efficacy and tolerance with amoxicillin suspension 50 mg/mlx2 and compare with amoxicillin suspension 25 mg/ml x3.Olsson et al |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_12.xlsx |
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Document reference: 48994 |
Study title: Evaluate efficacy in spefic infections and to compare amoxicillin 250 mg qid and 500 mg bd.Andrews et al |
Active substance: AMOXICILLIN |
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Document reference: 48972 |
Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44150 |
Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44197 |
Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44244 |
Study title: Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345. Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43818 |
Study title: Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available. Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43661 |
Study title: Hejgaard N, Diemer H. Bone scan in the patellofemoral pain syndrome. Int Orthop. 1987;11(1):29-33. Hejgaard N, Diemer H. Bone scan in the patellofemoral pain syndrome. Int Orthop. 1987;11(1):29-33. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43882 |
Study title: Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese. Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43698 |
Study title: Resolved splenic accumulation of Tc-99m HMDP after recovery of disseminated intravascular coagulation in a patient with rhabdomyosarcoma. Suga K, Matsunaga N, Kawamura T, Hara A, Kume N. Clin Nucl Med. 1999 Jun;24(6):414-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43507 |
Study title: Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44034 |
Study title: Fluoxetine: In Depression And Ocd (Compassionate Use) |
Active substance: FLUOXETINE |
Study summary document link (including results): |
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Document reference: 28332 |
Study title: Fluoxetine/Placebo In Panic Disorder |
Active substance: FLUOXETINE |
Study summary document link (including results): |
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Document reference: 28338 |
Study title: Impact Of Fluoxetine On Growth In Children And Adolescents |
Active substance: FLUOXETINE |
Study summary document link (including results): |
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Document reference: 28330 |
Study title: Pharmacokinetic Assessment of Fluoxetine and Norfluoxetine in Preadolescent and Adolescent Patients |
Active substance: FLUOXETINE |
Study summary document link (including results): fluoxetine B1Y-MC-HCIU Clinical Study Summary.pdf |
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Document reference: 47357 |
Study title: Reimão R, Lefévre AB.: Evaluation of flurazepam and placebo on sleep disorders in childhood. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28345 |
Study title: VALUTAZIONE IN PEDIATRIA DELL'ATTIVITA' IPNOINDUCENTE DEL FLURAZEPAM GOCCE (VAL 779) Rapisarda V.; Germana B. Formazione Psichiatrica, December 1, 1980 , No. 4/- (181-190) Evaluation of flurazepam and placebo on sleep disorders in childhood. Reimão R, Lefévre AB. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28344 |
Study title: A placebo controlled trial during the pollen season comparing the effects of intranasal Beclomethasone dipropionate and intranasal Fluticasone propionate in children and young adults with asthma and allergic rhinitis. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40054-ICHE3.pdf |
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Document reference: 28366 |
Study title: A randomised, double-blind, double-dummy, parallel group, multicentre study to compare the effect on growth measured by stadiometry of fluticasone propionate (100μg bd) administered via DISKUS™ with budesonide (200μg bd) administered via Turbuhaler in prepubescent children. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS40001-ICHE3.pdf |
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Document reference: 28384 |
Study title: A Randomized, Double-Blind, Double Dummy, Parallel Group Comparison of Fluticasone Propionate Inhalation Powder (50mcg BID) via DiskusTM with Oral Montelukast (5mg QD) Chewable Tablets in Children 6–12 years of Age with Persistent Asthma |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FPD40012-ICHE3.pdf |
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Document reference: 28389 |
Study title: Evaluate the efficacy of amoxicillin i ndifferent dosages i nthe treatment of gonococcal urethritis in the male. Compare the results with stnadard treatment.Watt et al. |
Active substance: AMOXICILLIN |
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Document reference: 48970 |
Study title: Controlled clinical study on the activity of a new mucoregulating drug in obstructive bronchial pathology with a marked hypersecretory feature. Paediatric experience. Min.Ped.1984,36(3),127-138. Romano C. et al. Minerva Pediatrica 1984, Romano |
Active substance: AMBROXOL |
Study summary document link (including results): Minerva Pediatrica 1984, Romano.pdf |
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Document reference: 48874 |
Study title: A randomized, stratified, double blind trial to compare safety and efficacy of the Fluvirin® Vaccine (a purified surface antigen vaccine) with Connaught Inactivated Influenza Vaccine Fluzone® (a split virion vaccine) in healthy children aged 6 to 47 months of age.Nicolay 1999, Vaccine 17 (1999) 2223-2228 |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): MPL-318-01.xlsx |
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Document reference: 49190 |
Study title: Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 24913 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IV FCA IN THE TREATMENT OF CANDIDIASIS IN THE LEUKEMIC PATIENTS |
Active substance: FLUCONAZOLE |
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Document reference: 27941 |
Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomography in patients with indeterminate computed tomography findings. Tsai MH, Huang WS, Tsai JJ, Chen YK, Changlai SP, Kao CH. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28141 |
Study title: JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978 |
Active substance: CITICOLINE |
Study summary document link (including results): Espadaler CITICOLINE MONOSODIUM_Ferrer Internacional.xls |
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Document reference: 24296 |
Study title: Radionuclide studies in paediatric nephro-urologyPiepsz A. Eur J Radiol. 2002 Aug;43(2):146-53. |
Active substance: CHROMIUM 51 |
Study summary document link (including results): Piepsz A 2002.pdf |
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Document reference: 24091 |
Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Hedström (Scand J Infec Dis 1: 175-180, 1969) |
Active substance: CLOXACILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Cloxacillin_1.xlsx |
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Document reference: 49082 |
Study title: symptomatic treatment of migraine in children: a systemic review of medications trials |
Active substance: CHLORPHENAMINE AND PARACETAMOL |
Study summary document link (including results): |
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Document reference: 24048 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
Active substance: CODEINE_AND_PARACETAMOL |
Study summary document link (including results): |
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Document reference: 24563 |
Study title: Experience with rnebendazol in children with multiple intestinal helminthiasis. 1974 |
Active substance: MEBENDAZOLE |
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Document reference: 31553 |
Study title: Compare the effectiveness in the treatment of chronic constipation of a lactulose preparation ("Duphalac") and "irritant" laxatives containing senna, anthraquinone derivatives or bisacodyl.Connolly et al |
Active substance: LACTULOSE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_2.xlsx |
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Document reference: 49067 |
Study title: Compare the effects of chemotherapy, chemotherapy combined with Lactulose, or Lactulose alone with regard to curtailing the pathological excretion of salmonellae.Sander-Treske et al |
Active substance: LACTULOSE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_4.xlsx |
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Document reference: 49069 |
Study title: Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32. |
Active substance: LACTULOSE |
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Document reference: 30993 |
Study title: Minuck M. Postoperative Analgesia - Comparison of Methotrimeprazine (Nozinan) and Meperidine (Demerol) as Postoperative Minuck M. Postoperative Analgesia - Comparison of Methotrimeprazine (Nozinan) and Meperidine (Demerol) as Postoperative |
Active substance: LEVOPROMAZINE |
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Document reference: 31164 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Cinnamomum-Homaccord N (drops) [AWB-AT] |
Active substance: Cinnamomum-Homaccord N |
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Document reference: 39829 |
Study title: Investigate the clinical use of Lactulose as laxative in constipated children.Bush |
Active substance: LACTULOSE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_3.xlsx |
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Document reference: 49068 |
Study title: To compare lactulose with standardized senna syrup in treatment of constipated children.Perkin |
Active substance: LACTULOSE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_1.xlsx |
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Document reference: 49066 |
Study title: LT4-monopreparation versus LT4-LT3-compound preparation in the treatment of diffuse endemic goitreActa Endocrinologica (Copenh) 1986, 113: 242-248 Bongers H.; 1986 |
Active substance: LEVOTHYROXINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48988 |
Study title: Therapie der Jodmangelstruma bei Jugendlichen mit Jodid oder einer Kombination von Jodid und Levothyroxin unter besonderer Berücksichtigung der Lipidparameter. Rönnefarth G., 1996 Klin Pädiatr 1996; 208: 123-128 |
Active substance: LEVOTHYROXINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48954 |
Study title: LT4-monopreparation versus LT4-LT3-compound preparation in the treatment of diffuse endemic goitreActa Endocrinologica (Copenh) 1986, 113: 242-248 Bongers H.; 1986 |
Active substance: LIOTHYRONINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48976 |
Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Claritine/Clarityn Syrup and Associated Tradenames (loratadine)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels |
Active substance: LORATADINE |
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Document reference: 48848 |
Study title: Multicentre, randomised, comparative double-blind and double placebo study in two parallel groups, of the efficacy and safety of ketoprofen (0.5 mg/kg/dose), versus paracetamol (15 mg/kg/dose), in repeated doses, in the treatment of febrile conditions in children aged 6 months to 6 years. |
Active substance: KETOPROFEN |
Study summary document link (including results): Ketoprofen-Study 4.pdf |
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Document reference: 30864 |
Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31137 |
Study title: [A measurement of V/V distribution by intravenous injection of Kr-81m and Tc-99m-MAA--a comparative study with Xe-133 inhalation method] [Article in Japanese]Kaku Igaku. 1988 Apr;25(4):323-9. Ohtani Y 1988 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48542 |
Study title: Can dynamic krypton-81m imaging separate regional ventilation and volume?Lythgoe MF 1992. J Nucl Med. 1992 Nov;33(11):1935-9. Comment in:J Nucl Med. 1992 Nov;33(11):1939-42. |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48534 |
Study title: Comparative assessment of the effects of 6-methyl-prednisolone and deflazacort in the maintenance therapy of rheumatoid arthritis patients - Colombo B, Sinigaglia L, Cagnoli M and Imbimbo B - 1986 - Report (reference 39) in the Clinical Documentation Deflazacort 6mg tablet - 04/1991 - |
Active substance: DEFLAZACORT |
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Document reference: 25632 |
Study title: Medical examiner reports of dextromethorphan exposures in the drug abuse warning network. -McElwee NE. et al.- 1991 (J. Clin. Res. Pharmacoepidemiol.; 5: 167) - Publication of Part IV Dextromethorphan HBr Syrup 1% - |
Active substance: DEXTROMETHORPHAN |
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Document reference: 25835 |
Study title: Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975) |
Active substance: DANTROLENE |
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Document reference: 25533 |
Study title: Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7. |
Active substance: DIAZEPAM |
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Document reference: 25938 |
Study title: AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ronald-S, Bonnema-Sally-K. IN Division of Pediatric Pulmonology, Department of Pediatrics, Kalamazoo Center for Medical Studies, Michigan State University, 49008, USA. Homnick@kcms.msu.edu. YR 2004.AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ron... |
Active substance: CYPROHEPTADINE |
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Document reference: 25235 |
Study title: Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, |
Active substance: VERAPAMIL |
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Document reference: 45535 |
Study title: Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, |
Active substance: VERAPAMIL |
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Document reference: 45545 |
Study title: Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, |
Active substance: VERAPAMIL |
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Document reference: 45541 |
Study title: (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68, (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68, |
Active substance: VERAPAMIL |
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Document reference: 45551 |
Study title: Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, |
Active substance: VERAPAMIL |
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Document reference: 45548 |
Study title: Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70, |
Active substance: VERAPAMIL |
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Document reference: 45560 |
Study title: Bronchiectasis in childhood. Comparison of chest roentgenograms, bronchography and lung scintigraphy.Pediatr Radiol. 1980 Jul;9(4):193-8. Vandevivere J 1980 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48556 |
Study title: [Pulmonary ventilation studies of asthmatic children with Kr-81m (author's transl)] [Article in Japanese]Nippon Igaku Hoshasen Gakkai Zasshi. 1979 May 25;39(5):499-505.Uchiyama G 1979 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48557 |
Study title: Assessment of lung perfusion impairment in patients with pulmonary artery-occlusive and chronic obstructive pulmonary diseases with noncontrast electrocardiogram-gated fast-spin-echo perfusion MR imaging. J Magn Reson Imaging. 2004 Oct;20(4):601-11. Ogasawara N 2004 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48793 |
Study title: COMPARATIVE STUDY OF AMPICILLIN/SULBACTAM VS CEFOTAXIME PLUS AMPICILLIN IN PREVENTING INFECTIONS OF BACTERIAL ETIOLOGY IN PATIENTS UNDERGOING ELECTIVE LIVER TRANSPLANTS |
Active substance: SULBACTAM |
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Document reference: 42657 |
Study title: Use of Tc-99m MAA in determining the etiology of increasing cyanosis following SVC-PA anastomosis for the hypoplastic left heart syndrome. Clin Nucl Med. 1991 Jun;16(6):410-2. Glass T 1991 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48822 |
Study title: Comparison of Bone and Gallium-67 Imagingin Heroin Users'ArthritisA. Bittini, P L. Dominguez, M. L. Martinez Pueyo, F. J. Lopez Longo, I. Monteagudo, and L. Carreflo. J Nuci Med 26:1377—1381, 1985 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48834 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULTAMICILLIN IN PATIENTS WITH RECURRENT TONSILLITIS DUE TO GABHS. |
Active substance: SULTAMICILLIN |
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Document reference: 43022 |
Study title: Fucidin® ointment: survey of clinical trial. Fucidin® ointment was applied once daily to 10 children with impetigo, 2 patients with eczema and 20 adults with infected ulcers. Treatment was successful in all cases of impetigo and in patients with superficial leg ulcers whereas the treatment of 6 patients with 'deeper' ulcers was discontinued because of pain on application. Inflammation was also seen in another subject. |
Active substance: FUSIDIC ACID |
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Document reference: 28678 |
Study title: Chong AL, Clinton F, Breatnach F, O'Marcaigh A, Butler K, O'Meara A. Cytomegalovirus infection in paediatric haemopoietic stem cell transplantation.Ir Med J. 2008 Jan;101(1):17-21.Chong AL, Clinton F, Breatnach F, O'Marcaigh A, Butler K, O'Meara A. Cytomegalovirus infection in paediatric haemopoietic stem cell transplantation.Ir Med J. 2008 Jan;101(1):17-21. |
Active substance: Foscarnet |
Study summary document link (including results): Chong et al 2008.pdf |
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Document reference: 39614 |
Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF INTRAABDOMINAL INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42859 |
Study title: Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9,Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9, |
Active substance: VERAPAMIL |
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Document reference: 45561 |
Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Holloway et al. (The American journal of clinical pathology, 1969 Jun;51(6):705-8) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_1.xlsx |
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Document reference: 49070 |
Study title: An Open-Label, Dose-Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children with Attention-Deficit/Hyperactivity Disorder |
Active substance: ATOMOXETINE |
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Document reference: 21979 |
Study title: The purpose uf this study was to determine what beneficiaI effect, if any, large doses of penicillin G procaine have on the treatment of hospitalized patients with pneumococcal pneumonia of varying severity, and to examine the effect of this treatment on the colonization and superinfection rates in these patients.Brewin et al. (JAMA 230:409-413, 1974) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_3.xlsx |
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Document reference: 49072 |
Study title: |
Active substance: BENZENTHONIUM AND LIDOCAINE |
Study summary document link (including results): |
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Document reference: 22286 |
Study title: A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. The Japanese Pediatric IgA Nephropathy Treatment Study Group.Yoshikawa N, Ito H, Sakai T, Takekoshi Y, Honda M, Awazu M, Ito K, Iitaka K, Koitabashi Y, Yamaoka K, Nakagawa K, Nakamura H, Matsuyama S, Seino Y, Takeda N, Hattori S, Ninomiya M. J Am Soc Nephrol. 1999 Jan;10(1):101-9. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49225 |
Study title: A randomized multicenter trial of OKT3 mAbs induction compared with intravenous cyclosporine in pediatric renal transplantation.Benfield MR1, Tejani A, Harmon WE, McDonald R, Stablein DM, McIntosh M, Rose S; CCTPT Study Group. Pediatr Transplant. 2005 Jun;9(3):282-92. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49267 |
Study title: Acute renal failure in paediatric systemic lupus erythematosus: treatment and outcome.Benseler SM, Bargman JM, Feldman BM, Tyrrell PN, Harvey E, Hebert D, Silverman ED. Rheumatology (Oxford). 2009 Feb;48(2):176-82 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49288 |
Study title: Adverse events leading to modification of therapy in a large cohort of patients with inflammatory bowel disease.Hindorf U, Lindqvist M, Hildebrand H, Fagerberg U, Almer S. Aliment Pharmacol Ther. 2006 Jul 15;24(2):331-42. |
Active substance: Azathioprine |
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Document reference: 49272 |
Study title: [Regional cerebral blood flow image by the method of single photon emission computed tomography: continuous intracarotid injection of krypton-81m (author's transl)] [Article in Japanese]Kaku Igaku. 1980 Aug;17(7):829-32. Maeda T 1980 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48555 |
Study title: Regional ventilation in infancy. Reversal of adult pattern.N Engl J Med. 1985 Dec 26;313(26):1626-8. Davies H, 1985 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48546 |
Study title: Right ventricular performance and pulmonary haemodynamics in adolescent and adult patients with cystic fibrosisEur J Pediatr. 1988 Dec;148(3):187-92.Burghuber OC 1988 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48541 |
Study title: Von Kleist-Retzow J-C et al., Klinik und Therapie d.Knollenblätterpilzverg. im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood); Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995 |
Active substance: (HERB) Milk thistle fruit, dry extract, 36 - 44 : 1 (Silymarin 77.5 %) (Legalon) |
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Document reference: 39712 |
Study title: Safety and immunogenicity of acellular pertussis combined with tetanus and diphtheria toxoids adsorbed and inactivated poliomyelitis vaccine (TdcP-IPV) in adolescents and adults compared to Td-mlPV and cP given separately in adolescents and compared to TdcP or Td given separately with IPV or cP in adults |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 21208 |
Study title: McIntyre−J, Hull−D. Comparing efficacy and tolerability of ibuprofen and paracetamol in fever. {Arch−Dis−Child}, Feb 1996, vol. 74, no. 2, p. 164−7McIntyre−J, Hull−D. Comparing efficacy and tolerability of ibuprofen and paracetamol in fever. {Arch−Dis−Child}, Feb 1996, vol. 74, no. 2, p. 164−7 |
Active substance: IBUPROFEN |
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Document reference: 29580 |
Study title: Wirksamkeit von Ichthocortin® Gel auf grampositive Bakterien bei Patienten mit Neurodermitis |
Active substance: HYDROCORTIZONE |
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Document reference: 29188 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. (Jan 1988) |
Active substance: IBUPROFEN |
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Document reference: 29380 |
Study title: A three month, double blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 mcg twice daily of Formoterol-HFA and 12 mcg twice daily of Formoterol-DPI (Foradil Aerolizer) in childrem with persistent asthmaStudy report |
Active substance: cur |
Study summary document link (including results): RA-RS-3301-002-05 (Synopsis).doc |
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Document reference: 49214 |
Study title: Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187. Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187. |
Active substance: CYCLOPENTOLATE |
Study summary document link (including results): Comparison of the effect of atropine and cyclopentolate on m.pdf |
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Document reference: 24707 |
Study title: 37. Osimani et al., An Fac Med Montev 1963; 48: 34-41 37. Osimani et al., An Fac Med Montev 1963; 48: 34-41 |
Active substance: PYRVINIUM |
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Document reference: 39566 |
Study title: To determine if systemic absorption of (pyrvinium pamoate) C1-316 occures in children following single oral doses of 5 mg/kg.Heffelfinger |
Active substance: PYRVINIUM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Pyrvin embonate_1.xls |
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Document reference: 49077 |
Study title: Treatment of Refractory Arrhythmias with Propafenone in Pediatric Patients |
Active substance: PROPAFENONE |
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Document reference: 35058 |
Study title: ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE VS. MEBENDOZOLE IN PATIENTS WITH ASCARIASIS. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf |
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Document reference: 46147 |
Study title: Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, |
Active substance: VERAPAMIL |
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Document reference: 45539 |
Study title: Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8,Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8, |
Active substance: VERAPAMIL |
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Document reference: 45538 |
Study title: Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9, Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9, |
Active substance: VERAPAMIL |
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Document reference: 45552 |
Study title: Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3, Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3, |
Active substance: VERAPAMIL |
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Document reference: 45558 |
Study title: Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, |
Active substance: VERAPAMIL |
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Document reference: 45564 |
Study title: Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, |
Active substance: VERAPAMIL |
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Document reference: 45562 |
Study title: Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, |
Active substance: VERAPAMIL |
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Document reference: 45554 |
Study title: Betaxolol in the treatment of arterial hypertension: summary of clinical studies - MR95, MR17, MR107 Betaxolol Core Dossier - April 1999 - Part IVB1 Clinical documentation Volume 2 |
Active substance: BETAXOLOL |
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Document reference: 41926 |
Study title: Azathioprine as a treatment option for uveitis in patients with juvenile idiopathic arthritis.Goebel JC, Roesel M, Heinz C, Michels H, Ganser G, Heiligenhaus A. Br J Ophthalmol. 2011 Feb;95(2):209-13 |
Active substance: Azathioprine |
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Document reference: 49293 |
Study title: Azathioprine for long-term maintenance of remission in autoimmune hepatitis.Johnson PJ, McFarlane IG, Williams R. N Engl J Med. 1995 Oct 12;333(15):958-63. |
Active substance: Azathioprine |
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Document reference: 49215 |
Study title: Azathioprine in patients with juvenile chronic arthritis: a longterm followup study.Savolainen HA1, Kautiainen H, Isomäki H, Aho K, Verronen P. J Rheumatol. 1997 Dec;24(12):2444-50. |
Active substance: Azathioprine |
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Document reference: 49222 |
Study title: Childhood-onset lupus nephritis: a single-center experience of pulse intravenous cyclophosphamide therapy.Barbano G, Gusmano R, Damasio B, Alpigiani MG, Buoncompagni A, Gattorno M, Perfumo F. J Nephrol. 2002 Mar-Apr;15(2):123-9. |
Active substance: Azathioprine |
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Document reference: 49253 |
Study title: Combined therapy with prednisolone, azathioprine, heparin-warfarin, and dipyridamole for paediatric patients with severe IgA nephropathy--is it relevant for adult patients?Yoshikawa N, Ito H. Nephrol Dial Transplant. 1999 May;14(5):1097-9. |
Active substance: Azathioprine |
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Document reference: 49227 |
Study title: Comparison between mycophenolate mofetil and azathioprine based immunosuppression in pediatric renal transplantation from living related donors.Antoniadis A, Papachristou F, Gakis D, Takoudas D, Sotiriou I. Transplant Proc. 1998 Dec;30(8):4085-6. |
Active substance: Azathioprine |
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Document reference: 49224 |
Study title: Assessment of thiopurine methyltransferase and metabolite formation during thiopurine therapy: results from a large Swedish patient population.Hindorf U1, Peterson C, Almer S. Ther Drug Monit. 2004 Dec;26(6):673-8. |
Active substance: Azathioprine |
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Document reference: 49266 |
Study title: Comparison of three different methods of estimating the glomerular filtration rate in children after renal transplantation.al-Harbi N, Lireman D. Am J Nephrol. 1997;17(1):68-71. |
Active substance: Azathioprine |
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Document reference: 49219 |
Study title: Controlled trial of pulse versus continuous prednisolone and cyclophosphamide in the treatment of systemic vasculitis.Adu D, Pall A, Luqmani RA, Richards NT, Howie AJ, Emery P, Michael J, Savage CO, Bacon PA. QJM. 1997 Jun;90(6):401-9. |
Active substance: Azathioprine |
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Document reference: 49221 |
Study title: A phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental painA phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental pain |
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
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Document reference: 29681 |
Study title: American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546 |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29067 |
Study title: A Single Dose, Randomized, Open-Label, Single Center, Two-Way Crossover Pharmacokinetic Study of Advil® Cold & Sinus Tablets in Children |
Active substance: IBUPROFEN |
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Document reference: 29539 |
Study title: Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures; Paediatr Anaesth 2002, 12(7):594-9 |
Active substance: FENTANYL |
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Document reference: 27190 |
Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Cedax Suspension/Keimax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels |
Active substance: CEFTIBUTEN |
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Document reference: 48847 |
Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Uroced/Cedax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels |
Active substance: CEFTIBUTEN |
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Document reference: 48850 |
Study title: Oral Cefixime is Similar to Continued Intravenous Antibiotics in the Empirical (Clin Infect Dis 2001; 32: 36-43); Paganini HR. Oral Cefixime is Similar to Continued Intravenous Antibiotics in the Empirical (Clin Infect Dis 2001; 32: 36-43); Paganini HR. |
Active substance: CEFIXIME |
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Document reference: 23421 |
Study title: An open randomised multicentre comparison of cefuroxime axetil suspension and amoxycillin syrup in the treatment of children with pharyngitis and tonsillitis. |
Active substance: CEFUROXIME |
Study summary document link (including results): Study CAET94 Cefuroxime Axetil (Suspension).xls |
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Document reference: 47731 |
Study title: Treatment of staphylococcal skin infections: a comparison of cephalexin and dicloxacillin. Dillon HC Jr. J Am Acad Dermatol. 1983 Feb;8(2):177-81. |
Active substance: Cephalexin |
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Document reference: 48898 |
Study title: Erfahrungen mit einem Faktor II-, IX- und X-Konzentrat. Laboratoriumsuntersuchungen, In-Vivo-Recovery und klinische Ergebnisse. Global-Druck und Verlag, Heidelberg, (1980).(Vinazzer H, Bergmann H.) |
Active substance: FACTOR VIII INHIBITOR BYPASSING ACT |
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Document reference: 26997 |
Study title: 99mTc-HMPAO single photon emission computed tomography (SPECT) in both asphyxiated and epileptic children with or without status epilepticusJ Child Neurol. 2005 Jul; 20(7):560-5. Oner n 2005 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48618 |
Study title: "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. " "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. " |
Active substance: PRAZEPAM |
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Document reference: 34644 |
Study title: OPEN, NON-COMPARATIVE STUDY DAY THE EFFICACY AND TOLERATION OF PIROXICAM FAST DISSOLVING DOSAGE FROM (FDDF) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34387 |
Study title: Study defined factors in the pathogenesis for relapse (bacteriological and clinical) in 337 children with URT infections with cultured group A beta hemolytic streptococci.Rosenstein et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_4.xlsx |
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Document reference: 49035 |
Study title: Palatal tremor in childhood: clinical and therapeutic considerations |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE07D0626 - Piracetam.pdf |
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Document reference: 45926 |
Study title: Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, |
Active substance: VERAPAMIL |
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Document reference: 45534 |
Study title: Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, |
Active substance: VERAPAMIL |
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Document reference: 45536 |
Study title: Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, |
Active substance: VERAPAMIL |
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Document reference: 45544 |
Study title: Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84,Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84, |
Active substance: VERAPAMIL |
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Document reference: 45553 |
Study title: Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82, Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82, |
Active substance: VERAPAMIL |
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Document reference: 45563 |
Study title: Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32, Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32, |
Active substance: VERAPAMIL |
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Document reference: 45549 |
Study title: Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind randomized cross−over study).Paterna S, Martino SG, Campisi D, Cascio IN, Marsala BA. La Clinica terapeutica, 31 Jul 1990, vol. 134, no. 2, p. 119−25, Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind random... |
Active substance: VERAPAMIL |
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Document reference: 45557 |
Study title: Favorable effects of immunosuppressive therapy in children with dilated cardiomyopathy and active myocarditis.Camargo PR, Snitcowsky R, da Luz PL, Mazzieri R, Higuchi ML, Rati M, Stolf N, Ebaid M, Pileggi F. Pediatr Cardiol. 1995 Mar-Apr;16(2):61-8. |
Active substance: Azathioprine |
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Document reference: 49216 |
Study title: Five-year outcome in pediatric patients with mycophenolate mofetil-based renal transplantation.Jungraithmayr TC, Wiesmayr S, Staskewitz A, Kirste G, Bulla M, Fehrenbach H, Dippell J, Greiner C, Griebel M, Helmchen U, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Tönshoff B, Weber LT, Zimmerhackl LB; German Pediatric Renal Transplantation Study Group. Transplantation. 2007 Apr 15;83(7):900-5. |
Active substance: Azathioprine |
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Document reference: 49279 |
Study title: Follow-up of children with autoimmune hepatitis treated with cyclosporine.Cuarterolo M, Ciocca M, Velasco CC, Ramonet M, González T, López S, Garsd A, Alvarez F. J Pediatr Gastroenterol Nutr. 2006 Nov;43(5):635-9. |
Active substance: Azathioprine |
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Document reference: 49277 |
Study title: Heart transplantation in patients with previous Fontan operations.Gamba A1, Merlo M, Fiocchi R, Terzi A, Mammana C, Sebastiani R, Ferrazzi P. J Thorac Cardiovasc Surg. 2004 Feb;127(2):555-62. |
Active substance: Azathioprine |
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Document reference: 49261 |
Study title: Improved efficacy of basiliximab over antilymphocyte globulin induction therapy in paediatric renal transplantation.Clark G1, Walsh G, Deshpande P, Koffman G. Nephrol Dial Transplant. 2002 Jul;17(7):1304-9. |
Active substance: Azathioprine |
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Document reference: 49255 |
Study title: Al-Kandari et al. Regional cerebral blood flow in patients with sickle cell disease: study with single photon emission computed tomographyAnnals of nuclear medicine (2007), 21(8), 439-45. Al-Kandari fa 2007 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48604 |
Study title: Altiay et al. 99mTc-HMPAO brain perfusion single-photon emission computed tomography in children with Down syndrome: relationship to epilepsy, thyroid functions, and congenital heart diseaseJournal of child neurology (2006), 21(7) 610-4. altiay s 2006 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48605 |
Study title: Brain Perfusion SPECT in Juvenile Neuro-Behc¸et’s DiseaseSilvia Vignola, Flavio Nobili, Paolo Picco, Marco Gattorno, Antonella Buoncompagni, Paolo Vitali, Giuliano Mariani, and Guido Rodriguez. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 8 • August 2001 |
Active substance: CERETEC |
Study summary document link (including results): vignola s 2001.pdf |
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Document reference: 48603 |
Study title: Chang et al. Comparison between technetium-99m hexamethylpropylene amineoxide labeled white blood cell abdomen scan and abdominal sonography to detect appendicitis in children with an atypical clinical presentation. Hepatogastroenterology.Hepatogastroenterology. 2003 Mar-Apr;50(50):426-9. Chen-chang c 2003 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48606 |
Study title: Charron et al. Assessment of terminal ileal and colonic inflammation in Crohn's disease with 99mTc-WBC.Acta Paediatr. 1999 Feb; 88(2):193-8 charron m 1999 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48607 |
Study title: Comparison of brain perfusion SPECT and MRI findings in children with neuronal ceroid-lipofuscinosis and in their families.Ann Nucl Med. 2002 May; 16(3):201-6. sayit e 2002 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48620 |
Study title: Diagnostic performance of 18F-FDG PET and ictal 99mTc-HMPAO SPET in pediatric temporal lobe epilepsy: Quantitative analysis by statistical parametric mapping, statistical probabilistic anatomical map, and subtraction ictal SPETJong Jin Lee a, Won Jun Kang a, Dong Soo Lee a,*, Jae Sung Lee a, Hee Hwang b, Ki Joong Kim b, Yong-Seung Hwang b, June-Key Chung a, Myung Chul Lee a. Seizure (2005) 14, 213—220 |
Active substance: CERETEC |
Study summary document link (including results): lee jj 2005.pdf |
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Document reference: 48595 |
Study title: Differences in 99mTc-HMPAO brain SPET perfusion imaging between Tourette’s syndrome and chronic tic disorder in childrenNan-Tsing Chiu1, Ying-Chao Chang2, Bi-Fang Lee1, Chao-Ching Huang3, Shan-Tair Wang4. European Journal of Nuclear Medicine Vol. 28, No. 2, February 2001 |
Active substance: CERETEC |
Study summary document link (including results): nan-tsing chiu 2001.pdf |
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Document reference: 48597 |
Study title: A Randomized, Multicenter Masked Comparison Trial of Poractant Alfa (Curosurf) versus Beractant (Survanta) in the Treatment of Respiratory Distress Syndrome in Preterm InfantsRangasamy Ramanathan, |
Active substance: PORACTANT ALFA |
Study summary document link (including results): DL-032 publication.pdf |
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Document reference: 49238 |
Study title: Comparison of Prophylaxis and Rescue Treatment With Curosurf in Neonates Less than 30 Weeks' Gestation: A Randomized TrialPediatrics 1993;92;768, Johannes Egberts, |
Active substance: PORACTANT ALFA |
Study summary document link (including results): 50.01-CT-02-93 publication.pdf |
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Document reference: 49231 |
Study title: Modifications of Surfactant Phospholipid Pattern in Premature Infants Treated with Curosurf. Clinical and Dietary Correlations.(Haumont D, Clercx A, Rossle C, Biver A, Carpentier Y A.) |
Active substance: PORACTANT ALFA |
Study summary document link (including results): Haumont D. (Published paper 910177).pdf |
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Document reference: 49244 |
Study title: Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curo4 trial)Please see report |
Active substance: PORACTANT ALFA |
Study summary document link (including results): EURO VI publication.pdf |
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Document reference: 49243 |
Study title: Porcine surfactant replacement therapy in newborns of 25-3 1 weeks' gestation: a randomized, multicentre trial of prophylaxis versus rescue with multiple low dosesActa Paediatr 84: 913-21. 1995, H Walti |
Active substance: PORACTANT ALFA |
Study summary document link (including results): 50.01-CT-04-93 publication.pdf |
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Document reference: 49234 |
Study title: Prophylactic or Early Selective Surfactant Combined With nCPAP in Very Preterm InfantsPediatrics 2010;125;e1402 |
Active substance: PORACTANT ALFA |
Study summary document link (including results): DM.PR.5000.002.04 publication.pdf |
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Document reference: 49239 |
Study title: Randomised ,multicentre,clinical study on the treatment with natural surfactant of neonatal respiratory distress syndrome in premature infants : comparison between early and late treatmentPediatrics, VOLUME 82 NOVEMBER 1988 NUMBER 5 |
Active substance: PORACTANT ALFA |
Study summary document link (including results): CH-CUR-0003 publication..pdf |
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Document reference: 49237 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL (AMS) DISORDERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34457 |
Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49263 |
Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594. |
Active substance: Azathioprine |
Study summary document link (including results): |
View full study record |
Document reference: 49270 |
Study title: Methotrexate treatment in pediatric Crohn disease patients intolerant or resistant to purine analogues.Weiss B, Lerner A, Shapiro R, Broide E, Levine A, Fradkin A, Bujanover Y. J Pediatr Gastroenterol Nutr. 2009 May;48(5):526-30 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49292 |
Study title: Monitoring 6-thioguanine nucleotide concentrations in Japanese children and adolescents with inflammatory bowel disease.Ohtsuka Y, Arai K, Aoyagi Y, Fujii T, Yamakawa Y, Ohtani K, Ikuse T, Baba Y, Inage E, Kudo T, Suzuki R, Nagata S, Shimizu T. J Gastroenterol Hepatol. 2010 Oct;25(10):1626-30 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49294 |
Study title: Monitoring azathioprine metabolite levels and thiopurine methyl transferase (TPMT) activity in children with inflammatory bowel disease.Paerregaard A, Schmiegelow K. Scand J Gastroenterol. 2002 Mar;37(3):371-2. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49252 |
Study title: Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data.Webb NJ, Prokurat S, Vondrak K, Watson AR, Hughes DA, Marks SD, Moghal NE, Fitzpatrick MM, Milford DV, Saleem MA, Jones CA, Friman S, Van Damme-Lombaerts R, Janssen F, Hamer C, Rhodes S. Pediatr Nephrol. 2009 Jan;24(1):177-82 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49286 |
Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part I).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49281 |
Study title: Effects of long-term methylphenidate treatment: A pilot follow-up clinical and SPECT studyAynur Pekcanlar Akaya,⁎, Gamze Çapa Kaya b, Neslihan İnal Emiroğlu a, Aysel Aydın b, E. Serap Monkulc,d, Cengiz Taşçı b, Süha Miral a, Hatice Durak b. Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 1219–1224 |
Active substance: CERETEC |
Study summary document link (including results): akay ap 2006.pdf |
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Document reference: 48592 |
Study title: Functional assessment of intracranial arachnoid cysts with TC99 m-HMPAO SPECT: a preliminary report.Childs Nerv Syst. 2006 Sep;22(9):1091-7. martínez-Lage jf 2006 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48614 |
Study title: Gibson et al. 99Tcm-HMPAO leucocyte labelling in orofacial granulomatosis and gastrointestinal Crohn's disease in childhood and early adulthoodNuclear medicine communications (2000), 21(2), 155-8. gibson j 2000 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48610 |
Study title: Griffiths et al. 99mTechnetium HMPAO imaging in children with the Sturge- Weber syndrome: a study of nine cases with CT and MRI correlationNeuroradiology (1997), 39(3), 219-24. Griffiths pd 1997 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48611 |
Study title: Hwang et al. Regional cerebral perfusion abnormalities in developmental language disorder. Statistical parametric mapping analysisEur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):131-7. hwang jw 2006 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48612 |
Study title: La gammagrafía con leucocitos marcados con 99mTc-HMPAO en el diagnóstico y seguimiento de la enfermedad inflamatoria intestinalJ. Verdú Ricoa, M. Juste Ruizb, R. Jovera, J. Muñoz Acostaa, J. Muñoza, A. Martínez Caballeroa, A. Antón Leala y O. Caballero Carpenaa. An Pediatr (Barc). 2006;64(5):457-63 |
Active substance: CERETEC |
Study summary document link (including results): verdu j 2006.pdf |
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Document reference: 48602 |
Study title: Parietal lobe epileptic focus identified on SPECT-MRI fusion imaging in a case of epilepsia partialis continua.Clin Nucl Med. 2006 Dec;31(12):826-8. matthews r 2006 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48615 |
Study title: SPECT FINDINGS IN CHILDREN WITH SPECIFIC LANGUAGE IMPAIRMENTMarianne Ors1, Erik Ryding1, Magnus Lindgren2, Peik Gustafsson3, Gösta Blennow4 and Ingmar Rosén1. Cortex, (2005) 41, 316-326 |
Active substance: CERETEC |
Study summary document link (including results): ors m 2005.pdf |
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Document reference: 48598 |
Study title: Tc-99 HMPAO cerebral SPECT imaging in brain death patients with complex spinal automatismTurkish journal of trauma & emergency surgery : TJTES (2002), 8(4), 198-201. Kahveci sf 2002 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48613 |
Study title: Tc-99m HMPAO labeled white blood cell imaging in a child with eosinophilic lung diseaseClinical nuclear medicine (2008), 33(1), 38-40 moralidis r 2008 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48616 |
Study title: Kremens B et al, High-dose consolidation with local radiation and bone marrow rescue in patients with advanced neuroblastoma, Med Pediatr Oncol. 1994;23(6):470-5 |
Active substance: ETOPOSIDE |
Study summary document link (including results): |
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Document reference: 26950 |
Study title: A 5-year, multicenter, open-label, parallel group, randomized study to demonstrate the short and long-term safety of Elidel (pimecrolimus, ASM981) cream 1% in the treatment of mild to moderate atopic dermatitis in infants (3 − < 12 months of age)Study report |
Active substance: PIMECROLIMUS |
Study summary document link (including results): Pimecrolimus Art.45 study.pdf |
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Document reference: 49194 |
Study title: In vitro generation of cytotoxic effectors activated by interleukin 2 (IL-2): Comparison of autologous peripheral blood stem cells (PBSC) from adults and children. Valteau-Couanet D et al. Bone Marrow Transplant June. 13, 2001, 869-75 |
Active substance: FLUOROURACIL |
Study summary document link (including results): |
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Document reference: 28274 |
Study title: A 3-week, open -label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in Patients with asthma |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47800 |
Study title: 18F-FDG PET/CT fusion imaging in paediatric solid extracranial tumours Biomedicine & Pharmacotherapy 60 (2006) 593–606. C. Nannia, D. Rubellob,*, P. Castelluccia, M. Farsada, R. Franchia, L. Rampinb M.D. Grossc, A. Al-Nahhasd, S. Fantia |
Active substance: Steripet |
Study summary document link (including results): nanni-2006.pdf |
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Document reference: 48738 |
Study title: Nabilone: an effective antiemetic in patients receiving cancer chemotherapy |
Active substance: NABILONE |
Study summary document link (including results): |
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Document reference: 32438 |
Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part II).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49282 |
Study title: Oral tacrolimus treatment of severe colitis in children.Bousvaros A1, Kirschner BS, Werlin SL, Parker-Hartigan L, Daum F, Freeman KB, Balint JP, Day AS, Griffiths AM, Zurakowski D, Ferry GD, Leichtner AM. J Pediatr. 2000 Dec;137(6):794-9. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49249 |
Study title: Short-term cyclosporine induces a remission of autoimmune hepatitis in children.Alvarez F, Ciocca M, Cañero-Velasco C, Ramonet M, de Davila MT, Cuarterolo M, Gonzalez T, Jara-Vega P, Camarena C, Brochu P, Drut R, Alvarez E. J Hepatol. 1999 Feb;30(2):222-7. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49226 |
Study title: The relationship between 99mTc-HMPAO brain SPECT and the scores of real life rating scale in autistic childrenMeryem Kayaa,*, Serap Karasalihog˘lub, Funda U¨ stu¨na, Aziz Gu¨ltekina, Tevfik Fikret C¸ ermika, Yes¸im Fazlıog˘lub, Mevlu¨t Tu¨rec, O¨ mer N. Yig˘itbas¸ıa, S¸ akir Berkardaa. Brain & Development 24 (2002) 77–81 |
Active substance: CERETEC |
Study summary document link (including results): kaya m 2002.pdf |
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Document reference: 48593 |
Study title: Transient Posterior Encephalopathy Induced by Chemotherapy in ChildrenRocı´o Sa´nchez-Carpintero, MD, PhD*, Juan Narbona, MD, PhD*, Reyes Lo´pez de Mesa, MD*, Javier Arbizu, MD‡, and Luis Sierrasesu´maga, MD, PhD†. Pediatr Neurol 2001;24:145-148. |
Active substance: CERETEC |
Study summary document link (including results): Sanchez r 2001.pdf |
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Document reference: 48600 |
Study title: Usefulness of Tc-99m HMPAO-labeled WBC heart scan to predict impaired ventricular function and coronary artery dilation in children with Kawasaki diseaseHsiu-Bao Hsua, Yun-Ching Fub,c,*, Shih-Chuan Tsaid, Ruoh-Fang Yene, Betau Hwangc,f. International Journal of Cardiology 92 (2003) 65– 69 |
Active substance: CERETEC |
Study summary document link (including results): hsiu-bao h 2003.pdf |
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Document reference: 48591 |
Study title: Utility of Tc 99m HMPAO SPECT in the early diagnosis of Rasmussen's syndromeItalian journal of neurological sciences (1998), 19(4),217-20. paladin f 1998 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48619 |
Study title: Tc-99m-HMPAO SPECT in the diagnosis of brain death in childrenPediatrics international : official journal of the Japan Pediatric Society (2004), 46(6), 711-4. okuyaz c 2005 |
Active substance: CERETEC |
Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
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Document reference: 48617 |
Study title: Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4. |
Active substance: CETIRIZINE |
Study summary document link (including results): |
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Document reference: 23659 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A study of the safety and efficacy of RG 5029Y (triamcinolone acetonide) aqueous nasal spray in patients with perennial allergic rhinitis -Procaccini RL -24/02/1994 |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46853 |
Study title: Study the therapeutic action (control and prevention fo asthma attacks) and safety of Triamcinolone hexacetonide in 60 ambulatory patients exhibiting asthma, by means of a trial in which it would be compared with other steroids.Valdés |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 48965 |
Study title: A multicentre double-blind group comparative study of the efficacy and safety of nedocromil sodium 2% ophthalmic solution in the treatment of Ragweed- induced seasonal allergic conjunctivitis - Melamed et al. - 1986 - Application for marketing autorisation - TILAVIST (Nedocromil Sodium 2% Eye drops) - Clinical documentation - OP Van Bijsterveld - 07/04/1993 - |
Active substance: NEDOCROMIL |
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Document reference: 46990 |
Study title: J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL. J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44608 |
Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part III).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49283 |
Study title: Steroid treatment for severe childhood IgA nephropathy: a randomized, controlled trial.Yoshikawa N, Honda M, Iijima K, Awazu M, Hattori S, Nakanishi K, Ito H; Japanese Pediatric IgA Nephropathy Treatment Study Group. Clin J Am Soc Nephrol. 2006 May;1(3):511-7. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49280 |
Study title: The replacement of azathioprine by mycophenolate mofetil in pediatric patients with specific risks in renal transplantation.Anguita A, Repetto HA, Rodriguez-Rilo L, Vazquez LA, Iturzaeta A, Morrone G, Deheza R, Maldonado L, Goldberg JL. Transplant Proc. 1999 Sep;31(6):2279. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49230 |
Study title: Thiopurine metabolite monitoring in paediatric inflammatory bowel disease.Ooi CY, Bohane TD, Lee D, Naidoo D, Day AS. Aliment Pharmacol Ther. 2007 Apr 15;25(8):941-7. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49278 |
Study title: produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52 |
Active substance: BARIUM SULPHATE |
Study summary document link (including results): |
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Document reference: 22197 |
Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6 |
Active substance: ASCORBIC ACID |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48908 |
Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6 |
Active substance: ASCORBIC ACID |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48909 |
Study title: Analyse critique des études cliniques Abbott, contains study 75-030 of Depakene syrup in epileptic children - Canlorbe P. - 03/04/1981 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45447 |
Study title: A Formulation of Aerosolized Tobramycin (BramitobR) in the Treatment of Patients with Cystic Fibrosis and Pseudomonas aeruginosa Infection A Double-Blind, Placebo-Controlled, Multicenter StudyChuchalinet al, Pediatr Drugs 2007; 9 Suppl. 1: 21-31 |
Active substance: TOBRAMYCIN |
Study summary document link (including results): DM.RS.10000.002.04 publication.pdf |
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Document reference: 49196 |
Study title: Efficacy, Safety, and Local Pharmacokinetics of Highly Concentrated Nebulized Tobramycin in Patients with Cystic Fibrosis Colonized with Pseudomonas aeruginosaLenoir et al, Pediatr Drugs 2007; 9 Suppl. 1: 11-20, 1174-5878/07/0001-0011/ |
Active substance: TOBRAMYCIN |
Study summary document link (including results): DM.PR.10000.001.01 publication.pdf |
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Document reference: 49195 |
Study title: A double-blind, randomised trial to compare treatment results for trimethoprim treatment in a once a day-dosage regimen with conventional thrice a day pivmecillinam in female patients with cystitis.Örsten et al |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_7.xlsx |
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Document reference: 49065 |
Study title: Compare the effectiveness of trimethoprim alone with both co-trimoxazole and sulphamethizole for the treatment of uncomplicated urinary tract infections in general practice.Keenan et al |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_6.xlsx |
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Document reference: 49064 |
Study title: Phase 1, Multicenter open-label trial to gain additional experience with topiramate among subjects with infantile spasms |
Active substance: TOPIRAMATE |
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Document reference: 44912 |
Study title: An open study to compare the clinical efficacy and tolerance of two sustained action corticosteroids in ORL manifestations.Larger (Publication Thérapeutique, No. 3 (Suppl.), Apr. 1979) |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 48963 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43110 |
Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6 |
Active substance: TINZANIDINE |
Study summary document link (including results): |
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Document reference: 44790 |
Study title: 41. Phase 3, double-blind, parallel-group, safety and efficacy study of TPM monotherapy in adults with refractory partial epilepsy. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44975 |
Study title: A double blinded trial to compare once a day dose regimen of trimethoprim with standard dose of two tablets twice daily of co-trimoxazole in the treatment of uncomplicated urinary tract infections in general practice.Cartwright et al |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_5.xlsx |
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Document reference: 49063 |
Study title: Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60 |
Active substance: PHENYLEPHRINE |
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Document reference: 33943 |
Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in, in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 mg of nebulized beclomethasone dipropionate or 750mg of nebulized Pulmicort® twice a day.study synopsis. Please see report |
Active substance: BECLAMETHASONE |
Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc |
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Document reference: 49206 |
Study title: Double Blind Double Dummy Multicenter Randomized Parallel-Group Design Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate Suspension for Nebulization and Beclomethasone Dipropionate Spray Via a Metered Dose Inhaler Plus Spacer in the 4-Week Treatment of the Exacerbation of Asthma in Pediatric Patients Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24. |
Active substance: BECLAMETHASONE |
Study summary document link (including results): DM.RS.1404.001.99 publication.pdf |
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Document reference: 49204 |
Study title: Double-Blind Randomized Parallel Group Design Multicentre Study of the Efficacy and Tolerability of Two Nasal Spray Presentations of Beclomethasone Dipropionate ( Clenil Aqua, Chiesi and Beconase Aqua®, Glaxo) 200 mcg/bid in Patients with Allergic RhinitisMarni Et AL |
Active substance: becLAMETHASONE |
Study summary document link (including results): R9010291 publication.pdf |
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Document reference: 49198 |
Study title: Double-Blind Randomized Parallel Group Design Multicentre Study of the Efficacy and Tolerability of Two Nasal Spray Presentations of Beclomethasone Dipropionate ( Clenil Aqua, Chiesi and Beconase Aqua®, Glaxo) 200 mcg/bid in Patients with Allergic Rhinitisstudy synopsis |
Active substance: BECLAMETHASONE |
Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc |
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Document reference: 49199 |
Study title: Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955. |
Active substance: BIOTIN |
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Document reference: 22596 |
Study title: Clinical trial to investigate the efficacy of Lederspan.Gedda |
Active substance: TRIAMCINOLONE |
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Document reference: 48961 |
Study title: Clinical trial to investigate the efficacy of Triamcinolone hexacetonide in patients with chronic articular reumatism.Kodama et al. |
Active substance: TRIAMCINOLONE |
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Document reference: 48962 |
Study title: [Injections and local infiltrations of triamcinolone hexacetonide (Lederle) in rheumatology]. [Article in Spanish] De Usobiaga JL. Rev Esp Reum Enferm Osteoartic. 1970 Apr;13(6):349-59. |
Active substance: TRIAMCINOLONE |
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Document reference: 48960 |
Study title: To show the effect of trimethoprim alone in patients with difficult urinary tract infections.Parkkulainen et al |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_1.xlsx |
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Document reference: 49059 |
Study title: "A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study. J Biederman, et al., Journal of Clinical Psychiatry 2006, 67(5): 727-35. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45291 |
Study title: Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.Soper DE1, Livengood C, Sheehan KL, Fenner DE, Martens MG, Nelson AL, Ismail M, Thorp JM, Lappin M, Fleury FJ, Long BJ, Blackwelder T, Sweet RL, Sagov S. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):150. |
Active substance: METRONIDAZOLE |
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Document reference: 48942 |
Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Nasonex and Associated Tradenames (Mometasone Furoate)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels |
Active substance: MOMETAZONE |
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Document reference: 48849 |
Study title: An open study to investigate the clinical efficacy and grade of pain relief in patients recieving Triamcinolone hexacetonide by intra-articular injections or paravertebral infusions.Bonilla |
Active substance: TRIAMCINOLONE |
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Document reference: 48959 |
Study title: Neuropathic osteonecrosis of the knee in childhood. Two cases of myelomeningocele. Kjaerulff H, Hejgaard N. Acta Orthop Scand. 1987 Aug;58(4):436-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43852 |
Study title: Radionuclide imaging of the patellofemoral joint in young adults with anterior knee pain.Dye SF, Boll DA. Orthop Clin North Am 1986 Apr;17(2):249-62. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48478 |
Study title: Open Randomized Parallel Group Design Trial Investigating the Efficacy and Tolerability of Beclomethasone Dipropionate (100 mcg qid) Dry Powder Delivered from Two Different Powder Inhalers (Chiesi and Glaxo) in the Treatment of Chronic Asthma in ChildrenJOURNAL OF AEROSOL MEDICINE, Volume 13, Number 1, 2000 |
Active substance: BECLAMETHASONE |
Study summary document link (including results): 15.02-CT-92-Pubblication.pdf |
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Document reference: 49201 |
Study title: Comparative Evaluation of Cefixime versus Amoxicillin-Clavulate Following Ceftriaxone Therapy of PneumoniaClin Pediatr 1996; 35: 629-633, Amir J., 1996 |
Active substance: CEFIXIME |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48974 |
Study title: Comparative Evaluation of Cefpodoxime Versus Cefixime in children with Lower Respiratory Tract InfectionsIndian J Pediatr 2004; 71: 517-521 Sengupta J. |
Active substance: CEFIXIME |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48975 |
Study title: An open study to examine whether enhanced control of asthma, assessed by peal flow measurements, was associated wth improvments in patients lifestyles |
Active substance: BUDESONIDE |
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Document reference: 48890 |
Study title: emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68 |
Active substance: BISACODYL |
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Document reference: 22725 |
Study title: Double blind, double dummy, multinational, multicenter, parallel-group design clinical trial of the efficacy and tolerability of budesonide spray aerosol (200 µg unit dose twice daily) administered via pMDI using the HFA-134a or the CFC propellant in a 12-week treatment period of mild to moderate persistent asthma in pediatric patients. Comparison with an open-label control group treated with budesonide HFA-134a (200 µg unit dose twice daily) given with the ‘JET’ spacer device |
Active substance: BUDESONIDE |
Study summary document link (including results): DM-PR-3307-003-03.doc |
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Document reference: 49197 |
Study title: Effect of budesonide on bronchial hyperresponsiveness and pulmonary function in patients with mild to moderate asthma.Kivity S, Fireman E, Greif J, Schwarz Y, Topilsky M. Ann Allergy. 1994 Apr;72(4):333-6. |
Active substance: BUDESONIDE |
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Document reference: 48891 |
Study title: Efficacy and tolerability of morniflumate in the treatment of acute pharyngotonsillitis in children. Clinica,anno XXIX, 77-84, gennaio-giugno 1990R.Riondino et al, 1990. Clinica Europea 1990, Riondino |
Active substance: MORNIFLUMATE |
Study summary document link (including results): Clinica Europea 1990, Riondino.pdf |
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Document reference: 48878 |
Study title: Treatment of acute bronchitis in childhood with morniflumate. Clinica,anno XXIX, 77-84, gennaio-giugno 1990L.Longo et al , 1990. Clinica Europea 1990 Longo |
Active substance: MORNIFLUMATE |
Study summary document link (including results): Clinica Europea 1990 Longo.pdf |
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Document reference: 48877 |
Study title: Recommended use of morphine in neonates, infants and children based on a literature review: Part 2 - Clinical use.Paediatr Anaesth 1997; 2: 93-101, Kart T, Christrup LL, Rasmussen M., 1997 |
Active substance: MORPHINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48929 |
Study title: Hofmann S, Knoefler R, Lorenz N, et al. Clinical experiences with low molecular weight heparins in pediatric patients. Thrombosis Research 2001;103: 345–53." |
Active substance: NADROPARIN |
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Document reference: 32450 |
Study title: Quach et al. Thyroid and hepatic function after high-dose (131) I-metaiodobenzylguanidine ((131 I) -MIBG) therapy for neuroblastoma Pediatr Blood Cancer. 2010 Sep 9 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48326 |
Study title: Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8 |
Active substance: DILTIAZEM |
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Document reference: 26148 |
Study title: A new bowel preparation for elective colon and rectal surgery. A prospective, randomized clinical trial.Wolff BG, Beart RW Jr, Dozois RR, Pemberton JH, Zinsmeister AR, Ready RL, Farnell MB, Washington JA 2nd, Heppell J. Archives of surgery (Chicago Ill. : 1960), Jul 1988, vol. 123, no. 7, p. 895−900 |
Active substance: ERYTHROMYCIN |
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Document reference: 26507 |
Study title: Neurology. 1995 Jan;45(1):123-6. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28201 |
Study title: Aspects of pharmacology of Gentamicin in Newborn Infants - Andersen JH. & Al - 1972 ( Acta Paediat. Scand. 61:343-9) - Publication in Gentamicin Registration Dossier - 1978 -Aspects of pharmacology of Gentamicin in Newborn Infants - Andersen JH. & Al - 1972 ( Acta Paediat. Scand. 61:343-9) - Publication in Gentamicin Registration Dossier - 1978 - |
Active substance: GENTAMYCIN |
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Document reference: 28890 |
Study title: A Double blind, placebo-controlled trial for further evaluation of the effect of these preparations in migraine and also of their side-effects.Kallós et al. (Translation of a paper from The Swedish Medical journal (Svenska Läkartidningen) 1958:55:1782 No. 24) |
Active substance: ergotamine |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_1.xlsx |
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Document reference: 49073 |
Study title: Comparisons of the effect of ergotamine tartrate adminislered intramuscularly, by inhalation (Medihaler ergotamine) or rectally in combination with meprobamate, chlorcyc1izine, and caffeine (Anervan suppositories ):t, in the treatment of migraine attacks.Kallós et al. REPRINTED FROM HEADACHE, October, 1964 |
Active substance: ergotamine |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_2.xlsx |
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Document reference: 49074 |
Study title: Compare the clinical efficacy and tolerance of a new erythromycin formulation, when administered twice or four times daily in acute bronchitis.Pekkanen (Rhinology, 21, 00-00, 1983) |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_2.xlsx |
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Document reference: 49050 |
Study title: Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39920 |
Study title: Postoperative emesis after pediatric strabismus surgery. the effect of dixyrazine compared to droperidol |
Active substance: DIXYRAZINE |
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Document reference: 26278 |
Study title: Examine the variability in erythromycin pharmacokinetics after single dose intravenous administration, determine the linearity of pharmacokinetic parameters after administration of different doses, evaluate the usefulness of non-invasive sampling techniques in studying erythromycin pharmacokinetics.Klaustin et al. (Br. J. Am. Pharmac. 1980, 273-279) |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_7.xlsx |
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Document reference: 49055 |
Study title: Treatment of Neonatal Sepsis with Ceftriaxone/Gentamicin and with Azlocillin/Gentamicin: A Clinical Comparison of Efficacy and Tolerability Chemotherapy1988; 34: 158-163, Wiese G. |
Active substance: GENTAMYCIN |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48934 |
Study title: Bassi F, Serio M. Treatment with an LH-RH agonist ('Zoladex' depot) in patients with precocious puberty. (Ita, English translation). Drugs under Experimental and Clinical Research 1990;16(Suppl):33-37 1990;(Suppl):33-37.Bassi F, Serio M. Treatment with an LH-RH agonist ('Zoladex' depot) in patients with precocious puberty. (Ita, English translation). Drugs under Experimental and Clinical Research 1990;16(Suppl):33-37 1990;(Suppl):33-37. |
Active substance: GOSERELIN |
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Document reference: 29003 |
Study title: A PROSPECTIVE SURVEY OF OPPORTUNISTIC INFECTIONS IN PATIENTS RECEIVING CHEMOTHERAPY FOR ACUTE LEUKEMIAS. |
Active substance: FLUCONAZOLE |
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Document reference: 27481 |
Study title: ONCE-WEEKLY ORAL FCA VS. PLACEBO IN THE PREVENTION OF MUCOCUTANEOUS FUNGAL INFECTIONS IN PATIENTS DISCHARGED FROM THE HOSPITAL AFTER BONE MARROW TRANSPLANTATION. |
Active substance: FLUCONAZOLE |
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Document reference: 27611 |
Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS ON IVH |
Active substance: FLUCONAZOLE |
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Document reference: 27520 |
Study title: Quality of life in a double-blind, randomised, placebo-controlled parallel study comparing the efficacy and safety of three dosage strengths of fexofenadine HCl (15, 30 and 60 mg BID) in paediatric patients (ages 6 to 11 years) in the treatment of Seasonal Allergic Rhinitis, 22 April 1998 |
Active substance: FEXOFENADINE |
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Document reference: 27259 |
Study title: SAFETY AND EFFICACY OF ORAL AND INTRAVENOUS FLUCONAZOLE IN PATIENTS WITH GASTRO-INTESTINAL CANDIDIASIS. |
Active substance: FLUCONAZOLE |
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Document reference: 27784 |
Study title: A comparative study of Fucidin H cream and Hydrocortisone cream in children (4-17 years) with a flare-up of atopic dermatitis. A study using non-invasive bioengineering techniques. |
Active substance: FRAMYCETIN |
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Document reference: 28625 |
Study title: To determine the apparent bioavailability of Dicloxacillin in children of ages ranging from 6 days to 11,5 years.Smith et al. (Dev Pharmacol Ther 1990;14:35-44) |
Active substance: dicloxacillin |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Dikloxacillin_1.xlsx |
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Document reference: 49078 |
Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V38P1.xlsx |
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Document reference: 49186 |
Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V38P1E1.xlsx |
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Document reference: 49185 |
Study title: Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X.Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34871 |
Study title: Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1991, vol. 9, no. 9, p. 1591-8, ISSN: 0732-183X.Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology ... |
Active substance: PROCARBAZINE |
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Document reference: 34875 |
Study title: De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35187 |
Study title: DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35200 |
Study title: Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7). |
Active substance: PROCARBAZINE |
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Document reference: 34841 |
Study title: Desjardins R_1981 Desjardins R_1981 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Desjardins R_1981_publication.pdf |
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Document reference: 34999 |
Study title: Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35216 |
Study title: Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35182 |
Study title: Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35191 |
Study title: Krizsa J, Husz S, Dobozy A. (1989). Szent-Gyrgyi Albert University Medical School, Hungary, Dermatological Department. Expert Clinical Study report. Inosiplex treatment of patients with herpes zosterKrizsa J, Husz S, Dobozy A. (1989). Szent-Gyrgyi Albert University Medical School, Hungary, Dermatological Department. Expert Clinical Study report. Inosiplex treatment of patients with herpes zoster |
Active substance: INOSINE |
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Document reference: 30134 |
Study title: Lento FG, Cannata G, Cannata M, et al.. Presented at del Convegno Siculo-Calabro di Malattie Infettive e Parassitarie; February 6-7, 1981, Messina, Italy. Report on 10 cases of herpes zoster treated with methisoprinolLento FG, Cannata G, Cannata M, et al.. Presented at del Convegno Siculo-Calabro di Malattie Infettive e Parassitarie; February 6-7, 1981, Messina, Italy. Report on 10 cases of herpes zoster treated with methisoprinol |
Active substance: INOSINE |
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Document reference: 30138 |
Study title: Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol.Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol. |
Active substance: INOSINE |
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Document reference: 30139 |
Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 150 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 140 mg I/ml and 300 mg I/ml Report DXC060 (date Jun 1999) |
Active substance: IODIXANOL |
Study summary document link (including results): DXC060 Redacted.pdf |
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Document reference: 48210 |
Study title: A phase III, randomised, blinded comparison of Iodixanol (VISIPAQUE; 320 mgI/mL) and OMNIPAQUE 350 (Iohexol) in pediatric patients requiring angiocardiographyStudy Report 1968 (Date May 1996) |
Active substance: IODIXANOL |
Study summary document link (including results): Study Report 1968 Redacted.pdf |
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Document reference: 48204 |
Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the headStudy Report 1966 (Date Jan 1996) |
Active substance: IODIXANOL |
Study summary document link (including results): Study Report 1966 Redacted.pdf |
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Document reference: 48202 |
Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the bodyStudy Report 1967 (Date Dec 1995) |
Active substance: IODIXANOL |
Study summary document link (including results): Study Report 1967 Redacted.pdf |
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Document reference: 48203 |
Study title: Pharmacokinetic study of a single dose of propofol in paediatric burnt patients under 3 years old. |
Active substance: PROPOFOL |
Study summary document link (including results): 0859FC-0003 Study Synopsis.pdf |
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Document reference: 46135 |
Study title: Propofol in pedriatic patients aged 1 month to 6 years |
Active substance: PROPOFOL |
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Document reference: 47083 |
Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures |
Active substance: PROPOFOL |
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Document reference: 46122 |
Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures under one hour duration |
Active substance: PROPOFOL |
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Document reference: 46123 |
Study title: The pharmacokinetics of Diprivan (propofol) in pediatric patients |
Active substance: PROPOFOL |
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Document reference: 46121 |
Study title: To determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia. |
Active substance: PROPOFOL |
Study summary document link (including results): BBMDE-0312.xls |
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Document reference: 47082 |
Study title: Tolerability of Propofol Braun 1% compared with Disoprivan 1% |
Active substance: PROPOFOL |
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Document reference: 46119 |
Study title: Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 |
Active substance: PROTAMINE |
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Document reference: 35086 |
Study title: Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Efficacy of sucrose to reduce pain in premature infants.pdf |
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Document reference: 46139 |
Study title: Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Efficacy of topical anesthetics to reduce pain in premature .pdf |
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Document reference: 46140 |
Study title: Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6. Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Paediatric cycloplegia.pdf |
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Document reference: 46142 |
Study title: Does ribavirin impact on the hospital course of children with respiratory syncytial virus (RSV) infection? An analysis using the pediatric investigators collaborative network on infections in Canada (PICNIC) RSV database.Does ribavirin impact on the hospital course of children with respiratory syncytial virus (RSV) infection? An analysis using the pediatric investigators collaborative network on infections in Canada (PICNIC) RSV database. |
Active substance: PYRITINOL |
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Document reference: 35231 |
Study title: Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1988, vol. 6, no. 12, p. 1845-50, ISSN: 0732-183X.Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol},... |
Active substance: PROCARBAZINE |
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Document reference: 34704 |
Study title: Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525. |
Active substance: PROCARBAZINE |
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Document reference: 34706 |
Study title: A randomised, parallel, double-blind phase III comparison between iodixanol, 270 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV039 (date Dec 1995) |
Active substance: IODIXANOL |
Study summary document link (including results): DXV039 Redacted.pdf |
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Document reference: 48206 |
Study title: A randomised, parallel, double-blind phase III comparison between iodixanol, 270 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV038 (date Mar 1996) |
Active substance: IODIXANOL |
Study summary document link (including results): DXV038 Redacted.pdf |
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Document reference: 48207 |
Study title: Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. |
Active substance: IODIXANOL |
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Document reference: 30348 |
Study title: AJR Am J Roentgenol. 2002 Aug;179(2):437-44. Multidetector CT: detection of active hemorrhage in patients with blunt abdominal trauma. Willmann JK, Roos JE, Platz A, Pfammatter T, Hilfiker PR, Marincek B, Weishaupt D. AJR Am J Roentgenol. 2002 Aug;179(2):437-44. Multidetector CT: detection of active hemorrhage in patients with blunt abdominal trauma. Willmann JK, Roos JE, Platz A, Pfammatter T, Hilfiker PR, Marincek B, Weishaupt D. |
Active substance: IODIXANOL |
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Document reference: 30351 |
Study title: An open phase II trial with iodixanol 320 mg I/ml and a double-blind, parallel, randomised phase III trial with iodixanol 320 mg I/ml compared to iohexol (Omnipaque) 350 mg I/ml Trial No. DXV036 (date Mar 1996) |
Active substance: IODIXANOL |
Study summary document link (including results): DXV036 Redacted.pdf |
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Document reference: 48209 |
Study title: An open phase II trial with iodixanol 320 mg I/mL, and a randomised, parallel, double-blind phase III comparison between iodixanol (VISIPAQUE), 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV041 (date Dec 1995) |
Active substance: IODIXANOL |
Study summary document link (including results): DXV041 Redacted.pdf |
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Document reference: 48205 |
Study title: Complications with Outpatient Angiography and Interventional ProceduresYoung N 2002. Cardiovasc Intervent Radiol (2002) 25:123–126 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48199 |
Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
Active substance: LEVOCABASTINE |
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Document reference: 31116 |
Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
Active substance: LEVOCABASTINE |
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Document reference: 31126 |
Study title: An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000 |
Active substance: LEVOCABASTINE |
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Document reference: 31136 |
Study title: 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 |
Active substance: PYRVINIUM |
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Document reference: 39585 |
Study title: 6. Baranski et al., Rev Inst Med trop 1971; 13: 422-427 6. Baranski et al., Rev Inst Med trop 1971; 13: 422-427 |
Active substance: PYRVINIUM |
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Document reference: 39535 |
Study title: 7. Barrios, An Hosp Milit Centr 1960; 2: 9-12 7. Barrios, An Hosp Milit Centr 1960; 2: 9-12 |
Active substance: PYRVINIUM |
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Document reference: 39536 |
Study title: 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352 |
Active substance: PYRVINIUM |
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Document reference: 39537 |
Study title: 9. Beck, J Am MEd Assoc 1964; 189: 511 9. Beck, J Am MEd Assoc 1964; 189: 511 |
Active substance: PYRVINIUM |
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Document reference: 39538 |
Study title: Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335 Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335 |
Active substance: PYRVINIUM |
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Document reference: 39532 |
Study title: A 3-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL¿) Immediate-release Tablets in Daily Doses of 400 mg and 600 mg Compared with Placebo in the Treatment of Children and Adolescents with Bipolar I Mania |
Active substance: QUETIAPINE |
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Document reference: 45051 |
Study title: Seroquel: "A NON-COMPARATIVE, OPEN-LABEL STUDY TO DEMONSTRATE THE EFFICACY AND TOLERABILITY OF QUETIAPINE IN ADOLESCENT PATIENTS WITH AN ACUTE SCHIZOPHRENIC EPISODE". |
Active substance: QUETIAPINE |
Study summary document link (including results): D1441C09025 Study Synopsis.pdf |
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Document reference: 45052 |
Study title: A STUDY OF PHARMACOKINETICS OF QUINAPRIL IN PEDIATRIC PATIENTS |
Active substance: QUINAPRIL |
Study summary document link (including results): 0906-000-434 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 45056 |
Study title: AN 8-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE SAFETY AND EFFICACY OF QUINAPRIL IN PEDIATRIC PATIENTS WITH HYPERTENSION |
Active substance: QUINAPRIL |
Study summary document link (including results): 0906-427 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 45057 |
Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68) |
Active substance: QUININE |
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Document reference: 45059 |
Study title: 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301 |
Active substance: PYRVINIUM |
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Document reference: 39583 |
Study title: 55. Turner, Johnson, J Pediatr 1962; 60: 243-251 55. Turner, Johnson, J Pediatr 1962; 60: 243-251 |
Active substance: PYRVINIUM |
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Document reference: 39584 |
Study title: 50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58. |
Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 35142 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47767 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 ıg) injected with orwithout hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47768 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47754 |
Study title: Comparative study of the immunogenicity and safety of two doses of Engerix-B administered to healthy infants at 2, 4 and 6 months of age. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47763 |
Study title: Comparative study of the immunogenicity and safety of two doses of Engerix-B in healthy adolescents. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47762 |
Study title: Comparative study of the immunogenicity and safety of two dosing schedules in neonates. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47755 |
Study title: Immunogenicity and protective efficacy of Smith Kline -RIT's rec-DNA hepatitis b vaccine (10mcg) in newborns of HBsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47766 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47757 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47758 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47759 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47760 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47761 |
Study title: Open, randomized study to evaluate the immunogenicity of Engerix®-B when administered according to a vaccination schedule of 0, 1 and 12 months to healthy adolescents at two different doses (10 µg vs 20 µg). |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47753 |
Study title: Risk of peripartal transmission of hepatitis B in children born to Hepatitis B positive mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47765 |
Study title: Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, 1992, Vol/Iss/Pg. 8/4 (215-218), ISSN: 0256-7040.Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, ... |
Active substance: PROCARBAZINE |
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Document reference: 34801 |
Study title: Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161. |
Active substance: PROCARBAZINE |
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Document reference: 34802 |
Study title: Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532. |
Active substance: PROCARBAZINE |
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Document reference: 34803 |
Study title: Clinical evaluation of R50547 eye drops on allergic conjunctivitis and vernal conjunctivitis. A sungle masked comparative study with Sodium Cromoglicate eye drops |
Active substance: LEVOCABASTINE |
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Document reference: 31066 |
Study title: Comparison of levocabastine a new selective H1-receptor antagonist and disodium cromoglycate in a nasal provocation test with allergen (11-44 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62501_Interventional_Levocabastine.xls |
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Document reference: 31076 |
Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31118 |
Study title: Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Dec 1997, vol. 29, no. 6, p. 544-52, ISSN: 0098-1532.Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina.... |
Active substance: PROCARBAZINE |
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Document reference: 34820 |
Study title: Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868). |
Active substance: PROCARBAZINE |
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Document reference: 34821 |
Study title: Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042.Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042. |
Active substance: PROCARBAZINE |
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Document reference: 34822 |
Study title: Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244).Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244). |
Active substance: PROCARBAZINE |
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Document reference: 34726 |
Study title: Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, Villejuif, France. Postoperative chemotherapy without irradiation for ependymoma in children under 5 years of age: a multicenter trial of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, 1 Mar 2001, vol. 19, no. 5, p. 1288-96, ISSN: 0732-183X.Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, ... |
Active substance: PROCARBAZINE |
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Document reference: 34727 |
Study title: Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205). |
Active substance: PROCARBAZINE |
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Document reference: 34728 |
Study title: Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X.Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X. |
Active substance: PROCARBAZINE |
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Document reference: 34730 |
Study title: Borowitz SM, et all. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. 2005 Apr;115(4):873-7. |
Active substance: Rabarbar + senna |
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Document reference: 40148 |
Study title: A phase III, randomised, controlled, multicenter study in adults, investigating the antibody response to postexposure rabies vaccination combined with Human Rabies Immune Globuline (HRIG) between two types of tissue culture rabies vaccines, Purified vero cell rabies vaccine (PVRV) and Purified chick embryo cell rabies vaccine (PCECV) |
Active substance: RABIES VACCINE FOR HUMAN USE PREPARED FROM CELL CULTURE (DIPLOID CELLS) |
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Document reference: 48384 |
Study title: Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1990, vol. 18, no. 4, p. 265-72, ISSN: 0098-1532.Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without la... |
Active substance: PROCARBAZINE |
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Document reference: 34748 |
Study title: Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34751 |
Study title: Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X.Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X. |
Active substance: PROCARBAZINE |
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Document reference: 34805 |
Study title: Khalil S_1996Khalil S_1996 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Khalil S_1996_publication.pdf |
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Document reference: 35002 |
Study title: Koenig HJ_1990Koenig HJ_1990 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Koenig HJ_1990_publication.pdf |
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Document reference: 35004 |
Study title: Mayzner ZE_1996Mayzner ZE_1996 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Mayzner ZE_1996_publication.pdf |
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Document reference: 35007 |
Study title: McKee K_1991McKee K_1991 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_McKee K_1991_publication.pdf |
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Document reference: 35008 |
Study title: Nad R_1975Nad R_1975 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Nad R_1975_publication.pdf |
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Document reference: 35009 |
Study title: New modalities in postoperative nausea and vomiting. |
Active substance: PROMETHAZINE |
Study summary document link (including results): New modalities in postoperative nausea and vomiting.pdf |
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Document reference: 35028 |
Study title: Pascarella MA_1983Pascarella MA_1983 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Pascarella MA_1983_publication.pdf |
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Document reference: 35012 |
Study title: Paul AK_1984Paul AK_1984 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Paul AK_1984_publication.pdf |
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Document reference: 35013 |
Study title: Pre-anaesthetic medication in paediatric day-care surgery. |
Active substance: PROMETHAZINE |
Study summary document link (including results): Pre-anaesthetic medication in paediatric day-care surgery.pdf |
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Document reference: 35040 |
Study title: Promethazine in general anaesthesia - Loyn W.G.G.- (Brit. J. Anaesth. 1956, 28, 126.) - Publication in PHENERGAN therapeutic summary 6th edition May & Baker Ltd.1976 - |
Active substance: PROMETHAZINE |
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Document reference: 35041 |
Study title: Publication 8 in PHENERGAN 25mg tablet, 0.1% syrup, 2,5% sol for injection. Clinical documentation. June 1988. Anaesthesia in children. -Anglade G.- (Maroc médical (1970), 50, 545-561.) |
Active substance: PROMETHAZINE |
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Document reference: 35043 |
Study title: Geist ET_1982Geist ET_1982 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Geist ET_1982_publication.pdf |
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Document reference: 35001 |
Study title: Publication in PROMETHAZINE Safety and efficacy review of medicines following UK authorities review of psychotropic and centrally acting drugs. May&Baker Ltd. Company April 1980. |
Active substance: PROMETHAZINE |
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Document reference: 35045 |
Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in Europe, Australasia, and Asia (LTS3256) |
Active substance: rasburicase |
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Document reference: 47280 |
Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in the United States and Canada (LTS3257) |
Active substance: rasburicase |
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Document reference: 47281 |
Study title: Evaluation of single agent rasburicase in treatment/ prevention of hyperuricemia associated with tumor lysis syndrome in adult and paediatric patients with lymphoma/ leukemia/solid tumor or malignancies at their first relapse or refractory disease |
Active substance: rasburicase |
Study summary document link (including results): |
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Document reference: 41509 |
Study title: Non-comparative open label |
Active substance: rasburicase |
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Document reference: 47284 |
Study title: Open label, single arm, multicentric Phase IV |
Active substance: rasburicase |
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Document reference: 47283 |
Study title: Open-label, multi-center study of SR29142 as uricolytic therapy/prophylaxis for hyperuricemia in pediatric patients with newly diagnosed hematological malignacies at high risk for Tumor Lysis Syndrome |
Active substance: rasburicase |
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Document reference: 41508 |
Study title: Phase IV study of Rasburicase for treatment of hyperuricemia in patients with tumoral lysis syndrome (Code: L_9436) |
Active substance: rasburicase |
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Document reference: 47282 |
Study title: Phase IV, compassionate use program of rasburicase for treatment of hyperuricemia in children and adolescent patients with tumor lysis syndrome |
Active substance: rasburicase |
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Document reference: 47278 |
Study title: Single arm, open label Phase IV |
Active substance: rasburicase |
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Document reference: 47285 |
Study title: An open label prospective study to observe the postmarketing safety of Euvax B Inj. |
Active substance: Recombinant DNA Hepatitis B Surface Antigen (HBsAg) |
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Document reference: 41089 |
Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants |
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
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Document reference: 40152 |
Study title: A randomized double-blind study of safety and efficacy of SMOF 20% vs. Intralipid 20% in infants and children requiring long-term parenteral nutrition |
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
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Document reference: 40151 |
Study title: Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114. |
Active substance: PROCARBAZINE |
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Document reference: 34824 |
Study title: Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Klinische Paediatrie, {Klin-Padiatr}, May-Jun 1986, vol. 198, no. 3, p. 137-46, ISSN: 0300-8630.Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Kl... |
Active substance: PROCARBAZINE |
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Document reference: 34826 |
Study title: Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 |
Active substance: PROTAMINE |
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Document reference: 35085 |
Study title: Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35179 |
Study title: Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75.Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75. |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35222 |
Study title: Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35201 |
Study title: An open label, multicenter, international pilot study evaluating the efficacy and safety of Pegylated interferon alfa-2a in combination with ribavirin in pediatric and teenage patients with CHC virus infection (CHIPS) [100 children adolescents aged 6 – 18 years with CHC (all genotypes)] |
Active substance: RIBAVIRIN |
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Document reference: 35302 |
Study title: Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93 Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35218 |
Study title: EFFICACY AND SAFETY OF AN INTERMITTENT REGIMEN INCLUDING RIFABUTIN (AMSAMYCIN LM 427) IN THE TREATMENT OF OUT-PATIENTS WITH MYCOBACTERIAL PULMONARY INFECTIONS. FARMITALIA CARLO ERBA INTERNAL REPORT LM 427/713I, OCTOBER 1990 |
Active substance: RIFABUTIN |
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Document reference: 35374 |
Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/714I NOVEMBER 1990 AGE RANGE 14-79 YEARS |
Active substance: RIFABUTIN |
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Document reference: 35369 |
Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/715I NOVEMBER 1990 AGE RANGE 15 -65 YEARSPuri H C et al. Severe hypertension in children with renal |
Active substance: RIFABUTIN |
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Document reference: 35370 |
Study title: Sedation for paediatric computed tomography |
Active substance: PROMETHAZINE |
Study summary document link (including results): Sedation for paediatric computed tomography.pdf |
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Document reference: 35048 |
Study title: Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street. |
Active substance: PROMETHAZINE |
Study summary document link (including results): Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street.pdf |
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Document reference: 35049 |
Study title: Romiti M_1980Romiti M_1980 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Romiti M_1980_publication.pdf |
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Document reference: 35014 |
Study title: Hanck A: Verhütung und Behandlung der postoperativen Darmatonie und anderer Formen der paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977; 27 (39): 6878, 6881-4,6887. Hanck A: Verhütung und Behandlung der postoperativen Darmatonie und anderer Formen der paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977; 27 (39): 6878, 6881-4,6887. |
Active substance: PYRITINOL |
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Document reference: 35229 |
Study title: Abdallah et al., Egypt Med Assoc 1965; 48: 396-398 Abdallah et al., Egypt Med Assoc 1965; 48: 396-398 |
Active substance: PYRVINIUM |
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Document reference: 39530 |
Study title: Mehta PD, Kulczycki J, Patrick BA, Sobczyk W, Wisniewski HM. J Neurol Sci. 1992 May;109(1):64-8. Effect of treatment on oligoclonal IgG bands and intrathecal IgG synthesis in sequential cerebrospinal fluid and serum from patients with subacute sclerosing panencephalitis.Mehta PD, Kulczycki J, Patrick BA, Sobczyk W, Wisniewski HM. J Neurol Sci. 1992 May;109(1):64-8. Effect of treatment on oligoclonal IgG bands and intrathecal IgG synthesis in sequential cerebrospinal fluid and serum from patients with subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30147 |
Study title: Patel P, Gemmell R, Carruth JASJ Laryngol Otol Dec 1987 101(12):1306-1307. Inosine pranobex in recurrent laryngeal papillomatosis.Patel P, Gemmell R, Carruth JASJ Laryngol Otol Dec 1987 101(12):1306-1307. Inosine pranobex in recurrent laryngeal papillomatosis. |
Active substance: INOSINE |
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Document reference: 30154 |
Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E |
Active substance: IODIXANOL |
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Document reference: 30349 |
Study title: Bartkowski S.B., Krystkowa K.M., Pruszkiewicz W., Zapala J.: Follow-up results of surgical treatment of post-traumatic diplopia. Bartkowski S.B., Krystkowa K.M., Pruszkiewicz W., Zapala J.: Follow-up results of surgical treatment of post-traumatic diplopia. |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35103 |
Study title: Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35099 |
Study title: Joannidis P: Doppelblinde klinische Prüfung von Solcoseryl Dental Adhäsipaste als Wundverband nach oral-chirurgischen Eingriffen. Dissertetion, durchgeführt unter der Leitung von Prof. Dr. A. Schrpeder, Direktor der Klinik für Zahnerhaltung der Univ. Bern, 1983 Joannidis P: Doppelblinde klinische Prüfung von Solcoseryl Dental Adhäsipaste als Wundverband nach oral-chirurgischen Eingriffen. Dissertetion, durchgeführt unter der Leitung von Prof. Dr. A. Schrpeder, Direktor der Klinik für Zahnerhaltung der Univ. Bern, 1983 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35094 |
Study title: "Krekeler G: Clinical study to assess the effect of Solcoseryl adhesive oinment on wound healing. Unpublished report 1979 Felber P, Gasser F: Double-blind clinical trial of Solcoseryl Dental Adhesive Paste for treating dental sores. Schweiz. Mschr. Zahnheilkunde, 1983, 93, 362-372" "Krekeler G: Clinical study to assess the effect of Solcoseryl adhesive oinment on wound healing. Unpublished report 1979 Felber P, Gasser F: Double-blind clinical trial of Solcoseryl Dental Adhesive Paste for treating dental sores. Schweiz. Mschr. Zahnheilkunde, 1983, 93, 362-372" |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35092 |
Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68) |
Active substance: QUININE |
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Document reference: 45064 |
Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/706I OCTOBER 1990 D93 AGE RANGE 15- 62 YEARS |
Active substance: RIFABUTIN |
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Document reference: 35372 |
Study title: PARTIALLY RANDOMIZED DOSE COMPARSION TRAIL OF COMPASSIONATE USE RIFABUTIN (AMSAMYCIN LM 427) IN AIDS OATIENTS WITH MYCOBACTERIUM AVIUM COMPLEX INFECTION FCE REPORT LM 427/723I FEBRUARY 1991 AGE RANGE 1-62 |
Active substance: RIFABUTIN |
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Document reference: 35376 |
Study title: PARTIALLY RANDOMIZED, DOSE COMPARISON TRIAL OF COMPASSIONATE USE RIFABUTIN (AMSAMYCIN LM 427) IN NON-AIDS PATIENTS WITH MYCOBACTERIUM AVIUM COMPLEX INFECTION. FCE REPORT: LM 427/719I MARCH, 1991 AGE RANGE: 0-91 YRS |
Active substance: RIFABUTIN |
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Document reference: 35377 |
Study title: RIFABUTIN FOR THE TREATMENT OF NEWLY DIAGNOSIED PULMONARYTUBERCULOIS: A MULTINATIONAL, RANDOMIZED COMPARATIVE STUDY VERUS RIFAMPICIN LUIS JULIO GONZALES-MONTANER AGE RANGE 15-67 |
Active substance: RIFABUTIN |
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Document reference: 35375 |
Study title: SAFETY OF RIFABUTIN (AMSAMYCIN, LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/708I OCTOBER 1990 AGE RANGE: 15-68 YRS |
Active substance: RIFABUTIN |
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Document reference: 35371 |
Study title: THE COMPASSIONATE USE OF RIFABUTIN FOR THE TREATMENT OF MYCOBACTERIU AVIUM COMPLEX DISEASE IN HIV POSITIVE PATIENTS. FCE REPORTS LM 427/720I JANUARY 1991 AGE RANGE 5 -61 |
Active substance: RIFABUTIN |
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Document reference: 35373 |
Study title: Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363).Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363). |
Active substance: PROCARBAZINE |
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Document reference: 34782 |
Study title: 11. Botero et al., Bol Chil Parasitol 1966; 21: 111-114 11. Botero et al., Bol Chil Parasitol 1966; 21: 111-114 |
Active substance: PYRVINIUM |
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Document reference: 39540 |
Study title: 12. Bruhn, Padelt, Padiatr Grenzgeb 1968 ; 7 : 331341 12. Bruhn, Padelt, Padiatr Grenzgeb 1968 ; 7 : 331341 |
Active substance: PYRVINIUM |
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Document reference: 39541 |
Study title: 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197 |
Active substance: PYRVINIUM |
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Document reference: 39542 |
Study title: 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214 |
Active substance: PYRVINIUM |
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Document reference: 39543 |
Study title: Farah-R, Golomb-H-M, Hallahan-D-E, Desser-R-K, Griem-M-L, Blough-R, Ultmann-J-E, Weichselbaum-R-R. Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, United States. Radiation therapy for pathologic stage III Hodgkin's disease with and without chemotherapy. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1989, Vol/Iss/Pg. 17/4 (761766), ISSN: 0360-3016.Farah-R, Golomb-H-M, Hallahan-D-E, Desser-R-K, Griem-M-L, Blough-R, Ultmann-J-E, Weichselbaum-R-R. Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, United States. Radiation therapy for pathologic stage III Hodgkin's disease with and without chemotherapy. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-... |
Active substance: PROCARBAZINE |
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Document reference: 34710 |
Study title: Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p. 211-4, ISSN: 0390-5616.Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p... |
Active substance: PROCARBAZINE |
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Document reference: 34711 |
Study title: Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325. |
Active substance: PROCARBAZINE |
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Document reference: 34712 |
Study title: Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236). |
Active substance: PROCARBAZINE |
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Document reference: 34713 |
Study title: 10. Biguet et al., Presse Med 1959; 67: 1739-1740 10. Biguet et al., Presse Med 1959; 67: 1739-1740 |
Active substance: PYRVINIUM |
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Document reference: 39539 |
Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E |
Active substance: IODIXANOL |
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Document reference: 30353 |
Study title: : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K |
Active substance: IODIXANOL |
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Document reference: 30356 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IODIXANOL |
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Document reference: 30352 |
Study title: Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population.Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Flinck A, Gottfridsson B. |
Active substance: IODIXANOL |
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Document reference: 30347 |
Study title: Iodixanol in paediatric excretory urography: efficiency and safety compared to iohexolDacher JN 1998. Pediatr Radiol (1998) 28: 112-114 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48195 |
Study title: J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K. J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K. |
Active substance: IODIXANOL |
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Document reference: 30355 |
Study title: Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377). |
Active substance: PROCARBAZINE |
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Document reference: 34768 |
Study title: Willoughby CR, Tesh JM, McAnulty PA, Tesh SA, Wilby OK. Teratology study of NY-198 in the rat (segment II). 1986. Internal Report |
Active substance: LOMEFLOXACIN |
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Document reference: 31400 |
Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68) |
Active substance: QUININE |
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Document reference: 45069 |
Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68) |
Active substance: QUININE |
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Document reference: 45074 |
Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68) |
Active substance: QUININE |
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Document reference: 45079 |
Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426) |
Active substance: QUININE |
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Document reference: 45060 |
Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426) |
Active substance: QUININE |
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Document reference: 45070 |
Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426) |
Active substance: QUININE |
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Document reference: 45075 |
Study title: McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Summer 1990, vol. 12, no. 2, p. 147-54, 29 refs, ISSN: 0192-8562.McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/o... |
Active substance: PROCARBAZINE |
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Document reference: 34785 |
Study title: McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1990, Vol/Iss/Pg. 12/2 (147-154), ISSN: 0192-8562.McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Jo... |
Active substance: PROCARBAZINE |
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Document reference: 34784 |
Study title: Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286). |
Active substance: PROCARBAZINE |
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Document reference: 34786 |
Study title: Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34787 |
Study title: Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R College of Physicians and Surgeons of Columbia University, New York, USA. Randomized study of intensive MOPP-ABVD with or without low-dose total-nodal radiation therapy in the treatment of stages IIB, IIIA2, IIIB, and IV Hodgkin's disease in pediatric patients: a Pediatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1997, vol. 15, no. 8, p. 2769-79, ISSN: 0732-183X.Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternb... |
Active substance: PROCARBAZINE |
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Document reference: 34874 |
Study title: Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations Office, 199 North Lake Ave, Pasadena, CA 91101, United States. Efficacy and toxicity of 12 courses of ABVD chemotherapy followed by low-dose regional radiation in advanced Hodgkin's disease in children: A report from the Childrens Cancer Study Group. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/12 (1971-1980), ISSN: 0732-183X.Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations... |
Active substance: PROCARBAZINE |
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Document reference: 34714 |
Study title: Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685. |
Active substance: PROCARBAZINE |
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Document reference: 34806 |
Study title: Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, IRCCS Policlinico San Matteo, Piazzale Golgi, 2, I-27100 Pavia, Italy. CNS-85 trial: A cooperative pediatric CNS tumor study - results of treatment of medulloblastoma patients. Child's Nervous System {CHILD-S-NERV-SYST}, 1996, Vol/Iss/Pg. 12/2 (87-96), ISSN: 0256-7040.Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, ... |
Active substance: PROCARBAZINE |
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Document reference: 34808 |
Study title: Pezzotta-S, Knerich-R, Butti-G. ICNG Coord. Cent., Neurosurg. Clin., Univ. Pavia, 27100 Pavia, Italy. Chemotherapy for medulloblastoma in children. Current status and future prospects. Child's Brain {CHILD-S-BRAIN}, 1982, Vol/Iss/Pg. 9/3-4 (294-298).Pezzotta-S, Knerich-R, Butti-G. ICNG Coord. Cent., Neurosurg. Clin., Univ. Pavia, 27100 Pavia, Italy. Chemotherapy for medulloblastoma in children. Current status and future prospects. Child's Brain {CHILD-S-BRAIN}, 1982, Vol/Iss/Pg. 9/3-4 (294-298). |
Active substance: PROCARBAZINE |
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Document reference: 34809 |
Study title: Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551. |
Active substance: PROCARBAZINE |
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Document reference: 34733 |
Study title: Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630.Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630. |
Active substance: PROCARBAZINE |
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Document reference: 34734 |
Study title: Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X. |
Active substance: PROCARBAZINE |
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Document reference: 34735 |
Study title: Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber experience. Pediatric hematology and oncology, {Pediatr-Hematol-Oncol}, Oct-Nov 2003, vol. 20, no. 7, p. 497-504, ISSN: 0888-0018.Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber... |
Active substance: PROCARBAZINE |
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Document reference: 34737 |
Study title: Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283).Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283). |
Active substance: PROCARBAZINE |
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Document reference: 34877 |
Study title: Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X. |
Active substance: PROCARBAZINE |
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Document reference: 34879 |
Study title: Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 1996, vol. 18, no. 1, p. 76-80, ISSN: 1077-4114.Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hem... |
Active substance: PROCARBAZINE |
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Document reference: 34880 |
Study title: Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, Vol/Iss/Pg. 60/3 (495-499).Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, V... |
Active substance: PROCARBAZINE |
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Document reference: 34810 |
Study title: Sedation in pediatric neuroimaging: The science and the art. |
Active substance: PROMETHAZINE |
Study summary document link (including results): Sedation in pediatric neuroimaging The science and the art.pdf |
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Document reference: 35050 |
Study title: Synergistic effect of promethazine with gentamycin in frequently recurring |
Active substance: PROMETHAZINE |
Study summary document link (including results): Synergistic effect of promethazine with gentamycin in frequently recurring.pdf |
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Document reference: 35053 |
Study title: Wallace G_1963Wallace G_1963 |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Wallace G_1963_publication.pdf |
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Document reference: 35015 |
Study title: van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004, vol. 42, no. 3, p. 210-5, ISSN: 1545-5009.van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004,... |
Active substance: PROCARBAZINE |
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Document reference: 34864 |
Study title: Perani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infectionsPerani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections |
Active substance: INOSINE |
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Document reference: 30155 |
Study title: Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections. |
Active substance: INOSINE |
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Document reference: 30156 |
Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1994, vol. 5 Suppl 2, p. 113-5, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official j... |
Active substance: PROCARBAZINE |
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Document reference: 34829 |
Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, Sep 1992, vol. 3 Suppl 4, p. 73-6, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}... |
Active substance: PROCARBAZINE |
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Document reference: 34830 |
Study title: Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35205 |
Study title: Giustina A et al. Impaired growth hormone (GH) response to pyridostigmine in type 1 diabetic patients with exaggerated GH-releasing hormone-stimulated GH secretion. J Clin Endocrinol Metab. 1990 Dec;71(6):1486-90 Giustina A et al. Impaired growth hormone (GH) response to pyridostigmine in type 1 diabetic patients with exaggerated GH-releasing hormone-stimulated GH secretion. J Clin Endocrinol Metab. 1990 Dec;71(6):1486-90 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35211 |
Study title: Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35219 |
Study title: Hanck A. Verhuetung und Behandlung der postoperativen Daratonie und anderer Formen des paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977;27:6878, 1881-4, 6887. Hanck A. Verhuetung und Behandlung der postoperativen Daratonie und anderer Formen des paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977;27:6878, 1881-4, 6887. |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35227 |
Study title: Hepatic enzyme abnormalities in children on triple therapy for tuberbulosis - Corrigan D, Paton J. - 1999 (Pediatr Pulmonol. 27(1): 37 - 42) Hepatic enzyme abnormalities in children on triple therapy for tuberbulosis - Corrigan D, Paton J. - 1999 (Pediatr Pulmonol. 27(1): 37 - 42) |
Active substance: RIFAMYCIN |
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Document reference: 35382 |
Study title: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -) |
Active substance: PROPAFENONE |
Study summary document link (including results): propafenone-m03681.pdf |
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Document reference: 35059 |
Study title: A comparative evaluation of Diprivan (propofol) versus standard anesthetic techniques when administered for the induction and maintenance of general anesthesia in pediatric patients undergoing surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
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Document reference: 46124 |
Study title: 16. Cabrera, Garcia, MD J 1961 ; 10 : 217-220 16. Cabrera, Garcia, MD J 1961 ; 10 : 217-220 |
Active substance: PYRVINIUM |
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Document reference: 39545 |
Study title: 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465 |
Active substance: PYRVINIUM |
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Document reference: 39546 |
Study title: 18. Cervova, Cs Pediat 1973; 28: 43 18. Cervova, Cs Pediat 1973; 28: 43 |
Active substance: PYRVINIUM |
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Document reference: 39547 |
Study title: 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 |
Active substance: PYRVINIUM |
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Document reference: 39548 |
Study title: 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488 |
Active substance: PYRVINIUM |
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Document reference: 39531 |
Study title: 20. Cho et al., Korean J of Parasitology 1977; 2: 100-108 20. Cho et al., Korean J of Parasitology 1977; 2: 100-108 |
Active substance: PYRVINIUM |
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Document reference: 39549 |
Study title: 21. Davis, Am J Dis Child 1966; 112: 49-51 21. Davis, Am J Dis Child 1966; 112: 49-51 |
Active substance: PYRVINIUM |
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Document reference: 39550 |
Study title: 22. Desai, BMJ 1962; 2: 1583-1585 22. Desai, BMJ 1962; 2: 1583-1585 |
Active substance: PYRVINIUM |
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Document reference: 39551 |
Study title: 23. Eriksen, Ugeskr Laeg 1964; 126: 801-803 23. Eriksen, Ugeskr Laeg 1964; 126: 801-803 |
Active substance: PYRVINIUM |
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Document reference: 39552 |
Study title: 24. Fossati, Minerva Med 1964; 55: 3578-3580 24. Fossati, Minerva Med 1964; 55: 3578-3580 |
Active substance: PYRVINIUM |
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Document reference: 39553 |
Study title: 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124 |
Active substance: PYRVINIUM |
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Document reference: 39554 |
Study title: 26. Garin, Pediatrie 1962; 17: 551-559 26. Garin, Pediatrie 1962; 17: 551-559 |
Active substance: PYRVINIUM |
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Document reference: 39555 |
Study title: 27. Giberti, Lenge, Prensa Med Arg 1961; 48: 2096-2097 27. Giberti, Lenge, Prensa Med Arg 1961; 48: 2096-2097 |
Active substance: PYRVINIUM |
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Document reference: 39556 |
Study title: 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621 |
Active substance: PYRVINIUM |
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Document reference: 39544 |
Study title: 28. Grinenko et al., Med Parazitol 1970; 39: 390-391 28. Grinenko et al., Med Parazitol 1970; 39: 390-391 |
Active substance: PYRVINIUM |
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Document reference: 39557 |
Study title: 29. Hsieh et al., J Formosan Med Assoc 1963; 62: 373-378 29. Hsieh et al., J Formosan Med Assoc 1963; 62: 373-378 |
Active substance: PYRVINIUM |
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Document reference: 39558 |
Study title: Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet |
Active substance: INOSINE |
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Document reference: 30160 |
Study title: Rouis BO, HamzaM, Doumbe P Laboratoires Delande; Paris 1987. Clinical Study Report Double-blind, placebo-controlled study of Isoprinosine for the treatment of severe or complicated measles.Rouis BO, HamzaM, Doumbe P Laboratoires Delande; Paris 1987. Clinical Study Report Double-blind, placebo-controlled study of Isoprinosine for the treatment of severe or complicated measles. |
Active substance: INOSINE |
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Document reference: 30162 |
Study title: Schaison, AG. (1977) [in French]. In: Journal Officiel du Hpital Saint-Louis, Paris. May 6. Expert Clinical Report. Isoprinosine in the immunodepressed patient: discussion of the results of a clinical study on the effectiveness conducted in a leukemia treatment centerSchaison, AG. (1977) [in French]. In: Journal Officiel du Hpital Saint-Louis, Paris. May 6. Expert Clinical Report. Isoprinosine in the immunodepressed patient: discussion of the results of a clinical study on the effectiveness conducted in a leukemia treatment center |
Active substance: INOSINE |
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Document reference: 30165 |
Study title: Serdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosisSerdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosis |
Active substance: INOSINE |
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Document reference: 30166 |
Study title: Sobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparationsSobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparations |
Active substance: INOSINE |
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Document reference: 30167 |
Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing PanencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing Panencephalitis |
Active substance: INOSINE |
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Document reference: 30168 |
Study title: J Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J. J Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J. |
Active substance: IODIXANOL |
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Document reference: 30350 |
Study title: Kryst L, Kowalik S, Barthowski S, Henning g: Multicenter comparative clinical trial of the treatment of alveolitis after tooth extraction with Solcoseryl Dental Adhesive Paste and Apernyl. Czas. Stomat. 1990, 43, 334-341 Kryst L, Kowalik S, Barthowski S, Henning g: Multicenter comparative clinical trial of the treatment of alveolitis after tooth extraction with Solcoseryl Dental Adhesive Paste and Apernyl. Czas. Stomat. 1990, 43, 334-341 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35091 |
Study title: Metah D: Treatment of lesions of the oral mucosa with Solcoseryl Dental Adhesive Paste. Zahnärztliche Praxis, 1987; 38 (4) 137-139 " Metah D: Treatment of lesions of the oral mucosa with Solcoseryl Dental Adhesive Paste. Zahnärztliche Praxis, 1987; 38 (4) 137-139 " |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35097 |
Study title: Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50 Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35088 |
Study title: Beseghi; Comparison of two non-absorbable antibiotics for treatment of bacterial enteritis in children; European Review for Medical and Pharmacological SciencesBeseghi; Comparison of two non-absorbable antibiotics for treatment of bacterial enteritis in children; European Review for Medical and Pharmacological Sciences |
Active substance: RIFAXIMIN |
Study summary document link (including results): rifaximin-article-Beseghi.pdf |
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Document reference: 47563 |
Study title: Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M. Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M. |
Active substance: RIFAXIMIN |
Study summary document link (including results): 2011-05-20-Clin Dat Results-Alfa Wassermann.xls |
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Document reference: 47566 |
Study title: Muniyappa; Use of Rifaximin in Pediatric Patients with Inflammatory Bowel DiseaseMuniyappa; Use of Rifaximin in Pediatric Patients with Inflammatory Bowel Disease |
Active substance: RIFAXIMIN |
Study summary document link (including results): rifaximin-article-Muniyappa.pdf |
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Document reference: 47565 |
Study title: Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21.Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21. |
Active substance: RIMEXOLONE |
Study summary document link (including results): Ocular-hypertensive and anti-inflammatory response to rimexo.pdf |
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Document reference: 35387 |
Study title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children ≥ 4 to < 16 Years Old with Osteogenesis Imperfecta |
Active substance: RISEDRONIC ACID |
Study summary document link (including results): Risedronate sodium - Study 1.pdf |
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Document reference: 35389 |
Study title: Muriel-F-S, Roca-Garcia-C, Schwartz-L, et-al. Grupo Argentino Tratam. Leucem. Aguda, Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin lymphoma. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (778).Muriel-F-S, Roca-Garcia-C, Schwartz-L, et-al. Grupo Argentino Tratam. Leucem. Aguda, Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin lymphoma. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (778). |
Active substance: PROCARBAZINE |
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Document reference: 34788 |
Study title: 30. Kleinschmidt, Med Welt 1963; 14: 377-379 30. Kleinschmidt, Med Welt 1963; 14: 377-379 |
Active substance: PYRVINIUM |
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Document reference: 39559 |
Study title: 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620 |
Active substance: PYRVINIUM |
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Document reference: 39560 |
Study title: 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467 |
Active substance: PYRVINIUM |
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Document reference: 39561 |
Study title: 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452 |
Active substance: PYRVINIUM |
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Document reference: 39562 |
Study title: 34. Molla, Donald, J Int Med Res 1977; 5: 136-138 34. Molla, Donald, J Int Med Res 1977; 5: 136-138 |
Active substance: PYRVINIUM |
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Document reference: 39563 |
Study title: Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532. |
Active substance: PROCARBAZINE |
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Document reference: 34715 |
Study title: Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34718 |
Study title: Three Dimensional CT Angiography for Patients with Congenital Heart Disease: Scanning Protocol for Pediatric PatientsJelnin V 2006. Catheterization and Cardiovascular Interventions 67:120-126 (2006) |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48200 |
Study title: J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA. J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA. |
Active substance: ioflupane (123l) |
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Document reference: 41498 |
Study title: Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ. |
Active substance: ioflupane (123l) |
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Document reference: 41501 |
Study title: Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P. Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P. |
Active substance: ioflupane (123l) |
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Document reference: 41499 |
Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in children |
Active substance: IOHEXOL |
Study summary document link (including results): |
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Document reference: 30357 |
Study title: Transplacental passage in rats and rabbits |
Active substance: CICLOSPORIN |
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Document reference: 24112 |
Study title: Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ |
Active substance: IOHEXOL |
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Document reference: 30358 |
Study title: Acta Radiol Suppl. 1983;366:126-33 Non-ionic contrast media in cardioangiography in infants. A comparison of iohexol and metrizamide. Hellström M, Jacobsson B, Eriksson BO, Jagenburg R Acta Radiol Suppl. 1983;366:126-33 Non-ionic contrast media in cardioangiography in infants. A comparison of iohexol and metrizamide. Hellström M, Jacobsson B, Eriksson BO, Jagenburg R |
Active substance: IOHEXOL |
Study summary document link (including results): |
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Document reference: 30359 |
Study title: EMLA: an aid to suture removal following cleft lip repair. |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31218 |
Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426) |
Active substance: QUININE |
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Document reference: 45080 |
Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152) |
Active substance: QUININE |
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Document reference: 45061 |
Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152) |
Active substance: QUININE |
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Document reference: 45066 |
Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152) |
Active substance: QUININE |
Study summary document link (including results): |
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Document reference: 45071 |
Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152) |
Active substance: QUININE |
Study summary document link (including results): |
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Document reference: 45076 |
Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152) |
Active substance: QUININE |
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Document reference: 45081 |
Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45) |
Active substance: QUININE |
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Document reference: 45062 |
Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45) |
Active substance: QUININE |
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Document reference: 45067 |
Study title: Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541.Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541. |
Active substance: PROCARBAZINE |
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Document reference: 34789 |
Study title: Neidhardt-M, Bailey-C-C, Gnekow-A, Kleihues-P, Michaelis-J, Wellek-S. (Medulloblastoma therapy studies MBL 80 and MED 84 of the Society of Pediatric Oncology and the Societe Internationale d'Oncologie Pediatrique (SIOP)). Klinische Paediatrie {Klin-Padiatr} 1987 May-Jun, VOL: 199 (3), P: 188-92, ISSN: 0300-8630.Neidhardt-M, Bailey-C-C, Gnekow-A, Kleihues-P, Michaelis-J, Wellek-S. (Medulloblastoma therapy studies MBL 80 and MED 84 of the Society of Pediatric Oncology and the Societe Internationale d'Oncologie Pediatrique (SIOP)). Klinische Paediatrie {Klin-Padiatr} 1987 May-Jun, VOL: 199 (3), P: 188-92, ISSN: 0300-8630. |
Active substance: PROCARBAZINE |
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Document reference: 34790 |
Study title: Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630.Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630. |
Active substance: PROCARBAZINE |
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Document reference: 34791 |
Study title: Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551. |
Active substance: PROCARBAZINE |
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Document reference: 34793 |
Study title: Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X.Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X. |
Active substance: PROCARBAZINE |
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Document reference: 34719 |
Study title: Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975.Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975. |
Active substance: PROCARBAZINE |
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Document reference: 34812 |
Study title: Cook MR et al. Side effects of low-dose pyridostigmine bromide are not related to cholinesterase inhibition. Aviat Space Environ Med. 2001 Dec;72(12):1102-6Cook MR et al. Side effects of low-dose pyridostigmine bromide are not related to cholinesterase inhibition. Aviat Space Environ Med. 2001 Dec;72(12):1102-6 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35189 |
Study title: van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. |
Active substance: PROCARBAZINE |
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Document reference: 34867 |
Study title: Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35210 |
Study title: Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405). |
Active substance: PROCARBAZINE |
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Document reference: 34738 |
Study title: Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X.Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34739 |
Study title: Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34740 |
Study title: Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis, TN 38101, United States. Efficacy and toxicity of multiagent chemotherapy and low-dose involved- field radiotherapy in children and adolescents with Hodgkin's disease. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1993, Vol/Iss/Pg. 11/1 (100-108), ISSN: 0732-183X.Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis... |
Active substance: PROCARBAZINE |
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Document reference: 34741 |
Study title: Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971. |
Active substance: PROCARBAZINE |
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Document reference: 34742 |
Study title: Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16). |
Active substance: PROCARBAZINE |
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Document reference: 34882 |
Study title: Zeltzer-L, LeBaron-S, Zeltzer-P-M. Division of Adolescent Medicine, Department of Pediatrics, The University of Texas Health Science Center at San Antonio, San Antonio, TX 78284, United States. The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1984, Vol/Iss/Pg. 2/6 (683-690).Zeltzer-L, LeBaron-S, Zeltzer-P-M. Division of Adolescent Medicine, Department of Pediatrics, The University of Texas Health Science Center at San Antonio, San Antonio, TX 78284, United States. The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. Journal of Clinical Oncolo... |
Active substance: PROCARBAZINE |
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Document reference: 34881 |
Study title: "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." |
Active substance: PROCHLOPERAZINE |
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Document reference: 34969 |
Study title: Efficacité et tolérance du progabide (SL 76.002) dans les syndromes spastiques d'origine cérébrale chez des enfants, adolescents, jeunes adultes - Ferriere G. - 04/1981 |
Active substance: PROGABIDE |
Study summary document link (including results): |
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Document reference: 34972 |
Study title: "Quality of life and micronised progesterone (200 mg) in adolescent menstrual cycle disorders" |
Active substance: PROGESTERONE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication_Besins.xls |
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Document reference: 34993 |
Study title: Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48].Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48]. |
Active substance: PROGLUMETACIN |
Study summary document link (including results): |
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Document reference: 34995 |
Study title: A comparative evaluation of Diprivan /Diprivan N20 versus thiopental/halothane/N20 versus Diprivan/Diprivan when administered for the induction and maintenance of general anesthesia in pedaitric patients undergoing general surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
Study summary document link (including results): |
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Document reference: 46125 |
Study title: A comparison of Diprivan (propofol) and thiopentone for induction of anaesthesia in children. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0208 Study Synopsis.pdf |
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Document reference: 46131 |
Study title: A comparison of the characteristics of propofol and methohexitone for induction and maintenance of anaesthesia in children. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0248 Study Synopsis.pdf |
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Document reference: 46134 |
Study title: A comparison of the characteristics of propofol and thiopentone for induction of general anaesthesia for paediatric surgery. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0186 Study Synopsis.pdf |
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Document reference: 46129 |
Study title: A comparison of venous tolerability and injection pain of Propofol diluted in a lipid emulsion and standard Propofol in the induction of anesthesia in children |
Active substance: PROPOFOL |
Study summary document link (including results): BBM0201-09_ICH-280306_FINAL-VERSION.pdf |
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Document reference: 47084 |
Study title: A multicenter, comparative, randomized trial to determine the overall safety and efficacy of 1% Diprivan vs 2% Diprivan vs standard agents without disodium edetate for sedation of trauma, postsurgical, or critically ill paediatric subjects. |
Active substance: PROPOFOL |
Study summary document link (including results): 0859IL0068 Study Synopsis.pdf |
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Document reference: 46137 |
Study title: A preliminary evaluation of the characteristics of propofol (Diprivan) for induction of general anaesthesia for paediatric surgery. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0141 Study Synopsis.pdf |
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Document reference: 46128 |
Study title: Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39 Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39 |
Active substance: PYRIDOSTIGMINE |
Study summary document link (including results): |
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Document reference: 35215 |
Study title: Remifentanil/propofol versus remifentanil/sevoflurane in- and outpatient paediatric surgery |
Active substance: REMIFENTANIL |
Study summary document link (including results): |
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Document reference: 35288 |
Study title: A randomised controlled trial comparing low molecular weight heparin (reviparin sodium) to standard of practice unfractionated heparin plus a vitamin K antagonist for the treatment of venous thromboembolism in a pediatric patient population. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL052.pdf |
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Document reference: 45107 |
Study title: An open-label dose-finding trial of low molecular weight heparin LU 47311 (Clivarine®) for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL057.pdf |
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Document reference: 35289 |
Study title: An open-label, dose-finding trial of low molecular weight heparin (Clivarine®) for the treatment of deep vein thrombosis/pulmonary embolism in a pediatric patient population. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL022.pdf |
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Document reference: 35291 |
Study title: An open-label, multicenter, randomized trial comparing low molecular weight heparin (reviparin) to standard of care for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL055.pdf |
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Document reference: 35290 |
Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30169 |
Study title: Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973 |
Active substance: RHUBARB AND SALICYLIC ACID |
Study summary document link (including results): |
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Document reference: 35293 |
Study title: Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thiemann-M, Schwarze-E-W. Department of Pediatric Hematology and Oncology, University Children's Hospital, Germany. schellon@uni-muenster.de. High cure rates and reduced long-term toxicity in pediatric Hodgkin's disease: the German-Austrian multicenter trial DAL-HD-90. The German- Austrian Pediatric Hodgkin's Disease Study Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1999, vol. 17, no. 12, p. 3736-44, ISSN: 0732-183X.Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thi... |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34834 |
Study title: Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536. |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34835 |
Study title: Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15). |
Active substance: PROCARBAZINE |
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Document reference: 34838 |
Study title: Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630.Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630. |
Active substance: PROCARBAZINE |
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Document reference: 34839 |
Study title: Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X. |
Active substance: PROCARBAZINE |
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Document reference: 34840 |
Study title: A study to assess the use of propofol for induction and maintenance of anaesthesia by continuous infusion for paediatric procedures. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0238 Study Synopsis.pdf |
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Document reference: 46133 |
Study title: An assessment of the characteristics of propofol for maintenance of anaesthesia by infusion for paediatric surgery. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0187 Study Synopsis.pdf |
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Document reference: 46132 |
Study title: 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121 |
Active substance: PYRVINIUM |
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Document reference: 39564 |
Study title: 36. Nassif et al., J Trop Med Hyg 1974 ; 77 : 270-271 36. Nassif et al., J Trop Med Hyg 1974 ; 77 : 270-271 |
Active substance: PYRVINIUM |
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Document reference: 39565 |
Study title: 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 |
Active substance: PYRVINIUM |
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Document reference: 39567 |
Study title: 39. Palicka, Cesk Pediatr 1971; 26: 563-565 39. Palicka, Cesk Pediatr 1971; 26: 563-565 |
Active substance: PYRVINIUM |
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Document reference: 39568 |
Study title: 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458 |
Active substance: PYRVINIUM |
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Document reference: 39533 |
Study title: 40. Pawlowski, Kolo-wrotkiewicz, Wiad Parazytol 1964; 10: 443-446 40. Pawlowski, Kolo-wrotkiewicz, Wiad Parazytol 1964; 10: 443-446 |
Active substance: PYRVINIUM |
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Document reference: 39569 |
Study title: 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55 |
Active substance: PYRVINIUM |
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Document reference: 39570 |
Study title: 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45 |
Active substance: PYRVINIUM |
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Document reference: 39571 |
Study title: 43. Plotnikov et al., Med Parazytol 1970; 39: 38: 387-390 43. Plotnikov et al., Med Parazytol 1970; 39: 38: 387-390 |
Active substance: PYRVINIUM |
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Document reference: 39572 |
Study title: 44. Priebe, Münch Med Wochenschr 1961; 103: 1730-1732 44. Priebe, Münch Med Wochenschr 1961; 103: 1730-1732 |
Active substance: PYRVINIUM |
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Document reference: 39573 |
Study title: 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288 |
Active substance: PYRVINIUM |
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Document reference: 39574 |
Study title: 46. Rodriguez et al., J Pediatr 1960; 25: 324-330 46. Rodriguez et al., J Pediatr 1960; 25: 324-330 |
Active substance: PYRVINIUM |
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Document reference: 39575 |
Study title: 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233 |
Active substance: PYRVINIUM |
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Document reference: 39576 |
Study title: 48. Sandars, Med J Aust 1963; 1: 722-725 48. Sandars, Med J Aust 1963; 1: 722-725 |
Active substance: PYRVINIUM |
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Document reference: 39577 |
Study title: Spicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic childrenSpicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic children |
Active substance: INOSINE |
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Document reference: 30171 |
Study title: Tekgul H, Tutuncuoglu S, Kutukculer N, Dizdarer G, Huseyinov A. J Child Neurol. 1999 Jul;14(7):418-21. Lymphocyte subsets and inflammatory mediators in patients with subacute sclerosing panencephalitis.Tekgul H, Tutuncuoglu S, Kutukculer N, Dizdarer G, Huseyinov A. J Child Neurol. 1999 Jul;14(7):418-21. Lymphocyte subsets and inflammatory mediators in patients with subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30173 |
Study title: Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course. |
Active substance: INOSINE |
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Document reference: 30174 |
Study title: Von Frenkell AR.. Laboratoires Delande; Paris 1987. Clinical Study Report. Statistical study concerning the clinical double blind study of Isoprinosine and a placebo for the the treatment of severe or complicated measlesVon Frenkell AR.. Laboratoires Delande; Paris 1987. Clinical Study Report. Statistical study concerning the clinical double blind study of Isoprinosine and a placebo for the the treatment of severe or complicated measles |
Active substance: INOSINE |
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Document reference: 30176 |
Study title: Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®. |
Active substance: INOSINE |
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Document reference: 30177 |
Study title: Yalaz K, Anlar B, Oktem F, Aysun S, Ustacelebi S, Gurcay O, Gucuyener K, Renda Y. Neurology. 1992 Mar;42(3 Pt 1):488-91. Intraventricular interferon and oral inosiplex in the treatment of subacute sclerosing panencephalitis.Yalaz K, Anlar B, Oktem F, Aysun S, Ustacelebi S, Gurcay O, Gucuyener K, Renda Y. Neurology. 1992 Mar;42(3 Pt 1):488-91. Intraventricular interferon and oral inosiplex in the treatment of subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30179 |
Study title: Insulin Lispro versus Humulin R in Adolescent Patients with Type I Diabetes |
Active substance: INSULIN (HUMAN) |
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Document reference: 30183 |
Study title: The Exclusive Use of Neutral Regular Human Insulin (rDNA) in the Treatment of Insulin-Dependent Diabetes Mellitus in Patients Who Have Never Received Insulin |
Active substance: INSULIN (HUMAN) |
Study summary document link (including results): Human insulin - B5K-MC-IBAI redacted CSR.PDF |
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Document reference: 30184 |
Study title: Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA |
Active substance: IOHEXOL |
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Document reference: 30363 |
Study title: Porteder H, Henning G: Improvment in wound healing after oral implantation with Solcoseryl Dental Adhesive paste. das deutsche Ärzteblatt, 1996, &, 320-323 Porteder H, Henning G: Improvment in wound healing after oral implantation with Solcoseryl Dental Adhesive paste. das deutsche Ärzteblatt, 1996, &, 320-323 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35090 |
Study title: Trzcinska-Dabrowska Z.; Kanigowska K.: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. Klin. Oczna 89: 27-28 (1987). Trzcinska-Dabrowska Z.; Kanigowska K.: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. Klin. Oczna 89: 27-28 (1987). |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35107 |
Study title: Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363 Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35089 |
Study title: Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042. |
Active substance: PROCARBAZINE |
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Document reference: 34700 |
Study title: Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532).Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532). |
Active substance: PROCARBAZINE |
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Document reference: 34702 |
Study title: Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955. |
Active substance: PROCARBAZINE |
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Document reference: 34703 |
Study title: 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416 |
Active substance: PYRVINIUM |
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Document reference: 39578 |
Study title: 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125 |
Active substance: PYRVINIUM |
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Document reference: 39534 |
Study title: 50. Seth, J Indian Med Assoc 1962; 38: 528-530 50. Seth, J Indian Med Assoc 1962; 38: 528-530 |
Active substance: PYRVINIUM |
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Document reference: 39579 |
Study title: 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334 |
Active substance: PYRVINIUM |
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Document reference: 39580 |
Study title: 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561 |
Active substance: PYRVINIUM |
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Document reference: 39581 |
Study title: 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130 |
Active substance: PYRVINIUM |
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Document reference: 39582 |
Study title: Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555.Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555. |
Active substance: PROCARBAZINE |
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Document reference: 34722 |
Study title: Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K |
Active substance: IOHEXOL |
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Document reference: 30364 |
Study title: Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR |
Active substance: IOHEXOL |
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Document reference: 30366 |
Study title: Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR |
Active substance: IOHEXOL |
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Document reference: 30367 |
Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenAJR Am J Roentgenol. 1991 Feb;156(2):345-50 Comparison of iohexol with barium in gastrointestinal studies of infants and children. Cohen MD, Towbin R, Baker S, Davis S, Becker C, Eggleston DE, Kehler M, Smith JA, Cory DA, White SJ. |
Active substance: IOHEXOL |
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Document reference: 30365 |
Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenJ Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. |
Active substance: IOHEXOL |
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Document reference: 30379 |
Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E |
Active substance: IOHEXOL |
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Document reference: 30370 |
Study title: Eur Radiol. 1997;7 Suppl 4:S120-2 Iopentol (Imagopaque 300) compared with iohexol (Omnipaque 300) and diatrizoate (Urografin 292) in pediatric urography. A clinical trial assessing adverse events and diagnostic information. Lanning P, Brekke O. Eur Radiol. 1997;7 Suppl 4:S120-2 Iopentol (Imagopaque 300) compared with iohexol (Omnipaque 300) and diatrizoate (Urografin 292) in pediatric urography. A clinical trial assessing adverse events and diagnostic information. Lanning P, Brekke O. |
Active substance: IOHEXOL |
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Document reference: 30371 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IOHEXOL |
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Document reference: 30372 |
Study title: Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B. Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B. |
Active substance: IOHEXOL |
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Document reference: 30374 |
Study title: Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41.Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Anesthetic effects from low concentrations of proparacaine a.pdf |
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Document reference: 46144 |
Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45) |
Active substance: QUININE |
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Document reference: 45077 |
Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45) |
Active substance: QUININE |
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Document reference: 45082 |
Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059) |
Active substance: QUININE |
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Document reference: 45063 |
Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059) |
Active substance: QUININE |
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Document reference: 45068 |
Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059) |
Active substance: QUININE |
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Document reference: 45073 |
Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059) |
Active substance: QUININE |
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Document reference: 45078 |
Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45) |
Active substance: QUININE |
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Document reference: 45072 |
Study title: Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70).Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70). |
Active substance: PROCARBAZINE |
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Document reference: 34795 |
Study title: Oberlin-O, Leverger-G, Pacquement-H, Raquin-M-A, Chompret-A, Habrand- J-L, Terrier-Lacombe-M-J, Bey-P, Bertrand-Y, Rubie-H, et al. Pediatrics Department, Institut Gustave Roussy, Villejuif, France. Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's disease: the experience of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1992, vol. 10, no. 10, p. 1602-8, ISSN: 0732-183X.Oberlin-O, Leverger-G, Pacquement-H, Raquin-M-A, Chompret-A, Habrand- J-L, Terrier-Lacombe-M-J, Bey-P, Bertrand-Y, Rubie-H, et al. Pediatrics Department, Institut Gustave Roussy, Villejuif, France. Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's... |
Active substance: PROCARBAZINE |
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Document reference: 34796 |
Study title: Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534.Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534. |
Active substance: PROCARBAZINE |
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Document reference: 34797 |
Study title: Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58). |
Active substance: PROCARBAZINE |
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Document reference: 34798 |
Study title: A Study to Compare the Efficacy and Safety of 0.25% Levobupivacaine to 0.25% Bupivacaine when Administered as a Caudal Extradural for PostOperative Analgesia in Paediatric In-Patients Undergoing Elective Orthopaedic or Major Urological Surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30590.pdf |
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Document reference: 47650 |
Study title: Astudy to assess the efficacy and safety of 0.25% levobupivacaine when administered as a caudal injection in paediatric patients undergoing hernia repair, circumcision or orchidopexy. |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30585.pdf |
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Document reference: 47649 |
Study title: Double-Blind Randomized Controlled Trial of05% L.evobupivacaine for Post-Operative Pain Control in Pediatric Patients Foliowing Hernia Repair Surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-CS007.pdf |
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Document reference: 47648 |
Study title: A comparative study of the treatment of seasonal rhinoconjunctivitis with levocabastine, up-to date and classical H1 inhibitors. 18"' Congress of the European Academy of Allergy and Clinical Immunology, Brussels, Belgium, NO-P292, July 3-7, 1999A comparative study of the treatment of seasonal rhinoconjunctivitis with levocabastine, up-to date and classical H1 inhibitors. 18"' Congress of the European Academy of Allergy and Clinical Immunology, Brussels, Belgium, NO-P292, July 3-7, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31132 |
Study title: A double-blind placebo-controlled study of levocabastine eye drops and nose spray in patients with hay fever (13-73 yrs) |
Active substance: LEVOCABASTINE |
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Document reference: 31093 |
Study title: A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31138 |
Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
Active substance: LEVOCABASTINE |
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Document reference: 31059 |
Study title: Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2)Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2) |
Active substance: RHUBARB AND SALICYLIC ACID |
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Document reference: 35294 |
Study title: Vorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patientsVorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patients |
Active substance: RHUBARB AND SALICYLIC ACID |
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Document reference: 35296 |
Study title: Placebo-controlled comparison of levamisole, pyrantel pamoate, thiabendazole, piperazine citrate, and varlaus dosages of mebendazole in the treatment of ascariasis and trichuriasis in children. 1975 |
Active substance: MEBENDAZOLE |
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Document reference: 31539 |
Study title: Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419. |
Active substance: PROCARBAZINE |
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Document reference: 34777 |
Study title: Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma? |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39899 |
Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
Active substance: LARATADINE |
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Document reference: 31016 |
Study title: The effectiveness of the homeopathic remedy Rhinital in the out-patient treatment of children suffering from perennial and seasonal rhinitis |
Active substance: Luffa operculata, Cardiospermum halicacabum, Galphimia glauca |
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Document reference: 39743 |
Study title: Liberal use of antibiotics and its effect in neonatal staphylococcal infection, with particular reference to erythromycin.Forfar J O, Keay A J, Maccabe A F, Gould J C, Bain A D. Lancet, {Lancet}, 6 Aug 1966, vol. 2, no. 7458, p. 295−300, ISSN: 0140−6736. |
Active substance: ERYTHROMYCIN |
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Document reference: 26564 |
Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059) |
Active substance: QUININE |
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Document reference: 45083 |
Study title: A comparative study of two different doses of Smith Kline-RIT rec-DNA Hepatitis B vaccine (10 mcg and 20 mcg). |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47756 |
Study title: A comparative, Single-Blind, Randomised Study of the Immunogenicity and Safety of Engerix-B administered at two different dose levels. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47764 |
Study title: Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X.Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X. |
Active substance: PROCARBAZINE |
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Document reference: 34743 |
Study title: Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1998, vol. 16, no. 3, p. 897-906, ISSN: 0732-183X.Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD i... |
Active substance: PROCARBAZINE |
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Document reference: 34744 |
Study title: Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50). |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34746 |
Study title: |
Active substance: PROMETHAZINE |
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Document reference: 35044 |
Study title: A controled surgical series treated with promethazine before inducation. - Smith A.H.- (N.Y. State J. Med. 19/03/1959, 1024-9). - Publication in PROMETHAZINE Safety and efficacy review of medicines following UK authorities review of psychotropic and centrally acting drugs. May&Baker Ltd. Company April 1980 - |
Active substance: PROMETHAZINE |
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Document reference: 34996 |
Study title: Acute poisoning in a children's hospital A 2-year experience |
Active substance: PROMETHAZINE |
Study summary document link (including results): Acute poisoning in a children's hospital A 2-year experience.pdf |
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Document reference: 35052 |
Study title: Advanced pediatric joint imaging |
Active substance: PROMETHAZINE |
Study summary document link (including results): Advanced pediatric joint imaging.pdf |
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Document reference: 35046 |
Study title: Adverse effects of meperidine, promethazine, and chlorpromazine for sedation in pediatric patients. |
Active substance: PROMETHAZINE |
Study summary document link (including results): Adverse effects of meperidine, promethazine, and chlorpromazine for sedation in pediatric patients.pdf |
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Document reference: 35000 |
Study title: Adverse reactions in children |
Active substance: PROMETHAZINE |
Study summary document link (including results): Adverse reactions in children.pdf |
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Document reference: 35038 |
Study title: An open-label randomized comparison of olanzapine versus risperidone in the treatment of childhood-onset schizophrenia |
Active substance: PROMETHAZINE |
Study summary document link (including results): An open-label randomized comparison of olanzapine versus risperidone in the treatment of childhood-onset schizophrenia.pdf |
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Document reference: 35030 |
Study title: Anasthesia for paediatric cardiac catheterization and angiocardiography. - Moffitt E.A. Dawson B. O'Neill N.C.- 1961 (Anaesth. And Analg., 1961, 40, 483.) - Publication in PHENERGAN therapeutic summary 6th edition May & Baker Ltd.1976 - |
Active substance: PROMETHAZINE |
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Document reference: 35003 |
Study title: Annotation The use of psychotropic medications in children A British view |
Active substance: PROMETHAZINE |
Study summary document link (including results): Annotation The use of psychotropic medications in children A British view.pdf |
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Document reference: 35029 |
Study title: Blanc VF_1991; Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgeryBlanc VF_1991; Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgery |
Active substance: PROMETHAZINE |
Study summary document link (including results): Bayer Pharma_Promethazine_Blanc VF_1991_publication.pdf |
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Document reference: 34998 |
Study title: Clinical observations with promethazine hydrochloride (PHERNERGAN ELIXIR), in paediatric practice. - Sarma D.N. Dass C.S.- (Indian Med. J., 1978, 72 (9), 156-157.) - Publication in PHENERGAN Tableelt 25mg, Syrup 1%, Sol inj 2,5%. Syndthesis documentation. French validation dossier 17/06 |
Active substance: PROMETHAZINE |
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Document reference: 35011 |
Study title: Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1994, Vol/Iss/Pg. 28/2 (381-386), ISSN: 0360-3016.Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {... |
Active substance: PROCARBAZINE |
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Document reference: 34818 |
Study title: Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562.Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562. |
Active substance: PROCARBAZINE |
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Document reference: 34819 |
Study title: Kato Z, Asano T, Kondo N. J Child Neurol. 2006 Feb;21(2):177-8. Inosiplex affects the spectra of proton magnetic resonance spectroscopy in subacute sclerosing panencephalitis.Kato Z, Asano T, Kondo N. J Child Neurol. 2006 Feb;21(2):177-8. Inosiplex affects the spectra of proton magnetic resonance spectroscopy in subacute sclerosing panencephalitis. |
Active substance: INOSINE |
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Document reference: 30129 |
Study title: Kho LK, Wulur H, Himawan T.. Abstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 1. Experiences in the management of dengue hemorrhagic feverKho LK, Wulur H, Himawan T.. Abstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 1. Experiences in the management of dengue hemorrhagic fever |
Active substance: INOSINE |
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Document reference: 30130 |
Study title: Kho LK. Report to Newport Pharmaceuticals, Inc: September 20, 1973. Isoprinosine in dengue fever, hepatitis, herpes zoster opthalmicus.Kho LK. Report to Newport Pharmaceuticals, Inc: September 20, 1973. Isoprinosine in dengue fever, hepatitis, herpes zoster opthalmicus. |
Active substance: INOSINE |
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Document reference: 30131 |
Study title: Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine |
Active substance: INOSINE |
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Document reference: 30132 |
Study title: Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. |
Active substance: INOSINE |
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Document reference: 30133 |
Study title: Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An analysis of the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania experience. University of Pennsylvania experience. Cancer, {Cancer}, 1 Jun 1992, vol. 69, no. 11, p. 2755-60, ISSN: 0008-543X.Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An ... |
Active substance: PROCARBAZINE |
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Document reference: 34779 |
Study title: Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085. Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085. |
Active substance: PROCARBAZINE |
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Document reference: 34781 |
Study title: A multi-center, 6-week, open label study to document the visual treatment characteristics of Elidel (pimecrolimus) cream 1% (twice daily application) by photography in patients >2 years old in the treatment of mild to moderate atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls |
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Document reference: 34089 |
Study title: A multi-center, 6-week, open label study to document the visual treatment characteristicsof Elidel (pimecrolimus) cream 1% (twice daily application) by photography in patients >2 years old in the treatment of mild to moderate atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2435 Art45 listing 2011.xls |
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Document reference: 47710 |
Study title: A randomized, multi-center, parallel-group, double-blind, vehicle-controlled study to evaluate the time of pruritus improvement during the first week of pimecrolimus cream 1% treatment in patients >2 years old with mild to moderate atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CUS08 Art45 listing 2011.xls |
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Document reference: 34104 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42753 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) IN THE TREATMENT OF PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42754 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULPERAZONE IN THE TREATMENT OF INFECTIONS IN LEUKEMIC CHILDREN. |
Active substance: SULBACTAM |
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Document reference: 42759 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF CEFOPERAZONE/SULBACTAM (1:1) IN THE EMPIRICAL TREATMENT OF SYSTEMIC INFECTIONS IN ADULT PATIENTS IN HOSPITAL KUALA LUMPUR |
Active substance: SULBACTAM |
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Document reference: 42847 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42851 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTION. |
Active substance: SULBACTAM |
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Document reference: 42854 |
Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF BONE/JOINT INFECTIONS AND OSTEOMYELITIS |
Active substance: SULBACTAM |
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Document reference: 42857 |
Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF SURGICAL INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42849 |
Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42852 |
Study title: AN OPEN, PROSPECTIVE STUDY OF SBT/CFP (1:1) IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER |
Active substance: SULBACTAM |
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Document reference: 42861 |
Study title: AN OPEN, PROSPECTIVE, STUDY OF THE EFFICACY AND SAFETY OF SBT/CFP (1:1) IN THE TREATMENT OF NOSOCOMIAL PNEUMONIA, IN ADULT PATIENTS. |
Active substance: SULBACTAM |
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Document reference: 42869 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42791 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
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Document reference: 42798 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42781 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
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Document reference: 42820 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42782 |
Study title: A single-centre, randomised, double-blind, placebo-controlled pilot study of cross-over design testing nifedipine in patients with cystic fibrosis. |
Active substance: NIFEPIDINE |
Study summary document link (including results): Bayer Pharma_Nifedipine_1123_study_synopsis.pdf |
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Document reference: 32631 |
Study title: Dr. Benezis Essai contrôle en double aveugle etablissant l'efficacité et la tolerance de l'acide niflumique gélule par rapport au placébo et au diclofenac dans les tendinites du membre inférieur. |
Active substance: NIFLUMIC ACID |
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Document reference: 32637 |
Study title: "Tolerability of Nimesulide and Ketoprofen in Paediatric Patients with Traumatic or Surgical Fractures, Facchini R et al. Drugs 46 (Suppl.1): 238-241, 1993 (only studies with patients 12-17 years are included, as use below 12 is contraindicated)" "Tolerability of Nimesulide and Ketoprofen in Paediatric Patients with Traumatic or Surgical Fractures, Facchini R et al. Drugs 46 (Suppl.1): 238-241, 1993 (only studies with patients 12-17 years are included, as use below 12 is contraindicated)" |
Active substance: NIMESULIDE |
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Document reference: 32648 |
Study title: Anticonvulsant toxicity in paediatric out-patients. |
Active substance: NITRAZEPAM |
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Document reference: 32659 |
Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Pharmacokinetics of teicoplanin in paediatric patients - Rosina R., Bernareggi A., Danese A., Cavenaghi L - 14 November 1986 |
Active substance: TEICOPLANIN |
Study summary document link (including results): Teicoplanin STUDY DRC 348.DLI 1039.xls |
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Document reference: 44301 |
Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients - Garaud J.J. - 9 March 1987 |
Active substance: TEICOPLANIN |
Study summary document link (including results): Teicoplanin STUDY EG-87-16.xls |
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Document reference: 44302 |
Study title: Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients. - Lemerle S, De la Roque F, Lamy R, et al. - J Antimicrob Chemother 1988; 21, S.A.: 112-116.Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients. - Lemerle S, De la Roque F, Lamy R, et al. - J Antimicrob Chemother 1988; 21, S.A.: 112-116. |
Active substance: TEICOPLANIN |
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Document reference: 44324 |
Study title: Teicoplanin in gram-positive paediatric infections. (Abstract) In: Abstracts of the 8th mediterranean congress of chemotherapy. - Careddi P, Boccazzi A, Mosconi G. - Athens, 24-29 May 1992: 236.Teicoplanin in gram-positive paediatric infections. (Abstract) In: Abstracts of the 8th mediterranean congress of chemotherapy. - Careddi P, Boccazzi A, Mosconi G. - Athens, 24-29 May 1992: 236. |
Active substance: TEICOPLANIN |
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Document reference: 44325 |
Study title: AD on face: A 6-month study with 3 week randomized, multicenter, double blind, vehicle-controlled, parallel phase followed by 23 week open-label phase to study the safety and efficacy of 1% SDS ASM981 cream in pediatric subjects with atopic dermatitis |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CES01 Art45 listing 2011.xls |
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Document reference: 34102 |
Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): |
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Document reference: 33042 |
Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , |
Active substance: PACLITAXEL |
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Document reference: 33044 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Paeonia-Salbe-Heel (ointment) [AWB-AT] |
Active substance: Paeonia-Heel - Salbe |
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Document reference: 40092 |
Study title: Study PALIOROS-PSZ-1001 is a multicenter, open-label, single- and multiple-dose study in subjects aged 10 to 17 years, inclusive, diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder to evaluate pharmcokinetics and tolerability. |
Active substance: PALIPERIDONE |
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Document reference: 45719 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFLAMMATION OF PELVIC DEAD SPACE POST-OPERATION OF GYNECOLOGICAL MALIGNANT DISEASE. |
Active substance: SULBACTAM |
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Document reference: 42823 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42822 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42830 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42831 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42832 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42836 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42841 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42842 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42844 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42827 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42845 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
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Document reference: 42819 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES |
Active substance: SULBACTAM |
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Document reference: 42818 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42808 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42816 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
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Document reference: 42811 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS WITH TOTAL PARENTAL NUTRITION (T.P.N.) PATIENTS |
Active substance: SULBACTAM |
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Document reference: 42776 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42772 |
Study title: Deaths in young children receiving nitrazepam. |
Active substance: NITRAZEPAM |
Study summary document link (including results): |
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Document reference: 32660 |
Study title: Human pharmacokinetics of nitrazepam:effect of age and disease. |
Active substance: NITRAZEPAM |
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Document reference: 32661 |
Study title: Improvement of mental retardation plus epilepsy in children following management. |
Active substance: NITRAZEPAM |
Study summary document link (including results): |
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Document reference: 32654 |
Study title: Incidence of Death in Patients with Intractable Epilepsy during Nitrazepam therapy. |
Active substance: NITRAZEPAM |
Study summary document link (including results): |
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Document reference: 32662 |
Study title: Infantile spasms. A retrospective study of 105 cases. |
Active substance: NITRAZEPAM |
Study summary document link (including results): |
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Document reference: 32658 |
Study title: Infantile spasms. Comparative trial of nitrazepam and corticotropin. |
Active substance: NITRAZEPAM |
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Document reference: 32652 |
Study title: Nitrazepam for refractory infantile spasms and the Lennox-Gastaut syndrome. |
Active substance: NITRAZEPAM |
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Document reference: 32656 |
Study title: Nitrazepam for the treatment of Lennox-Gastaut syndrome. |
Active substance: NITRAZEPAM |
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Document reference: 32655 |
Study title: Prospective study of first-choice topiramate therapy in newly diagnosed infantile spasms. |
Active substance: NITRAZEPAM |
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Document reference: 32653 |
Study title: Seizures with clonazepam: Discontinuation and suggestions for safe discontinuation rates in children. |
Active substance: NITRAZEPAM |
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Document reference: 32657 |
Study title: Short-term nonhormonal and nonsteroid treatment in West syndrome. Short-term nonhormonal and nonsteroid treatment in West syndrome. |
Active substance: NITRAZEPAM |
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Document reference: 32650 |
Study title: West syndrome: clinical and electroencephalographic follow up of 70 patients and response to its treatment with adrenocorticotropic hormone, prednisone, vigabatrin, nitrazepam and valproate. |
Active substance: NITRAZEPAM |
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Document reference: 32651 |
Study title: Nitrix oxide for inhalation, INOMAX® INOT22 1-Year and 3-Year Follow up report: comparison of supplemental Oxygen and nitric oxide for inhalation plus oxygen in the evaluation of the reactivity of the pulmonary vasculature during acute pulmonary vasodilator testing |
Active substance: Nitric oxide |
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Document reference: 41519 |
Study title: Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. |
Active substance: NITROUS OXIDE |
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Document reference: 32663 |
Study title: Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6. Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6. |
Active substance: NITROUS OXIDE |
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Document reference: 32664 |
Study title: Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183.Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183. |
Active substance: TEICOPLANIN |
Study summary document link (including results): |
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Document reference: 44326 |
Study title: Activity of telithromycin against erythromycin susceptible and resistant Streptococcus pyogenes and Streptococcus pneumoniae isolates from paediatric origin |
Active substance: telithromycin |
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Document reference: 41554 |
Study title: Activity of telithromycin and comparators against paediatric respiratory tract infection (RTI) isolates collected across Canada over the past 3 years (1997-1998, 1998-1999, and 1999-2000) |
Active substance: telithromycin |
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Document reference: 41558 |
Study title: Activity of telithromycin on clinical isolates of Streptococcus pyogenes and Streptococcus pneumoniae from paediatric patients in different regions of Italy |
Active substance: telithromycin |
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Document reference: 41553 |
Study title: Determination of the susceptibility of isolates of Streptococcus pneumoniae and Streptococcus pyogenes, from paediatric patients, to telithromycin and comparator compounds and identification of the mechanism of resistance in erythromycin A-resistant strains |
Active substance: telithromycin |
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Document reference: 41551 |
Study title: Evaluation of pharmacokinetics, safety, efficacy and acceptability of HMR3647 (20mg/kg and 30mg/kg q.d.) in pediatric patients with infection (a non-blind, randomised, parallel-group comparative study) |
Active substance: telithromycin |
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Document reference: 41572 |
Study title: Evaluation of the Safety, Efficacy, Pharmacokinetics and Acceptability of HMR 3647 20 mg/kg QD for 5 Days with Acute Otitis Media in Children(Multicenter, open label, non comparative study) |
Active substance: telithromycin |
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Document reference: 41574 |
Study title: Evaluation of the Safety, Pharmacokinetics, Efficacy and Acceptability of HMR 3647 20mg/kg QD for 5-7 Days with Community Acquired Pneumonia (CAP) in children. (Multicenter, open label, non comparative study) |
Active substance: telithromycin |
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Document reference: 41573 |
Study title: In vitro actibity of telithromycin (HMR3647) against Streptococcus pyogenes and Streptococcus pneumoniae clinical isolates from paediatric patients in Greece |
Active substance: telithromycin |
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Document reference: 41552 |
Study title: In vitro activity of antimicrobial agents against Streptococcus pyogenes in paediatrics : a Belgian multicenter study |
Active substance: telithromycin |
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Document reference: 41560 |
Study title: In vitro activity of telithromycin (HMR3647) against strains of S.pneumoniae and S. pyogenes isolated in Iceland and comparison with other antimicrobials |
Active substance: telithromycin |
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Document reference: 41556 |
Study title: In vitro activity of telithromycin and multiple comparison antibiotics against recent clinical isolates from children |
Active substance: telithromycin |
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Document reference: 41559 |
Study title: In vitro activity of telithromycin, including well characterized erythromycin. A - resistant clinical isolates of S. pneumoniae and S.pyogenes in paediatrics |
Active substance: telithromycin |
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Document reference: 41549 |
Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp011.pdf |
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Document reference: 48096 |
Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp012.pdf |
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Document reference: 48097 |
Study title: A Phase 2, Open-Label, Prospective, Safety and pK Study to Assess the Extended Use of Synagis (Seven Injections) in Infants and Children with or without CLD |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-w00-350.pdf |
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Document reference: 48108 |
Study title: A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33333 |
Study title: A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33340 |
Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33336 |
Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33335 |
Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992.A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33342 |
Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children. Jun 1991.A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children. Jun 1991. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33343 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD). |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42809 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.). |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42817 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42837 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42835 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.). |
Active substance: SULBACTAM |
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Document reference: 42765 |
Study title: McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50. McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50. |
Active substance: NITROUS OXIDE |
Study summary document link (including results): |
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Document reference: 32667 |
Study title: PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 |
Active substance: NITROUS OXIDE |
Study summary document link (including results): |
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Document reference: 32669 |
Study title: Puttick N, Rosen M. Propofol induction and maintenance with nitrous oxide in paediatric outpatient dental anaesthesia. A comparison with thioopentone-nitrous oxide-halothane. Anaesthesia. 1988; 43(8):646-9. Puttick N, Rosen M. Propofol induction and maintenance with nitrous oxide in paediatric outpatient dental anaesthesia. A comparison with thioopentone-nitrous oxide-halothane. Anaesthesia. 1988; 43(8):646-9. |
Active substance: NITROUS OXIDE |
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Document reference: 32670 |
Study title: Abdelkefi A, Abdennebi YB, Mellouli F, Othman TB, Torjman L, Ladeb S, Aouf S, Béjaoui M, Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779 |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32673 |
Study title: Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics 2000 Apr;105(4):E47. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32675 |
Study title: Baskett PJF, Hyland J, Deane M, Wray G. Analgesia for burns dressing in children. A dose-finding study for phenoperidine and droperidol with and without 50 per cent nitrous oxide and oxygen. Br J Anaesth 1969 Aug;41(8):684-8. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32676 |
Study title: Beh T, Splinter W, Kim J. In children, nitrous oxide decreases pain on injection of propofol mixed with lidocaine.Can J Anesth 2002;49(10);1061-1063 |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32677 |
Study title: Braam MJI, Bath AP, Spauwen PHM, Bailie FB. Survey of analgesia regimens in burns centres in the UK. Burns 1994 Aug;20(4):360-2. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32679 |
Study title: Bryan RA. The success of inhalation sedation for comprehensive dental care within the Community Dental Service. Int J Paediatr Dent 2002 Nov;12(6):410-4. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32680 |
Study title: Burton JH, Auble TE, Fuchs SM. Effectiveness of 50% nitrous oxide/50% oxygen during laceration repair in children. Acad Emerg Med 1998 Feb;5(2):112-7. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32681 |
Study title: Investigation of the efficacy, safety and acceptability of HMR 3647 (1-g divided 20% fine granule packets) in paediatric patients with infections ( a multi-center collaborative single-group non blinded study) |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41575 |
Study title: macrolide-resistant streptococci among pediatric patients in Denmark, Luxemburg, The Netherlands and Turkey |
Active substance: telithromycin |
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Document reference: 41548 |
Study title: Minimal inhibittory concentrations of telithromycin (Ketek) against Streptococcus pneumoniae, Heamophilus influenzae and Moraxella catarrhalis strains isolated from specimen of young patients (17 years old or less) and from specimen of adults (18 years old and older) |
Active substance: telithromycin |
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Document reference: 41557 |
Study title: Open Study to determine the concentration of telithromycin in the extracellular and intracellular compartments of middle ear fluid in children with acute otitis media or otitis media with spontaneous effusion after single oral administration of a telithromycin pediatric suspension |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41567 |
Study title: Pattern of killing of telithromycin and azithromycin against various strains of Streptococcus pneumoniae |
Active substance: telithromycin |
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Document reference: 41561 |
Study title: Susceptibility of 1034 Streptococcus pneumoniae and 1039 Streptococcus pyogenes strains from paediatric patients in ten central and eastern European contries to telithromycin, erythromycin A, azithromycin, clarithromycin, clindamycin, levofloxacin, quinupristin/dalfopristin, and penicillin G |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41555 |
Study title: Telithromycin epidemiological survey in Austria isolates from paediatric patients |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41547 |
Study title: A double blind, parallel, multicenter comparison of tenoxicam with naproxene in the treatment of children and adolescents suffering from Juvenile Chronic Arthritis (JCA). |
Active substance: TENOXICAM |
Study summary document link (including results): |
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Document reference: 44339 |
Study title: A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33338 |
Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33325 |
Study title: Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228 |
Active substance: PERMETHRIN |
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Document reference: 33897 |
Study title: Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413 |
Active substance: PERMETHRIN |
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Document reference: 33896 |
Study title: Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307) |
Active substance: PERPHENAZINE |
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Document reference: 33898 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42833 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
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Document reference: 42812 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42807 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANCY DISEASES |
Active substance: SULBACTAM |
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Document reference: 42804 |
Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASE |
Active substance: SULBACTAM |
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Document reference: 42763 |
Study title: CLINICAL TRIAL OF SULPERAZON ALONE OR SULPERAZON PLUS DALACIN-S FOR INFECTIONS IN PATIENTS WITH LUNG CANCER. |
Active substance: SULBACTAM |
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Document reference: 42826 |
Study title: CLINICAL TRIAL OF SULPERAZON PLUS FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS. STUDY COMPARATIVE TO WHETHER PATIENTS RECEIVES SBT/CFP OR FOSFOMYCIN. |
Active substance: SULBACTAM |
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Document reference: 42825 |
Study title: Cleary AG, Ramamon AV, Baildam E, Birch A, Sills JA, Davidson JE. Nitrous oxide analgesia during intra-articular injection for juvenile idiopathic arthritis. Arch Dis Child 2002;86:416-418. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32682 |
Study title: Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779 |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32674 |
Study title: Ekbom K, Jakobsson J, Marcus C. Nitrous oxide inhalation is a safe and effective way to facilitate procedures in paediatric outpatient departments. Arch Dis Child 2005;90:1073-1076. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32685 |
Study title: Evans JK, Buckley SL, Alexander AH, Gilpin AT. Analgesia for the reduction of fractures in children: A comparison of nitrous oxide with intramuscular sedation. J Pediatr Orthop 1995 Jan-Feb;15(1):73-7. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32687 |
Study title: Fauroux B, Onody P, Gall O, Tourniaire B, Koscielny S, Clément A. The efficacy of premixed nitrous oxide and oxygen for fiberoptic bronchoscopy in paediatric patients: A randomised, double-blind, controlled study. Chest 2004 Jan;125(1):315-21. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32688 |
Study title: Felmet K, Robins B, Tilford D, Hayflick SJ. Acute neurologic decompensation in an infant with cobalamin deficiency exposed to nitrous oxide. J Paediatr 2000;137;427-428 |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32689 |
Study title: Fishman G, Botzer E, Marouani N, DeRowe A. Nitrous oxide-oxygen inhalation for outpatient otologic examination and minor procedures performed on the uncooperative child. International Journal of Pediatric Otorhinolaryngology 2005;69:501-504. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32690 |
Study title: Frampton A, Browne GJ, Lam LT, Cooper MG, Lane LG. Nurse administered relative analgesia using high concentration nitrous oxide to facilitate minor procedures in children in an emergency department. Emerg Med J 2003;20:410-413. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32691 |
Study title: Gamis AS, Knapp JF, Glenski JA. Nitrous oxide analgesia in a pediatric emergency department. Ann Emerg Med 1989 Feb;18:177-181. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32693 |
Study title: Gregory PR, Sullivan JA. Nitrous oxide compared with intravenous regional anesthesia in pediatric forearm fracture manipulation. J Pediatr Orthop 1996;16:187-191. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32694 |
Study title: Heafield R, Jackson R. Entonox and its use in the orthopaedic out-patient department. The Pain Network Newsletter 2001 Summer;29:4-6. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32696 |
Study title: Hee HI, Goy RWL, Ng AS. Effective reduction of anxiety and pain during venous cannulation in children: a comparison of analgesic efficacy conferred by nitrous oxide, EMLA and combination. Paed Anaesth 2003;13:210-216. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32697 |
Study title: Hennrikus WL, Shin AY, Klingelberger CE. Self-administered nitrous oxide and a haematoma block for analgesia in the Outpatient reduction of fractures in children. J Bone Joint Surg 1995;77A(3);335-339 |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32698 |
Study title: A randomized, doble-blind, parallel group study to determine the effective duration (1,2 or 4 weeks) and safety of Lamisil (tablets) given once daily to patients with tinea capitis due to Trichophyton species (mainly T. tonsurans) |
Active substance: TERBINAFINE |
Study summary document link (including results): SFO327 T201MR.xls |
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Document reference: 44355 |
Study title: A randomized, double-blind, parallel group study to determine the effective duration (6, 8, 10 or 12 weeks) and safety of LamisilÒ (tablets) given once daily to patients with tinea capitis due to Microsporum species (mainly M. canis). |
Active substance: TERBINAFINE |
Study summary document link (including results): SFO327 T202MR.xls |
View full study record |
Document reference: 44356 |
Study title: A comparison in children with chronic asthma, of terbutaline sulphate administered either as a metered aerosol with Nebuhaler(TM) or as a nebulised solution. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-2104 Study Synopsis.pdf |
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Document reference: 44385 |
Study title: A comparison of Bricanyl Turbuhaler to Ventolin Inhaler in asthmatic children currently using Ventolin Inhaler. |
Active substance: TERBUTALINE |
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Document reference: 44429 |
Study title: A comparison of terbutaline Turbuhaler and salbutamol aerosol inhaler in paediatric asthmatic patients with reversible airways obstruction. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-9209 Summary.pdf |
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Document reference: 44430 |
Study title: A comparison of terbutaline Turbuhaler® and salbutamol Rotahaler in asthmatic pre-school children. |
Active substance: TERBUTALINE |
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Document reference: 44427 |
Study title: A comparison of the Bricanyl Turbohaler and Ventolin Rotahaler in asthmatic children. |
Active substance: TERBUTALINE |
Study summary document link (including results): Terbutaline Bricanyl 01-2131 interventional.xls |
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Document reference: 44416 |
Study title: TO DETERMINE THE SAFETY AND EFFICACY OF ORAL SULTAMICILLIN VS. CLAVULANIC ACID/AMOXICILLIN IN PEDIATRIC PATIENTS WITH ACUTE OTITIS MEDIA. |
Active substance: SULTAMICILLIN |
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Document reference: 43024 |
Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SBT/AMP FOLLOWED BY ORAL STM IN THE TREATMENT OF BACTERIAL INFECTIONS. |
Active substance: SULTAMICILLIN |
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Document reference: 42955 |
Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SBT/AMP, FOLLOWED BY ORAL SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH THE ENTERIC FEVER SYNDROME. |
Active substance: SULTAMICILLIN |
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Document reference: 42954 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS. |
Active substance: SULTAMICILLIN |
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Document reference: 43012 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF UTI. |
Active substance: SULTAMICILLIN |
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Document reference: 43060 |
Study title: TO EVALUATE THE EFFICACY OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF BRONCHO-PNEUMONIA. |
Active substance: SULTAMICILLIN |
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Document reference: 43059 |
Study title: TO STUDY THE EFFICACY AND SAFETY OF ORAL STM FOR THE TREATMENT OF ACUTE PNEUMOPATHY AND LOWER RESPIRATORY TRACT INFECTION |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 42991 |
Study title: Sultopiride study in paediatric psychiatry - Delagrange - 02/08/89 |
Active substance: SULTOPRIDE |
Study summary document link (including results): |
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Document reference: 43067 |
Study title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Efficacy, Safety and Tolerability of Sumatriptan Nasal Spray (10mg or 20mg) in the Treatment of Acute Migraine in Patients Aged 12-17. |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUM30042-ICHE3.pdf |
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Document reference: 43068 |
Study title: GCV/93/006 A Double-Blind study to compare the efficacy & safety of oral sumatriptan (50mg-100mg) |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-S2CT40-ICHE3.pdf |
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Document reference: 43071 |
Study title: COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN VS METRONIDAZOLE/GENTAMICIN IN COLORECTAL SURGERY PROPHYLAXIS |
Active substance: SULBACTAM |
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Document reference: 42676 |
Study title: COMPARATIVE STUDY ON THE PROPHYLAXIS OF ABDOMINAL SURGERIES WITH INJECTABLE SULBACTAM - AMPICILLIN (UNASYN) VERSUS CEPHALOSPORINS. |
Active substance: SULBACTAM |
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Document reference: 42679 |
Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFUROXIME IN THE TREATMENT OF PERIORBITAL CELLULITIS AND/OR OTHER FACIAL CELLULITIS AND/OR EPIGLOTTIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS |
Active substance: SULBACTAM |
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Document reference: 42642 |
Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFUROXIME IN THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFECTIONS (E.G., PERIORBI-TAL CELLULITIS) AND/OR OSTEOMYELITIS/SUPPURATIVE ARTHRITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS. |
Active substance: SULBACTAM |
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Document reference: 42643 |
Study title: CONTROLLED, BLINDED, RANDOMIZED CLINICAL TRIAL OF THE EFFICACY AND TOXICITY OF AMPICILLIN/SULBACTAM VS AMPICILLIN/GENTAMYCIN/CLINDAMYCIN IN POSTPARTUM ENDOMETRIOSIS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42658 |
Study title: EFFICACY AND SAFETY OF BID DOSAGE OF PARENTERAL SULBACTAM/AMPICILLIN IN MILD-MODERATE SURGICAL INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42733 |
Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV037 (date Dec 1995) |
Active substance: IODIXANOL |
Study summary document link (including results): DXV037 Redacted.pdf |
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Document reference: 48208 |
Study title: EFFICACY AND SAFETY OF SBT/AMP IN PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42685 |
Study title: EFFICACY AND SAFETY OF SBT/AMP IN PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42695 |
Study title: EFFICACY AND SAFETY OF SBT/CFP IN MODERATE TO SEVERE BACTERIAL INFECTIONS IN SURGICAL PATIENTS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42848 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN (UNASYN) VS. PIPERCILLIN IN PATIENTS WITH EXACERBATION OF CHRONIC AND ACUTE LOWER RESPIRATORY INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42703 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN NEWBORN PATIENTS WITH SEVERE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42701 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN PATIENTS WITH SEVERE ORL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42702 |
Study title: Kanagasundaram SA, Lane LJ, Cavalletto BP, Keneally JP, Cooper MG. Efficacy and safety of nitrous oxide in alleviating pain and anxiety during painful procedures. Arch Dis Child 2001;84:492-495. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32702 |
Study title: Lembert N, Wodey E, Geslot D, Ecoffey C. Prévention de la douleur à l’injection du propofol chez l’infant: comparaison de l’inhalation de protoxyde d’azote à l’injection de lidocaine. Ann Fr Anesth Réanim 2002;21;263-270 |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32705 |
Study title: Luhmann JD, Kennedy RM, Jaffe DM, McAllister JD. Continuous-flow delivery of nitrous oxide and oxygen: A safe and cost-effective technique for inhalation analgesia and sedation of pediatric patients. Pediatric Emergency Care 1999;15(6):388-392. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32706 |
Study title: Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Annals of Emergency Medicine 2001;37(1):20-27. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32707 |
Study title: McNeely JK, Buczulinski B, Rosner D. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology 2000;93(6);1549-1550 |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32708 |
Study title: Vetter TR. A comparison of EMLA cream versus nitrous oxide for pediatric venous cannulation. J Clin Anesth 1995;7;486-490 |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32710 |
Study title: Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, crossover clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. British Journal of Anaesthesia 2003 Dec;91(6):850-856. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32711 |
Study title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX (Nonacog Alfa, Recombinant Human Factor IX) for Usual Use |
Active substance: NONACOG ALFA |
Study summary document link (including results): |
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Document reference: 41494 |
Study title: A. Huber: Which contraceptive for adolescents? Sexualmedizin 9; 154-157 (1980) |
Active substance: NONOXINOL-9 |
Study summary document link (including results): |
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Document reference: 32719 |
Study title: H. Brehm, W. Haase: The alternative to hormonal contraception?, Med. Welt 26 (N.F.; 1610-1617 (1975) |
Active substance: NONOXINOL-9 |
Study summary document link (including results): |
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Document reference: 32717 |
Study title: J. Dimpfl, W. Salomon, K.-H. Schicketanz: The sperizidal barrier. Sexualmedizin 13; 95-98 (1984) J.Balmer, P.Hartmann, K.-H Schicketanz: Sexual behaviour during intravaginal contraception. Sexualmedizin 15: 244-248 (1986) |
Active substance: NONOXINOL-9 |
Study summary document link (including results): |
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Document reference: 32720 |
Study title: W. Salomon, W. Haase: Intravaginal contraception. Results of a prospective long-term study of the foam ovoid. Sexualmedizin 6; 198-202(1977) |
Active substance: NONOXINOL-9 |
Study summary document link (including results): |
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Document reference: 32718 |
Study title: A Multicenter, Open‑Label Study to Compare On‑Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX‑R) in Subjects With Severe Hemophilia B |
Active substance: NONACOG ALFA |
Study summary document link (including results): |
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Document reference: 41495 |
Study title: A comparison of the efficacy of terbutaline delivered via Turbuhaler® and pressurised metered dose inhaler (pMDI) plus Nebuhaler® in the treatment of moderate to severe acute asthmatic children. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
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Document reference: 44428 |
Study title: A comparison of the efficacy of terbutaline sulphate, inhaled via Turbuhaler and via nebulization, in the management of acute severe asthma in small children. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-2200 Summary.pdf |
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Document reference: 44412 |
Study title: A cumulative dose-response study of terbutaline in asthmatic children. A comparison between Turbuhaler and metered dose inhaler (MDI) |
Active substance: TERBUTALINE |
Study summary document link (including results): Terbutaline Bricanyl 01-2129 interventional.xls |
View full study record |
Document reference: 44408 |
Study title: A double-blind comparison between terbutaline Turbuhaler and terbutaline metered dose inhaler (MDI). |
Active substance: TERBUTALINE |
Study summary document link (including results): Terbutaline Bricanyl 01-9032 interventional.xls |
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Document reference: 44405 |
Study title: A double-blind study comparing Bricanyl MDI and Bricanyl Turbuhaler in patients with acute asthmatic attacks. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2214.pdf |
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Document reference: 44413 |
Study title: A comparison of Bricanyl Turbuhaler and Berotec dry powder inhaler in asthmatic children. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2135.pdf |
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Document reference: 44417 |
Study title: Assessment of Turbuhaler in patients with severe acute asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2215.pdf |
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Document reference: 44411 |
Study title: Bricanyl Turbuhaler in hyperreactive patients. A comparison with Bricanyl metered dose inhaler (MDI) and placebo MDI. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2201.pdf |
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Document reference: 44410 |
Study title: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with Ventolin Rotahaler. |
Active substance: TERBUTALINE |
Study summary document link (including results): Terbutaline Bricanyl 01-2159 interventional.xls |
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Document reference: 44420 |
Study title: Clinical Trial to evaluate the efficacy of terbutaline in preventing exercise induced asthma when administered to children via the spacer aerosol. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-6032.pdf |
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Document reference: 44435 |
Study title: Comparison of Bricanyl depot tablets 5 mg and ordinary tablets 2.5 mg in children with bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
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Document reference: 44395 |
Study title: GCV/93/008 A Double-Blind study to compare the efficacy & safety of oral Sumartriptan (50mg or 100mg) in the treatment of migraine in adolescents |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-S2CT37-ICHE3.pdf |
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Document reference: 43070 |
Study title: GCV/96/007 A double-blind,randomised,placebo-controlled study to compare the safety & efficacy of oral sumatriptan (25mg,50mg, &100mg) in the acute treatment of migraine in adolescents. |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUMB2003-ICHE3.pdf |
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Document reference: 43080 |
Study title: RM1998/00017/00 A double blind placebo controlled parallel group study to evaluate three dose levels (5mg, 10mg and 20mg) of sumatripaten nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs of age). |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUMA3005-ICHE3.pdf |
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Document reference: 43078 |
Study title: RM2003/00271/00 A double blind placebo controlled, parallel group study to evaluate two dose levels (5mg and 20mg) of sumatriptan nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs). |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUM30045-ICHE3.pdf |
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Document reference: 43073 |
Study title: Lecha M, 2005: Tacalcitol in the treatment of psoriasis vulgaris: the Spanish experience. (556 patients aged 6-86 years; 6 % <18 years) |
Active substance: TACALCITOL |
Study summary document link (including results): |
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Document reference: 43083 |
Study title: publication : Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years |
Active substance: TACALCITOL |
Study summary document link (including results): |
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Document reference: 43082 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN PARENTERAL IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42739 |
Study title: EFFICACY AND TOLERANCE OF SULBACTAM/AMPICILLIN FOLLOWED BY ORAL SULTAMICILLIN IN PATIENTS WITH HEAD AND NECK ABSCESSES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42670 |
Study title: EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IN PATIENTS WITH NON-SEVERE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42729 |
Study title: EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN VS. NETILMICIN PLUS METRONIDAZOLE USED IN SHORT TERM PERIOPERATIVE PROPHYLAXIS IN PATIENTS WHO UNDERGO ABDOMINAL SURGERY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42709 |
Study title: EFFICACY OF UNASYN IN PATIENTS WITH ACUTE DISEASE OF THE LUNGS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42691 |
Study title: MULTICENTER CLINICAL STUDY OF SBT/AMP IN PEDIATRIC PATIENTS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42673 |
Study title: MULTICENTER OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SBT/AMP IN BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS IN ADULT PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42735 |
Study title: MULTICENTER OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN GYNECOLOGICAL AND OBSTETRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42669 |
Study title: MULTICENTRIC OPEN NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SBT/AMP IN INTRA-ABDOMINAL SURGICAL INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42736 |
Study title: MULTICENTRIC, OPEN NONCOMPARATIVE STUDY OF EFFICACY AND SAFETY OF SBT/AMP IN BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS IN PEDIATRIC PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42734 |
Study title: NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP IN THE TREATMENT OF PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42730 |
Study title: OPEN COMPARATIVE STUDY OF SBT/AMP VS. AMPICILLIN IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS IN ADULT PATIENTS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42699 |
Study title: OPEN COMPARATIVE STUDY OF SULBACTAM/CEFOPERAZONE (1:2) VS. CEFTAZIDIME PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42865 |
Study title: OPEN MULTICENTRIC STUDY OF THE EFFICACY AND SAFETY OF THE COMBINATION SBT/CFP (1:2) IN THE TREATMENT OF PATIENTS (ADULTS AND CHILDREN) WITH SEVERE INFECTIONS (VTI) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42864 |
Study title: OPEN NON-COMPARATIVE EVALUATION IN THE PROPHYLAXIS OF SURGICAL WOUND INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42684 |
Study title: OPEN NON-COMPARATIVE SAFETY/EFFICACY STUDY SULBACTAM/AMPICILLIN IM/IV IN THE TREATMENT OF BACTERIOLOGICAL ENT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42745 |
Study title: Norfloxacin interferes with cyclosporine disposition in pediatric patients undergoing renal transplantation; Clin. Pharmacol. Ther. 1995 Sep. 58(3): 322-327 |
Active substance: NORFLOXACIN |
Study summary document link (including results): |
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Document reference: 32721 |
Study title: Post-marketing surveillance study 2006-2007 on specific immunotherapy with NHD Mites/Pollen preparations in a Cluster-doseescalationregimen. Age of patients: 4-65 Years |
Active substance: NovoHelisenDepot Mites/Pollen |
Study summary document link (including results): |
View full study record |
Document reference: 47787 |
Study title: Comparison of an amino acid mixture and protein hydrolysates in treatment of infants with phenylketonuria |
Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
Study summary document link (including results): |
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Document reference: 32724 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-006] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40084 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-AT] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40085 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (injection solution) [AWB-081] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40086 |
Study title: De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22.De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22. |
Active substance: NYSTATIN |
Study summary document link (including results): |
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Document reference: 32728 |
Study title: Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982)Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982) |
Active substance: NYSTATIN |
Study summary document link (including results): |
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Document reference: 32729 |
Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
View full study record |
Document reference: 44394 |
Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
View full study record |
Document reference: 44432 |
Study title: Comparison of Bricanyl(R) depot tablets 5 mg b.i.d. with ordinary oral ß-agonist treatment b.i.d. in children with bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
View full study record |
Document reference: 44396 |
Study title: Comparison of the effects of inhaled and oral terbutaline and their combination on large and small airways's function in patients with chronic bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2161.pdf |
View full study record |
Document reference: 44422 |
Study title: Comparison of the effects of inhaled dry powder and aerosol terbutaline on large and small airways' function in patients with chronic bronchial asthma. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-2160.pdf |
View full study record |
Document reference: 44421 |
Study title: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with nebuhaler. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-2155 Study Synopsis.pdf |
View full study record |
Document reference: 44419 |
Study title: A Phase 3, Randomized, Double-Blind Study Comparing Twice Daily FK506 Cream 0.03% Versus Cream Vehicle in the Treatment of Atopic Dermatitis in Pediatric Subjects |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 47773 |
Study title: Phase 3, randomized, double-blind, multi-center, vehicle-controlled, parallel, two-treatment group study stratified by baseline PSGA and investigative site to evaluate the efficacy and safety of tacrolimus cream 0.03% applied twice daily (bid) compared to cream vehicle applied bid for the treatment of atopic dermatitis. |
Active substance: Tacrolimus |
Study summary document link (including results): |
View full study record |
Document reference: 47772 |
Study title: Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years |
Active substance: TALCACITOL MONOHYDRATE (EFALIZUMAB) |
Study summary document link (including results): |
View full study record |
Document reference: 36704 |
Study title: THE TREATMENT OF ACUTE PELVIC INFECTIONS WITH PARENTERAL SBT/AMP. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42744 |
Study title: OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IMIV IN THE TREATMENT OF PEDIATRICS WITH VARIOUS BACTERIAL INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42689 |
Study title: RANDOMIZED CONTROLLED CLINICAL TRIAL COMPARING CEFAZOLIN + METRONIDAZOLE TO AMPICILLIN/SULBACTAM IN MAJOR HEAD & NECK SURGERY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42664 |
Study title: SBT/AMP NON-COMPARATIVE OPEN TRIAL. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42672 |
Study title: THE COMPARISON OF SULBACTAM/AMPICILLIN (UNASYN) AND AMPICILLIN/GENTAMICIN IN THE TREATMENT OF CHORIOAMNIONITIS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42665 |
Study title: Observational use study of the tolerability of Octenisept in premature infants with a gestational age of less than 27 weeks, at the Department of Neonatology of the Charite Campus Virchow Clinic.(Director: Prof. Dr. med. Michael Obladen.2002. |
Active substance: OCTENIDINE |
Study summary document link (including results): |
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Document reference: 32734 |
Study title: OPEN NON-COMPARATIVE STUDY TO DETERMINE THE CONCENTRATION OF SBT/AMP IN JUVENILE CARTILAGE. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42688 |
Study title: Long-acting terbutaline administered by mouth to children aged 8 - 14 years with chronic asthma. A comparison with Theo-Dur. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-2092 Summary.pdf |
View full study record |
Document reference: 44398 |
Study title: Zethionate injection 200 mg and 300 mg abridged application for a product licence. Part IV Clinical documentation - Volume 1.Zethionate injection 200 mg and 300 mg abridged application for a product licence. Part IV Clinical documentation - Volume 1. |
Active substance: PENTAMIDINE ISETHIONATE |
Study summary document link (including results): |
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Document reference: 45839 |
Study title: Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report - |
Active substance: PENTOXYFILLINE |
Study summary document link (including results): |
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Document reference: 45845 |
Study title: Progressive hearing loss in hearing impaired children: immediate results of antiphlogistic-rheologic infusion therapy. Michael Streppel, Claus Wittekindt, Hasso von Wedel, Martin Walger, Hans Jakob Schondorf, Olaf Michel, Eberhard Stennert. International Journal of Pediatric Otorhinolaryngology 57 (2001) 129-136 |
Active substance: PENTOXYFILLINE |
Study summary document link (including results): |
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Document reference: 45848 |
Study title: A 12 week multi-center study consisting of a 6 week double-blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel Cream 1% in mild to moderate head and neck atopic dermatitis patients (2-11 years of age, inclusive) intolerant of topical corticosteroids. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2440 Art45 listing 2011.xls |
View full study record |
Document reference: 34091 |
Study title: TO COMPARE AND ASSESS THE EFFICACY OF SBT/AMP VS CEFOXITIN IN THE PREVENTION OF INFECTIVE COMPLICATIONS FOLLOWING RECTAL SURGERY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42698 |
Study title: TO COMPARE THE EFFICACY AND SAFETY OF A SINGLE DOSE IM S/A PLUS PROBENECID AND SINGLE DOSES OF S/A WITHOUT PROBENECID IN TREATMENT OF |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42756 |
Study title: TO COMPARE THE EFFICACY AND SAFETY OF A SINGLE DOSE OF SULBACTAM/ AMPICILLIN IM PLUS ORAL PROBENECID IN THE TREATMENT OF GONORRHEA. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42721 |
Study title: TO COMPARE THE EFFICACY AND SAFETY OF SBT/AMP VS GENTAMYCIN/ORNIDAZOLE BY PARENTERAL ROUTE FOR TREATMENT OF ABDOMINAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42693 |
Study title: TO CONTINUE TO COMPARE THE EFFICACY AND SAFETY OF SULBACTAM AND AMPICILLIN CO-ADMINISTERED INTRAVENOUSLY WITH THAT OF CONVENTIONAL THERAPY CHLORAMPHENICOL & AMPICILLIN IN THE TREATMENT OF INFANTS & CHILDREN BACTERIAL MENINGITIS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42644 |
Study title: TO DETERMINE THE EFFICACY AND SAFETY OF SBT/AMP FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42726 |
Study title: TO DETERMINE THE EFFICACY AND SAFETY OF SBT/AMP FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH URTI. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42727 |
Study title: A multi-centre, randomised, double masked, parallel-group study completed in the USA, Mexico and Brazil comparing the safety and efficacy of topical Ofloxacin 0.3% ophthalmix solution against that of topical Trimethoprim sulphate/Polymyxin B sulphate combination ophthalmic solution as a positive control, in infants, from birth to 31 days of age, with bacterial conjunctivitis. |
Active substance: OFLOXACIN |
Study summary document link (including results): |
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Document reference: 41625 |
Study title: Etude de l'efficacité et de la tolérance de l'ofloxacine en solution auriculaire dans le traitement des otorrhées purulentes de l'enfant sur aérateur transtympanique, sur cavité d'évidement et sur otite chronique à tympan ouvert. - Dr Narcy - Fev. 1995 |
Active substance: OFLOXACIN |
Study summary document link (including results): Ofloxacin STUDY FD.93.280.04.xls |
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Document reference: 32745 |
Study title: Special Toxicity : Effects of orally administered DL-8280 for 7 days on the knee and elbow joints of immature rats. Comparison with structurally relating compounds - ONO - 30 June 1984 (ofloxacin Daiichi Dossier) |
Active substance: OFLOXACIN |
Study summary document link (including results): |
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Document reference: 32751 |
Study title: Special Toxicity : Effects of orally administered DL-8280 on diarthric joints of immature dogs (no effect dose level and reversibility of arthropathy). - 0N0 - 6 Apr. 1984 (ofloxacin Daiichi Dossier) |
Active substance: OFLOXACIN |
Study summary document link (including results): |
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Document reference: 32752 |
Study title: Special Toxicity : Joint toxicity of DR-3355 in Juvenile Rats: Comparison with DR-3354 and Ofloxacin. - Michiyuki Kato - 1990 (Levofloxacin MAA Initial - MRP Dossier - Vol. 46: 167-183) |
Active substance: OFLOXACIN |
Study summary document link (including results): |
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Document reference: 32755 |
Study title: Nasal wash in allergic rhinitis |
Active substance: OHER NASAL PREPARATIONS_NATURAL ELMS SALT |
Study summary document link (including results): |
View full study record |
Document reference: 32758 |
Study title: Treatment of exercise induced asthma in adualts. A comparison between Bricanyl Turbuhaler and Ventolin metered dose inhaler. |
Active substance: TERBUTALINE |
Study summary document link (including results): 01-2186 Study Synopsis.pdf |
View full study record |
Document reference: 44424 |
Study title: A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of Elidel® Cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroids |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2442 Art45 listing 2011.xls |
View full study record |
Document reference: 34092 |
Study title: A 20-week study with a 4 week randomized, multi-center, double-blind, vehicle-controlled, parallel-group phase followed by a 12 week open label phase and a 4 week follow-up phase to study the efficacy and safety of 1% SDZ ASM981 cream in pediatric subjects with atopic dermatitis and to collect information about the time and extent of relapse. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CDE04 Art45 listing 2011.xls |
View full study record |
Document reference: 34093 |
Study title: A 26-week study with a 6-week, randomized, multi-center, investigator-blinded, exploratory comparative trial of the tolerability, safety and efficacy of Elidel® (pimecrolimus, SDZ ASM981) cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric subjects with moderate atopic dermatitis, followed by a 20-week open-label phase to study the safety of Elidel® (pimecrolimus, SDZ ASM981) cream 1%. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls |
View full study record |
Document reference: 47707 |
Study title: A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when ASM981 (pimecrolimus) cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in children and adolescents 2 - 17 years of age |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls |
View full study record |
Document reference: 34132 |
Study title: A 27 week study, 3 week randomized, multicenter, double blind, parallel group, vehicle control and 24 week open label phase, to evaluate efficacy , tolerability and safety, of ASM 981 (pimecrolimus) cream 1% in pediatric patients with mild to moderate atopic dermatitis in face |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls |
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Document reference: 34099 |
Study title: TO DETERMINE THE SAFETY AND EFFICACY OF SBT/AMP FOR THE TREATMENT OF PATIENTS WITH METHICILLIN-RESISTANT STAPH INFECTIONS OF THE SKIN AND SOFT TISSUE. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42725 |
Study title: TO EVALUATE THE CLINICAL EFFICACY OF S/S IN HOSPITALIZED PATIENT WITH URINARY TRACT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42682 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAMUSCULARLY THREE/FOUR TIMES PER DAY TO PATIENTS WITH VARIOUS INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42715 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAVENOUSLY EVERY 8 HOURS COMPARED TO NETILMYCIN 100 MG, PLUS METRONIDAZOLE TWO TIMES A DAY IN THE TREATMENT OF PATIENTS WITH INTRA ABDOMINAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42708 |
Study title: TO EVALUATE THE SAFETY AND EFFICACY OF SULBACTAM/AMPICILLIN COMPARED TO CEFOTETAN IN THE TREATMENT OF BACTERIAL ETIOLOGY INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42697 |
Study title: UNASYN IM/IV, OPEN, NON COMPARATIVE EVALUATION IN THE TREATMENT OF ACUTE AND CHRONIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42683 |
Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SULBACTAM/AMPICILLIN FOLLOWED BY ORAL SULTAMICILLIN IN TREATING SEVERE LOWER RESPIRATORY TRACT INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42677 |
Study title: Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized, Flexible-Dose, Double-Blind Comparison with Placebo |
Active substance: OLANZAPINE |
Study summary document link (including results): |
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Document reference: 32759 |
Study title: A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions |
Active substance: OLMESARTAN MEDOXOMIL |
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Document reference: 32762 |
Study title: An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension |
Active substance: OLMESARTAN MEDOXOMIL |
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Document reference: 32763 |
Study title: Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions: a double-masked, environmental study of patient preference. Leonardi A, Zafirakis P. Curr Med Res Opin. 2004 Aug;20(8):1167-73. Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions: a double-masked, environmental study of patient preference. Leonardi A, Zafirakis P. Curr Med Res Opin. 2004 Aug;20(8):1167-73. |
Active substance: olopatadine |
Study summary document link (including results): Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions a double-masked, environmental study of patient preference. Leonardi A, Z... |
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Document reference: 41584 |
Study title: Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis: a real-world comparison of efficacy and ocular comfort. Ganz M, Koll E, Gausche J, Detjen P, Orfan N. Adv Ther. 2003 Mar-Apr;20(2):79-91. Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis: a real-world comparison of efficacy and ocular comfort. Ganz M, Koll E, Gausche J, Detjen P, Orfan N. Adv Ther. 2003 Mar-Apr;20(2):79-91. |
Active substance: olopatadine |
Study summary document link (including results): Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis a real-world comparison of efficacy and ocular comfort... |
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Document reference: 41583 |
Study title: Olsalazine vs sulfalazine in mild to moderate childhood ulcerative colitis: results of the Paediatrici gastroenterology Collaborative Research Group Clinical TrialFerry et al |
Active substance: OLSALAZINE |
Study summary document link (including results): Ferry et al - Olsalazine sodium.pdf |
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Document reference: 32765 |
Study title: Tolerance of olsalazine in young patients treated for ulcerative colitis |
Active substance: OLSALAZINE |
Study summary document link (including results): L342G26R1 - Olsalazine sodium.pdf |
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Document reference: 32766 |
Study title: A bioavailability study of omeprazole comparing three different liquid formulations after single dose administration to healthy volunteers, 17 November 1996 |
Active substance: OMEPRAZOLE |
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Document reference: 41623 |
Study title: The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294 |
Active substance: TERLIPRESSIN |
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Document reference: 44439 |
Study title: Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226 |
Active substance: TESTOSTERONE UNDECANOATE |
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Document reference: 44441 |
Study title: Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925 |
Active substance: TESTOSTERONE UNDECANOATE |
Study summary document link (including results): |
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Document reference: 44440 |
Study title: Immuntherapie bei kindern mit hilfe eines multibakteriellen ribosomenpräparates |
Active substance: Tetanus Vaccine (Adsorbed) |
Study summary document link (including results): |
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Document reference: 41393 |
Study title: Only case reports/review: - Comparaison of weight gain in treatments for Tourette Syndrome: tetrabenazine versus neuroleptic drug (J.Child Neurol. 2008). - Only case reports/review: - Comparaison of weight gain in treatments for Tourette Syndrome: tetrabenazine versus neuroleptic drug (J.Child Neurol. 2008). - |
Active substance: TETRABENAZINE |
Study summary document link (including results): |
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Document reference: 44442 |
Study title: Children's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pkChildren's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pk |
Active substance: TETRACOSACTIDE |
Study summary document link (including results): |
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Document reference: 44469 |
Study title: Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836 |
Active substance: SULFASALAZINE |
Study summary document link (including results): |
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Document reference: 42877 |
Study title: Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis. Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis. |
Active substance: SULFASALAZINE |
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Document reference: 42884 |
Study title: Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis. |
Active substance: SULFASALAZINE |
Study summary document link (including results): |
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Document reference: 42887 |
Study title: A Multicenter, Randomized, Single-Blind Study to Evaluate Omeprazole for the Treatment of Clinically Diagnosed GERD in Pediatric Patients Ages 0 months through 24 months, Inclusive, 18 October 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32791 |
Study title: Evaluation of the role of acidic and non-acidic reflux in recurrent respiratory and chronic ear, nose,and throat (ENT) diseases in children by using multichannel intraluminal impedance (MII) apparatus |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32778 |
Study title: Department of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.grDepartment of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.gr |
Active substance: TETRACOSACTIDE |
Study summary document link (including results): |
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Document reference: 44462 |
Study title: Department of Paediatrics, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. asiri26@hotmail.comDepartment of Paediatrics, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. asiri26@hotmail.com |
Active substance: TETRACOSACTIDE |
Study summary document link (including results): |
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Document reference: 44458 |
Study title: Department of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jpDepartment of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jp |
Active substance: TETRACOSACTIDE |
Study summary document link (including results): |
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Document reference: 44454 |
Study title: Department of Pediatrics, Tokyo Women's Medical University, JapanDepartment of Pediatrics, Tokyo Women's Medical University, Japan |
Active substance: TETRACOSACTIDE |
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Document reference: 44473 |
Study title: Heiskala, H., Riikonen, R., Santavuori, P., Simell, O., Airaksinen, E., Nuutila, A., and Perheentupa, J.Heiskala, H., Riikonen, R., Santavuori, P., Simell, O., Airaksinen, E., Nuutila, A., and Perheentupa, J. |
Active substance: TETRACOSACTIDE |
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Document reference: 44476 |
Study title: Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery: a randomized controlled trial. Carden SM, Colville DJ, Davidson AJ, McKenzie IM, Mackey DA, McKenzie J, Elder JE. Aust N Z J Ophthalmol. 1998 Nov;26(4):289-97. Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery: a randomized controlled trial. Carden SM, Colville DJ, Davidson AJ, McKenzie IM, Mackey DA, McKenzie J, Elder JE. Aust N Z J Ophthalmol. 1998 Nov;26(4):289-97. |
Active substance: TETRACAINE |
Study summary document link (including results): Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery a randomized controlled trial. Carden SM, Colville DJ, Davids.pdf |
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Document reference: 44446 |
Study title: Open study on pain free cutting of split skin grafts using local anaesthetic cream1988 |
Active substance: TETRACAINE |
Study summary document link (including results): Tetracaine_1988.xls |
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Document reference: 48143 |
Study title: Open study to collect clinical results, particularly in children with a preparation of Tetracaine gel 4% w/w1990 |
Active substance: TETRACAINE |
Study summary document link (including results): Tetracaine_1990.xls |
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Document reference: 48142 |
Study title: A comparative study of high-dose and low-dose ACTH therapy for West syndromeA comparative study of high-dose and low-dose ACTH therapy for West syndrome |
Active substance: TETRACOSACTIDE |
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Document reference: 44474 |
Study title: Wong−A et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double− blind study. {CLIN−PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313−324)Wong−A et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double− blind study. {CLIN−PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313−324) |
Active substance: PARACETAMOL |
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Document reference: 45770 |
Study title: Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92 |
Active substance: PARACETAMOL |
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Document reference: 45771 |
Study title: |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33260 |
Study title: |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33261 |
Study title: |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33262 |
Study title: Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288)Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288) |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33291 |
Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6 |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33249 |
Study title: Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7 |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33252 |
Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7 |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33270 |
Study title: Cunningham M*,Barsanti F,Merrell R,Lentz E: Final Study Report: A Comparative Study of Single-Dose Intramuscular (IM) Ceftriaxone Versus Single-Dose IM Bicillin CR plus Oral Trimethoprim-Sulfamethoxazole for the Treatment of Uncomplicated Acute Otitis Media in Infants and Children (Howie Protocol) |
Active substance: Sulfamethoxazole trimethoprim |
Study summary document link (including results): |
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Document reference: 45248 |
Study title: Cunningham M*,Barsanti F,Merrell R,Lentz E: Final Study Report: A Comparative Study of Single-Dose Intramuscular (IM) Ceftriaxone and a 10-Day Oral (PO) Course of Trimethorprim-sulfamethoxazole for the Treatment of Acute Otitis Media in Infants and Children (Klein Protocol) |
Active substance: Sulfamethoxazole trimethoprim |
Study summary document link (including results): |
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Document reference: 45249 |
Study title: Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700.Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700. |
Active substance: SULFASALAZINE |
Study summary document link (including results): |
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Document reference: 42897 |
Study title: The impact of omeprazole on children with cystic fibrosis who require high dose pancreatic enzymes. |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32777 |
Study title: Treatment of Helicobacter pylori gastritis in paediatrics: improvement of the eradication rate by adjunction of omeprazole to dual antibiotheraphy (BE) |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32774 |
Study title: Treatment of Helicobacter pylori infection in children with recurrent abdominal pain (EE and FI) |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32773 |
Study title: Use of magnesium omeprazole (MOPRAL) for treating pathological gastroesophagael reflux in children (Mexico) |
Active substance: OMEPRAZOLE |
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Document reference: 32775 |
Study title: Effects of nedocromil sodium on exercise induced bronchoconstriction exacerbated by inhalation of cold air - S. Oseid et al. - 1995 (Scand J Med Sci Sports vol 5) - Publication in Nedocromil sodium HFA- 227- metered dose inhaler-Part IV clinical Documentation - no author- 26/03/1998 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47003 |
Study title: Estudio comparativo del effecto protector del cromoglicato y el nedocromil en ninos con asma de esfuerzo - A. Rabameda et al. - 1993 ( Rev Esp Alergol Immnunol Clin vol 8) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47029 |
Study title: Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7. Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7. |
Active substance: TETRACAINE |
Study summary document link (including results): Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T.pdf |
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Document reference: 44445 |
Study title: Single-blinded, reference drug controlled to assess the comparative efficacy and safety of Tetracaine gel versus EMLA cream prior to venepuncture or venous cannulation 1993 |
Active substance: TETRACAINE |
Study summary document link (including results): Tetracaine_Amegel199302.xls |
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Document reference: 48145 |
Study title: The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, Schreiner MS. J AAPOS. 2007 Jun;11(3):273-6;Epub 2007 Mar 26.The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, Schreiner MS. J AAPOS. 2007 Jun;11(3):273-6;Epub 2007 Mar 26. |
Active substance: TETRACAINE |
Study summary document link (including results): The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, S.pdf |
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Document reference: 44444 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43391 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44148 |
Study title: Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002 |
Active substance: PENTOXYFILLINE |
Study summary document link (including results): |
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Document reference: 45847 |
Study title: Clinical study;Administration of Sedotussin to infants and young children. Final evaluation and expert report involving 5,024 patients. |
Active substance: PENTOXYVERINE |
Study summary document link (including results): ARCE94C1701(2) - Pentoxyverine.pdf |
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Document reference: 47360 |
Study title: Open, single-dose, phase i study to evaluate the pharmacokinetic parameters of pentoxyverine and its major metabolites in plasma and urine of children with upper respiratory tract infection. |
Active substance: PENTOXYVERINE |
Study summary document link (including results): 9738 - Pentoxyverine - MRCE99K0801.pdf |
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Document reference: 45861 |
Study title: Besedovsky A, Li BUK. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. CURR GASTROENTEROL REP 2004; 6(3): 247−253 |
Active substance: Peppermint Oil 0.200 ml |
Study summary document link (including results): |
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Document reference: 40115 |
Study title: Treatment of metastatic bone pain with strontium-89. Robinson RG 1987 Int J Rad Appl Instrum B. 1987; 14(3):219-22 R G Robinson et al. |
Active substance: STRONTIUM 89 |
Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
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Document reference: 48215 |
Study title: Lopez-Herce J. Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and Sucralfate. Crit Care Med 1992; 20: 1082-1089. Lopez-Herce J. Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and Sucralfate. Crit Care Med 1992; 20: 1082-1089. |
Active substance: SUCRALFATE |
Study summary document link (including results): |
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Document reference: 42608 |
Study title: Comparison of the protective effects of cromolyn sodium in the treatment of exercice-induced asthma in children - FM. De Benedictis et al. - 1994 (J Allergy Clin Immunol vol 94) - Publication dans le Rapport d'expert clinique sur la compatibilité sur Tiliade et des chambres de mélanges -Tilade 2 mg/ dose, suspension pour inhalation buccale pour flacon pressurisé - Clotilde Bremard-Oury - 07/1996 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47001 |
Study title: Multicentre double-bind crossover study comparing flavoured nedocromil sodium (Tilade mint) 16 mg daily and matching placebo, both delivered via a large volume spacer in the management of paediatric asthma - Dr A R Harndern et al. - 30/03/1994 |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47004 |
Study title: Multicentre double-blind group comparative study assess the efficacy of substituting nedocromil sodium (Tilade) 8 mg daily and sodium cromoglycate (Intal) 20 mg daily in paediatric patients currently maintained on sodium cromoglycate 20 mg daily - D. Hilde et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47005 |
Study title: Protective effect of nedocromil sodium (4 mg) given by metered dose inhaler, with or whithout an extension tube (Autry-Altounyan Spacer Device), Against exercise-induced bronchoconstriction in children with asthma : A placebo-controlled double-blind crossover trial - A. Boner - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47008 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44195 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44242 |
Study title: A 3 week randomized, multicenter, double blind, vehicle-controlled, parallel-group study to evaluate the efficacy and safety of Pimecrolimus cream 1% in children between 2-12 years with mild to moderate atopic dermatitis (Speed Study) |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CES02 Art45 listing 2011.xls |
View full study record |
Document reference: 34103 |
Study title: A 3-month open label study assessing the efficacy and tolerability of Elidel (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CSA01 Art45 listing 2011.xls |
View full study record |
Document reference: 34116 |
Study title: A 6-month study of the utility of Elidel cream 1% in the long-term management of pediatric patients with severe AD |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CDE10 Art45 listing 2011.xls |
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Document reference: 34095 |
Study title: A 6-month, randomized, multi-center, parallelgroup, double-blind, vehicle controlled study to evaluate the efficacy and safety of ASM981 (pimecrolimus) cream 1% BID vs. standard of care in the management of mild to moderate atopic dermatitis in children 3 months to 11 years. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CUS04 Art45 listing 2011.xls |
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Document reference: 47706 |
Study title: Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245. Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245. |
Active substance: SUCRALFATE |
Study summary document link (including results): |
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Document reference: 42606 |
Study title: Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996 |
Active substance: SUFENTANYL |
Study summary document link (including results): |
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Document reference: 42622 |
Study title: The combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. LuewenThe combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. Luewen |
Active substance: SUFENTANYL |
Study summary document link (including results): |
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Document reference: 42623 |
Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFTRIAXONE IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42629 |
Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFOTAXIME IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42649 |
Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFUROXIME IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42645 |
Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VS AMPICILLIN AND CHLORAMPHENICOL IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42640 |
Study title: A COMPARATIVE STUDY OF SBT/AMP IN COMPLICATED URINARY TRACT INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42674 |
Study title: A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP VS CEFUROXIME IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42717 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS METRONIDAZOLE/GENTAMYCIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42635 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFOXITIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42632 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFOXITIN/DOXYCYCLINE OR CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42630 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFTRIAXONE IN`THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFECTIONS (E.G. PERIORBITAL CELLULITIS) AND/OR OSTEOMYELITIS/SUPPURATIVE ARTHRITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42641 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CLINDAMYCIN PLUS GENTAMICIN VERSUS CEFOXITIN IN THE TREATMENT OF POST PARTUM ENDOMETRITIS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42651 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF POST CESAREAN SECTION ENDOMETRITIS INFECTIONS OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42636 |
Study title: Report of a double-blind group comparative trial comparing nedocromil sodium (2 mg four times a day) and placebo in the management of bronchial asthma in children - R. Ronchetti - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47009 |
Study title: Report on a double-blind crossover study to compare the efficacy and duration of action of nedocromil sodium (4 mg) and placebo, Given by pressurised aerosol exercise-induced asthma in children, carried out - M. Silvermann - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47011 |
Study title: Report on a matched-pairs double-blind comparative study on the effects of nedocromil sodium (4mg * 4) with placebo on non-specific bronchial reactivity changes in asthmatic children when re-exposed to allergen (House Dust Mite) in a natural environment - Prof. Boner - 1987 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47012 |
Study title: Report on a Multicentre Blinded Group Comparative Study Comparative Nedocromil Sodium (Tilade), Beclomethasone Dipropionate (Becotide) and Placebo in the Management of Asthma |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47021 |
Study title: Spacing devices and metered-dose inhalers in childhood asthma - H. Levinson et al. - 1983 (J Pediatrics vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47044 |
Study title: The addition of nedocromil sodium to maintenance therapy in the management of patients with bronchial ashma - AJ. Williams et al. - 1986 (Eur J Resp Dis vol 69) - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) -Clinical documentation -29/08/1995 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47045 |
Study title: Tilad mint aerosole - Clinical documentation PART IV |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47022 |
Study title: Twelve month open assessment study of the safety and acceptability of flavoured nedocromil sodium (4 mg, QID) in the management of paediatric asthma - J. Cater et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47015 |
Study title: Young MR, Lowry JH, Laird JD, Ferguson WR. 99Tcm-MDP bone scanning of injuries of the carpal scaphoid. Injury. 1988 Jan;19(1):14-7. Young MR, Lowry JH, Laird JD, Ferguson WR. 99Tcm-MDP bone scanning of injuries of the carpal scaphoid. Injury. 1988 Jan;19(1):14-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43836 |
Study title: Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44069 |
Study title: A double-blind, randomized, placebo-controlled, paired study to evaluate the efficacy and safety of combined use of Elidel and Cutivate in children with severe atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): |
View full study record |
Document reference: 47709 |
Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310 |
Active substance: OXYGEN |
Study summary document link (including results): |
View full study record |
Document reference: 45412 |
Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310 |
Active substance: OXYGEN |
Study summary document link (including results): |
View full study record |
Document reference: 45418 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM PLUS DOXYCYCLINE VERSUS CEFOXITIN/DOXYCYCLINE IN THE TREATMENT OF PELVIC INFLAMMATORY DISEASE OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42660 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOTETAN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42656 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN AS EARLY EMPIRIC THERAPY FOLLOWING PENETRATING AND BLUNT TRAUMA TO THE ABDOMEN |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42662 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42634 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN IN THE TREATMENT OF PELVIC INFLAMMATORY DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42653 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF POST-CAESAREAN SECTION ENDOMETRITIS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42667 |
Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VS CEFAZOLIN OR CEFOTETAN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42659 |
Study title: A COMPARISON OF CEFOBID (CEFOPERAZONE) PLUS SULBACTAM VERSUS PRIMAXIN (IMIPENEN-CILASTATIN) IN THE THERAPY OF FEBRILE NEUTROPENIC PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42661 |
Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS AMIKACIN OR GENTAMICIN PLUS AMPICILLIN AND METRONIDAZOLE IN THE TREATMENT OFPATIENTS WITH AN INTRA-ABDOMINAL INFECTION |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42637 |
Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS AMPICILLIN PLUS TOBRAMYCIN IN THE TREATMENT OF PATIENTS WITH BILIARY TRACT INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42655 |
Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CLINDAMYCIN PLUS GENTAMICIN VS CEFOXITIN IN THE TREATMENT OF POSTPARTUM ENDOMETRITIS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42627 |
Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS CEFOTAXIME IN THE TREATMENT OF RECURRENT OR COMPLICATED URINARY TRACT INFECTIONS OF BACTERIAL ETIOLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42639 |
Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS PRIMAXIN (IMIPENEM-CILASTATIN) IN THE THERAPY OF FEBRILE NEUTROPENIC PATIENTS |
Active substance: SULBACTAM |
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Document reference: 42666 |
Study title: A COMPARISON OF SULPERAZONE (SULBACTAM/CEFOPERAZONE) VERSUS CEFOBID (CEFOPERAZONE) IN THE TREATMENT OF INTRA ABDOMINAL INFECTIONS OF BACTERIAL ETIOLOGY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42846 |
Study title: A DOUBLE-BLIND COMPARATIVE STUDY OF ONCE VS TWICE ADMINISTRATION OF SBT/AMP IV IN THE PROPHYLAXIS OF POST-HYSTERECTOMY GYNECOLOGICAL |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42712 |
Study title: A MULTICENTER COMPARISON OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) VSCEFUROXIME IN THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFEC-TIONS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42646 |
Study title: A MULTICENTER COMPARISON OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) + OPTIONAL AMINOGLYCOSIDE VS AMPICILLIN AMINOGLYCOSIDE IN THE TREATMENT OF INTRA-ABDOMINAL INFECTIONS OF BACTERIAL ETIOLOGY IN OSPITALIZED PEDIATRIC PATIENTS |
Active substance: SULBACTAM |
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Document reference: 42647 |
Study title: A MULTICENTER STUDY OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) IN THE TREATMENT OF PERIORBITAL/PRESEPTAL AND FACIAL CELLULITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42648 |
Study title: A NON-COMPARATIVE STUDY OF UNASYN IM/IV (SULBACTAM/AMPICILLIN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF COMMUNITY ACQUIRED INFECTIONS. A MULTICENTER TRIAL. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42737 |
Study title: A NON-COMPARATIVE STUDY TO ASSESS THE EFFICACY AND SAFETY OF SULBACTAM/ AMPICILLIN IN PEDIATRIC PATIENTS IN BACTERIAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42723 |
Study title: Dose response study of caudal neostigmine for postoperative analgesia in paediatric patients undergoing genitourinary surgery.Dose response study of caudal neostigmine for postoperative analgesia in paediatric patients undergoing genitourinary surgery. |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47049 |
Study title: Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) |
Active substance: NEOSTIGMINE |
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Document reference: 47055 |
Study title: Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children.Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children. |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47057 |
Study title: Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian. Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43791 |
Study title: Zwillich SH, Comer SS, Lee E, Erdman WA, Lipsky PE. Treatment of the seronegative spondyloarthropathies with sulfasalazine. J Rheumatol Suppl. 1988 Sep;16:33-9. Review. Zwillich SH, Comer SS, Lee E, Erdman WA, Lipsky PE. Treatment of the seronegative spondyloarthropathies with sulfasalazine. J Rheumatol Suppl. 1988 Sep;16:33-9. Review. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43812 |
Study title: Dagan R, Einhorm M, Howard CB, Williams AH. Outpatient and inpatient teicoplanin treatment for serious grm-positive infections in children. Pediatr Infedt Dis J 1993; 12 (6/2): S 17-S 20. |
Active substance: TEICOPLANIN |
Study summary document link (including results): |
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Document reference: 44311 |
Study title: Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647 |
Active substance: OXYGEN |
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Document reference: 45419 |
Study title: Götte−R, Liedtke−R. (On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)). {Med−Klin}, 6 Jan 1978, vol. 73, no. 1, p. 28−33Götte−R, Liedtke−R. (On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)). {Med−Klin}, 6 Jan 1978, vol. 73, no. 1, p. 28−33 |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33266 |
Study title: Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870) |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33283 |
Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
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Document reference: 33285 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33331 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33317 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33332 |
Study title: A NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP IN THE TREATMENT OF PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42686 |
Study title: A RANDOMIZED, COMPARATIVE TRIAL OF CEFOPERAZONE/SULBACTAM VS. CEFTAZIDIME VS. PRIMAXIN FOR THE TREATMENT OF INSTITUTIONALLY ACQUIRED DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42654 |
Study title: AMPICILLIN/SULBACTAM VERSUS PLACEBO FOR THE INHIBITION OF PREMATURE LABOR OF PATIENTS ON TOCOLYSIS AND IN THE PROLONGATION OF THE LATENT PERIOD AFTER PREMATURE RUPTURE OF THE FETAL MEMBRANES |
Active substance: SULBACTAM |
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Document reference: 42650 |
Study title: AN OPEN COMPARATIVE PERIOPERATIVE PROPHYLAXIS STUDY OF SULBACTAM/ AMPICILLIN IN SINGLE DOSE VS. PROCAINE PENICILLIN PLUS CHLORAMPHENICOL IN PATIENTS WHO UNDERGO CAESAREAN SECTION |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42711 |
Study title: AN OPEN COMPARATIVE STUDY OF SBT/CFP VS. CEFTAZIDIME PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42867 |
Study title: AN OPEN COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP VS CEFOTAXIME IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42690 |
Study title: AN OPEN MULTICENTER STUDY OF SBT/CFP (1:2) IN THE TREATMENT OF PATIENTS WITH MODERATE TO SEVERE ABDOMINAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42871 |
Study title: AN OPEN MULTICENTER STUDY OF SULBACTAM/CEFOPERAZONE (1:2) IN THE TREATMENT OF PEDIATRIC PATIENTS WITH MODERATE OR SEVERE BACTERIAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42870 |
Study title: AN OPEN MULTICENTRIC STUDY OF SULBACTAM/CEFOPERAZONE (1:2) IN THE TREATMENT OF PATIENTS WITH INTRAHOSPITALARY PNEUMONIA. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42862 |
Study title: AN OPEN MULTICENTRIC STUDY OF SULPERAZONE (SULBACTAM/CEFOPERAZONE 1:2) IN THE TREATMENT OF PATIENTS WITH INTRAHOSPITALARY PNEUMONIA. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42872 |
Study title: AN OPEN NON COMPARATIVE STUDY OF PARENTERAL SULBACTAM/AMPICILLIN IN THE TREATMENT OF MIXED AEROBIC/ANAEROBIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42722 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF EFFICACY AND SAFETY OF SBT/AMP PARENTERAL IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42731 |
Study title: An open non-comparative study of Sulbactam plus Ampicillin in Serious Infections in Paediatric Patients |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42874 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN I.V. IN THE TREATMENT OF HOSPITALIZED INFECTION PATIENTS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42707 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN I.V. IN THE TREATMENT OF INTRA ABDOMINAL INFECTION |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42710 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULBACTAM/CEFOPERAZONE (1:1) IN THE EMPIRICAL TREATMENT OF MODERATE TO SEVERE SYSTEMIC INFECTION IN ADULT PATIENTS IN HOSPITAL |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42866 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42850 |
Study title: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication] |
Active substance: Nervoheel - Tabletten |
Study summary document link (including results): |
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Document reference: 40081 |
Study title: Bacopoulou, 2009;Netilmicin in the neonate: pharmacokinetic analysis and influence of parenteral nutrition Pharm World Sci (2009) 31:365–368 DOI 10.1007/s11096-009-9278-z |
Active substance: NETILMICIN |
Study summary document link (including results): |
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Document reference: 32622 |
Study title: Bouissou, 2008; PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).Prospective, Randomized Trial Comparing Short and Long Intravenous Antibiotic Treatment of Acute Pyelonephritis in Children: Dimercaptosuccinic Acid Scintigraphic Evaluation at 9 Months |
Active substance: NETILMICIN |
Study summary document link (including results): |
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Document reference: 32619 |
Study title: Comparison of 5 milligrams of netilmicin per kilogram of body weight once daily versus 2 milligrams per kilogram thrice daily for treatment of gram-negative pyelonephritis in children; publication from american society for microbiology "antimicrobial agents and chemotherapy, july 1992, p 1499-1503, vol 36, No 7. |
Active substance: NETILMICIN |
Study summary document link (including results): |
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Document reference: 32618 |
Study title: Post-marketing study 2001-2005 with NHD Pollen in patients with saisonal allergic rhinitis, conjunctivitis and possibly asthmatic disorders, so far only statistical analysis. Age of patients: 5-67 Years |
Active substance: NHD POLLEN |
Study summary document link (including results): |
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Document reference: 47786 |
Study title: "The effect of continuous epidural analgesia with sufentanil and bupivacaine during and after thoracic surgery on the plasma cortisol concentration and pain relief" |
Active substance: NICOMORPHINE |
Study summary document link (including results): |
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Document reference: 32624 |
Study title: Hurt RD et al. Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels. Arch Pediatr Adolesc med 2000; 154: 31-37 |
Active substance: NICOTINE |
Study summary document link (including results): |
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Document reference: 32628 |
Study title: Killen JD et al. Randomised clinical trial of the effiacy of bupropion combined with nicotine patch in the treatment of adolescent smokers. J Consult Clin Psychol 2004; 72: 729-735 |
Active substance: NICOTINE |
Study summary document link (including results): |
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Document reference: 32627 |
Study title: Moolchan ET et al. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction.Pediatrics 2005; 115: 407-414 |
Active substance: NICOTINE |
Study summary document link (including results): |
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Document reference: 32625 |
Study title: Smith TA et al. Nicotine patch therapy in adolescent smokers. Pediatrics 1996; 98: 659-667 |
Active substance: NICOTINE |
Study summary document link (including results): |
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Document reference: 32629 |
Study title: Expert Report in Clinical documentation for Marketing Autorisation Application (June 1987): Pharmacokinetic study of teicoplanin in paediatrics after a single dose of 6 mg/kg - Tarral A., Thomson G., Geisert J., Willard D., Monteil H. - 9 February 1987 |
Active substance: TEICOPLANIN |
Study summary document link (including results): |
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Document reference: 44292 |
Study title: Expert Report to amend therapeutic indications: Treatment of paediatric patients - Roscigno G. - 28 June 1991 |
Active substance: TEICOPLANIN |
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Document reference: 44295 |
Study title: Outpatient and inpatient teicoplanin treatment for serious grm-positive infections in children. - Dagan R, Einhorm M, Howard CB, Williams AH. -Pediatr Infedt Dis J 1993; 12 (6/2): S 17-S 20. |
Active substance: TEICOPLANIN |
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Document reference: 44305 |
Study title: Pharmacokinetics of teicoplanin in pediatric patients. - Terragna A, Ferrea G, Loy A et al. (1988). - Antimicrobial Agents and Chemotherapy 32, 1223-1226. |
Active substance: TEICOPLANIN |
Study summary document link (including results): |
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Document reference: 44307 |
Study title: A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33339 |
Study title: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 33334 |
Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415 |
Active substance: Peppermint Oil 0.200 ml |
Study summary document link (including results): |
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Document reference: 21225 |
Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415 |
Active substance: Peppermint Oil 0.200 ml |
Study summary document link (including results): |
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Document reference: 40113 |
Study title: Verträglichkeit und Wirksamkeit von Pinimenthol® Erkältungssalbe bei Patienten mit Erkältungskrankheiten der Luftwege. |
Active substance: per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g/ per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g |
Study summary document link (including results): |
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Document reference: 40118 |
Study title: Efficacy of Tonsiotren for acute angina catarrhalis. |
Active substance: Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg |
Study summary document link (including results): |
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Document reference: 39744 |
Study title: Campo JV. Coping with ignorance: Exploring pharmacologic management for pediatric functional abdominal pain. J PEDIATR GASTROENTEROL NUTR 2005; 41(5): 569−574 |
Active substance: Peppermint Oil 0.200 ml |
Study summary document link (including results): |
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Document reference: 40114 |
Study title: Acceptability, safety, pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril S 90652 (daily dose 0.025 to 0.135 mg/kg) in hypertensive children -an open, non comparative, 3-month then at least 24-months duration multicentre study. |
Active substance: PERINDOPRIL |
Study summary document link (including results): perindopril_CL2-90652-002_synopsis.pdf |
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Document reference: 45867 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTION. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42853 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42855 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42856 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42696 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42738 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42740 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42758 |
Study title: An Open Non-Comparative Study using a combination of Sulbactam plus Ampicillin or Penicillin G in serious but not life threatening infections in Paediatric Patients |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42873 |
Study title: AN OPEN NON-COMPARATIVE STUDY, Q COMBINATION OF SULBACTAM SODIUM WITH AMPICILLIN IN SERIOUS INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42625 |
Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SULBACTAM/CFP IN THE TREATMENT OF INTRAABDOMINAL INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42860 |
Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF SBT/AMP PARENTERAL FOLLOWED OF ORAL STM FOR THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS INCLUDING BRONCHO-PNEUMONIA AND ASPIRATION PNEUMONIA |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42755 |
Study title: AN OPEN PLACEBO COMPARATIVE STUDY OF SBT/AMP-IV IN THE PROPHYLAXIS OF POST SURGICAL OBSTETRIC AND GYNECOLOGICAL INFECTIONS. A MULTICENTRIC TRIAL DURATION OF STUDY APP. ONE POST-SURGERY WEEK. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42719 |
Study title: AN OPEN STUDY OF PARENTERAL SULBACTAM SODIUM/AMPICILLIN. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42624 |
Study title: AN OPEN, COMPARATIVE STUDY OF SBT/CFP VS. PIPERACILLIN PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42868 |
Study title: AN OPEN, COMPARATIVE STUDY OF SULBACTAM/CEFOPERAZONE PLUS AMIKACIN VS. CEFTAZIDIME PLUS AMIKACIN (1:2) IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42863 |
Study title: AN OPEN, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF SBT/CPZ (1:1) PLUS AMIKACIN VS CEFTAZIDIME PLUS AMIKACIN IN THE EMPIRIC TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42858 |
Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42751 |
Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND TOLERABILITY OF SULTAMICILLIN (SULBACTAM/AMPICILLIN) IN THE TREATMENT OF CHILDREN PATIENTS WITH SKIN AND SUBCUTANEOUS TISSUE INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42678 |
Study title: AN OPEN, NON-COMPARATIVE STUDY IN PARENTERAL SULBACTAM/AMPICILLIN IN CASES OF MIXED AEROBIC/ANAEROB INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42732 |
Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42752 |
Study title: Jürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. GermanJürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. German |
Active substance: CYCLOPHOSPHAMIDE |
Study summary document link (including results): |
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Document reference: 24944 |
Study title: Final Summary of Japanese Retrospective Surveillance and Prospective Studies in Children Less than 1 Year of Age. |
Active substance: oseltamivir |
Study summary document link (including results): |
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Document reference: 47896 |
Study title: "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr5.xls |
View full study record |
Document reference: 47718 |
Study title: "Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44"Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr4.xls |
View full study record |
Document reference: 47717 |
Study title: Open-label, cross-over, randomized, reference-controlled, multicenter study to investigate the parents’ preference for Creon for children over Creon 12000 U in infants with pancreatic exocrine insufficiency due to cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-3118.pdf |
View full study record |
Document reference: 47669 |
Study title: "OPEN-LABEL, MULTICENTRE, RANDOMISED CROSSOVER STUDY TO lNVESTlGATE THE PATIENT'S PREFERENCE OF CREON to 000 MINIMICROSPHERES OVER CREON 12000 IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY CAUSED BY CYSTIC FIBROSIS". |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K245-5002.pdf |
View full study record |
Document reference: 47655 |
Study title: Open-label, randomized, three-way, cross-over single-center study to Prove the equivalence of a single dose of Creon® 10,000 Minimicrospheres™ and Pancrease by using the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-3111.pdf |
View full study record |
Document reference: 47667 |
Study title: Open. randomized. crossover, multicenter study to investigate relative patient preference for Creane 10 000 Minimicrospheres1M versus Creone 8 000 microspheres in patients with pancreatic exocrine insufficiency caused by cystic fibrosis. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-3105.pdf |
View full study record |
Document reference: 47666 |
Study title: Randomized, open-label, cross-over study comparing the efficacy and tolerance of Creon® Forte and Cotazym S Forte® in children and young adults with cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K224-5010.pdf |
View full study record |
Document reference: 45111 |
Study title: 10.) Oral enzyme therapy in the treat- ment of recurrent respiratory inflamma- tions in patients with indication of immunological in- vestigation before start of treatment |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40102 |
Study title: 11.) Systemic en- zyme therapy in the treatement of supra- condylar fractures of the humerus in Children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40103 |
Study title: 12.) Influence of Wobenzym treat- ment in children with increased sickness rate |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40104 |
Study title: 14.) Oral Enzyme Therapy of Re- current Respiratory Inflammations in Children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40105 |
Study title: Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. |
Active substance: TOBRAMYCIN |
Study summary document link (including results): |
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Document reference: 25751 |
Study title: A comparison of 0.3% Tobramycin Ophthalmic Solution (TOBREX New) vs TOBREX Ophthalmic Solution (TOBREX) for Treatment of Bacterial Conjunctivitis (C9998). |
Active substance: TOBRAMYCIN |
Study summary document link (including results): |
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Document reference: 44819 |
Study title: 38. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom (patients < 2 years)). |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44972 |
Study title: 38. Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44881 |
Study title: A study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 650 mg in the treatment of post-operative dental pain. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 88-856.pdf |
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Document reference: 47509 |
Study title: A Study Comparing the Efficacy and Safety of Acetaminophen Sustained Release 1300 mg to Acetaminophen Regular Release 650 mg in the Treatment of Post-Operative Episiotomy Pain. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 88-857.pdf |
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Document reference: 47510 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-206.pdf |
View full study record |
Document reference: 47503 |
Study title: An open trial to assess the acceptability and tolerance of Lonarid mono syrup in children. |
Active substance: PARACETAMOL |
Study summary document link (including results): Paracetamol_U96-0101_synopsis.pdf |
View full study record |
Document reference: 45778 |
Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results). |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45776 |
Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks - 12 months results. |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45777 |
Study title: Clinical trial comparing the safety and efficacy of acetaminophen with that of ibuprofen in the treatment of acute musculo-skeletal injury |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45788 |
Study title: Clinical trial comparing the safety and efficacy of acetaminophen with that of ibuprofen in the treatment of acute musculo-skeletal injury |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45795 |
Study title: Comparison of the antipyretic activity of ibuprofen and paracetamol in children with pyrexia. |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45802 |
Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84.Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33642 |
Study title: Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33639 |
Study title: Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 25781 |
Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72.Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33640 |
Study title: Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970 |
Active substance: PARACETAMOL |
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Document reference: 45751 |
Study title: Study of the pharmacokinetic linearity of three paediatric doses of paracetamol (50, 125, and 250mg) administered as a new Synthelabo formulation, and their bioequivlence with a standard formulation of DOLIPRANE dosed at 16mg healthy male young volunteers. Open, randomised, cross-over and single-center study. |
Active substance: PARACETAMOL |
Study summary document link (including results): 2890 98 FR 001.pdf |
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Document reference: 47077 |
Study title: Tarlin−L et al. A comparison of the antipyretic effect of acetaminophen and aspirin. Another approach to poison prevention. {Am−J−Dis−Child}, Dec 1972, vol. 124, no. 6, p. 880−2Tarlin−L et al. A comparison of the antipyretic effect of acetaminophen and aspirin. Another approach to poison prevention. {Am−J−Dis−Child}, Dec 1972, vol. 124, no. 6, p. 880−2 |
Active substance: PARACETAMOL |
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Document reference: 45752 |
Study title: Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) |
Active substance: PARACETAMOL |
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Document reference: 45753 |
Study title: The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397) The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397) |
Active substance: PARACETAMOL |
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Document reference: 45754 |
Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain |
Active substance: PARACETAMOL |
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Document reference: 45727 |
Study title: Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3 Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3 |
Active substance: PARACETAMOL |
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Document reference: 45756 |
Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain |
Active substance: PARACETAMOL |
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Document reference: 45728 |
Study title: Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618 |
Active substance: PARACETAMOL |
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Document reference: 45757 |
Study title: "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - " "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - " |
Active substance: OXYBUTYNIN |
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Document reference: 32986 |
Study title: "Oxybutynin Chloride (Ditropan) in Enuresis - Buttarazzi P J. - The Journal of Urology - 1977 (118: 46) - Publication in UK registration file -" "Oxybutynin Chloride (Ditropan) in Enuresis - Buttarazzi P J. - The Journal of Urology - 1977 (118: 46) - Publication in UK registration file -" |
Active substance: OXYBUTYNIN |
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Document reference: 32988 |
Study title: "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - " "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - " |
Active substance: OXYBUTYNIN |
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Document reference: 32991 |
Study title: Valutazione dell’effetto antalgico e della tollerabilità di un nuovo dosaggio di paracetamolo sciroppo nelle faringotonsilliti in pediatria. Studio in doppio cieco verso placebo, controllato verso ketoprofene sale di lisina. |
Active substance: PARACETAMOL |
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Document reference: 45774 |
Study title: 39. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures) TOP-GER-3 (patients > 12) |
Active substance: TOPIRAMATE |
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Document reference: 44882 |
Study title: 37. Topamax 1st line add on (patients >12 years) |
Active substance: TOPIRAMATE |
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Document reference: 44902 |
Study title: 37. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures (patients > 12 years)). |
Active substance: TOPIRAMATE |
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Document reference: 44971 |
Study title: 4. Phase 3, randomized, double-blind, PBO-controlled, parallel group, multicenter, dose-response study to evaluate the efficacy and safety of TPM vs. PBO in migraine prophylaxis (plus OL Ext) |
Active substance: TOPIRAMATE |
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Document reference: 44837 |
Study title: 40. Phase 3, open-label, safety and efficacy, adjunctive or monotherapy study in adults with refractory partial epilepsy originally entered in Studies Y1/Y2/Y3, and who received PBO in the original study. |
Active substance: TOPIRAMATE |
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Document reference: 44974 |
Study title: 41. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom) (patients < 2 years) |
Active substance: TOPIRAMATE |
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Document reference: 44903 |
Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext) |
Active substance: TOPIRAMATE |
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Document reference: 44838 |
Study title: 6. Open study of topamax as adjunct treatment in patients with partial onset seizures : assessing the low and slow titration regimen. |
Active substance: TOPIRAMATE |
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Document reference: 44940 |
Study title: 6. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext) |
Active substance: TOPIRAMATE |
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Document reference: 44839 |
Study title: 9. Long-term, open-label study of topamax (topiramate) used as adjunctive therapy in patients with partial onset seizures with or without secondary generalization. |
Active substance: TOPIRAMATE |
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Document reference: 44943 |
Study title: 9. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with Lennox-Gastaut syndrome |
Active substance: TOPIRAMATE |
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Document reference: 44842 |
Study title: Publication in CES0506 - Lavin B - 30/06/2006 Comparative efficacy, safety, and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous nasal sprays in patients with fall seeasonal allergic rhinitis - Gross - 2002 (Annals of allergy asthma & immunology 89; 1: 56-62, 2002) |
Active substance: TRIAMCINOLONE |
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Document reference: 46833 |
Study title: Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640).Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640). |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33624 |
Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 33725 |
Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 33723 |
Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 33724 |
Study title: |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol 95-530 TRAMAP-ANAG-007.pdf |
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Document reference: 47513 |
Study title: A multinational, multicentre, prospective, Zaldiar post marketing surveillance observation to assess the safety of Zaldiar (tramadol/paracetamol 37.5 mg/325 mg) and patient satisfaction in the routine Latin American clinical setting |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 44977 |
Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-002.pdf |
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Document reference: 47519 |
Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-003.pdf |
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Document reference: 47520 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-010.pdf |
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Document reference: 47521 |
Study title: Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lajouanine P. - 06/04/72Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lajouanine P. - 06/04/72 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33958 |
Study title: Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650 |
Active substance: PHENYTOIN |
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Document reference: 33968 |
Study title: Tanner, M. S., Bhave, S. A., Pradhan, A. M., and Pandit, A. N. Department of Child Health, University of Leicester Clinical trials of penicillamine in Indian childhood cirrhosis Arch.Dis.Child 1987;62:1118-1124. Tanner, M. S., Bhave, S. A., Pradhan, A. M., and Pandit, A. N. Department of Child Health, University of Leicester Clinical trials of penicillamine in Indian childhood cirrhosis Arch.Dis.Child 1987;62:1118-1124. |
Active substance: PENICILLAMINE |
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Document reference: 33848 |
Study title: Canadian experience with Pneumodine ( Pentamidine isethionate) in the treatment of Pneumocystis carinii Pneumonia : A retrospective analysis of the results of patients receiving Pneumodine as emergency treatment during 1986, 1987 and the first half of 1988.Canadian experience with Pneumodine ( Pentamidine isethionate) in the treatment of Pneumocystis carinii Pneumonia : A retrospective analysis of the results of patients receiving Pneumodine as emergency treatment during 1986, 1987 and the first half of 1988. |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45821 |
Study title: Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45823 |
Study title: Isethionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Documentation clinique - Synthèse bibliographique - Aout 1987.Isethionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Documentation clinique - Synthèse bibliographique - Aout 1987. |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45824 |
Study title: Iséthionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Rapport d'expert concernant la documentation clinique - R. Woehrle - 20 Mai 1988Iséthionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Rapport d'expert concernant la documentation clinique - R. Woehrle - 20 Mai 1988 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45825 |
Study title: J Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou PJ Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou P |
Active substance: PIDOTIMOD |
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Document reference: 34074 |
Study title: Viitanen H, et all. Analgesic efficacy of rectal acetaminophen and ibuprofen alone or in combination for paediatric day-case adenoidectomy. Br J Anaesth. 2003 Sep;91(3):363-7.Viitanen H, et all. Analgesic efficacy of rectal acetaminophen and ibuprofen alone or in combination for paediatric day-case adenoidectomy. Br J Anaesth. 2003 Sep;91(3):363-7. |
Active substance: PARACETAMOL |
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Document reference: 45760 |
Study title: Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632) |
Active substance: PARACETAMOL |
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Document reference: 45762 |
Study title: Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17 |
Active substance: PARACETAMOL |
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Document reference: 45763 |
Study title: Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21)Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21) |
Active substance: PARACETAMOL |
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Document reference: 45764 |
Study title: Weisse−M−E et al. Fever response to acetaminophen in viral vs. bacterial infections. {Pediatr−Infect−Dis−J}, Dec 1987, vol. 6, no. 12, p. 1091−4Weisse−M−E et al. Fever response to acetaminophen in viral vs. bacterial infections. {Pediatr−Infect−Dis−J}, Dec 1987, vol. 6, no. 12, p. 1091−4 |
Active substance: PARACETAMOL |
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Document reference: 45765 |
Study title: When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7 When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7 |
Active substance: PARACETAMOL |
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Document reference: 45766 |
Study title: Wilson, Brown, Bocchini, Kearno; Ther Drug Monitoring 1982Wilson, Brown, Bocchini, Kearno; Ther Drug Monitoring 1982 |
Active substance: PARACETAMOL |
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Document reference: 45767 |
Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
Active substance: PARACETAMOL |
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Document reference: 45768 |
Study title: Pentamidine-induced hypoglycemia in patients with the acquired immune deficiency syndrome. Celijne M. Stahl-Baylis, M.D. Concetta M.Kalman, R.N., and Oscar L. Laskin, M.D. NY. Clin. Pharmacol. Ther. March 1986Pentamidine-induced hypoglycemia in patients with the acquired immune deficiency syndrome. Celijne M. Stahl-Baylis, M.D. Concetta M.Kalman, R.N., and Oscar L. Laskin, M.D. NY. Clin. Pharmacol. Ther. March 1986 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45827 |
Study title: Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med |
Active substance: PARACETAMOL |
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Document reference: 45758 |
Study title: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640) |
Active substance: TRIAMCINOLONE |
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Document reference: 46836 |
Study title: Publication in Rapport d'Expert sur la documentation pharmaco-toxicologique - Roquet F - 15/08/1995 A thirty day comparison of the oral toxicity of CL 30,980 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b-hydroxy-16a,17a-(isopropylidenedioxy)-21-(tetrahydropyran-2-yloxy)- and CL 22,353 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b,21-dihydroxy-16a,17a-(isopropylidenedioxy)- in rats - Kanegis LA - 26/09/1960 (Safety Evaluation.studies. PR Volume 6, 2694-2726) |
Active substance: TRIAMCINOLONE |
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Document reference: 46838 |
Study title: Report in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 A phase III, single center, randomised, cross-over paediatric trial with Nasacort AQ nasal spray assessing short term growth in patients with allergic rhinitis - Kane R- 15/08/2007 |
Active substance: TRIAMCINOLONE |
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Document reference: 46840 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with perennial allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46841 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal (ragweed) allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46842 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46843 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal ragweed allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46844 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46845 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46846 |
Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
Active substance: PHLEUM PRATENSE |
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Document reference: 34030 |
Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
Active substance: Phleum pratense |
Study summary document link (including results): |
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Document reference: 40128 |
Study title: Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lafargues G. - 23/03/72Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lafargues G. - 23/03/72 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
Study summary document link (including results): |
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Document reference: 33957 |
Study title: Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428 |
Active substance: OXITRIPTAN |
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Document reference: 32944 |
Study title: Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1 |
Active substance: OXITRIPTAN |
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Document reference: 32945 |
Study title: Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE. |
Active substance: PIDOTIMOD |
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Document reference: 34069 |
Study title: Pneumocystis carinii pneumonia and altered host resistance : treatement of one patient with pentamidine isethionate. Patterson, J.H. , Lindsey, I.L., Edwards, E.S. and Logan Jr., W.D. (1966) Pediatrics 38:388-397Pneumocystis carinii pneumonia and altered host resistance : treatement of one patient with pentamidine isethionate. Patterson, J.H. , Lindsey, I.L., Edwards, E.S. and Logan Jr., W.D. (1966) Pediatrics 38:388-397 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45828 |
Study title: Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45834 |
Study title: Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45836 |
Study title: Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02)Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02) |
Active substance: THEOPHYLLINE |
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Document reference: 44727 |
Study title: Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02 |
Active substance: THEOPHYLLINE |
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Document reference: 44723 |
Study title: Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280 |
Active substance: THEOPHYLLINE |
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Document reference: 44719 |
Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , |
Active substance: OXITRIPTAN |
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Document reference: 32962 |
Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children |
Active substance: PARACETAMOL |
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Document reference: 45792 |
Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children |
Active substance: PARACETAMOL |
Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf |
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Document reference: 45798 |
Study title: Double-blind comparison of the taste of children's anacin-3 liquid vs. children tylenol liquid in normal children |
Active substance: PARACETAMOL |
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Document reference: 45786 |
Study title: Double-blind, single-dose study of the safety and analgesic efficacy of ibuprofen liquid, acetaminophen liquid, and placebo (liquid vehicle) following orthodontic treatmen |
Active substance: PARACETAMOL |
Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf |
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Document reference: 45799 |
Study title: Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial |
Active substance: PARACETAMOL |
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Document reference: 45800 |
Study title: Essai comparatif en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge de 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’enfant pesant entre 4 et 26 kg. Essai en double aveugle, comparatif sur deux groupes parallèles, multicentrique, phase III.Publication = Treluyer JM. Et al : Antipyretic efficacy of an initial 30 mg/kg loading dose of acetaminophen versus a 15 mg/kg maintenance dose. |
Active substance: PARACETAMOL |
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Document reference: 45780 |
Study title: Comparison of IM pethidine, diazepam and flunitrazepam as premedicants in children undergoing otolaryngological surgery - L Lindgren Br J. - 1979 (Anaesth 1979, 51 321-327) - Publication in expert report DOL01VOL2 - |
Active substance: PETHIDINE |
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Document reference: 45868 |
Study title: An observational study collecting data on the efficacy and tolerability of Elidel® (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis after one and six weeks in real life practice. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CSA02 Art45 listing 2011.xls |
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Document reference: 34117 |
Study title: Elidel PMS trial with Elidel in patients with AD. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CDE07 Art45 listing 2011.xls |
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Document reference: 34094 |
Study title: Elidel Tolerability, Safety and Efficacy in Dermatitis Atopic Patients (El-Tosca) |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CID01 Art45 listing 2011.xls |
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Document reference: 34114 |
Study title: A 12 month open label non-controlled extension to a randomized multicenter, parallel-group, double-blind, vehicle controlled study to evaluate the efficacy and safety of 1% SDZ ASM981 cream in the long-term management of atopic dermatitis in children from 3 months to 23 months |
Active substance: PIMECROLIMUS |
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Document reference: 34129 |
Study title: 16.) Evaluation of effectivness of Wobenzym Therapy in children with recurrent obstructive bronchitis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40106 |
Study title: 18.) Prophylaxis and treatment chronic hepatitis in children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
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Document reference: 40107 |
Study title: 19.) Efficacy of oral enzyme therapy in the complex treat- ment of atopic dermatitis in children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40108 |
Study title: 20.) Efficacy of oral enzyme therapy in children with atopic dermatitis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40109 |
Study title: 22.) Enzyme prepa- rations in abdominal surgery |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40110 |
Study title: 23.) Use of Woben- zym for pseudo- tuberculosis and yersiniosis of children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40111 |
Study title: A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33612 |
Study title: A single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988.A single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33604 |
Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33600 |
Study title: A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33611 |
Study title: Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3 |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33577 |
Study title: Essai comparative en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’entant pesant entre 4 et 26 kg |
Active substance: PARACETAMOL |
Study summary document link (including results): DO 428.pdf |
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Document reference: 47080 |
Study title: Etude multicentrique, ouverte, non comparative, de l'acceptabilite et de la tolerance du paracetamol suspension buvable pediatrique a 4,8% - J. Lalau Keraky, C. Leblond-Joly, V. Dubourg, M. Kabir-Ahmadi, C. Kempf - May 25th, 2007. |
Active substance: PARACETAMOL |
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Document reference: 45779 |
Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30 mg/kg ou de 15 mg/kg, chez l’enfant âgé de 1 à 6 ans. |
Active substance: PARACETAMOL |
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Document reference: 45782 |
Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30mg/kg ou de 15mg/kg, chez l’enfant âgé de 1 à 6 ans |
Active substance: PARACETAMOL |
Study summary document link (including results): DO466.pdf |
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Document reference: 47079 |
Study title: ETUDE MULTICENTRIQUE, RANDOMISEE, EN DOUBLE AVEUGLE, COMPARANT L EFFET ANTIPYRETIQUE DU PARACETAMOL EN DOSES REPETEES, APRES UNE DOSE INITIALE DE 15 MG/KG OU DE 30 MG/KG CHEZ L ENFANT PESANT ENTRE 4 ET 26 KG ET AGE D AU MOINS 1 MOIS |
Active substance: PARACETAMOL |
Study summary document link (including results): DO465.pdf |
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Document reference: 47078 |
Study title: Etude multicentrique, randomisée, en double aveugle, comparant l’effet antipyrétique du paracétamol en doses répétées, après une dose initiale de 15 mg/kg ou de 30 mg/kg, chez l’enfant pesant entre 4 et 26 kg et âgé d’au moins 1 mois. |
Active substance: PARACETAMOL |
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Document reference: 45781 |
Study title: Confronto in doppio cieco controllato tra placebo e paracetamolo |
Active substance: PARACETAMOL |
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Document reference: 45773 |
Study title: Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7 |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45772 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-012.pdf |
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Document reference: 47522 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-013.pdf |
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Document reference: 47523 |
Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile of oral tramadol hydrochloride in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-007; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 45808 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 45806 |
Study title: Evaluation of the safety profile of oral tramadol for the treatment of painful conditions in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-008; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): |
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Document reference: 45809 |
Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-001 and TRAM-PEDS-006; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): |
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Document reference: 45805 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): |
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Document reference: 45810 |
Study title: ELPASO-Elidel Patient Self-observation |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CDE11 Art45 listing 2011.xls |
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Document reference: 34096 |
Study title: An observation post-marketing surveillance (PMS) study evaluating efficacy and safety of Elidel (pimecrolimus) cream 1% in patients >=3 months of age with mild to moderate dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CPH01 Art45 listing 2011.xls |
View full study record |
Document reference: 34100 |
Study title: A Phase 2, Open-Label, Prospective, Safety and pK Study to Assess the Extended Use of Synagis (Seven Injections) in Infants and Children with or without CLD |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-w00-350.pdf |
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Document reference: 48109 |
Study title: A Phase 4, Prospective, Open-Label, Multi-Center Study to Assess the Use of Synagis® in Preterm Infants Born 29-32 Weeks Gestation Less Than or Equal to 6 Months of Age without Chronic Lung Disease |
Active substance: palivizumab |
Study summary document link (including results): |
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Document reference: 41609 |
Study title: A Phase I Pilot Safety and Phannacokinetics Study ofMEDI-493, a Respiratory Syncytial Virus (RSV) Humanized Monoclonal Antibody, Administered Intravenously in Bone Marrow or Stem Cell Transplant Recipients with RSV Infection |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp034.pdf |
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Document reference: 48101 |
Study title: A Phase I Safety, Tolerance and Pharmacokinetics Study ofMEDI-493. a Respiratory Syncytial Virus Humanized Monoclonal Antibody, Administered Intravenously in Bone Marrow or Stem-Cell Transplant Recipient Patients |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp004.pdf |
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Document reference: 48092 |
Study title: A Phase I Study of the Safety, Tolerance and Phannacokinetics of Reconstituted Lyophilized MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Administered Intravenously at 15 mg/kg and 30 mg/kg in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp045.pdf |
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Document reference: 48104 |
Study title: A Phase I/II study of the safety, tolerance and pharmacokinetics of MED 493 conducted in otherwise healthy hospitalised children with Respiratory Syncytial Virus Infection |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp009.pdf |
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Document reference: 48094 |
Study title: A Phase I/II study of the safety, tolerance and pharmacokinetics of MED 493 conducted in otherwise healthy hospitalised children with Respiratory Syncytial Virus Infection |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp009.pdf |
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Document reference: 48095 |
Study title: A Phase II Study ofthe Safety, Tolerance,Phannacokinetics,and Effect on Viral Load in Tracheal Aspirates of MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, in Children on Mechanical Ventilation for Respiratory Syncytial Virus Infection |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp026.pdf |
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Document reference: 48100 |
Study title: A Phase II, Randomized, Double-Blind, Two-Period, Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palivizumab (MEDI-493, Synagis®), a Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children with a History of Prematurity |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp097.pdf |
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Document reference: 48106 |
Study title: "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - " "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - " |
Active substance: OXYBUTYNIN |
Study summary document link (including results): |
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Document reference: 32993 |
Study title: A Multi-center, Inpatient, Open-Label, Dose-Ranging Study to Characterize the Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in Patients from Birth to 4 Years of Age, Who Require Opioid Analgesia |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45393 |
Study title: MF-OXY-010898 Oxycodone in post-operative pain |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45396 |
Study title: Multi-center, double-blind, randomised, dose ranging study, in pediatric patients 5 to ≤ 16 years of age receiving morphine as standard supplementary pain medication to evaluate pharmacokinetics, efficacy and safety of oxy pediatric liquid (1 mg/ml) versus placebo in the treatment of acute moderate to severe pain. (USA & EU) |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45394 |
Study title: Multiple dose, open-label, multicentric study for the conversion of immediate release Oxycodone (OxyIR) dose to controlled release Oxycodone (OxyContin) in order to assess the pharmacokinetics and characterize the efficacy and safety in pediatric patients from 6 to 16 years old. (USA & EU) |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45395 |
Study title: OXN9002 safety and efficacy of Targin in patients with pain |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45398 |
Study title: OXY4407 Pain controlling with Oxygesic |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45397 |
Study title: Oxycodone in post-operative pain |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45390 |
Study title: Pain controlling with Oxygesic |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45391 |
Study title: safety and efficacy of Targin in patients with pain |
Active substance: OXYCODONE |
Study summary document link (including results): |
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Document reference: 45392 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33615 |
Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6 |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33570 |
Study title: Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23)Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23) |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33568 |
Study title: Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60.Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60. |
Active substance: PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33941 |
Study title: An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33594 |
Study title: A Phase IV Double-Blind Single Dose Study of the Relative Efficacy and Safety of Acetaminophen 650 mg, Acetaminophen 650 mg With Phenyltoloxamine Citrate 60 mg, Phenyltoloxamine Citrate 60 mg, and Placebo in the Treatment of Postoperative Pain Following Oral Surgery. |
Active substance: PARACETAMOL PHENYLTOXOLAMINE |
Study summary document link (including results): paracetamol 0-235.pdf |
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Document reference: 47506 |
Study title: A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Safety and Effectiveness of Zemplar in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric End Stage Renal Disease Subjects on Hemodialysis |
Active substance: PARICALCITOL |
Study summary document link (including results): Paricalcitol-2001022.pdf |
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Document reference: 45819 |
Study title: A 16 Week Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Tolerability of Paroxetine in the Treatment of Children and Adolescents with Social Anxiety Disorder/Social Phobia |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-676-fullCSR.pdf |
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Document reference: 48342 |
Study title: A 38-Week, Two Phase, Multicenter Study to Investigate the Safety and Effectiveness of Paroxetine (10-60 mg/day) in the Treatment of Children and Adolescent Outpatients with Obsessive-Compulsive Disorder |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-453-fullCSR.pdf |
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Document reference: 48341 |
Study title: A Double-blind, Multicentre Placebo Controlled Study of Paroxetine in Adolescents with Unipolar Major Depression |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-377-fullCSR.pdf |
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Document reference: 48339 |
Study title: A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-329-acute-fullCSR.pdf |
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Document reference: 48337 |
Study title: A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression–Continuation Phase |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-329-continuation-fullCSR.pdf |
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Document reference: 48338 |
Study title: A Multicenter Study to Assess the Pharmacokinetics of Paroxetine Following Repeat Dose Administration in Children and Adolescents with Obsessive- Compulsive Disorder (OCD) and/or Depression |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-715-fullCSR.pdf |
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Document reference: 48345 |
Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study) |
Active substance: PHLEUM PRATENSE |
Study summary document link (including results): |
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Document reference: 34029 |
Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study) |
Active substance: Phleum pratense |
Study summary document link (including results): |
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Document reference: 40127 |
Study title: A Phase III/IV Multicenter Evaluation ofthe Immunogenicity ofPalivizumab (Synagis®) in Children who Previously Received Palivizumab (Synagis®) Prophylaxis and Children Receiving the Drug for the First Time |
Active substance: palivizumab |
Study summary document link (including results): |
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Document reference: 47445 |
Study title: A Phase IIII, Rising, Repeated Dose, Safety, Tolerance and Pharmacokinetics Study of MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Conducted in Premature Infants and Infants with Bronchopulmonary Dysplasia |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp005.pdf |
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Document reference: 48093 |
Study title: A Phase IJII Study of the Safety. Tolerance and Phannacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Conducted in Otherwise Healthy Children Hospitalized with Respiratory Syncytial Virus Infection |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp013.pdf |
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Document reference: 48098 |
Study title: A Phase IV study of fie safety of Synagis (Palivizumabib) for Prophylaxis of Respiratory Syncytial Virus Disease in Children with Cystic Fibrosis |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-ma001.pdf |
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Document reference: 48107 |
Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33326 |
Study title: A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996.A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33323 |
Study title: A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33337 |
Study title: An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33320 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33341 |
Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6 |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33300 |
Study title: A single blind study to compare the efficacy and safety of intravenous Granisetron with Chlorpromazine combined with Dexamethasone for the prophylaxis of cytotoxic induced emesis in paediatric patients with malignant disease |
Active substance: GRANISETRON |
Study summary document link (including results): |
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Document reference: 29024 |
Study title: Double-blind comparative clinical study of iopromide (SHL414A) versus amidotrizoate (Visotrast-370Ò) in angiocardiography in 50 newborns and infants |
Active substance: IOPROMIDE |
Study summary document link (including results): Bayer Pharma_Iopromide_86058_study_synopsis.pdf |
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Document reference: 46901 |
Study title: A double blind, multiple dose study of the antipyretic activity and tolerability of ibuprofen and paracetamol in burns pyrexia in children. |
Active substance: IBUPROFEN |
Study summary document link (including results): |
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Document reference: 29457 |
Study title: Gurer YK, Kukner S, Sarica B. Pediatr Neurol. 1996 Jan;14(1):72-4. Intravenous g-globulin treatment in a patient with subacute sclerosing panencephalitis.Gurer YK, Kukner S, Sarica B. Pediatr Neurol. 1996 Jan;14(1):72-4. Intravenous g-globulin treatment in a patient with subacute sclerosing panencephalitis. |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30116 |
Study title: Post-operative therapeutic decision making in a new Japanese protocol (JPLT-2) for pediatric hepatic malignancies with pulmonary metastasis. ;Ohno-Y. Asian Journal of Surgery, 2001, Vol/Iss/Pg. 24/4 (341-346)Post-operative therapeutic decision making in a new Japanese protocol (JPLT-2) for pediatric hepatic malignancies with pulmonary metastasis. ;Ohno-Y. Asian Journal of Surgery, 2001, Vol/Iss/Pg. 24/4 (341-346) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30305 |
Study title: Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams. |
Active substance: INDOMETHACIN |
Study summary document link (including results): |
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Document reference: 29934 |
Study title: Report on ibuprofen in thetretament of juvenile rheumatoid arthritis - initial observation by Dr G Husby ( Norway ) |
Active substance: IBUPROFEN |
Study summary document link (including results): |
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Document reference: 29442 |
Study title: |
Active substance: Inactivated hepatitis A virus |
Study summary document link (including results): |
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Document reference: 47326 |
Study title: To study the effect duration of two different doses of IFN-gamma in patients with chronic granulomatous disease (CGD) on functional responses of neutrophils (PMN). |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30203 |
Study title: Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41.Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41. |
Active substance: PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33936 |
Study title: "Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605"Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr2..xls |
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Document reference: 47715 |
Study title: "Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206"Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr8.xls |
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Document reference: 47721 |
Study title: "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr7.xls |
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Document reference: 47720 |
Study title: "The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251"The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr6.xls |
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Document reference: 47719 |
Study title: "The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139"The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr3..xls |
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Document reference: 47716 |
Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study |
Active substance: PHLEUM PRATENSE |
Study summary document link (including results): |
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Document reference: 34031 |
Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study |
Active substance: Phleum pratense |
Study summary document link (including results): |
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Document reference: 40129 |
Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract |
Active substance: PHLOROGLUCINOL |
Study summary document link (including results): |
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Document reference: 34032 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
Study summary document link (including results): |
View full study record |
Document reference: 33430 |
Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
Study summary document link (including results): |
View full study record |
Document reference: 33439 |
Study title: Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130)Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
Study summary document link (including results): |
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Document reference: 33386 |
Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique) |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): |
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Document reference: 45877 |
Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique) |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): |
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Document reference: 45889 |
Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with chloramphenicol. |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48445 |
Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with chloramphenicol. |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48446 |
Study title: A multicentre, randomised, investigator-blind, parallel group study to compare Efficacy and safety of Fucithalmic® with norfloxacin 0.3% |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48447 |
Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with rifamycin 1%Arrata et al |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48453 |
Study title: A multicentre, randomised, open, parallel group study to compare clinical and bacteriological effect as well as safety and acceptability of Fucithalmic® with Minims® eye drops in neonates with a clinical diagnosis of acute conjonctivitis. |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48442 |
Study title: A multicentre,randomised, controlled, parallel group study to compare efficacy and safety of Fucithalmic® with ofloxacin 0.3%. |
Active substance: FUSIDIC ACID |
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Document reference: 48444 |
Study title: A multicentre,randomised, open-label, parallel group study to compare efficacy and safety of Fucithalmic® with tobramycin 0.3%. |
Active substance: FUSIDIC ACID |
Study summary document link (including results): |
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Document reference: 48443 |
Study title: A single centre, randomised, single-blind, parallel group study to compare efficacy and safety of Fucithalmic® compared with chloramphenicol |
Active substance: FUSIDIC ACID |
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Document reference: 48448 |
Study title: An open label study to compare efficacy and safety of Fucithalmic® with chloramphenicol. |
Active substance: FUSIDIC ACID |
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Document reference: 48455 |
Study title: An open label study to compare efficacy and safety of Fucithalmic® with Fucidin® eye drop.J. Hvidberg |
Active substance: FUSIDIC ACID |
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Document reference: 48451 |
Study title: An open label, randomised study to compare efficacy and safety of Fucithalmic® with neosporin.Yacinto U Dy, Llacco, Int. J. of clinical practices, Vol 7., No. 3., 1991 |
Active substance: FUSIDIC ACID |
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Document reference: 48450 |
Study title: An open randomised study to compare efficacy and safety of Fucithalmic® with chloramphenicolPetounis AD. 4th Mediterranean congress of chemotherapy 1984 |
Active substance: FUSIDIC ACID |
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Document reference: 48458 |
Study title: An open randomised study to compare efficacy and safety of Fucithalmic® with neosporin.Yacinto U Dy, Llacco Int. J. of clinical practices, Vol 7., No. 3., 1991 82 pts (4-75) |
Active substance: FUSIDIC ACID |
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Document reference: 48461 |
Study title: Efficacy and safety of Fucithalmic® compared with chloramphenicolHørven I |
Active substance: FUSIDIC ACID |
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Document reference: 48460 |
Study title: Efficacy and tolerability of Fucidin® eye dropThanpaichitra |
Active substance: FUSIDIC ACID |
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Document reference: 48454 |
Study title: Gentamicin in paediatrics - McAllister TA. - 1974 (Postgraduate Med. J., 50, Suppl 7: 45-52) - Publication in Gentamicin Registration Dossier - 1978 - |
Active substance: GENTAMYCIN |
Study summary document link (including results): |
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Document reference: 28912 |
Study title: Double-blind, randomized, multi-centre, crossover, placebo-controlled pilot study OXC is indicated for use in treatment of partial seizures in adults and pediatric patients ≥6 years of age. This is a pilot study to assess its efficacy in outpatient children and adoloscents with behavioural disorders |
Active substance: OXACARBAZEPINE |
Study summary document link (including results): oxacarbazepine-TRI476BES04 Art45 Listing 2011.xls |
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Document reference: 45121 |
Study title: A pharmacokinetic study of oxatomide in paediatrics patients |
Active substance: OXATOMIDE |
Study summary document link (including results): |
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Document reference: 45384 |
Study title: Comparison of cetirizine and oxatomide in preschool children with perennial allergic rhinitis. A multicenter study. |
Active substance: OXATOMIDE |
Study summary document link (including results): |
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Document reference: 45380 |
Study title: Double-blind multicenter study on the efficacy and tolerability of cetirizine compared with oxatomide in chronic idiopathic urticaria in preschool children |
Active substance: OXATOMIDE |
Study summary document link (including results): |
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Document reference: 45382 |
Study title: Efficacy and safety of cetirizine and oxatomide in young children with perennial allergic rhinitis : a 10-day, multicenter, double-blinded, randomised, parallel-group study. |
Active substance: OXATOMIDE |
Study summary document link (including results): |
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Document reference: 45379 |
Study title: Oggiano N, Nicora M L'oxatomide nell'asma bronchiale. Rassegna dei principali dati farmacologici e clinici. |
Active substance: OXATOMIDE |
Study summary document link (including results): |
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Document reference: 45377 |
Study title: 8.) An open pilot clinical trial Woben- zym for imporvement of treatment results in resistant and complicated case of pulmonary tuberculo- sis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40100 |
Study title: 9.) Clinical efficacy of orally applied enzyme medicine Wobenzym in pa- tients with first time diagnosed diabetes mellitus |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40101 |
Study title: Efficacy and Safety of Woben- zym as Antidema- tous Therapy in Dentosurgical Operations |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40096 |
Study title: Efficacy and Safety of Woben- zym as Antidema- tous Therapy in Meniscectomies |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40097 |
Study title: Efficacy and Safety of Woben- zym/Wobenzym N in the post trau- matic treatment after sport injuries and surgery |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40099 |
Study title: Efficacy and Safety of Woben- zym/Wobenzym N in Patients with inflammatory diseases of the respiratory tract and Sinusitis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40098 |
Study title: Influence of therapy by Woben-zym on immune and metabolic parametrs at children with chronic hepatitis B |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40112 |
Study title: Oral Enzyme Therapy of Re- current Respiratory Infections in Children |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40093 |
Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310 |
Active substance: OXITRIPTAN |
Study summary document link (including results): |
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Document reference: 32949 |
Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310 |
Active substance: OXITRIPTAN |
Study summary document link (including results): |
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Document reference: 32955 |
Study title: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 102.pdf |
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Document reference: 47515 |
Study title: K.L.I.P.S. (ketoprofen lysine salt: an Italian pediatric study). Multicentre, randomised, double-blind clinical study aimed at assessing antiphlogistic, antipyretic and pain-killing efficacy of ketoprofen lysine salt suppositories in children suffering... |
Active substance: PARACETAMOL |
Study summary document link (including results): Paracetamol_U97-0250_synopsis.pdf |
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Document reference: 45775 |
Study title: Leary−P−M et al. Antipyretic effect of oral v. rectal paracetamol. {S−Afr−Med−J}, Dec 1997, vol. 87, no. 12, p. 1708Leary−P−M et al. Antipyretic effect of oral v. rectal paracetamol. {S−Afr−Med−J}, Dec 1997, vol. 87, no. 12, p. 1708 |
Active substance: PARACETAMOL |
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Document reference: 33354 |
Study title: Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676 |
Active substance: PARACETAMOL |
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Document reference: 45729 |
Study title: A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J, Mitchell T, Haigh C. Pediatr Hematol Oncol. 2000 Sep; 17(6):445-55.A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J... |
Active substance: ONDASETRON |
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Document reference: 32804 |
Study title: Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. |
Active substance: ONDASETRON |
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Document reference: 32807 |
Study title: Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703.Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703. |
Active substance: ONDASETRON |
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Document reference: 32805 |
Study title: Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79 |
Active substance: ONDASETRON |
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Document reference: 32806 |
Study title: Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17 |
Active substance: ONDASETRON |
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Document reference: 32808 |
Study title: Fucithalmic in acute conjunctivitis. Open, randomized comparison of fusidic acid, chloramphenicol and framycetin eye drops.Dirdal M. Acta Ophthalmol 1987; 65: 129-133. |
Active substance: FUSIDIC ACID |
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Document reference: 48456 |
Study title: The document describes a West German trial. 337 patients . 90 patients were under the age of 10, 63 patients aged 11-20. |
Active substance: FUSIDIC ACID |
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Document reference: 28676 |
Study title: The bronchodilator efficacy of Berotec tablets as measured after single doses (day 1) by comparison with the standard therapeutic agent (ephedrine) with particular emphasis on onset of action and duration of action. 2. The persistence of bronchodila... |
Active substance: IPRATROPIUM |
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Document reference: 30546 |
Study title: Wobenzym in the Treatment of Patients with Juvenile chronic Arthritis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
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Document reference: 40094 |
Study title: Clinical outcomes of treatment with oral pantoprazole in patients aged 5 to 11 years with symptomatic GERD ; safety and tolerability. Out patient,randomized, double-blind, parallel-group. |
Active substance: PANTOPRAZOLE |
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Document reference: 45720 |
Study title: Efficacy and tolerabilty in items of pHmetry of pantoprazole 20 mg (0,5-1,0 mg/kg/day) in pediatrics patients aged 6 to 16 years. |
Active substance: PANTOPRAZOLE |
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Document reference: 45721 |
Study title: Pharmacokinetics of a sigle oral dose of pantoprazole 20 mg or 40 mg in pediatric patients aged 5 to 16 years ; safety an tolarability. Open label, randomized, age-stratified, parallel-group study. |
Active substance: PANTOPRAZOLE |
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Document reference: 45722 |
Study title: PK of a single dose of intravenous pantoprazole in pediatric patients aged 2 to 16 years ; PD; safety and tolerability. Open label, randomized, age-stratified, parallel-groupe study. |
Active substance: PANTOPRAZOLE |
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Document reference: 45723 |
Study title: PK of pantoprazole in pediatrics patients at least 1 year but less than 2 yers of age ; safety and tolerabilty. Open-label, randomized, inpatient study. |
Active substance: PANTOPRAZOLE |
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Document reference: 45724 |
Study title: Safety and tolerabilty or oral pantoprazole in subjects aged 12 to 16 years with symptomatic GERD ; efficacy (treatment outcome). Outpatient, randomized; double-blind, parallel-treatment group study. |
Active substance: PANTOPRAZOLE |
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Document reference: 45725 |
Study title: A Blinded, Single-Dose, Parallel Study Comparing the Anitpyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever |
Active substance: PARACETAMOL |
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Document reference: 45783 |
Study title: Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477) |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33546 |
Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33555 |
Study title: The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6.The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6. |
Active substance: PARACETAMOL AND PHENYLPROPANOLAMINE AND PHENYLTOLOXAMINE |
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Document reference: 33616 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33645 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33647 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33649 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33650 |
Study title: Prophylactic Treatment with Wobenzym after Sport Injuries in Karate Fighters |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
Study summary document link (including results): |
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Document reference: 40095 |
Study title: Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p)Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p) |
Active substance: PARACETAMOL |
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Document reference: 45730 |
Study title: Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35 |
Active substance: PARACETAMOL |
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Document reference: 45731 |
Study title: Non-comparative, open-label, multicentre study of the acceptability and tolerability of 4.8% paediatric paracetamol oral suspension |
Active substance: PARACETAMOL |
Study summary document link (including results): PARACL00859.pdf |
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Document reference: 47081 |
Study title: Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84) |
Active substance: PARACETAMOL |
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Document reference: 45733 |
Study title: Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 25043 |
Study title: Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84) |
Active substance: PARACETAMOL |
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Document reference: 45735 |
Study title: Paracetamol for treating fever in children. {Cochrane Database Syst Rev}, 2002, no. 2 |
Active substance: PARACETAMOL |
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Document reference: 45801 |
Study title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Longterm Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD) |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-716-fullCSR.pdf |
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Document reference: 48346 |
Study title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Obsessive-Compulsive Disorder (OCD) |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-704-fullCSR.pdf |
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Document reference: 48344 |
Study title: A Randomized, Multicenter, 8-Week, Double-blind, Placebo-Controlled Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-701-fullCSR.pdf |
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Document reference: 48343 |
Study title: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trialW Voskuijl BMJ Gut 2004 |
Active substance: PEG 3350 |
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Document reference: 48370 |
Study title: Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51.Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51. |
Active substance: pegfilgrastim |
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Document reference: 41579 |
Study title: The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4.The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4. |
Active substance: ONDASETRON |
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Document reference: 32809 |
Study title: A Phase IV, Case-Matched, Cohort Surveillance Study in Preterm Children Who Receive SYNAGIS@ Prophylaxis in the First Year of Life Versus Preterm Children Without RSV Prophylaxis: Incidence of RSV Hospitalization and Assessment of Disease Severity in the Season Following Prophylaxis |
Active substance: palivizumab |
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Document reference: 41608 |
Study title: A pivotal Phase III study of MED-493, for the prophylaxis of severe RSV disease in premature infantsand infants with BPD |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp018.pdf |
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Document reference: 48099 |
Study title: A Study of the Safety, Tolerance, and Efficacy of Palivizumab (MEDI-493, Synagis®) for Prophylaxis of Respiratory Syncytial Virus in Children with Congenital Heart Disease |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp048.pdf |
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Document reference: 48105 |
Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Northern Hemisphere |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-w98-271-northern-hemisphere.pdf |
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Document reference: 48110 |
Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Southern Hemisphere |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-w98-271-southern-hemisphere.pdf |
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Document reference: 48111 |
Study title: Compassionate Use of MEDI-493, a Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Severe RSV Disease in Children With Lung Disease Who Are Intolerant to RespiGam® Infusions |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp041.pdf |
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Document reference: 48103 |
Study title: Evaluation of immunogenicity of IM MED-493 in children who previously received IM MED-493 prophylaxis and children receiving IM MED-493 for the first time |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp036.pdf |
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Document reference: 48102 |
Study title: Phase I/II Clinical Trials Investigation of Safety and Pharmacokinetics after Administration of MEDI-493 (Palivizumab) in Premature Infants and Pediatric Chronic Pulmonary Disease Patients |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-j-med-99-002.pdf |
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Document reference: 48090 |
Study title: Safety and Efficacy Study of Palivizumab in Children with Congenital Heart Disease (Phase III Clinical Trial) |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-m03-637.pdf |
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Document reference: 48091 |
Study title: Double-blind Pediatric Study to Assess the Safety, Pharmacokinetics and Efficacy of Single IV Doses of Palonosetron, 3.0 μg/kg or 10.0 μg/kg, in the Prevention of Chemotherapy- Induced Nausea and Vomiting |
Active substance: PALONOSETRON HYDROCHLORIDE |
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Document reference: 47743 |
Study title: J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K. J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44588 |
Study title: J Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martà V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, FlotatsJ Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martà V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, Flotats |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44590 |
Study title: J Am Coll Cardiol. 1998 Dec;32(7):1938-42. Exercise-induced abnormal blood pressure responses are related to subendocardial ischemia in hypertrophic cardiomyopathy. Yoshida N, Ikeda H, Wada T, Matsumoto A, Maki S, Muro A, Shibata A, Imaizumi T. J Am Coll Cardiol. 1998 Dec;32(7):1938-42. Exercise-induced abnormal blood pressure responses are related to subendocardial ischemia in hypertrophic cardiomyopathy. Yoshida N, Ikeda H, Wada T, Matsumoto A, Maki S, Muro A, Shibata A, Imaizumi T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44591 |
Study title: J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese] J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese] |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44593 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33653 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33654 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33655 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33656 |
Study title: A comparative study using a single dose of acetaminophen, acetaminophen/pseudoephedrine, pseudoephedrine alone, and placebo in dental pain. CSR 163. Protocol 91-123, Unpublished Report 289 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): paracetamol_pseudoephedrine 91-123.pdf |
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Document reference: 47415 |
Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7 |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33540 |
Study title: A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32 A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33632 |
Study title: Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 |
Active substance: PHENYLEPHRINE |
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Document reference: 45102 |
Study title: Randomized, double-blind, multicentre, comparative study of the efficacy and safety of VIBROCIL (without neomycin) gel vs. TRIOFAN gel in patients with acute rhinitis)Meran 1993 |
Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE |
Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Meran_1993.xls |
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Document reference: 48028 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33651 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33652 |
Study title: A multi-centre, open label study to assess the safety of 1% penciclovir cream in adolescent patients with recurrent herpes simplex labialis infection |
Active substance: PENCICLOVIR |
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Document reference: 45820 |
Study title: Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. |
Active substance: PENICILLAMINE |
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Document reference: 33839 |
Study title: Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590. Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590. |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33847 |
Study title: Comparison of cefuroxime axetil and phenoxymethyl penicillin for the treatment of children with solitary erythema migrans. Arnez M, Radsel-Medvescek A, Pleterski-Rigler D, Fuzic-Sablijic E, Strle F.Wien Klin Wochenschr (1999) 111/22-23: 916-922.Comparison of cefuroxime axetil and phenoxymethyl penicillin for the treatment of children with solitary erythema migrans. Arnez M, Radsel-Medvescek A, Pleterski-Rigler D, Fuzic-Sablijic E, Strle F.Wien Klin Wochenschr (1999) 111/22-23: 916-922. |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33841 |
Study title: A randomised,multicenter comparison of Curosurf and Survanta in the treatment of established neonatal rerspiratory distress syndrome |
Active substance: PHOSPHOLIPIDS |
Study summary document link (including results): |
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Document reference: 34043 |
Study title: Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) |
Active substance: PHOSPHOLIPIDS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 34045 |
Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study |
Active substance: Phosphor-Homaccord |
Study summary document link (including results): |
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Document reference: 40135 |
Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063) |
Active substance: PHYTOMENADION |
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Document reference: 34046 |
Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063) |
Active substance: PHYTOMENADION |
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Document reference: 34053 |
Study title: 13C02 breath test with 13C-labelled hiolein for the non-invasive determination of exocrine pancreatic function in healthy subjects and in patients with cystiC fibrosis: Efficacy assessment of pancreatic enzyme replacement in children with cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-629.pdf |
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Document reference: 47658 |
Study title: A Phase III Long-term Administration Study of SA-001 in the Treatment of Cystic Fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-3117.pdf |
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Document reference: 47668 |
Study title: A prospectively randomized, cross-over study to evaluate the acceptability of Creon® granules in sachets with Creon® 8000 capsules in the treatment of pancreatic insufficiency in cystic fibrosis patients |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-592.pdf |
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Document reference: 47657 |
Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6 |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33406 |
Study title: Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390)Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390) |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33383 |
Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7 |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33375 |
Study title: Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22 |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33385 |
Study title: Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75.Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75. |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33628 |
Study title: Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4 |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33361 |
Study title: Etude d'efficacité et tolérance biologique ouverte multicentrique 320 patients dont 31 de 15 ans et moins |
Active substance: TRETINOIN |
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Document reference: 46731 |
Study title: Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris" Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris" |
Active substance: TRETINOIN |
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Document reference: 46732 |
Study title: Tretinoin gel microspheres 0,04% versus 0,1% in adolescents and adults with mild to moderate acne vulgaris: a 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial. Berger R, Rizer R, Barba A, Wilson D, Stewart D, Grossman R, Nighland M, Weiss J. Clin Ther. 2007 jun; 29(6): 1086-97 "This study was conducted to assess the efficacy and safety profile of a lower-dose TGM (0,04%) formulation compared with TGM 0,1% for the treatment of mild to moderate acne vulgaris. Patients ranged in age from 12 to 41 years" Tretinoin gel microspheres 0,04% versus 0,1% in adolescents and adults with mild to moderate acne vulgaris: a 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial. Berger R, Rizer R, Barba A, Wilson D, Stewart D, Grossman R, Nighla... |
Active substance: TRETINOIN |
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Document reference: 46733 |
Study title: A Phase III multicenter, open-label, long term safety study of Triamcinolone acetonide forte HFA-134a oral inhaler treatment in moderate to severe asthmatic children, involving 250 patients - No author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46822 |
Study title: Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44697 |
Study title: Rev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, Verdú Rico J, Alcalá Santaella R, MRev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, Verdú Rico J, Alcalá Santaella R, M |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44698 |
Study title: Tolerability and efficacy of VIBROCIL paediatric drops: multicentric, open trial, in children aged between 1 and 6 years, suffering from nasal congestionVerhegge 1994 |
Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE |
Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Verhegge_1994.xls |
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Document reference: 48029 |
Study title: Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58 |
Active substance: PHENYLEPHRINE |
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Document reference: 33939 |
Study title: Oxatomide in children with allergic rhinoconjuctivitis. Comparison of two different dosage schemes. |
Active substance: OXATOMIDE |
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Document reference: 45378 |
Study title: Clinical study of Adumbran" syrup of Boehringer Ingelheim (generic name "oxazepam")." |
Active substance: OXAZEPAM |
Study summary document link (including results): Oxazepam_U76-0287_SYNOPSIS.pdf |
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Document reference: 45387 |
Study title: Final report on the study of the product Z 10-TR at the university eye hospital in Mainz. |
Active substance: OXAZEPAM |
Study summary document link (including results): Oxazepam_U64-0066_SYNOPSIS.pdf |
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Document reference: 45388 |
Study title: Investigations into the effect of Adumbran suppositories in children |
Active substance: OXAZEPAM |
Study summary document link (including results): Oxazepam_U70-0340_SYNOPSIS.pdf |
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Document reference: 45389 |
Study title: Report on the experience with the use of Adumbran. |
Active substance: OXAZEPAM |
Study summary document link (including results): Oxazepam_U70-0342_SYNOPSIS.pdf |
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Document reference: 45386 |
Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063) |
Active substance: PHYTOMENADION |
Study summary document link (including results): |
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Document reference: 34055 |
Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063) |
Active substance: PHYTOMENADION |
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Document reference: 34068 |
Study title: Bioavailability of Konakino MM, Ro 01-6722/130, oral and parenteral in mature neonates at birth (>2000g) and the evolution of vitamin K1 plasma level in breastfed babies |
Active substance: PHYTOMENADION |
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Document reference: 34059 |
Study title: Comparative bioavailability and kinetics of Konakion MM: Ro 01-6722/122, oral and parenteral in infants suffering from chronic cholestasis |
Active substance: PHYTOMENADION |
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Document reference: 34057 |
Study title: Comparative tolerability and efficacy study: vitamin K1 mixed micelles solution versus vitamin K1 solution containing Cremophor EL both administered in a single dose i.m. to babies suffering from chronic cholestasis |
Active substance: PHYTOMENADION |
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Document reference: 34063 |
Study title: Comparative tolerability of Ro 01-6722/120 (Konakion MM) and Ro 01-6722/092 (Konakion commercial form with Cremophor) 5 mg/0.5 ml i.m. in healthy new-born and premature babies. |
Active substance: PHYTOMENADION |
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Document reference: 34064 |
Study title: Efficacy and tolerability of Konakion MM Ro 01-6722/135, 1mg vitamin K1 i.v. and 2mg vitamin K1 p.o. in the prophylactic treatment against hemorrhagic disease in premature infants |
Active substance: PHYTOMENADION |
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Document reference: 34065 |
Study title: Final Study Report: A Comparison of the effect of Oral Viatamin K1 (Ro-6722/139) and intramuscular vitamin K(Konakion tween 80 Ro 01-6722/143) in exclusively breast-fed neonates on PIVKA II plasma concentrations and prothrombin time. |
Active substance: PHYTOMENADION |
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Document reference: 34047 |
Study title: Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - |
Active substance: OXITRIPTAN |
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Document reference: 32919 |
Study title: Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - |
Active substance: OXITRIPTAN |
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Document reference: 32929 |
Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33391 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33605 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33591 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45891 |
Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45872 |
Study title: Rev Esp Med Nucl. 1999 Jun;18(3):197-203. [Thallium-201 uptake in lung and heart with different types of stress. Study in healthy volunteers] [Article in Spanish] Maceira AM, Cabrera A, Albaladejo VJ, GarcÃa Velloso MJ, Richter JA, Coma-Canella I. Rev Esp Med Nucl. 1999 Jun;18(3):197-203. [Thallium-201 uptake in lung and heart with different types of stress. Study in healthy volunteers] [Article in Spanish] Maceira AM, Cabrera A, Albaladejo VJ, GarcÃa Velloso MJ, Richter JA, Coma-Canella I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44699 |
Study title: Rev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, Gómez Rio M, RodrÃguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos FonRev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, Gómez Rio M, RodrÃguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos Fon |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44700 |
Study title: Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44701 |
Study title: South Med J. 1986 Nov;79(11):1337-8. Preoperative localization of parathyroid adenomas using thallium-technetium subtraction scintigraphy. Gordon L, Carr D. South Med J. 1986 Nov;79(11):1337-8. Preoperative localization of parathyroid adenomas using thallium-technetium subtraction scintigraphy. Gordon L, Carr D. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44705 |
Study title: A double-blind comparative trial of Tizanidine and diazepam in the treatment of chronic spasticity in patients with hemiplegia |
Active substance: TIZANIDINE |
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Document reference: 44783 |
Study title: A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8 |
Active substance: TIZANIDINE |
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Document reference: 38513 |
Study title: A multicenter, double-blind, randomised, placebo-controlled study to assess the efficacy and tolerability of Tizanidine tablets in patients suffering from spasticity resulting from spinal cord injury |
Active substance: TIZANIDINE |
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Document reference: 44780 |
Study title: Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - |
Active substance: OXITRIPTAN |
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Document reference: 32927 |
Study title: Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611 |
Active substance: OXITRIPTAN |
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Document reference: 32938 |
Study title: A Blinded, Single-Dose, Parallel Study Comparing the Antipyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever |
Active substance: PARACETAMOL |
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Document reference: 45784 |
Study title: A clinical trial comparing the safety and efficacy of aspirin 800mg with caffeine 64mg with that of acetaminophen 1000mg in the treatment of acute musculoskeletal injury |
Active substance: PARACETAMOL |
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Document reference: 45787 |
Study title: A clinical trial comparing the safety and efficacy of aspirin 800mg with caffeine 64mg with that of acetaminophen 1000mg in the treatment of acute musculoskeletal injury |
Active substance: PARACETAMOL |
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Document reference: 45794 |
Study title: A Combined Analysis of the Data Provided by Drs. J. Hopkinson, W. Bare, and R. Posatko's Tylenol 500 (Acetaminophen) Studies. Unpublished Report TA8A2, Nov 1972 and Teal TW. Dr. John Hopkinson's Tylenol 500 (Acetaminophen) Study. Unpublished Report TA8A3. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol TA8A2 and TA8A3.pdf |
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Document reference: 47518 |
Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children. |
Active substance: PARACETAMOL |
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Document reference: 45791 |
Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children. |
Active substance: PARACETAMOL |
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Document reference: 45797 |
Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil Suspension (10 mg/kg), acetaminophen (15 mg/kg), and a vehicle control in the relief of sore throat pain in children |
Active substance: PARACETAMOL |
Study summary document link (including results): Ibuprofen-WM-375A.pdf |
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Document reference: 45790 |
Study title: A Double-Blind Study of PARAFON FORTE, Acetaminophen, PARAFLEX, and Placebo in Outpatients Following Surgical Removal of Impacted Third Molars. Protocol ASD, Unpublished Report SR-199-02. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol ASD.pdf |
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Document reference: 47516 |
Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82 |
Active substance: OXITRIPTAN |
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Document reference: 32950 |
Study title: Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - |
Active substance: OXITRIPTAN |
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Document reference: 32920 |
Study title: Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246 |
Active substance: OXITRIPTAN |
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Document reference: 32951 |
Study title: Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647 |
Active substance: OXITRIPTAN |
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Document reference: 32956 |
Study title: Expertise clinique du produit C1491 oxolamine phosphate sirop adulte -prilon- |
Active substance: OXOLAMINE AND PROPYLPHENAZONE |
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Document reference: 32971 |
Study title: Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3 |
Active substance: PARACETAMOL |
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Document reference: 45737 |
Study title: Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold FormulaPhase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula |
Active substance: PARACETAMOL |
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Document reference: 45739 |
Study title: Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993 |
Active substance: PARACETAMOL |
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Document reference: 45740 |
Study title: Résultats et accidents de la prophylaxie par la pénicilline - Dagonet (Y.) & Gautier (M.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 417 - 434)Résultats et accidents de la prophylaxie par la pénicilline - Dagonet (Y.) & Gautier (M.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 417 - 434) |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45883 |
Study title: Streptococcal infection in pediatric patients. Comparison of dicloxacillin with phenoxymethyl penicillin - Aronovitz (G. H.), Morgan (D. L.) & Spitzer (T. Q.) - 1968 (Amer. J. Dis. Child., 116, 66-69, July).Streptococcal infection in pediatric patients. Comparison of dicloxacillin with phenoxymethyl penicillin - Aronovitz (G. H.), Morgan (D. L.) & Spitzer (T. Q.) - 1968 (Amer. J. Dis. Child., 116, 66-69, July). |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45884 |
Study title: Table ronde sur l'infection streptococcique - Mozziconacci (P.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 381 - 388)Table ronde sur l'infection streptococcique - Mozziconacci (P.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 381 - 388) |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45885 |
Study title: A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals’ two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age). |
Active substance: oral live attenuated human rotavirus |
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Document reference: 45713 |
Study title: Oraalinen rehydraatio hypotonisella ja isotonisella liuoksella ja Lactobacillus GG-bakteeri akuutin ripulitaudin hoidossa |
Active substance: ORAL REHYDRATION SALT FORMULATIONS |
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Document reference: 32811 |
Study title: Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990)Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990) |
Active substance: ORAL REHYDRATION SALT FORMULATIONS |
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Document reference: 32810 |
Study title: Comparison of the effect of Alupent 20 mg and placebo when given as syrup (2 teaspoonsful) and tablet (one tablet) by pulmonary function tests in asthmatic children. |
Active substance: ORCIPRENALINE |
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Document reference: 45363 |
Study title: Comparative double-blind trial between DS 103-282 and baclofen in the treatment of spasticity doe to cerebal palsy |
Active substance: TIZANIDINE |
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Document reference: 44781 |
Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60 |
Active substance: TIZANIDINE |
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Document reference: 38508 |
Study title: Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51. |
Active substance: TIZANIDINE |
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Document reference: 38512 |
Study title: Treatments for spasticity and pain in multiple sclerosis: a systematic review.Beard S, Hunn A, Wight J. Health technology assessment (Winchester England), {Health−Technol− Assess}, 2003, vol. 7, no. 40, p. iii, ix−x, 1−111Treatments for spasticity and pain in multiple sclerosis: a systematic review.Beard S, Hunn A, Wight J. Health technology assessment (Winchester England), {Health−Technol− Assess}, 2003, vol. 7, no. 40, p. iii, ix−x, 1−111 |
Active substance: TIZANIDINE |
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Document reference: 38509 |
Study title: A controlled, double-blind, clinical therapeutic, comparative study with two parallel groupd (DS 103-282 and diazepam) in ambulant/hospitalised patients with multiple sclerosis |
Active substance: TIZANIDINE |
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Document reference: 44782 |
Study title: 19. Antiepilepsy drug effectiveness in pediatric partial epilepsy. |
Active substance: TOPIRAMATE |
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Document reference: 44953 |
Study title: 2. A double-blind trial comparing the efficacy, tolerability and safety of monotherapy topiramate versus phenytoin in subjects with seizures indicative of new onset epilepsy. |
Active substance: TOPIRAMATE |
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Document reference: 44936 |
Study title: A double-blind, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-223.pdf |
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Document reference: 47505 |
Study title: A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 2000 mg, 1500 mg, 1000 mg, 500 mg, and placebo in the treatment of pain following oral or periodontal surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 1-221.pdf |
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Document reference: 47507 |
Study title: A double-blind, single-dose comparison of Advil 400 vs. APAP 1000 vs. placebo in the relief of post operative oral surgery pain |
Active substance: PARACETAMOL |
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Document reference: 45785 |
Study title: A double-blind, single-dose comparison of Advil 400 vs. APAP 1000 vs. placebo in the relief of post operative oral surgery pain |
Active substance: PARACETAMOL |
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Document reference: 45793 |
Study title: A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-214.pdf |
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Document reference: 47504 |
Study title: A multi-clinic report on the relative effectiveness of PARAFON FORTE® tablets, PARAFLEX® chlorzoxazone tablets, TYLENOL® acetaminophen tablets, and placebo as prescribed for the relief of pain associated with skeletal muscle spasms of the lower back. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol S and SIS 149-3-01.pdf |
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Document reference: 47517 |
Study title: Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22 Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33657 |
Study title: Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double blind study. {CLIN PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313 324) Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double blind study. {CLIN PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313 324) |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33658 |
Study title: Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870) Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870) |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33659 |
Study title: Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32.Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33643 |
Study title: Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5 Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33631 |
Study title: Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3 |
Active substance: PARACETAMOL |
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Document reference: 45741 |
Study title: Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 |
Active substance: PARACETAMOL |
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Document reference: 45743 |
Study title: Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72 |
Active substance: PARACETAMOL |
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Document reference: 45744 |
Study title: Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202.Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202. |
Active substance: PARACETAMOL |
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Document reference: 45745 |
Study title: Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556) |
Active substance: PARACETAMOL |
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Document reference: 45746 |
Study title: Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5 |
Active substance: PARACETAMOL |
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Document reference: 45747 |
Study title: Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985 |
Active substance: PARACETAMOL |
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Document reference: 45748 |
Study title: Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66. Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66. |
Active substance: PENICILLAMINE |
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Document reference: 33842 |
Study title: Study to compare Alupent syrup with Quadrinal and Brondecon: serial pulmonary function studies to be the criteria after single doses of each. |
Active substance: ORCIPRENALINE |
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Document reference: 45358 |
Study title: Study to compare the duration of action of Alupent syrup, Quadrinal, and Brondecon. |
Active substance: ORCIPRENALINE |
Study summary document link (including results): Orciprenaline sulphate_U66-0252_synopsis.pdf |
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Document reference: 45357 |
Study title: Study to compare the effect of two teaspoons of Alupent syrup with one 20 mg Alupent tablet, and with placebo. |
Active substance: ORCIPRENALINE |
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Document reference: 45360 |
Study title: AComparison of the Efficacy and Safety of CREON®20 and Placebo in the Treatment of Steatorrhea in Adult Cystic Fibrosis Patients with Clinical Exocrine Pancreatic Insufficiency |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S223-3102.pdf |
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Document reference: 47665 |
Study title: AComparison of the Efficacy and Safety ofCREON®20 and Placebo in the Treatment of Steatorrhea in Pediatric and Adolescent Cystic Fibrosis Patients with Clinical Exocrine Pancreatic Insufficiency |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S223-3101.pdf |
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Document reference: 47664 |
Study title: An open, multicenter, long-term study to assess the efficacy and tolerance of Kreon® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis in comparison with a historical control group of healthy children. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-584.pdf |
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Document reference: 47656 |
Study title: Clinical Trial of High Lipase Pancreatic Enzyme Supplementation in Cystic Fibrosis: Evaluation of Creon® 25 000 |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K224-5006.pdf |
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Document reference: 47654 |
Study title: Creon 8000 vs Creon 25: An Open Label Comparative Study |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-223-8-01.pdf |
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Document reference: 47652 |
Study title: General efficacy and patient acceptance of Alupent Syrup. |
Active substance: ORCIPRENALINE |
Study summary document link (including results): Orciprenaline sulphate_U70-0089_synopsis.pdf |
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Document reference: 45362 |
Study title: Double-blind, double-placebo controlled study comparing Creon® with Pancrex V Forte® tablets in the management of children with cystic fibrosis. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREON-8402.pdf |
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Document reference: 47661 |
Study title: Double-blind, multicenter, crossover study comparing the efficacy and tolerance of Creon® 25 000 versus Panzytrat® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K224-5001.pdf |
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Document reference: 47653 |
Study title: Double-blind, multicenter, randomized, crossover study to prove equivalent efficacy of Creon® 10 000 minimicrospheresTM and Creon® 8 000 microspheres in patients with pancreatic exocrine insufficiency caused by cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K245-5004.pdf |
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Document reference: 45110 |
Study title: 2. Topamax (topiramate) monotherapy comparison trial to standard monotherapy in the treatment of newly diagnosed epilepsy (rwj-17021-000); phase IIIb |
Active substance: TOPIRAMATE |
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Document reference: 44835 |
Study title: 20. Low dose topiramate monotherapy substitution trial in young epilepsy patients failing first conventional anticonvulsant. |
Active substance: TOPIRAMATE |
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Document reference: 44954 |
Study title: 23. Double blind trial for partial onset seizures efficacy. |
Active substance: TOPIRAMATE |
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Document reference: 44957 |
Study title: 25. Open-label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or mentally handicapped patients aged 14 or older. |
Active substance: TOPIRAMATE |
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Document reference: 44959 |
Study title: 26. Infantile spasms with hypsarrhythmia. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44960 |
Study title: 27. Compassionate use of Topamax. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44961 |
Study title: 28. Retrospective chart review of patients diagnosed with infantile spasms and hypsarrythmia. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44962 |
Study title: 29. A retrospective chart review of infants with infantile spasm of which some were treated with Topamax. |
Active substance: TOPIRAMATE |
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Document reference: 44963 |
Study title: 32. Safety and Efficacy of Topamax in Monotherapy or Combined Therapy in Children & Adult Patients with Epilepsy, in an Observational Study with Medium Duration of 8 Months. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44966 |
Study title: 33. Study of the optimization of anti-epileptic treatment in paediatric patients. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44967 |
Study title: 36. Topamax 1st line add on |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44880 |
Study title: 36. Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy (patients > 2 years)). |
Active substance: TOPIRAMATE |
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Document reference: 44970 |
Study title: Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33634 |
Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33641 |
Study title: Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33637 |
Study title: Efficacy of Sinubid (Sinutab® SA) in children. Research Report 932-0040. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): paracetamol_pseudoephedrine RR932-0040.pdf |
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Document reference: 47416 |
Study title: Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33959 |
Study title: Effect of pseudoephedrine on nasal airflow in patients with nasal congestion associated with common cold. Rhinology 1998; 36(2):73-6 Effect of pseudoephedrine on nasal airflow in patients with nasal congestion associated with common cold. Rhinology 1998; 36(2):73-6 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33635 |
Study title: Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33843 |
Study title: Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85. Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85. |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33846 |
Study title: Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35. Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35. |
Active substance: PENICILLAMINE |
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Document reference: 33840 |
Study title: Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33849 |
Study title: Roelofs, R. I., de Arango, G. S., Law, P. K., Kinsman, D., Buchanan, D. C., and Park, J. H. Treatment of Duchenne's muscular dystrophy with penicillamine. Results of a double-blind trial Arch.Neurol. 1979;36:266-268. Roelofs, R. I., de Arango, G. S., Law, P. K., Kinsman, D., Buchanan, D. C., and Park, J. H. Treatment of Duchenne's muscular dystrophy with penicillamine. Results of a double-blind trial Arch.Neurol. 1979;36:266-268. |
Active substance: PENICILLAMINE |
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Document reference: 33845 |
Study title: Final Study Report: Bioavailability of three Vitamin K1 preparations (cremophore /119, mixed micelles /131, mixed micelles /141) relative to Tween 80/143 formulation (M10400/BK14677) |
Active substance: PHYTOMENADION |
Study summary document link (including results): |
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Document reference: 34049 |
Study title: Final Study report: Influence of intravenous, Intramuscular and oral administration of Konakion MM Paediatric on Bilirubin Binding to albumin in Full-Term Neonates (BK15055) |
Active substance: PHYTOMENADION |
Study summary document link (including results): |
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Document reference: 34048 |
Study title: Double-blind, placebo-controlled, randomized, multicenter, crossover study to investigate Whether the dose~dependent effect of Creon· MinimicrospheresTN on the postprandial fat assimilation can be shown with the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-4004.pdf |
View full study record |
Document reference: 47670 |
Study title: Double-blind, randomized, cross-over study comparing the efficacy and tolerance of Creon® and Pancrease® in children and young adults with cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREON-586.pdf |
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Document reference: 47660 |
Study title: Double~blind, bicenter, randomized, crossover study to prove equivalent efficacy and tolerance of Creon® 25 000 Minimicrospheres™ versus Creon® 25 000 Microspheres (Pankreon® forte) in patients with pancreatic exocrine insufficiency caused by cystic fibrosis. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S248-3002.pdf |
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Document reference: 47672 |
Study title: George DE, Toskes PP, Sitren HS, Downey ::..r. Comparison of two pancreatic enzyme supplements in patients with cystic fibrosis. Adv Therapy 1990;7:109-118. (RR.1044-01). |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-RR1044-01.pdf |
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Document reference: 47663 |
Study title: "OPEN LABEL. MULTICENTER, CROSSOVER STUDY TO DEMONSTRATE THE PATIENTS'PREFERENCE OF CREON 8000 OVER PANCREASE IN TilE TREATMENT OF PANCREATIC EXOCRINE INSUFFICIENCY INDUCED BY CYSTIC FIBROSIS |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-636.pdf |
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Document reference: 47659 |
Study title: Open single-center study to investigate the pharmacodynamics of Creon® 25 000 minimicrospheres measured by 13C.triglyceride breath test and gastric emptying measured by 13C_octanoate breath test in cystic fibrosis patients using healthy children not receiving Creon® 25 000 minimicrospheres as controls |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S248-2001.pdf |
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Document reference: 47671 |
Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33606 |
Study title: A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33613 |
Study title: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33608 |
Study title: A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33607 |
Study title: A randomize, multicenter, double-blind, placebo-controlled, parallel group study of the 12 month effect of treatment with once daily triamcinolone acetonide (NASACORT® AQ Nasal Spray 110 µg or NASACORT® HFA Nasal Aerosol 220 µg) on the growth velocity of children, 2 to 8 years of age, with perennial allergic rhinitis (PAR) - No author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46821 |
Study title: A randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of Nasacort AQ 110 μg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 1.pdf |
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Document reference: 46825 |
Study title: A randomized, placebo-controlled, parallel-group, multiple dose study of RG 5029Y on Hypotalamic-pituitary-Adrenal (HPA) function and pharmacokinetic profile in pediatric patients with allergic rhinitis - Rom D - 22/12/1995 - Report in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 - |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 4.pdf |
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Document reference: 46826 |
Study title: A single-center, double-blind, placebo-controlled, randomized study to determine the time of onset of sustained relief after the first dose of NASACORT® AQ (TAA 220 µg) in symptomatic patients with allergic rhinitis - Pedersen M - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46827 |
Study title: An open-label long term study of the safety of Nasacort 134a Nasal Inhaler in patients with perennial allergic rhinitis - Simpson BE - 15/11/1996 |
Active substance: TRIAMCINOLONE |
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Document reference: 46828 |
Study title: An open-label, long-term study of WHR 5029 NasacortTM) in patients with perennial rhinitis - No Author - No date - Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 - |
Active substance: TRIAMCINOLONE |
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Document reference: 46829 |
Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 2.pdf |
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Document reference: 46830 |
Study title: Controlled clinical study comparing the efficacy of twice daily applications of westcort (hydrocortisone valerate) cream 0,2% and Kenalog (triamcinolonacetonide) cream 0,1% in the treatment of children with atopic dermatitis. |
Active substance: TRIAMCINOLONE |
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Document reference: 46820 |
Study title: A Phase III multicenter, parallel group, randomized, open study of Triamcinolone acetonide HFA 75µg oral inhaler, compared to Beclomethasone dipropionate in mild symptomatic to moderate asthmatic children, involving 280 patients - No author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46823 |
Study title: Nasacort® (triamcinolone acetonide nasal aerosol) vs Claritin® (loratadine) in patients with seasonal ragweed allergic rhinitis - No Author - 22/04/1994 - Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/199 - |
Active substance: TRIAMCINOLONE |
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Document reference: 46831 |
Study title: Phase III, Single Center, Randomized, Cross-Over Pediatric Trial With Nasacort AQ Nasal Spray Assessing Short Term Growth In Patients With Allergic Rhinitis |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 5.pdf |
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Document reference: 47347 |
Study title: Surgery. 1984 Dec;96(6):1078-82. Preliminary results of thallium 201 and technetium 99m subtraction scanning of parathyroid glands. Wheeler MH, Harrison BJ, French AP, Leach KG. Surgery. 1984 Dec;96(6):1078-82. Preliminary results of thallium 201 and technetium 99m subtraction scanning of parathyroid glands. Wheeler MH, Harrison BJ, French AP, Leach KG. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44707 |
Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstractEfficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33956 |
Study title: Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33955 |
Study title: Five medium term double blind controlled trials in children comparing Ditropan with placeboFive medium term double blind controlled trials in children comparing Ditropan with placebo |
Active substance: OXITRIPTAN |
Study summary document link (including results): |
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Document reference: 32921 |
Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132 |
Active substance: OXITRIPTAN |
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Document reference: 32960 |
Study title: Randomized comparative trial to evaluate efficacy and tolerability of Konakion MM, Ro 01-6722/135, Konakion drops Ro 01-6722/119 intramuscularly in the prophylaxis of hemorrhagic disease in newbord, breastfed infants |
Active substance: PHYTOMENADION |
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Document reference: 34062 |
Study title: Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319 |
Active substance: PIDOTIMOD |
Study summary document link (including results): Aivazis_2002_pidotimod.pdf |
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Document reference: 34077 |
Study title: Arzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli LArzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli L |
Active substance: PIDOTIMOD |
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Document reference: 34076 |
Study title: Studio clinico dell'Uniplus. Rapporto sperimentale |
Active substance: OXOLAMINE AND PROPYLPHENAZONE |
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Document reference: 32972 |
Study title: A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
View full study record |
Document reference: 33614 |
Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
Study summary document link (including results): |
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Document reference: 33610 |
Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33609 |
Study title: Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132)Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132) |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45886 |
Study title: Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432. |
Active substance: PHENTOLAMINE |
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Document reference: 33929 |
Study title: Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197. Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197. |
Active substance: PHENTOLAMINE |
Study summary document link (including results): |
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Document reference: 33928 |
Study title: Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20.Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20. |
Active substance: PHENYLEPHRINE |
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Document reference: 33942 |
Study title: Thyroid. 2006 Dec;16(12):1243-9. Characterization of follicular thyroid nodules at fine needle aspiration biopsy using double phase thallium-201 imaging: comparison of visual and semiquantitative analyses. Kim SJ, Kim IJ, Kang YH, Kim YK. Thyroid. 2006 Dec;16(12):1243-9. Characterization of follicular thyroid nodules at fine needle aspiration biopsy using double phase thallium-201 imaging: comparison of visual and semiquantitative analyses. Kim SJ, Kim IJ, Kang YH, Kim YK. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44709 |
Study title: Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M. Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44711 |
Study title: Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T. Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44706 |
Study title: Clinical and microbiological study comparing CILOXAN Ophthalmic Solution to TOBREX Ophthalmic Solution for treating bacterial conjunctivitis in children (C9174), |
Active substance: TOBRAMYCIN |
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Document reference: 44817 |
Study title: Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604. |
Active substance: OXITRIPTAN |
Study summary document link (including results): |
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Document reference: 32943 |
Study title: A phase III multiple dose use study of APAP extended release pediatric chewable tablets compared to Children’s Tylenol® chewable tablets in the treatment of febrile children. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 93-341.pdf |
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Document reference: 47511 |
Study title: A phase III multiple dose use study of APAP extended release pediatric suspension compared to Children’s Tylenol® elixir in the treatment of febrile children. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 94-406.pdf |
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Document reference: 47512 |
Study title: A Randomized, Double-Blind, Double-Dummy, Single-Center Pilot Study of the Speed of Onset of Analgesia of Extra Strength TylenolÒ Adult Liquid (1000 mg) Compared with Extra Strength Tylenol® Caplet (1000 mg) in Post-Operative Dental Pain |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 98-046.pdf |
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Document reference: 47514 |
Study title: A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994.A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994. |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 33437 |
Study title: A Single-Dose, Double-Blind, Placebo-Controlled Study of the Relative Efficacy and Safety of Acetaminophen at Doses of 500 mg and 1000 mg in Postoperative Dental Pain |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 02-156.pdf |
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Document reference: 47508 |
Study title: Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery. Morton NS, Benham SW, Lawson RA, McNicol LR. Paediatr Anaesth. 1997;7(3):221-6.Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery. Morton NS, Benham SW, Lawson RA, McNicol LR. Paediatr Anaesth. 1997;7(3):221-6. |
Active substance: OXYBUPROCAINE |
Study summary document link (including results): Diclofenac vs oxybuprocaine eyedrops for analgesia.pdf |
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Document reference: 45105 |
Study title: "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -" "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -" |
Active substance: OXYBUTYNIN |
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Document reference: 32981 |
Study title: "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - " "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - " |
Active substance: OXYBUTYNIN |
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Document reference: 32982 |
Study title: Five medium term double blind controlled trials in children comparing Ditropan with placebo Five medium term double blind controlled trials in children comparing Ditropan with placebo |
Active substance: OXYBUTYNIN |
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Document reference: 32994 |
Study title: Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4 |
Active substance: PARACETAMOL |
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Document reference: 45749 |
Study title: Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11 |
Active substance: PARACETAMOL |
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Document reference: 45750 |
Study title: Alonso EM, Piper JB, Echols G, Thistlethwaite JR, Whitington PF . (1996) . Allograft rejection in pediatric recipients of living related liver transplants . Hepatology 23 :40-43Alonso EM, Piper JB, Echols G, Thistlethwaite JR, Whitington PF . (1996) . Allograft rejection in pediatric recipients of living related liver transplants . Hepatology 23 :40-43 |
Active substance: PHENYLEPHRINE |
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Document reference: 33944 |
Study title: Study to investigate the efficacy, side effects and possible development of tolerance associated with the use of Alupent syrup in asthmatic children, as compared with syrup of ephedrine. Effects of single doses of either medication on pulmonary function |
Active substance: ORCIPRENALINE |
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Document reference: 45361 |
Study title: Comparative evaluation of intravenous and oral ornidazole vs. clindamycin in acute infections due to anaerobic bacteria. |
Active substance: ORNIDAZOLE |
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Document reference: 45375 |
Study title: Multiple i.v. dose pharmacokinetics of ornidazole (TIBERAL) in neonates |
Active substance: ORNIDAZOLE |
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Document reference: 45373 |
Study title: Prospective, non-comparative, one center study, evaluating the efficacy and safety of the combination of 2g ceftriaxone plus 1g ornidazole administered as a short intravenous infusion once daily in the treatment of severe chorioamnionitis. |
Active substance: ORNIDAZOLE |
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Document reference: 45374 |
Study title: Short term treatment of symptomatic and asymptomatic giardisis with ordinazole (Ro-07-0207). Comparaison of the efficacy of a single dose given once or for 2 or 3 consecutive days |
Active substance: ORNIDAZOLE |
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Document reference: 45376 |
Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication] |
Active substance: Traumeel - Ampullen |
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Document reference: 40282 |
Study title: Oberbaum, M et al.: A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer 2001;92(3):684-690 [IIT-publication] |
Active substance: Traumeel - Ampullen |
Study summary document link (including results): |
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Document reference: 40281 |
Study title: Volosovetz A.P. et al: Efficience of antihomotoxic Traumeel S preparation applied in the form of intravenous injection in the combined intensive therapy of newborns suffering from brain hypoxia-ischemia. Biological Therapy (Ukraine), 2004, 2: 24-28 [IIT-publication] |
Active substance: Traumeel - Ampullen |
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Document reference: 40286 |
Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication] |
Active substance: Traumeel S |
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Document reference: 40270 |
Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication |
Active substance: Traumeel S |
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Document reference: 40269 |
Study title: Oberbaum, M et al.: A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer 2001;92(3):684-690 [IIT-publication] |
Active substance: Traumeel S |
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Document reference: 40268 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of tendopathy with Traumeel S (ointment) [AWB-146]; |
Active substance: Traumeel S |
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Document reference: 40275 |
Study title: Volosovetz A.P. et al: Efficience of antihomotoxic Traumeel S preparation applied in the form of intravenous injection in the combined intensive therapy of newborns suffering from brain hypoxia-ischemia. Biological Therapy (Ukraine), 2004, 2: 24-28 [IIT- |
Active substance: Traumeel S |
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Document reference: 40271 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31487 |
Study title: |
Active substance: TIAGABINE |
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Document reference: 38489 |
Study title: |
Active substance: TIAGABINE |
Study summary document link (including results): |
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Document reference: 38490 |
Study title: |
Active substance: TIAGABINE |
Study summary document link (including results): |
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Document reference: 38493 |
Study title: |
Active substance: TIAGABINE |
Study summary document link (including results): |
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Document reference: 38494 |
Study title: |
Active substance: TIAGABINE |
Study summary document link (including results): |
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Document reference: 38495 |
Study title: Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D. Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44495 |
Study title: Am Heart J. 1986 Apr;111(4):760-7. Resting thallium-201 myocardial perfusion patterns in patients with severe left ventricular dysfunction: differences between patients with primary cardiomyopathy, chronic coronary artery disease, or acute myocardial infAm Heart J. 1986 Apr;111(4):760-7. Resting thallium-201 myocardial perfusion patterns in patients with severe left ventricular dysfunction: differences between patients with primary cardiomyopathy, chronic coronary artery disease, or acute myocardial inf |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44496 |
Study title: Kaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, SoKaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, So |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44639 |
Study title: Kaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, TaKaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, Ta |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44640 |
Study title: Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I. Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44641 |
Study title: Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44642 |
Study title: Kaku Igaku. 1987 Feb;24(2):177-80. [Quantitative estimation of right ventricular pressure overloading by Tl-201 myocardial SPECT] [Article in Japanese] Kunieda E, Ogawa K, Nishiguchi I, Kubo A, Hashimoto S, Iwanaga S, Handa S. Kaku Igaku. 1987 Feb;24(2):177-80. [Quantitative estimation of right ventricular pressure overloading by Tl-201 myocardial SPECT] [Article in Japanese] Kunieda E, Ogawa K, Nishiguchi I, Kubo A, Hashimoto S, Iwanaga S, Handa S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44643 |
Study title: Kaku Igaku. 1993 Jan;30(1):41-9. [Assessment of congenital heart disease by a thallium-201 SPECT study in children: accuracy of estimated right to left ventricular pressure ratio] [Article in Japanese] Ishii I, Nakajima K, Taki J, Taniguchi M, Bunko H,Kaku Igaku. 1993 Jan;30(1):41-9. [Assessment of congenital heart disease by a thallium-201 SPECT study in children: accuracy of estimated right to left ventricular pressure ratio] [Article in Japanese] Ishii I, Nakajima K, Taki J, Taniguchi M, Bunko H, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44644 |
Study title: Die behandlung extrapyramidaler bewegungsstorungen im kindes alter mit tiapridal R - Klepel H. Gebelt H. - 04/86 Traitement par le tiapridal des troubles moteurs extra-pyramidaux chez l'enfant - Klepel H. Gebelt H. - 04/86 |
Active substance: TIAPRIDE |
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Document reference: 44751 |
Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese] Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese] |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44670 |
Study title: Nippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, NabNippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, Nab |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44671 |
Study title: Nippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, SotobNippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, Sotob |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44672 |
Study title: Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L. Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44673 |
Study title: Nucl Med Commun. 2000 Aug;21(8):729-34. Thallium-201 myocardial SPET in patients with collagen disease. Ishida R, Murata Y, Sawada Y, Nishioka K, Shibuya H. Nucl Med Commun. 2000 Aug;21(8):729-34. Thallium-201 myocardial SPET in patients with collagen disease. Ishida R, Murata Y, Sawada Y, Nishioka K, Shibuya H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44675 |
Study title: A Multicentre Open Randomised Parallel-Group Trial of Meropenem versus Ceftoxamine plus Metronidazole in the Treatment of Abdominal Infections |
Active substance: MEROPENEM TRIHYDRATE |
Study summary document link (including results): 3591IL0027.xls |
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Document reference: 31623 |
Study title: A Single-Blind Randomised Comparative Study of MERREM (Meropenem) Versus Cefotaxime in the Treatment of Acute Bacterial Meningitis in Hospitalised Infants and Children. |
Active substance: MEROPENEM TRIHYDRATE |
Study summary document link (including results): 3591IL0065.xls |
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Document reference: 31621 |
Study title: Meropenem versus Ceftazidime plus Amikacin as Empirical Therapy for Fever in Cancer Patients with Granulocytopenia; A Prospective, Randomised, Multicentre Study. |
Active substance: MEROPENEM TRIHYDRATE |
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Document reference: 31620 |
Study title: Support for recruitment to Turkish study comparing Merrem with Ceftazidime + Amikacin in the empirical treatment of febrile infective episodes in neutropenic padiatric patients in Latin America. |
Active substance: MEROPENEM TRIHYDRATE |
Study summary document link (including results): 3591IL9006.xls |
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Document reference: 31624 |
Study title: A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO DETERMINE THE PHARMACOKINETICS OF MESALAMINE FOLLOWING ADMINISTRATION OF 30 MG/KG/DAY, 60 MG/KG/DAY, AND 90 MG/KG/DAY AS 400 MG DELAYEDRELEASE TABLETS GIVEN EVERY 12 HOURS FOR 28 DAYS TO CHILDREN AND ADOLESCENTS WITH ACTIVE ULCERATIVE COLITIS |
Active substance: MESALAZINE |
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Document reference: 31644 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IV AND/OR PO O.S. FLUCONAZOLE IN THE TREATMENT OF PEDIATRIC PATIENTS WITH SYSTEMIC CANDIDIASIS. THIS IS A COMPASSIONATE TREATMENT. |
Active substance: FLUCONAZOLE |
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Document reference: 27374 |
Study title: Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44499 |
Study title: A comparison of single dose caudal tramadol, tramadol plus bupivacaine and bupivacaine administration for postoperative analgesia in children - Gunduz M, Ozengiz D, Ozbek H, Isik G - 2001 (Paediatric Anaesthesia, 2001; 11: 323-326) |
Active substance: TRAMADOL |
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Document reference: 45015 |
Study title: - A double-blind, randomised, placebo-controlled clinical study to investigate the efficacy and safety of Tramal ® drops and midazolam in children undergoing dental extraction under general anaesthesia - Treatment of postoperative pain with tramadol HCl in children - Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen |
Active substance: TRAMADOL |
Study summary document link (including results): Tramadol HCL STUDY 02-27.xls |
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Document reference: 45013 |
Study title: A randomised, double-blind, multicenterclinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children - Habre W (Multicenter) - 2002 |
Active substance: TRAMADOL |
Study summary document link (including results): Tramadol HCL STUDY PCP1.xls |
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Document reference: 45016 |
Study title: A randomised, double-blind, multicentre clinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children |
Active substance: TRAMADOL |
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Document reference: 45004 |
Study title: An open multicenter study on the efficacy and safety of tramadol HCl (Tramal®) in the management of postoperative pain and other acute pain conditions in children - Lenkiewicz T - May 2, 1996 |
Active substance: TRAMADOL |
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Document reference: 45017 |
Study title: An open, multicenter study on the efficacy and safety of tramadol hydrochloride (Tramal ®) in the management of postoperative pain and other acute pain conditions in children |
Active substance: TRAMADOL |
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Document reference: 45002 |
Study title: Paediatric clinical trial of FLO 1347 Drops - Fontaine G. - 02/02/73 |
Active substance: TIAPRIDE |
Study summary document link (including results): Tiapride STUDY 73-00079-EN-00.xls |
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Document reference: 44745 |
Study title: Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143 |
Active substance: TIAPRIDE |
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Document reference: 38472 |
Study title: Treatment of pain due to drepanocytosis with tiapride - H. NyaméTreatment of pain due to drepanocytosis with tiapride - H. Nyamé |
Active substance: TIAPRIDE |
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Document reference: 38469 |
Study title: Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I. Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44525 |
Study title: Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S. Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44526 |
Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60. |
Active substance: TINZANIDINE |
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Document reference: 44792 |
Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60. |
Active substance: TINZANIDINE |
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Document reference: 44804 |
Study title: Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group.Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group. |
Active substance: TINZANIDINE |
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Document reference: 44794 |
Study title: Efficacy of neuroprotectors in patients with tension headaches.Efficacy of neuroprotectors in patients with tension headaches. |
Active substance: TINZANIDINE |
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Document reference: 44784 |
Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TINZANIDINE |
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Document reference: 44788 |
Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TINZANIDINE |
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Document reference: 44800 |
Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14 |
Active substance: TINZANIDINE |
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Document reference: 44789 |
Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14 |
Active substance: TINZANIDINE |
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Document reference: 44801 |
Study title: Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery. Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery. |
Active substance: MILRINONE |
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Document reference: 32023 |
Study title: Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12)Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12) |
Active substance: MILRINONE |
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Document reference: 32024 |
Study title: Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34)Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34) |
Active substance: MILRINONE |
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Document reference: 32029 |
Study title: Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393) |
Active substance: MILRINONE |
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Document reference: 32031 |
Study title: Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552) |
Active substance: TRAMADOL |
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Document reference: 45020 |
Study title: AWB-MF/TRA/011096, 23-Jul-1997. Post marketing surveillance, Drug monitoring - Therapie mit Tramundin Tropfen N bei mittelstarken bis starken Schmerzen mit verschiedenen Ursachen. (Tramundin oral solution therapy in moderate to severe pain of various origin) (Germany) |
Active substance: TRAMADOL |
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Document reference: 45044 |
Study title: J Nucl Med. 1991 Feb;32(2):237-41. Assessment of myocardial perfusion in patients after the arterial switch operation. Vogel M, Smallhorn JF, Gilday D, Benson LN, Ash J, Williams WG, Freedom RM. J Nucl Med. 1991 Feb;32(2):237-41. Assessment of myocardial perfusion in patients after the arterial switch operation. Vogel M, Smallhorn JF, Gilday D, Benson LN, Ash J, Williams WG, Freedom RM. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44611 |
Study title: Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, Côté M, Plourde G, Lemieux B. Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, Côté M, Plourde G, Lemieux B. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44527 |
Study title: Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44528 |
Study title: Cancer. 1987 Dec 1;60(11):2621-3. Early and delayed thallium 201 imaging. Diagnosis of patients with cold thyroid nodules. Bleichrodt RP, Vermey A, Piers DA, de Langen ZJ. Cancer. 1987 Dec 1;60(11):2621-3. Early and delayed thallium 201 imaging. Diagnosis of patients with cold thyroid nodules. Bleichrodt RP, Vermey A, Piers DA, de Langen ZJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44529 |
Study title: Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44530 |
Study title: Chest. 1987 Aug;92(2):371-4. Hypertrophic cardiomyopathy and myocardial ischemia with normal coronary arteries. Kelly TA, Watson DD, DiMarco JP, Gibson RS. Chest. 1987 Aug;92(2):371-4. Hypertrophic cardiomyopathy and myocardial ischemia with normal coronary arteries. Kelly TA, Watson DD, DiMarco JP, Gibson RS. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44531 |
Study title: Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M. Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44532 |
Study title: The assessment of the safety and efficacy of tramadol suppositories compared to paracetamol suppositories when administered as pre-medication together with midazolam in subjects aged 3 to 7 years |
Active substance: TRAMADOL |
Study summary document link (including results): synopsis-tra-rsa-2.pdf |
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Document reference: 44997 |
Study title: The Respiratory Effects of Tramadol in Children under Halothane Anaesthesia - A Double-Blind, Placebo Controlled Comparison with Pethidine |
Active substance: TRAMADOL |
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Document reference: 44994 |
Study title: The Respiratory Effects of Tramadol in Children under Halothane Anaesthesia - A Double-Blind, Placebo Controlled Comparison with Pethidine |
Active substance: TRAMADOL |
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Document reference: 45003 |
Study title: Eur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AKEur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AK |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44565 |
Study title: Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44566 |
Study title: Eur J Nucl Med. 1986;11(9):368-70. 201Tl myocardial imaging in a cardiac rejection episode. Richter J, Herreros J, Serena A, Pardo J, Azanza JR, Charvet MA, Honorato J, Arcas R. Eur J Nucl Med. 1986;11(9):368-70. 201Tl myocardial imaging in a cardiac rejection episode. Richter J, Herreros J, Serena A, Pardo J, Azanza JR, Charvet MA, Honorato J, Arcas R. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44569 |
Study title: Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235) |
Active substance: MILRINONE |
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Document reference: 32032 |
Study title: A repeat dose, open-label, safety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns |
Active substance: Live Yeast Cell Derivative , Shark Liver Oil |
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Document reference: 40031 |
Study title: Preparation H ointment (WH-66-228) repeated insult patch test |
Active substance: Live Yeast Cell Derivative , Shark Liver Oil |
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Document reference: 40030 |
Study title: Efficacy and safety evaluation of Lodoxamide Ophthalmic Solution versus OPTICROM Ophthalmic Solution in patients with vernal conjunctivitis, giant papillary conjunctivitis and allergic/atopic conjunctivitis (C8559) |
Active substance: LODOXAMIDE |
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Document reference: 46925 |
Study title: Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lomefloxacin in Japan. May 1996. Meta-analysis of Refs 2-20, Part IV of BIRD October 1993 (Refs 3, 14, 18-34, Part IV of BIRD November 1997)Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and o... |
Active substance: LOMEFLOXACIN |
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Document reference: 31380 |
Study title: J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY. J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44615 |
Study title: J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A. J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44617 |
Study title: A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86. A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86. |
Active substance: TIAGABINE |
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Document reference: 38481 |
Study title: A Single Dose Study to Define Pharmacokinetic Parameters of Tiagabine HCl in Pediatric Patients with Complex Partial SeizuresEfficiency of pulmonary administration of tobramycin solution for inhalation in cystic fibrosis using an improved drug delivery system. (Chest. 2003 Jan;123(1):28-36) |
Active substance: TIAGABINE |
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Document reference: 38533 |
Study title: A single-blind, tolerability and preliminary efficacy study of tiagabine in children with epilepsyPhase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. |
Active substance: TIAGABINE |
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Document reference: 38527 |
Study title: An Open-Label Extension Study of Tiagabine HCl in the Treatment of Patients with Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38522 |
Study title: An Open-Label Extension Study of Tiagabine HCl in the Treatment of Pediatric Patients with Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38535 |
Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. Cochereau I, Meddeb-Ouertani A, Khairallah M, Amraoui A, Zaghloul K, Pop M, Delval L, Pouliquen P, Tandon R, Garg P, Goldschmidt P, Bourcier T. Br J Ophthalmol. 2007 Apr;91(4):465-9;Epub 2006 Oct 18. |
Active substance: TIAGABINE |
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Document reference: 38528 |
Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44991 |
Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 45817 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with dextropropoxyphene and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44989 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44987 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 45813 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44986 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44988 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 45812 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 45814 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section |
Active substance: TRAMADOL |
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Document reference: 44984 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain |
Active substance: TRAMADOL |
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Document reference: 44985 |
Study title: Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44645 |
Study title: Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3.Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46712 |
Study title: Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4.Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46711 |
Study title: Double-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publicationDouble-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publication |
Active substance: TRAXENAMIC ACID |
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Document reference: 46707 |
Study title: Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46708 |
Study title: Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9 |
Active substance: TRAXENAMIC ACID |
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Document reference: 46716 |
Study title: Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46720 |
Study title: A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7.A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46715 |
Study title: Result of an antifibrinolytic treatment using tranexamic acid for the reduction of blood-loss during and after tonsillectomy. Schweiz Med Wochenschr. 1977 Jun 4;107(22):780-4.Result of an antifibrinolytic treatment using tranexamic acid for the reduction of blood-loss during and after tonsillectomy. Schweiz Med Wochenschr. 1977 Jun 4;107(22):780-4. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46723 |
Study title: Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9 |
Active substance: TRAXENAMIC ACID |
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Document reference: 46718 |
Study title: 10. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in pediatric subjects with uncontrolled partial onset seizures with or without secondarily generalized seizures |
Active substance: TOPIRAMATE |
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Document reference: 44843 |
Study title: 11. Phase 1, multicenter, open-label trial to gain additional experience with topiramate among subjects with infantile spasms. |
Active substance: TOPIRAMATE |
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Document reference: 44875 |
Study title: 11. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary generalized tonic-clonic seizures |
Active substance: TOPIRAMATE |
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Document reference: 44844 |
Study title: 12. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes |
Active substance: TOPIRAMATE |
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Document reference: 44845 |
Study title: 12. Phase 3, double-blind, randomized, parallel group study comparing the safety and efficacy of 2 doses of topiramate as monotherapy in the treatment of newly diagnosed or recurrent epilepsy in pediatric and adult subjects. (plus OL ext) |
Active substance: TOPIRAMATE |
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Document reference: 44876 |
Study title: 13. Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures. |
Active substance: TOPIRAMATE |
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Document reference: 44877 |
Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy unsatisfactorily controlled with other antiepileptic medicationTreatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops. Jackson WB, Low DE, Dattani D, Whitsitt PF, Leeder RG, MacDougall R. Can J Ophthalmol. 2002 Jun;37(4):228-37; discussion 237. |
Active substance: TIAGABINE |
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Document reference: 38529 |
Study title: An Open-Label Study of the Safety of Long-Term Tiagabine HCl Administration in Patients with Epilepsy |
Active substance: TIAGABINE |
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Document reference: 38526 |
Study title: A compassionate Program of Tiagabine HCl in Treatment of Pediatric Patients with Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38536 |
Study title: Compassionate Use of Tiagabine HCl in Patients with Refractory Epilepsy |
Active substance: TIAGABINE |
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Document reference: 38524 |
Study title: Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44501 |
Study title: Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S. Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44646 |
Study title: Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44647 |
Study title: Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K. Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44648 |
Study title: Kaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh KKaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh K |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44649 |
Study title: Kardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia OKardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia O |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44650 |
Study title: Klin Padiatr. 1998 Jul-Aug;210(4):239-42. Monitoring tumor activity in low grade glioma of childhood. MÃlenkamp G, Riemann B, Kuwert T, Sträter R, Kurlemann G, Schober O, Jürgens H, Wolff JE. Klin Padiatr. 1998 Jul-Aug;210(4):239-42. Monitoring tumor activity in low grade glioma of childhood. MÃlenkamp G, Riemann B, Kuwert T, Sträter R, Kurlemann G, Schober O, Jürgens H, Wolff JE. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44651 |
Study title: Kokyu To Junkan. 1984 Feb;32(2):161-4. [Thallium-201 myocardial scintigram in primary pulmonary hypertension] [Article in Japanese] Fujii I, Handa S, Yamazaki H, Nakamura Y. Kokyu To Junkan. 1984 Feb;32(2):161-4. [Thallium-201 myocardial scintigram in primary pulmonary hypertension] [Article in Japanese] Fujii I, Handa S, Yamazaki H, Nakamura Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44652 |
Study title: A phase IV, single-blind, multi-centre, randomized, controlled study to evaluate the safety, tolerability and immunogenicity of two Tick-Borne Encephalitis (TBE) vaccines: Novartis Vaccines's Encepur® Kinder and "licensed comparator" vaccine (Baxter's FSME Immun® Junior) administered according to two different schedules in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48385 |
Study title: Pediatr Cardiol. 1993 Mar;14(2):67-74. Discordance between thallium-201 scintigraphy and coronary angiography in patients with Kawasaki disease: myocardial ischemia with normal coronary angiogram. Fukazawa M, Fukushige J, Takeuchi T, Narabayashi Pediatr Cardiol. 1993 Mar;14(2):67-74. Discordance between thallium-201 scintigraphy and coronary angiography in patients with Kawasaki disease: myocardial ischemia with normal coronary angiogram. Fukazawa M, Fukushige J, Takeuchi T, Narabayashi |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44679 |
Study title: Pediatr Cardiol. 1996 Mar-Apr;17(2):71-6. Long-term outcome of coronary abnormalities in patients after Kawasaki disease. Fukushige J, Takahashi N, Ueda K, Hijii T, Igarashi H, Ohshima A. Pediatr Cardiol. 1996 Mar-Apr;17(2):71-6. Long-term outcome of coronary abnormalities in patients after Kawasaki disease. Fukushige J, Takahashi N, Ueda K, Hijii T, Igarashi H, Ohshima A. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44680 |
Study title: Pediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, BerberogPediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, Berberog |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44681 |
Study title: Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al. Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44682 |
Study title: Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44683 |
Study title: A pilot study of topiramate in subjects with infantile spasms. |
Active substance: TOPIRAMATE |
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Document reference: 44853 |
Study title: A pilot study of topiramate in subjects with infantile spasms. |
Active substance: TOPIRAMATE |
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Document reference: 44944 |
Study title: A randomized , open-label, multicenter study with open-label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (aged 1 to 24 months, inclusive) with refractory partial-onset seizures |
Active substance: TOPIRAMATE |
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Document reference: 44862 |
Study title: A randomized, double-blind, placebo-controlled, fixe dose-ranging study to assess the safety and tolerability and efficacy of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy for infants (1 to 23 months of age, inclusive) with refractoty partial onset seizures, with open-label extension. |
Active substance: TOPIRAMATE |
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Document reference: 44863 |
Study title: A randomized, open label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (Aged 1 to 24 months, inclusive) with refractory partial-onset seizures |
Active substance: TOPIRAMATE |
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Document reference: 44932 |
Study title: A retrospective chart review of infants with infantile spasm of which some were treated with Topamax |
Active substance: TOPIRAMATE |
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Document reference: 44868 |
Study title: A double-blind trial comparing the efficacy, tolerability and safety of monotherapy topiramate versus phenytoin in subjects with seizures indicative of new onset epilepsy |
Active substance: TOPIRAMATE |
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Document reference: 44846 |
Study title: A retrospective review of infants with infantile spasm of which some were treated with Topamax |
Active substance: TOPIRAMATE |
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Document reference: 44924 |
Study title: A pilot study of topiramate in subjects with infantile spasms |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44911 |
Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy |
Active substance: TOPIRAMATE |
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Document reference: 44859 |
Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy |
Active substance: TOPIRAMATE |
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Document reference: 44933 |
Study title: Compassionate use of Topamax |
Active substance: TOPIRAMATE |
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Document reference: 44867 |
Study title: Double-blind trial for partial onset seizures efficacy |
Active substance: TOPIRAMATE |
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Document reference: 44920 |
Study title: Double-blind, randomized, parallel group trial comparing 2 dosages of topiramate as monotherapy in pediatric and adult subjects with recently diagnosed epilepsy characterized by partial onset seizures. |
Active substance: TOPIRAMATE |
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Document reference: 44891 |
Study title: Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44505 |
Study title: MULTICENTRIC NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF FCA FOR THE TREATMENT OF SEVERE SYSTEMIC CANDIDIASIS AND CRYPTOCOCCAL MENINGITIS |
Active substance: FLUCONAZOLE |
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Document reference: 28035 |
Study title: Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789) |
Active substance: TRAMADOL |
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Document reference: 45021 |
Study title: Caudal tramadol for postoperative analgesia in paediatric hypospadias surgery - Prosser Dp, Davis A, Booker PD, Murray A - 1997 (Br J Anaesth 1997; 79: 293-296)Caudal tramadol for postoperative analgesia in paediatric hypospadias surgery - Prosser Dp, Davis A, Booker PD, Murray A - 1997 (Br J Anaesth 1997; 79: 293-296) |
Active substance: TRAMADOL |
Study summary document link (including results): |
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Document reference: 45022 |
Study title: Clinical investigation of the effect and safety of Tramal in paediatric postoperative administration |
Active substance: TRAMADOL |
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Document reference: 45007 |
Study title: Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464) |
Active substance: TRAMADOL |
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Document reference: 45023 |
Study title: Single-blind, randomized, multicenter comparison of FSME IMMUN NEW and ENCEPUR: safety and tolerability of two vaccinations in healthy volunteers aged 16 to 65 years |
Active substance: Tick-Borne Encephalitis Virus |
Study summary document link (including results): |
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Document reference: 21204 |
Study title: Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44534 |
Study title: Spasmodic torticollis: treatment with Tizanidine.Spasmodic torticollis: treatment with Tizanidine. |
Active substance: TINZANIDINE |
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Document reference: 44799 |
Study title: Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double−blind, placebo−controlled trial. US Tizanidine Study Group.Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double−blind, placebo−controlled trial. US Tizanidine Study Group. |
Active substance: TINZANIDINE |
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Document reference: 44795 |
Study title: Treatment of spasticity with tizanidine in multiple sclerosis.Treatment of spasticity with tizanidine in multiple sclerosis. |
Active substance: TINZANIDINE |
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Document reference: 44798 |
Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy).Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). |
Active substance: TINZANIDINE |
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Document reference: 44786 |
Study title: (The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5(The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5 |
Active substance: DILTIAZEM |
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Document reference: 26131 |
Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6 |
Active substance: TINZANIDINE |
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Document reference: 44802 |
Study title: Pharmacokinetic Study of Tinzaparin Sodium in Paediatric Patients |
Active substance: TINZAPARIN |
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Document reference: 44805 |
Study title: A PROSPECTIVE RANDOMIZED TRIAL OF FCA VS. AMPHOTERICIN B FOR EMPERIC ANTI-FUNGAL THERAPY OF THE NEUTROPENIC FEBRILE PATIENTS. |
Active substance: FLUCONAZOLE |
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Document reference: 27986 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of Nasacort® (triamcinolone acetonide nasal aerosol) in pediatric patients with seasonal allergic rhinitis - No Author - 31/07/1992 |
Active substance: TRIAMCINOLONE |
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Document reference: 46848 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of NasacortTM (triamcinolone acetonide nasal aerosol) in pediatric patients with perennial allergic rhinitis - No Author - 15/04/1991 |
Active substance: TRIAMCINOLONE |
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Document reference: 46849 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of RG 5029Y aqueous nasal spray in pediatric patients with spring grass seasonal allergic rhinitis - Simpson BE - 31/08/1995 |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-312 CSR.xls |
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Document reference: 46850 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of the safety and efficacy of RG5029Y (triamcinolone acetonide) aqueous nasal spray in adolescent patients with ragweed allergic rhinitis - Procaccini RL - 25/02/1994 |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-302 CSR.xls |
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Document reference: 46851 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A study of the safety and efficacy of RG 5029Y (triamcinolone acetonide) aqueous nasal spray in patients with perennial allergic rhinitis - Cassel D- 22/11/1994 |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-305 CSR.xls |
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Document reference: 46852 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term safety of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46854 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term study of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46855 |
Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with seasonal allergic rhinitis - No Author - No date |
Active substance: TRIAMCINOLONE |
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Document reference: 46847 |
Study title: Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242) |
Active substance: TRAMADOL |
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Document reference: 45024 |
Study title: Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190) |
Active substance: TRAMADOL |
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Document reference: 45025 |
Study title: Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262) |
Active substance: TRAMADOL |
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Document reference: 45026 |
Study title: Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582)Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582) |
Active substance: TRAMADOL |
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Document reference: 45027 |
Study title: Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44536 |
Study title: Circulation. 1996 Nov 1;94(9 Suppl):II38-43. Midterm results after surgical repair of the anomalous origin of the coronary artery. Lambert V, Touchot A, Losay J, Piot JD, Henglein D, Serraf A, Lacour-Gayet F, Planche C. Circulation. 1996 Nov 1;94(9 Suppl):II38-43. Midterm results after surgical repair of the anomalous origin of the coronary artery. Lambert V, Touchot A, Losay J, Piot JD, Henglein D, Serraf A, Lacour-Gayet F, Planche C. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44537 |
Study title: Tramadol hydrochloride: short-term efficacy in pain following dental surgery |
Active substance: TRAMADOL |
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Document reference: 45816 |
Study title: Eur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sofEur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sof |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44572 |
Study title: Eur J Nucl Med. 2001 Mar;28(3):273-81. High uptake of L-3-[123I]iodo-alpha-methyl tyrosine in pilocytic astrocytomas. Weckesser M, Matheja P, Rickert CH, Sträter R, Palkovic S, LÃttgen J, Kurlemann G, Paulus W, Wassmann H, Schober O. Eur J Nucl Med. 2001 Mar;28(3):273-81. High uptake of L-3-[123I]iodo-alpha-methyl tyrosine in pilocytic astrocytomas. Weckesser M, Matheja P, Rickert CH, Sträter R, Palkovic S, LÃttgen J, Kurlemann G, Paulus W, Wassmann H, Schober O. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44574 |
Study title: Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8.Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8. |
Active substance: TRIHEXYPHENIDYL |
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Document reference: 46737 |
Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days’administration of 450 mg theophylline (BY158K) per day. |
Active substance: THEOPHYLLINE |
Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf |
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Document reference: 21676 |
Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days` administration of 450 mg theophylline (BY158K) per day |
Active substance: THEOPHYLLINE |
Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf |
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Document reference: 44729 |
Study title: AWB-BL /UNI-300-400/151092, 22-Jan-1997, Wirksamkeit und Verträglichkeit einer individuelle angepassten Theophyllintherapie mit Uniphyllin/Uniphyllin 300 bei Patienten mit chronisch obstruktiver Bronchitis. Efficacy and safety of an individually adopted therapy with Theophyllin (Uniphyllin/Uniphyllin 300) in patient with chronic obstructive bronchitis (Germany) |
Active substance: Theophylline anhydrous |
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Document reference: 40255 |
Study title: J Pediatr. 1979 Feb;94(2):244-7. Thallium 201 scintigraphy in patients with anomalous origin of the left coronary artery from the main pulmonary artery. Rabinovitch M, Rowland TW, Castaneda AR, Treves S. J Pediatr. 1979 Feb;94(2):244-7. Thallium 201 scintigraphy in patients with anomalous origin of the left coronary artery from the main pulmonary artery. Rabinovitch M, Rowland TW, Castaneda AR, Treves S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44624 |
Study title: J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW. J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44626 |
Study title: J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44627 |
Study title: Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TIAGABINE |
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Document reference: 38504 |
Study title: Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556)Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556) |
Active substance: TRAMADOL |
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Document reference: 45037 |
Study title: Tramadol iv vs nalbuphine iv, 47 children aged 1 to 10 years old. IIS on tramadol in children undergoing endoscopic surgery for reflux oesophagitis. One-year double-blind comparison of post-op tramadol (bolus of 2 mg/kg BW + infusion of 8 mg/kg BW over 24 h) vs nalbuphine. |
Active substance: TRAMADOL |
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Document reference: 45011 |
Study title: Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21) |
Active substance: TRAMADOL |
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Document reference: 45038 |
Study title: Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185) |
Active substance: TRAMADOL |
Study summary document link (including results): |
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Document reference: 45039 |
Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain |
Active substance: TRAMADOL |
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Document reference: 44996 |
Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain |
Active substance: TRAMADOL |
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Document reference: 45012 |
Study title: Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171 |
Active substance: TRAMADOL |
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Document reference: 45040 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain |
Active substance: TRAMADOL |
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Document reference: 45811 |
Study title: Treatment of postoperative pain with tramadol HCl in children |
Active substance: TRAMADOL |
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Document reference: 44993 |
Study title: - Treatment of postoperative pain with tramadol HCl in children - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen |
Active substance: TRAMADOL |
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Document reference: 45014 |
Study title: Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992 |
Active substance: TRAMADOL |
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Document reference: 45041 |
Study title: The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6.The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46717 |
Study title: Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46714 |
Study title: Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4.Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46721 |
Study title: Tranexamic acid in paediatric cardiac surgery. Indian J Med Res. 2003 Aug;118:86-9Tranexamic acid in paediatric cardiac surgery. Indian J Med Res. 2003 Aug;118:86-9 |
Active substance: TRAXENAMIC ACID |
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Document reference: 46713 |
Study title: Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21.Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46722 |
Study title: Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46709 |
Study title: The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46719 |
Study title: Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish.Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46724 |
Study title: Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6.Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46710 |
Study title: Priftis, K. N., Papadimitriou, A., Anthracopoulos, M. B., Gatsopoulou, E., Fretzayas, A., Nicolaidou, P., and Chrousos, G. P.Priftis, K. N., Papadimitriou, A., Anthracopoulos, M. B., Gatsopoulou, E., Fretzayas, A., Nicolaidou, P., and Chrousos, G. P. |
Active substance: TETRACOSACTIDE |
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Document reference: 44461 |
Study title: Use of ACTH and prednisolone in infantile spasms: experience from a developing countryUse of ACTH and prednisolone in infantile spasms: experience from a developing country |
Active substance: TETRACOSACTIDE |
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Document reference: 44470 |
Study title: BERATO 1969, DESRUS FOURNIE 1969, REBOUILLAT 1966, WEBER 1986, BADY 1969, GENEVIEVE 1970, GERAUD 1968, GRIMAUD CHEVRIER 1971, 1968, JAROUSSE 1973, BERARD 1969, GILLE 1970, MASSE 1969, PREVOT 1969, VIALLE 1969, SCHILLIRO 1971 - Publications in the Clinical expert report - Dr.A.Hernandez vidal - No date - |
Active substance: TETRAZEPAM |
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Document reference: 44480 |
Study title: Acta Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, EActa Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, E |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44482 |
Study title: Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651 |
Active substance: TIAGABINE |
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Document reference: 38471 |
Study title: Randomised, double-blind placebo controlled cross-over study of efficacy and safety of tiagabine as adjunctive treatment of partial seizures in children with epilepsyTreatment with tobramycin solution for inhalation reduces hospitalizations in young CF subjects with mild lung disease. (Pediatr Pulmonol. 2004 Oct; 38(4):314-20) |
Active substance: TIAGABINE |
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Document reference: 38532 |
Study title: Randomised, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of Tiagabine Administered TID as Adjunctive Treatment for Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38525 |
Study title: Safety and Efficacy of BID and QID Dosing with Tiagabine HCl versus Placebo as Adjunctive Treatment for Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38523 |
Study title: Am J Med. 1984 Aug;77(2):286-92. Myocardial perfusion abnormalities in asymptomatic patients with systemic lupus erythematosus. Hosenpud JD, Montanaro A, Hart MV, Haines JE, Specht HD, Bennett RM, Kloster FE. Am J Med. 1984 Aug;77(2):286-92. Myocardial perfusion abnormalities in asymptomatic patients with systemic lupus erythematosus. Hosenpud JD, Montanaro A, Hart MV, Haines JE, Specht HD, Bennett RM, Kloster FE. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44509 |
Study title: Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M. Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44510 |
Study title: Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44653 |
Study title: Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44654 |
Study title: Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R. Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44655 |
Study title: Kokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, TadaokKokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, Tadaok |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44657 |
Study title: Kokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, KaKokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, Ka |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44658 |
Study title: Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y,Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44659 |
Study title: Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN. Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44687 |
Study title: Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K. Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44691 |
Study title: Radioisotopes. 1984 Oct;33(10):691-8. [Thallium-201 chloride dynamic analysis using thallium-201 chloride and sodium iodide-131 thyroid subtraction scintigraphy] [Article in Japanese] Morimoto S, Hiraki Y, Togami I, Kaji M, Niiya H, Joja I, Yamamoto H,Radioisotopes. 1984 Oct;33(10):691-8. [Thallium-201 chloride dynamic analysis using thallium-201 chloride and sodium iodide-131 thyroid subtraction scintigraphy] [Article in Japanese] Morimoto S, Hiraki Y, Togami I, Kaji M, Niiya H, Joja I, Yamamoto H, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44692 |
Study title: JC-AWB TOP0003 (patients > 2 years) - Veränderungen durch Topamax - Die sicht des Patienten TOPAMAX - the view of the Patient) |
Active substance: TOPIRAMATE |
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Document reference: 44928 |
Study title: Long-term, open-label study of topamax (topiramate) used as adjunctive therapy in patients with partial onset seizures with or without secondary generalization |
Active substance: TOPIRAMATE |
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Document reference: 44852 |
Study title: Low dose topiramate monotherapy substitution trial in young epilepsy patients failing first conventional anticonvulsant. |
Active substance: TOPIRAMATE |
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Document reference: 44860 |
Study title: Open label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or metally handicapped patients aged 14 or older |
Active substance: TOPIRAMATE |
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Document reference: 44923 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase ii |
Active substance: TOPIRAMATE |
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Document reference: 44851 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II |
Active substance: TOPIRAMATE |
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Document reference: 44909 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II. |
Active substance: TOPIRAMATE |
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Document reference: 44942 |
Study title: Infantile spasms with hypsarrhythmia |
Active substance: TOPIRAMATE |
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Document reference: 44866 |
Study title: JC-AWB TOP 0009 (patients >12years) - Topamax 1st line add on |
Active substance: TOPIRAMATE |
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Document reference: 44927 |
Study title: Open study of topamax as adjunct treatment in patients with partial onset seizures : assessing the low and slow titration regimen |
Active substance: TOPIRAMATE |
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Document reference: 44850 |
Study title: Open-label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or mentally handicapped patients aged 14 or older |
Active substance: TOPIRAMATE |
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Document reference: 44865 |
Study title: Open-study of topamax as adjunct treatment in patients with partial onset seizures: assessing the low and slow titration regimen. |
Active substance: TOPIRAMATE |
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Document reference: 44906 |
Study title: Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44515 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: TRAMADOL |
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Document reference: 44979 |
Study title: Evaluation of the Safety Profile and Clinical Effectiveness of Two Dosing Levels of Oral Tramadol Hydrochloride with Acetaminophen for the Treatment of Postsurgical Pain in Children and Adolescents Aged Seven to Sixteen Years |
Active substance: TRAMADOL |
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Document reference: 44976 |
Study title: Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390) |
Active substance: CODEINE_AND_PARACETAMOL |
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Document reference: 24514 |
Study title: Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63. Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63. |
Active substance: TIMOLOL |
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Document reference: 44763 |
Study title: A NON COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 300MG VAGINAL OVULES FO THE SINGLE DOSE TREATMENT OF VAGINAL YEAST INFECTIONS |
Active substance: TIOCONAZOLE |
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Document reference: 44806 |
Study title: A NON-COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 100MG VAGINAL OVULES FOR THE TREATMENT OF VAGINAL CANDIDIASIS WITH A 3 DAY COURSE OF THERAPY |
Active substance: TIOCONAZOLE |
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Document reference: 44809 |
Study title: An Open, Non-comparative Study of the Efficacy and Safety of Tioconazole in Neonates and Infants with Candidal Diaper Rash |
Active substance: TIOCONAZOLE |
Study summary document link (including results): TCN-TR-94-001A EMA Pediatric Web Synopsis.pdf |
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Document reference: 48036 |
Study title: Double-Blind Comparison of the Efficacy, Toleration, and Safety of Tioconazole Base 1% and Tioconazole Base 2% w/w Creams in the Treatment of Patients with Fungal Infection of the Skin |
Active substance: TIOCONAZOLE |
Study summary document link (including results): EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 48031 |
Study title: Double-blind Comparison of the Efficacy, Toleration, and Safety of Tioconazole Hydrochloride 2% w/w and Econazole Nitrate 1% Creams in the Treatment of Patients with Fungal Infection of the Skin or with Erythrasma |
Active substance: TIOCONAZOLE |
Study summary document link (including results): 13-1 EMA Pediatric Web Synopsis.pdf |
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Document reference: 44810 |
Study title: A CLINICAL STUDY ENTITLED TROSID (TIOCONAZOL) SOLUTION. A EFFICACY OPEN LABEL STUDY IN THE TREATMENT OF ONYCHOMYCOSIS (ST. JOHAN´S HOSPITAL FOR DISEASE OF SKIN (LONDON) AND DEPARTMENT OF DERMATOLOGY-UNIVERSITY OF GRALGOW. CLINICAL AND EXPERIMENTAL DERMATOLOGY, 10, 11-115, 1985) |
Active substance: TIOCONAZOLE |
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Document reference: 44808 |
Study title: Efficacy, Safety, and Toleration of a 28% Tioconazole Solution Compared with a 2% Miconazole Tincture in Treatment of Fungal Nail Infection |
Active substance: TIOCONAZOLE |
Study summary document link (including results): EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48030 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (PEIOS SWITZERLAND) |
Active substance: TIOCONAZOLE |
Study summary document link (including results): |
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Document reference: 44811 |
Study title: Phase 1, multicenter, open-label trial to gain additional experience with topiramate among subjects with infantile spasms. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44884 |
Study title: Phase 3, double-blind, parallel-group, safety and efficacy study of TPM monotherapy in adults with refractory partial epilepsy. |
Active substance: TOPIRAMATE |
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Document reference: 44873 |
Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary eneralized tonic-clonic seizures. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44895 |
Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes. |
Active substance: TOPIRAMATE |
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Document reference: 44896 |
Study title: Phase 3, double-blind, randomized, parallel group study comparing the safety and efficacy of 2 doses of topiramate as monotherapy in the treatment of newly diagnosed or recurrent epilepsy in pediatric and adult subjects. (plus OL ext) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44893 |
Study title: J Cardiogr. 1982 Dec;12(4):1009-21. [Myocardial imaging in patients with transposition of the great arteries: comparison between Mustard and Rastelli operations] [Article in Japanese] Ono Y, Tanimoto T, Kohata T, Arakaki Y, Takanashi S, Takahashi O, KaJ Cardiogr. 1982 Dec;12(4):1009-21. [Myocardial imaging in patients with transposition of the great arteries: comparison between Mustard and Rastelli operations] [Article in Japanese] Ono Y, Tanimoto T, Kohata T, Arakaki Y, Takanashi S, Takahashi O, Ka |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44594 |
Study title: J Cardiogr. 1982 Jun;12(2):387-99. [Myocardial imaging in patients with Kawasaki disease: exercise stress imaging and serial studies] [Article in Japanese] Ono Y, Tanimoto T, Kijima Y, Kohata T, Suzuki A, Kamiya T, Nishimura T, Kozuka T. J Cardiogr. 1982 Jun;12(2):387-99. [Myocardial imaging in patients with Kawasaki disease: exercise stress imaging and serial studies] [Article in Japanese] Ono Y, Tanimoto T, Kijima Y, Kohata T, Suzuki A, Kamiya T, Nishimura T, Kozuka T. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44595 |
Study title: J Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, KamiyaJ Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, Kamiya |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44596 |
Study title: J Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, NaitoJ Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, Naito |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44597 |
Study title: J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44598 |
Study title: Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45)Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45) |
Active substance: TRAMADOL |
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Document reference: 45030 |
Study title: Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413) |
Active substance: TRAMADOL |
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Document reference: 45031 |
Study title: Nalbuphine vs. Tramadol. Efficacy and safety of nalbuphine in postoperative pain after surgery in children |
Active substance: TRAMADOL |
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Document reference: 45008 |
Study title: Open clinical study on the analgesic effect of tramadol in patients with burn pain |
Active substance: TRAMADOL |
Study summary document link (including results): Tramadol STUDY 86-03-95.xls |
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Document reference: 45010 |
Study title: J Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operatiJ Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operati |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44629 |
Study title: Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I. Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44631 |
Study title: Clin Nucl Med. 1989 Jul;14(7):492-3. Thallium-201 imaging in anomalous left coronary artery originating from pulmonary trunk. Kim SM, Park CH, Intenzo CM, Baht AM. Clin Nucl Med. 1989 Jul;14(7):492-3. Thallium-201 imaging in anomalous left coronary artery originating from pulmonary trunk. Kim SM, Park CH, Intenzo CM, Baht AM. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44544 |
Study title: Clin Nucl Med. 1989 Nov;14(11):827-30. Tl-201 myocardial SPECT in patients with Duchenne's muscular dystrophy: a long-term follow-up. Nagamachi S, Jinnouchi S, Ono S, Hoshi H, Inoue K, Watanabe K. Clin Nucl Med. 1989 Nov;14(11):827-30. Tl-201 myocardial SPECT in patients with Duchenne's muscular dystrophy: a long-term follow-up. Nagamachi S, Jinnouchi S, Ono S, Hoshi H, Inoue K, Watanabe K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44545 |
Study title: Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44547 |
Study title: Clin Nucl Med. 1992 Oct;17(10):806-11. Early and delayed imaging of Tc-99m HMPAO versus Tl-201 in benign and malignant thyroid tumors. Similar uptake but different retention. Ohnishi T, Noguchi S, Murakami N, Harao M, Jinnouchi S, Hoshi H, Futami S, NagClin Nucl Med. 1992 Oct;17(10):806-11. Early and delayed imaging of Tc-99m HMPAO versus Tl-201 in benign and malignant thyroid tumors. Similar uptake but different retention. Ohnishi T, Noguchi S, Murakami N, Harao M, Jinnouchi S, Hoshi H, Futami S, Nag |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44550 |
Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 45818 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (ARTNER AUSTRIA) |
Active substance: TIOCONAZOLE |
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Document reference: 44812 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (GRANETZNY WEST GERMANY) |
Active substance: TIOCONAZOLE |
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Document reference: 44813 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIOSIS (DR PEIOS SWITZERLAND) |
Active substance: TIOCONAZOLE |
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Document reference: 44814 |
Study title: A comparative trial of DS 103-282 and diazepam in patients with spasticity due to cerebrovascular accidents |
Active substance: TIZANIDINE |
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Document reference: 44779 |
Study title: Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. Müller S, Müller P, Meyer R, Volkmann H, Gottschild Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. Müller S, Müller P, Meyer R, Volkmann H, Gottschild |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44579 |
Study title: Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M. Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44580 |
Study title: Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A. Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44581 |
Study title: Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y. Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44582 |
Study title: J Cardiol. 1991;21(2):437-44. [Usefulness and limitations of stress 201-thallium myocardial imaging in patients with Kawasaki disease] [Article in Japanese] Ono Y, Kohata T, Iwatani H, Okuno M, Suzuki A, Kamiya T, Nishimura T, Takamiya M. J Cardiol. 1991;21(2):437-44. [Usefulness and limitations of stress 201-thallium myocardial imaging in patients with Kawasaki disease] [Article in Japanese] Ono Y, Kohata T, Iwatani H, Okuno M, Suzuki A, Kamiya T, Nishimura T, Takamiya M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44599 |
Study title: J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M, J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44600 |
Study title: Comparative Efficacy and Safety of Muscoril® 4 mg BID Ampoules versus Placebo in Orthopedo-Traumatologic Pathologies : a Monocentre Double-Blind Randomised Clinical Trial |
Active substance: THIOCOLCHICOSIDE |
Study summary document link (including results): Thiocolchicoside - Study 1.pdf |
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Document reference: 44740 |
Study title: Controlled clinical researches on the activity and tolerability of different preparations of Muscoril (ampoules, capsules, cream, ointment) for the comparison with other active injectable preparation or with placebo per os and for local application, in patients with painful contractures of different origin STUDY MARIANI |
Active substance: THIOCOLCHICOSIDE |
Study summary document link (including results): Thiocolchicoside STUDY Mariani.xls |
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Document reference: 47996 |
Study title: Jpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, ShimoyamaJpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, Shimoyama |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44634 |
Study title: Safety and Efficacy of Tiagabine HCl Monotherapy for the Inpatient Treatment of Complex Partial Seizures: A Placebo–Controlled Study |
Active substance: TIAGABINE |
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Document reference: 38520 |
Study title: Safety and Efficacy of Tiagabine HCl Monotherapy in the Treatment for Partial Seizures: High Dose versus Low Dose |
Active substance: TIAGABINE |
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Document reference: 38530 |
Study title: Evaluation and comparison of safety and effectiveness of L.A.N.D., phenylephrine, and a vehicle control in patients with allergic and non-allergic rhinitis. |
Active substance: TRAMAZOLINE |
Study summary document link (including results): Tramazoline Hydrochloride_U70-0210_synopsis.pdf |
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Document reference: 46699 |
Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain |
Active substance: TRAMADOL |
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Document reference: 44983 |
Study title: Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, PInt J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, P |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44585 |
Study title: Levocabastine eye drops and nasal spray in seasonal allergic rhino conjunctivitis: a single-blind comparison with antazolineaphazoline eye drops and flunisolide nasal spray (17-54 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD43871_Interventional_Levocabastine.xls |
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Document reference: 31094 |
Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS IN ICU. |
Active substance: FLUCONAZOLE |
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Document reference: 27877 |
Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (11-71 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62120_Interventional_Levocabastine.xls |
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Document reference: 31108 |
Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (12-46 yrs) |
Active substance: LEVOCABASTINE |
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Document reference: 31111 |
Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (3-66 yrs) |
Active substance: LEVOCABASTINE |
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Document reference: 31112 |
Study title: Levocabastine eye drops in the treatment of vernal conjunctivitis: a double-blind comparison with placebo (5-59 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62491_Interventional_Levocabastine.xls |
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Document reference: 31104 |
Study title: Data collection for observational study (AWB) on tolerability of thyme preparations in children up to 12 years |
Active substance: Thyme , liquid extract (1:2-2,5) |
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Document reference: 40256 |
Study title: Muz V.A., Zubkova S.T. : Effects of antihomotoxic Thyreoidea compositum preparation in the treatment of children suffering from autoimmune thyreoiditis. Biological Therapy (Ukraine), 2003, 3: 31-34 [IIT-publication]; |
Active substance: Thyreoidea compositum |
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Document reference: 40259 |
Study title: Sysoeva N.A: Dynamics of selected homeostatic parameters in children suffering from thyroid gland pathology under the influence of combined treatment. Therapeutic Medico-Biological Vestnik, 2006, 9(2) [IIT-publication]; |
Active substance: Thyreoidea compositum |
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Document reference: 40258 |
Study title: Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44485 |
Study title: Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44486 |
Study title: Acta Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in tActa Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in t |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44487 |
Study title: AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL. AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44489 |
Study title: Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601 |
Active substance: TIAGABINE |
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Document reference: 38436 |
Study title: Safety and Efficacy of Three Dose Levels of Tiagabine HCl versus Placebo as Adjunctive Treatment for Complex Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38521 |
Study title: Safety and efficacy of Tiagabine HCl in the treatment of Pediatric Patients with Partial Seizures |
Active substance: TIAGABINE |
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Document reference: 38534 |
Study title: Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB. Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44524 |
Study title: Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S, Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44517 |
Study title: Kyobu Geka. 1979 Oct 1;32(10):772-80. [Thallium-201 myocardial scintigraphy and cardiac pool scintigraphy with technetium-99m labelled human serum albumin of complicated anomalous heart--their comparison with contrast angiography (author's transl] [ArtiKyobu Geka. 1979 Oct 1;32(10):772-80. [Thallium-201 myocardial scintigraphy and cardiac pool scintigraphy with technetium-99m labelled human serum albumin of complicated anomalous heart--their comparison with contrast angiography (author's transl] [Arti |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44662 |
Study title: Minn Med. 1983 Apr;66(4):229-33. A comparison of thallium-201 myocardial imaging with exercise-ECG and coronary angiography in 28 patients with suspected ischemic heart disease. Forstrom LA, Cook AM, Schwartz JS, Loken MK. Minn Med. 1983 Apr;66(4):229-33. A comparison of thallium-201 myocardial imaging with exercise-ECG and coronary angiography in 28 patients with suspected ischemic heart disease. Forstrom LA, Cook AM, Schwartz JS, Loken MK. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44664 |
Study title: Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S. Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44666 |
Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44669 |
Study title: COMPARE EFFICACY OF PROPHYLACTIC PREOPERATIVE DOSES OF FASIGYN 500 AND METROGYL AS ADJUNCTS TO ANTIMICROBIAL REGIMENS OF AMPICILLIN AND/OR GENTAMICIN IN ELECTIVE INTRAABDOMINAL OR PELVIC SURGERY. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-88-003 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 44775 |
Study title: Levocabastine nasal spray in the treatment of perennial rhinitis: a double-blind comparison with placebo following by an open comparison with beclomethasone (6.5-70 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62486_Interventional_Levocabastine.xls |
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Document reference: 31083 |
Study title: Levocabastine nasal spray in the treatment of rhinitis in asthmatic children: a double-blind comparison with placebo (6-15 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62485_Interventional_Levocabastine.xls |
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Document reference: 31077 |
Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate (17-63 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62437_Interventional_Levocabastine.xls |
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Document reference: 31091 |
Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a single blind comparison with beclomethasone and placebo |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD126855_Interventional_Levocabastine.xls |
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Document reference: 31057 |
Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a single-blind comparison with beclomethasone and placebo (12-50 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62488_Interventional_Levocabastine.xls |
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Document reference: 31080 |
Study title: Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996 |
Active substance: LEVOCABASTINE |
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Document reference: 31130 |
Study title: Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70. Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70. |
Active substance: LEVOCABASTINE |
Study summary document link (including results): |
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Document reference: 31140 |
Study title: Multicentre double-blind comparison of levocabastine eye drops with sodium cromoglycate in the treatment of seasonal allergic conjunctivitis (8-74 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD59786_Interventional_Levocabastine.xls |
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Document reference: 31110 |
Study title: AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E. AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44490 |
Study title: Phase 3, open-label, safety and efficacy, adjunctive or monotherapy study in adults with refractory partial epilepsy originally entered in Studies Y1/Y2/Y3, and who received PBO in the original study. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44872 |
Study title: Phase 3, randomized, double-blind, placebo-controlled, parallel study with an open-label extension designed to evaluate the safety and efficacy of topiramate in subjects 6 to 15 years of age who had headache symptoms that met the proposed IHS Classification of Pediatric Migraine with or without aura. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44935 |
Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44886 |
Study title: PRI/TOP GER 4 (Patients > 2 years) - Topamax in der Therapie kindlicher Epilepsien (Topamax in the therapy of Chillike Epilepsy) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44929 |
Study title: Safety and efficacy of Topamax in monotherapy or combined therapy in children and adult patient with epilepsy in an observational study with medium duration of 6 months. |
Active substance: TOPIRAMATE |
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Document reference: 44925 |
Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograpAnticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograp |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44518 |
Study title: Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44520 |
Study title: Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery |
Active substance: TRAMADOL |
Study summary document link (including results): Tramadol STUDY 86-04-95.xls |
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Document reference: 44995 |
Study title: OPEN CLINICAL STUDY ON THE ANALGESIC EFFICACY OF TRAMADOL (TRAMAL) IN CHILDREN WITH POST-OPERATIVE PAIN AFTER ABDOMINAL SURGERY |
Active substance: TRAMADOL |
Study summary document link (including results): synopsis-wis-al-tra86-04-95.pdf |
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Document reference: 45006 |
Study title: Open randomized clinical trial study to compare the efficacy and safety of Tramadol 2mg/Kg to pethidine 1 mg/Kg and to nalbuphine 0,1 mg/Kg in children with postoperative pain after lower abdominal surgery |
Active substance: TRAMADOL |
Study summary document link (including results): |
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Document reference: 44998 |
Study title: EFFICACY AND TOLERABILITY OF TINIDAZOLE IN 2 DIFFERENT DOSES. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-90-001 EMEA Pediatric Web Synopsis.pdf |
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Document reference: 44776 |
Study title: EFFICACY AND TOLERABILITY OF TINIDAZOLE, 2 DIFFERENT DOSES, IN INTESTINAL AMEBIASIS. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-90-002 EMA Paediatric Web Synopsis.pdf |
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Document reference: 44777 |
Study title: EFFICACY OF PROPHYLACTIC PREOPERATIVE USE OF FASIGYN AS AN ADJUNCT TO ANTIMICROBIAL REGIMENS OF AMPICILLIN AND/OR GENTAMICIN IN ELECTIVE INTRA-ABDOMINAL OR PELVIC SURGERY. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-88-002 EMEA Pediatric Web Synopsis.pdf |
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Document reference: 44774 |
Study title: EVALUATE EFFICACY AND TOLERATION OF FASIGYN 500 MG IN SYMPTOMATIC INTESTINAL AMEBIASIS. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-88-001 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 44773 |
Study title: THE TREATMENT OF AMOEBIASIS IN CHILDREN |
Active substance: TINIDAZOLE |
Study summary document link (including results): |
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Document reference: 44771 |
Study title: THE TREATMENT OF AMOEBIC LIVER ABSCESS IN CHILDREN |
Active substance: TINIDAZOLE |
Study summary document link (including results): |
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Document reference: 44772 |
Study title: A RANDOMIZED, ASSESSOR-BLIND, PARALLEL GROUP COMPARISON OF FASIGYN OS TBS. AND ENTAMIZOLE FORTE TBS. IN INTESTINAL AMEBIASIS WITH COLONIC SYMPTOMS. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-91-001 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 44778 |
Study title: THE TREATMENT OF GIARDIASIS IN CHILDREN |
Active substance: TINIDAZOLE |
Study summary document link (including results): |
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Document reference: 44770 |
Study title: THE TREATMENT OF T VAGINALIS INFECTIONS IN CHILDREN |
Active substance: TINIDAZOLE |
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Document reference: 44769 |
Study title: A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group.A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. |
Active substance: TINZANIDINE |
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Document reference: 44793 |
Study title: A multi−centre, double−blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia.A multi−centre, double−blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia. |
Active substance: TINZANIDINE |
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Document reference: 44797 |
Study title: A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain.A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain. |
Active substance: TINZANIDINE |
Study summary document link (including results): |
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Document reference: 44796 |
Study title: Randomized, double-blind study comparing efficacy and tolerance of 2 anti-allergic eye drops LEVOPHTA versus ALMIDE in allergic conjunctivitis |
Active substance: LEVOCABASTINE |
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Document reference: 31056 |
Study title: Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997 |
Active substance: LEVOCABASTINE |
Study summary document link (including results): |
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Document reference: 31127 |
Study title: Comparison of the onset of (i) Levocabastine nasal spray and (ii) levocabastine nasal spray plus eye drops with oral loratadine in subjects with seasonal allergic rhinitis |
Active substance: LEVOCABASTINE |
Study summary document link (including results): |
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Document reference: 31058 |
Study title: Conjunctival provocation test comparing levocabastine with cromoglycate and placebo (9-17 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62434_Interventional_Levocabastine.xls |
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Document reference: 31095 |
Study title: Double-blind comparison of levocabastine eye drops with placebo in patients with seasonal allergic conjunctivitis: a Belgian multicentre study (5-67 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62497_Interventional_Levocabastine.xls |
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Document reference: 31103 |
Study title: Double-blind comparison of levocabastine eye drops with placebo in the topical treatment of seasonal allergic conjunctivitis (7-66 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62494_Interventional_Levocabastine.xls |
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Document reference: 31102 |
Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate and placebo in the topical treatment of seasonal allergic conjunctivitis (9-55 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62496_Interventional_Levocabastine.xls |
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Document reference: 31100 |
Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate eye drops in the treatment of the ocular symptoms of seasonal allergic rhinoconjunctivitis |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62703_Interventional_Levocabastine.xls |
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Document reference: 31069 |
Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate in the topical treatment of season allergic conjunctivitis (9-54 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD59785_Interventional_Levocabastine.xls |
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Document reference: 31098 |
Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate in the topical treatment of perennial allergic rhinitis (8-49 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD59788_Interventional_Levocabastine.xls |
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Document reference: 31089 |
Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate in the topical treatment of season allergic rhinitis (8-42 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62484_Interventional_Levocabastine.xls |
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Document reference: 31078 |
Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate nasal spray in the treatment of seasonal allergic rhinitis (11-50 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62483_Interventional_Levocabastine.xls |
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Document reference: 31090 |
Study title: Study of the optimization of anti-epileptic treatment in paediatric patients |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44870 |
Study title: Topamax (topiramate) monotherapy comparison trial to standard monotherapy in the treatment of newly diagnosed epilepsy (rwj-17021-000); phase iiib |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44892 |
Study title: Topamax 1st line add on (patients >12 years). |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44968 |
Study title: TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom) (patients < 2 years) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44890 |
Study title: Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy) (patients > 2 years) |
Active substance: TOPIRAMATE |
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Document reference: 44889 |
Study title: Veränderungen durch Topamax - Die Sicht des Patienten (Changes through TOPAMAX - The View of the Patient) (patients > 2 years) |
Active substance: TOPIRAMATE |
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Document reference: 44888 |
Study title: J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44602 |
Study title: J Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, MalhotJ Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, Malhot |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44603 |
Study title: Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349)Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349) |
Active substance: TRAMADOL |
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Document reference: 45033 |
Study title: Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42) Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42) |
Active substance: TRAMADOL |
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Document reference: 45034 |
Study title: Preemptive analgesia with tramadol and fentamyl in paediatric neurosurgery - Chiaretti A and Coll. - 2000 (Child's Nerv Syst, 2000; 16: 93-100)Preemptive analgesia with tramadol and fentamyl in paediatric neurosurgery - Chiaretti A and Coll. - 2000 (Child's Nerv Syst, 2000; 16: 93-100) |
Active substance: TRAMADOL |
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Document reference: 45043 |
Study title: Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214)Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214) |
Active substance: TRAMADOL |
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Document reference: 45035 |
Study title: Jpn Heart J. 1990 Nov;31(6):867-74. Dipyridamole-induced ischemia in a child with jeopardized collaterals after Kawasaki syndrome. Yamamoto S, Matsuura H, Umezawa T, Saji T, Matsuo N, Yabe Y. Jpn Heart J. 1990 Nov;31(6):867-74. Dipyridamole-induced ischemia in a child with jeopardized collaterals after Kawasaki syndrome. Yamamoto S, Matsuura H, Umezawa T, Saji T, Matsuo N, Yabe Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44637 |
Study title: Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H. Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44553 |
Study title: Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44554 |
Study title: Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H. Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44557 |
Study title: Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC. Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44560 |
Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication] |
Active substance: Traumeel - Ampullen |
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Document reference: 40283 |
Study title: Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996 |
Active substance: LEVOCABASTINE |
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Document reference: 31129 |
Study title: Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000 |
Active substance: LEVOCABASTINE |
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Document reference: 31117 |
Study title: Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000 |
Active substance: LEVOCABASTINE |
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Document reference: 31133 |
Study title: Epidemiologische Begleituntersuchungen yur Gruppenprophylaxe 2000 - Gutachten (Prof. Dr. K. Pieper, im Auftrag der Deutschen Arbeitsgemeinschaft fuer Jugendzahnpflege, 2001 ISBN 3/926 228 16-4) |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24625 |
Study title: J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44607 |
Study title: EFFICACY AND SAFETY OF FLUCONAZOLE IN PATIENTS WITH OROPHARINGEAL CANDIDIASIS WITHOUT AIDS |
Active substance: FLUCONAZOLE |
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Document reference: 27404 |
Study title: J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44609 |
Study title: The influence of mucolytic treatment on patency of airways. |
Active substance: MESNA |
Study summary document link (including results): DE80H064P - Mesna.pdf |
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Document reference: 31681 |
Study title: 131I-metaiodobenzylguanidine (131I-MIBG) therapy for residual neuroblastoma: a mono-institutional experience with 43 patientsBritish Journal of Cancer (1999), 81(8), 1378-1384 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48316 |
Study title: Dahllof et al. Severe oral mucositis after therapeutic administration of [131I] MIBG in a child with neuroblastomaOral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct; 92(4):420-3 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): Dahllof G 2001.pdf |
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Document reference: 48329 |
Study title: Hoefnagel et al. 131I-MIBG as a first-line treatment in high-risk neuroblastoma patients, Nuclear medicine communications (1994), 15(9), 712-7 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48319 |
Study title: EFFECT OF PIROXICAM AND NAPROXEN ON MENSTRUAL PAIN AND ASSOCIATED SYMPTOMS IN PATIENTS WITH PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34425 |
Study title: EFFECT OF PIROXICAM ON PAIN, RESTRICTION OF FUNCTION AND DURATION OF SICK LEAVE IN PATIENTS WITH ACUTE LUMBAGO. |
Active substance: PIROXICAM |
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Document reference: 34424 |
Study title: EFFECT OF PIROXICAM ON POST OPERATIVE DENTAL PAIN, SWELLING AND TRISMUS FOLLOWING REMOVAL OF BILATERALLY IMPACKED THIRD MOLAR TEETH. |
Active substance: PIROXICAM |
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Document reference: 34476 |
Study title: Michon JM et al. An open-label, multicentre, randomised phase 2 study of recombinant human granulocyte colony-stimulating factor (filgrastim) as an adjunct to combination chemotherapy in paediatric patients with metastatic neuroblastoma. Eur J Cancer. 1998 Jun;34(7):1063-9Michon JM et al. An open-label, multicentre, randomised phase 2 study of recombinant human granulocyte colony-stimulating factor (filgrastim) as an adjunct to combination chemotherapy in paediatric patients with metastatic neuroblastoma. Eur J Cancer. 1998 Jun;34(7):1063-9 |
Active substance: MITOXANTRONE |
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Document reference: 32240 |
Study title: Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421 |
Active substance: MITOXANTRONE |
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Document reference: 32093 |
Study title: Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25. |
Active substance: METHOZSALEN |
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Document reference: 31716 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2003 |
Active substance: METAMIZOLE |
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Document reference: 31702 |
Study title: Painless dental extraction in children. |
Active substance: LIDOCAINE |
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Document reference: 31222 |
Study title: Randomisierte doppelblinde Pilotstudie mit parallelen Gruppen zum Vergleich von Dynexan A Gel (Prüfname KRL) mit Placebo zur Prüfung der Wirksamkeit und Verträglichkeit bei Zahnungsbeschwerden bei Kleinkindern und Festlegen geeigneter Instrumente. |
Active substance: LIDOCAINE |
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Document reference: 31216 |
Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain |
Active substance: LIDOCAINE |
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Document reference: 31237 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain |
Active substance: LIDOCAINE |
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Document reference: 31234 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain |
Active substance: LIDOCAINE |
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Document reference: 31233 |
Study title: Social functioning in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. |
Active substance: METOPIMAZINE |
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Document reference: 31964 |
Study title: Study of Vogalene drops in gastro-oesophageal reflux in nursing infants clinical, radiological, endoscopic and histological assessment - Ghisolfi J., Olives J.P., Rives J.J. - 09/1979 |
Active substance: METOPIMAZINE |
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Document reference: 31962 |
Study title: Vogalene suppositoire enfant et nourisson-dossier pharmaceutique (dossier de validation du 09/01/87) - No author - No date |
Active substance: METOPIMAZINE |
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Document reference: 31963 |
Study title: A Safety, Tolerability and Pharmacokinetics Study of TOPROL XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Patients: A Multicenter, Open-Label Extension of Protocol 307A |
Active substance: METOPROLOL |
Study summary document link (including results): D4020C00001 CSR Synopsis.pdf |
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Document reference: 31965 |
Study title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study. |
Active substance: METOPROLOL |
Study summary document link (including results): D4020C00033 CSR Synopsis.pdf |
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Document reference: 31966 |
Study title: Blood pressure results on patients treated with intravenous Metronidazole (FLAGYL). Study Blood Pressure |
Active substance: METRONIDAZOLE |
Study summary document link (including results): Metronidazole STUDY Blood Pressure.xls |
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Document reference: 47999 |
Study title: Clinical study comparing the effects of Lisuride and placebo in hyperkinetic children. |
Active substance: LISURIDE |
Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_EXC009_study_synopsis.pdf |
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Document reference: 31301 |
Study title: 107.208 - A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
Active substance: MELOXICAM |
Study summary document link (including results): Meloxicam_U03-1727_synopsis.pdf |
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Document reference: 31592 |
Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
Active substance: MELOXICAM |
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Document reference: 31594 |
Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
Active substance: MELOXICAM |
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Document reference: 31595 |
Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
Active substance: MELOXICAM |
Study summary document link (including results): Meloxicam_U03-1429_synopsis.pdf |
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Document reference: 31596 |
Study title: Melperone in low doses in anxious neurotic patients. A double-blind placebo-controlled clinical study. |
Active substance: MELPERONE |
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Document reference: 31599 |
Study title: Comparative study of Ibuprofen syrup and Paracetamol syrup in soft-tissue injuries in children |
Active substance: IBUPROFEN |
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Document reference: 29425 |
Study title: The effect of methylperon (Eunerpan) on aggressive and auto-aggressive behaviour in mentally retarded patients--a double blind study (author's transl)a |
Active substance: MELPERONE |
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Document reference: 31602 |
Study title: The pharmacological management of aggressive and autoaggressive behaviour in mentally retarded patients with melperone |
Active substance: MELPERONE |
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Document reference: 31601 |
Study title: Clinical study of Alkeran Injection as a pretreatment of hematopoietic stem cell transplantation in patients with pediatric cancer (including 1-year follow-up survey) |
Active substance: MELPHALAN |
Study summary document link (including results): Study-OM2000-00004-00 Melphalan.xls |
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Document reference: 31603 |
Study title: A double-blind comparison study of pivampicillin suspension and cefaclor suspension in the treatment of acute otitis media |
Active substance: PIVAMPICILLIN |
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Document reference: 46047 |
Study title: Absorption in children and Infants following oral administration of Pivampicillin; Part of SE/DK expert report. Prof. C simon (Kiel) |
Active substance: PIVAMPICILLIN |
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Document reference: 46048 |
Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coliAntibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli |
Active substance: PIVAMPICILLIN |
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Document reference: 46050 |
Study title: Comparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in childrenComparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46051 |
Study title: Comparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in childrenComparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46052 |
Study title: Comparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in childrenComparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46063 |
Study title: Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in childrenComparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46062 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 LEO sponsored |
Active substance: PIVAMPICILLIN |
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Document reference: 46049 |
Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain |
Active substance: LIDOCAINE |
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Document reference: 31230 |
Study title: A clinical study of plasma concentrations of lidocaine and prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part B) |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 20_85-EM09 (Part B) CSR Synopsis.pdf |
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Document reference: 31240 |
Study title: A clinical study of plasma concentrations of lidocaine and prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part B) |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 20_85-EM09 (Part B) CSR Synopsis.pdf |
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Document reference: 47238 |
Study title: A clinical study of the plasma concentrations of lidocaine, prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part C) |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 21_85-EM09 (Part C) CSR Synopsis.pdf |
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Document reference: 47237 |
Study title: Double-blind, randomised, active-control, dose-response, 4 parallel groups, 72-hour study. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD83859_Interventional_Loperamide oxide.xls |
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Document reference: 47583 |
Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain |
Active substance: LIDOCAINE |
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Document reference: 31232 |
Study title: Loracarbef in pediatric patients with skeletal infections |
Active substance: LORACARBEF |
Study summary document link (including results): Loracarbef - B9U-US-AZDD Synopsis with AE table.pdf |
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Document reference: 31451 |
Study title: Loracarbef: Multiple dose pharmacokinetics in paediatric patients |
Active substance: LORACARBEF |
Study summary document link (including results): Loracarbef - B9U-MC-AZAC Synopsis.pdf |
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Document reference: 31456 |
Study title: Publication: Single-dose treatment of giardiasis in children: a comparison of tinidazole and metronidazole - A.J. Gazder & coll. - 1977Publication: Single-dose treatment of giardiasis in children: a comparison of tinidazole and metronidazole - A.J. Gazder & coll. - 1977 |
Active substance: METRONIDAZOLE |
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Document reference: 31971 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuriaLong term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria |
Active substance: PIVAMPICILLIN |
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Document reference: 46061 |
Study title: " The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
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Document reference: 34662 |
Study title: "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" |
Active substance: PREDNICARBATE |
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Document reference: 34680 |
Study title: Open-label The study was conducted to evaluate the loperamide solutions since, it was found that the capsule form was not suitable for children on account of age. Children from 9 days to 2 years of age, hospitalised in a general paediatric assistance service for acute diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD10146_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31428 |
Study title: PLASMA AND MILK CONCENTRATIONS OF TOTAL 14C-COMPOUNDS AND OF UNCHANGED DRUG IN THE RAT AFTER ADMINISTRATION OF 14C-LABELLED PREPARATION |
Active substance: MAPROTILINE |
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Document reference: 31525 |
Study title: REPORT ON REPRODUCTIVE STUDY ON MAPROTILINE (BA 34276) IN RATS. (SEGMENT I AND SEGMENT III STUDY); ORIGIN=PCS JAPAN; CONTRACTOR=1; |
Active substance: MAPROTILINE |
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Document reference: 31527 |
Study title: A comparative study of the effectiveness of Pyrantel pamoate, mebendazol (Janssen) and generically equivalent mebendazole (Nordia) in intestinal helminthiasis in Papua New Guinea children. |
Active substance: MEBENDAZOLE |
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Document reference: 31548 |
Study title: A new broad spectrum anthelminhtic. |
Active substance: MEBENDAZOLE |
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Document reference: 31544 |
Study title: "Clean-up" follow-up sludy of mebendazale in an eradication program of trichuriasis. 1973 |
Active substance: MEBENDAZOLE |
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Document reference: 31545 |
Study title: Clinical evaluation of mebendazole in Taenia infestations. 1973 |
Active substance: MEBENDAZOLE |
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Document reference: 31541 |
Study title: Clinical Study of Vermox Trichoencaphalosis and other Helminthiases |
Active substance: MEBENDAZOLE |
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Document reference: 31535 |
Study title: Determination of lormetazepam and glucuronide in plasma and milk in mothers and in plasma of babies, women 2 - 3 days after delivery p.o. for 10 days |
Active substance: LORMETAZEPAM |
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Document reference: 31469 |
Study title: Intraoperative tolerance of lormetazepam I.V. (intravenous) in infants, children and adolescents |
Active substance: LORMETAZEPAM |
Study summary document link (including results): Bayer Pharma_Lormetazepam_80011_study_synopsis.pdf |
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Document reference: 31468 |
Study title: Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8.Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8. |
Active substance: MEFENAMIC ACID |
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Document reference: 31580 |
Study title: Double-blind studies with mefloquine and in combination with sulfadoxine-pyrimethamine in 120 adults and 120 children with falciparum malaria in Vietnam. Leimer R*,Anh T K,Kim N V,Arnold K,Chien V V,Bich N N,Thoa K,Ladinsky J |
Active substance: MEFLOQUINE |
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Document reference: 31585 |
Study title: Single dose pharmacokinetics of sulfadoxine, pyrimethamine and mefloquine in thai children following administration of one tablet Fansimef, Schwartz D E*,Weidekamm E,Heizmann P,Chongsuphajaisiddhi T,Portmann R |
Active substance: MEFLOQUINE |
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Document reference: 31586 |
Study title: Summary and comment on: Clinical study comparing the effects of Lisuride and placebo in hyperkinetic children |
Active substance: LITHIUM |
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Document reference: 31312 |
Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5 |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41234 |
Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5 |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41370 |
Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41244 |
Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41380 |
Study title: Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016.Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016. |
Active substance: PREDNISOLONE |
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Document reference: 34684 |
Study title: EFFICACY AND SAFETY OF FELDENE IN PATIENTS WITH PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34360 |
Study title: EFFICACY AND SAFETY OF FELDENE VS. INDOMETHACIN IN PATIENTS WITH R.A. |
Active substance: PIROXICAM |
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Document reference: 34309 |
Study title: EFFICACY AND SAFETY OF PIROXICAM AND MEFENAMIC ACID TAKEN AT THE ONSET OF MENSTRUAL PAIN BY PATIENTS SUFFERING FROM PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34337 |
Study title: EFFICACY AND SAFETY OF PIROXICAM AT THE ONSET OF PAIN DUE TO PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34432 |
Study title: EFFICACY AND SAFETY OF PIROXICAM DISPERSIBLE TABLETS IN THE TREATMENT OF PRIMARY DYSMENORRHEA COMPARED TO MEFENAMIC ACID AND HYOSCINE BUTILBROMIDE AND PYRAZOLONE. |
Active substance: PIROXICAM |
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Document reference: 34361 |
Study title: EFFICACY AND SAFETY OF PIROXICAM IN JUVENILE RHEUMOTOID ARTERITIC PATIENTS |
Active substance: PIROXICAM |
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Document reference: 34418 |
Study title: EFFICACY AND SAFETY OF PIROXICAM IN PATIENTS WITH JUVENILE RHEUMATOID ARTHRITIS. |
Active substance: PIROXICAM |
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Document reference: 34419 |
Study title: EFFICACY AND SAFETY OF PIROXICAM IN PATIENTS WITH OSTEROARTHRITIS OF THE KNEE. |
Active substance: PIROXICAM |
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Document reference: 34349 |
Study title: EFFICACY AND SAFETY OF PIROXICAM VS. KETOPROFENE IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34396 |
Study title: EFFICACY AND SAFETY OF PIROXICAM VS. PLACEBO IN THE TREATMENT OF CANCER PATIENTS. |
Active substance: PIROXICAM |
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Document reference: 34380 |
Study title: EFFICACY AND SAFETY OF PIROXICAM WHEN TAKEN AT THE ONSET OF PAIN DUE TO PRIMARY DYSMENORRHEA IN YOUNG WOMEN FROM 12 - 16 YEARS OF AGE. |
Active substance: PIROXICAM |
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Document reference: 34431 |
Study title: EFFICACY AND TOLERANCE OF FELDENE SUPP. WITH BEDTIME IN PATIENTS WITH OA OF KNEES AND OR HIPS. |
Active substance: PIROXICAM |
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Document reference: 34338 |
Study title: EFFICACY AND TOLERANCE OF PIROXICAM IN THE TREATMENT OF POSTOPERATIVE ABDOMINAL PAIN IN CHOLECYSTECTOMIZED PATIENTS. |
Active substance: PIROXICAM |
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Document reference: 34346 |
Study title: EFFICACY AND TOLERATION OF FELDENE DISPERSIBLE TABLETS IN COMPARISON WITH DISPERSIBLE ASA (DISPRIN) IN PATIENTS WITH NON-ARTICULRHEUMATIS. |
Active substance: PIROXICAM |
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Document reference: 34486 |
Study title: EFFICACY AND TOLERATION OF FELDENE DISPERSIBLE TBS. COMPARED TO PARACETAMOL IN POST EPISIOTOMY CASES ESP.IN REGARD TO ITS RELIEF OF POST SURGICAL PAIN. |
Active substance: PIROXICAM |
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Document reference: 34487 |
Study title: Clinical Trials an Mebendazole in the treatment of intestinal Nemalodes |
Active substance: MEBENDAZOLE |
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Document reference: 31530 |
Study title: Comparative drug trials on the efficacy of Mebendazole and Flubendazole in the treatrment of Trichuris trichiura and Ascaris lumbricoides infections In children. |
Active substance: MEBENDAZOLE |
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Document reference: 31532 |
Study title: Dose Range Study of Flubendazole in Children vith Ascaris lumbricoides and/ or Trichuris trichiura infections.1979 |
Active substance: MEBENDAZOLE |
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Document reference: 31533 |
Study title: Dose-range study of Flubendazole in the treatment of hookworm disease and trichuriasis. 1980 |
Active substance: MEBENDAZOLE |
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Document reference: 31540 |
Study title: Efficacy of single dose Mebendazole against soil- transmitted infestinal nematodes in elementary school chlldren. |
Active substance: MEBENDAZOLE |
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Document reference: 31551 |
Study title: Experiences uin the treatment of childhood oxyuriasis with Mebendazole |
Active substance: MEBENDAZOLE |
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Document reference: 31538 |
Study title: Mebendazole in the treatment of intestinal helminthiasis in low socie-economic group In Ujung Pandang, South Sulawesi 1974 |
Active substance: MEBENDAZOLE |
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Document reference: 31550 |
Study title: Mebendazole in the treatment of Symptomatic Trichuriasis. A preliminary Efficiency report. 1973 |
Active substance: MEBENDAZOLE |
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Document reference: 31546 |
Study title: Open trial of mebendazola in Trichuris trichiura and Hookworm Infections. 1972 |
Active substance: MEBENDAZOLE |
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Document reference: 31543 |
Study title: Prevention effort of erratic migration on medical treatment of intestinal worm disease with combination of Mebendazole and Pyrantel pamoate. |
Active substance: MEBENDAZOLE |
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Document reference: 31536 |
Study title: Clinical trial of Vermox supplied by the hungarien finn Medimpex 1976 |
Active substance: MEBENDAZOLE |
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Document reference: 31534 |
Study title: Clinical trial with mebendazole in schoolchildren 1972 |
Active substance: MEBENDAZOLE |
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Document reference: 31542 |
Study title: Single-blind comparison of flubendazole, mebendazole and placebo in the treatment of trichiuriasis ascariasis and hookworm disease. 1981 |
Active substance: MEBENDAZOLE |
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Document reference: 31531 |
Study title: Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7.Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7. |
Active substance: METHOZSALEN |
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Document reference: 31717 |
Study title: Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5. |
Active substance: METHOZSALEN |
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Document reference: 31719 |
Study title: Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4.Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4. |
Active substance: METHOZSALEN |
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Document reference: 31720 |
Study title: H. Machida. The pediatric patients with inflammatory bowel disease – “I am special?”. Canadian J Gastroenterol Vol.6 No 6 Nov/Dec 1992 H. Machida. The pediatric patients with inflammatory bowel disease – “I am special?”. Canadian J Gastroenterol Vol.6 No 6 Nov/Dec 1992 |
Active substance: MESALAZINE |
Study summary document link (including results): |
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Document reference: 31639 |
Study title: J. B. Punati et al. Safety of high dose oral mesalamine in pediatric patients with inflammatory bowel disease. Abstract # 1267 DDW New Orleans, 2004. J. B. Punati et al. Safety of high dose oral mesalamine in pediatric patients with inflammatory bowel disease. Abstract # 1267 DDW New Orleans, 2004. |
Active substance: MESALAZINE |
Study summary document link (including results): |
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Document reference: 31638 |
Study title: Observational study of the efficacy and safety of Salofalk 500mg/1000mg Granu-Stix for the acute and maintenance of remission treatment of ulcerative colitis patients |
Active substance: MESALAZINE |
Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofalk granules_Dr Falk Pharma GmbH.xls |
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Document reference: 31627 |
Study title: Lormetazepam intravenous as premedication in paediatric surgery |
Active substance: LORMETAZEPAM |
Study summary document link (including results): Bayer Pharma_Lormetazepam_79137_study_synopsis.pdf |
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Document reference: 46902 |
Study title: Assessment of the efficacy and safety of lymecycline compared to minocycline in the treatment of acne |
Active substance: LYMECYCLINE |
Study summary document link (including results): |
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Document reference: 31476 |
Study title: Efficacy and safety of Tetralysal 300mg compared to Vibramycin-D 100mg in subjects with acne vulgaris |
Active substance: LYMECYCLINE |
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Document reference: 31477 |
Study title: Klingebiel et al. Initial experiences in the treatment of children with metastatic and recurrent neuroblastoma using meta-iodobenzylguanidine Klinische Padiatrie (1986), 198(3), 230-6 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48320 |
Study title: ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557 |
Active substance: LEVOCARNITINE |
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Document reference: 31143 |
Study title: The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72 |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31142 |
Study title: Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975. |
Active substance: METHOZSALEN |
Study summary document link (including results): |
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Document reference: 31722 |
Study title: Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975. |
Active substance: METHOZSALEN |
Study summary document link (including results): |
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Document reference: 31724 |
Study title: A randomized, multi-center, single-blind, placebo-controlled cross-over study planned to assess the efficacy in the early part of the school day of two methylphenidate delivery system, Ritalin LA® 20 mg versus Concerta 18 and 36 mg. |
Active substance: METHYLPHENIDATE |
Study summary document link (including results): Ritalin-EMA spreadsheet_CRIT124DUS07.xls |
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Document reference: 47443 |
Study title: A double-blind parallel group study comparing EMLA cream 5% with placebo in capillary blood sampling of neonates |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 15_AG-EML-002 (87EM10) CSR Synopsis.pdf |
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Document reference: 47243 |
Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunisation with diphtheria-tetanus-pertussis-inactivated poliovirus-haemophilus influenzae b and hepatitis B vaccines using |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 14_DC-EMB-0002 CSR Synopsis.pdf |
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Document reference: 47244 |
Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunization with measles-mumbs-rubella vaccines using EMLA patch for the reduction of pain associated with subcutaneous injection in twelve month old infants, 1998 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 13_DC-EMB-0001 CSR Synopsis.pdf |
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Document reference: 47245 |
Study title: R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10. R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10. |
Active substance: MESALAZINE |
Study summary document link (including results): |
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Document reference: 31643 |
Study title: A clinical evaluation of UCB in paediatrics |
Active substance: MESNA |
Study summary document link (including results): DE75C051 - Mesna.pdf |
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Document reference: 31653 |
Study title: A clinical test of ucb 3983, a new mucolytic agent, in a department for anesthesia and intensive care. |
Active substance: MESNA |
Study summary document link (including results): |
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Document reference: 31687 |
Study title: A controlled trial of intermittent aerosol therapy with sodium 2 mercaptoethane sulfonate in patients with cystic fibrosis. |
Active substance: MESNA |
Study summary document link (including results): DE79A151 - Mesna.pdf |
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Document reference: 31659 |
Study title: A controlled trial of intermittent aerosol therapy with sodium 2-mercaptoethane sulphonate in patients with cystic fibrosis. |
Active substance: MESNA |
Study summary document link (including results): CE70L242 - Mesna.pdf |
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Document reference: 31661 |
Study title: Berezniuk V.V., Lamza H.B: Application of composite antihomotoxic preparations in the treatment of children suffering from acute sinusites. Biological Therapy (Ukraine), 2006, 2: 26-29 [IIT-publication] |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40064 |
Study title: A Pilot Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Memantine in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder (ADHD) Combined Type |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41492 |
Study title: Clinical observation and experience with memantine in the treatment of spastic movement disorders. |
Active substance: Memantine Hydrochloride |
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Document reference: 41487 |
Study title: Clinical study of the new antispastic agent Akatinol Memantine. |
Active substance: Memantine Hydrochloride |
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Document reference: 41488 |
Study title: Efficacy and tolerability of Akatinol Memantine in patients with neurogenic bladder dysfunction due to transverse lesion of the cord. |
Active substance: Memantine Hydrochloride |
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Document reference: 41490 |
Study title: Experience with memantine in the treatment of severe spastic and extrapyramidal movement disturbances in combination or following stereotactic surgery. |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41489 |
Study title: Study on the efficacy of peroral memantine in spastic patients (secondary to infantile cerebral lesion). |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41484 |
Study title: Therapy of spasticity with memantine - experiences of a multicentre trial. |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41486 |
Study title: Use of Akatinol Memantine in spasticity syndrome. |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41485 |
Study title: Assessment of the immunogenicity and safety of a meningococcal A/C diptheria conjugate vaccine administered in two-year old children in comparison with a licensed meningococcal A/C polysaccharide vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41268 |
Study title: Control of serogroup C meningococcal meningitis by mass vaccination in Catalonia (Spain). |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41254 |
Study title: The early prevention of asthma in atopic children (EPAAC(TM)) study. a multi-country, double blind, placebo-controlled, randomized, parallel group trial: evaluation of the efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for 18 months in preventing the onset of asthma in 12 to 24 months old children who suffer from atopic dermatitis and are sensitized to grass pollen and / or house dust mite allergens. |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): |
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Document reference: 31154 |
Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31383 |
Study title: Takashi Kiyohora, Departement of ophthalmology, School of medicine, Nihon University, Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes. 1989-1990.Takashi Kiyohora, Departement of ophthalmology, School of medicine, Nihon University, Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes. 1989-1990. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31365 |
Study title: Takeo Shimo et al, Central Research Laboratory, Hokuriku Seiyaku Co., Ltd. Oral Arthrotoxicity Study of NY-198 in adult rats. Internal report.Vernal keratoconjunctivitis in Thailand. Kosrirukvongs P, Vichyanond P, Wongsawad W. Asian Pac J Allergy Immunol. 2003 Mar;21(1):25-30. |
Active substance: LOMEFLOXACIN |
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Document reference: 31405 |
Study title: The combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in JapanThe combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in Japan |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31360 |
Study title: Astra Report A randomized, open label, comparative parallel group study to evaluate the efficacy and safety of EMLA® Cream and 1% Xylocaine® infiltration in males for relief of pain associated with the removal of genital warts by cryotherapy. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 11_93-EML-18 CSR Synopsis.pdf |
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Document reference: 47247 |
Study title: Astra Report No 802 10 AC 093-1 A Clinical Study On A Single Unit Dose Package of Emla (Emla Patch) and Emla 5% Cream Used to Reduse Pain From Venupuncture in Children. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 24_89 EM 04 CSR Synopsis.pdf |
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Document reference: 47236 |
Study title: Astra Report No 802-10 AC 064-1 Local anaesthesia with EMLA Cream for cautery of condylomata acuminata of the genital mucosa in women - effect of application time. 86EM04 (Part I) |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 09_86-EM04 CSR Synopsis.pdf |
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Document reference: 47249 |
Study title: Astra Report No. 802-10 AC 062-1 Local Anaesthesia with Emla Cream for Laser Treatment of Condylomata Acuminata in Women. A Double-blind Comparison with Placebo to Evaluate the Time of Onset and Duration of Anaesthesia of the Genital Mucosa. 86EM07 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 10_86-EM07 CSR Synopsis.pdf |
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Document reference: 47248 |
Study title: Astra Report No. 802-10 AC 094 Clinical Study On Two Single Unit Dose Packages (Emla Patch) and Emla 5 % Cream Used to Reduce Pain at I.V Cannulation in Children |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 29_88EM01 CSR Synopsis.pdf |
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Document reference: 47231 |
Study title: Biometrical analysis of a controlled double-blind crossover study on 48 patients. EMLA vs Placebo WG85EM01 (Astra Study 802-10 AC 068-1) |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 25_85-EM01 (WG85EM01) CSR Synopsis.pdf |
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Document reference: 47235 |
Study title: Determination of a minimum application time for efficacy of a 5% lidocaine-prilocaine cream, EMLA (Eutectic Mixture of Local Anaesthetics), used for relief of venipuncture pain in children. Astra Report 802-10 AC 015-2, March 31, 1983. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 07_81PO34 CSR Synopsis.pdf |
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Document reference: 47250 |
Study title: Double-blind evaluation of a lidocaine-prilocaine cream (EMLA) for venous cannulation pain in children |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 31_83-P029 CSR Synopsis.pdf |
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Document reference: 47229 |
Study title: Open-label, randomised, multicentre study; Patients aged between 24-47 months inclusive; had symptoms of diarrhoea for no longer than 48 hours just prior to entering the study; no history of chronic diarrhoea, had not received any other antidiarrhoeal treatment during this episode, and over 10 kg in weight. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD15842_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31439 |
Study title: "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997" "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997" |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32037 |
Study title: Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399)Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32034 |
Study title: Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80)Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32035 |
Study title: The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32036 |
Study title: The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117)The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32038 |
Study title: Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32040 |
Study title: Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32044 |
Study title: Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969 Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32049 |
Study title: Mexitil vs. Norpace: Multicenter study |
Active substance: MEXILETINE |
Study summary document link (including results): Mexiletine hydrochloride_U83-0384_synopsis.pdf |
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Document reference: 31978 |
Study title: Near asphyxiation of a neonate due to miconazole oral gelNear asphyxiation of a neonate due to miconazole oral gel |
Active substance: MICONAZOLE |
Study summary document link (including results): |
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Document reference: 31996 |
Study title: Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye.Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31359 |
Study title: Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye. No report date.Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31379 |
Study title: |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31523 |
Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Convulsions hypomagnésemique chez le nouveau-né - Stern L, Harpur ER - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31506 |
Study title: Open-label; Male and female patients aged between 2 and 72 months suffering from acute diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD7234_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31412 |
Study title: Open-label; Out-patients suffering from acute diarrhoea of different aetiologies. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD7451_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31413 |
Study title: Open-label; Out-patients with different types of acute diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD7570_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31416 |
Study title: Randomised, double-blind, parallel, multi-site, placebo-controlled factorial designed study. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD115307_Interventional_Loperamide hydrochloride.xls |
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Document reference: 31432 |
Study title: Randomised, parallel, double blind, multisite, placebo-controlled. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD162326_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31431 |
Study title: Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32.Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32. |
Active substance: LOPERAMIDE |
Study summary document link (including results): |
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Document reference: 31440 |
Study title: The effect of single dose mebendazole on the egg reduction rates (ERR) and cure rates (CR) in patients with Ascaris-, Trichuris- and hookworm infestations. 1985 |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31549 |
Study title: The efficacy of rnebendazole in the treatment of enterobius 1973 |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31552 |
Study title: The use of Mebendazol in the treatment of enterobiasis |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31537 |
Study title: Therapeutical effectiveness and safety of 2% mebendazole syrup In various helminthiases. 1975 |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31547 |
Study title: Downey, L.J. A multicentre, double-blind, placebo-controlled study of the efficacy and acceptability of mebeverine liquid in the treatment of the irritable bowel syndrome of childhood. (Non-organic recurrent abdominal pain).; Duphar Report 1985 No. H. 103.905/M |
Active substance: MEBEVERINE |
Study summary document link (including results): Mebeverinr-H.103.905M.pdf |
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Document reference: 31559 |
Study title: Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32048 |
Study title: Cancemi G. La chetonuria nei bambini operati di adenotonsillectomia Boll.Mal.Orecchio,Gola,Nano, 87,307,1969Cancemi G. La chetonuria nei bambini operati di adenotonsillectomia Boll.Mal.Orecchio,Gola,Nano, 87,307,1969 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32045 |
Study title: Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32043 |
Study title: Huguet P. Use of topically applied DR 1303 (lomefloxacin 0.3%) in comparison with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis. August 31, 1993. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31398 |
Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionJun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infection |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31358 |
Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31378 |
Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31393 |
Study title: Study of measles vaccination in child health centres in Paris |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41233 |
Study title: Study of measles vaccination in child health centres in Paris |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41369 |
Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31508 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31509 |
Study title: Phase II study of high-dose [131I] metaiodobenzylguanidine therapy for patients with metastatic pheochromocytoma and paragangliomaJ Clin Oncol. 2009 Sep 1; 27(25):4162-8. Epub 2009 Jul 27 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48317 |
Study title: Stable disease and improved health-related quality of life (HRQoL) following fractionated low dose 131I-metaiodobenzylguanidine (MIBG) therapy in metastatic paediatric paraganglioma: observation on false "reverse" discordance during pre-therapy work up and its implication for patient selection for high dose targeted therapyBasu et al. |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48310 |
Study title: Therapeutic use of 131I-metaiodobenzylguanidine (MIBG) in neuroblastoma: a phase II study in nine patientsMedical and pediatric oncology (1987), 15(4), 205-11 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48318 |
Study title: Grillage MG et al. A randomised, double-blind study of mebeverine versus dicyclomine in the treatment of functional abdominal pain in young adults.; Br J Clin Pract. 1990 May;44(5):176-9. |
Active substance: MEBEVERINE |
Study summary document link (including results): |
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Document reference: 31554 |
Study title: Martin, Dr. A.J. A multi-centre double-blind placebo controlled study of the efficacy and acceptability of the Mebeverine liquid in the treatment of the irritable bowel syndrome of childhood (non-organic recurrent abdominal pain); Duphar Report 1982 No. H.103.905 |
Active substance: MEBEVERINE |
Study summary document link (including results): |
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Document reference: 31558 |
Study title: Otte, RA. Medical report of a randomized, double-blind, placebo controlled study of Mebeverine liquid in the treatment of the acute symptoms of the irritable bowel syndrome of childhood (non-organic recurrent abdominal pain).; Duphar Report 1983 |
Active substance: MEBEVERINE |
Study summary document link (including results): Mebeverine-H.103.907.pdf |
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Document reference: 31557 |
Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli |
Active substance: MECILLINAM |
Study summary document link (including results): |
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Document reference: 31562 |
Study title: BASSALY M., BOROLOSSY A.W., MOUSA A.H. Oral therapy of urinary schistosomiasis with Lucanthone HCl. The effect of Meclizine HCl on the incidence of its side effects. J.EGYPT.MED.ASSOC. 1961. 44:704-11. |
Active substance: MECLIZINE HYDROCHLORIDE |
Study summary document link (including results): Bassaly.xls |
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Document reference: 47882 |
Study title: FAGAN J.E., KAPLAN B.J., RAYMOND J.E., EDGINGTON E.S. & AL. The failure of antimotion sickness medication to improve reading in developmental dyslexia: results of a randomized trial. J.DEV.BEHAV.PEDIATR. DEC-1988. 9(6):359-366. |
Active substance: MECLIZINE HYDROCHLORIDE |
Study summary document link (including results): Fagan.xls |
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Document reference: 47883 |
Study title: LEVINSON H.N. Dramatic favorable responses of children with learning disabilities or dyslexia and attention deficit disorder to antimotion sickness medications : four case reports. PERCEPT.MOT.SKILLS 1991. 73/3 PT 1,723-738 |
Active substance: MECLIZINE HYDROCHLORIDE |
Study summary document link (including results): Levinson.xls |
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Document reference: 47884 |
Study title: |
Active substance: MECLOZINE |
Study summary document link (including results): ADPE91M0302.pdf |
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Document reference: 31564 |
Study title: |
Active substance: MECLOZINE |
Study summary document link (including results): PDEE92L0503.pdf |
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Document reference: 31565 |
Study title: |
Active substance: MECLOZINE |
Study summary document link (including results): RAE90C1918P.pdf |
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Document reference: 31566 |
Study title: "Comparison of an intravenous pulse of methylprednisolone versus oral corticosteroid in severe acute rheumatic carditis: a randomized clinical trial - Camara EJ - March 2002 (Cardiol Young 12(2):119-24) - Publication in CES0735-EN-E01 - Leonetti L - 29/09/2007 -" |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): |
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Document reference: 31921 |
Study title: Controlled, double-blind group comparison of a twice daily (maximum 3 weeks) use of methylprednisolone aceponate 0.1 % cream and prednicarbate 0.25 % cream (Dermatop) in children with atopic dermatitis |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_87105_study_synopsis.pdf |
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Document reference: 47736 |
Study title: Double-blind, randomized, reference-controlled, multicenter, parallelgroup study to compare the efficacy and safety of Advantan ointment once daily with Protopic 0.03% ointment twice daily over maximum 3 weeks in 250 children and adolescents with atopic dermatitis |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_308962_study_synopsis.pdf |
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Document reference: 47734 |
Study title: Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31374 |
Study title: Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31389 |
Study title: Kazuto Kajihara, Department of Ophthalmology Ohtahara Red Cross Hospital, Keio University School of Medicine, Clinical study of a new synthetic antimicrobial agent, Lomefloxacin ophthalmic solution in bacterial external eye infections. 1989-1990.Kazuto Kajihara, Department of Ophthalmology Ohtahara Red Cross Hospital, Keio University School of Medicine, Clinical study of a new synthetic antimicrobial agent, Lomefloxacin ophthalmic solution in bacterial external eye infections. 1989-1990. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31366 |
Study title: Krivopustov S.P., Domanskiy O.B: Effectiveness of antihomotoxic remedies to treat pediatric mesenterial adenitis patients. Biological Therapy (Ukraine), 2006, 1: 30-32 [IIT-publication] |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40059 |
Study title: Samoilenko I.G.,Yulish E.I., Gadetskaya S.G., Buchtiarov E.V.: New approach to treat pediatric patients suffering from bronchial asthma associated with intracellular infection. Biological Therapy (Ukraine), 2006, 4: 10-13 [IIT-publication] |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40057 |
Study title: Bereznoi V.V., Marushko T.V., Orliuk I.B. et al.: Application of antihomotoxic preparations in the combined treatment of rheumatoid arthritis in pediatric patients.Biological Therapy (Ukraine), 2004, 1: 23-27 [IIT-publication] |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40056 |
Study title: Godovanetz Yu.D., et al: Effectiveness of antihomotoxic therapy in the correction of neurological and metabolical impairments in newborns suffered from perinatal hypoxic stress. Biological Therapy (Ukraine), 2004, 2: 16-23 and 3-4: 36-45 [IIT-publication |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40063 |
Study title: Double-blind, multinational, multicentre, parallel-group, placebo-controlled design clinical trial of the efficacy and safety of nebulized beclomethasone dipropionate (400 mcg b.i.d.) plus as needed salbutamol versus as needed salbutamol or as needed salbutamol/beclomethasone fixed combination, in the 12-week treatment of young childrem with asthma symptoms. |
Active substance: MADIPIDINE |
Study summary document link (including results): |
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Document reference: 31478 |
Study title: Comparative study of an acellular (P.M.sv.) and a whole cell (Wellcome) Pertussis vaccines com bined with Diphtheria and Tetanus vaccines in healthy infants according to 2 schedules in the U.K. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
Study summary document link (including results): |
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Document reference: 41410 |
Study title: Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 - |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31711 |
Study title: The prolongation of the EPAAC(TM) trial (early prevention of asthma in atopic children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (lctz-lctz, lctz-plc and plc-plc): evaluating the long term efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the epaactm trial (A00309). |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): ARVD02J2302 - Levocetirizine.pdf |
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Document reference: 31150 |
Study title: The prolongation of the EPAAC™ trial (Early Prevention of Asthma in Atopic Children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluating the long term efficacy and safety of levocetirizine (5 mg/mL oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the EPAAC™ trial (A00309) |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): A00384 - Levocetirizine - RPCE04B0203.pdf |
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Document reference: 47307 |
Study title: A Multiclinic Study of the Efficacy, Safety Tolerance and Pharmacology of a Range of Doses of PRIMAXIN (MK0787/MK0791) or Imipenem/Cilastatin in low Birth weight (LBW) Infants. |
Active substance: LEVODROPROPIZINE |
Study summary document link (including results): |
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Document reference: 31160 |
Study title: A Study of the Efficacy, Pharmaco-kinetics, Safety and Tolerability of Intravenously Administered Multiple doses of MK-787/MK-791 in Neonates, including Premature Infants. |
Active substance: LEVODROPROPIZINE |
Study summary document link (including results): |
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Document reference: 31161 |
Study title: A Study of the Pharmacology Profile, Safety and Tolerability of Intravenously Administered Single and Multiple Doses of MK0787/MK0791 in Neonates. |
Active substance: LEVODROPROPIZINE |
Study summary document link (including results): |
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Document reference: 31159 |
Study title: Humanitarian Use of Imipenem/Cilastatin Sodium in Neonates.Corboz RJ. Klinische Aspekte depressiver Zustände. Helv. Paediat. Acta 1983; 38: 425-437 |
Active substance: LEVODROPROPIZINE |
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Document reference: 31162 |
Study title: Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160 |
Active substance: LEVODROPROPIZINE |
Study summary document link (including results): |
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Document reference: 31163 |
Study title: Methylprednisolone aceponate milk (1x daily for 14 days): Its efficacy and tolerance in comparison to Alfason® Crelo (2x daily) in the treatment of acute eczema in children. |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_93116_study_synopsis.pdf |
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Document reference: 47735 |
Study title: Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5.Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5. |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): |
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Document reference: 31925 |
Study title: EMLA cream for the removal of mollusca contagiosa on patients with atopic dermatitis. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 27_86-EM14 CSR Synopsis.pdf |
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Document reference: 47233 |
Study title: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part I: Full term infants. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 22_85-EM15 (Part I) CSR Synopsis.pdf |
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Document reference: 31239 |
Study title: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part II: Full term infants. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 23_85-EM15 (Part II) CSR Synopsis.pdf |
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Document reference: 47222 |
Study title: Evaluate the pain relieving effect of EMLA Cream in oriental infants and possible adverse reactions. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 01_83-P013 CSR Synopsis.pdf |
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Document reference: 47223 |
Study title: Impact of a mass immunization campaign against serogroup C meningococcus in the Province of Quebec, Canada. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): link to document |
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Document reference: 41253 |
Study title: Results of a vaccination campaign in Brazil (1974 - 1975) using the meningococcal polysaccharide A + C vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41272 |
Study title: A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have RecUlTent and/or Persistent Acute Otitis Media |
Active substance: Levofloxacin |
Study summary document link (including results): LO FBO-OTMD-002.pdf |
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Document reference: 45233 |
Study title: A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting |
Active substance: Levofloxacin |
Study summary document link (including results): LOFBIV-PCAP-003.pdf |
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Document reference: 45231 |
Study title: Pharmacokinetics and Middle Ear Fluid Penetration of Levofloxacin in Children Undergoing Tympanostomy Tube Placement for Serious Otitis Media |
Active substance: Levofloxacin |
Study summary document link (including results): LOFBO-PHI-I09.pdf |
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Document reference: 45234 |
Study title: Voutilainen R et al. Masked clinical trial between lomefloxacin 0.3% (DR 1303) eye drops and fusidic acid 1% in patients with acute bacterial conjunctivitis. October 4, 1994. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31396 |
Study title: Willoughby CR, Tesh JM, McAnulty PA, Higgins C, Tesh SA, Wilby OK. Peri- and postnatal study in the rat (segment III). 1986. Internal Report |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31401 |
Study title: Willoughby CR, Tesh JM, McAnulty PA, Higgins C, Wilby OK, Tesh SA. Reproductive function and fertility study of NY-198 in the rat (segment I). 1987. Internal report. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31399 |
Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31371 |
Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 31386 |
Study title: Evaluation of Emla 5% Cream for Alleviation of Pain in Connection with Tetanus Vaccination in School Children. 83P027 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 26_83-P027 CSR Synopsis.pdf |
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Document reference: 47234 |
Study title: Lidocaine/prilocaine Cream (EMLA(R) Versus Infiltration Anaesthesia: A Comparison of the Analgesic Efficacy for Punch Biopsy and Electrocoagulation of Genital Warts in Men |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 32_86-EM26 CSR Synopsis.pdf |
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Document reference: 47228 |
Study title: Multi-centre, double-blind, randomised, placebo-control, dose-response, 4 parallel groups, 72-hour study. |
Active substance: loperamide oxide |
Study summary document link (including results): LMD84718_Interventional_Loperamide oxide.xls |
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Document reference: 47587 |
Study title: A Retrospective Analysis of the Effect of Kaletra (lopinavir/ritonavir) Compared with Viracept (nelfinavir) and Norvir (ritonavir) in HIV-Infected Pediatric Patients - Switzerland |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41523 |
Study title: De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35.De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35. |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41532 |
Study title: Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000 |
Active substance: LEVOCABASTINE |
Study summary document link (including results): |
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Document reference: 31135 |
Study title: Single-blind comparison of levocabastine eye drops with sodium cromoglycate eye drops in the treatment of season allergic conjunctivitis (15-59 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62436_Interventional_Levocabastine.xls |
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Document reference: 31097 |
Study title: The effect of levocabastine compared with sodium cromoglycate in patients with both birch and grass pollen allergy |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD125356_Interventional_Levocabastine.xls |
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Document reference: 31068 |
Study title: The efficacy of levocabastine eye drops in birch pollinosis a double-blind comparison with sodium cromoglycate in the area surrounding Linköping, Motala and Mjölby (6-19 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62429_Interventional_Levocabastine.xls |
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Document reference: 31106 |
Study title: The efficacy of levocabastine eye drops inn birch pollinosis: a double-blind comparison with sodium cromoglycate in the area surrounding Umeå (7-19 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62121_Interventional_Levocabastine.xls |
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Document reference: 31107 |
Study title: The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51.The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51. |
Active substance: LEVOCABASTINE |
Study summary document link (including results): |
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Document reference: 31139 |
Study title: A double-blind, randomised crossover trial to compare the efficacy of SARNA Lotion with Eurax Lotion in patients with generalised pruritus as a consequence of renal disease (uraemic pruritis). |
Active substance: MENTHOL/CAMPHOR |
Study summary document link (including results): Article 45_Ref_C0147_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 40067 |
Study title: Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390 |
Active substance: MICONAZOLE |
Study summary document link (including results): nawrot_miconazole.pdf |
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Document reference: 47618 |
Study title: An exploratory unblinded trail of Levovist (SH U 508A) used in B-mode sonography in comparison with radiologically monitored voiding cystourethrography in diagnosis of vesicoureterorenal reflux in children (with subsequent blinded reading of the results) |
Active substance: MICROPARTICLES OF GALACTOSE |
Study summary document link (including results): |
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Document reference: 31999 |
Study title: Open, uncontrolled dose finding study with SH U 454 as an echocardiographic contrast agent for clarification of congenital malformations involving the right heart in patients from 0 - 18 years |
Active substance: MICROPARTICLES OF GALACTOSE |
Study summary document link (including results): |
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Document reference: 32000 |
Study title: de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2.de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2. |
Active substance: MIDAZOLAM |
Study summary document link (including results): |
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Document reference: 32001 |
Study title: Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. |
Active substance: MIDAZOLAM |
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Document reference: 32005 |
Study title: Yoshie Ishiryu, Katsuhiro Suzuki, Department of Ophthalmology, Fukushima Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infections. No report date.Yoshie Ishiryu, Katsuhiro Suzuki, Department of Ophthalmology, Fukushima Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31375 |
Study title: Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31370 |
Study title: Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31385 |
Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31510 |
Study title: Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766) Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766) |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31522 |
Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur... |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
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Document reference: 31511 |
Study title: MAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaireMAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaire - Dr Ch. BLATRIX 11.04.72 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 246.6.004.xls |
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Document reference: 31512 |
Study title: |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33648 |
Study title: Phase I trial of the effectiveness and safety of loperamide oxide in the treatment of diarrhoea resulting from different pathophysiological mechanisms (12-75 yrs) |
Active substance: LOPERAMIDE AND SIMETICONE |
Study summary document link (including results): |
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Document reference: 31448 |
Study title: An evaluation of antiemetic agents in the control of vomiting in children. |
Active substance: MECLOZINE |
Study summary document link (including results): DE76M282P.pdf |
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Document reference: 31563 |
Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8. |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): |
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Document reference: 31569 |
Study title: A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11 |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): A679_M-5400-0144 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 31567 |
Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): MPAASC-0012-277 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 31568 |
Study title: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non Hormonal Contraceptive Users |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): A6791022 PhRMA Web Synopsis.pdf |
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Document reference: 48025 |
Study title: Therapeutic value of levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (9-46 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD56650_Interventional_Levocabastine.xls |
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Document reference: 31109 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate and placebo (9-52 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62487_Interventional_Levocabastine.xls |
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Document reference: 31079 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with placebo (12-81 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62507_Interventional_Levocabastine.xls |
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Document reference: 31084 |
Study title: Keiko Yano, Department of Ophthalmology, St. John Sakuramachi Hospital, Clinical experience with 0.3% LFLX ophthalmic solution, 1989-1990Keiko Yano, Department of Ophthalmology, St. John Sakuramachi Hospital, Clinical experience with 0.3% LFLX ophthalmic solution, 1989-1990 |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31368 |
Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionsKeizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31356 |
Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31376 |
Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31391 |
Study title: Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31373 |
Study title: Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31388 |
Study title: Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31369 |
Study title: Clinical and immunological study on RA27/3 and cendehill strains of rubella vaccines during a vaccination campaign in Brittany and Mayenne in France |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41361 |
Study title: Comparative study of 3 different strains of rubella vaccines |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41360 |
Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31513 |
Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUTRapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUT- 12/1967 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.002.xls |
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Document reference: 31514 |
Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg)Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. NAYRAC- 11/1967 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.001.xls |
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Document reference: 31515 |
Study title: "Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -" |
Active substance: METAMIZOLE |
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Document reference: 31712 |
Study title: Antipyretic therapy - Rajeshwari K. - 1997 (Indian Pediatr., 34; 5, 407-413) - Publication in a clinical overview - No author - 24/05/2006 - |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31691 |
Study title: Metamizole (dipyrone) drops versus paracetamol suppositories in the treatment of fever in childood. Switzerland |
Active substance: METAMIZOLE |
Study summary document link (including results): Metamizol STUDY X107-4028 SWITZERLAND.xls |
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Document reference: 47986 |
Study title: Metamizole (dipyrone) drops versus paracetamol suppositories in the treatment of fever in children. Mexico |
Active substance: METAMIZOLE |
Study summary document link (including results): Metamizol STUDY X107-4028 MEXICO.xls |
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Document reference: 47987 |
Study title: Metamizole (dipyrone) suppositories versus paracetamol suppositories in the treatment of fever in children. Final clinical and statistical report No.X107/4037 respectively X107/4/M/T/401/FI-Thailand, Hoechst AG, Frankfurt. Simasathien S. et al.;1995 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 - |
Active substance: METAMIZOLE |
Study summary document link (including results): Metamizol STUDY X107-4037 THAILAND.xls |
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Document reference: 31708 |
Study title: Pharmacokinetics and therapeutic study with Nimesulide suppositories in children with postoperative pain and inflammation - SCHARLI - No date |
Active substance: METAMIZOLE |
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Document reference: 31693 |
Study title: The Incidence of Bone Fractures in Depo-Medroxyprogesterone Acetate (DMPA) Users and Non-users in Women in the General Practice Research Database (GPRD) |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): DMPA GPRD EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48024 |
Study title: Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8 |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): |
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Document reference: 31570 |
Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8. |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 31575 |
Study title: A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11 |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 31574 |
Study title: Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8. Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8. |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 41621 |
Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 31578 |
Study title: Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6 |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 31572 |
Study title: Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 31384 |
Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionsMasakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31357 |
Study title: El Galamate B6 en paidopsiquiatriaFolch y Soler |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): GB6-Folch y Soler.pdf |
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Document reference: 48084 |
Study title: El GB6 en la disfuncion cerebral minimaEspadaler |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): GB6-Espadaler.pdf |
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Document reference: 48083 |
Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31486 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1994 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31694 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1995 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31695 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1996 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31696 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1998 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31697 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1999 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
View full study record |
Document reference: 31698 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2000 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31699 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2001 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31700 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2002 |
Active substance: METAMIZOLE |
Study summary document link (including results): |
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Document reference: 31701 |
Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: LEVONORGESTREL |
Study summary document link (including results): |
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Document reference: 31168 |
Study title: |
Active substance: LEVOPROMAZINE |
Study summary document link (including results): |
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Document reference: 31166 |
Study title: Analgesia Agents. Canad Anaesth Soc J 1972; 19/1: 87-96Analgesia Agents. Canad Anaesth Soc J 1972; 19/1: 87-96 |
Active substance: LEVOPROMAZINE |
Study summary document link (including results): |
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Document reference: 31165 |
Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis |
Active substance: LEVOPROMAZINE |
Study summary document link (including results): |
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Document reference: 31167 |
Study title: Hemodynamics and Pharmacokinetics of 24 Hour Infusion of Levosimendan in Children with Congenital Heart Disease after Cardiopulmonary Bypass Surgery: A Prospective, Randomised, Placebo-Controlled, Double-Blind, Single-Center Study |
Active substance: LEVOSIMENDAN |
Study summary document link (including results): |
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Document reference: 31169 |
Study title: Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8. |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): |
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Document reference: 31932 |
Study title: Hrachovy, R. A., Frost, J. D., Jr., Glaze, D. G., and Rose, D. Department of Neurology, Baylor College of Medicine, Houston, Texas 77030 Treatment of infantile spasms with methysergide and alpha-methylparatyrosine Epilepsia 1989;30:607-610. Hrachovy, R. A., Frost, J. D., Jr., Glaze, D. G., and Rose, D. Department of Neurology, Baylor College of Medicine, Houston, Texas 77030 Treatment of infantile spasms with methysergide and alpha-methylparatyrosine Epilepsia 1989;30:607-610. |
Active substance: METHYLSERGIDE |
Study summary document link (including results): |
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Document reference: 31957 |
Study title: Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166. |
Active substance: METHYLSERGIDE |
Study summary document link (including results): |
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Document reference: 31958 |
Study title: Alizaprida, nuevo antiemetico en pediatria. Evaluacion clinica comparativa a metoclopramida STUDY 89-00616- ES-00 |
Active substance: METOCLOPRAMIDE |
Study summary document link (including results): Metoclopramide STUDY 89-00616-ES-00.xls |
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Document reference: 47988 |
Study title: Etude comparative Alizapride/Metoclopramide (forme gouttes buvables). Prevention et traitement des nausees et vomissements provoques par Ia chimiotherapie antineoplasique chez le nourrisson et l'enfant. |
Active substance: METOCLOPRAMIDE |
Study summary document link (including results): Metoclopramide STUDY 1813D635.xls |
View full study record |
Document reference: 47991 |
Study title: 48 Hour Human Patch Test for Skin Irritation of a range of Oilatum Plus Lotion Formulations.A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9. |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): Article 45_Ref_C0472_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 31284 |
Study title: A single-centre, randomised, evaluator-blinded parallel-group study to compare the efficacy and safety of Oilatum Plus (antiseptic oil-based additive) and Q.V.Bath Oil (non antiseptic oil-based bath additive) in the treatment of atopic eczema. |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): |
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Document reference: 31283 |
Study title: Symptomastic magnesium deficiency in severe infantile gastroenteritis in Jamaica - Back EH, Montgomery RSD, Ward EE - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Symptomastic magnesium deficiency in severe infantile gastroenteritis in Jamaica - Back EH, Montgomery RSD, Ward EE - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31496 |
Study title: Mistabron treatment of patients with pulmonary complications in intensive medical care unit. |
Active substance: MESNA |
Study summary document link (including results): |
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Document reference: 31680 |
Study title: Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912)Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912) |
Active substance: MESNA |
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Document reference: 31648 |
Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31495 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31481 |
Study title: A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991 |
Active substance: MEPIVACAINE |
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Document reference: 31608 |
Study title: Garofalo, Salvatore; Briganti, Vito; Cavallaro, Sebastiano; Pepe, Ernesto; Prete, Marina; Suteu, Liana; Tavormino, Paolo: Nickel Gluconate - Mercurius Heel - Potentised Swine Organ Preparations. International Journal of Pediatric Otorhinolaryngology 2007 |
Active substance: Mercurius-Heel S |
Study summary document link (including results): |
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Document reference: 40068 |
Study title: Allaert; Comparison of Dynexan 2 % against Placebo; 2001 |
Active substance: LIDOCAINE |
Study summary document link (including results): Lidocaine_Dynexan study_00576.xls |
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Document reference: 45236 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31227 |
Study title: Evaluation of three topical anaesthetic agents against pain: a clinical study. |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31219 |
Study title: A multi-centre, double-blind, randomised, placebo-control, two parallel groups, 72 hour study in patients with chronic diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD86872_Interventional_Loperamide oxide.xls |
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Document reference: 47588 |
Study title: Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18 |
Active substance: LOPERAMIDE |
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Document reference: 31422 |
Study title: Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999)Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999) |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): |
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Document reference: 31285 |
Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate). |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): Article 45_Ref_C0474_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 31286 |
Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp. |
Active substance: LIQUID PARAFFIN AND TAR |
Study summary document link (including results): Article 45_Ref_C0200_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 31287 |
Study title: Treatment of needle punlcture pain in children with a new topical lidocaine/prilocaine preparation |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 05_81-P008 CSR Synopsis.pdf |
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Document reference: 47227 |
Study title: Efficacy and tolerability of Ambroxol Lozenges 20mg in relieving the pain of sore throat in adolescent patients with acute viral pharyngitis – A randomised, double-blind, placebo-controlled parallel group... |
Active substance: AMBROXOL |
Study summary document link (including results): Ambroxol Hydrochloride_U06-1404_Synopsis.pdf |
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Document reference: 46554 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate (6-39 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62504_Interventional_Levocabastine.xls |
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Document reference: 31092 |
Study title: Tolerance of levocabastine eye drops; an open study in volunteers and patients (13-65 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62435_Interventional_Levocabastine.xls |
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Document reference: 31096 |
Study title: Young patients with both birch and grass pollen allergy - the effect of levocabastine compared with sodium cromoglycate (7-16 yrs) |
Active substance: LEVOCABASTINE |
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Document reference: 31114 |
Study title: L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. |
Active substance: LEVOCARNITINE |
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Document reference: 31141 |
Study title: ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51) |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31146 |
Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ... |
Active substance: LEVOCARNITINE |
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Document reference: 31145 |
Study title: Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701..Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701.. |
Active substance: MIDAZOLAM |
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Document reference: 32007 |
Study title: Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9 |
Active substance: MIDAZOLAM |
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Document reference: 32008 |
Study title: Comparison of Miocamycin versus Amoxicillin in lower respiratory tract infections in children. Clinical response and effect on natural killer activity - C. Agostini et al. - Journal Internat. Medical Research 1988, 16; 305-311 |
Active substance: MIDECAMYCIN |
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Document reference: 32016 |
Study title: La miocamicina nel tratamento di infezione delle vie aeree in pazienti di età pediatrica - N. Principi, P. Marchisio, J. Onorato - G. Ital. Chemioter., 33, 129-134, 1986 |
Active substance: MIDECAMYCIN |
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Document reference: 32015 |
Study title: Studio comparativo tra miocamicina ed eritromicina nell'erradicazione di streptococco B-emolitico di Gruppo a ed influenza di miocamicina sulla fagocitosi dei polimorfonucleati verso streptococco autologo - M. Borzani, F. Varotto, L.Garlaschi, et al. - Riv. Inf. Ped. 1989, 1, 29-35 |
Active substance: MIDECAMYCIN |
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Document reference: 32014 |
Study title: Clinical trial for efficacy and safety of miglitol ( Bay m 1099) in insulin - dependent diabetic children - Petzinna D. and al. - 16/06/1994 Miglitol Initial Registration Dossier - 1995 - Part IV Vol 294 |
Active substance: MIGLITOL |
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Document reference: 32018 |
Study title: Clinical trial to assess the efficacy and tolerability of Bay m 1099 (Miglitol) in insulin-dependent diabetic children - H Schulz and al. - 27/11/1990 Migliotl Initial Registration Dossier - 1995 - Part IV Vol 292 |
Active substance: MIGLITOL |
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Document reference: 32019 |
Study title: Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300)Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300) |
Active substance: MILRINONE |
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Document reference: 32021 |
Study title: Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37 |
Active substance: LOPERAMIDE |
Study summary document link (including results): |
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Document reference: 31429 |
Study title: Double-blind, placebo-controlled study. Male and female paediatric patients; who had 4 or more watery bowel movements in the last 24 hours. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD10972_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31447 |
Study title: Double-blind, randomised, comparative study; Patients of 14 or more years of age with presence of incapacitating acute diarrhoea (four or more unformed stools during the 24-hour period prior to consultation) |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD8743_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31420 |
Study title: Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31516 |
Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31517 |
Study title: Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31518 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31519 |
Study title: Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of antiretrovirals. Pediatr Infect Dis J. 2005 Oct;24(10):867-73Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of anti... |
Active substance: lopinavir / ritonavir |
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Document reference: 41531 |
Study title: Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006 |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41530 |
Study title: A Comparative Trial of a Loperamide and Simethicone Combination Product vs Loperamide Alone, Simethicone Alone and Placebo in the Treatment of Acute Diarrhea With Gas-Related Abdominal Discomfort |
Active substance: LORACARBEF |
Study summary document link (including results): |
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Document reference: 31459 |
Study title: Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7. |
Active substance: MEFENAMIC ACID |
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Document reference: 41620 |
Study title: Comparison of the effectiveness of fennel and mefenamic acid on pain intensity in dysmenorrhoea.; Modaress Nejad V et al., East Mediterr Health J. 2006 May-Jul;12(3-4):423-7.Comparison of the effectiveness of fennel and mefenamic acid on pain intensity in dysmenorrhoea.; Modaress Nejad V et al., East Mediterr Health J. 2006 May-Jul;12(3-4):423-7. |
Active substance: MEFENAMIC ACID |
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Document reference: 41619 |
Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31377 |
Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31392 |
Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31372 |
Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date. |
Active substance: LOMEFLOXACIN |
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Document reference: 31387 |
Study title: Mizuto Suzuki, Department of ophthalmology, Nagatsuda Kosei General Hospital, Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infection. 1989-1990.Mizuto Suzuki, Department of ophthalmology, Nagatsuda Kosei General Hospital, Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infection. 1989-1990. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31364 |
Study title: Montero J, Pastor JC et al. Double blind clinical trial between lomefloxacin 0.3% (DR 1303) eye drops and gentamicin 0.3% in patients with acute bacterial conjunctivitis. December 15, 1994. |
Active substance: LOMEFLOXACIN |
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Document reference: 31395 |
Study title: Orzalesi N et al. Double masked double dummy clinical trial between Lomefloxacin (DR 1303) and Tobramycin eye drops in 2x40 subjects with microbiologically confirmed acute bacterial conjunctivitis with the objective to compare efficacy, safety and local tolerance. December 9, 1994. |
Active substance: LOMEFLOXACIN |
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Document reference: 31394 |
Study title: Patterson A, Agius-Fernandez A. Use of topically applied lomefloxacin 0.3% (DR 1303) in comparison to chloramphenicol 0.5% in the treatment of acute bacterial conjunctivitis. July 7, 1993. |
Active substance: LOMEFLOXACIN |
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Document reference: 31397 |
Study title: ASSESS THE ANALGESIC EFFICACY OF PIROXICAM IN A VARIETY OF PAINFUL CONDITIONS IN SPORTS MEDICINE, NOT SEVER ENOUGH TO REQUIRE M.S.. |
Active substance: PIROXICAM |
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Document reference: 34484 |
Study title: CLINICAL STUDY OF PIROXICAM SUPPOSITORY IN PATIENTS WITH OSTEOARTHRITIS LOW BACK PAIN AND PERIARTHRITIS HUMEROSCAPULARIS (III): A NATIONWIDE STUDY BY GENERAL PRACTIONERS. |
Active substance: PIROXICAM |
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Document reference: 34468 |
Study title: COMPARE SAFETY AND EFFICACY OF PIROXICAM WITH PROPOXYPHENE IN POST- OPERATIVE PAIN. |
Active substance: PIROXICAM |
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Document reference: 34463 |
Study title: COMPARISON OF PIROXICAM VS PARACETAMOL IN PATIENTS WITH DENTAL SURGERY |
Active substance: PIROXICAM |
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Document reference: 34433 |
Study title: D/B PARALLEL COMPARISON OF SINGLE DOSES OF PIROXICAM (TWO DOSE LEVELS), ASPIRIN & PLACEBO IN PATIENTS WITH POST-OPERATIVE PAIN |
Active substance: PIROXICAM |
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Document reference: 34310 |
Study title: D/B, PARALLEL, COMPARATIVE STUDY OF PIROXICAM(3-DOSAGE REGIMENS),IBUPROFEN & PLACEBO IN PATS WITH ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
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Document reference: 34311 |
Study title: DB, PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES) ASPIRIN & PLACEBO IN PATIENTS WITH POSTOPERATIVE DENTAL PAIN |
Active substance: PIROXICAM |
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Document reference: 34317 |
Study title: AN OPEN, NON-COMPARATIVE STUDY WITH PIROXICAM (FELDENE) IM IN THE TREATMENT OF PATIENTS WITH ACUTE LOW BACK PAIN |
Active substance: PIROXICAM |
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Document reference: 34356 |
Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ASPIRIN AND PLACEBO IN PATIENTS WITH POSTEPISIOTOMY PAIN. A MULTIPLE-CENTER STUDY. |
Active substance: PIROXICAM |
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Document reference: 34316 |
Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), AND PLACEBO IN PATIENTS WITH PRIMART DYSMENORRHEA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34314 |
Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), AND PLACEBO IN PATIENTS WITH PRIMART DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34315 |
Study title: DOUBLE-BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (THREE DOSAGE REGIMENS), IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DY SMENORRHEA |
Active substance: PIROXICAM |
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Document reference: 34319 |
Study title: DOUBLE-BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (THREE DOSAGE REGIMENS), IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA |
Active substance: PIROXICAM |
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Document reference: 34320 |
Study title: DOUBLE-BLIND RANDOMIZED COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PIROXICAM DT VS PLACEBO IN THE TREATMENT OF PATIENTS WITH NON- BACTERIAL PHARYNGOAMYGDALITIS |
Active substance: PIROXICAM |
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Document reference: 34350 |
Study title: DOUBLE-BLIND, PARALLEL, COMAPRATIVE STUDY OF ONCE DAILY DOSING OF PIROXICAM (THREE DOSAGE REGIMENS) IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA |
Active substance: PIROXICAM |
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Document reference: 34321 |
Study title: DRUG USE INVESTIGATIONAL OF FELDENE SUPPOSITORY IN THE TREATMENT OF VARIOUS DISEASES WITH PAIN |
Active substance: PIROXICAM |
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Document reference: 34467 |
Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
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Document reference: 31520 |
Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
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Document reference: 31521 |
Study title: Troubles during dentition. Study concerning treatment with a homeopatic complex preparation |
Active substance: Magnesium phosphoricum C6, Chamomilla recutita D6, Calcium carbonicum C8, Passiflora D6 |
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Document reference: 40066 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2004 |
Active substance: METAMIZOLE |
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Document reference: 31703 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2005 |
Active substance: METAMIZOLE |
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Document reference: 31704 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2006 |
Active substance: METAMIZOLE |
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Document reference: 31705 |
Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2007 |
Active substance: METAMIZOLE |
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Document reference: 31706 |
Study title: The analgesic effect of Tilidin in comparaison to Metamizol drops in posttraumatic pain in childhood - Von Bülow - 1988 (Therapiwoche 1988; 38: 1232-1234) |
Active substance: METAMIZOLE |
Study summary document link (including results): Metamizole magnesium_U05-1666_synopsis.pdf |
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Document reference: 31710 |
Study title: Three-year experience with Novalgin inj. In the treatment of acute pain in child age: analgetic effect, safety of treatment and incidence of indesirable effects. Kralinsky K. et al.; Cs Pediat 1998; 53:689-692 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 - |
Active substance: METAMIZOLE |
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Document reference: 31707 |
Study title: Ensayo clinico a doble ciego para el tratamiento de las afecciones respiratorias agudas con metoxibutropato en jarabe al 3% |
Active substance: METHOXYBUTROPATE |
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Document reference: 31726 |
Study title: Studio clinico controllato sull’efficacia e tollerabilità del metoxibutropato vs nimesulide in campo otorino laringoiatrico |
Active substance: METHOXYBUTROPATE |
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Document reference: 31725 |
Study title: Intensive cardiac management in patients with trisomy 13 or trisomy 18.; Kaneko Y et al., Am J Med Genet A. 2008 Jun 1;146A(11):1372-80Intensive cardiac management in patients with trisomy 13 or trisomy 18.; Kaneko Y et al., Am J Med Genet A. 2008 Jun 1;146A(11):1372-80 |
Active substance: MEFENAMIC ACID |
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Document reference: 31583 |
Study title: Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70 |
Active substance: MEFENAMIC ACID |
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Document reference: 31582 |
Study title: Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8 |
Active substance: MEFENAMIC ACID |
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Document reference: 31581 |
Study title: Perichondritis; Kadzombe EA et al., Lancet. 1988 Oct 29;2(8618):1010-1Perichondritis; Kadzombe EA et al., Lancet. 1988 Oct 29;2(8618):1010-1 |
Active substance: MEFENAMIC ACID |
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Document reference: 31577 |
Study title: Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8 |
Active substance: MEFENAMIC ACID |
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Document reference: 31576 |
Study title: Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91. Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91. |
Active substance: MEFENAMIC ACID |
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Document reference: 31573 |
Study title: Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5. Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5. |
Active substance: MEFENAMIC ACID |
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Document reference: 31579 |
Study title: Zusammenfassung der einzelberichte von 13 klinischen prufern uber paspertin-suppositorien fur kinder(8 mg metoclopramid pro zapfchen) - Hennies - 05/10/1971 |
Active substance: METOCLOPRAMIDE |
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Document reference: 31959 |
Study title: Etude comprative en double aveugle Alizapride versus Metopimazine dans les traitements des vomissements chez le nourrisson et l'enfant - Pr. Tron et coll. - 09/1988 |
Active substance: METOPIMAZINE |
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Document reference: 31961 |
Study title: Reiko Minagawa, Department of Ophthalmology, Kounan Hospital, Clinical effects of Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. 1989.Reiko Minagawa, Department of Ophthalmology, Kounan Hospital, Clinical effects of Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. 1989. |
Active substance: LOMEFLOXACIN |
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Document reference: 31363 |
Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
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Document reference: 31367 |
Study title: Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31497 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31499 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31500 |
Study title: Observational use study of the tolerability of Octenisept in premature infants in the neonatal intensive care unit of Innsbruck University Hospital. University clinic for paediatric and juvenile medicine. 2000. |
Active substance: OCTENIDINE |
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Document reference: 32739 |
Study title: HAB-053 |
Active substance: inactivated hepatitis a virus and hepatitis b surface antigen (rdna) |
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Document reference: 41482 |
Study title: Naproxen versus indomethacin as night-time medication for patients with rheumatoid arthritis |
Active substance: INDOMETHACIN |
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Document reference: 29971 |
Study title: Erfahrungen mit dem Präparat Bebulin bei Therapie von Patienten mit Hämophilie B (Lechner K 1974) (BEBULIN Experiences with Bebulin in the Therapy of Hemophilia B patients |
Active substance: FACTOR VIII INHIBITOR BYPASSING ACT |
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Document reference: 26992 |
Study title: Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41. |
Active substance: MITOXANTRONE |
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Document reference: 32208 |
Study title: Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22 |
Active substance: MITOXANTRONE |
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Document reference: 32148 |
Study title: Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan.Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan. |
Active substance: POLIDOCANOL |
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Document reference: 46072 |
Study title: Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112 |
Active substance: POLIDOCANOL |
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Document reference: 46069 |
Study title: Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328 |
Active substance: POLIDOCANOL |
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Document reference: 46071 |
Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 58. Protocol 3-278, Unpublished Report 172. |
Active substance: IBUPROFEN AND PARACETAMOL |
Study summary document link (including results): ibuprofen_paracetamol 3-278.pdf |
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Document reference: 47389 |
Study title: Kubba, H., MacAndie, C., Botma, M., Robison, J., O'Donnell, M., Robertson, G., and Geddes, N. Department of Otolaryngology Head and Neck Surgery, Royal Hospital for Sick Children, Yorkhill, Glasgow, UK. A prospective, single-blind, randomized controlled trial of antiseptic cream for recurrent epistaxis in childhood Clin.Otolaryngol.Allied Sci. 2001;26:465-468. |
Active substance: CHLORHEXIDINE_AND_NEOMYCIN |
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Document reference: 23934 |
Study title: Open label pharmacokinetic evaluation of single oral doses of dolasetron mesilate for the prevention of acute (24-hour) nausea and vomiting in paediatric cancer patients receiving moderately to highly emetogenic chemotherapy - Lariviere - 28 April 1995 |
Active substance: DOLASETRON |
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Document reference: 26302 |
Study title: Extension of Study LUI-01-00 in Austria: LUIVAC treatment under daily life conditions in patients with recurrent respiratory tract infections including obstructive pulmonary diseases |
Active substance: Bacterial lysate |
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Document reference: 41833 |
Study title: Morphine combined with doxapram or naloxone. A study of post-operative pain relief.Gupta et al. (Anaesthesia, 1974, Volume 29, pages 33-39) |
Active substance: Doxapram |
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Document reference: 48441 |
Study title: Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979 |
Active substance: CEFOTAXIME |
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Document reference: 23479 |
Study title: The influence of a synthetic antihistamine upon the bodyweight and height in children |
Active substance: Buclizine |
Study summary document link (including results): CE70A063-translation.pdf |
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Document reference: 42014 |
Study title: Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764. |
Active substance: BIOTIN |
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Document reference: 22625 |
Study title: A comparison of Pivmecillinam and Co-trimoxazole in the treatment of simple cystitis in general practice; D. Guttmann, J of antimicrobial chemotherapy 1977, 3 suppl. B 137-140 A comparison of Pivmecillinam and Co-trimoxazole in the treatment of simple cystitis in general practice; D. Guttmann, J of antimicrobial chemotherapy 1977, 3 suppl. B 137-140 |
Active substance: PIVMECILLINAM |
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Document reference: 34528 |
Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli; Thoren A. et al Journal of Infectious Diseases, 1980, 141: 27-31 Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli; Thoren A. et al Journal of Infectious Diseases, 1980, 141: 27-31 |
Active substance: PIVMECILLINAM |
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Document reference: 34530 |
Study title: Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994.Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994. |
Active substance: PREDNISOLONE |
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Document reference: 34685 |
Study title: Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34563 |
Study title: A twelve week, double-blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with specific written language difficulties (dyslexia). |
Active substance: PIRACETAM |
Study summary document link (including results): DE84G047 - Piracetam.pdf |
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Document reference: 45895 |
Study title: Acao do piracetam no tratamento de criancas com paralisia cerebral. |
Active substance: PIRACETAM |
Study summary document link (including results): DP76D141P - Piracetam.pdf |
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Document reference: 45971 |
Study title: SPECIAL INVESTIGATION FOR LONG-TERM USE ON RELPAX |
Active substance: ELETRIPTAN |
Study summary document link (including results): A1601093 EMA Paediatrics Web Synopsis.pdf |
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Document reference: 26360 |
Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - SOUTH AMERICA |
Active substance: Hepatitis A Vaccine for Children (80 U/dose) |
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Document reference: 40915 |
Study title: A double-blind, placebo-controlled study to compare different treatments for acute wheezy bronchitis in 123 children aged 1.5-18 months. |
Active substance: BUDESONIDE |
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Document reference: 48430 |
Study title: A double-blind, randomised, comparative study of the effect of nebulised budesonide (Pulmiocort) and adrenaline in acute laryngo-tracheo-bronchitis (croup) |
Active substance: BUDESONIDE |
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Document reference: 48426 |
Study title: A new mode of administering metered-dose inhalers (MDIs) to infants by adapting a face-mask to a spacer through a connection with an adjustable expiratory flow resistance. 8 infants with intermittent clinical signs of obstructive lung function aged 12-36 months |
Active substance: BUDESONIDE |
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Document reference: 48417 |
Study title: A prospective, double-blind, parallel study to investigate the effect on the baseline adrenal function of increasing doses of topical steroids in 41 children (aged 7-15 years) with mild bronchial asthma. |
Active substance: BUDESONIDE |
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Document reference: 48408 |
Study title: A randomised cross-over study of two consecutive week treatment periods to compare the ease of handling and application by the parents and the acceptability by the child of two spacer devices, NebuChamber® and Babyhaler®, in the treatment of young children aged 6 – 59 months with symptoms of asthma. |
Active substance: BUDESONIDE |
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Document reference: 48424 |
Study title: A randomized, double-blind study to test the hypothesis that a reduction of bronchial hyperresponsiveness after treatment with an inhaled corticosteroid would result in an enhanced tolerance to an antigen in 38 patients (7-14 years). |
Active substance: BUDESONIDE |
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Document reference: 48414 |
Study title: Comparison of three topical antimicrobials for acute bacterial conjunctivitis. Lohr JA, Austin RD, Grossman M, Hayden GF, Knowlton GM, Dudley SM. Pediatr Infect Dis J. 1988 Sep;7(9):626-9. Comparison of three topical antimicrobials for acute bacterial conjunctivitis. Lohr JA, Austin RD, Grossman M, Hayden GF, Knowlton GM, Dudley SM. Pediatr Infect Dis J. 1988 Sep;7(9):626-9. |
Active substance: PREDNISOLONE AND SULFACETAMIDE |
Study summary document link (including results): Comparison of three topical antimicrobials.pdf |
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Document reference: 46112 |
Study title: Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361 |
Active substance: PREDNISONE |
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Document reference: 34689 |
Study title: Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157 |
Active substance: PREDNISONE |
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Document reference: 34688 |
Study title: Pregabalin BID Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study in Patients With Partial Seizures (Protocol 1008-034) |
Active substance: pregabalin |
Study summary document link (including results): 1008-034 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48039 |
Study title: PREGABALIN BID OPEN-LABEL ADD-ON TRIAL: AN OPEN-LABEL, MULTICENTER FOLLOW-ON STUDY TO DETERMINE LONG-TERM SAFETY AND EFFICACY IN PATIENTS WITH PARTIAL SEIZURES |
Active substance: pregabalin |
Study summary document link (including results): 1008-035 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41578 |
Study title: Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975 |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32046 |
Study title: Montefusco S.,Masciullo V.,Fiorani F.,Longo A. Biochetasi fiale e bustine nel trattamento del vomito nella gestosi gravidica Quad.Clin.Ostet.Ginecol.,39(2),139-143,1984Montefusco S.,Masciullo V.,Fiorani F.,Longo A. Biochetasi fiale e bustine nel trattamento del vomito nella gestosi gravidica Quad.Clin.Ostet.Ginecol.,39(2),139-143,1984 |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32042 |
Study title: Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975 |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32047 |
Study title: Safety and tolerability of Kiddi Pharmaton Fizz effervescent tablets, comparing the marketed formula with an improved one with a reduced mineral amount, and a comparator product: A double-blind, controlled, randomised, three arm cross-over study in children. |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32039 |
Study title: Baker KS et al Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV J Clin Oncol. 2000 Jun;18(12):2427-34Baker KS et al Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV J Clin Oncol. 2000 Jun;18(12):2427-34 |
Active substance: MITOXANTRONE |
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Document reference: 32146 |
Study title: Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9 |
Active substance: MITOXANTRONE |
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Document reference: 32108 |
Study title: Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39934 |
Study title: A randomized, double-blind study to test the hypothesis that treatment with an inhaled anti-inflammatory drug (BUD) but not an inhaled beta-agonist (terbutaline) would reduce bronchial responsiveness in children with asthma ad with minimal or no bronchoconstriction in 19 children (7-16 years) with allergic asthma and minimal or no bronchoconstriction attending an outpatient respiratory clinic. |
Active substance: BUDESONIDE |
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Document reference: 48411 |
Study title: A randomized, double-blind to compare the long-term effect in children (7-16 years) of regular bronchodilator plus antiinfalmmatory treatment using inhaled corticosteroids with regular bronchodilator treatment alone |
Active substance: BUDESONIDE |
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Document reference: 48421 |
Study title: An open study to assess the optimal dose of BUD for patients (7-80 years) with asthma of mild to moderate severity. |
Active substance: BUDESONIDE |
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Document reference: 48428 |
Study title: An open-label study to evaluate the efficacy and tolerability of budesonide (Pulmicort®) administered by Nebuhaler® (a large volume spacer) in a Kenyan Negroid population (Men or women, 16 years or above) who had not been treated with inhaled GCS during the previous three months. |
Active substance: BUDESONIDE |
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Document reference: 48425 |
Study title: An open, prospective study to evalute the efficacy and safety of a 1-year administration of inhaled BUD via a spacer device in 16 children (3.5-7 years) with severe asthma lasting from 1 to 4 years (mean 3 years). |
Active substance: BUDESONIDE |
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Document reference: 48412 |
Study title: An open, prospective study to investigate the respiratory membrane permeability to plasma proteins and its relatio to bronchial hyperreactivity. In addition, the effect of therapy with inhaled glucocorticosteroids in 14 patients with stable bronchial asthma and eight healthy volunteers (range, 16 to 68 yr). |
Active substance: BUDESONIDE |
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Document reference: 48418 |
Study title: Comparision of equal dose of budesonide inhaled from a Nebuhaler (aerosol) and from a Turbuhaler (powder) in a 4-weeks cross-over study in asthmatic children 10 - 15 years old |
Active substance: BUDESONIDE |
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Document reference: 48435 |
Study title: Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984 |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32041 |
Study title: Effect of methyldopa, propranolol, and propranolol plus minoxidil in the management of hypertension associated with renal disease in children. |
Active substance: MINOXIDIL |
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Document reference: 32063 |
Study title: Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554 |
Active substance: MINOXIDIL |
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Document reference: 32056 |
Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8 |
Active substance: MITOXANTRONE |
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Document reference: 32232 |
Study title: Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25 |
Active substance: MITOXANTRONE |
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Document reference: 32157 |
Study title: Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14 |
Active substance: MITOXANTRONE |
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Document reference: 32168 |
Study title: Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80 |
Active substance: MITOXANTRONE |
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Document reference: 32202 |
Study title: Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9. |
Active substance: MITOXANTRONE |
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Document reference: 32176 |
Study title: Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58.Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58. |
Active substance: MITOXANTRONE |
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Document reference: 32234 |
Study title: Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9.Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9. |
Active substance: MITOXANTRONE |
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Document reference: 32245 |
Study title: Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8 |
Active substance: MITOXANTRONE |
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Document reference: 32149 |
Study title: Tanaka K et al High-dose chemotherapy and autologous peripheral blood stem-cell transfusionafter conventional chemotherapy for patients with high-risk Ewing's tumors J Orthop Sci. 2002;7(4):477-82Tanaka K et al High-dose chemotherapy and autologous peripheral blood stem-cell transfusionafter conventional chemotherapy for patients with high-risk Ewing's tumors J Orthop Sci. 2002;7(4):477-82 |
Active substance: MITOXANTRONE |
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Document reference: 32111 |
Study title: Doppelblinde, randomisierte, Placebo-kontrollierte klinische Studie zum Nachweis der therapeutischen Wirksamkeit und Verträglichkeit von Natriumbituminosulfonat-haltigen Dragees bei Akne vulgarisTraumatic lesions of adrenal glands in paediatrics: about three cases; Capaccio E; Radiol. Med.; 2006 vol.111 p.906-910 |
Active substance: GADOTERIC ACID |
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Document reference: 28873 |
Study title: Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8. |
Active substance: MITOXANTRONE |
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Document reference: 32207 |
Study title: Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29 |
Active substance: MITOXANTRONE |
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Document reference: 32096 |
Study title: Paulussen M et al. EICESS 92 (European Intergroup Cooperative Ewing's Sarcoma Study)-preliminary results Klin Padiatr. 1999 Jul-Aug;211(4):276-83Paulussen M et al. EICESS 92 (European Intergroup Cooperative Ewing's Sarcoma Study)-preliminary results Klin Padiatr. 1999 Jul-Aug;211(4):276-83 |
Active substance: MITOXANTRONE |
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Document reference: 32182 |
Study title: Paulussen M et al. Second malignancies after ewing tumor treatment in 690 patients from a cooperative German/Austrian/Dutch study. Ann Oncol. 2001 Nov;12(11):1619-30.Paulussen M et al. Second malignancies after ewing tumor treatment in 690 patients from a cooperative German/Austrian/Dutch study. Ann Oncol. 2001 Nov;12(11):1619-30. |
Active substance: MITOXANTRONE |
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Document reference: 32179 |
Study title: Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91 |
Active substance: MITOXANTRONE |
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Document reference: 32247 |
Study title: Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children; Alam A.N. et al, 1994, Scand J Gastroenterol, 29: 313-317 Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children; Alam A.N. et al, 1994, Scand J Gastroenterol, 29: 313-317 |
Active substance: PIVMECILLINAM |
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Document reference: 34537 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 |
Active substance: PIVMECILLINAM |
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Document reference: 34536 |
Study title: Adler – Effective Treatment of Constipation and Encopresis with MOVICOL (Macrogol 3350 with electrolytes) in Children and Adolescents. |
Active substance: POLIDOCANOL COMBINATIONS |
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Document reference: 34581 |
Study title: Dyslexia: diagnosis and treatment in children with piracetam on an out-patient basis. |
Active substance: PIRACETAM |
Study summary document link (including results): DE84D277 - Piracetam.pdf |
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Document reference: 45982 |
Study title: Effect of piracetam on endocrine activities, linear growth, puberty and cognitive functions in 60 children with learning disabilities. a double-blind study of 24 and 52 weeks. Part I - endocrinological aspects. Part II - psychological aspects. |
Active substance: PIRACETAM |
Study summary document link (including results): CE88K241 - Piracetam.pdf |
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Document reference: 45901 |
Study title: Multicenter, double-blind, multiple-dose, placebo-controlled dose-response study of ebastine in children with seasonal ragweed allergy |
Active substance: EBASTINE |
Study summary document link (including results): RP-64305X-106_Ebastine_EUdraCT_reduced datafields-CP-Almirall.xls |
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Document reference: 48069 |
Study title: A phase II, controlled, single-center study to assess safety and immunogenicity of a primary vaccination course with one dose of Haemophilus influenzae type b (Hib) conjugate vaccine containing Aluminum Phosphate (Hib/AlPO4 vaccine), given alone or concomitantly with Measles, Mumps and Rubella Vaccine (MMR, Morupar®, licensed by Chiron, now Novartis Vaccines and Diagnostics), in healthy children 12-15 months of age. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48391 |
Study title: an observer blind, randomized, parallel groups, single-center, exploratory Phase IV study to evaluate immunogenicity of two intramuscular doses of influenza vaccine in pediatric subjects. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48387 |
Study title: Prasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papillomaPrasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papilloma |
Active substance: INOSINE |
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Document reference: 30158 |
Study title: Efficacy and usability of Sch 1000 in capsules with powder inhalator in paediatrics (pilot study). Phase III. |
Active substance: IPRATROPIUM |
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Document reference: 30569 |
Study title: Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2) |
Active substance: PRISTINAMYCIN |
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Document reference: 46115 |
Study title: Bibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English VersionBibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English Version |
Active substance: PRISTINAMYCIN |
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Document reference: 46116 |
Study title: Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74. |
Active substance: MITOXANTRONE |
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Document reference: 32212 |
Study title: Phase IV, double- blind, double-dummy, multicenter clinical study randomized in two parallel groups comparing the efficacy and safety of pristinamycin (PYOSTACINE) at an oral dose of 1 gram twice a day for ten days versus oxacillin (BRISTOPEN) at an oral dose of 1 gram twice a day for 10 days in the treatment of superficial bacterial skin infections in 250 outpatients. Study report PY 403 - Phase IV, double blind, double-dummy, multicenter clinical study, randomised, in two parallel groups, comparing the efficacy and safety of pristinamycin (Pyostacine®) at the posology of 1 gramm orally twice a day for 10 days, versus oxacilline (Bristopen®) at the posology of 1 gramm orally twice a day for 10 days, in the treatment of superficial cutaneous bacterial infections in 250 out-patient. -... |
Active substance: PRISTINAMYCIN |
Study summary document link (including results): Pristinamycin STUDY SPECIA PY 403.xls |
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Document reference: 46118 |
Study title: Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommittee of the French Society of Paediatric Oncology (SFOP). British journal of cancer, {Br-J-Cancer}, Nov 1999, vol. 81, no. 5, p. 835-40, ISSN: 0007-0920.Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommi... |
Active substance: PROCARBAZINE |
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Document reference: 34697 |
Study title: Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658 |
Active substance: MINOXIDIL |
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Document reference: 32051 |
Study title: The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34575 |
Study title: Dry and Itching Skin - therapy with a new preparation, containing urea and polidocanol. |
Active substance: POLIDOCANOL AND UREA |
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Document reference: 34578 |
Study title: Clinical study of piracetam in paediatric neuro-psychiatry. |
Active substance: PIRACETAM |
Study summary document link (including results): DE73G025 - Piracetam.pdf |
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Document reference: 45925 |
Study title: Clinical use of piracetam in epileptic patients. |
Active substance: PIRACETAM |
Study summary document link (including results): PDEE91A1702 - Piracetam.pdf |
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Document reference: 45928 |
Study title: Comparison effects of vascular preparates in patients with cerebrovascular pathology. |
Active substance: PIRACETAM |
Study summary document link (including results): PDEE97C1402 - Piracetam.pdf |
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Document reference: 46005 |
Study title: Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996. Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996. |
Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
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Document reference: 30965 |
Study title: Comparison of cimetidine and diphenhydramine in the treatment of acute urticaria, Moscati R.M., Ann. Emerg. Med. 1990; 19: 12-15 |
Active substance: Dextromethorphan + Diphenhydramine + L-Menthol |
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Document reference: 25867 |
Study title: Hamann K.-F. and Bonkowsky V., Minzöl - Wirkung auf die Nasenschleimhaut von Gesunden, DAZ 15/1987 pp.:855-858 |
Active substance: Mint oil, partly dementolised (HERB) |
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Document reference: 40072 |
Study title: Clinical report on the efficacy and tolerability of miocamycin (HM/MIO) in paediatric patients with respiratory tract infections |
Active substance: MIOCAMYCIN |
Study summary document link (including results): Miocamycin_Synopses.doc |
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Document reference: 47538 |
Study title: A 24 week double−blind, randomised controlled trial comparing the efficacy, tolerability and health economic aspects of mirtazapine and paroxetine in depressed patients presenting to their general practitioners in the United Kingdom. |
Active substance: MIRTAZAPINE |
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Document reference: 32069 |
Study title: A multicenter, randomized, double−blind, placebo−controlled, efficacy and safety study of Remeron in outpatient children and adolescents with major depressive disorder |
Active substance: MIRTAZAPINE |
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Document reference: 32065 |
Study title: Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223 |
Active substance: MITOXANTRONE |
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Document reference: 32171 |
Study title: Results of plasma samples analysis for mivacurium from a study of the efficacy and safety of mivacurium in paediatric patients (P45-19). TBZZ/89/0014/00 referenced in THRS/89/0031 as available on request (in D921698) . |
Active substance: MIVACURIUM |
Study summary document link (including results): Study TBZZ-89-0014-00-Mivacurium Chloride.xls |
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Document reference: 32256 |
Study title: Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie. |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46074 |
Study title: Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46075 |
Study title: CLINICAL EXPERIENCE OF COMPARISON OF THREE DIFFERENT DOSE REGIMENS OF LEUPROLIDE ACETATE FOR PUBERAL BLOCKADE IN PATIENTS WITH PRECOCIOUS CENTRAL PUBERTY |
Active substance: LEUPRORELIN |
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Document reference: 31042 |
Study title: Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7 |
Active substance: CODEINE_AND_PARACETAMOL |
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Document reference: 24540 |
Study title: Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465 |
Active substance: CEFACLOR |
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Document reference: 23381 |
Study title: Rees JK et al. Dose intensification in acute myeloid leukaemia: greater effectiveness at lower cost. Principal report of the Medical Research Council's AML9 study. MRC Leukaemia in Adults Working Party. Br J Haematol. 1996 Jul;94(1):89-98.Rees JK et al. Dose intensification in acute myeloid leukaemia: greater effectiveness at lower cost. Principal report of the Medical Research Council's AML9 study. MRC Leukaemia in Adults Working Party. Br J Haematol. 1996 Jul;94(1):89-98. |
Active substance: MITOXANTRONE |
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Document reference: 32195 |
Study title: Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33. |
Active substance: MITOXANTRONE |
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Document reference: 32070 |
Study title: Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33. |
Active substance: MITOXANTRONE |
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Document reference: 32082 |
Study title: PASSAGE OF BC 105 INTO RAT MILK.; N/A - Klybeck archive |
Active substance: PIZOTIFEN |
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Document reference: 34543 |
Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
Active substance: Plantago Ovata Tinnevelly Senna Pods |
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Document reference: 40138 |
Study title: Nolan T et al., Randomized trial of laxatives in treatment of childhood encopresis.The Lancet 338, 1991, 8766: 523-527 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
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Document reference: 40036 |
Study title: Roth OA., Therapeutic observations on constipation; Med. Welt 1969;20:536-7 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
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Document reference: 40038 |
Study title: Sölter et al., Summary of clinical results with Prodiem Plain, a bowel-regulating agent; Today´s Therapeutic Trends (1983);1(1):45-59 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
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Document reference: 40039 |
Study title: Zawodsky L., Problems of a double-blind trial, as exemplified by a laxative; Der Praktische Arzt 1976;30:1182-92 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
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Document reference: 40037 |
Study title: Effets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de PediatrieEffets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de Pediatrie |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46076 |
Study title: Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46077 |
Study title: Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495.Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495. |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46078 |
Study title: Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46079 |
Study title: Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46080 |
Study title: Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46081 |
Study title: Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46082 |
Study title: Evaluation of efficacy of piracetam in add-on treatment of partial epilepsy in children. |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE98L2605 - Piracetam.pdf |
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Document reference: 46014 |
Study title: Evaluation of the effect of piracetam upon learning impairments in subjects with a border-line intellectual level. |
Active substance: PIRACETAM |
Study summary document link (including results): DE79E081 - Piracetam.pdf |
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Document reference: 45976 |
Study title: Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999 |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24630 |
Study title: A Phase III Randomized Single-Blind Study to Evaluate the Safety of the 9-Valent Pneumococcal, Meningococcal Group C Saccharide-CRM197 Conjugate Combination Vaccine Compared to Licensed 7-Valent Pneumococcal Conjugate Vaccine (Prevnar®) Administered to Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
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Document reference: 41588 |
Study title: A Phase III Randomized, Controlled Study to Compare the Safety and Immunogenicity of Two Different Formulations of a 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine Concurrently Administered at Two Different Sites With DTaP-IPV- HepB/Hib in Healthy Infants at 3, 4 and 5 Months of Age |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
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Document reference: 41589 |
Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls |
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Document reference: 34122 |
Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls |
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Document reference: 47711 |
Study title: Depistage des grossesses a risque eleve a la maternite du centre hospitalier departemental Felix Guyon (St. Denis - Ile de la Reunion) et surveillance de l'evolution des nouveaux-nes. Chapitre IV : essai de prophylaxie et de traitement de l'asphyxie perinatale par la 2-pyrrolidone acetamide ou piracetam (Nootropyl). |
Active substance: PIRACETAM |
Study summary document link (including results): DF76E241T - Piracetam.pdf |
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Document reference: 45957 |
Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 24740 |
Study title: A Stratified, Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate via the Multi-Dose Powder Inhaler 50mcg BID, 100mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic Asthma. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FLTA2007-ICHE3.pdf |
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Document reference: 28376 |
Study title: Comparative study of the activity and tolerability of new glycoactive corticosteroid (deflazacort) compared to prednisone in the long-term treatment of systemic lupus erythematosus and rheumatoid arthritis - Schiavetti L - 6 October 1979 - Report (reference 76 in the clinical documentation deflazacort 6mg tablet - 04/1991 - |
Active substance: DEFLAZACORT |
Study summary document link (including results): Deflazacort STUDY Schiavetti.xls |
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Document reference: 25635 |
Study title: DTPa-HBV-IPV-103 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
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Document reference: 41516 |
Study title: Study title: A Multicentre, single arm prospective, open label study to assess the safety of Elidelâ (SDZ ASM 981 - pimecrolimus) cream 1% in patients with atopic dermatitis (Rainbow study) |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CAE01 Art45 listing 2011.xls |
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Document reference: 34111 |
Study title: Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84.Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84. |
Active substance: MIRTAZAPINE |
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Document reference: 32067 |
Study title: Protocol for a multi−centre, open−labelled, randomised, prospective, clinical naturalistic pharmacokinetic and pharmacodynamic postmarketing surveillance study based on Therapeutic Drug Monitoring (TDM) with mirtazapine in depressed patients |
Active substance: MIRTAZAPINE |
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Document reference: 32068 |
Study title: Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32 |
Active substance: MITOXANTRONE |
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Document reference: 32221 |
Study title: Improvement of acupuncture on independent walking ability in children with cerebral paralysis. |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE05B0306 - Piracetam.pdf |
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Document reference: 45969 |
Study title: On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application - Med Klin, 6 Jan 1978, vol. 73, no. 1, p. 28-33On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application - Med Klin, 6 Jan 1978, vol. 73, no. 1, p. 28-33 |
Active substance: PARACETAMOL |
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Document reference: 45734 |
Study title: Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980)Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980) |
Active substance: DANTROLENE |
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Document reference: 25531 |
Study title: Antman KH et al Response to ifosfamide and mesna: 124 previously treated patients with metastatic or unresectable sarcoma J Clin Oncol. 1989 Jan;7(1):126-31. Erratum in: J Clin Oncol 1989 Sep;7(9):1369Antman KH et al Response to ifosfamide and mesna: 124 previously treated patients with metastatic or unresectable sarcoma J Clin Oncol. 1989 Jan;7(1):126-31. Erratum in: J Clin Oncol 1989 Sep;7(9):1369 |
Active substance: MITOXANTRONE |
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Document reference: 32163 |
Study title: Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901.Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901. |
Active substance: MITOXANTRONE |
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Document reference: 32178 |
Study title: Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41.Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41. |
Active substance: MITOXANTRONE |
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Document reference: 32219 |
Study title: Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95 |
Active substance: MITOXANTRONE |
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Document reference: 32244 |
Study title: Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32 |
Active substance: MITOXANTRONE |
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Document reference: 32094 |
Study title: Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186 |
Active substance: BENZENTHONIUM AND LIDOCAINE |
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Document reference: 22285 |
Study title: Betaxolol SL75.212-10 Acute oral toxicity in "young" rats - AM. Orloff, D. Branceni Betaxolol Core Dossier - April 1999 - Part III Pharmaco-toxicological documentation Volume 2 |
Active substance: BETAXOLOL |
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Document reference: 41927 |
Study title: The efficacy and side effects of a new corticosteroid aerosol, Budesonide, were assessed in 28 patients with chronic asthma in a double-blind cross-over study comparing it with Beclomethasone Dipropionate. |
Active substance: BUDESONIDE |
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Document reference: 48405 |
Study title: 1α-hydroxycholecalciferol treatment of long-term haemodialysis patients1α-hydroxycholecalciferol treatment of long-term haemodialysis patients |
Active substance: ALFACALCIDOL |
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Document reference: 46332 |
Study title: Use of budesonide administered through Nebuhaler together with a Laerdal face mask in severe asthmatics aged 1-3 years with at least a six month history of troublesome asthma and thought by their parents to be responsive to bronchodilators. Two weeks of run-in was followed by six months treatment period. Double-blind, parallell group |
Active substance: BUDESONIDE |
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Document reference: 48434 |
Study title: Sampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. JapaneseSampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. Japanese |
Active substance: MITOXANTRONE |
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Document reference: 32077 |
Study title: Sampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. JapaneseSampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. Japanese |
Active substance: MITOXANTRONE |
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Document reference: 32085 |
Study title: A Phase III Randomized, Double-Blind Trial to Compare the Immunogenicity of Three Unique Lots of 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine in Infants. Amendment to Evaluate the Responses to a Fourth Dose of DTaP Vaccine Given Concurrently with 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41590 |
Study title: A Randomized, Controlled, Single-Blinded Study to Determine Equivalence of Immunogenicity Between a 7-Valent Pneumococcal Conjugate Vaccine and a 9-Valent Pneumococcal Conjugate Vaccine Administered Concurrently at Separate Sites with a DTPa/IPV+Hib Vaccine in Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41591 |
Study title: Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33. |
Active substance: MITOXANTRONE |
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Document reference: 32249 |
Study title: Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Bassotti-G, and al; Digestion {DIGESTION}, 1999, Vol/Iss/Pg. 60/1 (69-73), ISSN: 0012-2823. Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Bassotti-G, and al; Digestion {DIGESTION}, 1999, Vol/Iss/Pg. 60/1 (69-73), ISSN: 0012-2823. |
Active substance: BISACODYL |
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Document reference: 22726 |
Study title: Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000). |
Active substance: CAMPHOR AND DIPHENHYDRAMINE AND ZINC |
Study summary document link (including results): |
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Document reference: 23184 |
Study title: Randomized Controlled Comparison of PREVEsNAR booster Dose Administration at 15 or 18 Months of Age. |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41598 |
Study title: An open, comparative study of the efficacy of 0.5% podophyllotoxin lotion (self-application) and 25% podophyllin solution (hospital based application) in the treatment of Condylomata acuminata in males and females. |
Active substance: PODOPHYLLOTOXIN |
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Document reference: 34545 |
Study title: A double-blind randomized, uninational, multicenter, two parallel groups, active controlled study to compare the effects of the treatment with Transipeg 2,95 g or Forlax Junior 4 g in children with constipation |
Active substance: POLIDOCANOL |
Study summary document link (including results): |
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Document reference: 46073 |
Study title: A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4 |
Active substance: POLIDOCANOL |
Study summary document link (including results): |
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Document reference: 46070 |
Study title: Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 |
Active substance: POLIDOCANOL |
Study summary document link (including results): |
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Document reference: 46068 |
Study title: "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843 "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843 |
Active substance: PIPOTIAZINE |
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Document reference: 34141 |
Study title: A 36-week, double blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with developmental reading disorder (dyslexia). |
Active substance: PIRACETAM |
Study summary document link (including results): RRCE92E1404 - Piracetam.pdf |
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Document reference: 45915 |
Study title: Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32143 |
Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients |
Active substance: MIVACURIUM |
Study summary document link (including results): |
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Document reference: 32257 |
Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients |
Active substance: MIVACURIUM |
Study summary document link (including results): |
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Document reference: 32258 |
Study title: A double-blind, placebo controlled, randomized, cross over study of the efficacy and safety of mizolastine 10mg in patients suffreing from primary acquired cold uticaria (URICOLD study). Dubertret L. Murrietta Aguguttes M. Ben-Soussen P. Magnier G. Pelenc M.-N. Pellegri-Guegnault B., Tudor D. 13/02/1997. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine-Study 1.pdf |
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Document reference: 32259 |
Study title: Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23) |
Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL |
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Document reference: 23987 |
Study title: AN OPEN COMPARATIVE STUDY TO COMPARE THE EFFICACY, TOLERATION AND SAFETY OF IV AND ORAL FLUCONAZOLE WITH ORAL KETOCONAZOLE IN THE PROPHYLAXIS OF FUNGAL COLONIZATION AND INFECTION IN PATIENTS WITH ALLOGENEIC BONE MARROW TRANSPLANT. |
Active substance: FLUCONAZOLE |
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Document reference: 27361 |
Study title: COMPASSIONATE USE PROTOCOL FOR THE TREATMENT OF A THREE-YEAR OLD CHILD WITH SCEDOSPORIUM INFECTION |
Active substance: FLUCONAZOLE |
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Document reference: 27341 |
Study title: TO COMPARE THE EFFICACY OF FLUCONAZOLE VS. ORAL KETOCONAZOLE IN THE PREVENTION OF FUNGAL INFECTION IN PATIENTS RECEIVING CHEMOTHERAPY FOR HEMATOLOGICAL DISEASE. |
Active substance: FLUCONAZOLE |
Study summary document link (including results): |
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Document reference: 28028 |
Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF ORAL FCA IN THE PREVENTION OF SYSTEMIC FUNGAL INFECTIONS IN PATIENTS RECEIVING CHEMOTHERAPY FOR HAEMOTOLOGICAL DISEASE |
Active substance: FLUCONAZOLE |
Study summary document link (including results): |
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Document reference: 27847 |
Study title: EFFICACY, SAFETY AND PRACTICABILITY OF FLUCONAZOLE VS. LOCAL CLOTRIMAZOLE THERAPY IN PATIENTS WITH VAGINAL CANDIDIASIS. |
Active substance: FLUCONAZOLE |
Study summary document link (including results): |
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Document reference: 27788 |
Study title: Comparison of oral transmucosal fentanyl citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair; Annals of Emergency Medicine 1996, 28(4): 385-90 |
Active substance: FENTANYL |
Study summary document link (including results): |
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Document reference: 27140 |
Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
Study summary document link (including results): |
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Document reference: 48393 |
Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
Study summary document link (including results): |
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Document reference: 48394 |
Study title: EFFICACY AND TOLERATION OF IM PIROXICAM IN PATIENTS SUFFERING FROM SPORTS RELATED INJURIES. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34472 |
Study title: EFFICACY AND TOLERATION OF ORAL PIROXICAM IN PATIENTS SUFFERING FROM NON ARTICULAR RHEUMATISM. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34375 |
Study title: Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32092 |
Study title: A clinical trial of pyrrolidine acetamide (piracetam) "Nootrobil" alone and combined with other drugs in the treatment of enuresis nocturna. |
Active substance: PIRACETAM |
Study summary document link (including results): SRCE92J2801 - Piracetam.pdf |
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Document reference: 45896 |
Study title: A double-blind, parallel group, study to compare the efficacy and safety of piracetam with placebo in children with specific learning disabilities. |
Active substance: PIRACETAM |
Study summary document link (including results): RAE91A102 - Piracetam.pdf |
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Document reference: 45902 |
Study title: A non-blind, uncontrolled pilot study of the effects of piracetam on the pattern of hemolysis and sickle cell crisis in patients with sickle cell anemia. |
Active substance: PIRACETAM |
Study summary document link (including results): ARCE00G0418 - Piracetam.pdf |
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Document reference: 45910 |
Study title: A randomised, cross-over, double blind, placebo controlled clinical study to evaluate the effficacy of piracetam 400 mg/kg/day as add-on therpay in the treatment of cortical myoclonus of angelman syndrome. |
Active substance: PIRACETAM |
Study summary document link (including results): RRCE01G1902 -Piracetam.pdf |
View full study record |
Document reference: 45899 |
Study title: Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32153 |
Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32126 |
Study title: Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
View full study record |
Document reference: 32235 |
Study title: Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32237 |
Study title: Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32215 |
Study title: Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32129 |
Study title: Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
Study summary document link (including results): |
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Document reference: 34564 |
Study title: Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
Study summary document link (including results): |
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Document reference: 34565 |
Study title: Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
Study summary document link (including results): |
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Document reference: 34573 |
Study title: OPEN, NON-COMPARATIVE STUDY OF FLUCONAZOLE IN PATIENTS WITH COCCIDIOIDAL MENINGITIS |
Active substance: FLUCONAZOLE |
Study summary document link (including results): |
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Document reference: 28052 |
Study title: A double-blind, single dose parallel study to compare analgesic efficacy and side effects profile of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of muscle contraction ('tension') headache |
Active substance: IBUPROFEN |
Study summary document link (including results): |
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Document reference: 29478 |
Study title: AN OPEN-LABEL EXTENSION STUDY OF GABAPENTIN IN CHILDREN WITH EPILEPSY WHO HAVE PARTICIPATED IN THE DOUBLE-BLIND STUDY 945-186 |
Active substance: GABAPENTIN |
Study summary document link (including results): |
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Document reference: 28763 |
Study title: A multicenter comparative trial of cefprozil (500 mg QD) versus cefaclor (250 mg TID) in the treatment of mild to moderate skin and skin structure infections in pediatric patients (final report on study AI414-075). |
Active substance: CEFPROZIL |
Study summary document link (including results): Protocol ai414-075 All centers Cefprozil.pdf |
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Document reference: 23570 |
Study title: Randomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in childrenRandomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in children |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46065 |
Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32123 |
Study title: Bacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. ItalianBacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. Italian |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32103 |
Study title: Sokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. FrenchSokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. French |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32095 |
Study title: Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66.Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32203 |
Study title: Voûte PA et al A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI)Ann Oncol. 1999 Oct;10(10):1211-8Voûte PA et al A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI)Ann Oncol. 1999 Oct;10(10):1211-8 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32135 |
Study title: Candy D et al Study title: A single centre study to assess the safety and efficacy of Movicol in the treatment of faecal impaction in children followed by a double-blind randomised phase to compare the safety and efficacy of Movicol and lactulose for maintenance therapy. J of Paediatric Gastro Enterol & Nutrition 2006;43: 65-70 |
Active substance: POLIDOCANOL COMBINATIONS |
Study summary document link (including results): |
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Document reference: 34579 |
Study title: Guest JF, Candy D, Clegg JP et al – Clinical and economic impact of using macrogol 3350 plus electrolytes in an outpatient setting compared to enemas and suppositories and manual evacuation to treat paediatric faecal impaction based on actual clinical proactive in England and Wales. Curr Med Res Opin. 2007 Sep;23(9):2213-25 |
Active substance: POLIDOCANOL COMBINATIONS |
Study summary document link (including results): |
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Document reference: 34580 |
Study title: JF Mougenot non blind controlled study on 32 patients aged from 3 to 13.5 years old in Feb 1995. |
Active substance: POLIDOCANOL COMBINATIONS |
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Document reference: 47214 |
Study title: lodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexolWright NB 2002. The British Journal of Radiology, 75 (2002), 127- 135 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48194 |
Study title: Pugh RNH. Single dose oral treatment in urinary schistosomiasis: a double blind trial. BMJ 1983; 286: 429-432. Pugh RNH. Single dose oral treatment in urinary schistosomiasis: a double blind trial. BMJ 1983; 286: 429-432. |
Active substance: PRAZIQUANTEL |
Study summary document link (including results): |
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Document reference: 34646 |
Study title: Schutte CH. Effectiveness of Praziquantel against the south African strains of Schistosoma haematobium and S. Mansoni. Sa Med J 1983; 64: 7-10.Schutte CH. Effectiveness of Praziquantel against the south African strains of Schistosoma haematobium and S. Mansoni. Sa Med J 1983; 64: 7-10. |
Active substance: PRAZIQUANTEL |
Study summary document link (including results): |
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Document reference: 34648 |
Study title: CROSSOVER COMPARATIVE PHARMACOKINETIC STUDY OF TWO 3MG PRAZOSIN SUSTAINED RELEASE DELIVERY SYSTEMS: SIXTEEN HOUR VS TWENTY HOUR 85% RELEASE TIMES |
Active substance: PRAZOCIN |
Study summary document link (including results): |
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Document reference: 46105 |
Study title: TO CONFIRM THE EFFICACY AND TOLERANCE OF TREATMENT WITH PRAZOSIN ASSOCIATED WITH CHLORTHALIDONE AND WITH FUROSEMIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. |
Active substance: PRAZOCIN |
Study summary document link (including results): |
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Document reference: 46110 |
Study title: TO DETERMINE WHETHER THE ADDITION OF ORALLY ADMINISTERED PRAZOSIN IMPROVES PULMONARY FUNCTION IN PATIENTS WITH CHRONIC ASTHMA. |
Active substance: PRAZOCIN |
Study summary document link (including results): |
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Document reference: 46111 |
Study title: TOLERATION OF PIROXICAM IN PATIENTS WITH PRIMARY DYSMENORRHOEA. |
Active substance: PRAZOCIN |
Study summary document link (including results): |
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Document reference: 46106 |
Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial |
Active substance: PRAZOCIN /POLYTHIAZIDE |
Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf |
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Document reference: 46108 |
Study title: Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4. Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43601 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44206 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44253 |
Study title: Transient ischaemia of the proximal femoral epiphysis in the child. Interpretation of bone scintimetry for diagnosis in hip pain. Wingstrand H, Bauer GC, Brismar J, Carlin NO, Pettersson H, Sundén G. Acta Orthop Scand. 1985 Jun;56(3):197-203. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43942 |
Study title: Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43954 |
Study title: Use of Stereotactic PET Images in Dosimetry Planning of Radiosurgery for Brain Tumors: Clinical Experience and Proposed ClassificationTHE JOURNAL OF NUCLEAR MEDICINE, Vol. 45, No. 7, July 2004. Marc Levivier, MD, PhD1; Nicolas Massager, MD1; David Wikler, MS2; Jose´ Lorenzoni, MD1; Salvador Ruiz, MD1; Daniel Devriendt, MD3; Philippe David, MD4; Franc¸oise Desmedt, MS3; Ste´phane Simon, MS3; Paul Van Houtte, MD3; Jacques Brotchi, MD1; and Serge Goldman, MD2 |
Active substance: Steripet |
Study summary document link (including results): levivier-2004.pdf |
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Document reference: 48737 |
Study title: TO STUDY THE ANALGESIC EFFECT AND TOLERATION OF FELDENE ADMINISTERED BY INTRAMUSCULAR ROUTE AT THE BEGINNING OF TREATMENT IN PATIENTS SUFFERING FROM RHEUMATOLOGY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34383 |
Study title: TO STUDY THE EFFICACY AND SAFETY OF PIROXICAM DISPERSIBLE TABLETS IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34392 |
Study title: TO STUDY THE EFFICACY AND SAFETY OF PIROXICAM INJECTION VERSUS DICLOFENAC INJECTION IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS, OCCURRED WHILE PRACTISING SPORTS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34393 |
Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN PAINFUL ACUTE LOW BACK DISORDERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34370 |
Study title: Vrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 yVrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 y |
Active substance: RHUBARB AND SALICYLIC ACID |
Study summary document link (including results): |
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Document reference: 35295 |
Study title: TO STUDY THE EFFICACY, INCIDENCE AND SEVERITY OF LOCAL AND SYSTEMIC ADVERSE REACTIONS OF IM PIROXICAM ADMINISTRATION IN ACUTE LOW BACK PAIN FOLLOWED BY ORAL TREATMENT WHEN NECESSARY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34354 |
Study title: TO STUDY THE ONSET OF ACTION OF INTRAMUSCULAR PIROXICAM IN COMPARISON WITH THE ORAL FORM IN PATIENTS WITH ACUTE LOW BACK PAIN, SCIATALGIA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34381 |
Study title: TO STUDY THE PAIN-RELIEVING EFFECT OF PIROXICAM VS. BARALGIN AND FELDENE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34344 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF PIROXICAM SUPPOSITORY IN PATIENTS WITH OSTEOARTHRITIS OF HIP/KNEE LUMBAGO OR TRAUMA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34405 |
Study title: A comparison of Pondocillin® and Calcipen® in children with acute otitis media |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46046 |
Study title: Yalcin S, Turoglu HT, Ozdamar S, Sadikoglu Y, Gurbuzer B, Yenici O. Ewing's tumor of the mandible. Oral Surg Oral Med Oral Pathol. 1993 Sep;76(3):362-7. Yalcin S, Turoglu HT, Ozdamar S, Sadikoglu Y, Gurbuzer B, Yenici O. Ewing's tumor of the mandible. Oral Surg Oral Med Oral Pathol. 1993 Sep;76(3):362-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43652 |
Study title: Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75. Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44047 |
Study title: Pineoblastoma imaged during bone scintigraphy. McCormack S, Raftery R, Palmgren D, Leonard JC. Clin Nucl Med. 1995 Nov;20(11):1023-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43580 |
Study title: Extraosseous localization of 99mTc-MDP in ganglioneuroblastoma. Shih WJ, DeLand FH, Domstad PA, Johnston EH. Eur J Nucl Med. 1982;7(7):336-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44100 |
Study title: Pulmonary metastases on bone scan in a patient with osteogenic sarcoma. Shikare S, Tilve GH. J Postgrad Med. 1992 Oct-Dec;38(4):201-2, 198. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43687 |
Study title: Treatment of pain in pediatric patients; Journal of Pharmacy Practice 2003, 16(4): 261-275 |
Active substance: FENTANYL |
Study summary document link (including results): |
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Document reference: 27189 |
Study title: Clival osteoblastoma in a child. Case illustration. McDonald PJ, Matouk CC, Papsin B, Rutka JT. J Neurosurg. 2003 May;98(5):1133. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43422 |
Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43471 |
Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44156 |
Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44203 |
Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44250 |
Study title: Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21. Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43432 |
Study title: Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562. |
Active substance: PROCARBAZINE |
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Document reference: 34778 |
Study title: [Clinical evaluation of multiple exostoses (17 cases) on bone scintigraphy] Japanese. Yamada T, Nakamura M, Sugita R, Satou A, Sakamoto K. Nippon Igaku Hoshasen Gakkai Zasshi. 1991 Mar 25;51(3):282-8. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43744 |
Study title: Tc-99m MDP uptake by an advanced colon cancer lesion in a juvenile patient. Yamada T, Shuke N, Takahashi K, Katada R, Mineta M, Nagasawa K, Hanaoka H, Aburano T, Miyamoto K, Suzuki Y. Clin Nucl Med. 2000 Apr;25(4):295-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43487 |
Study title: Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43667 |
Study title: Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43709 |
Study title: Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43913 |
Study title: Van Den Bossche B, Lambert B, De Winter F, Kolindou A, Dierckx RA, Noens L, et al.. 18FDG PET versus high-dose 67Ga scintigraphy for restaging and treatment follow-up of lymphoma patients. [vanden-bossche-2002]Nucl Med Commun. 2002 Nov;23(11):1079-83. Van Den Bossche B 2002 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48707 |
Study title: A double-blind, placebo-controlled, multicentred study of mizolastine (SL85.0324) (10mg/d) efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPERAN study). - Scadding G. Bachert C. Dunmore C. Favennec C. Mathieu G. Steinerstauch P. Weber F.- 06/09/1994 |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY 94-00611-EN-00.xls |
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Document reference: 32260 |
Study title: An open-labelled, multicentred study of mizolastine (SL85.0324-00) (10mg and 15mg/d) to assess the long-term safety and long-term efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPEREX Study). - Scadding G. Tasman A.J. Dunmore C. Favennec E. Mathieu G. Steinerstauch P. Weber F.- 10/06/1998 |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY 94-00939-EN-01.xls |
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Document reference: 32261 |
Study title: Assessment of the therapeutic efficacy and safety of mizolastine in the treatment of chronic idiopathic urticaria. Open-label study of increasing doses (5-10-20mg per day in 2 divided doses) (URTIOC study). -Sayag J. Tudor D. Demontrond V. Narbonne G. Ben-soussen P.- 05/05/1993 |
Active substance: MIZOLASTINE |
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Document reference: 32262 |
Study title: Comparative safety and efficacy of 3 doses of mizolastine versus placebo in the treatment of seasonnal allergic rhinitis (RHINASE study). - Dry J. Theron M. DEMONTROND V. ATTALI P.- 14/05/1992 STUDY 85.0324.FR.05 |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY 85.0324.FR.05.xls |
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Document reference: 32263 |
Study title: Comparative study of the efficacy and safety of 10mg mizolastine and 10mg cetirizine versus placebo in seasonal allergic rhino-conjunctivitis in adults.Double blind placebo-controlled study (MIZOCET study). - Ben-soussen P. Senn N. Tudor D.- 31/09/1994. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY 94-00672-EN-00.xls |
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Document reference: 32264 |
Study title: Comparative study of the efficacy and safety or mizolastine 10mg and terfenadine 120mg versus placebo in seasonal allergic rhino-conjunctivitis (MIZOTER study). - Broseta V. Murrieta M. Seen N. Tudor D. 13/09/1994 |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY 94-00197-EN-00.xls |
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Document reference: 32265 |
Study title: Comparative study to determine the efficacy and safety of mizolastine (15mg/d as a single dose) versus dexchlorpheniramine (12mg/d as two devided doses) in the treatment of chronic rhinitis in adults (POLRIC study). - Haguenauer J.P. Tudor D. Mathieu G. Demontrond V. Guerault E. Soubrane C.- 09/07/1993 |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY M.44.04.93.03.xls |
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Document reference: 32266 |
Study title: Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 |
Active substance: MIZOLASTINE |
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Document reference: 32272 |
Study title: CStudy to compare the efficacy and safety of 3 doses of mizolastine (SL85.0324) versus placebo in the treatment of perennial allergic rhinitis. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine STUDY M.44.02.93.002.xls |
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Document reference: 47994 |
Study title: Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46083 |
Study title: Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83. Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44003 |
Study title: McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8. McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44112 |
Study title: AWB-Rei/100797 2 March 1999: Post marketing surveillance for Betaisodona ointment in paediatrics |
Active substance: POVIDONE IODINE |
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Document reference: 34612 |
Study title: Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41. Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41. |
Active substance: PRALIDOXIME |
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Document reference: 46084 |
Study title: Use-result surveillance for pranoprofen ophtalmic solution. Clinical data for paediatric use (post marketing surveillance). |
Active substance: PRANOPROFEN |
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Document reference: 46086 |
Study title: Dyslipidemia in pediatric renal disease: epidemiology, pathophysiology and management |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46093 |
Study title: Pharmacokinetics of Pravastatin in a paediatric population |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46097 |
Study title: Inefficacy of piracetam in the prevention of painful crises in children and adolescents with sickle cell disease. |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE05H2932 - Piracetam.pdf |
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Document reference: 45917 |
Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial |
Active substance: PRAZOCIN /POLYTHIAZIDE |
Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf |
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Document reference: 46109 |
Study title: A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
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Document reference: 34664 |
Study title: A double-blind multicentre parallel group study comparing HOE777 fatty ointment with betamethasone valerate 0,1% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis - M. Dietz et al. - 1982 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Dietz.xls |
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Document reference: 34665 |
Study title: "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34666 |
Study title: Remarques sur quelques effets therapeutiques du piracetam (1e partie). |
Active substance: PIRACETAM |
Study summary document link (including results): DF79K121P - Piracetam.pdf |
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Document reference: 45959 |
Study title: Report on the clinical use of Nootropil (UCB 6215) in psychic disorders occurring in severely burnt patients. |
Active substance: PIRACETAM |
Study summary document link (including results): CE72E041 - Piracetam.pdf |
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Document reference: 45911 |
Study title: "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
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Document reference: 34675 |
Study title: "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" |
Active substance: PREDNICARBATE |
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Document reference: 34677 |
Study title: "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" |
Active substance: PREDNICARBATE |
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Document reference: 34678 |
Study title: A COMPARATIVE STUDY OF PRX AND NAPROXEN IN THE TREATMENT OF PRIMARY DYSMENORRHEA |
Active substance: PIROXICAM |
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Document reference: 34352 |
Study title: A DOUBLE-BLIND COMPARATIVE STUDY OF PRX FDDF BY SUBLINGUAL ROUTE VS. PLACEBO IN THE TREATMENT OF PRIMARY HEADACHE |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34404 |
Study title: Le syndrome de down. Etude comparative de l'activite therapeutique du Noostan. |
Active substance: PIRACETAM |
Study summary document link (including results): DS77F021C - Piracetam.pdf |
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Document reference: 45942 |
Study title: The action of 2-pyrrolidone acetamide (piracetam) and acetamide as sickling inhibitors and desickling agents of the erythrocytes of patients suffering from sickle cell disease. |
Active substance: PIRACETAM |
Study summary document link (including results): DE76M292 - Piracetam.pdf |
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Document reference: 45933 |
Study title: Ishii T et al The effects of high-dose ifosfamide in the treatment of bone and soft tissue Sarcomas Gan To Kagaku Ryoho. 1997 Nov;24(14):2123-30. JapaneseIshii T et al The effects of high-dose ifosfamide in the treatment of bone and soft tissue Sarcomas Gan To Kagaku Ryoho. 1997 Nov;24(14):2123-30. Japanese |
Active substance: MITOXANTRONE |
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Document reference: 32161 |
Study title: Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29 |
Active substance: MITOXANTRONE |
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Document reference: 32162 |
Study title: Jürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. GermanJürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. German |
Active substance: MITOXANTRONE |
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Document reference: 32106 |
Study title: A PARALLEL DOUBLE BLIND STUDY OF THE EFFECT OF FELDENE AS ADJUNCT THERAPY TO PREVENT LUNG DAMAGE IN CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA LUNG INFECTION. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34435 |
Study title: A SINGLE-BLIND COMPARATIVE STUDY OF PIROXICAM FDDF BY SUBLINGUAL ROUTE VS. PLACEBO IN THE TREATMENT OF PRIMARY HEADACHE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34403 |
Study title: AN OPEN COMPARATIVE STUDY OF PARENTERAL PIROXICAM VERSUS PARENTERAL LYSINE ACETYL-SALICYLATE FOR THE TREATMENT OF OSTEO ARTICULAR PAIN (DUE TO SICKLE CRISIS) |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34495 |
Study title: AN OPEN COMPARATIVE TRIAL OF PIROXICAM VS. SULINDAC IN THE TREATMENT OF PATIENTS WITH ACUTE LOW BACK PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34365 |
Study title: AN OPEN NON COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND SAFETY OF PIROXICAM FAST DISSOLVING DOSAGE FROM (FELDENE FAST) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS IN INTERNAL MEDICINE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34417 |
Study title: A COMPARATIVE STUDY OF PARENTERAL PIROXICAM VS. PARENTERAL LYSINE ACETYLSALICYLATE FOR THE TREATMENT OF OSTEOARTICULAR PAINFUL ATTACKS DURING SICKLE CELL DISEASE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34461 |
Study title: AN OPEN NON COMPARATIVE TRAIL WITH PIROXICAM PARENTERAL IN ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34357 |
Study title: AN OPEN NON-COMPARATIVE OF THE EFFICACY AND SAFETY OF 05% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL (AMS) DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34454 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF PIROXICAM BY S.L. ROUTE IN THE TREATMENT OF DENTAL PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34402 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF PIROXICAM FDDF BY S.L. ROUTE IN THE TREATMENT OF PRIMARY HEADACHE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34401 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL FELDENE (PRX) GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34366 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL FELDENE (PRX) GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34469 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34455 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES DUE TO SOCCER OR BASKETBALL. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34437 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF FELDENE (PIROXICAM) IN SOLUTION IN THE TREATMENT OF PATIENTS WITH POSTOPERATIVE |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34470 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN THE TREATMENT OF POST-OPERATIVE DENTAL PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34456 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34494 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF A PRX FDDF TAB IN THE TREATMENT OF ACUTE LOW BACK PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34439 |
Study title: AN OPEN NON-COMPARATIVE TRIAL WITH PARENTERAL PRX IN THE TREATMENT OF ACUTE DISORDERS |
Active substance: PIROXICAM |
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Document reference: 34407 |
Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY OF THE ANALGESIC ACTIVITY OF FELDENE FDDF (PIROXICAM) IN PATIENTS WITH ACUTE MUSCULOSKELETAL POST TRAUMATIC PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34459 |
Study title: Ferrari S et al Ifosfamide and actinomycin-D, added in the induction phase to vincristine,cyclophosphamide and doxorubicin, improve histologic response and prognosis in patients with non metastatic Ewing's sarcoma of the extremity J Chemother. 1998 Dec;10(6):484-91Ferrari S et al Ifosfamide and actinomycin-D, added in the induction phase to vincristine,cyclophosphamide and doxorubicin, improve histologic response and prognosis in patients with non metastatic Ewing's sarcoma of the extremity J Chemother. 1998 Dec;10(6):484-91 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32100 |
Study title: Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24 |
Active substance: MITOXANTRONE |
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Document reference: 32120 |
Study title: OPEN NON-COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND TOLERATION OF PIROXICAM FAST DISSOLVING DOSAGE FORM (FDDF) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34339 |
Study title: OPEN NON-COMPARATIVE STUDY ON THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS AGUDIZATION OF CHRONIC RHEUMATIC SITUATIONS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34452 |
Study title: OPEN NON-COMPARATIVE TRIAL ON THE EFFICACY AND TOLERANCE OF PIROXICAM IM 20MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34451 |
Study title: OPEN NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PIROXICAM FDDF BY S.L. ROUTE IN THE TREATMENT OF PRIMARY DYSMENORRHEA |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34400 |
Study title: OPEN, NON-COMPARATIVE STUDY OF EFFICACY AND TOLERATION OF PRX GEL 0.5% IN FENCERS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34368 |
Study title: OPEN, NON-COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF FELDENE FAST IN THE TREATMENT OF ACUTE MUSCULO SKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34416 |
Study title: OPEN, NON-COMPARATIVE STUDY WITH FELDENE 20 MG CAPSULES IN PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34443 |
Study title: OPEN, NON-COMPARATIVE TRIAL OF THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34449 |
Study title: OPEN, NON-COMPARATIVE TRIAL ON THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34448 |
Study title: OPEN, NONCOMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF PIROXICAM TOPICAL GEL 0.5% IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34446 |
Study title: OPEN,NON-COMPARATIVE STUDY WITH PIROXICAM IM IN ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34445 |
Study title: Radiographic and scintigraphic features of modeling and remodeling in the heterotopic skeleton of patients who have fibrodysplasia ossificans progressiva. Kaplan FS, Strear CM, Zasloff MA. Clin Orthop Relat Res. 1994 Jul;(304):238-47. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43621 |
Study title: Karayalcin U, Karayalcin B, Yakupoglu G, Yildiz A, Erkilic M. Tc-99m-HMDP bone uptake quantification and plasma osteocalcin levels in hemodialysis patients--a preliminary study. Ann Nucl Med. 1992 Feb;6(1):9-12. Karayalcin U, Karayalcin B, Yakupoglu G, Yildiz A, Erkilic M. Tc-99m-HMDP bone uptake quantification and plasma osteocalcin levels in hemodialysis patients--a preliminary study. Ann Nucl Med. 1992 Feb;6(1):9-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43711 |
Study title: Limb-sparing procedures: postoperative planar bone scan appearance. Kaste SC, Rao BN, Meyer WM, Lynch M. Pediatr Radiol. 1996 Oct;26(10):750-3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43561 |
Study title: Bone scans in the diagnosis of bone crisis in patients who have Gaucher disease. Katz K, Mechlis-Frish S, Cohen IJ, Horev G, Zaizov R, Lubin E. J Bone Joint Surg Am. 1991 Apr;73(4):513-7. Erratum in: J Bone Joint Surg Am 1991 Jun;73(5):791. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43741 |
Study title: Simons KS, Pickkers P, Bleeker-Rovers CP, Oyen WJ, van der Hoeven JG.. Epub 2009 Oct 22. F-18-fluorodeoxyglucose positron emission tomography combined with CT in critically ill patients with suspected infection. [simons-2010]Intensive Care Med. 2010 Mar;36(3):504-11. Simons KS 2010 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48699 |
Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with mizolastine 10 mg during 14-28 days. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine-Study 2.pdf |
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Document reference: 32267 |
Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with Misolastine 10mg (OD) during 14-28 days (PANEOS study). Murrietta M. 04/10/1999. |
Active substance: MIZOLASTINE |
Study summary document link (including results): |
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Document reference: 32269 |
Study title: Pharmacokinetic study of myzolastine paediatric syrup in allergic children aged 6 to 12 years. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine-Study 3.pdf |
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Document reference: 32270 |
Study title: A 6-Week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdrawel Study to Evaluate the Continued Efficacy of Modafinil at Dosages Up to 425 mg/day in Patients with Attention-Defizit/Hyperactivity Disorder who are Resonders to Modafinil Treatment, Followed by a 12-month Open-Label Extension Period. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45280 |
Study title: Safety and efficacy of pravastatin in pediatric heart transplant patients |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46101 |
Study title: PHASE III DOUBLE BLIND CROSSOVER COMPARATIVE TRIAL IN PATIENTS WITH PRIMARY DYSMENORRHEA |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34322 |
Study title: PHASE III DOUBLE BLIND PARALLEL COMPARATIVE TIRAL OF PATIENTS WITH POSTOPERATIVE PAIN |
Active substance: PIROXICAM |
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Document reference: 34313 |
Study title: PIROXICAM CREAM FOR IONOPHORETIC USE IN REACUTIZED OSTEOARHRITHIS: THE RESULTS OF A COMPARATIVE PLACEBO CONTROLLED STUDY VERSUS KETOPROFEN AND DICLOFENAC |
Active substance: PIROXICAM |
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Document reference: 34398 |
Study title: PIROXICAM GEL IN THE TREATMENT OF ACUTE POST TRAUMATIC MILD TO MODERATE MUSCULOSKELETAL DISORDERS OPEN NON-COMPARATIVE MULTICENTER STUDY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34364 |
Study title: PIROXICAM IN THE TREATMENT OF POST-OPERATIVE PAIN FOLLOWING GYN SURGERY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34388 |
Study title: PROTOCOL FOR THE DOUBLE-BLIND, PARALLE COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ACETAMINOPHEN/CODEINE AND PLACEBO IN PATIENTSWITH POSTOPERATIVE DENTAL PAIN |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34312 |
Study title: A double-blind parallel group study comparing HOE777 0.25% fatty ointment with vehicle in patients with mild to moderate atopic or eczematous contact dermatitis. |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Fredriksson.xls |
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Document reference: 34667 |
Study title: A double-blind three centre parallel group study comparing HOE777 0,25%emollient cream with Ultralan emollent cream in patients with mild to very severe atopic or eczematous contact dermatitis and in psoriasis patients - J. Deschilder et al. - 1982 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Deschilder.xls |
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Document reference: 34656 |
Study title: "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34668 |
Study title: A double-blind two centre parallel group study comparing HOE777 0.25% aqueous cream, with betamethasone valerate 0.1% aqueous cream in patients with slight to very severe atopic or excematous contact dermatitis |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Pestzoldt.xls |
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Document reference: 48014 |
Study title: [Diagnostic evaluation of skeletal scintigraphy in comparison to roentgen studies in histiocytosis X in childhood. Case report] German. Wagenknecht C, Lips H, Nitz I, Hilgenfeld E. Kinderarztl Prax. 1990 Jul;58(7):355-62. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43760 |
Study title: Wardlaw JM, Best JJ, Hughes SP. Dynamic bone imaging in the investigation of local bone pathology--when is it useful? Clin Radiol. 1991 Feb;43(2):107-12. Wardlaw JM, Best JJ, Hughes SP. Dynamic bone imaging in the investigation of local bone pathology--when is it useful? Clin Radiol. 1991 Feb;43(2):107-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43748 |
Study title: Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese. Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43443 |
Study title: Stauss J, Franzius C, Pfluger T, Juergens KU, Biassoni L, Begent J, et al..Guidelines for 18F-FDG PET and PET-CT imaging in paediatric oncology. [stauss-2008]Eur J Nucl Med Mol Imaging 2008; 35:1581–1588. Stauss J 2008 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48701 |
Study title: Stumpe KD, Urbinelli M, Steinert HC, Glanzmann C, Buck A, von Schulthess GK. Whole-body positron emission tomography using fluorodeoxyglucose for staging of lymphoma: effectiveness and comparison with computed tomography. [stumpe-1998]Eur J Nucl Med. 1998 Jul;25(7):721-8. Stumpe KD 1998 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48702 |
Study title: Safety and efficacy of pravastatin therapy for the prevention of hyperlipidemia in pediatric and adolescent cardiac transplant patients |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46102 |
Study title: Should pediatric patients with hyperlipidemia receive drug therapy? |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46104 |
Study title: " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Archives of Pediatrics and Adolescent Medicine {ARCH-PEDIATR-ADOLESC- MED}, 2007, Vol/Iss/Pg. 161/7 (690-696), eISSN: 1538-3628, ISSN: 1072-4710. " " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepr... |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34641 |
Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34643 |
Study title: "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm.fr. Anxiolytics, hypnotics, and antidepressants dispensed to adolescents in a French region in 2002. Pharmacoepidemiology and Drug Safety {PHARMACOEPIDEMIOL-DRUG-SAF}, 2006, Vol/Iss/Pg. 15/7 (494-503), eISSN: 1099-1557, ISSN: 1053-8569. " "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm.... |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34638 |
Study title: A double-blind two centre parallel group study comparing HOE777 0.25% fatty ointment with topisolon 0.25% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Plewig.xls |
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Document reference: 48015 |
Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Rajka.xls |
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Document reference: 34657 |
Study title: The migraine: benign paroxysmal vertigo of childhood complex. |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE99M0703 - Piracetam.pdf |
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Document reference: 45958 |
Study title: The selectivity of action of preparations for metabolic therapy of mentally deficient children. |
Active substance: PIRACETAM |
Study summary document link (including results): DRU81B233P - Piracetam.pdf |
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Document reference: 45919 |
Study title: Accumulation of MDP in primary childhood hepatic malignancies and their metastases. Mandell GA, Heyman S. Clin Nucl Med. 1983 Dec;8(12):594-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44019 |
Study title: The Utility of a 3-Dimensional, Large-Field-Of-View, Sodium Iodide Crystal–Based PET Scanner in the Presurgical Evaluation of Partial EpilepsyTHE JOURNAL OF NUCLEAR MEDICINE ,Vol. 42, No. 8, August 2001. Terence J. O’Brien, Rodney J. Hicks, Robert Ware, David S. Binns, Michael Murphy, and Mark J. Cook |
Active substance: Steripet |
Study summary document link (including results): obrien-2001.pdf |
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Document reference: 48740 |
Study title: Piracetam in the management of spasticity in cerebral palsy. |
Active substance: PIRACETAM |
Study summary document link (including results): DE78F222P - Piracetam.pdf |
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Document reference: 45974 |
Study title: Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32150 |
Study title: Traitement de l'enurese nocturne par la medication associee de la dixyrazine et du piracetam. |
Active substance: PIRACETAM |
Study summary document link (including results): DE79G022 - Piracetam.pdf |
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Document reference: 45898 |
Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32117 |
Study title: Bowel visualization on bone scan because of protein losing enteropathy. Roach PJ, Itrato D, Treves ST. Clin Nucl Med. 1994 Dec;19(12):1114-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43606 |
Study title: Sympathetic denervation due to neuroblastoma. Roach PJ, Treves ST. Clin Nucl Med. 1994 Nov;19(11):1023-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43611 |
Study title: Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43666 |
Study title: Gentet JC et al Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology Eur J Cancer. 1997 Feb;33(2):232-7Gentet JC et al Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology Eur J Cancer. 1997 Feb;33(2):232-7 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32140 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, fixed-dosage (340 or 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, Including a 2-Week (Blined) Withdrawel Period. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45282 |
Study title: Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32141 |
Study title: Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32112 |
Study title: PROTOCOL FOR THE DOUBLE-BLIND, PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ASPIRIN AND PLACEBO IN PATIENTS WITH POSTOPERATIVE DENTAL PAIN |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34318 |
Study title: Relazione Clinica sull'uso del preparato Piroxicam FDDF nel trattamento delle affezioni muscoloscheletriche acute |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34328 |
Study title: Relazione Clinica Sull'uso del preparato Piroxicam FDDF per via sublinguale vs Diclofenac nel trattamento delle Affezioni mu-scoloscheltriche acute |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34327 |
Study title: Relazione Clinical sull'uso del preparato Piroxicam FDDF per via sublinguale nel trattamento della dismenorrea primaria |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34329 |
Study title: SINGLE-BLIND COMPARATIVE STUDY ON THE ANALGESIC EFFICACY OF PRX VS. TENOXICAM IN THE TREATMENT OF LOW BACK PAIN WITH A SINGLE ADMINISTRATION |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34397 |
Study title: TO ASSESS THE ANALGESIC EFFICACY OF PIROXICAM 20 MG (1 M) IN A VARIETY OF PAINFUL CONDITIONS WITH ACUTE ONSET IN SPORTS MEDICINE WHICH DO NOT INVOLVE ANY INJURY. |
Active substance: PIROXICAM |
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Document reference: 34331 |
Study title: TO ASSESS THE EFFECT OF PIROXICAM 0.5% GEL ON THE PAIN AND STIFFNESS IN OSTEOARTHRITIC JOINT AS COMPARED TO PLACEBO. |
Active substance: PIROXICAM |
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Document reference: 34438 |
Study title: TO ASSESS THE EFFICACY AND SAFETY OF PIROXICAM COMPARED TO PARACETAMOL WHEN TAKEN AT THE ONSET OF PAIN DUE TO 1 DEGREE DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34427 |
Study title: TO COMPARE CLINICAL EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS AND IBUPROFEN TABS IN THE TREATMENT OF AMS DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34394 |
Study title: Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available. Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43856 |
Study title: Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43827 |
Study title: Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43989 |
Study title: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA.Schneider R. Chapter 7: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA. Elsevier Saunders; 2005:86-117 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 47923 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45281 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45283 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34347 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS FROM DIFFERENT ATHLETIC TEAMS WITH AMS. |
Active substance: PIROXICAM |
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Document reference: 34422 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH ACUTE MUSCULO-SKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34345 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH AMS. |
Active substance: PIROXICAM |
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Document reference: 34420 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH LOW BACK PAIN. |
Active substance: PIROXICAM |
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Document reference: 34377 |
Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH OSTEOARTHROSIS OF THE KNEE. |
Active substance: PIROXICAM |
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Document reference: 34326 |
Study title: EFFICACY OF PIROXICAM 20 MG VS. ISOXICAM 200 MG IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS. |
Active substance: PIROXICAM |
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Document reference: 34390 |
Study title: EFFICACY OF PIROXICAM IM VS PLACEBO IN POSTOPERATIVE PAIN AND STUDY OF REVERSE REACTIONS. |
Active substance: PIROXICAM |
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Document reference: 34342 |
Study title: TO COMPARE EFFICACY OF PIROXICAM IM AND NOVALGIN IM IN THE PROMOTION OF ANALGESIA AND WOUND HEALING IN PATIENTS AFTER ABDOMINAL SURGERY. |
Active substance: PIROXICAM |
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Document reference: 34491 |
Study title: TO COMPARE THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSAL AND DICLOFENAC IN THE TREATMENT OF ACUTE MUSCULOSKELETAL INJURIES. |
Active substance: PIROXICAM |
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Document reference: 34343 |
Study title: TO COMPARE THE EFFICACY, SAFETY AND USEFULNESS OF PIROXICAM SUPPOSITORY WITH THOSE OF DICLOFENAC IN CONTROL OF PATIENTS WITH OSTEOARTHRITIS BY DOUBLE-BLIND COMPARATIVE METHOD. |
Active substance: PIROXICAM |
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Document reference: 34406 |
Study title: TO COMPARE THE LOCAL TOLERATION OF THREE FORMULATIONS OF PIROXICAM INJECTED BY IM. ROUTE CONTAINING EACH 20MG OF ACTIVE INGREDIENT. |
Active substance: PIROXICAM |
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Document reference: 34382 |
Study title: TO CONFIRM THE EFFICACY AND TOLERATION OF PIROXICAM AS DISPERSIBLE TABLETS IN THE CONTROL OF DYSMENORRHEA PAIN. |
Active substance: PIROXICAM |
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Document reference: 34411 |
Study title: TO DETERMINE THE EFFICACY AND SAFETY OF FELDENE IM (PIROXICAM) WHEN USED FOR THE TREATMENT OF POST-OPERATIVE PAIN; FOLLOWING SURGERY. |
Active substance: PIROXICAM |
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Document reference: 34458 |
Study title: TO EVALUATE PIROXICAM SUPPOSITORIES FOR THE TREATMENT OF OSTEOARTHRITIS COMPARED TO A COMBINATION OF SUPPOSITORIES AND TABLETS OF DICLOFENAC. |
Active substance: PIROXICAM |
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Document reference: 34478 |
Study title: TO EVALUATE THE ANALGESIC AND ANTIINFLAMATORY EFFECT OF PIROXICAM IN PATIENTS WITH GONBARTHROSIS. |
Active substance: PIROXICAM |
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Document reference: 34479 |
Study title: TO EVALUATE THE EFFECTIVENESS AND SAFETY OF INJECTABLE PIROXICAM IN THE MANAGEMENT OF POST-OPERATIVE PAIN. |
Active substance: PIROXICAM |
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Document reference: 34362 |
Study title: " Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34658 |
Study title: Clinical efficacy and tolerance of various regenit preparations |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Orfanos.xls |
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Document reference: 48013 |
Study title: Bone scan patterns in acute osteomyelitis. Scoles PV, Hilty MD, Sfakianakis GN. Clin Orthop Relat Res. 1980 Nov-Dec;(153):210-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44136 |
Study title: A 16-week, randomized, multi-center, parallel- group, pimecrolimus-blinded, controlled study (4 week treatment period followed by a 12 week observational period) to evaluate the safety of concomitant use of ASM981 (pimecrolimus) cream 1% (BID) plus topical corticosteroids (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2439 Art45 listing 2011.xls |
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Document reference: 34090 |
Study title: Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58. |
Active substance: PYRIDOSTIGMINE |
Study summary document link (including results): |
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Document reference: 35226 |
Study title: Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43416 |
Study title: Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296. |
Active substance: PRAZEPAM |
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Document reference: 34637 |
Study title: "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. " "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. " |
Active substance: PRAZEPAM |
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Document reference: 34639 |
Study title: "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, P411-413." "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, ... |
Active substance: PRAZEPAM |
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Document reference: 34642 |
Study title: " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. " " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. " |
Active substance: PRAZEPAM |
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Document reference: 34640 |
Study title: Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415. Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415. |
Active substance: PRAZIQUANTEL |
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Document reference: 34647 |
Study title: Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59. |
Active substance: PRAZIQUANTEL |
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Document reference: 34645 |
Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses. |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Drebinger 405DT.xls |
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Document reference: 48010 |
Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses. |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Drebinger 402DT.xls |
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Document reference: 48011 |
Study title: Klinisches gutachten - 3.4 Wirksamkeit nephrotischen syndrome (page 26) - Studie 65: kinder mit lipoid nephrose - Dr. Drebinger - 03/10/1980 |
Active substance: PIRETANIDE |
Study summary document link (including results): |
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Document reference: 34299 |
Study title: Therapeutisch Erprobung - 2.6.4: Indikation nephrotisches syndrom (pages 1307 to 1380) - Studie 65 : Clinical assessment of HOE118 in children with nephrotic syndrom - Grünberg J - No date |
Active substance: PIRETANIDE |
Study summary document link (including results): |
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Document reference: 34300 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43504 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44159 |
Study title: Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7. Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43653 |
Study title: Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44175 |
Study title: Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44029 |
Study title: Psychopathologic analysis of mild forms of mental deficiency. |
Active substance: PIRACETAM |
Study summary document link (including results): DRU81B231P - Piracetam.pdf |
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Document reference: 45973 |
Study title: Pyrrolidone acetamide as an auxiliary drug in the treatment of cerebral palsy. |
Active substance: PIRACETAM |
Study summary document link (including results): DP76H051P - Piracetam.pdf |
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Document reference: 45995 |
Study title: Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 |
Active substance: PIRITRAMIDE |
Study summary document link (including results): pothmann_piritramide.pdf |
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Document reference: 34302 |
Study title: A CLINICAL EVALUATION OF FELDENE -- SUPPOSITORY IN PATIENTS WITH RHEUMATOID ARTHRITIS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34305 |
Study title: Variant pathogenetic therapy in the acute phase of hypoxic-traumatic brain damage in immature children. |
Active substance: PIRACETAM |
Study summary document link (including results): DRU87G074P - Piracetam.pdf |
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Document reference: 46018 |
Study title: Soft tissue uptake of Tc99m-MDP in acute lymphoblastic leukemia. Marwah A, Kumar R, Dasan J B, Choudhury S, Bandopadhyaya G, Malhotra A. Clin Imaging. 2002 May-Jun;26(3):206-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43448 |
Study title: Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43873 |
Study title: Three-phase radionuclide bone imaging in sports medicine. Rupani HD, Holder LE, Espinola DA, Engin SI. Radiology. 1985 Jul;156(1):187-96. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43940 |
Study title: Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43612 |
Study title: Tian M, Zhang H, Oriuchi N, Higuchi T, Endo K.. Epub 2004 Mar 11. Comparison of 11C-choline PET and FDG PET for the differential diagnosis of malignant tumors. [tian-2004]Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1064-72. Tian M 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48704 |
Study title: Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9 |
Active substance: MITOXANTRONE |
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Document reference: 32142 |
Study title: Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32081 |
Study title: Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32130 |
Study title: Hübner G et al. Intensive post-remission therapy in acute myeloid leukemia. Results of a prospective comparative study by the South Germany Hemoblastosis Group Med Klin (Munich). 1996 Apr 12;91 Suppl 3:26-32Hübner G et al. Intensive post-remission therapy in acute myeloid leukemia. Results of a prospective comparative study by the South Germany Hemoblastosis Group Med Klin (Munich). 1996 Apr 12;91 Suppl 3:26-32 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32196 |
Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32131 |
Study title: Meyer RM et al. Escalated as compared with standard doses of doxorubicin in BACOP therapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1993 Dec 9;329(24):1770-6.Meyer RM et al. Escalated as compared with standard doses of doxorubicin in BACOP therapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1993 Dec 9;329(24):1770-6. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32216 |
Study title: Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32118 |
Study title: Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8.Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8. |
Active substance: MITOXANTRONE |
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Document reference: 32184 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF PARENTAL PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS WHEN ADMINISTERED AS A LOADING DOSE OF 40 MG STARTING FOR TWO DAYS, FOLLOWED BY 20 MG INTRAMUSCULAR OR ORAL. |
Active substance: PIROXICAM |
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Document reference: 34492 |
Study title: TO EVALUATE THE LONG TERM EFFECTS OF TUBAL MORPHOLOGY AND FUNCTION AFTER PUD IN PATIENTS TREATED DURING THE ACUTE EPISODE WITH EITHER DOXYCYCLINE PLUS TINIDAZOLE PLUS PIROXICAM OR PLACEBO. |
Active substance: PIROXICAM |
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Document reference: 34462 |
Study title: Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43497 |
Study title: Turner CD, Chi S, Marcus KJ, MacDonald T, Packer RJ, Poussaint TY, et al.. Epub 2006 Sep 22. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. [turner-2007]J Neurooncol. 2007 Mar;82(1):95-101. Turner CD 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48705 |
Study title: Uchida Y, Minoshima S, Kawata T, Motoori K, Nakano K, Kazama T, et al.. Diagnostic value of FDG PET and salivary gland scintigraphy for parotid tumors. [uchida-2005]Clin Nucl Med. 2005 Mar;30(3):170-6. Uchida Y 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48706 |
Study title: EFFICACY OF PIROXICAM IN COMPARISON WITH NAPROXEN OR PLACEBO IN LARGE PATIENT POPULATION WITH ACUTE M.D. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34428 |
Study title: EFFICACY OF PIROXICAM IN OUTPATIENTS WITH SPORT-RELATED MUSCULO-SKELETAL INJURIES |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34473 |
Study title: EFFICACY OF PIROXICAM IN PATIENTS WITH URTI. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34371 |
Study title: EFFICACY OF PIROXICAM IN RELIEVING MENSTRUAL PAIN. |
Active substance: PIROXICAM |
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Document reference: 34336 |
Study title: EFFICACY OF PIROXICAM TO BE EVALUATED IN PATIENTS WITH ARTHROSIS OF KNEW/OR HIP, OR BURSITIS AND /OR TENDINITIS OF ELBOW OR SHOULDER |
Active substance: PIROXICAM |
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Document reference: 34335 |
Study title: EFFICACY OF PIROXICAM VS MEFANAMIC ACID IN PATIENTS WITH PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34330 |
Study title: EFFICACY OF PIROXICAM VS. NAPROXEN IN PATIENTS WITH RHEUMATIOD ARTHRITIS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34441 |
Study title: EFFICACY OF PIROXICAM VS. PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
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Document reference: 34488 |
Study title: EVALUATE EFFICACY AND TOLERATION OF PIROXICAM ON RATE OF SYMPTOMATIC RECOVERY IN ACUTE P. FALCIPARUM MALARIAL ATTACK AGAINST THOSE OF ASA AND TYLENOL. |
Active substance: PIROXICAM |
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Document reference: 34493 |
Study title: EVALUATE THE PAIN RELIEVING EFFECT OF PIROXICAM COMBINED WITH EPIDURAL MORPHINE AFTER MAJOR ABDOMINAL SURGERY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34369 |
Study title: EVALUATION OF THE EFFICACY AND TOLERATION OF PIROXICAM AS ADJUVANT THERAPY IN THE TREATMENT OF THE PAIN-DYSFUNCTION SYNDROME OF THE TEMPOROMANDIBULAR JOINT. |
Active substance: PIROXICAM |
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Document reference: 34340 |
Study title: EXTENSIVE WORLDWIDE STUDIES TO DISCOVER EVEN RARE SIDE EFFECTS BY MEANS OF LHIGH PATIENT NUMBERS. ALSO IF ONE CAPSULE OF PIROXICAM 20 MG WOULD BE ADVANTAGIOUS TO 2 CAPS OF 10 MG. |
Active substance: PIROXICAM |
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Document reference: 34367 |
Study title: INVESTIGATE WHETHER PIROXICAM CREAM AND GEL 1% OR CREAM AND GEL CONTAINING THE SAM EXCIPIENT EXCEPT PIROXICAM INDUCE ANY UNWANTED LOCAL SIDE EFFECTS AS ASSESSED BY A PATCH TEST. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34430 |
Study title: Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 |
Active substance: URINARY CONCREMENT SOLVENTS |
Study summary document link (including results): |
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Document reference: 39154 |
Study title: Fibrin clot lysis by thrombolytic agent is impaired in newborns due to a low plasminogen concentration |
Active substance: Urokinase |
Study summary document link (including results): 1440499.pdf |
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Document reference: 48378 |
Study title: Intrapleural urokinase in the treatment of complicated parapneumonic pleural effusions and empyema |
Active substance: Urokinase |
Study summary document link (including results): 8866590.pdf |
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Document reference: 48379 |
Study title: Does UDCA improve histological changes in liver disease in cystic fibrosis? |
Active substance: URSODEOXYCOLIC ACID |
Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Ursodeoxycholic acid_Ursofalk capsules_Dr Falk Pharma GmbH.xls |
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Document reference: 39159 |
Study title: Influence of Bile Acids on Postnatal Development im Preterm Infants during the first weeks of life; A controlled study with Ursodeoxycholic acid. |
Active substance: URSODEOXYCOLIC ACID |
Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Ursodeoxycholic acid_Ursofalk suspenion_Dr Falk Pharma GmbH.xls |
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Document reference: 39160 |
Study title: A Double-blind, Multi-centre Study Comparing Oral Valaciclovir and Aciclovir for the Suppression of CMV Infection and Disease Following Allogeneic Bone Marrow Transplantation |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-123-016-ICHE3.pdf |
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Document reference: 47355 |
Study title: A multicentre, randomised, double-blind, parallel, placebo controlled study of two dosing regimens of valaciclovir compared to placebo for the prevention/blockage of the progression of the cold sore lesion beyond the papular stage. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS230028-ICHE3.pdf |
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Document reference: 45427 |
Study title: A multicentre, randomised, double-blind, parallel, placebo-controlled study of two dosing regimens of valaciclovir compared to placebo for the reduction in length of cold sore episodes. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS230027-ICHE3.pdf |
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Document reference: 45426 |
Study title: A multicenter, retrospective, cohort, comparative epidemiologic study of the incidence of pre-specified abnormalities in cranial MRI in pediatric subjects with seizure disorders |
Active substance: VIGABATRIN |
Study summary document link (including results): Vigabatrin-Study 1.pdf |
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Document reference: 47304 |
Study title: "A parallel group study comparing oral adjuctive vigabatrin with placebo in children with uncontrolled complex partial seizures - Valentine C, Mettert N, Mosier M, Michon AM, and the Vigabatrin protocol 221 investigative cohort - 1998 (Epilepsia In press (abstract) 1998) Publication in Consolidated Responses to Questions raised in Article 12 Referral Procedure - 11/1998" |
Active substance: VIGABATRIN |
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Document reference: 39386 |
Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension.DOI: 10.1177/0091270008329547 Journal publication: Journal Clinical Pharmacology 2009;49:235-241 |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls |
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Document reference: 47269 |
Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension. |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls |
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Document reference: 48168 |
Study title: Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92.Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92. |
Active substance: VECURONIUM |
Study summary document link (including results): |
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Document reference: 45533 |
Study title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Venlafaxine ER in Pediatric Patients |
Active substance: Venlafaxine |
Study summary document link (including results): 0600B1-169-US EMA Pediatrics Web Synopsis.pdf |
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Document reference: 47931 |
Study title: A comparative study of the efficacy of and tolerance to 4mg salbutamol controlled release tablets (Volmax) and 1mg ketotifen tablets (Zaditen) administered twice daily in the management of childhood asthma |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35572 |
Study title: A comparison of intravenous salbutamol, aminophylline and the combination in the treatment of acute severe asthma in children. Report No. GPM/85/008 |
Active substance: SALBUTAMOL |
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Document reference: 35567 |
Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/001 |
Active substance: SALBUTAMOL |
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Document reference: 35547 |
Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/007 |
Active substance: SALBUTAMOL |
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Document reference: 35568 |
Study title: DIAGNOSTIC ANALYSIS IN PATIENTS WITH CHILDHOOD ONSET GROWTH HORMONE DEFICIENCY DURING TRANSITION FROM ADOLESCENCE TO ADULTHOOD |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-9002-020 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41650 |
Study title: Efficacy and Safety of Humatrope® in Patients with Ullrich-Turner Syndrome Turner syndrome |
Active substance: Somatropin |
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Document reference: 41638 |
Study title: EFFICACY OF GENOTONORM IN PREPUBERTAL CHILDREN WITH SHORT STATURE SECONDARY TO A NEUROSECRETORY DYSFUNCTION. COMPARISON OF EFFICACY ON GROWTH WITH GROWTH HORMONE DEFICIENT CHILDREN AND CONSTITUTIONAL SHORT STATURE CHILDREN |
Active substance: Somatropin |
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Document reference: 41677 |
Study title: A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLGB3019-ICHE3.pdf |
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Document reference: 42050 |
Study title: A Multicentre, Randomised, Double-Blind, Parallel-Group Study Comparing Pressurised Inhaler and Dry Powder Formulations of Salmeterol Xinafoate 50μg bd in Children With Reversible Airways Obstruction |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLPT03-ICHE3.pdf |
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Document reference: 47697 |
Study title: A multicentre, randomised. double-blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50mcg twice daily from the diskhaler) compared with placebo (from the diskhaler) with salbutamol (200mcg to use 'as required' from the diskhaler) in children with asthma. Report No. GRP/95/011 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SMS30013-ICHE3.pdf |
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Document reference: 42048 |
Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf |
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Document reference: 42041 |
Study title: Comparative study of corticotrophin vs vigabatrin therapy in infantile spasm - Ahmed R. - 2007 (Pak J Med Sci 2007; 23: 1 141-144) Publication in CES 0759 dated 16 Nov 2007 signed A. Giudicelli |
Active substance: VIGABATRIN |
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Document reference: 39387 |
Study title: Infantile spasms and West Syndrome Efficacy of short-term ACTH and vigabatrin treatment - Pintaudi M, Baglietto G, Pessagno A, Gaggero R - 2005 (Boll. Lega Ital. Epilepsia 2005; 169-170) Publication in CES 0741 dated 16 Nov 2006 signed A Giudicelli |
Active substance: VIGABATRIN |
Study summary document link (including results): |
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Document reference: 39390 |
Study title: Non-comparative, prospective and observational multicenter study to detect early visual field defects, their frequency and clinical course in first-time vigabatrin (Sabril®) treatment for refractory partial epilepsy (CANADIAN VIGABATRIN STUDY). |
Active substance: VIGABATRIN |
Study summary document link (including results): Vigabatrin-Study 4.pdf |
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Document reference: 39393 |
Study title: Open, multicentre study of the prevalence, incidence and clinical course of visual field defects in adults and children with refractory partial epilepsy treated with antiepileptic drugs. |
Active substance: VIGABATRIN |
Study summary document link (including results): Vigabatrin-Study 2.pdf |
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Document reference: 47305 |
Study title: A phase I evaluation of oral and intravenous vinorelbine tartrate in Paediatric Cancer Patients |
Active substance: VINORELBINE |
Study summary document link (including results): |
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Document reference: 39399 |
Study title: Etude DEFI. Idiopathic partial GH deficiency. Continuous versus discontinuous GH administration. |
Active substance: Somatropin |
Study summary document link (including results): GHD-F-5-F_Norditropin.pdf |
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Document reference: 41763 |
Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227 |
Active substance: Silimarin (HERB) |
Study summary document link (including results): |
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Document reference: 39876 |
Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227 |
Active substance: Silimarin (HERB) |
Study summary document link (including results): |
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Document reference: 40197 |
Study title: The Treatment of Toxic Liver Damage with legalon; Z Klin Med; 1992, 47(2): 87-92 |
Active substance: Silimarin (HERB) |
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Document reference: 39874 |
Study title: The Treatment of Toxic Liver Damage with legalon; Z Klin Med; 1992, 47(2): 87-92 |
Active substance: Silimarin (HERB) |
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Document reference: 40195 |
Study title: Therapeutische Möglichkeiten mit Legalon in der Pädiatrie; Medica 1983; 4 (11): 3-6 |
Active substance: Silimarin (HERB) |
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Document reference: 39875 |
Study title: Therapeutische Möglichkeiten mit Legalon in der Pädiatrie; Medica 1983; 4 (11): 3-6 |
Active substance: Silimarin (HERB) |
Study summary document link (including results): |
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Document reference: 40196 |
Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf |
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Document reference: 47699 |
Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf |
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Document reference: 42040 |
Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf |
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Document reference: 47698 |
Study title: OPEN-LABELED, MULTI-CENTER, SINGLE ARM STUDY TO DETERMINE PATIENT/CARE GIVER PREFERENCE OF INJEX, THE NEEDLE FREE, AUTOINJECTION DEVICE FOR ADMINISTRATION OF GENOTROPIN. |
Active substance: Somatropin |
Study summary document link (including results): GENAJT-0029-003 PhRMA Web Synopsis .pdf |
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Document reference: 41665 |
Study title: Praticability and acceptability study of Stylomaxr in patients with somatropin insufficiency |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41821 |
Study title: Protocol A: The Effects of Biosynthetic Human Growth Hormone Treatment in the Management of Children with Familial Short Stature. Protocol B: A Comparative Evaluation of Growth Hormone, anabolic steroids and a combinationof the two in stimulating the Grow |
Active substance: Somatropin |
Study summary document link (including results): GHRETARD-BPD-8-9-10-UK_Norditropin.pdf |
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Document reference: 41779 |
Study title: Clinical Protocol for a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Compare the Efficacy and Tolerability of Valdecoxib vs. Tramadol in Treatment of Acute Ankle Sprains |
Active substance: Valdecoxib |
Study summary document link (including results): |
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Document reference: 47444 |
Study title: A comparative review of the adverse effects of anticonvulsants in children with epilepsy. - Wallace SJ. - Drug safety 1996; 15(6): 378-393. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45436 |
Study title: "Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease" |
Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
Study summary document link (including results): |
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Document reference: 41459 |
Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease |
Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
Study summary document link (including results): |
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Document reference: 41460 |
Study title: A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45540 |
Study title: Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32, Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45546 |
Study title: Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45555 |
Study title: Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group.Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group. |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45550 |
Study title: Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45556 |
Study title: Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45542 |
Study title: Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45543 |
Study title: Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45547 |
Study title: Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92 Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92 |
Active substance: SILYMARIN |
Study summary document link (including results): |
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Document reference: 42171 |
Study title: Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227. |
Active substance: SILYMARIN |
Study summary document link (including results): |
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Document reference: 42173 |
Study title: Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6. Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6. |
Active substance: SILYMARIN |
Study summary document link (including results): |
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Document reference: 42172 |
Study title: Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91 Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91 |
Active substance: SIMETICONE |
Study summary document link (including results): |
View full study record |
Document reference: 42205 |
Study title: Safety and efficacy of Growth Hormone treatment of Patients with growth hormone deficiency by means of a pen injector (Nordiject) |
Active substance: Somatropin |
Study summary document link (including results): YU_GHD_001_GHD_Norditropin.pdf |
View full study record |
Document reference: 41767 |
Study title: Study of the effect of subcutaneous administration of two doses of biosynthetic growth hormone (Norditropin) on growth and metabolic parameters in pre-pubertal children with growth hormone deficiency |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41755 |
Study title: J.A.R. Calderon: Uso de Pantogar en la terapia contra la caida difusa del cabello y danos estructurales del mismo, 2003 |
Active substance: VITAMIN COMBINATIONS |
Study summary document link (including results): |
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Document reference: 39401 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0002-ENE01 |
Active substance: VALPROIC ACID |
Study summary document link (including results): Valproic Acid STUDY 022-6-133-V1.xls |
View full study record |
Document reference: 45437 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0364-ENE01 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45440 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0368-ENE01 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45441 |
Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42434 |
Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42547 |
Study title: A Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-Center Study of VENTOLIN™ (albuterol) HFA MDI delivered with facemask and two different holding chambers in Subjects aged 24 to <48 months with asthma symptoms (i.e. wheeze, cough, dyspnea or chest tightness) or consistent with asthma or obstructive airway disease or bronchospasm. |
Active substance: SALBUTAMOL |
Study summary document link (including results): Salbutamol Sulphate-SB020001-ICHE3.pdf |
View full study record |
Document reference: 47684 |
Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Clinical Trial Assessing the Safety and Efficacy of Albuterol Powder 200mcg QID via the DISKUS versus Albuterol Aerosol 200mcg (180mcg Ex-Actuator) versus Placebo in Pediatric Subjects Aged 4-11 Years with Asthma. Report No. RM1997/00754/00 |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35569 |
Study title: An open cross-over comparison of controlled release salbutamol tablets (4mg bd) with individually titrated slow release theophylline (Theodur) in the management of chronic reversible airways obstruction in children (ST 388). Report No. GRP/88/013 |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35573 |
Study title: Combivent vs. salbutamol in patients with metacholine-induced bronchospasm |
Active substance: SALBUTAMOL |
Study summary document link (including results): Ipratropium bromide_salbutamol sulphate_U00-0040_synopsis.pdf |
View full study record |
Document reference: 30743 |
Study title: Comparison of the bronchodilating effect of salbutamol inhaled with low inspiratory flow from Easyhaler with that of salbutamol aerosol |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35552 |
Study title: Easyhaler, Diskus and Turbohaler. A comparison of correct use and acceptability of three devices. |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35550 |
Study title: T. Orłowski - ,,Clinical evaluation of the preparation Salbutamol tablets and syrup" |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35553 |
Study title: Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42216 |
Study title: Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42215 |
Study title: Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42 |
Active substance: SIMETICONE |
Study summary document link (including results): |
View full study record |
Document reference: 42193 |
Study title: Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9 |
Active substance: SIMETICONE |
Study summary document link (including results): |
View full study record |
Document reference: 42187 |
Study title: A study of the safety of sodium divalproate (Dépakote®) in adolescents suffering from bipolar disorder in manic, mixed or hypomanic phase |
Active substance: VALPROIC ACID |
Study summary document link (including results): Sodium Valproate-Study 1.pdf |
View full study record |
Document reference: 47744 |
Study title: American Academy of Pediatrics. Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. Pediatrics 1999; 103: 1307-1309. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45445 |
Study title: Baumann RJ. Prevention and management of febrile convulsions. Paedriatr Drugs 2001; 3: 585-592. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45452 |
Study title: Baumann RJ. et al. Treatment of children with simple febrile convulsions: the AAP practice parameter. Pediatr Neurol 2000; 23:11-17. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45451 |
Study title: A multicentre, open, centrally randomised, parallel group study of the evaluation of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day bid versus ceflacor 20mg/Kg/day bid in a 5 to 10 days treatment of lower respiratory tract infections in children - Kotze A. - 06/98 |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): RU28965D3003.pdf |
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Document reference: 45230 |
Study title: AN OPEN FOLLOW-UP TRIAL EVALUATING THE CLINICAL COURSE OF PATIENTS WITH CYSTIC FIBROSIS AFTER GROWTH HORMONE TREATMENT ENDED WITHIN PHARMACIA CLINICAL TRIAL 307- MET-9002-026 |
Active substance: Somatropin |
Study summary document link (including results): GENOT-9002-079 PhRMA Web Synopsis.pdf |
View full study record |
Document reference: 41663 |
Study title: An Open label, Randomized, Crossover, Patient/Parent Preference Trial of Norditropin® SimpleXx™ versus Humatrope®, Nutropin-AQ® and Genotropin™ in Children with Growth Hormone Deficiency |
Active substance: Somatropin |
Study summary document link (including results): hGH-2060_Norditropin.pdf |
View full study record |
Document reference: 41819 |
Study title: An open randomized, multicentre,2-period crossover trial evaluating accaptance/ convenience and pain perception of the new liquid formulation versus freeze-dried Norditropin® |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41806 |
Study title: T. Ortowski - "Clinical evaluation of preparation Salbutamol tablets and syrup" |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35554 |
Study title: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. |
Active substance: SALICYLIC ACID AND UREA |
Study summary document link (including results): |
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Document reference: 35590 |
Study title: GENOTROPIN IN CHILDREN WITH INTRAUTERINE GROWTH RETARDATION. AN OPEN, MULTICENTER, COMPARATIVE, RANDOMISED, NATIONAL STUDY |
Active substance: Somatropin |
Study summary document link (including results): 93-8122-008 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41678 |
Study title: A Randomized, Double-Blind, Double-Dummy, Five-Way Crossover Comparative Clinical Trial of Single Doses of Salmeterol 25, 50, and 100 mcg via the Diskus (Multidose Powder Inhaler), Albuterol Rotacaps 200 mcg via Rotahaler, and placebo in Pediatirc Subjects Aged 4-11 Years with Asthma. Report No. RM1996/00351/00; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42021 |
Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparative Clinical Trial of the Effects of Twelve Week Courses of 50mcg and 25mcg Salmeterol Powder Bid via the Diskus Versus Ventolin Rotacaps 200mcg QID Versus Placebo in Pediatric Subjects Aged 4-11 Years with Mild to Moderate Asthma. Report No. RM1997/00414/00; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42022 |
Study title: A randomized, double-blind, double-dummy, single-dose, four-way cross-over comparison of salmeterol 25mcg and 50mcg given by the multi-dose powder inhaler (DISKUSTM), albuterol 180mcg given by the metered-dose inhaler, and placebo for the prevention of exercise-induced bronchospasm in pediatric subjects with asthma. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol Xinafoate-SLGA2014-ICHE3.pdf |
View full study record |
Document reference: 42020 |
Study title: A Randomized, Double-Blind, Double-Dummy, Single-Dose, Three-Way Crossover Comparison of Salmeterol Xinafoate 50mcg and Placebo Given by the Multi-Dose Powder Inhaler and Diskhaler for the Prevention of Exercise-Induced Bronchospasm in Pediatric Patients with Asthma. Report No. UCR/95/014 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42019 |
Study title: The use of multivitamin-preparations in paediatricsThe use of multivitamin-preparations in paediatrics |
Active substance: VITAMINS |
Study summary document link (including results): |
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Document reference: 45566 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT] |
Active substance: Vomitusheel |
Study summary document link (including results): |
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Document reference: 40309 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel S (suppositories) [AWB-AT] |
Active substance: Vomitusheel S |
Study summary document link (including results): |
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Document reference: 40310 |
Study title: International clinical study to investigate the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octate (=Wilate). |
Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION |
Study summary document link (including results): |
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Document reference: 45578 |
Study title: International clinical study to investigate the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octate (=Wilate). |
Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION |
Study summary document link (including results): |
View full study record |
Document reference: 45581 |
Study title: A randomized, open label, comparative multicenter study of voriconazole versus conventional amphotericin B → fluconazole in the treatment of candidemia in non neutropenic subjects |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-608 PhRMA Web Synopsis.pdf |
View full study record |
Document reference: 48051 |
Study title: A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia |
Active substance: VORICONAZOLE |
Study summary document link (including results): A1500603 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48053 |
Study title: An Historical Control Study of the Efficacy of Standard Therapy in Acute Aspergillosis to Allow Comparison with the Efficacy of Voriconazole in Protocol 150-304 |
Active substance: VORICONAZOLE |
Study summary document link (including results): A1501003 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48054 |
Study title: Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989)) Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989)) |
Active substance: SERRAPEPTASE |
Study summary document link (including results): |
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Document reference: 42123 |
Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. October 7, 1999 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): Ferrer_ Spain_ Ser-960603.pdf |
View full study record |
Document reference: 42125 |
Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. January 29, 1999 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): Ferrer_ Spain_ Ser-960602.pdf |
View full study record |
Document reference: 48114 |
Study title: Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): |
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Document reference: 45241 |
Study title: A multicenter 10-week randomized double-blind, Placebo-controlled flexible dose outpatient study of Sertraline in children and adolescents with major depressive disorder. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42130 |
Study title: A multicenter 10-week randomized double-blind, placebo-controlled flexible dose outpatient study of sertraline in children and adolescents with major depressive disorder. (Strength: 25, 50mg; Pharmaceutical form: tablet) |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42143 |
Study title: A multicenter 24-week open-label extension study of Sertraline in children and adolescent outpatients previously diagnosed with major depressive disorder. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42131 |
Study title: A multicenter 24-week open-label extension study of sertraline in children and adolescent putpatients previously diagnosed with major depressive disorder. (Strenght: 50mg; Pharmaceutical form: tablet) |
Active substance: SERTRALINE |
Study summary document link (including results): |
View full study record |
Document reference: 42144 |
Study title: A single-blind comparative study of sertraline in the treatment of depressed patients. (Strength: 25, 50mg; Pharmaceutical form: tablet) |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42149 |
Study title: A single-blind comparative study of Sertraline with Imipramine in the treatment of depressed patients. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42140 |
Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE. A TWOYEAR FOLLOW UP TRIAL WITHOUT TREATMENT COMPRISING THE PATIENTS FROM THE FORMER TWO TREATMENT ARMS. |
Active substance: Somatropin |
Study summary document link (including results): |
View full study record |
Document reference: 41714 |
Study title: GH THERAPY IN PARTIAL GHD ADOLESCENTS: EVALUATION OF EFFICACY BASED ON BODY COMPOSITION AND COMPARISON OF 2 DIFFERENT DOSES OF GENOTONORM(REGISTERED) OPEN LABEL, RANDOMIZED, COMPARATIVE, CONTROLLED, PARALLEL-GROUP, MULTICENTER PHASE IIIB TRIAL |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-9002-016 (A6281018) PhRMA Web Synopsis.pdf |
View full study record |
Document reference: 41648 |
Study title: Barkun A. Commonly used preparations for colonoscopy: Efficacy, tolerability and safety - A Canadian association of gastroenterology position paper. Can J Gastroenterol, November 1, 2006, 699-710Barkun A. Commonly used preparations for colonoscopy: Efficacy, tolerability and safety - A Canadian association of gastroenterology position paper. Can J Gastroenterol, November 1, 2006, 699-710 |
Active substance: SIMETICONE |
Study summary document link (including results): |
View full study record |
Document reference: 42176 |
Study title: A single centre, double blind, parallel group, placebo controlled study, to evaluate the effect of inhaled Salmeterol xinafoate (50mcg bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma. Report No. VCL/ME/1998/004 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLMP03-ICHE3.pdf |
View full study record |
Document reference: 42058 |
Study title: A Randomized, Double-Blind, Comparative Trial of the Effects of Twelve Week Courses of Salmeterol Xinafoate Rotadisks versus Placebo in Pediatric Patients Aged 4 to 11 years with Mild-to-Moderate Asthma. Report No. RD1996/00083/00; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42045 |
Study title: A single centre, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single and chronic dosing with salmeterol 50mcg (as xinafoate) twice daily and sodium cromoglycate 20mg four times daily in children with reversible airways' constriction. Report No. GRP/94/046 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42055 |
Study title: A single centre, randomised, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single dosing with salmeterol xinafoate 50mcg delivered via the multi-dose powder inhaler and sodium cromoglycate 20mg delivered via the spinhaler in children aged 6-11 years with reversible airways disease. Report No. GRP/95/025 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SMDT08-Salmetrol Xinafoate (Serevent Diskus).xls |
View full study record |
Document reference: 42033 |
Study title: The Efficacy and Safety of Growth Hormone Treatment in Non-growth Hormone Deficient Patients with Short Stature Caused By Turner Syndrome |
Active substance: Somatropin |
Study summary document link (including results): Somatropin-B9R-JE-T01A.xls |
View full study record |
Document reference: 41633 |
Study title: Clinical comparative assessment of efficacy, tolerance and toxicity of Dipromal and Depakina in the treatment of epilepsy in children |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45460 |
Study title: Clinical results obtained during treatment with Depakene conducted in psychiatric hospitals - Beaudouin - No date - Publication 9 in Clinical trials with Depakene - No author - No date - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45464 |
Study title: Clinical trials with a new antiepileptic, sodium dipropylacetate - Dereux and al. - 1967 (Congrès de Psychiatrie et de Neurologie de langue française) Publication 4 in Clinical trials with Depakene - No author - No date |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45465 |
Study title: Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. - American Academy of Pediatrics. - Pediatrics 1999; 103: 1307-1309. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45466 |
Study title: Comparative clinical and pharmacokinetic study of a new slow release versus conventional preparations of valproic acid in children with intractable epilepsy - Braisn and Development, 1992, 14 (5), p.304-308 - Imaizumi T., Izumi T., Fukuyama Y. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45467 |
Study title: Continuous sodium valproate or pheobarbitone in the prevention of simple febrile-Comparison by a double blind trial - E. Ngwane. - 1980 (Arch Dis Childhood 1980;55:171-174) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45468 |
Study title: Depacon administration, safety and efficacy in a hospital setting - Short DW. and al. - 1999 ( Epilepsia 1999 - 40 (suppl 7) : 226 (abstract 3.248) ) - Publication in Ergenyl Vial Expert report on the clinical documentation - HUFNAGEL 14/11/2006 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45471 |
Study title: Divalproex sodium treatment in late adolescent and young adult acute mania - Papatheodorou G. Kutcher SP. - 1993 (Psychopharmacol Bull 1993, 29 : 213-19) - Publication in expert report on the clinical documentation - Giudicelli A. -05/2002 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45472 |
Study title: An Open Label, Non-Comparative Protocol for the Emergency Use of Voriconazole in Patients with Life-threatening, Invasive Mycoses who are failing on currently available antifungal Agents |
Active substance: VORICONAZOLE |
Study summary document link (including results): A1501050 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48057 |
Study title: An Open Label, Non-comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48050 |
Study title: A twelve week double blind multicentre comparaison of sertraline and placebo in patients with obsessive-compulsive disorder. (Strength: 50mg; Pharmaceutical form: capsules) |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42142 |
Study title: An open study investigating the efficacy, safety and tolerability of STL in patients with treatment refractory depressive illness. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42134 |
Study title: An open-label, comparative study of sertraline with maprotiline in the treatment of depressed patients. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42151 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42256 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42288 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42320 |
Study title: Bowring AR, Mackay D, Taylor FR. The treatment of napkin dermatitis: a double-blind comparison of two steroid-antibiotic combinations. Pharmatherapeutica. 1984;3(9):613-7Bowring AR, Mackay D, Taylor FR. The treatment of napkin dermatitis: a double-blind comparison of two steroid-antibiotic combinations. Pharmatherapeutica. 1984;3(9):613-7 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42218 |
Study title: Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42221 |
Study title: Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42174 |
Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42426 |
Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42539 |
Study title: To evaluate the effect of two years of treatment with three different dose regimens of Norditropin® SimpleXx® on height in children with intrauterine growth retardation ages 3 to <8 years at start of treatment; a randomized, parallel, multinational trial |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1424_Norditropin.pdf |
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Document reference: 41775 |
Study title: Traitement par Hormone biosynthétique MAXOMAT d'enfants en cours de puberté présentant un retard de croissance sévère à début intra-utérin (retard d'au moins -2,5 DS) |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41825 |
Study title: Study of the effect of subcutaneous administration of two doses of biosynthetic growth hormone (Norditropin®) on growth and metabolic parameters in pre-pubertal children with growth hormone deficiency |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41756 |
Study title: TREATMENT OF 94 PATIENTS WITH TURNER SYNDROME WITH RECOMBINANT HUMAN GROWTH HORMONE FOR TWO YEARS. THE RESULT OF A MUNTICENTRIC STUDY IN JAPAN. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41741 |
Study title: TREATMENT WITH GENOTROPIN IN GIRLS WITH TURNER'S SYNDROME AGED 3-9 YEARS. AN OPEN-LABELLED, NONCOMPARATIVE MULTICENTER TRIAL IN SWEDEN. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41735 |
Study title: Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42222 |
Study title: Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42203 |
Study title: An Open Label, Non-comparative, Multicentre, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48049 |
Study title: B. Romański - ,,Comparative clinical trial of the prep. Xylogel 0.05% and 0.1% in the form of nasal gel and Xylometazolin 0.05% and 0.1% in the form of nasal drops manufactured by WPW Polfa in patients with rhinitis of nose mucous membrane" |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): |
View full study record |
Document reference: 45637 |
Study title: Bumbalo, T.S. (1960) Xylometazoline HCl, a new nasal medication for paediatric use (an evaluation). West. Med. 1, 9 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Bumbalo_1960.xls |
View full study record |
Document reference: 45638 |
Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42257 |
Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42289 |
Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatmetn of lower respiratory tract infections in children - Rostand A. - 11/86 |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): |
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Document reference: 35472 |
Study title: An open, multicenter study of oral Roxithromycin sachet formulation - 2.5mg/kg to 5.Omg/kg bid - in the treatment of pediatrics patients with respiratory and cutaneous infections. |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): Roxithromycin STUDY FF8596548.xls |
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Document reference: 48004 |
Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 - |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): |
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Document reference: 35481 |
Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatment of lower respiratory tract infections in children - Rostand A. - 11/86 |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): FF9296530.pdf |
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Document reference: 35458 |
Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 - |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): |
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Document reference: 35482 |
Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42246 |
Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42278 |
Study title: A 2-week, randomized, double-blind, parallel-group study in pediatric subjects with asthma aged 4 to11 years to examine the pharmacokinetics of fluticasone propionate (FP) and salmeterol (SALM) from the FP/SALM combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg). Report No. RM2004/00114/00 |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35602 |
Study title: A Multicentre, Randomised, Double-blind, Double-dummy, Parallel Group Comparison of Three Treatments: 1) Seretide (50/100 mcg Strength)bd via Diskus/Accuhaler Inhaler, 2) Fluticasone Propionate 200 mcg bd via Diskus Inhaler, 3) Fluticasone Propionate 100mcg bd via Diskus/Accuhaler Inhaler in Children Aged 4-11 Years with Asthma. Report No. BP1999/00102/00 |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35594 |
Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100/50mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm. Report No. RM2005/00343/00 |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35592 |
Study title: A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol Diskus Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate Diskus 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2001/00010/07 |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35595 |
Study title: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. |
Active substance: SALICYLIC ACID AND UREA |
Study summary document link (including results): |
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Document reference: 35589 |
Study title: De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42231 |
Study title: Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques. Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42226 |
Study title: Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42227 |
Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42360 |
Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42473 |
Study title: Epilepsy in general paediatric practice - Muddiman M.J. and al. - 1983 (Br. J. Clin. Pract., 1983 symposium, suppl. 27, 99-104) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45478 |
Study title: Herranz JL et al. Side effects of valproate in monotherapy controlled by plasma levels: a study in 88 pediatric patients. Epilepsia 1982;23:203-14. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45486 |
Study title: Roxithromycin 1OOmg paediatric tablet - Multicenter clinical trial |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): Roxithromycin STUDY FFR8796523.xls |
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Document reference: 48007 |
Study title: Roxithromycin 50 mg paediatric tablet - Multicenter clinical trial. |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): Roxithromycin STUDY FFR 87 965 19.xls |
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Document reference: 48006 |
Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35600 |
Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal” |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35599 |
Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/016 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42026 |
Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/018 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42034 |
Study title: Growth-promoting effect of a recombinant Human Growth Hormone NN-798 on Achondroplasia – A 1-year, comparative study between two dose groups. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41803 |
Study title: A single-centre, cross-over study to compare the duration of protection against exercise-induced bronchoconstriction following single dose Salmeterol 50mcg and Sodium cromoglycate 40mcg in children with reversible airways. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SMS40124-ICHE3.pdf |
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Document reference: 42068 |
Study title: Lewison, E. (1970) Comparison of the effectiveness of topical and oral nasal decongestants. Eye, ear, nose & throat monthly, 49:16 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Lewison_1970.xls |
View full study record |
Document reference: 45646 |
Study title: McNeill M.D. (1960) A new topical vasoconstrictor, (xylometazoline) n paediatrics. Gen. Pract. 24(4):342-344 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - McNeill_1960.xls |
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Document reference: 45648 |
Study title: ASSESSMENT OF TREATMENT WITH GENOTROPIN IN PAEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME. MULTICENTER, RANDOMIZED, OPEN AND WITH A CONTROL GROUP WITHOUT TREATMENT |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41645 |
Study title: Sertraline in the treatment of depressed patients. An open non-comparative multicenter study. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42136 |
Study title: Sertraline treatment of adolescent outpatients with major depression. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42133 |
Study title: Sertraline treatment of adolescent outpatients with major depression. (Strength: 50mg; Pharmaceutical form: tablet) |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42146 |
Study title: A Phase II, Randomized, Open-Label Study to Compare the Safety and Efficacy of Sevoflurane Versus Halothane Administered with Nitrous Oxide and Oxygen in ASA Class I and II Pediatric Patients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-124.pdf |
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Document reference: 42160 |
Study title: Humatrope® (Somatropin) Drug Monitoring in Patients with Short Stature |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41640 |
Study title: INTRODUCTION OF A NEW GENOTROPIN NEEDLE FREE DEVICE - A FUNCTIONALITY AND PATIENT PERCEPTION STUDY OF INJEX |
Active substance: Somatropin |
Study summary document link (including results): GENAJT-0029-002 PhRMA Web Synopsis.pdf |
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Document reference: 41666 |
Study title: Corazziari E et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci. 1996 Aug;41(8):1636-42Corazziari E et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci. 1996 Aug;41(8):1636-42 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42210 |
Study title: Danielsson B, Hwang CP. Treatment of infantile colic with surface active substance (Simethicone). Acta Paediatr Scan. October 2, 1985, 446-50Danielsson B, Hwang CP. Treatment of infantile colic with surface active substance (Simethicone). Acta Paediatr Scan. October 2, 1985, 446-50 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42199 |
Study title: A single-centre, randomised, double-blind, placebo controlled, parallel group study to evaluate the efficacy of salmeterol (50mcg BD via the diskhaler) in children aged 6-16 years who have asthma that is difficult to control. Report No. GRP/95/024; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SLPX01- SMS30029-Salmeterol Xinafoate-Serevent Rotadisks.xls |
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Document reference: 42062 |
Study title: A two centre study to assess the ease of handling and efficacy of salmeterol 50mcg twice daily delivered via a multidose powder inhaler compared with terbutaline sulphate 500mcg three times daily delivered via a turbohalerTM in children aged 6-11 years with reversible airways disease. Report No. GRP/95/017 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SMDT07-SLGB4005-Salmetrol Xinafoate (Serevent Diskus).xls |
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Document reference: 42032 |
Study title: A two-centre, double-blind, placebo controlled three way cross-over study to determine the duration of action of salmeterol 25mcg and 50mcg administered via Diskhaler against exercise induced bronchoconstriction in children with asthma. Further to compare the effect of salmeterol 50mcg x 2 and salbutamol 200mcg x 2 administered via adiskhaler for 6 weeks, on bronchial hyperreactivity in two parallel groups. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42057 |
Study title: TREATMENT WITH RECOMBINANT HUMAN GROWTH HORMONE IN SHORT CHILDREN AFTER RENAL TRANSPLANTATION FOR CHRONIC RENAL FAILURE IN SPAIN. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41732 |
Study title: Use Result Survey of Humatrope® Therapy for Pituitary Drawfism Not Accompanied by Epiphyseal Closure |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41637 |
Study title: Efficacy of lodoxamide 0.1% versus N-Acetyl Aspartyl Glutamic Acid 6% Ophthalmic solutions in Patients with Vernal KeratoconjunctivitisEfficacy of lodoxamide 0.1% versus N-Acetyl Aspartyl Glutamic Acid 6% Ophthalmic solutions in Patients with Vernal Keratoconjunctivitis |
Active substance: SPAGLUMIC ACID |
Study summary document link (including results): |
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Document reference: 42575 |
Study title: Major malformations in infants exposed to antiepileptic drugs in utero with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. - Wide K et al. - Acta Paediatr 2004;93:174-6. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45494 |
Study title: Monotherapie par le valproate de sodium dans les epilepsies de l'enfant - Dulac O. and al. - 1982 (arch. Fr. Pediatr., 1982, 39, (6), 347-352) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45499 |
Study title: Open-study of the efficacy and safety of LA 40220 SRF in the treatment of partial seizure/generalized epilepsy |
Active substance: VALPROIC ACID |
Study summary document link (including results): Sodium Valproate-Study 2.pdf |
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Document reference: 47745 |
Study title: A Phase III, Multicenter, Open-Label Study Evaluating the Effect of Multiple Exposure to Sevoflurane for the Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-098.pdf |
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Document reference: 42158 |
Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Outpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-090.pdf |
View full study record |
Document reference: 42156 |
Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-091.pdf |
View full study record |
Document reference: 42157 |
Study title: A Phase III, Randomized, Open-Label Study to Compare the Safety, Tolerability and Recovery Characteristics of Sevoflurane Versus Halothane Administered with Nitrous Oxide and Oxygen in ASA Class I and II Pediatric Patients Undergoing Ambulatory Surgery |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-125.pdf |
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Document reference: 42161 |
Study title: A Phase III, Single Center, Open-Label Study Evaluating the Production of Compound A When Sevoflurane is Administered for the Induction and Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Patients |
Active substance: SEVOFLURANE |
Study summary document link (including results): |
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Document reference: 42162 |
Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42321 |
Study title: Ge ZZ et al. The role of simeticone in small-bowel preparation for capsule endoscopy. Endoscopy. 2006 Aug;38(8):836-40Ge ZZ et al. The role of simeticone in small-bowel preparation for capsule endoscopy. Endoscopy. 2006 Aug;38(8):836-40 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42202 |
Study title: Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42219 |
Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42310 |
Study title: Study of the clinical and biological efficacity of NAAXIA SINE® in vernal keratoconjunctivitis |
Active substance: SPAGLUMIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 42574 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (ampoules) [AWB-AT] |
Active substance: Spascupreel - Ampullen/ Spascupreel S |
Study summary document link (including results): |
View full study record |
Document reference: 40205 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (injection solution/suppositories/tablets) [AWB-073] |
Active substance: Spascupreel - Tabletten/ Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40207 |
Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Spascupreel (tablets) in the treatment of spasms of the gastrointestinal tract [AWB-136] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
View full study record |
Document reference: 40210 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S tablets [AWB-134] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40209 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (tablets) [AWB-034] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40208 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S (suppositories) [AWB-135] |
Active substance: Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40212 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel S (suppositories) [AWB-AT] |
Active substance: Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
View full study record |
Document reference: 40211 |
Study title: Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C., |
Active substance: SOBREROL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Mucodox (Sobrerol).pdf |
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Document reference: 42225 |
Study title: Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4. Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42229 |
Study title: BSS Alcon Studies: Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction in Pediatric Patients. |
Active substance: SODIUM CHLORIDE |
Study summary document link (including results): |
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Document reference: 42233 |
Study title: A repeat dose open-label, seafety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns |
Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL |
Study summary document link (including results): |
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Document reference: 39447 |
Study title: Preparation H ointment (WH-66-228) repeated insult patch test |
Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL |
Study summary document link (including results): |
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Document reference: 39446 |
Study title: Coursaget P, Fritzell B, Blondeau C, Saliou P and Diop-Mar I. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995; 13: 109-111 |
Active substance: Yellow Fever Vaccine (Live) |
Study summary document link (including results): |
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Document reference: 41386 |
Study title: Mouchon D, Pignon D, Vicens R, Tu-Ha-Tnanh, Tekaia F, Teulières L and Garrigue G. Etude de la vaccination combinée rougeole-fièvre jaune chez l’enfant africain âgé de 6 à 10 mois. [Study of the combined vaccination against measles and yellow fever in African infants aged 6-10 months]. Bull Soc Path Ex 1990; 83: 537-551 |
Active substance: Yellow Fever Vaccine (Live) |
Study summary document link (including results): |
View full study record |
Document reference: 41388 |
Study title: 9188IL0138: A Multicenter, Randomized, Double-blind,Placebo-controlled Parallel-group, 15-week Trial of Zafirlukast (ACCOLATE) Versus Low-dose Inhaled Corticosteroids After a 7-day Course of Oral Corticosteroids in Subjects With Asthma |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0138 CSR Synopsis.pdf |
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Document reference: 45604 |
Study title: A Double-Blind, Double-Dummy, Placebo-controlled 13-Week Comparison of ICI 204,219 (20 mg BID) with Sodium Cromoglycate in Patients with Mild to Moderate Asthma |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0059 Summary.pdf |
View full study record |
Document reference: 45585 |
Study title: A Double-blind, Parallel Group Trial of Zafirlukast (ACCOLATE) 20 mgbid in Combination With Cetirizine (ZYRTEC) 10 mg at Bedtime VersusCetirizine (ZYRTEC) 10 mg at Bedtime for the Treatment of Subjects WithChronic Idiopathic UrticariaBrief Report |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188US0024 CSR Summary.pdf |
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Document reference: 45609 |
Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42402 |
Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42515 |
Study title: The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): |
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Document reference: 35459 |
Study title: Results of retrospective Analysis about application of NHO Pollen for hypersensitivity. Age of patients: 6 to79 Years, 104 Patients |
Active substance: Rye grass;Velvet grass;Timothy Grass;Dermatophagoides farinae;Dermatophagoides farinae;Dermatophagoides pteronyssinus;Dermatophagoides pteronyssinus;Fescue;Grama;Hazel;Alder;Birch-tree;Rye;Rye;Barley extract;Wheat;Gramineous;Gramineous; |
Study summary document link (including results): |
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Document reference: 40155 |
Study title: Results of retrospective Analysis about hypersensitivity with Novo-Helisen® oral Mites. Age of patients: 2 to 37 Years |
Active substance: Rye grass;Velvet grass;Timothy Grass;Dermatophagoides farinae;Dermatophagoides farinae;Dermatophagoides pteronyssinus;Dermatophagoides pteronyssinus;Fescue;Grama;Hazel;Alder;Birch-tree;Rye;Rye;Barley extract;Wheat;Gramineous;Gramineous; |
Study summary document link (including results): |
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Document reference: 40157 |
Study title: 14. Mycoserological study of the treatment of paediatric cystic fibrosis patients with Saccharomyces boulardii (Saccharomyces cerevisiae Hansen CBS 5926).; Mycoses 1995 ; 38 : 119-123. |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
View full study record |
Document reference: 40168 |
Study title: 18. Effects of Saccharomyces boulardii in children with acute diarrhoea.; Acta Paediatrica 2005, 94 (1) : 44-47 |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
View full study record |
Document reference: 40172 |
Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42261 |
Study title: A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50μg (from a Diskhaler) after a single dose and after treatment with 50μg twice daily, for 28 days in children and adolescents with asthma. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLGB4003-ICHE3.pdf |
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Document reference: 42046 |
Study title: A double-blind, double-dummy, placebo-controlled, crossover study to compare the effects of salmeterol 50mcg inhaled from a Diskus inhaler at low and high flow rates in children with exercise induced bronchoconstriction. Report No. GRP/95/041 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42024 |
Study title: A double-blind, double-dummy, placebo-controlled, crossover study to compare the effects of salmeterol 50mcg inhaled from a Diskus inhaler at low and high flow rates in children with exercise induced bronchoconstriction. Report No. GRP/95/039 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42031 |
Study title: A double-blind, three-way crossover study assessing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd and 100mcg bd compared with salbutamol 200mcg qds for the treatment of severe chronic asthma in children 5-16 years old. Report No. GRP/95/019 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42049 |
Study title: Erythrocyte Sodium-Lithium Countertransport and Proliferative Diabetic Retinopathy.Invest Ophthalmol Vis Sci. 2000 May;41(6):1482-5. |
Active substance: SODIUM CHROMATE |
Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc |
View full study record |
Document reference: 48285 |
Study title: Kinetics, distribution, and sites of destruction of indium-111 oxine labeled red cells in haemolytic anemia.J Clin Pathol 1985;38:128-32. |
Active substance: SODIUM CHROMATE |
Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc |
View full study record |
Document reference: 48287 |
Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42267 |
Study title: Prevention and management of febrile convulsions. - Baumann RJ. - Paedriatr Drugs 2001; 3: 585-592. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45509 |
Study title: STUDY OF TOLERANCE OF THE SODIUM DIVALPROATE (DEPAKOTE) AT TEENAGERS SUFFERING FROM BIPOLAR IN PHASE MANIAC, MIXED DISORDER OR HYPOMANIAQUE |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45514 |
Study title: Treatment of children with simple febrile convulsions: the AAP practice parameter. - Baumann RJ. et al. - Pediatr Neurol 2000; 23:11-17. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45521 |
Study title: A multicenter, double-blind comparison of ACCOLATE (ICI 204,219) with cromolyn sodium (INTAL, Fisons) and placebo in mild to moderate asthmatic patients - 9188/0057 |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0057 Summary.pdf |
View full study record |
Document reference: 45583 |
Study title: 21. Saccharomyces boulardii in acute childhood diarrhoea : a randomized, placebo-controlled study.; Acta Paediatrica, 2007;96(4) : 538-4122. J Int Med Res. 2007 Mar-Apr;35(2):201- |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
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Document reference: 40175 |
Study title: 23. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
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Document reference: 40177 |
Study title: Efectos de Saccharomyces boulardii en ninos con diarrea cronica, en especial causada por giardiasis.Revista Mexicana de Puericultura et Pediatria 1995 ; 2 (12) : 5 pages |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
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Document reference: 40165 |
Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Spain. |
Active substance: Somatropin |
Study summary document link (including results): TRN 88-158 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41654 |
Study title: A multi-centre, double-blind, randomised, parallel group study comparing the addition of inhaled salmeterol with an increase in the dose of inhaled fluticasone propionate in asthmatic patients on a low or intermediate dose of inhaled steroid. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SMS30073-ICHE3.pdf |
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Document reference: 42056 |
Study title: A Multi-centre, Randomised, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Dry Powder Formulations of Salmeterol Xinafoate 25μg and 50μg Twice Daily With Salbutamol 200μg Twice Daily Given in Children With Reversible Airways Obstruction |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLPT02-ICHE3.pdf |
View full study record |
Document reference: 42071 |
Study title: A multicentre, open study to assess the ease of handling and efficacy of salmeterol xinafoate 50mcg twice daily delivered via a multi-dose powder inhaler in both adult and paediatric patients with reversible airways disease. Report No. GRP/94/034 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42023 |
Study title: A multicentre, open study to assess the ease of handling and efficacy of salmeterol xinafoate 50mcg twice daily delivered via a multi-dose powder inhaler in both adult and paediatric patients with reversible airways disease. Report No. GRP/94/036 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42030 |
Study title: Multicentre clinical trial in young girls with Turner's syndrome treated with biosynthetic growth hormone 191 AA. Comparative trial of Genotropin vs Genotropin plus synthetic anabolic drugs |
Active substance: Somatropin |
Study summary document link (including results): TRN 86-092 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41661 |
Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42299 |
Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42331 |
Study title: Prediction of root caries in periodontally treated patients maintained with different fluoride programmes. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42403 |
Study title: Prediction of root caries in periodontally treated patients maintained with different fluoride programmes. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42516 |
Study title: Prevention. Part 7: professionally applied topical fluorides for caries prevention. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42366 |
Study title: Prevention. Part 7: professionally applied topical fluorides for caries prevention. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42479 |
Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42069 |
Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42072 |
Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
View full study record |
Document reference: 42074 |
Study title: A Multicenter, Double-blind Comparison of Zafirlukast (ACCOLATE) withPlacebo in Pediatric Subjects with Mild-to-moderate Asthma |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0150 CSR Summary.pdf |
View full study record |
Document reference: 45607 |
Study title: A multicenter, double-blind, placebo controlled trial of Accolate TM (ICI 204,219) in mild to moderate asthmatiac patients needing chronic treatment: 13 weeks efficacy and up to a 2-year open label safety extension |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): |
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Document reference: 45582 |
Study title: A Multicenter, Randomized, Double-blind, Parallel-group, 13-Week TrialComparing Two Doses of Zafirlukast (ACCOLATE) in Combination WithLow-dose Inhaled Corticosteroids Versus High-dose Inhaled CorticosteroidsAlone in Subjects with Mild-to-Moderate Asthma |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0094 Summary.pdf |
View full study record |
Document reference: 45588 |
Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Zafirlukast (ACCOLATE) In Subjects Who Present to the Emergency Department with Asthma Exacerbations |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0093 CSR Summary.pdf |
View full study record |
Document reference: 45599 |
Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial ofZafirlukast (ACCOLATE) in Patients with Mild-to-moderate Asthma:3 Weeks Efficacy and up to 104 Weeks Open-label, Safety Extension (12 -79 yrs) |
Active substance: ZAFIRLUKAST |
Study summary document link (including results): 9188IL0095 COLD Summary1.pdf |
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Document reference: 45589 |
Study title: Cohorte d'enfants pubères pour l'étude de l'effet du traitement par hormone de croissance biosynthétqiue MAXOMAT sur la taille adulte des enfants présentant un retard de croissance severe a debut intra-utérin (taille inférieure ou égale à 3DS) |
Active substance: Somatropin |
Study summary document link (including results): |
View full study record |
Document reference: 41822 |
Study title: Comparison of the Effects of Frequency of Growth Hormone Administration on Growth Rate and Biochemical Parameters of Carbohydrate Metabolism |
Active substance: Somatropin |
Study summary document link (including results): UK-GHD-010-GHD_Norditropin.pdf |
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Document reference: 41759 |
Study title: DIAGNOSTIC ANALYSIS IN PATIENTS WITH CHILDHOOD ONSET GROWTH HORMONE DEFICIENCY DURING TRANSITION FROM ADOLESCENCE TO ADULTHOOD |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-9002-019 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41649 |
Study title: A Phase III, Single Center, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane on Hepatic Metabolism in the Induction and Maintenance of Anesthesia in Pediatric Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-084.pdf |
View full study record |
Document reference: 42155 |
Study title: An open-label, multi-center, phase IV study to evaluate the efficacy and safety profiles of sevoflurane in pediatric subjects of different ages undergoing inpatient surgery with general anesthesia |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-CHIN-05-001.pdf |
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Document reference: 42152 |
Study title: Drug Metabolism Report No. 8 - The Minimum Alveolar Concentration (MAC), and Maintenance and Recovery Characteristics of Sevoflurane in Pediatric Patients |
Active substance: SEVOFLURANE |
Study summary document link (including results): |
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Document reference: 42159 |
Study title: Sevoflurane versus Halothane in the induction and maintenance of anesthesia in pediatric patients (Abbott Affiliate sponsored study - drug administered) |
Active substance: SEVOFLURANE |
Study summary document link (including results): |
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Document reference: 42153 |
Study title: The Minimum Alveolar Concentration (MAC), and Maintenance and Recovery Characteristics of Sevoflurane in Pediatric Patients |
Active substance: SEVOFLURANE |
Study summary document link (including results): sevoflurane-ghba532.pdf |
View full study record |
Document reference: 48115 |
Study title: Norditropin® and Norditropin® cartridges: An open-label, randomized, comparative safety and efficacy trial in children with growth hormone deficiency |
Active substance: Somatropin |
Study summary document link (including results): HGH-2124_Norditropin.pdf |
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Document reference: 41757 |
Study title: Norditropin® in children with growth failure associated with IGF deficiency: A 12 months open-label, randomized, parallel group study. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41798 |
Study title: OPEN-LABEL, MULTI-CENTER, SINGLE ARM STUDY TO DETERMINE PATIENT/CAREGIVER PREFERENCE OF INJEX, THE NEEDLE-FREE, AUTOINJECTION DEVICE FOR THE ADMINISTRATION OF GENOTROPIN IN NEEDLE PHOBIC CHILDREN |
Active substance: Somatropin |
Study summary document link (including results): GENAJT-0029-005 PhRMA Web Synopsis.pdf |
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Document reference: 41664 |
Study title: Li BUK, Besedovsky A. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. Curr Gastroenterol Rep. June 1, 2004, 247-53Li BUK, Besedovsky A. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. Curr Gastroenterol Rep. June 1, 2004, 247-53 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42185 |
Study title: Clinical study of Salmeterol xinafoate dry powder. Study on paediatric patients with bronchial asthma. Report No. JJA/93/007 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SMS30009-SD103-Salmeterol Xinafoate-Serevent Rotadisks.xls |
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Document reference: 42044 |
Study title: Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9, Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45537 |
Study title: Vit. B6 and valproic acid in treatment of infantile spasms, Masatoshi Ho., pag. 331-336, 1991 - Pediatric Neurol. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45527 |
Study title: Wallace SJ. A comparative review of the adverse effects of anticonvulsants in children with epilepsy. Drug safety 1996; 15(6): 378-393. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45528 |
Study title: Analyse des résultats obtenus avec le DEPAMIDE chez des enfants atteints d'instabilité psychomotrice (hyperkinésie) - F. MAIRLOT - 11/01/77 |
Active substance: VALPROMIDE |
Study summary document link (including results): |
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Document reference: 45529 |
Study title: Etude comparative du DEPAMIDE et du DEPAKINE dans le traitement de l'épilepsie associée à des troubles caractériels - M. SMIDTS - 16/01/78 |
Active substance: VALPROMIDE |
Study summary document link (including results): |
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Document reference: 45530 |
Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of ageDOI: 10.1161/HYPERTENSIONAHA.108.111054 Journal reference: Hypertension - Journal of the American Heart Association 2008;52:1-7. |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls |
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Document reference: 47270 |
Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of age |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls |
View full study record |
Document reference: 48169 |
Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive PatientsDOI: 1111/j.1751-7176.2011.00432.x Journal Clinical Hypertension: 2011;13:357-365 |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls |
View full study record |
Document reference: 47268 |
Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive Patients |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls |
View full study record |
Document reference: 48167 |
Study title: Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes |
Active substance: SIBUTRAMINE |
Study summary document link (including results): sibutramine-danielsson.xls |
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Document reference: 48136 |
Study title: Use of Sibutramine in Obese Mexican Adolescents: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial |
Active substance: SIBUTRAMINE |
Study summary document link (including results): sibutramine-garciamorales.xls |
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Document reference: 48137 |
Study title: A 7 -Day, Open-Label, Multicenter, Pharmacokinetic study (Part 1) followed by a 7-Day, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study (Part 2) of IV Sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure and at risk for PPHN. |
Active substance: sildenafil |
Study summary document link (including results): A1481157 PhRMA Web Synopsis.pdf |
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Document reference: 41606 |
Study title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study of intravenous Sidenafil in the treatment of children, aged 0 to 17 with pulmonary hypertension. |
Active substance: sildenafil |
Study summary document link (including results): A1481134 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41605 |
Study title: Effects of self-applied topical fluoride preparations in orthodontic patients. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42448 |
Study title: McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42177 |
Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42293 |
Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42325 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42262 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42294 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42326 |
Study title: Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4, Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45559 |
Study title: Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45565 |
Study title: Insect sting allergy. A study from 1980 to 2003 of patients who started treatment with venom immunotherapy between 1980 and 1998 |
Active substance: VESPULA SPP |
Study summary document link (including results): |
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Document reference: 39385 |
Study title: Endo et al. The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808) |
Active substance: URINARY CONCREMENT SOLVENTS |
Study summary document link (including results): |
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Document reference: 39157 |
Study title: Kinugasa Effect of PSC in Preventing Renal Sones in Siblings with Cystinuria; Shinyaku to Rhinsho 1987, 36, 9 |
Active substance: URINARY CONCREMENT SOLVENTS |
Study summary document link (including results): |
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Document reference: 39158 |
Study title: Factors governing the use of topical fluorides: time and patient acceptability. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42338 |
Study title: Factors governing the use of topical fluorides: time and patient acceptability. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42451 |
Study title: Saccharomyces boulardii for Clostridium difficile-associated enteropathies in infants. Journal of Pediatric Gastroenterology and Nutrition 1993 ; 16 : 419-425. |
Active substance: Saccharomyces boulardii |
Study summary document link (including results): |
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Document reference: 40180 |
Study title: Treatment of acne with a yeast preparation;Fortschr Med. 1989 Sep 10; 107(26):563-6. German. |
Active substance: Saccharomyces boulardii |
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Document reference: 40184 |
Study title: Factor analysis as a means of determining response to chemotherapy in patients with osteogenic sarcoma. Edeline V, Frouin F, Bazin JP, Di Paola M, Kalifa C, Contesso G, Parmentier C, Lumbroso J, Di Paola R. Eur J Nucl Med. 1993 Dec;20(12):1175-85. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43642 |
Study title: Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43814 |
Study title: Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9. Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43479 |
Study title: Sports-related groin pain: evaluation with MR imaging. Ekberg O, Sjöberg S, Westlin N. Eur Radiol. 1996;6(1):52-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43571 |
Study title: Wong VC, Sun JG, Yeung DW. Pilot study of efficacy of tongue and body acupuncture in children with visual impairment. [wong-2006-b]J Child Neurol. 2006 Jun;21(6):463-73. Wong VC 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48713 |
Study title: Wong VC, Sun JG, Yeung DW. Pilot study of positron emission tomography (PET) brain glucose metabolism to assess the efficacy of tongue and body acupuncture in cerebral palsy. [wong-2006-a]J Child Neurol. 2006 Jun;21(6):456-62. Wong VC 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48712 |
Study title: Wu H, Dimitrakopoulou-Strauss A, Heichel TO, Lehner B, Bernd L, Ewerbeck V, et al.. Quantitative evaluation of skeletal tumours with dynamic FDG PET: SUV in comparison to Patlak analysis. [wu-2001]Eur J Nucl Med. 2001 Jun;28(6):704-10. Wu H 2001 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48714 |
Study title: A study for investigating the growth in patients with skeletal dysplasia. An extension of wider indications. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41804 |
Study title: A STUDY OF THE EFFICACY AND SAFETY OF GENOTONORM (REGISTERED) IN SHORT STATURE PATIENTS WITH A HISTORY OF INTRAUTERINE GROWTH RETARDATION. A TWO-YEAR, OPEN RANDOMIZED STUDY. GENETICMOLECULAR AND BIOCHEMICALHORMONONAL EVALUATION |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-0021-003 PhRMA Web Synopsis .pdf |
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Document reference: 41643 |
Study title: A study to compare Safety and Effect on Final Height of two different models of treating Growth Retardation with Norditropin PenSet 12/24 in Turner´s Syndrome |
Active substance: Somatropin |
Study summary document link (including results): GHTUR-ROV-2-CRO..MAC_Norditropin.pdf |
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Document reference: 41771 |
Study title: A study to compare Safety and Effect on Final Height of two different models of treating Growth Retardation with Norditropin PenSet 12/24 in Turner´s Syndrome |
Active substance: Somatropin |
Study summary document link (including results): GHTUR-ROV-2-SK_Norditropin.pdf |
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Document reference: 41772 |
Study title: A Two-Week Functionality and Patient Perception Study of Genotropin MiniQuick |
Active substance: Somatropin |
Study summary document link (including results): 94-0351-003 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41674 |
Study title: A Two-Week Functionality and Patient Perception Study of Genotropin MiniQuick |
Active substance: Somatropin |
Study summary document link (including results): 94-0351-001 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41675 |
Study title: Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5. Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43624 |
Study title: Thallium- 201 uptake in eosinophilic granuloma of the frontal bone: Comparison with Technitium- 99m-MDP imaqinq.Flores LG II, Hoshi H. Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, et al. J Nucl Med 1995; 36:107-10. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 47918 |
Study title: Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169, Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169, |
Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE |
Study summary document link (including results): |
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Document reference: 42234 |
Study title: Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478 Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478 |
Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE |
Study summary document link (including results): |
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Document reference: 42235 |
Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42346 |
Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42459 |
Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40242 |
Study title: Reports of Postmarketing Experience, Post Authorisation safety study, Tavipec capsules, Panosch, B., 2007 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40231 |
Study title: Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42576 |
Study title: Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30 |
Active substance: SPIRAMYCIN |
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Document reference: 42586 |
Study title: Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976 |
Active substance: SPIRAMYCIN |
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Document reference: 42577 |
Study title: Etude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR FileEtude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR File |
Active substance: SPIRAMYCIN |
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Document reference: 42578 |
Study title: Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42579 |
Study title: Fetal Toxoplasmosis: Outcome of Pregnancy and Infant Follow-Up After In Utero Treatment.Hohlfeld P; Daffos F; Thulliez P; Aufrant C; Couvreur J; MacAleese J J.Pediatr. 115, No. 5, Pt. 1, 765-69, 1989 |
Active substance: SPIRAMYCIN |
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Document reference: 42587 |
Study title: QT interval prolongation and cardiac arrest during antibiotic therapy with spiramycin in a newbron child - Stramba-Badiale et al in American Heart Jounal 1993, vol 126, number 3, part I |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42588 |
Study title: A study for investigating the growth in patients with skeletal dysplasia. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41805 |
Study title: Etude de la biodisponibilité relative de la suspension à 10 pour cent par rapport au comprimé dose à 500 mg (formulation de référence) chez le sujet jeune en bonne santé - MM. A. Le Liboux, G. Montay, A. Frydman et J. Gaillot - No date |
Active substance: SECNIDAZOLE |
Study summary document link (including results): |
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Document reference: 42120 |
Study title: Evaluation de l'efficacité et de la tolérance d'une suspension de secnidazole dans le traitement de la dysentrie ambienne aiguë non compliquée chez l'enfant - Dr F. Djebbar - No date |
Active substance: SECNIDAZOLE |
Study summary document link (including results): Secnidazole STUDY SZ8002.xls |
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Document reference: 42114 |
Study title: Evaluation of the efficacy and safety of a single dose of secnidazole suspension (30 mg/kg) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingano - 1988 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42115 |
Study title: Evaluation of the efficacy and tolerance of a suspension of secnidazole in the treatment of acute uncomplicated amoebic dysentery in children (Study n° SZ 80002) - Dr J.M. Cardo-Salles, Dr Tall, Bobo Di Oulasso, Dr Josseran, Prof R. Lenoble - 1987 to 1988 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42116 |
Study title: RP 14539 - Comparative acute oral toxicity of secnidazole in juvenil rats aged 4 weeks and in rats aged 8 weeks - André S., Curaudeau A., Caillaud J.M., Boddaert A. Mazuret A. & Cordier A. - 1989 (Rapport ST/CRV/Tox. N° 254) |
Active substance: SECNIDAZOLE |
Study summary document link (including results): |
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Document reference: 42117 |
Study title: Secnidazole paediatric granules in amoebiasis / giardiasis |
Active substance: SECNIDAZOLE |
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Document reference: 42118 |
Study title: Study of the relative bioavailability of the 10 % suspension in relation to the tablet each containing 500 mg (reference formulation) in the young healthy subject - A. Le Liboux, G. Montay, A. Frydman and J. Gaillot - 1987 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42119 |
Study title: Strauss, Leon Christiaan: The Efficacy of a homeopathic Preparation in the Management of Attention Deficit Hyperactivity Disorder. Biol Ther 2000 (18):197-201 [IIT-publication] |
Active substance: Selenium-Homaccord/Selenium-Homaccord - Tropfen |
Study summary document link (including results): |
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Document reference: 40189 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43219 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43229 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43239 |
Study title: A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)] |
Active substance: SERRAPEPTASE |
Study summary document link (including results): |
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Document reference: 42124 |
Study title: Prophylaxis of postoperative swellings in gnathic surgery: Administration of ice versus serrapeptase |
Active substance: SERRAPEPTASE |
Study summary document link (including results): 2011-08-30 Serrapeptase AN21 synopsis.pdf |
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Document reference: 42122 |
Study title: Serrapeptase vs. Diclofenac - Postoperative treatment of children. Controlled study. (Comparative study) |
Active substance: SERRAPEPTASE |
Study summary document link (including results): 2011-08-30 Serrapeptase AN02_89 Synopsis.pdf |
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Document reference: 42121 |
Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42253 |
Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42285 |
Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42317 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43249 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43313 |
Study title: Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available. Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44014 |
Study title: Estudio prospectivo para evaluar la seguridad y tolerabilidad del Enema Casen en pacientes pediátricos |
Active substance: SODIUM PHOSPHATE |
Study summary document link (including results): |
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Document reference: 42561 |
Study title: Effects of sodium picosulfate on pediatric constipation. Judgement of effects by double blind test. |
Active substance: SODIUM PICOPSULPHATE |
Study summary document link (including results): Sodium Picosulfate_U73-0409_synopsis.pdf |
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Document reference: 47463 |
Study title: Use of Laxoberal in paediatric patients |
Active substance: SODIUM PICOPSULPHATE |
Study summary document link (including results): Sodium Picosulfate_U80-0501_synopsis.pdf |
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Document reference: 47464 |
Study title: A study to test the efficacy of E45 Cream on nappy rash |
Active substance: SOFT PARAFFIN |
Study summary document link (including results): |
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Document reference: 42563 |
Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate). |
Active substance: SOFT PARAFFIN |
Study summary document link (including results): |
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Document reference: 42564 |
Study title: Use test Tolerance in use study in children with shower products for dry skin or skin prone to Eczema. |
Active substance: SOFT PARAFFIN |
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Document reference: 42562 |
Study title: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication] |
Active substance: Solidago compositum-Heel - Ampullen |
Study summary document link (including results): |
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Document reference: 40199 |
Study title: Camphor, Sweetman, S.C., Martindale, The complete drug reference, 33 edition, Pharmaceutical Press, 1589-1590. |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40227 |
Study title: Camphora (Campher), Monographie BGA/BfArM (Komission E), 1984, Heftnummer 228 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40228 |
Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children, Tibballs, J., Med. J. Aust. 1995; 163: 177-180 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40232 |
Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E. |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
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Document reference: 40238 |
Study title: The comparative efficacy of local anticaries agents][Article in Russian |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42371 |
Study title: The comparative efficacy of local anticaries agents][Article in Russian |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42484 |
Study title: Kaladze N.N., Titova E.V.: Antihomotoxic preparations in the combined treatment of secondary osteopenia in children suffering from chronic pyelonephritis. Therapy (Ukraine), 2007, 3: 15-19 [IIT-publication] |
Active substance: Solidago compositum-Heel - Ampullen |
Study summary document link (including results): |
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Document reference: 40198 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Solidago compositum S (ampoules) [AWB-AT] |
Active substance: Solidago compositum-Heel - Ampullen |
Study summary document link (including results): |
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Document reference: 40200 |
Study title: Comparison of intra-examiner reproducibility in scoring caries in primary teeth of two scoring systems used to monitor caries progression. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42541 |
Study title: Double-blind dose-response study comparing ropivacaine 1 mg/kg, 2 mg/kg and 3 mg/kg (fixed volume of 1 mL/kg of ropivacaine solutions 1 mg/mL, 2 mg/mL and 3 mg/mL, respectively). Single caudal block. 4-12 years. |
Active substance: ROPIVACAINE |
Study summary document link (including results): |
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Document reference: 35453 |
Study title: Long term safety in adolescent patients |
Active substance: RIZATRIPTAN |
Study summary document link (including results): EMAart45_Rizatripan.pdf |
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Document reference: 47419 |
Study title: Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available. Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43387 |
Study title: Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4. Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43473 |
Study title: Chronic recurrent multifocal osteomyelitis involving both jaws: report of a case including magnetic resonance correlation. Flygare L, Norderyd J, Kubista J, Ohlsson J, Vallo-Christiansen J, Magnusson B. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Feb;83(2):300-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43553 |
Study title: Irreversible long-term pulmonary functional impairments after adenovirus type-7 pneumonia: assessment with xenon-133 ventilation and Tc-99m MAA perfusion studies. Suga K, Ishikawa Y, Motoyama K, Kume N, Matsunaga N. Eur Radiol. 2000;10(9):1411-5. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48232 |
Study title: Lung perfusion scans in patients with congenital heart defects. Tamir A, Melloul M, Berant M, Horev G, Lubin E, Blieden LC, Zeevi B. J Am Coll Cardiol. 1992 Feb;19(2):383-8. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Tamir A 1992.pdf |
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Document reference: 48278 |
Study title: Lung perfusion scintigraphy in patients with congenital heart disease: sensitivity and important pitfalls. Boothroyd AE, McDonald EA, Carty H. Nucl Med Commun. 1996 Jan;17(1):33-9. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48256 |
Study title: Massive intestinal albumin loss after Fontan operation. Sano T, Tajiri H, Nakajima T, Matsushita T, Kayatani F, Kanaya-Ida S, Ozaki Y, Nose O, Okada S. Acta Paediatr Jpn. 1991 Jun;33(3):384-8. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Levin DP 1991.pdf |
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Document reference: 48280 |
Study title: Protein losing enteropathy (PLE) detected by Tc99m-labelled human serum albumin abdominal scintigraphy--case report Hubalewska-Hola A 2003. Przegl Lek. 2003;60(9):606-8 Hubalewska-Hola et al. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE Nanocoll response List of published articles.doc |
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Document reference: 48218 |
Study title: A CROSSOVER, MULTI-CENTRE, RANDOMISED, MULTIPLE DOSE, SAFETY STUDY OF THE ADMINISTRATION OF GENOTROPIN USING INJEX, A NEEDLE FREE INJECTOR AND A NEEDLE INJECTION DEVICE, IN PEDIATRIC PATIENTS CURRENTLY USING GROWTH HORMONE FOR GROWTH HORMONE DEFICIENCY |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-0539-003 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41646 |
Study title: A 104-week, multi-centre, randomised, double-blind, parallel-group, no treatment controlled (open-label) trial investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age. |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1516_Norditropin.pdf |
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Document reference: 41776 |
Study title: A clinical evaluation of the effectiveness and safety of the administration of recombinant human growth hormone in growth hormone deficient children: a multicentre trial conducted in Japan. |
Active substance: Somatropin |
Study summary document link (including results): TRN 86-042 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41662 |
Study title: QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42589 |
Study title: Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24.Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43295 |
Study title: Evaluation of monoclonal antibody MIB-1 in the mammary epithelium adjacent to fibroadenomas in premenopausal women treated with Tamoxifen. De Sousa JA, De Seixas MT, De Lima GR, Baracat EC, Gebrim LH. Breast Journal 7(6)()(pp 392-397), 2001 Date of Publication: 2001 2001;(6):392-397.Evaluation of monoclonal antibody MIB-1 in the mammary epithelium adjacent to fibroadenomas in premenopausal women treated with Tamoxifen. De Sousa JA, De Seixas MT, De Lima GR, Baracat EC, Gebrim LH. Breast Journal 7(6)()(pp 392-397), 2001 Date of Publication: 2001 2001;(6):392-397. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43280 |
Study title: Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24.Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43153 |
Study title: Diffuse hepatic uptake of technetium-99m methylene diphosphonate in a patient receiving high dose methotrexate. Flynn BM, Treves ST. J Nucl Med. 1987 Apr;28(4):532-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43868 |
Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42063 |
Study title: Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish. Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44074 |
Study title: Chronic recurrent multifocal osteomyelitis. Cyrlak D, Pais MJ Skeletal Radiol. 1986;15(1):32-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43918 |
Study title: Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available. Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43660 |
Study title: Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9. Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43931 |
Study title: QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42597 |
Study title: Rovamycine infant 0.375MIU, children 0.750MIU,older children 1.5 MIU - Spiramycin granules in sachets - part IV A.2.1 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42591 |
Study title: Rovamycine nourrissons 0.375 MUI-rovamycine enfants 0.750MUI rovamycine grands enfants 1.5MUI:grnules de spiramycine en sachets (partie IV A.2. etude n°1 du dossier d'AMM) - Mai 1992 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42592 |
Study title: Rovamycine sirop - Sirop dosé à 2,5 p.100 (p/v) soit 125 mg ou 0,375 M.U.I. de spiramycine par cuillerée à café - J. Gaillot - 15 mars 1976 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42593 |
Study title: Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300) Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300) |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42581 |
Study title: Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis in children - D. Soebardja et al. - 1987 - Paediatrica Indonesiana (27: 223-230)Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis in children - D. Soebardja et al. - 1987 - Paediatrica Indonesiana (27: 223-230) |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42582 |
Study title: Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215)Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215) |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42584 |
Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42594 |
Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42599 |
Study title: Application of fluoride varnish Duraphat with a cotton carrier respectively a syringe for cartridges--a comparison study. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42472 |
Study title: Treatment modalities in patients with hepatocellular carcinoma: A retrospective series in a single institution in Mexico. [Spanish]. Treatment modalities in patients with hepatocellular carcinoma: A retrospective series in a single institution in Mexico. [Spanish]. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43268 |
Study title: Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337.Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43113 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
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Document reference: 43321 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of thvon Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of th |
Active substance: TAMOXIFEN |
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Document reference: 43329 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
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Document reference: 43339 |
Study title: De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. European Journal of Cancer 2003; 39(7):891-898.De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. European Journal of Cancer 2003; 39(7):891-898. |
Active substance: TAMOXIFEN |
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Document reference: 43098 |
Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42250 |
Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42282 |
Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42314 |
Study title: Application of fluoride varnish Duraphat with a cotton carrier respectively a syringe for cartridges--a comparison study. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42359 |
Study title: Al Naeem AN, Powe J, Bakheet S, Elgazzar AH. Displaced urinary bladder creating an unusual pattern on bone scan mimicking disease. Clin Nucl Med. 1999 Feb;24(2):137-8. No abstract available. Al Naeem AN, Powe J, Bakheet S, Elgazzar AH. Displaced urinary bladder creating an unusual pattern on bone scan mimicking disease. Clin Nucl Med. 1999 Feb;24(2):137-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43516 |
Study title: Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81. Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44271 |
Study title: Algra PR, Bloem JL, Tissing H, Falke TH, Arndt JW, Verboom LJ. Detection of vertebral metastases: comparison between MR imaging and bone scintigraphy. Radiographics. 1991 Mar;11(2):219-32. Algra PR, Bloem JL, Tissing H, Falke TH, Arndt JW, Verboom LJ. Detection of vertebral metastases: comparison between MR imaging and bone scintigraphy. Radiographics. 1991 Mar;11(2):219-32. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43746 |
Study title: Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2. Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43796 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
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Document reference: 43349 |
Study title: Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81. Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43926 |
Study title: Comparative evaluation of the role of NaF, APF & Duraphat topical fluoride applications in the prevention of dental caries--a 2 1/2 years study. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42431 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
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Document reference: 43198 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
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Document reference: 43208 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
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Document reference: 43218 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
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Document reference: 43228 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
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Document reference: 43238 |
Study title: Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9. Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43411 |
Study title: Elgazzar AH, Jahan S, Motawei S, Abdel-Dayem HM. Tc-99m MDP uptake in hepatoblastoma. Clin Nucl Med. 1989 Feb;14(2):143. No abstract available. Elgazzar AH, Jahan S, Motawei S, Abdel-Dayem HM. Tc-99m MDP uptake in hepatoblastoma. Clin Nucl Med. 1989 Feb;14(2):143. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43794 |
Study title: Bone scintigraphy in the assessment of spondylolysis in patients attending a sports injury clinic. Elliott S, Hutson MA, Wastie ML. Clin Radiol. 1988 May;39(3):269-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43815 |
Study title: Bone scintigraphy in preschool children with lower extremity pain of unknown origin. Englaro EE, Gelfand MJ, Paltiel HJ. J Nucl Med. 1992 Mar;33(3):351-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43702 |
Study title: Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9. Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44057 |
Study title: Blumenkopf B, Hartshorne MF, Bauman JM, Cawthon MA, Patton JA, Friedman AH. Craniotomy flap osteomyelitis: a diagnostic approach. J Neurosurg. 1987 Jan;66(1):96-101. Blumenkopf B, Hartshorne MF, Bauman JM, Cawthon MA, Patton JA, Friedman AH. Craniotomy flap osteomyelitis: a diagnostic approach. J Neurosurg. 1987 Jan;66(1):96-101. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43878 |
Study title: Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51. Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43604 |
Study title: Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German. Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43739 |
Study title: The bullhead sign: scintigraphic pattern of sternocostoclavicular hyperostosis and pustulotic arthroosteitis. Freyschmidt J, Sternberg A. Eur Radiol. 1998;8(5):807-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43532 |
Study title: Pulmonary arteriovenous malformations in patients with hereditary hemorrhagic telangiectasia. Cottin V, Plauchu H, Bayle JY, Barthelet M, Revel D, Cordier JF. Am J Respir Crit Care Med. 2004 May 1;169(9):994-1000. Epub 2004 Jan 23.Comment in: Am J Respir Crit Care Med. 2004 May 1;169(9):978-9. 2nd reference is published by the same publisher as the first citation. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48224 |
Study title: Pulmonary arteriovenous malformations: effect of embolization on right-to-left shunt, hypoxemia, and exercise tolerance in 66 patients. Gupta P, Mordin C, Curtis J, Hughes JM, Shovlin CL, Jackson JE. AJR Am J Roentgenol. 2002 Aug;179(2):347-55. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48226 |
Study title: Pulmonary scintigraphic findings in children with pectus excavatum by the comparison of chest radiograph indices. Kao CH, Liao SQ, Wang SJ, Yeh SH. Clin Nucl Med. 1992 Nov;17(11):874-6. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48274 |
Study title: Quantification of right to left shunt at rest and during exercise in patients with pulmonary arteriovenous malformations. Whyte MK, Peters AM, Hughes JM, Henderson BL, Bellingan GJ, Jackson JE, Chilvers ER. Thorax. 1992 Oct;47(10):790-6. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48275 |
Study title: Reduced effect of inhaled beta 2-adrenergic agonists on lung mucociliary clearance in patients with cystic fibrosis. Mortensen J, Hansen A, Falk M, Nielsen IK, Groth S Chest. 1993 Mar;103(3):805-11. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48273 |
Study title: Reversal of intrapulmonary shunting in cirrhosis after liver transplantation demonstrated by perfusion lung scan. Levin DP, Pison CF, Brandt M, Weber A, Paradis K, Laberge JM, Blanchard H. J Nucl Med. 1991 May;32(5):862-4. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48281 |
Study title: Reversal of severe hepato-pulmonary syndrome in congenital hepatic fibrosis after living-related liver transplantation. Nagral A, Nabi F, Humar A, Nagral S, Doctor N, Khubchandani SR, Amdekar YK Indian J Gastroenterol. 2007 Mar-Apr;26(2):88-9 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48221 |
Study title: Reversed ventilation-perfusion mismatch involving a pediatric patient in congestive heart failure. Zucker I, Heyman S, Ozdemir S. J Nucl Med. 1997 Nov;38(11):1681-3. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Zucker I 1997.pdf |
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Document reference: 48245 |
Study title: Right-to-left pulmonary shunting in pediatric hepatopulmonary syndrome. Murakami JW, Rosenbaum DM. Clin Nucl Med. 1999 Nov;24(11):897. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48237 |
Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43371 |
Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44146 |
Study title: Male breast disorders in Jordan - Disease patterns and management problems. Male breast disorders in Jordan - Disease patterns and management problems. |
Active substance: TAMOXIFEN |
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Document reference: 43269 |
Study title: [Left distal femoral diaphysis-metaphyseal injury in a 13-year-old patient] Spanish. Delgado García M, Mitjavila Casanovas M, Balsa Bretón MA, Castillejos Rodríguez L, Alonso García P, Cañamaque García L, Penín González J, Pey Illera C. Rev Esp Med Nucl. 2000 Sep;19(5):356-60. Spanish. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44251 |
Study title: Bone scintigraphy in calcific discitis of childhood.Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med. 1990 Feb;31(2):234-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43768 |
Study title: Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14. Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43740 |
Study title: Warbey VS, Schleyer PJ, Barrington SF, O’Doherty MJ. The new EANM paediatric dosage card – does it conform to ALARA for PET/CT? [warbey-2007]Eur J Nucl Med Mol Imaging 2007; 34 : 1881 - 1882. Schleyer PJ 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48710 |
Study title: Wickmann L, Lüders H, Dörffel W.. [18- FDG-PET-findings in children and adolescents with Hodgkin's disease: retrospective evaluation of the correlation to other imaging procedures in initial staging and to the predictive value of follow up examinations] [Translated] [wickmann-2003-en]Klin Padiatr. 2003 May-Jun;215(3):146-50. Wickmann L 2003 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48711 |
Study title: Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31) |
Active substance: SPIRAMYCIN |
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Document reference: 42595 |
Study title: Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31) |
Active substance: SPIRAMYCIN |
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Document reference: 42598 |
Study title: Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7.Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7. |
Active substance: SPIRAMYCIN |
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Document reference: 42596 |
Study title: Blake GM et al. Strontium-89 therapy: strontium kinetics and dosimetry in two patients treated for metastasizing osteosarcoma. Blake GM 1987 Br J Radiol. 1987 Mar; 60(711):253-9 |
Active substance: STRONTIUM 89 |
Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
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Document reference: 48216 |
Study title: Bone pain palliation with strontium-89 in children. Giammarile F 1998 Med Pediatr Oncol. 1998 Mar; 30(3):199-200 F Giammarile et al. |
Active substance: STRONTIUM 89 |
Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
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Document reference: 48213 |
Study title: Pain palliation with strontium-89 in children with metastatic disease Charron M 1996 Med Pediatr Oncol. 1996 Jun; 26(6):393-6 |
Active substance: STRONTIUM 89 |
Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
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Document reference: 48212 |
Study title: Strontium-89 for palliation of bone pain. Gompakis N 2003 Med Pediatr Oncol. 2003 Feb;40(2):136 Gompakis N et al |
Active substance: STRONTIUM 89 |
Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
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Document reference: 48214 |
Study title: Harrison SA, Neuschwander Tetri BA. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clinics In Liver Disease 2004; 8(4):861-879.Harrison SA, Neuschwander Tetri BA. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clinics In Liver Disease 2004; 8(4):861-879. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43137 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43105 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43126 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43145 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43165 |
Study title: Archer D, Babyn P, Gilday D, Greenberg MA. Potentially misleading bone scan findings in patients with hepatoblastoma. Clin Nucl Med. 1993 Dec;18(12):1026-31. Archer D, Babyn P, Gilday D, Greenberg MA. Potentially misleading bone scan findings in patients with hepatoblastoma. Clin Nucl Med. 1993 Dec;18(12):1026-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43643 |
Study title: Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43977 |
Study title: Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available. Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44255 |
Study title: Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients. Clin Nucl Med. 1997 Aug;22(8):532-5. Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients. Clin Nucl Med. 1997 Aug;22(8):532-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44257 |
Study title: Bomanji J, Nagaraj N, Jewkes R, Fields M, Maini RN. Pachydermoperiostosis: technetium-99m-methylene diphosphonate scintigraphic pattern. J Nucl Med. 1991 Oct;32(10):1907-9. Bomanji J, Nagaraj N, Jewkes R, Fields M, Maini RN. Pachydermoperiostosis: technetium-99m-methylene diphosphonate scintigraphic pattern. J Nucl Med. 1991 Oct;32(10):1907-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43725 |
Study title: Bone scintigraphy in calcific discitis of childhood.Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med 1990 31{2):234-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48475 |
Study title: Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93. Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43626 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43248 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43316 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43325 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination WiRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination Wi |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43332 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination WiRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination Wi |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43335 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43343 |
Study title: An Open Label, Randomized, Multi-center, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Risedronate Administered as a Single Oral Dose of 2.5 mg or 5 mg in Children ≤ 30 kg and 5 mg or 10 mg in Children> 30 kg with Osteogenesis Imperfecta |
Active substance: RISEDRONIC ACID |
Study summary document link (including results): Risedronate sodium- Study 2.pdf |
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Document reference: 35390 |
Study title: "Alpha-Project" Long time Neuroleptic Therapy with Risperidone, age of the patients 14-85. To acquire - modalities of administration of RISPERDAL, mode and frequency of adverse reactions, mode and extent of therapeutic action of RISPERDAL under the routine of daily practice. |
Active substance: RISPERIDONE |
Study summary document link (including results): AlphaProject_Non-interventional_Risperidone.xls |
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Document reference: 35410 |
Study title: Non interventional study for optimisation of ambulant therapy-switch to Risperdal (SWITCH), age of patients 16-100 |
Active substance: RISPERIDONE |
Study summary document link (including results): JC-AWB-RIS-0004_Non-interventional_Risperidone.xls |
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Document reference: 35412 |
Study title: Even-Sapir E, Flusser G, Lerman H, Lievshitz G, Metser U. SPECT/multislice low-dose CT: a clinically relevant constituent in the imaging algorithm of nononcologic patients referred for bone scintigraphy. J Nucl Med. 2007 Feb;48(2):319-24. Even-Sapir E, Flusser G, Lerman H, Lievshitz G, Metser U. SPECT/multislice low-dose CT: a clinically relevant constituent in the imaging algorithm of nononcologic patients referred for bone scintigraphy. J Nucl Med. 2007 Feb;48(2):319-24. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43365 |
Study title: Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available. Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43575 |
Study title: Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43961 |
Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44193 |
Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44240 |
Study title: Successful liver transplantation in a child with biliary atresia and hepatopulmonary syndrome. Liang CD, Chen CL, de Villa VH, Tiao MM, Cheng YF. J Formos Med Assoc. 2001 Jun;100(6):403-6. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Liang CD 2001.pdf |
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Document reference: 48227 |
Study title: The value of bronchodilator administration in asthmatic patients before lung imaging. Roach PJ, Treves ST. Clin Nucl Med. 1995 Jun;20(6):491-3. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
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Document reference: 48260 |
Study title: Unexpected myocardial uptake on perfusion lung scan in the hepatopulmonary syndrome. Demirkale P, Mudun A, Karasulu L, Erelel M, Cantez S. Clin Nucl Med. 1999 Aug;24(8):610-1. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
View full study record |
Document reference: 48240 |
Study title: Use of Tc-99m MAA in determining the etiology of increasing cyanosis following SVC-PA anastomosis for the hypoplastic left heart syndrome. Glass T, Heyman S, Seliem M, Murphy J, Norwood WI. Clin Nucl Med. 1991 Jun;16(6):410-2. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc |
View full study record |
Document reference: 48279 |
Study title: Usefulness of selective contrast echocardiography and selective scintigraphy for the evaluation of pulmonary arteriovenous fistula in a patient with systemic arterial supply to a normal lung. Masutani S, Senzaki H, Taketazu M, Kobayashi J, Kobayashi T, Asano H, Kyo S, Yokote Y. J Pediatr Surg. 2005 Mar;40(3):E51-4 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Masutani S 2005.pdf |
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Document reference: 48223 |
Study title: Clinical relevance of left ventricular volumes and function assessed by gated SPECT in paediatric patients El-Maghraby TAF 2004 Int J Cardiovasc Imaging. 2004 Apr; 20(2):127-34 El-Maghraby TAF et al. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE Myoview response List of published articles.doc |
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Document reference: 48217 |
Study title: 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available. 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43468 |
Study title: A MULTICENTRE STUDY ON THE CAPACITY OF THE IGF-I STIMULATION TEST TO PREDICT THE GROWTH PROMOTING EFFECT OF STANDARD AND HIGH DOSES OF GENOTONORM(REGISTERED) IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY |
Active substance: Somatropin |
Study summary document link (including results): A6281023 (307-MET-9002-040) PhRMA Clinical Study Synopsis.pdf |
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Document reference: 41745 |
Study title: A MULTICENTRE, OPEN RANDOMISED, CROSS-OVER STUDY COMPARING THE CONVENIENCE AND SAFETY OF GENOTROPIN KABIQUICK 2, 3 AND 4 IU WITH GENOTROPIN 12 IU MULTIDOSE VIAL |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41723 |
Study title: A MULTICENTRE, OPEN, RANDOMISED, CROSS-OVER STUDY, COMPARING THE CONVENIENCE AND SAFETY OF GENOTROPIN 16IU KABIPEN WITH GENOTROPIN 12IU MULTIDOSE VIAL |
Active substance: Somatropin |
Study summary document link (including results): 90-008 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41724 |
Study title: A retrospective survey of children being treated with Norditropin® on named patient basis after renal transplantation. |
Active substance: Somatropin |
Study summary document link (including results): GHCRF-BPD-10-NL_Norditropin.pdf |
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Document reference: 41788 |
Study title: High-dose tamoxifen added to concurrent biochemotherapy with decrescendo interleukin-2 in patients with metastatic melanoma. O'Day SJ, Boasberg PD, Kristedja TS, Martin M, Wang HJ, Fournier P et al. Cancer 2001;92(3):609-19 2001;(3):609-619. High-dose tamoxifen added to concurrent biochemotherapy with decrescendo interleukin-2 in patients with metastatic melanoma. O'Day SJ, Boasberg PD, Kristedja TS, Martin M, Wang HJ, Fournier P et al. Cancer 2001;92(3):609-19 2001;(3):609-619. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43281 |
Study title: High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial. High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43274 |
Study title: Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available. Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44000 |
Study title: [Acute hematogenic osteomyelitis after impetiginized scabies] Gaida G, Töllner U, Krüpe H, Haas JP. Klin Padiatr. 1985 Nov-Dec;197(6):489-91. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43927 |
Study title: Garty I, Koren A, Garzozi H. Frontal and orbital bone infarctions causing periorbital swelling in patients with sickle cell anemia. Arch Ophthalmol. 1984 Oct;102(10):1486-8. Garty I, Koren A, Garzozi H. Frontal and orbital bone infarctions causing periorbital swelling in patients with sickle cell anemia. Arch Ophthalmol. 1984 Oct;102(10):1486-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43982 |
Study title: Domstad PA, Coupal JJ, Kim EE, Blake JS, DeLand FH. 99mTc-hydroxymethane diphosphonate: a new bone imaging agent with a low tin content. Radiology. 1980 Jul;136(1):209-11. Domstad PA, Coupal JJ, Kim EE, Blake JS, DeLand FH. 99mTc-hydroxymethane diphosphonate: a new bone imaging agent with a low tin content. Radiology. 1980 Jul;136(1):209-11. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44143 |
Study title: Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43719 |
Study title: Radionuclide imaging of the patellofemoral joint in young adults with anterior knee pain. Dye SF, Boll DA. Orthop Clin North Am. 1986 Apr;17(2):249-62. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43914 |
Study title: Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available. Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44070 |
Study title: Salmeterol xinafoate (dry powder) phase II study in paediatric patients with bronchial asthma - single dose crossover comparative study between aerosol and dry powder. Report No. JJA/93/001 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42042 |
Study title: Serevent VS Placebo : Paediatric asthma, exercise-induced. A multicentre, double-blind. parallel group study to assesss the efficacy of serevent 50mcg.bd vs placebo.bd (via the accuhaler) on the prevention of exercise induced asthma in children. A real-life situation. Report No. SLGB4021R |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42027 |
Study title: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42110 |
Study title: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42111 |
Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42107 |
Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42108 |
Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42109 |
Study title: To establish the pharmacokinetic properties of scopolamine in children |
Active substance: SCOPOLAMINE |
Study summary document link (including results): |
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Document reference: 42112 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43170 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43176 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43184 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43194 |
Study title: Efficacy and safety of Salmeterol in patients with asthma controlled with inhaled corticosteroids |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SMS40012-ICHE3.pdf |
View full study record |
Document reference: 42028 |
Study title: Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43282 |
Study title: Effect of short-term, low-dose treatment with tamoxifen in patients with primary dysmenorrhea. Pierzynski P, Swiatecka J, Oczeretko E, Laudanski P, Batra S, Laudanski T. Gynecological Endocrinology 2006;22(12):698-703 2006;(12):698-703.Effect of short-term, low-dose treatment with tamoxifen in patients with primary dysmenorrhea. Pierzynski P, Swiatecka J, Oczeretko E, Laudanski P, Batra S, Laudanski T. Gynecological Endocrinology 2006;22(12):698-703 2006;(12):698-703. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43259 |
Study title: Effects of low dose tamoxifen on normal breast tissue from premenopausal women. De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. European Journal of Cancer 2003; 39(7):891-898. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. European Journal of Cancer 2003; 39(7):891-898. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43270 |
Study title: Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191.Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43276 |
Study title: Efficacy and tolerance evaluation of secnidazole suspension single dose (30 mg/kg/day) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingans - No date |
Active substance: SECNIDAZOLE |
Study summary document link (including results): Secnidazole STUDY Cimerman.xls |
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Document reference: 42113 |
Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42339 |
Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42452 |
Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian] |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42393 |
Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian] |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42506 |
Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42342 |
Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42455 |
Study title: Comparative evaluation of the role of NaF, APF & Duraphat topical fluoride applications in the prevention of dental caries--a 2 1/2 years study. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42544 |
Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43204 |
Study title: Barai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yield. J Postgrad Med. 2004 Jul-Sep;50(3):180-3; discussion 183-4. Barai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yield. J Postgrad Med. 2004 Jul-Sep;50(3):180-3; discussion 183-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43397 |
Study title: Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1. Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43392 |
Study title: Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available. Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43738 |
Study title: Batte WG Jr, Yeh SD, Rosenblum MK, Larson SM. Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia. Clin Nucl Med. 1991 Jun;16(6):421-4. Batte WG Jr, Yeh SD, Rosenblum MK, Larson SM. Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia. Clin Nucl Med. 1991 Jun;16(6):421-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44268 |
Study title: Placebo controlled study during one year comparing the addition of Salmeterol with an increase of the dose of the inhaled corticosteroid in asthmatic children already on treatment with inhaled corticosteroids. Report No. GM1998/00044/00 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol Xinafoate-SLGB4014-ICHE3.pdf |
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Document reference: 42053 |
Study title: American Association of Poison Control Centers. Camphor Poisoning: an evidence-based practice guideline for out-of-hospital management, Manoguerra, A.S., Clin.Toxicol. (Phila) 2006; 44 (4): 357-370 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40219 |
Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40218 |
Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598 |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40226 |
Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40221 |
Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207 |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40222 |
Study title: Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43 |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40216 |
Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106 |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40214 |
Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children. Tibballs J, Med J Aust., 1995, 163:177-80. |
Active substance: Spike oil |
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Document reference: 40224 |
Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E. |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40217 |
Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43353 |
Study title: Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43299 |
Study title: Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394.Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43116 |
Study title: Comparative study of the increase in acid solubility resistance of enamel using different fluoride treatments]. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42409 |
Study title: Comparative study of the increase in acid solubility resistance of enamel using different fluoride treatments]. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42522 |
Study title: Comparison of intra-examiner reproducibility in scoring caries in primary teeth of two scoring systems used to monitor caries progression. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42428 |
Study title: "Organon Risperdal - Non interventional study 2002, age of the patients 15-92. To document efficacy and tolerance of RISPERDAL in psychotic and psychosis-associated symptoms |
Active substance: RISPERIDONE |
Study summary document link (including results): |
View full study record |
Document reference: 35411 |
Study title: "Organon Risperdal -AWB 2002" /(Organon Risperdal - Non Interventional study 2002) age of the patients 15-92 |
Active substance: RISPERIDONE |
Study summary document link (including results): AWB2002_Non-interventional_Risperidone.xls |
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Document reference: 35400 |
Study title: Pharmacokinetics and safety of risperidone in children with autistic disorder after a single oral dose of risperidone. Part I: Pharmackinetics and prolactin response. Part II: Tolerability, cardiovascular safety and laboratory safety. |
Active substance: RISPERIDONE |
Study summary document link (including results): |
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Document reference: 35422 |
Study title: Randomized, double-blind, multicenter, 8-week study in adolescents with a DSM-IV diagnosis of schizophreniac and suffering from an acute episode (PANSS total score 60-120) |
Active substance: RISPERIDONE |
Study summary document link (including results): RIS-USA-231_Interventional_Risperidone.xls |
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Document reference: 35394 |
Study title: Schizophrenia, 1992, Yagi G et al (Japaneses phase II study): Minimum age 16 |
Active substance: RISPERIDONE |
Study summary document link (including results): |
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Document reference: 35397 |
Study title: Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67. Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43370 |
Study title: Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8. Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43761 |
Study title: Firooznia H, Rafii M, Golimbu C, Sokolow J. Computerized tomography of pelvic osteomyelitis in patients with spinal cord injuries. Clin Orthop Relat Res. 1983 Dec;(181):126-31. Firooznia H, Rafii M, Golimbu C, Sokolow J. Computerized tomography of pelvic osteomyelitis in patients with spinal cord injuries. Clin Orthop Relat Res. 1983 Dec;(181):126-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44021 |
Study title: Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study. Sengespeik HC et al., Arzneimittelforschung, 1998: 990-4. |
Active substance: Spike oil |
Study summary document link (including results): |
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Document reference: 40225 |
Study title: National Poisons Information Service Center, United Kingdom. Poison Information Monograph: Camphor, 1996 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40220 |
Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40213 |
Study title: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929 |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40215 |
Study title: Reports of Postmarketing experience, Post Authorisation safety study. Panosch B, Montavit, 2007-05-23. |
Active substance: Spike oil |
Study summary document link (including results): |
View full study record |
Document reference: 40223 |
Study title: American Association of Poison Control Centers. Camphor Poisoning: an evidence-based practice guideline for out-of-hospital management, Manoguerra, A.S., Clin.Toxicol. (Phila) 2006; 44 (4): 357-370 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40229 |
Study title: Antiobstruktive Wirksamkeit von Cineol bei Atemwegserkrankungen, Grimm, H., Therapiewoche 1987; 37: 4306-4311 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40241 |
Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40237 |
Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40233 |
Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40236 |
Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40235 |
Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106 |
Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
Study summary document link (including results): |
View full study record |
Document reference: 40240 |
Study title: Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233 Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233 |
Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE |
Study summary document link (including results): |
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Document reference: 42238 |
Study title: Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40. Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43389 |
Study title: Adams BK, Parkar S, Al-Haider ZY. Technetium-99m MDP bone scintigraphy shows multiple abnormalities in sickle cell disease. Arch Dis Child. 2003 Jul;88(7):631. No abstract available. Adams BK, Parkar S, Al-Haider ZY. Technetium-99m MDP bone scintigraphy shows multiple abnormalities in sickle cell disease. Arch Dis Child. 2003 Jul;88(7):631. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43419 |
Study title: Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73. Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43613 |
Study title: Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available. Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43498 |
Study title: al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41. al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43680 |