- Trials with a EudraCT protocol (50)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
Query did not match any clinical trials.
| 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: Treatment of acne vulgaris with topical isotretinoin |
| Active substance: ISOTRETINOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30760 |
| Study title: PROPHYLAXIS OF FUNGAL INFECTION WITH DIFLUCAN IN PATIENTS WITH COLLAGEN DISEASE ON THE LONG TERM, AND LARGE-DOSAGE STEROID THERAPY. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27865 |
| Study title: Prophylaxis, costs and effectiveness of gram positive therapy in neatropenic children |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27454 |
| Study title: Prophylaxis, costs and effectiveness of gram positive therapy in neatropenic children |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27818 |
| Study title: PROSPECTIVE COMPARATIVE TRIAL OF AMPHOTERICIN B VS. FCA IN NEONATAL SYSTEMIC FUNGAL INFECTIONS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27643 |
| Study title: PROSPECTIVE COMPARATIVE TRIAL OF AMPHOTERICIN B VS. FCA IN NEONATAL SYSTEMIC FUNGAL INFECTIONS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28005 |
| Study title: Serum mepivacaine concentrations after intraoral injection in young children. Chin, K.L. et al, J. Calif.Dent. Assoc. 2003Serum mepivacaine concentrations after intraoral injection in young children. Chin, K.L. et al, J. Calif.Dent. Assoc. 2003 |
| Active substance: MEPIVACAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31606 |
| Study title: A Controlled Study on the Effect of an Absorbable Sustained Release Artificial Tear Substitute on the Dry Eye Syndrome Frequently Associated with Familial Dysautonomia. |
| Active substance: HYDROXYPROPYL CELLULOSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29218 |
| Study title: Long Term Study of the Effect of a Sustained Release Artificial Tear Substitute (SR-AT) on Keratoconjunctivitis Sicca. |
| Active substance: HYDROXYPROPYL CELLULOSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29217 |
| Study title: Hypereosinophilic syndrome: a multicentre, retrospective analysis of clinical characteristics and response to therapy2009 |
| Active substance: HYDROXYUREA |
| Study summary document link (including results): 19910029.pdf |
| View full study record |
| Document reference: 48369 |
| Study title: Cazzola G, Cavalieri S, Solbiati M. (1978) Presented at del Convegno Nazionale della Societa Italiana per lo Studio delle Malattie Infettive e Parassitarie; September 16-17, Ancona, Italy; 1-23. Study of the activity of Isoprinosine® in herpes virus infections.Cazzola G, Cavalieri S, Solbiati M. (1978) Presented at del Convegno Nazionale della Societa Italiana per lo Studio delle Malattie Infettive e Parassitarie; September 16-17, Ancona, Italy; 1-23. Study of the activity of Isoprinosine® in herpes virus infections. |
| Active substance: INOSINE |
| Study summary document link (including results): |
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| Document reference: 30086 |
| Study title: Cohen AL, Antonini GM, Stefano JC La Prensa Medica Argentina. 1973; 60(8):267-278. A clinical study of various viral infections treated with methisoprinol syrup.Cohen AL, Antonini GM, Stefano JC La Prensa Medica Argentina. 1973; 60(8):267-278. A clinical study of various viral infections treated with methisoprinol syrup. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30091 |
| Study title: Effects of dextroamphetamine, chlorpromazine, and hydroxy- zine on behavior and performance in hyperactive children |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE92B1901.pdf |
| View full study record |
| Document reference: 29266 |
| Study title: Effects of hydroxyzine hydrochloride on the reaction time performance of schizophrenic children |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE92B0504.pdf |
| View full study record |
| Document reference: 29257 |
| Study title: Efficacy of hydroxyzine vs diphenhydramine in atopic dermatitis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29345 |
| Study title: Electromyography: its potential as an adjunct to other monitored parameters during conscious sedation in children receiving dental treatment. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE91B1826.pdf |
| View full study record |
| Document reference: 29365 |
| Study title: Empleo del clorhidrato de hidroxicina en el tratamiento de la urticaria cronica. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): DS76H021P.pdf |
| View full study record |
| Document reference: 29312 |
| Study title: Evaluation of analgesic, sedative, antipyretic effects of the combination acetaminophen plus hydroxyzine in pediatrics. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPP92K0719.pdf |
| View full study record |
| Document reference: 29341 |
| Study title: Effect of prolonged indomethacin therapy on renal function and selected vasoactive hormones in very-low-birth-weight infants with symptomatic patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29886 |
| Study title: Effects of early indomethacin administration on oxygenation and surfactant requirement in low birth weight infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29887 |
| Study title: Effects of early therapy with indomethacin on the manifestation of a persistent ductus arteriosus in extremely underweight premature infants |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29888 |
| Study title: Effects of indomethacin and ibuprofen on mesenteric and renal blood flow in preterm infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29889 |
| Study title: Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29890 |
| Study title: Effects of indomethacin on cerebral haemodynamics in very preterm infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29891 |
| Study title: Effects of indomethacin on cerebral hemodynamics at rest and during endotracheal suctioning in preterm neonates. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29892 |
| Study title: Effects of indomethacin on viral replication markers in asymptomatic carriers of hepatitis B: a randomized, placebo-controlled trial. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29893 |
| Study title: Effects of prenatal exposure to betamethasone and indomethacin on the glomerular filtration rate in the preterm infant. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29894 |
| Study title: Effects of prolonged versus acute indomethacin therapy in very low birth-weight infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29895 |
| Study title: Effects of repeated indomethacin administration on cerebral oxygenation and haemodynamics in preterm infants: combined near infrared spectrophotometry and Doppler ultrasound study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29896 |
| Study title: Effects on cerebral blood flow velocities of slow and rapid infusion of indomethacin. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29897 |
| Study title: Künzer Th., Retrospective investigation on children (2-12 years) concerning safety and tolerability and dosage of Echinacin Lozenges; unpublished report (1997) |
| Active substance: (HERB) Purple cone flower, pressed juice, 1.7 - 2.5 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39726 |
| Study title: Taylor et al.JAMA December 3, 2003-Vol 290, No. 21 Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children |
| Active substance: (HERB) Purple cone flower, pressed juice, 1.7 - 2.5 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39728 |
| Study title: Weber et al. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 11, Number 6, 2005, pp. 1021–1026 Echinacea purpurea for Prevention of Upper Respiratory Tract Infections in Children |
| Active substance: (HERB) Purple cone flower, pressed juice, 1.7 - 2.5 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39729 |
| Study title: PROSPECTIVE OPEN PILOT COMPARATIVE STUDY OF SAFETY & EFFICACY OF FCA PARENTERAL/ORAL VS STANDARD PROPHYLACTIC REGIMEN IN PREVENTION OF FUNGAL INFECTIONS IN PTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY OR IN PTS SUFFERING FROM APLASTIC ANEMIA |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27396 |
| Study title: PROSPECTIVE OPEN PILOT COMPARATIVE STUDY OF SAFETY & EFFICACY OF FCA PARENTERAL/ORAL VS STANDARD PROPHYLACTIC REGIMEN IN PREVENTION OF FUNGAL INFECTIONS IN PTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY OR IN PTS SUFFERING FROM APLASTIC ANEMIA |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27761 |
| Study title: RANDOMIZED CONTROLLED STUDY COMPARING ORAL FLUCONAZOLE TO TOPICAL CLOTRIMAZOLE IN THE TREATMENT OF VAGINAL CANDIDIASIS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27648 |
| Study title: RANDOMIZED CONTROLLED STUDY COMPARING ORAL FLUCONAZOLE TO TOPICAL CLOTRIMAZOLE IN THE TREATMENT OF VAGINAL CANDIDIASIS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28010 |
| Study title: RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY OF FLUCONAZOLE PARENTERAL/ORAL IN THE PREVENTION OF FUNGAL INFECTIONS IN PATIENTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY FOR ACUTE MYELOGENOUS LEUKEMIA (AML). |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27397 |
| Study title: RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY OF FLUCONAZOLE PARENTERAL/ORAL IN THE PREVENTION OF FUNGAL INFECTIONS IN PATIENTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY FOR ACUTE MYELOGENOUS LEUKEMIA (AML). |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27762 |
| Study title: RETROSPECTIVE CONTROLLED ANALYSIS OF FLUCONAZOLE PROPHYLAXIS IN PATIENTS WITH ACUTE MYELOGENOUS LEUKEMIA. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27619 |
| Study title: RETROSPECTIVE CONTROLLED ANALYSIS OF FLUCONAZOLE PROPHYLAXIS IN PATIENTS WITH ACUTE MYELOGENOUS LEUKEMIA. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27981 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN CRYPTOCOCCAL MENINGITIS IN PATIENTS WHO CANNOT BE TREATED ADEQUATELY WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27677 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN CRYPTOCOCCAL MENINGITIS IN PATIENTS WHO CANNOT BE TREATED ADEQUATELY WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28039 |
| Study title: A comparison of the antipruritic efficacy of hydroxyzine and cyproheptadine in children with atopic dermatitis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29282 |
| Study title: A Double-Blind Parallel Study to Compare the Efficacy and Side Effects of an Ibuprofen 400 mg/Pseudoephedrine 60 mg Combination, an Ibuprofen 200 mg/Pseudoephedrine 30 mg Combination, and Placebo in the Treatment of Sinus HeadacheA Double-Blind Parallel Study to Compare the Efficacy and Side Effects of an Ibuprofen 400 mg/Pseudoephedrine 60 mg Combination, an Ibuprofen 200 mg/Pseudoephedrine 30 mg Combination, and Placebo in the Treatment of Sinus Headache |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29669 |
| Study title: Evaluation of the effect of nitrous oxide and hydroxyzine in controlling the behavior of the pediatric dental patient. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE93B0817.pdf |
| View full study record |
| Document reference: 29337 |
| Study title: Efficacy and safety of echinacea in treating upper respoiratory tract infections in children. A randomized controlled trial.Taylor JA, Weber W, Standish L et al. JAMA 2003;290: 2824-2830Efficacy and safety of echinacea in treating upper respoiratory tract infections in children. A randomized controlled trial.Taylor JA, Weber W, Standish L et al. JAMA 2003;290: 2824-2830 |
| Active substance: (HERB) Echinacea purpurea L extract |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39702 |
| Study title: The physiological effects of supplemental oxygen versus nitrous oxide/oxygen during conscious sedation of pediatric dental patients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE00L1003.pdf |
| View full study record |
| Document reference: 29290 |
| Study title: Assessment of the effect of 2.5 mg and 5 mg Th 1165a Linctus in school children compared with placebo. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30590 |
| Study title: Assessment of the therapeutic effect and tolerance of Th 1165a Linctus in 12 infants and 12 school children at doses of 3 x 1.25 mg and 3 x 2.5 mg. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30591 |
| Study title: Assessment of the therapeutic effect of Th 1165a-linctus with several days' administration in infants. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30601 |
| Study title: Assessment of therapeutic effect and tolerance of Th 1165a suppositories after repeated administration in infants and school children. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30597 |
| Study title: A randomized open study to investigate the boosting effect of VAQTA and AVAXIM following a single dose of AVAXIM (PM-MSD U98-XQ-003) |
| Active substance: Inactivated hepatitis A virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41464 |
| Study title: Evaluation of the safety, immunogenicity and protective efficacy of an inactivated hepatitis A vaccine in healthy children. |
| Active substance: Inactivated hepatitis A virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41115 |
| Study title: Letson GW et al. Effect of maternal antibody on immunogenicity of hepatitis A vaccine in infantsJ Pediatr 2004;144:327-32Letson GW et al. Effect of maternal antibody on immunogenicity of hepatitis A vaccine in infantsJ Pediatr 2004;144:327-32 |
| Active substance: Inactivated hepatitis A virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41112 |
| Study title: Open study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per ml dose injected according to a 0, 12 month schedule in healthy adolescents. |
| Active substance: Inactivated hepatitis A virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21206 |
| Study title: Antipyretic effects of indomethacin in acute infectious diseases--a double blind testa |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29822 |
| Study title: Can dopamine prevent the renal side effects of indomethacin? A prospective randomized clinical study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29827 |
| Study title: Clinical and objective assessments of naproxen through 5 years of clinical experience. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29831 |
| Study title: The spectrum of antihistamines adversely affecting pulmonary function in asthmatic children. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29330 |
| Study title: The therapeutic effectiveness of nitrous oxide and chloral hydrate administered orally, rectally, and combined with hydroxyzine for pediatric dentistry. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29305 |
| Study title: Uber die klinische bedeutung der ataraktika “tranquillanten” unter besonderer berucksichtigung ihrer anwendung in der kinderheilkunde |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29222 |
| Study title: Urticaria cronica. Caracteristicas, diagnostico y tratamiento. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPS92M2124.pdf |
| View full study record |
| Document reference: 29360 |
| Study title: Urticaria in thai children. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE92D1427.pdf |
| View full study record |
| Document reference: 29357 |
| Study title: Ketoconazole shampoo in the treatment of dandruff and/or seborrheic dermatitits: a randomized, double-blind placebo-controlled comparison of different concentrations |
| Active substance: KETOCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30831 |
| Study title: Th 1165a suppositories 7.5 mg. An assessment of the effect of Th 1165a suppositories in school children during the night on the frequency of acute attacks of bronchospasm, on chronic dyspnoea, and the necessity for adjunctive therapy. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30585 |
| Study title: The effect of administration technique on bronchodilator response to fenoterol in a metered dose inhaler. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30613 |
| Study title: Randomized double-blind controlled trial comparing the effects of ibuprofen with indomethacin on cerebral hemodynamics in preterm infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30007 |
| Study title: Regional hemodynamic effects of dopamine in the indomethacin-treated preterm infant |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30011 |
| Study title: Retrospective economic evaluation of a controlled trial of indomethacin prophylaxis for patent ductus arteriosus in premature infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30016 |
| Study title: Combined treatment with a nonselective nitric oxide synthase inhibitor (l-NMMA) and indomethacin increases ductus constriction in extremely premature newborns. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29839 |
| Study title: Comparative effectiveness of voltaren and indomethacin in rheumatoid arthritis (according to the data of a double-blind study)a |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29840 |
| Study title: A Phase 1, Open-label Study Evaluating the Safety and Pharmacokinetics of a Single Intravenous Infusion of a Chimeric Monoclonal Antibody to Human TNFα (Infliximab) in Pediatric Inflammatory Bowel Disease Subjects Receiving Maintenance Treatment with Infliximab |
| Active substance: Infliximab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47439 |
| Study title: A Randomized, Double-blind Study of Anti-TNFα Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate for the Treatment of Subjects with Polyarticular Juvenile Rheumatoid Arthritis |
| Active substance: Infliximab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47436 |
| Study title: A Randomized, Double-blind Study of Anti-TNFα Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate for the Treatment of Subjects with Polyarticular Juvenile Rheumatoid Arthritis • OLE study report synopsis |
| Active substance: Infliximab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47437 |
| Study title: A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNFα Chimeric Monoclonal Antibody (Infliximab, REMICADE®) in Pediatric Subjects with Moderate to Severe Crohn’s Disease |
| Active substance: Infliximab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47438 |
| 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: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41210 |
| Study title: Adame G Oral itraconazole in the treatment of tinea manus and tinea pedis. Clinical summary on R51211, August 1987. (14-54 years, LMD56451)Adame G Oral itraconazole in the treatment of tinea manus and tinea pedis. Clinical summary on R51211, August 1987. (14-54 years, LMD56451) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30793 |
| Study title: Alcantara R. Treatment of dermatomycosis with 100 mg itraconazole o.d. during fifteen or thirty days. Janssen Research Foundation Products Information service. Clinical research report, February 1988. (5-90 years, LMD59929)Alcantara R. Treatment of dermatomycosis with 100 mg itraconazole o.d. during fifteen or thirty days. Janssen Research Foundation Products Information service. Clinical research report, February 1988. (5-90 years, LMD59929) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30779 |
| Study title: An open evaluation of itraconazole oral solution in paediatric patients undergoing treatment for haematological malignancy or solid tumour. Safety findings. |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): LMD129189_Interventional_Itraconazole.xls |
| View full study record |
| Document reference: 45124 |
| Study title: An open study on the pharmacokinetics and safety of itraconazole oral solution in 24 cystic fibrosis subjects |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): LMD172168_Interventional_Itraconazole.xls |
| View full study record |
| Document reference: 47581 |
| Study title: Boogaerts MA, Verhoef GE, Zachee P, Demuynck H, Verbist L, De Beulke K. Antifungal prophylaxis with itraconazole in prolonged neutropenia: Correlation with plasma levels. Proceedings of the 2nd internationa symposium on itraconazole, Antwerp, Belgium, June 22-23, 1989. Mycoses 32 (suppl.1), p.103-108, 1989. (9-78 years, LMD69411)Boogaerts MA, Verhoef GE, Zachee P, Demuynck H, Verbist L, De Beulke K. Antifungal prophylaxis with itraconazole in prolonged neutropenia: Correlation with plasma levels. Proceedings of the 2nd internationa symposium on itraconazole, Antwerp, Belgium, June 22-23, 1989. Mycoses 32 (suppl.1), p.103-108, 1989. (9-78 years, LMD69411) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30811 |
| Study title: Coninx S, et al Double-blind comparison of itraconazole with griseofulvin in the treatment of tinea Corporis and tinea cruris. Clinical research report on R051211 no-71, May 1987. (2-78 years, LMD56442)Coninx S, et al Double-blind comparison of itraconazole with griseofulvin in the treatment of tinea Corporis and tinea cruris. Clinical research report on R051211 no-71, May 1987. (2-78 years, LMD56442) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30784 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN LIFE THREATENING DEEP MYCOSES |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27674 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN LIFE THREATENING DEEP MYCOSES |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28036 |
| Study title: Selective COX-2 inhibitor versus indomethacin for the prevention of heterotopic ossification after hip replacement: a double-blind randomized trial of 100 patients with 1-year follow-up. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30020 |
| Study title: A double-blind, placebo-controlled, crossover trial of ketotifen versus hydroxyzine in the treatment of pediatric mastocytosis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29280 |
| Study title: A prospective study of 2 sedation regimens in children: chloral hydrate, meperidine, and hydroxyzine versus midazolam, meperidine, and hydroxyzine. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE07C2107.pdf |
| View full study record |
| Document reference: 29340 |
| Study title: A retrospective study of chloral hydrate, meperidine, hydroxyzine, and midazolam regimens used to sedate children for dental care. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE01A1503.pdf |
| View full study record |
| Document reference: 29366 |
| Study title: A study of quadriceps contracture-causing factor by the analysis of muscle injection according to medical records. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): RACH90J0558P.pdf |
| View full study record |
| Document reference: 29306 |
| Study title: A study to compare the effectiveness of temazepam and a chloral hydrate/hydroxyzine combination in sedating paediatric dental patients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE94F2815.pdf |
| View full study record |
| Document reference: 29356 |
| Study title: Acute urticaria in infancy and early childhood: a prospective study. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE99E3106.pdf |
| View full study record |
| Document reference: 29307 |
| Study title: Adverse central nervous system effects of older antihistamines in children. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE96K0715.pdf |
| View full study record |
| Document reference: 29344 |
| Study title: Hydroxyzine versus cetirizine in the treatment of atopic dermatitis in children |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): DIE90J061 - Cetirizine.pdf |
| View full study record |
| Document reference: 29220 |
| Study title: Furosemide does not prevent indomethacin-induced renal side effects in preterm infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29906 |
| Study title: Furosemide prevents the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29907 |
| Study title: High efficacy and minor renal effects of indomethacin treatment during individualized fluid intake in premature infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29909 |
| Study title: Improved quantification of 8-epi-prostaglandin F2 alpha and F2-isoprostanes by gas chromatography/triple-stage quadrupole mass spectrometry: partial cyclooxygenase-dependent formation of 8-epi-prostaglandin F2 alpha in humans. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29914 |
| Study title: Indomethacin and corticosteroids: an additive constrictive effect on the fetal ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29919 |
| Study title: Götte and Roschke A supportive measure in the treatment of acute infections of the respiratory tract in children with recurring infections of the upper respiratory tract; päd (7) 2001 |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39716 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN PATIENTS WITH NON-LIFE THREATENING MYCOSIS WHO CANNOT BE TREATED ADEQUATELY TREATED WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27676 |
| Study title: SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN PATIENTS WITH NON-LIFE THREATENING MYCOSIS WHO CANNOT BE TREATED ADEQUATELY TREATED WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28038 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN CANCER PATIENTS WITH OROPHARYNGEAL AND OESOPHAGEAL CANDIDIASIS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27651 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN CANCER PATIENTS WITH OROPHARYNGEAL AND OESOPHAGEAL CANDIDIASIS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28013 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH LIFE THREATENING DEEP MYCOSES. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27675 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH LIFE THREATENING DEEP MYCOSES. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28037 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH LIFE-THREATENING DEEP MYCOSES, WHO CANNOT BE TREATED ADEQUATELY WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27449 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH LIFE-THREATENING DEEP MYCOSES, WHO CANNOT BE TREATED ADEQUATELY WITH AVAILABLE AGENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27813 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH OROPHARYNGEAL CANDIDIASIS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27426 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE IN PATIENTS WITH OROPHARYNGEAL CANDIDIASIS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27791 |
| Study title: SAFETY AND EFFICACY OF FLUCONAZOLE PO VS. AMPHOTERICIN B SUSPENSION IN PREVENTION OF CANDIDIASIS IN LEUKEMIC PATIENTS UNDERGOING CHEMOTHERAPY. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27961 |
| Study title: SAFETY AND EFFICACY OF ORAL AND INTRAVENOUS FLUCONAZOLE IN PATIENTS WITH GASTRO-INTESTINAL CANDIDIASIS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27419 |
| Study title: Antihistamine selection in patients with allergic rhinitis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29361 |
| Study title: A Double-Blind, Parallel Study to Compare the Efficacy and Side Effects of an Ibuprofen 400 mg/Pseudoephedrine 60 mg Combination, An Ibuprofen 200 mg/Pseudoephedrine 30 mg Combination, and Placebo in the Treatment of Sinus Headache. Protocol 86-638A, Unpublished Report TA93. |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): ibuprofen_pseudoephedrine 86-638A.pdf |
| View full study record |
| Document reference: 29645 |
| Study title: A Double-Blind, Parallel Study to Compare the Efficacy and Side Effects of an Ibuprofen 400 mg/Pseudoephedrine 60 mg Combination, An Ibuprofen 200 mg/Pseudoephedrine 30 mg Combination, and Placebo in the Treatment of Sinus Headache. Protocol 86-638B, Unpublished Report TA94. |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): ibuprofen_pseudoephedrine 86-638B.pdf |
| View full study record |
| Document reference: 29646 |
| Study title: A Double-Blind, Parallel Study to Compare the Efficacy and Side Effects of an Ibuprofen 400 mg/Pseudoephedrine 60 mg Combination, An Ibuprofen 200 mg/Pseudoephedrine 30 mg Combination, and Placebo in the Treatment of Sinus Headache. Protocol 86-638C, Unpublished Report TA95 |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): ibuprofen_pseudoephedrine 86-638C.pdf |
| View full study record |
| Document reference: 29647 |
| Study title: Hydroxyzine: pharmacokinetics and antipruritic effect in children with atopic dermatitis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29342 |
| Study title: Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE96L1314.pdf |
| View full study record |
| Document reference: 29285 |
| Study title: L’hydroxyzine dans le traitement des affections allergiques. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPS92D0750.pdf |
| View full study record |
| Document reference: 29326 |
| Study title: Taylor et al. Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children.; JAMA December 3, 2003-Vol 290, No. 21 |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39717 |
| Study title: Wber et al. Echinacea purpurea for Prevention of Upper Respiratory Tract Infections in Children; THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 11, Number 6, 2005, pp. 1021–1026 |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39718 |
| Study title: Künzer,Retrospective investigation on children (2-12 years) concerning safety and tolerability and dosage of Echinacin Lozenges; unpublished report (1997) |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1, 85 % |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39722 |
| Study title: Taylor et al. Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children; JAMA December 3, 2003-Vol 290, No. 21 |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1, 85 % |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39719 |
| Study title: Weber et al. Echinacea purpurea for Prevention of Upper Respiratory Tract Infections in Children; THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 11, Number 6, 2005, pp. 1021–1026 |
| Active substance: (HERB) Purple cone flower, dried pressed juice, 31.5 - 53.6 : 1, 85 % |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39720 |
| Study title: Effect of valerian, Valeriana edculis, on sleep difficulties in children with intellectual deficits: randomised trial.; Francis AJ, Dempster RJ. Phytomedicine 2002 May; 9(4): 273-279 |
| Active substance: (HERB) Valeriana officinalis L. extract |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39723 |
| Study title: A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children; Article published: Mueller SF; Klement S. Phytomedicine (Jena) 2006;13(6): 383-387 |
| Active substance: (HERB) Valeriana officinalis L. extract Melissa officinalis L. extract |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39725 |
| Study title: HX181-Appréciation en ouvert de l'activité et de la tolérance héxomedine solution chez l'enfant (dossier de modification de formule du 30/10/87) -partie IVB - Paupe and Prost - 27/04/1986Kettelhut, B. V., Berkebile, C., Bradley, D., and Metcalfe, D. D. Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Disease, Bethesda, Md 20892 A double-blind, placebo-controlled, crossover trial of ketotifen versus hydroxyzine in the treatment of pediatric mastocytosis J.Allergy Clin.Immunol. 1989;83:866-870. |
| Active substance: HEXAMIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29119 |
| Study title: HX181-Open study to assess the activity and tolerance of hexomedine solution in children (french dossier-change in formulation-30/10/87)-partie IVB - Paupe and Prost - 27/04/1986Simons, F. E., Simons, K. J., Becker, A. B., and Haydey, R. P. Pharmacokinetics and antipruritic effects of hydroxyzine in children with atopic dermatitis J.Pediatr. 1984;104:123-127. |
| Active substance: HEXAMIDINE |
| Study summary document link (including results): Hexamidine STUDY 0000103117.xls |
| View full study record |
| Document reference: 29120 |
| Study title: Prevention of nosocomial infection in a pediatric intensive care unit (PICU) through the use of selective digestive decontamination. Ruza F, Alvarado F, Herruzo R, Delgado MA, García S, Dorao P, Goded F. Eur J Epidemiol. 1998 Oct;14(7):719-27.Prevention of nosocomial infection in a pediatric intensive care unit (PICU) through the use of selective digestive decontamination. Ruza F, Alvarado F, Herruzo R, Delgado MA, García S, Dorao P, Goded F. Eur J Epidemiol. 1998 Oct;14(7):719-27. |
| Active substance: HEXETIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29121 |
| Study title: Thomas JG et al. Managing the complexity of a dynamic biofilm. J Am Dent Assoc 2006; 137: 10s-15sThomas JG et al. Managing the complexity of a dynamic biofilm. J Am Dent Assoc 2006; 137: 10s-15s |
| Active substance: HEXETIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29122 |
| Study title: Comparative double-blind study of the bronchodilating effect of ipratropium bromide administered as inhalation powder with two different powder inhalators in children with bronchial asthma. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30552 |
| Study title: Comparative double-blind study of the bronchodilating effect of ipratropium bromide administered as inhalation powder with two different powder inhalators in children with bronchial asthma. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): Ipratropium bromide_U97-0051_synopsis.pdf |
| View full study record |
| Document reference: 30713 |
| Study title: Comparison of the bronchodilatory effect of nebulised ipratropium bromide and fenoterol in children with acute crisis of asthma. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30632 |
| 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') headacheA 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 AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29679 |
| Study title: Fluoride tablets in pre-school age - effect on primary and permanent teethRoland Andersson, Hans Grahnen. Swed Dent J69 137 - 143 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1969-anderesson-Fluoride Tablets in Preschool Age - Effect on Primary and Permanent Teeth.pdf |
| View full study record |
| Document reference: 48767 |
| Study title: Phadke−M−A et al. Ibuprofen in children with infective disorders−−antipyretic efficacy. {Br−J−Clin−Pract}, Nov−Dec 1985, vol. 39, no. 11−12, p. 437−40Phadke−M−A et al. Ibuprofen in children with infective disorders−−antipyretic efficacy. {Br−J−Clin−Pract}, Nov−Dec 1985, vol. 39, no. 11−12, p. 437−40 |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29733 |
| Study title: Comparative evaluation of the effects of indomethacin and ibuprofen on cerebral perfusion and oxygenation in preterm infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29841 |
| Study title: Comparative study of the clinical effects of ibuprofen and indomethacin in rheumatoid arthritis. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29842 |
| Study title: Commentary on the dosage of Buscopan® injection solution in children and juveniles. Boehringer Ingelheim in-house files, May 1995. |
| Active substance: HYOSCINE-N-BUTYLBROMIDE |
| Study summary document link (including results): Hyoscine Butylbromide_U96-0263_synopsis.pdf |
| View full study record |
| Document reference: 47311 |
| Study title: Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 |
| Active substance: HYPERTONIC SOLUTIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29378 |
| Study title: Improved Acidosis Correction and Recovery of Mesothelial Cell Mass with Neutral-pH Bicarbonate Dialysis Solution among Children Undergoing Automated Peritoneal Dialysis, 2003 |
| Active substance: HYPERTONIC SOLUTIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29377 |
| Study title: Phadke−M−A et al. Ibuprofen in children with infective disorders−−antipyretic efficacy. {Br−J−Clin−Pract}, Nov−Dec 1985, vol. 39, no. 11−12, p. 437−40Phadke−M−A et al. Ibuprofen in children with infective disorders−−antipyretic efficacy. {Br−J−Clin−Pract}, Nov−Dec 1985, vol. 39, no. 11−12, p. 437−40 |
| Active substance: IBUPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29596 |
| Study title: The effect of antenatal dexamethasone administration on the fetal and neonatal ductus arteriosus. A randomized double-blind study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30028 |
| Study title: The effect of indomethacin on renal function in children with congenital nephrogenic diabetes insipidus |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30029 |
| Study title: The effects of indomethacin on refractoriness following exercise both with and without a bronchoconstrictor response. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30030 |
| Study title: The hemodynamic effects of antenatal indomethacin and a beta-sympathomimetic agent on the fetus and the newborn: a randomized study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30031 |
| Study title: Continuous versus multiple rapid infusions of indomethacin: effects on cerebral blood flow velocity. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29850 |
| Study title: Controlled study of the effects of indomethacin on cerebral blood flow velocities in newborn infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29852 |
| Study title: Does indomethacin reduce heterotopic bone formation after operations for acetabular fractures? A prospective randomised study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29859 |
| Study title: Anlar B, Yalaz K, Imir T, Turanli G. Eur Neurol. 1994;34(1):44-7. The effect of inosiplex in subacute sclerosing panencephalitis: a clinical and laboratory study.Anlar B, Yalaz K, Imir T, Turanli G. Eur Neurol. 1994;34(1):44-7. The effect of inosiplex in subacute sclerosing panencephalitis: a clinical and laboratory study. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30069 |
| Study title: Large scale safety study of the DTacP-IPV {acellular TETRACOQ®) vaccine, administered in combination (one injection site) or in assocation two injection sites) with Haemophilus influenzae Type b vaccine (Act-HIB®) for primary and booster immunisation |
| Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41203 |
| 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 in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm. Report No. RM2005/00345/00 |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35593 |
| Study title: Indomethacin versus radiation therapy for prophylaxis against heterotopic ossification in acetabular fractures: a randomised, prospective study. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29943 |
| Study title: Intravenous indomethacin as postoperative analgesic in children: acute effects on blood pressure, heart rate, body temperature and bleeding. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29952 |
| Study title: Intravenous indomethacin therapy in infants with a patent ductus arteriosus complicating other congenital heart defects. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29954 |
| Study title: The response of normal and asthmatic subjects to prostaglandins E2 and F2alpha by different routes, and their significance in asthma. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30035 |
| Study title: The use of dopamine for the prevention of the renal side effects of indomethacin in premature infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30038 |
| Study title: Assessment of the effects of 2 sedation regimens on cardiopulmonary parameters in pediatric dental patients: a retrospective study. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE06J1502.pdf |
| View full study record |
| Document reference: 29238 |
| Study title: Bullous mastocytosis : diffuse cutaneous mastocytosis with extensive blisters mimicking scalded skin syndrome or erythema multiforme |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29263 |
| Study title: Cetirizine vs hydroxyzine. Atopic dermatitis in children. Statistical report |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): 9039 - Cetirizine - MRCE91M1101.pdf |
| View full study record |
| Document reference: 29221 |
| Study title: Clinical evaluation of hydroxyzine hydrochloride in pediatric anesthesia and its effect on arousal time. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29304 |
| Study title: Clinical observation to evaluate the patient oriented dosages of Palladon® retard with respect to circadian variations in pain intensity (0.1% of patients 10-19 years) (Germany) |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29374 |
| Study title: Aydin OF, Senbil N, Gurer YK. J Child Neurol. 2006 Mar;21(3):256-60. Nonconvulsive status epilepticus on electroencephalography in a case with subacute sclerosing PanencephalitisAydin OF, Senbil N, Gurer YK. J Child Neurol. 2006 Mar;21(3):256-60. Nonconvulsive status epilepticus on electroencephalography in a case with subacute sclerosing Panencephalitis |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30073 |
| Study title: Azzara A, Meozzi A, Carulli G, Margelli A, Tangheroni F, Serravalle E, Ambrogi F. Presented at Session 18: Italian Society of Chemotherapy, 13th National Congress; June 9-11, 1983; Catania, Italy; 2(3):399-400. Normalization of neutrophilic functions in children suffering from recurrent chronic infections after cyclic therapy with methisoprinol.Azzara A, Meozzi A, Carulli G, Margelli A, Tangheroni F, Serravalle E, Ambrogi F. Presented at Session 18: Italian Society of Chemotherapy, 13th National Congress; June 9-11, 1983; Catania, Italy; 2(3):399-400. Normalization of neutrophilic functions in children suffering from recurrent chronic infections after cyclic therapy with methisoprinol. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30075 |
| Study title: Mast cell quantification in the skin of children with atopic dermatitis : its value in diagnosis and in assessing the effctiveness of therapy |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE97H2007.pdf |
| View full study record |
| Document reference: 29268 |
| Study title: Indomethacin and its effect on renal function and urinary kallikrein excretion in premature infants with patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29920 |
| Study title: Indomethacin and the stress response to hysterectomy. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29921 |
| Study title: Indomethacin as an analgesic after hysterectomy. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29922 |
| Study title: Indomethacin prophylaxis or expectant treatment of patent ductus arteriosus in extremely low birth weight infants? |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29935 |
| Study title: Clinical studies on hydroxyzine in childrens’ premedication in adenoidectomy and tonsillectomy. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): DID89A026P-ADPD94M1940.pdf |
| View full study record |
| Document reference: 29331 |
| Study title: A pilot comparative study evaluating the analgesic effect of using a single dose of an ibuprofen 200 mg / acetaminophen 650 mg combination or ibuprofen 400 mg in post-operative dental pain A pilot comparative study evaluating the analgesic effect of using a single dose of an ibuprofen 200 mg / acetaminophen 650 mg combination or ibuprofen 400 mg in post-operative dental pain |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29663 |
| Study title: Negative effect on the electroencephalogram of hydroxyzine pamoate at therapeutic dosage. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29225 |
| Study title: Paediatric mastocytosis : retrospective study of 15 cases |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPP02J2001.pdf |
| View full study record |
| Document reference: 29237 |
| Study title: Pharmacokinetics and antipruritic effects of hydroxyzine in children with atopic dermatitis. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29343 |
| Study title: Preliminary study on the use of hydroxyzine in psychosomatic affections |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): CE56F151P.pdf |
| View full study record |
| Document reference: 29253 |
| Study title: Xiao Z. An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine (corrected) hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold. Chinese journal of internal medicine 2002; 41(8):547-9Xiao Z. An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine (corrected) hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold. Chinese journal of internal medicine 2002; 41(8):547-9 |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29750 |
| Study title: A Study of the Pharmacology Profile, Safety and Tolerability of Intravenously Administered Single Doses of MK0787/MK0791 in Neonates. |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29752 |
| 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: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29753 |
| Study title: Coagulation Factor IX (human) AlphanineSD affinity purified, solvent detergent treated, an open label study of viral safety in previously untreated subjects with Haemophilia B. |
| Active substance: HUMAN COAGULATION FACTOR IX |
| Study summary document link (including results): 01 ATC 91-11(synopsis).pdf |
| View full study record |
| Document reference: 47316 |
| 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. Stat Rpt 77. Protocol 84-462, Unpublished Report 201. |
| Active substance: IBUPROFEN AND PARACETAMOL |
| Study summary document link (including results): ibuprofen_paracetamol 84-462.pdf |
| View full study record |
| Document reference: 47399 |
| Study title: A Pilot Comparative Study Evaluating the Analgesic Effect of Using a Single Dose of an Ibuprofen 200 mg / Acetaminophen 650 mg Combination or Ibuprofen 400 mg in Post-Operative Dental Pain. |
| Active substance: IBUPROFEN AND PARACETAMOL |
| Study summary document link (including results): ibuprofen_paracetamol 98-053.pdf |
| View full study record |
| Document reference: 47413 |
| Study title: A single dose study to compare the efficacy and side effects of ibuprofen suspension to placebo in children 5 through 11 years of age with post-operative pain secondary to either inguinal or umbilical herniorrhaphy. Jul 1995.A single dose study to compare the efficacy and side effects of ibuprofen suspension to placebo in children 5 through 11 years of age with post-operative pain secondary to either inguinal or umbilical herniorrhaphy. Jul 1995. |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29691 |
| Study title: A case of haemorrhagic lung edema treated by indomethacin in a term infantBaker CJ, Melish NM, Hall RT, et al. and the multicenter group for the study of immune globulin in neonates. Intravenous immune globulin for the prevention of nosocomial infection in low-birth-weight neonates. N Engl J Med 1992; 327 (4): 213-219 |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29790 |
| Study title: A clinical trial of indomethacin and ibuprofen in dysmenorrhea.Evaluation of prophylactic passive immunization using IGIV to prevent late onset neonatal infection among low birth weight(< 1750 grams) neonates. Baxter Internal ReportBB IND 1628: June, 1992 |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29791 |
| Study title: Anwendungsbeobachtung Aknichthol soft N Lotio |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29757 |
| Study title: Anwendungsbeobachtung zu Natriumbituminosulfonat 20% (Ichtholan T) bei Neurodermitis |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29762 |
| Study title: Anwendungsbeobachtung zum Nachweis der Wirksamkeit und Verträglichkeit von Ichthoseptal® Creme bei Patienten mit Acne papulo-pustulosa bzw. entzündlicher Acne comedonica |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29763 |
| Study title: AWB bei Neurodermitis |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29764 |
| Study title: AWB bei Psoriasis bzw. seborrh. Ekzem |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29760 |
| Study title: Doppelblinde, kontrollierte klinische Prüfung zum Wirksamkeits- und Verträglichkeitsnachweis von Akne-Lotion I bei Patienten mit mittelschwererer Akne vulgaris |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29756 |
| Study title: Monozentrische, prospektive, randomisierte, kontrollierte Doppelblindstudie zum Nachweis der Wirksamkeit und Verträglichkeit von 4 % Natriumbituminosulfonat, hell in einer O/W-Emulsion versus der (angefärbten) Grundlage bei Kindern mit leichter bis mittelschwerer Neurodermitis |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29765 |
| Study title: Monozentrische, prospektive, randomisierte, kontrollierte, observer-blind Studie zum Nachweis der Wirksamkeit und Verträglichkeit von Natriumbituminosulfonat, hell (20 %ig) in einer Gelgrundlage (Ichtholan® T Gel) versus Fusidinsäure (2 %ig) in einer Cremegrundlage (Fucidine® Creme) bei Patienten mit bakteriell-bedingten Hauterkrankungen im Alter vom 4. Lebensmonat bis zum 18. Lebensjahr |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29761 |
| Study title: Überprüfung der Wirksamkeit und Verträglichkeit einer Milchschorf Creme bei Säuglingen und Kleinkindern bis zum vollendeten 2. Lebensjahr |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29759 |
| Study title: Überprüfung der Wirksamkeit und Verträglichkeit einer Neurodermitis Creme bei Säuglingen und Kindern bis zum vollendeten 6. Lebensjahr |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29766 |
| Study title: Pilot assessment of the effect and tolerability of Th 1165a as a capsule administered with a powder inhaler and assessment of the powder inhaler. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30568 |
| Study title: Pilot assessment of the effect and tolerability of Th 1165a as a capsule administered with a powder inhaler and assessment of the powder inhaler. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30670 |
| Study title: Prospective study with fenoterol mdi in patients with bronchoconstrictions. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30617 |
| Study title: Study of the booster effect of IPV vaccination on children |
| Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41196 |
| Study title: Therapeutic effect of non-steroidal anti-inflammatory agents in eye disease |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30041 |
| Study title: Therapeutic effectiveness of paracetamol in rheumatoid arthritis. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30042 |
| Study title: Treatment of ureteral and biliary pain with an injectable salt of indomethacin. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30051 |
| Study title: Treatment of ureteric colic. Intravenous versus rectal administration of indomethacin. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30052 |
| Study title: Effect in man of aspirin, standard indomethacin, and sustained release indomethacin preparations on gastric bleeding. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29875 |
| Study title: Effect of dopamine on failure of indomethacin to close the patent ductus arteriosus. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29876 |
| Study title: Effect of early targeted indomethacin on the ductus arteriosus and blood flow to the upper body and brain in the preterm infant. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29877 |
| Study title: Effect of graduated intravenous and standard rectal doses of indomethacin on cerebral blood flow in healthy volunteers. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29878 |
| Study title: Effect of high dose ramipril with or without indomethacin on glomerular selectivity. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29879 |
| Study title: Effect of indometacin in a child with pseudohypoaldosteronism |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29880 |
| Study title: Effect of indomethacin on adenosine-induced bronchoconstriction. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29881 |
| Study title: Effectiveness and Safety of the Angiotensin II Antagonist Irbesartan in Children With Chronic Kidney Diseases |
| Active substance: irbesartan |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41533 |
| Study title: Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003 |
| Active substance: ISOTONIC SOLUTIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30758 |
| Study title: A double-blind, placebo-controlled trial to evaluate the efficacy and safety of topically applied 0.1% isotretinoin cream for the treatment of acne vulgaris. |
| Active substance: ISOTRETINOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30761 |
| Study title: Open-label, Randomized, Dose Ranging Study of Three Different Doses of Ritonavir in Combination with 3TC+d4T in Children Infected with HIV |
| Active substance: ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41580 |
| Study title: Effect of a partial substitution of invert sugar for surcose in combination with Duraphat treatment in caries development in pre-school children1991-frostell |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1991-frostell-Effect of a partial substitution of invert sugar for surcose in combination with Duraphat treatment in caries development in pre-scho... |
| View full study record |
| Document reference: 49116 |
| Study title: Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental caries1979-koch |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1979-koch-Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental c... |
| View full study record |
| Document reference: 49105 |
| Study title: Effect of topical applied stannous fluoride on dental caries experience children1955-Howell |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1955-Howell-Effect of topical applied stannous fluoride on dental caries experience children.pdf |
| View full study record |
| Document reference: 49132 |
| Study title: Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29963 |
| Study title: Mannheimer lecture. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29968 |
| Study title: Modulation of the immediate allergic wheal reaction in the skin by drugs inhibiting the effects of leukotriene C4 and prostaglandin D2. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29970 |
| Study title: Near-infrared spectroscopy as a screening tool for patent ductus arteriosus in extremely low birth weight infants. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29972 |
| Study title: Neonatal consequences of the use of indomethacin during pregnancy. A prospective study of 83 pregnant women and 115 neonates |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29973 |
| Study title: Neurodevelopmental follow-up at 36 months' corrected age of preterm infants treated with prophylactic indomethacin. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29975 |
| Study title: Neurodevelopmental outcome at 36 months' corrected age of preterm infants in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial. |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29976 |
| Study title: A non-randomised, single-centre, retrospective, controlled trial using stored serum samples to investigate the immunogenicity of NovoRapid® and Actrapid® in children and adolescents from onset of Type 1 diabetes. |
| Active substance: insulin detemir |
| Study summary document link (including results): ANA-1676 synopsis.pdf |
| View full study record |
| Document reference: 47338 |
| Study title: A single-centre, randomised, double-blind, cross-over trial comparing the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes, LPLV October 2005 |
| Active substance: insulin detemir |
| Study summary document link (including results): NN304-1633-synopsis.pdf |
| View full study record |
| Document reference: 41577 |
| Study title: Open uncontrolled clinical trial of iotrolan 300 for gastrointestinal diagnosis in childrenTurk J Pediatr. 1995 Oct-Dec;37(4):305-13 The effects of contrast media on renal function in children: comparison of ionic and non-ionic agents. Buyan N, Arab M, Hasanoğlu E, Gökçora N, Ercan S |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30382 |
| Study title: Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213)Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30234 |
| Study title: Effect of supplementing iodine on child intellectual development in iodine deficient areas. ;Chen-Z-H. Chinese Journal of Endemiology, 2006, Vol/Iss/Pg. 25 /1 (75-77)Effect of supplementing iodine on child intellectual development in iodine deficient areas. ;Chen-Z-H. Chinese Journal of Endemiology, 2006, Vol/Iss/Pg. 25 /1 (75-77) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30235 |
| Study title: Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280)Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30236 |
| Study title: Effects of salt iodization in the treatment of endemic goiter in school children of rural origin in Cameroon. ;Ngogang-J. Annales d'Endocrinologie, 1993, Vol/Iss/Pg. 54/3 (191-196)Effects of salt iodization in the treatment of endemic goiter in school children of rural origin in Cameroon. ;Ngogang-J. Annales d'Endocrinologie, 1993, Vol/Iss/Pg. 54/3 (191-196) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30237 |
| Study title: Effects on school children of prophylaxis of mothers with iodized oil in an area of iodine deficiency. ; Fierro-Benitez-R. Journal of Endocrinological Investigation, 1988, Vol/Iss/Pg. 11/5 (327-335)Effects on school children of prophylaxis of mothers with iodized oil in an area of iodine deficiency. ; Fierro-Benitez-R. Journal of Endocrinological Investigation, 1988, Vol/Iss/Pg. 11/5 (327-335) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30238 |
| Study title: Treatment of acute infectious diarrhoea in infants and children with a mixture of three Lactobacillus rhamnosus strains: a randomized, double-blind, placebo-controlled trial – SZYMANSKI H., PEJCZ J. and al. – 2006.Treatment of acute infectious diarrhoea in infants and children with a mixture of three Lactobacillus rhamnosus strains: a randomized, double-blind, placebo-controlled trial – SZYMANSKI H., PEJCZ J. and al. – 2006. |
| Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30973 |
| Study title: “Clinical report on the effect of lactitol for the treatment of intestinal stasis in newborns and toddlers" Investigator: Prof. M. T. Duillo Report date: 23.05.1986“Clinical report on the effect of lactitol for the treatment of intestinal stasis in newborns and toddlers" Investigator: Prof. M. T. Duillo Report date: 23.05.1986 |
| Active substance: LACTITOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30986 |
| Study title: Pirotte B, Goldman S, Dewitte O, Massager N, Wikler D, Lefranc F, et al.. Integrated positron emission tomography and magnetic resonance imaging-guided resection of brain tumors: a report of 103 consecutive procedures. [pirotte-2006]J Neurosurg. 2006 Feb;104(2):238-53. Pirotte B 2006 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48691 |
| Study title: Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129)Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30291 |
| Study title: Neonatal screening for congenital hypothyroidism results and perspectives; François Delange. Horm Res 1997; 48:51-61Neonatal screening for congenital hypothyroidism results and perspectives; François Delange. Horm Res 1997; 48:51-61 |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30292 |
| Study title: Percutaneous direct puncture glue embolization of high-flow craniofacial arteriovenous lesions: A new circular ring compression device with a beveled edge. ; Ryu-C-W. American Journal of Neuroradiology, 2007, Vol/Iss /Pg. 28/3 (528-530)Percutaneous direct puncture glue embolization of high-flow craniofacial arteriovenous lesions: A new circular ring compression device with a beveled edge. ; Ryu-C-W. American Journal of Neuroradiology, 2007, Vol/Iss /Pg. 28/3 (528-530) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30297 |
| Study title: The effect of a fluoride gel used for supervising toothbrushing 15 to 30 times per yearMarthaler 1970 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Marthaler 1970 The effect of a fluoride gel.pdf |
| View full study record |
| Document reference: 49172 |
| Study title: The effect on human dental caries of weekly oral rinsing with a sodium fluoride mouth wash duraphat rinse clinical1971-Horowitz |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1971-Horowitz-the effect on human dental caries of weekly oral rinsing with a sodium fluoride mouthwashduraphat rinse clinical.pdf |
| View full study record |
| Document reference: 49127 |
| Study title: The effects of aminfluoride on nibition of caries in pre-school children and school children in rijekaOstric 1977 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Ostric 1977 The effects of aminfluoride.pdf |
| View full study record |
| Document reference: 49173 |
| Study title: The relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico2004-stookey, caries research |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 2004-stookey-the relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico.pdf |
| View full study record |
| Document reference: 49090 |
| Study title: Evaluation of the accuracy of steady-state krypton-81m method for calculating right ventricular ejection fraction.Ham HR 1986, J Nucl Med. 1986 May;27(5):593-601. |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): Ham 1986.pdf |
| View full study record |
| Document reference: 48787 |
| Study title: Evaluation of the effects of nasal septal deviation and its surgery on nasal mucociliary clearance in both nasal cavities.Am J Rhinol. 2007 Mar-Apr;21(2):180-3. Ulusoy B 2007 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48790 |
| Study title: "Controlled, randomised, parallel-group, single-centre clinical trial in patients; Duration: Expected treatment duration was 15 days. " Durand 1986 |
| Active substance: Lactitol |
| Study summary document link (including results): 2011_EMAspreadsheet_Importal_Durand 1986.xls |
| View full study record |
| Document reference: 48149 |
| Study title: Open-label, non-comparative clinical trial in patients and healthy subjects. Doorenbos H |
| Active substance: Lactitol |
| Study summary document link (including results): 2011_EMAspreadsheet_Importal_Doorenbos H.xls |
| View full study record |
| Document reference: 48147 |
| Study title: Prevention of dextran-induced anaphylactic reactions by hapten inhibition. III. A Scandinavian multicenter study on the effects of 20 ml dextran 1, 15%, administered before dextran 70 or dextran 40.Renck H, Ljungström KG, Hedin H, Richter W. Acta Chir Scand. 1983;149(4):355-60. |
| Active substance: Dextran |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48941 |
| Study title: Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443.Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443. |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30301 |
| Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LARATADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31017 |
| Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LARATADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31015 |
| Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LARATADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31018 |
| Study title: Topical application of a fluoride protective varnish for caries prophylaxis1973-maiwald |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1973-maiwald-Topical application of a fluoride protective varnish for caries prophylaxis.pdf |
| View full study record |
| Document reference: 49101 |
| Study title: Gingival recession and wedge-shaped defects with regular use of an amine fluoride-containing gel applied with a toothbrushSchiffner 1995 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Schiffner 1995 Gingival recession and wedge-shaped.pdf |
| View full study record |
| Document reference: 49177 |
| 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 |
| View full study record |
| Document reference: 48803 |
| Study title: Krypton-81m ventilation and technetium-99m macroaggregated albumin perfusion scintigraphy for detection of pulmonary embolism: the first experience in Taiwan. Zhonghua Yi Xue Za Zhi (Taipei). 2000 Dec;63(12):876-84. Cherng SC 2000 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48801 |
| 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 |
| View full study record |
| Document reference: 48798 |
| Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood. Br J Radiol. 1993 Nov;66(791):1031-4. Kenney IJ 1993 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48819 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25204 |
| Study title: AN OPEN STUDY OF CEFOPERAZONE PLUS SULBACTAM IN THE TREATMENT OF SEVERE SKIN AND SKIN STRUCTURE INFECTIONS OF BACTERIAL ETIOLOGY |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42638 |
| Study title: CLINICAL USEFULNESS OF SULTAMICILLIN FINE GRANULES FOR TONSILLITIS AND ACUTE BRONCHITIS OF CHILDREN |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43006 |
| Study title: Application of Intravenous Contrast in PET/CT:Does It Really Introduce Significant Attenuation Correction Error?J Nucl Med 2005; 46:283–291. Yat-Yin Yau, MD1; Wing-Sze Chan, BSc1; Yat-Man Tam, MSc1; Phil Vernon, PhD2; So Wong1; Marc Coel, MD3; and Simon Kwok-Fai Chu1 |
| Active substance: Steripet |
| Study summary document link (including results): yau-2005.pdf |
| View full study record |
| Document reference: 48747 |
| 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 |
| View full study record |
| Document reference: 47350 |
| Study title: Phase IB Trial of Leflunomide in Pediatric Subjects with Polyarticular Course Juvenile Rheumatoid Arthritis (JRA) |
| Active substance: LEFLUNOMIDE |
| Study summary document link (including results): Leflunomide-Study 1.pdf |
| View full study record |
| Document reference: 47348 |
| Study title: Population pharmacokinetics of A77 1726 (M1) after oral administration of leflunomide in pediatric subjects with polyarticular course juvenile rheumatoid arthritis |
| Active substance: LEFLUNOMIDE |
| Study summary document link (including results): Leflunomide-Study 4.pdf |
| View full study record |
| Document reference: 47351 |
| Study title: Rini JN, Manalili EY, Hoffman MA, Karayalcin G, Mehrotra B, Tomas MB, et alFDG versus Ga-67 for detecting splenic involvement in Hodgkin's disease. [rini-2002]Clin Nucl Med. 2002 Aug;27(8):572-7. F-18. Rini JN 2002 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48693 |
| 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 |
| View full study record |
| Document reference: 48694 |
| Study title: Jarman underproveleged area scores, tooth decay and the effect of water fluoridation1997-jones |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1997-jones-Jarman underproveleged area scores, tooth decay and the effect of water fluoridation.pdf |
| View full study record |
| Document reference: 49123 |
| Study title: Kollective Karies pravention in Vorchulatter unter Verwendung eines Fluoridhaltingen lackes1980-treide |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1980-treide-Kollective Karies pravention in Vorchulatter unter Verwendung eines Fluoridhaltingen lackes.pdf |
| View full study record |
| Document reference: 49107 |
| Study title: Perspectives on the use of Prenatal Fluoride Administration for Prevention of Dental Caries: a reactors comments1981-Stamm. Journal of Dentistry for Children, March - April, 1951 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1981-Stamm-Perspectives on the use of Prenatal Fluoride Administration for Prevention of Dental Caries.pdf |
| View full study record |
| Document reference: 48772 |
| Study title: Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of ageJ. Widenheim, Dowen Birked, Lars Granath, Georg Lindgren 1986. Community Dent Oral Epidemiol |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1986-Widenheim-Preeruptive effect of NaF Tablets on Caries in Children from 12 to 17 years of age.pdf |
| View full study record |
| Document reference: 48776 |
| Study title: Measurements on the rapid and medium-acting bronchodilating effect of ipratropium bromide administered by aerosol in children with allergic bronchial asthma. Arch Med Int 1981,33,25-40Capristo A. et al ArchMedInterna 1981, Capristo |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): ArchMedInterna 1981, Capristo.pdf |
| View full study record |
| Document reference: 48888 |
| 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 |
| View full study record |
| Document reference: 48887 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47342 |
| Study title: Bestic JM, Peterson JJ, Bancroft LW.. Review. Erratum in: Radiographics. 2010 Jan-Feb;30(1):301. Pediatric FDG PET/CT: Physiologic uptake, normal variants, and benign conditions [corrected]. [bestic-2009] Radiographics. 2009 Sep-Oct;29(5):1487-500. Bestic JM 2009 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48632 |
| Study title: Buchmann I, Reinhardt M, Elsner K, Bunjes D, Altehoefer C, Finke J, et al.. 2-(fluorine-18)fluoro-2-deoxy-D-glucose positron emission tomography in the detection and staging of malignant lymphoma. A bicenter trial. [buchmann-2001]Cancer. 2001 Mar 1;91(5):889-99. Buchmann I, 2001 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48636 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30328 |
| Study title: The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123)The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30331 |
| Study title: The huon peninsula endemic: The effectiveness of an intramuscular depot of iodized oil in the control of endemic goitre.;Mc Cullagh. The medicinal journal of Australia 769-777The huon peninsula endemic: The effectiveness of an intramuscular depot of iodized oil in the control of endemic goitre.;Mc Cullagh. The medicinal journal of Australia 769-777 |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30332 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31051 |
| Study title: Efficacy and safety of leuprorelin 3.75 mg administered by subcutanous injection every 28 days in the treatment of central precocious puberty |
| Active substance: LEUPRORELIN |
| Study summary document link (including results): 2011-08-11 Leuprorelin TAP-III-90-004 Synopsis.pdf |
| View full study record |
| Document reference: 31050 |
| Study title: Lupron Injection (Lupron depot) combined results of independent investigators' studies of Leuprolide acetate in the treatment of central precocious puberty |
| Active substance: LEUPRORELIN |
| Study summary document link (including results): 2011-08-11 Leuprorelin P-90-053 Synopsis.pdf |
| View full study record |
| Document reference: 31049 |
| Study title: Preventive effect of high-fluoride dentifrice in caries-active adolescents2010-Nordstrom |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 2010-Nordstrom-preventive effect of high-fluoride dentifrice in caries-active adolescents.pdf |
| View full study record |
| Document reference: 49099 |
| Study title: stannous fluoride topically applied os effective-data at the end of a five years study1965-Rothhaar |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1965-Gish-Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride.pdf |
| View full study record |
| Document reference: 49148 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30194 |
| Study title: BL 103836,GCGD4-002 - Long-term safety and efficacy of Actimmune therapy in children with chronic granulomatous disease (CGD): Summary of data from the National Institutes of Health cohort in children initiating Actimmune prior to 1 year of age and prior to 3 years of age, respectively. |
| Active substance: INTERFERON GAMMA (1B) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30198 |
| Study title: 3 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 2523 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 252 |
| Active substance: IOVERSOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30402 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30397 |
| Study title: Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465)Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30251 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30258 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30989 |
| Study title: Janeczko J, Baranowska M, Romanowska B. (1991) Przeglad Epidemiologiczny.; 45(4):267-271. Effect of Isoprinosine® and acyclovir on the clinical course of chickenpox and herpes zosterJaneczko J, Baranowska M, Romanowska B. (1991) Przeglad Epidemiologiczny.; 45(4):267-271. Effect of Isoprinosine® and acyclovir on the clinical course of chickenpox and herpes zoster |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30128 |
| Study title: Optimal imaging strategy for community-acquired Staphylococcus aureus musculoskeletal infections in children.Browne LP, Mason EO, Kaplan SL, Cassady CI, Krishnamurthy R, Guillerman RP. Pediatr Radiol 2008;38:841-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48583 |
| Study title: Peroperative isotopic detection in the treatment of osteoid osteoma in childrenLacheretz M, Herbaux B. Hossein-Foucher C. Lecouffe P. Richir M. Chirurgie 1989;115(7):413-6 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48494 |
| Study title: Publication 53: Radiation dose to patients from radiopharmaceuticalsICRP (lnternation Commission on Radiological Protection). Pergamon Press 1987 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48490 |
| 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 |
| View full study record |
| Document reference: 30991 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31002 |
| Study title: Limited mobilization effect of G-CSF (Lenograstim) for blood stem cells in children with solid tumors - Kawano Y. et al (Eur J Cancer - 31:238)Limited mobilization effect of G-CSF (Lenograstim) for blood stem cells in children with solid tumors - Kawano Y. et al (Eur J Cancer - 31:238) |
| Active substance: LENOGRASTIM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31041 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31037 |
| Study title: Retrospective survey for documentation of appllication and dosage of CM Leptandra comp. (drops) in children < 12 years of age [Bef-016] |
| Active substance: Leptandra compositum |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40046 |
| Study title: Effect on a 30 second topical stannous fluoride treatement on dental caries reductions in children1964-Mercer |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1964-Mercer-Effect on a 30 second topical stannous fluoride treatement on dental caries reductions in children.pdf |
| View full study record |
| Document reference: 49146 |
| Study title: Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride1965-Gish |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1965-Gish-Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride.pdf |
| View full study record |
| Document reference: 49147 |
| Study title: Effect on dental caries in children in a non fluoride area of combined use of three agents containing stannous fluoride1964-Bixler |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1964-Bixler-Effect on dental caries in children in a non fluoride ares of combined use of three agents containing stannous fluoride.pdf |
| View full study record |
| Document reference: 49145 |
| Study title: Effectiveness of fornightly tooth brushing with amine fluorides in caries-prone subjectsRan 1991 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Ran 1991 Effectiveness of fornightly tooth brushing.pdf |
| View full study record |
| Document reference: 49176 |
| Study title: Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial1996-bravo, Community Dent. Oral Epidemiol. 1996: 24: 42-6 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1995-seppa-Fluoride varnish versus acidulated phosphate fluoride gel.pdf |
| View full study record |
| Document reference: 49121 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48568 |
| Study title: Quantitative bone SPECT in young males with delayed puberty and hypogonadism: implications for treatment of low bone mineral densityLubushitzky R. Front D. losi levsky G. Bettman L. Frenkel A. Kolodny GM. et al. J Nucl Med 1998 Jan;39(1):104-7 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48500 |
| Study title: Iodine in contrast agents and skin disinfectants is the major cause for hypothyroidism in premature infants during intensive care Horm Res. 1987;28(1):42-9 l'Allemand D 1987 |
| Active substance: IOHEXOL |
| Study summary document link (including results): l'Allemand D 1987.pdf |
| View full study record |
| Document reference: 48869 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48862 |
| Study title: De González AB, Mahesh M, Kim K-P, Bhargavan M, Lewis R, Mettler F, Land C. Arch Projected cancer risks from computed tomographic scans performed in the United States in 2007. [de-gonzalez-2009]Intern Med 2009; 169 : 2071 - 2077. De González AB 2009 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48639 |
| Study title: Developmental hemispheric asymmetry of interregional metabolic correlation of the auditory cortex in deaf subjects.NeuroImage 19 (2003) 777–783 .E. Kang,a D.S. Lee,a,* J.S. Lee,a H. Kang,a C.H. Hwang,b S.H. Oh,b C.S. Kim,b J.-K. Chung,a M.C. Lee,a M.J. Jang,a,c Y.J. Lee,c P. Morosan,d and K. Zillesd |
| Active substance: Steripet |
| Study summary document link (including results): kang-2003.pdf |
| View full study record |
| Document reference: 48734 |
| Study title: Early Irradiation Effects Observed on Magnetic Resonance Imaging and Angiography, and Positron Emission Tomography for Arteriovenous Malformations Treated by Gamma Knife Radiosurgery. Stereotact Funct Neurosurg 1995;61(suppl1):25S-269. 1VY Glio? D.H.C. Pollb, R.S. Lilic, 1VY Cll~i~lCg.Y~ ,S llio1~~, S.S. Cllalgc, C.Y Cllo~lgK~;,Y CIze~zS~.,H . Yellc, L.S. Leeb |
| Active substance: Steripet |
| Study summary document link (including results): guo-1994.pdf |
| View full study record |
| Document reference: 48730 |
| 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 |
| View full study record |
| Document reference: 48745 |
| Study title: Treatment of Unresectable Primary Liver Cancer: With Reference to Cytoreduction and Sequential Resection.; Zhao-You Tang. World J. Surg. 19, 47-52, 1995.Treatment of Unresectable Primary Liver Cancer: With Reference to Cytoreduction and Sequential Resection.; Zhao-You Tang. World J. Surg. 19, 47-52, 1995. |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30342 |
| 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 |
| View full study record |
| Document reference: 47651 |
| Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with acute otitis media or otitis media with effusion after single oral administration of 20mg/kg or 30mg/kg of a telithromycin pediatric suspension |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41566 |
|
Study title: Renal prostaglandin E |
| Active substance: INDOMETHACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30013 |
| Study title: Long-term safety and efficacy of Actimmune therapy in children with chronic granulomatous disease (CGD): Summary of data from the National Institutes of Health cohort in children initiating Actimmune prior to 1 year of age and prior to 3 years of age, respectively. |
| Active substance: INTERFERON GAMMA (1B) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30206 |
| Study title: Long-term safety and efficay of Actimmune therapy in young children with chronic granulomatous disease (CGD): An integrated summary of data extracted from Studies I0016g, I0016g(A),I0034g, and I0286n in children initiating Actimmune therapy prior to 1 year of age and prior to 3 years of age, respectively. |
| Active substance: INTERFERON GAMMA (1B) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30207 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48645 |
| Study title: Furth C, Steffen IG, Amthauer H, Ruf J, Misch D, Schönberger S, Kobe C, Denecke T, Stöver B, Hautzel H, Henze G, Hundsdoerfer P.. Epub 2009 Aug 10.Early and late therapy response assessment with [18F]fluorodeoxyglucose positron emission tomography in pediatric Hodgkin's lymphoma: analysis of a prospective multicenter trial. [furth-2009]J Clin Oncol. 2009 Sep 10;27(26):4385-91. Furth C 2009 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48651 |
| 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 |
| View full study record |
| Document reference: 49096 |
| Study title: The suspected scaphoid fracture and isotope bone imaging. Brown JN. Injury. 1995 Sep;26(7):479-82. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48836 |
| Study title: The suspected scaphoid fracture and isotope bone imaging.Brown JN. Injury 1995 Sep;26(7):479-82. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48582 |
| Study title: Unexpected stomach uptake of technetium-99m-MDPSpicer JA. Slaton CK. Raveill TG. Baxter KG. Preston DF. Hladik WB. J Nucl Med Tech 1999 27(1):43-4 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48517 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48116 |
| Study title: Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643 |
| Active substance: IOBITRITOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30211 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30214 |
| Study title: Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258 |
| Active substance: IOVERSOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30410 |
| Study title: Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504 |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30263 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 30271 |
| Study title: Assessment of the effectiveness of supervised oral hygiene programmes by means of different indicesMaiwald 1993 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Maiwald 1993 Assessment of the effectiveness.pdf |
| View full study record |
| Document reference: 49170 |
| Study title: Fries P.. Final Report. Munich, Germany; Dermatological Clinic and Polyclinic of Technical University of Munich; 04 February.1985. Treatment of herpes simplex virus infection with Delimmun®. Fries P.. Final Report. Munich, Germany; Dermatological Clinic and Polyclinic of Technical University of Munich; 04 February.1985. Treatment of herpes simplex virus infection with Delimmun®. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30103 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30106 |
| Study title: Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol.Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30108 |
| Study title: Utility of delayed whole-body bone scintigraphy after directed three-phase scintigraphyDavenport MS, Brown RKJ, Frey KA. AJR 2009;193:338-42. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48596 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49080 |
| 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 |
| View full study record |
| Document reference: 48797 |
| Study title: Preoperative oral antiemetics for reducing postoperative vomiting after tonsillectomy in childrenFujii Y., 1999, Anesth Analg. 1999 Jun; 88 (6): 1298-30 |
| Active substance: PERPHENAZINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48911 |
| Study title: Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7.Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7. |
| Active substance: LACTULOSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30992 |
| Study title: Simultaneous HPLC determination with light-scattering detection of lactulose and mannitol in studies of intestinal permeability in pediatrics.Marsilio R, D'Antiga L, Zancan L, Dussini N, Zacchello F. Clin Chem. 1998 Aug;44(8 Pt 1):1685-91.Simultaneous HPLC determination with light-scattering detection of lactulose and mannitol in studies of intestinal permeability in pediatrics.Marsilio R, D'Antiga L, Zancan L, Dussini N, Zacchello F. Clin Chem. 1998 Aug;44(8 Pt 1):1685-91. |
| Active substance: LACTULOSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31003 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lamioflur (drops) [AWB-AT] |
| Active substance: Lamioflur |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40045 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 31008 |
| 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 |
| View full study record |
| Document reference: 41536 |
| Study title: A MULTICENTER, DOUBLE-BLIND, FOLLOW-UP TRIAL EVALUATING THE LONG-TERM SAFETY OF LEVETIRACETAM (1000 TO 3000 MG/DAY B.I.D.) AND CARBAMAZEPINE (400 TO 1200 MG/DAY ORAL B.I.D.), USED AS MONOTHERAPY IN SUBJECTS ( 16 YEARS) COMING FROM THE N01061 TRIAL. |
| Active substance: levetiracetam |
| Study summary document link (including results): N01093 - Levetiracetam - RRCE05L2109.pdf |
| View full study record |
| Document reference: 41534 |
| Study title: Caries inhibiting effect of different modes of Duraphat reapplication-A three year radiographic study1991-peterson, Caries Res. 1991:25:70-73 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1991-peterson-Caries inhibiting effect of different modes of Duraphat reapplication-A three year radiographic study.pdf |
| View full study record |
| Document reference: 49117 |
| Study title: Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data1986-kirkegaard |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1986-kirkegaard-Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data.pdf |
| View full study record |
| Document reference: 49113 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48820 |
| Study title: Radioimmunodetection of melanoma: preliminary results of a prospective study. Int J Biol Markers. 1986 Jan-Apr;1(1):47-54. Buraggi G 1986 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48827 |
| 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 |
| View full study record |
| Document reference: 48919 |
| Study title: A single-blind trial to investigate the ethiology of bacterial respiratory tract infections and the efficacy of penicillin V (Kåvepenin) and erythromycin (Ery-Max) in these infections.Hovelius et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_10.xlsx |
| View full study record |
| Document reference: 49041 |
| Study title: An open, randomized trila to evaluate if dose and frequency given bt American Heart Association coul be reduced (250 000 units x3 for 10 days)for streptococcal pharyngitis.Breese et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_3.xlsx |
| View full study record |
| Document reference: 49034 |
| 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 |
| View full study record |
| Document reference: 49042 |
| Study title: Hostility differentiates the brain metabolic effects of nicotine.Cognitive Brain Research 18 (2004) 142–148. James H. Fallona, David B. Keatorb, James Mbogoric, Jessica Turnerd, Steven G. Potkine. |
| Active substance: Steripet |
| Study summary document link (including results): fallon-2004.pdf |
| View full study record |
| Document reference: 48728 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42626 |
| Study title: Jacobs F, Thierens H, Piepsz A, Bacher K, van de Wiele C, Ham H et al. Optimised tracer-dependent dosage cards to obtain weight-independent effective doses. [jacobs 2005Eur J Nucl Med Mol Imaging 2005; 32 : 581 - 588. Jacobs F 2005 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48662 |
| Study title: Caries preventive effect of high fluoride and xylitol containing dentifrices1992-Cutress- |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1992-Cutress-caries preventive effect of high fluoride and xylitol containing dentifrices.pdf |
| View full study record |
| Document reference: 49094 |
| Study title: Caries preventive effect of three topical fluorides_1% years clinical trial in Chandigarh schoolchildren of North India1984-tewari- |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1984-tewari-Caries preventive effect of three topical fluorides_1% years clinical trial in Chandigarh schoolchildren of North India.pdf |
| View full study record |
| Document reference: 49111 |
| 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 |
| View full study record |
| Document reference: 49114 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30310 |
| Study title: Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91)Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30311 |
| Study title: Tc-99m MAA total-body imaging to detect intrapulmonary right-to-left shunts and to evaluate the therapeutic effect in pulmonary arteriovenous shunts. Clin Nucl Med. 1996 Mar;21(3):197-202. Lu G 1996 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48815 |
| Study title: Tc-99m MAA SPECT in pectus excavatum: assessment of perfusion volume changes after correction by the Nuss procedure. Clin Nucl Med. 2005 Dec;30(12):779-82. Kinuya K 2005 |
| Active substance: TECHNETIUM (99m) |
| Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
| View full study record |
| Document reference: 48791 |
| Study title: Determine concentration of pcV in serum and in middle ear exudate and to isolate bacteria in the ear exsudate during the course of treatment with penicillin V in acute otitis media in children.Ingvarsson et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_15.xlsx |
| View full study record |
| Document reference: 49046 |
| Study title: determine concentration of pcV in serum and in middle ear exudate at various intervals of administration of different doses and to correlate the susceptibility in vitro of H Infl to pcVKamme et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_5.xlsx |
| View full study record |
| Document reference: 49036 |
| 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 |
| View full study record |
| Document reference: 49043 |
| Study title: Physiological and clinical estimate of the relief of nasal flow obstruction in allergic rhinitis: effects of topical decongestant (oxymetazoline).J Asthma Res 1969; 7: 65-73, Cohen BM, Duffy EP., 1969 |
| Active substance: OXYMETAZOLINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48922 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30218 |
| Study title: Kamel E, Hany TF, Burger C, Treyer V, Lonn AH, von Schulthess GK, et al.. CT vs 68Ge attenuation correction in a combined PET/CT system: evaluation of the effect of lowering the CT tube current. [kamel-2002]Eur J Nucl Med Mol Imaging. 2002 Mar;29(3):346-50. Kamel E 2002 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48665 |
| 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 |
| View full study record |
| Document reference: 48669 |
| 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 |
| View full study record |
| Document reference: 48672 |
| Study title: Radiological aspects of a case of Waldmann's disease. ; Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)Radiological aspects of a case of Waldmann's disease. ; Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30319 |
| Study title: Radiological aspects of a case of Waldmann's disease. Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)Radiological aspects of a case of Waldmann's disease. Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30318 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30322 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48584 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30422 |
| Study title: Perforated versus non perforated acute appendicitis : accuracy of multidetector CT detection; BIXBY SD; Radiology ; 2006 vol.241 n.3 p.780 786Perforated versus non perforated acute appendicitis : accuracy of multidetector CT detection; BIXBY SD; Radiology ; 2006 vol.241 n.3 p.780 786 |
| Active substance: IOVERSOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30423 |
| Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42543 |
| Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MOP scintigraphyKauffman WM. Winer-Muram H. Sandlund JT. Clin Nucl Med 1995 20(8):741 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48492 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48844 |
| Study title: Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastomaShulkin BL. Shapiro B. Hutchinson RJ. J Nucl Med 1992 Oct;33(10):1735-40 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48516 |
| Study title: Effects of renal failure and metabolic diseases upon bone scanning in children.Schumichen C. Annales de Radiologie 1983 26(6):498-504 |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48758 |
| Study title: Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756 |
| Active substance: IOVERSOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30425 |
| Study title: Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005. Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005. |
| Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30968 |
| Study title: A study to test the efficacy of E45 Cream on nappy rash |
| Active substance: LANOLIN SOFT PARAFFIN AND FAT PRODUCTS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31012 |
| Study title: Prevention and control of iodine deficiency: A review of a study on the effectiveness of oral iodized oil in Malawi. ;Furnee-C-A. European Journal of Clinical Nutrition, 1997, Vol /Iss/Pg. 51/SUPPL. 4 (9-10)Prevention and control of iodine deficiency: A review of a study on the effectiveness of oral iodized oil in Malawi. ;Furnee-C-A. European Journal of Clinical Nutrition, 1997, Vol /Iss/Pg. 51/SUPPL. 4 (9-10) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30312 |
| 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 |
| View full study record |
| Document reference: 48805 |
| Study title: Wirksames und sicheres Rhinologikum für Säuglinge. (Effective and safe rhinological agent for infants).Pädiatrische Nachrichten 2000; 3: 14-15, Teichmann B, Tschaikin M., 2000 |
| Active substance: OXYMETAZOLINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48927 |
| 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 |
| View full study record |
| Document reference: 49044 |
| Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx |
| View full study record |
| Document reference: 49031 |
| Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx |
| View full study record |
| Document reference: 49032 |
| Study title: investigate serum concentrations achieved with potassium salt of penicillin V i n2 different galenic forms.Perlhagen et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_2.xlsx |
| View full study record |
| Document reference: 49033 |
| Study title: Investigate the minimum age limit in children accepting penicillin administered as tablets instead of mixture.Edvardsson et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_14.xlsx |
| View full study record |
| Document reference: 49045 |
| Study title: Investigate the possibility to administer penicillin V in a twice daily dosage regimen.Edlund et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_6.xlsx |
| View full study record |
| Document reference: 49037 |
| Study title: Moll AC, Hoekstra OS, Imhof SM, Comans EF, Schouten-van Meeteren AY, van der Valk P, et al. Ophthalmic Genet. 2004 Mar;25(1):31-5. Fluorine-18 fluorodeoxyglucose positron emission tomography (PET) to detect vital retinoblastoma in the eye: preliminary experience. [moll-2004]Moll AC 2004 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48679 |
| Study title: Muzik O, Pourabdollah S, Juhasz C, Chugani DC, Janisse J, Draghici S.. Application of an objective method for localizing bilateral cortical FDG PET abnormalities to guide the resection ofepileptic foci. [muzik-2005]IEEE Trans Biomed Eng. 2005 Sep;52(9):1574-81. Muzik O 2005 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48680 |
| Study title: Myocardial Viability Assessed by Positron Emission Tomography in Infants and Children After the Arterial Switch Operation and Suspected Infarction(J Am Coll Cardiol 2000;36:1676–83). Carsten Rickers, MD,* Karin Sasse, MD,* Ralph Buchert, PHD,† Heiko Stern, MD,* Jo¨rg van den Hoff, PHD,‡ Martin Lu¨beck, MD,† Jochen Weil, MD* |
| Active substance: Steripet |
| Study summary document link (including results): rickers-2000.pdf |
| View full study record |
| Document reference: 48743 |
| Study title: Djelovanje aminofluorida - elmex gelee na: Effect of amine fluorideRajic 1977 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): Rajic 1977 Djelovanje aminofluorida - elmex gelee na.pdf |
| View full study record |
| Document reference: 49174 |
| Study title: The anticariogenic effectiveness od a single application of stannous fluoride in children residing in an optimum fluoride area1960-Muhler |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1960-Muhler-The anticariogenic effectiveness od a single application of stannous fluoride in children residing in an optimum fluoride area.pdf |
| View full study record |
| Document reference: 49140 |
| Study title: the anticariogenic effects of one and two X application of stannous fluoride on the deciduous and permanent teeth of children1962-Salter |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49144 |
| 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 |
| View full study record |
| Document reference: 49095 |
| Study title: The caries preventing effect of mouthrinsing with 0.025 percent sodium fluoride solution in Swedish children. Forsman B. Community Dent Oral Epidemiol. 1974;2(2):58-65. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48944 |
| Study title: The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar1984-holm |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1984-holm-The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar.pdf |
| View full study record |
| Document reference: 49110 |
| 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 |
| View full study record |
| Document reference: 49104 |
| Study title: The caries-preventive effect of a fluoride varnish in the fissures of the first permanent molar. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42369 |
| 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 |
| View full study record |
| Document reference: 48785 |
| 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 |
| View full study record |
| Document reference: 48789 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45755 |
| Study title: Use of the antiseptic Octenisept in children at the Fachklinik Hornheide.1996. |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32736 |
| Study title: Effect of dextran on blood volume and interactions with volume regulatory systems.Haldemann G, Schaer H, Spring C, Frey P, Gebauer U, Hossli G. Intensive Care Med. 1979 Mar;5(1):11-4. |
| Active substance: Dextran |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48937 |
| Study title: Effect of 10 yr of the iodine supplementation on the hearing threshold of iodine deficient schoolchildren. ; Azizi-F. Journal of Endocrinological Investigation, 2005, Vol/Iss/Pg. 28/7 (595-598)Effect of 10 yr of the iodine supplementation on the hearing threshold of iodine deficient schoolchildren. ; Azizi-F. Journal of Endocrinological Investigation, 2005, Vol/Iss/Pg. 28/7 (595-598) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30231 |
| 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): |
| View full study record |
| Document reference: 30232 |
| Study title: Effect of iodized oil treatment on the development of thyroid autoimmunity in adolescent females. ; Hashim-F-A Annals of Saudi Medicine, 2000, Vol/Iss/Pg. 20/5-6 (445-446)Effect of iodized oil treatment on the development of thyroid autoimmunity in adolescent females. ; Hashim-F-A Annals of Saudi Medicine, 2000, Vol/Iss/Pg. 20/5-6 (445-446) |
| Active substance: IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30233 |
| Study title: Otsuka H, Graham MM, Kubo A, Nishitani H.. The effect of oral contrast on large bowel activity in FDG-PET/CT. [otsuka-2005]Ann Nucl Med. 2005 Apr;19(2):101- 8. Otsuka H 2005 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48687 |
| 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 |
| View full study record |
| Document reference: 48688 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43948 |
| Study title: Malik MH. Simultaneous dual isotope studies in the diagnosis of infection. J Nucl Med. 1985 Jul;26(7):722-5. Malik MH. Simultaneous dual isotope studies in the diagnosis of infection. J Nucl Med. 1985 Jul;26(7):722-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43938 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44275 |
| Study title: Kroiss A, Böck F, Perneczky G, Auinger C, Weidlich G, Kleinpeter G, Brenner H. [Immunoscintigraphy for the detection of inflammation foci in bone and joint diseases] Wien Klin Wochenschr. 1990 Dec 21;102(24):713-7. German. Kroiss A, Böck F, Perneczky G, Auinger C, Weidlich G, Kleinpeter G, Brenner H. [Immunoscintigraphy for the detection of inflammation foci in bone and joint diseases] Wien Klin Wochenschr. 1990 Dec 21;102(24):713-7. German. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43751 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43496 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 28441 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47920 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43530 |
| Study title: Early detection of subperiosteal abscesses by ultrasonography. A means for further successful treatment in pediatric osteomyelitis. Kaiser S, Rosenborg M. Pediatr Radiol. 1994;24(5):336-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43641 |
| Study title: Estimate plasma peak concentrations of ampicillin obtained after rectal administration of single doses of ampicillin suppositories given to children.Movin et al. (1987-06-15) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_25.xlsx |
| View full study record |
| Document reference: 49024 |
| 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 |
| View full study record |
| Document reference: 49018 |
| Study title: Investigate the rapidity of change in excretion rate of Ampicillin and Methicillin in the days after birth and demonstrate the effect of premature birth upon the excretion rates.Boe et al. (Pediatrics, vol. 39, no. 2, Feb 1967) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_8.xlsx |
| View full study record |
| Document reference: 49001 |
| 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 |
| View full study record |
| Document reference: 47793 |
| Study title: Effects on the respiratory tract and male reproductive organs in young rats given formoterol fumarate (D2522) in lactose by the inhalation route for 3 months |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47838 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44173 |
| Study title: Assessment of growth activity in the mandibular condyles by single-photon emission computed tomography (SPECT). Kajan ZD, Motevasseli S, Nasab NK, Ghanepour H, Abbaspur F. Aust Orthod J. 2006 Nov;22(2):127-30. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43368 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43541 |
| 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): |
| View full study record |
| Document reference: 21216 |
| Study title: Effectiveness of a Vi capsular polysaccharide vaccine |
| Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41448 |
| 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): |
| View full study record |
| Document reference: 41447 |
| Study title: Safety and immunogenicity of Vi CPS vaccine in teenagers |
| Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21215 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 46145 |
| Study title: Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43980 |
| Study title: Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7. Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43946 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 43431 |
| 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): |
| View full study record |
| Document reference: 44220 |
| 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 |
| View full study record |
| Document reference: 48999 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 46150 |
| 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): |
| View full study record |
| Document reference: 35198 |
| Study title: Tam YH, Yeung CK, Lee KH. Seven-day is more effective than 4-day ranitidine bismuth citrate-based triple therapy in eradication of Helicobacter pylori in children: a prospective randomized study. Aliment Pharmacol Ther. 2006 Jul 1;24(1):81-6.Tam YH, Yeung CK, Lee KH. Seven-day is more effective than 4-day ranitidine bismuth citrate-based triple therapy in eradication of Helicobacter pylori in children: a prospective randomized study. Aliment Pharmacol Ther. 2006 Jul 1;24(1):81-6. |
| Active substance: RANITIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35277 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ranunculus-Homaccord (drops) [AWB-AT] |
| Active substance: Ranunculus-Homaccord |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40150 |
| Study title: Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available. Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43395 |
| Study title: Hodder SC, Rees JI, Oliver TB, Facey PE, Sugar AW. SPECT bone scintigraphy in the diagnosis and management of mandibular condylar hyperplasia. Br J Oral Maxillofac Surg. 2000 Apr;38(2):87-93. Hodder SC, Rees JI, Oliver TB, Facey PE, Sugar AW. SPECT bone scintigraphy in the diagnosis and management of mandibular condylar hyperplasia. Br J Oral Maxillofac Surg. 2000 Apr;38(2):87-93. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43481 |
| Study title: Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84. Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44132 |
| Study title: [Scintigraphic aspect of infantile cortical hyperostosis (Caffey's disease)] French. Taillefer R, Danais S, Marton D. J Can Assoc Radiol. 1983 Mar;34(1):12-5. French. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44046 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPO40003.pdf |
| View full study record |
| Document reference: 28362 |
| Study title: Due to the lack of good diagnostic techniques it can be difficult to diagnose asthma in young children. The symptoms can be such that anti-inflammatory medication is given as test medication; however there is a lack of clinical data in a large group of wheezy infants using objective endpoints. The aim of this study was to evaluate the effects of fluticasone propionate on lung function and symptom scores in infants with recurrent and persistent wheeze. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FMS30060-ICHE3.pdf |
| View full study record |
| Document reference: 28398 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43669 |
| Study title: Open pilot study to evaluate different dosages in various infections.Murdoch |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_8.xlsx |
| View full study record |
| Document reference: 48997 |
| 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 |
| View full study record |
| Document reference: 48995 |
| Study title: Long-term scintigraphic appearance of extremities following bone tumor resection and allograft reconstruction. Smith JT, Smith LM, Rinsky L, Goris ML. Clin Nucl Med. 1991 Dec;16(12):907-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43722 |
| Study title: Effect of growth hormone on metaphyseal uptake of 99mTc-methylene diphosphonate. Klingensmith WC 3rd, Klingensmith GJ, Tollefsen SE, Schalch DS. J Clin Endocrinol Metab. 1981 Jun;52(6):1162-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44123 |
| Study title: Battered child syndrome. Uncommon pelvic fractures detected by bone scintigraphy. Tan TX, Gelfand MJ. Clin Nucl Med. 1997 May;22(5):321-2. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43552 |
| Study title: [Peroperative isotopic detection in the treatment of osteoid osteoma in children] French. Lacheretz M, Herbaux B, Hossein-Foucher C, Lecouffe P, Richir M. Chirurgie. 1989;115(7):413-6. French. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43798 |
| Study title: To determine the blood and tonsil levels of ampicillin after rectal and oral administration.Baba et al. (1983-05-04) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_9.xlsx |
| View full study record |
| Document reference: 49009 |
| Study title: To investigate the absorption and excretion of ampicillin from supporitories given to children.Iwai et al. (1983-05-04) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_12.xlsx |
| View full study record |
| Document reference: 49010 |
| Study title: To investigate the absorption and excretion of ampicillin from supporitories given to children.Nakazawa et al. (1983-05-16) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_16.xlsx |
| View full study record |
| Document reference: 49015 |
| Study title: To investigate the absorption of ampicillin from suppositories in children.Motohiro et al. (1983-05-09) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_15.xlsx |
| View full study record |
| Document reference: 49012 |
| Study title: Effect of long-term treatment with fluticasone propionate on bone density, growth and lung function in childhood asthma. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FMS40175-ICHE3.pdf |
| View full study record |
| Document reference: 28388 |
| Study title: Efficacy of treatment with inhaled fluticasone and the effect of priming and activation of PMN cells in children with allergy and asthma. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FMS40229-ICHE3.pdf |
| View full study record |
| Document reference: 28405 |
| Study title: Pharmacodynamics of the 88mcg BID dose of the Hydrofluoroalkane propellant formulation of inhaled Fluticasone Propionate following Administration via the Metered-dose Inhaler in Pediatric Subjects 4 to 11 years of age with Asthma |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FAP19052-ICHE3.pdf |
| View full study record |
| Document reference: 28390 |
| 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 |
| View full study record |
| Document reference: 28367 |
| 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 |
| View full study record |
| Document reference: 28418 |
| Study title: Treatment with inhaled corticosteroids in wheezing pre-school children: is there a predictable effect? |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone -Propionate-FMS40257-ICHE3.pdf |
| View full study record |
| Document reference: 28396 |
| Study title: Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43472 |
| Study title: Sacroiliitis as a sole manifestation of Brucella melitensis infection in a child. Miron D, Garty I, Tal I, Horovitz Y, Kedar A. Clin Nucl Med. 1987 Jun;12(6):466-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43860 |
| Study title: The value of quantitative sacroiliac scintigraphy in detection of sacroiliitis. Miron SD, Khan MA, Wiesen EJ, Kushner I, Bellon EM. Clin Rheumatol. 1983 Dec;2(4):407-14. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44020 |
| Study title: Osteomyelitis in the neonate. Clinical aspects and the role of radiography and scintigraphy in diagnosis and management. Mok PM, Reilly BJ, Ash JM. Radiology. 1982 Dec;145(3):677-82. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44066 |
| Study title: Investigate the relationship between relapses in H. influenzae meningitis and the ability of ampicillin to penetrate to the CSF.Coleman et al. (The journal of pediatrics May 1969) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_7.xlsx |
| View full study record |
| Document reference: 49008 |
| Study title: Single-blind trial to evaluate the efficacy and safety of ampicillin suppositories in bacterial pneumonia in children using i.v. ampicillin as reference drug.Motohiro et al. (1983-05-09) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_21.xlsx |
| View full study record |
| Document reference: 49020 |
| Study title: Study plasma concentrations after rectal administration of ampicillin suppositories to children.Movin et al. (1987-06-15) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_23.xlsx |
| View full study record |
| Document reference: 49022 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44110 |
| Study title: Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. [Semiquantitative SPECT of anterior dislocation of the temporomandibular joint disk] Rofo. 1987 Jan;146(1):13-7. German. Erratum in: ROFO 1987 Apr;146(4):487. Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. [Semiquantitative SPECT of anterior dislocation of the temporomandibular joint disk] Rofo. 1987 Jan;146(1):13-7. German. Erratum in: ROFO 1987 Apr;146(4):487. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43886 |
| Study title: Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8. Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43840 |
| Study title: A 3-month, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg b.i.d. (corresponding to the metered doses 6μg and 12μg, respectively) in asthmatic children aged 6 to 17 years. |
| Active substance: FORMOTEROL |
| Study summary document link (including results): SD-037-0003 Study Synopsis.pdf |
| View full study record |
| Document reference: 47798 |
| Study title: A double-blind, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses of 6μg and 12μg, respectively) in asthmatic children. |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47803 |
| 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): |
| View full study record |
| Document reference: 44267 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43736 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47857 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47861 |
| Study title: Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32083 |
| Study title: Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43764 |
| Study title: A double blind trial to evaluate the incidence of diarrhea and C. difficile toxin (CDT) folloing therapy with ampicillin (AMP), amoxicillin (AMOX), or trimethoprim-sulfamethoxazole (TMP-SMX) for otitis media.Hyams et al. (Pediatr Infect Dis. 1984 Sep-Oct;3(5):433-6) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_30.xlsx |
| View full study record |
| Document reference: 49029 |
| Study title: Unexpected stomach uptake of technetium-99m-MDP. Spicer JA, Slaton CK, Raveill TG, Baxter KG, Preston DF, Hladik WB. J Nucl Med Technol. 1999 Mar;27(1):43-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43508 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43911 |
| Study title: To investigate the absorption of ampicillin from suppositories.Kida et al. (1983-05-04) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_13.xlsx |
| View full study record |
| Document reference: 49013 |
| Study title: To study changes in fecal bacterial flora, including its sensitivity to ampicillin, after rectal and oral administration of ampicillin. Fecal ampicillin concetrations were also studied.Motohiro et al. (1986-10-17) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_14.xlsx |
| View full study record |
| Document reference: 49014 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28400 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Study FPC40002-Fluticasone propionate-Cutivate - approved.xls |
| View full study record |
| Document reference: 28406 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Study FPC40001-Fluticasone propionate-Cutivate - approved.xls |
| View full study record |
| Document reference: 28427 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLT411.pdf |
| View full study record |
| Document reference: 28430 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28431 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLT412.pdf |
| View full study record |
| Document reference: 28433 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPL10005.pdf |
| View full study record |
| Document reference: 47739 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPL30004.pdf |
| View full study record |
| Document reference: 47740 |
| Study title: Quantitative bone SPECT in young males with delayed puberty and hypogonadism: implications for treatment of low bone mineral density. Lubushitzky R, Front D, Iosilevsky G, Bettman L, Frenkel A, Kolodny GM, Israel O. J Nucl Med. 1998 Jan;39(1):104-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43538 |
| Study title: Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22. Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43537 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49000 |
| Study title: A Single-blind, randomized trial to Evaluate the efficacy and safety of ampicillin suppositories in the treatment of acute suppurative otitis media by a well controlled method using ampicillin dry syrup as control.Baba et al. (1985-09-27) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_20.xlsx |
| View full study record |
| Document reference: 49019 |
| Study title: Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6. Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43519 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43677 |
| Study title: Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43743 |
| Study title: To study the absorption and excretion of the 250 mg ampicillin supporitory in children.Nishimura et al. (1983-05-04) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_18.xlsx |
| View full study record |
| Document reference: 49017 |
| Study title: To study the pharmacokinetics of ampicillin suppositories in children.Toyonaga et al. (1983-05-06) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_17.xlsx |
| View full study record |
| Document reference: 49016 |
| Study title: A pilot single centre, randomised, double-blind, crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7-15 years. |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40101-ICHE3.pdf |
| View full study record |
| Document reference: 28448 |
| Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Symptomatic Pediatric Subjects (4-11 Years) With Asthma |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30031-ICHE3.pdf |
| View full study record |
| Document reference: 28453 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47594 |
| 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 |
| View full study record |
| 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: Quantitative sacro-iliac scintigraphy. I. Methodological aspects. Pitkänen M, Lahtinen T, Hyödynmaa S, Mutru O, Länsimies E. Scand J Rheumatol. 1982;11(4):199-202. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44096 |
| Study title: Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6. Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43861 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49002 |
| 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): |
| View full study record |
| Document reference: 43793 |
| Study title: Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43515 |
| 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: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44141 |
| Study title: Photopenia in skeletal scintigraphy of suspected bone and joint infection. Murray IP. Clin Nucl Med. 1982 Jan;7(1):13-20. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44095 |
| 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: Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43614 |
| 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): |
| View full study record |
| Document reference: 46646 |
| Study title: To study the absorption of ampicillin suppositories in children.Jozaki et al. (1983-03-10) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_11.xlsx |
| View full study record |
| Document reference: 49011 |
| 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: Single-dose, double-blind, double dummy, mono-center, randomized two fold crossover study to assess the therapeutic equivalence of Formoterol versus Foradil Aerolizer 12 μg/dose in asthmatic pediatric subjects followed by a 1 month open-label period with |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47865 |
| Study title: Testicular effects of formoterol fumarate (D2522) given orally to young rats for three months, using salbutamol sulphate as a reference compound |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47867 |
| Study title: THE EFFECT OF INHALED BETA-AGONISTS ON CHRONIC NONALLERGIC AIRWAY RESPONSIVENESS IN CHILDREN WITH ASTHMA |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 BA-EP4 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47868 |
| 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: Abdel-Haq NM, Asmar BI. Human herpesvirus 6 (HHV6) infection. Indian Journal of Pediatrics~ 71(1):89-96, January 2004 2004;(1):-96, January 2004. Abdel-Haq NM, Asmar BI. Human herpesvirus 6 (HHV6) infection. Indian Journal of Pediatrics~ 71(1):89-96, January 2004 2004;(1):-96, January 2004. |
| Active substance: FOSCARNET |
| Study summary document link (including results): Abdel-Haq NM et al 2004.pdf |
| View full study record |
| Document reference: 28585 |
| Study title: AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL. AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL. |
| Active substance: FOSCARNET |
| Study summary document link (including results): MCGRATH BJ and Newman CL 1994.pdf |
| View full study record |
| Document reference: 28572 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Study FLU-KI-4186-Fluticasone propionate-Cutivate - approved.xls |
| View full study record |
| Document reference: 47741 |
| Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44192 |
| Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44239 |
| 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: 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, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Study FLNL45-Fluticasone_Flixonase.xls |
| View full study record |
| Document reference: 28363 |
| 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 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: 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: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43631 |
| Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43636 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49028 |
| Study title: The role of bone scintigraphy in the evaluation of the suspected abused child. Sty JR, Starshak RJ. Radiology. 1983 Feb;146(2):369-75. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44051 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44233 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43823 |
| Study title: Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available. Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43826 |
| Study title: "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
| Active substance: AMIODARONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45156 |
| Study title: Describing three children, two with meningitis and one with septicemia, from whom ampicillin-resistant Haemophilus influenzae type B were isolated from the CSF, blood or both. At least one case represents ampicillin failure in the treatment of H. influenzae meningitis because of resistence of the organism to the drug.Ousama et al. (JAMA, July 15 1974, Vol 229, No 3) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_7.xlsx |
| View full study record |
| Document reference: 49007 |
| Study title: Determine the plasma concentrations after rectal administration of ampicillin suppositories in children, and when possible to estimate the urine concentrations of ampicillin and the bioavailability of the suppository.Eriksson et al. (1991-08-12) |
| Active substance: AMPICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_28.xlsx |
| View full study record |
| Document reference: 49027 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44181 |
| Study title: Cost-appropriateness of whole body vs limited bone imaging for suspected focal sports injuries. Clin Nucl Med. 1986 Jul;11(7):469-73. Nagle CE. Clin Nucl Med. 1986 Jul;11(7):469-73. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43904 |
| Study title: Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43527 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43492 |
| Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MDP scintigraphy. Kauffman WM, Winer-Muram H, Sandlund JT. Clin Nucl Med. 1995 Aug;20(8):741. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43592 |
| Study title: Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1. Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43691 |
| Study title: Unilateral medullary sponge kidney detected on bone scan. Juweid M, Richards CH, Heyman S. Clin Nucl Med. 1993 Jan;18(1):73-4. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43675 |
| Study title: Juweid ME, Menda Y, O'Dorisio MS, Bushnell D, Blake M, Madsen M, Johnson J, Graham MM. 111In-pentetreotide versus bone scintigraphy in the detection of bony metastases of neuroblastoma. Nucl Med Commun. 2002 Oct;23(10):983-9. Juweid ME, Menda Y, O'Dorisio MS, Bushnell D, Blake M, Madsen M, Johnson J, Graham MM. 111In-pentetreotide versus bone scintigraphy in the detection of bony metastases of neuroblastoma. Nucl Med Commun. 2002 Oct;23(10):983-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43435 |
| Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44286 |
| Study title: Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available. Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43682 |
| Study title: Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22. Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43644 |
| Study title: Nicholson RL, Manglal-Lan B, Wilkins K. Reverse oblique reconstruction for SPECT of the spine. Clin Nucl Med. 1991 Jul;16(7):478-81. Nicholson RL, Manglal-Lan B, Wilkins K. Reverse oblique reconstruction for SPECT of the spine. Clin Nucl Med. 1991 Jul;16(7):478-81. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43733 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29053 |
| Study title: Kuhn JJ, Hendley JO, Adams KF, Clark JW, Gwaltney JM. Antitussive effect of guaifenesin in young adults with natural colds. Chest 1982 82;6: 713-718Kuhn JJ, Hendley JO, Adams KF, Clark JW, Gwaltney JM. Antitussive effect of guaifenesin in young adults with natural colds. Chest 1982 82;6: 713-718 |
| Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29063 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29064 |
| Study title: |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41161 |
| 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): |
| View full study record |
| Document reference: 41159 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43951 |
| Study title: Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43943 |
| Study title: Effect and tolerance of amoxicillin with and without probenecid.Alergant. |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48969 |
| Study title: Efficacy in General PracticeJorna J Lees |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48971 |
| Study title: Evaluate efficacy in spefic infections and to compare amoxicillin 250 mg qid and 500 mg bd.Andrews et al |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48972 |
| Study title: Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available. Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43811 |
| Study title: Vorne M, Saukko T. Detection of malignant soft tissue tumors in bone imaging. Eur J Nucl Med. 1984;9(4):180-4. Vorne M, Saukko T. Detection of malignant soft tissue tumors in bone imaging. Eur J Nucl Med. 1984;9(4):180-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44008 |
| Study title: Unexpected myocardial uptake on bone scintigraphy in an infant with Kawasaki disease. Macdonald WB, Troedson RG. Clin Nucl Med. 2001 May;26(5):455. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43454 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43818 |
| Study title: Heinle A, Carrasquillo JA, Neumann RD. Two unusual cases of metastatic osteosarcoma detected by Tc-99m MDP bone scintigraphy. Clin Nucl Med. 1989 Dec;14(12):889-93. Heinle A, Carrasquillo JA, Neumann RD. Two unusual cases of metastatic osteosarcoma detected by Tc-99m MDP bone scintigraphy. Clin Nucl Med. 1989 Dec;14(12):889-93. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43776 |
| Study title: Infantile infectious sacroiliitis. Sueoka BL, Johnson JF, Enzenauer R, Kolina JS. Pediatr Radiol. 1985;15(6):403-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43960 |
| Study title: Pharmacokinetics of Oral and Rectal Flurbiprofen in Childrene |
| Active substance: FLURBIPROFEN |
| Study summary document link (including results): flurbiprofen-m84016-scaroni.xls |
| View full study record |
| Document reference: 48076 |
| Study title: Post-Tonsillectomy Treatment with Flurbiprofen and Phenylprenazone in Children |
| Active substance: FLURBIPROFEN |
| Study summary document link (including results): flurbiprofen-m84017-catalano.xls |
| View full study record |
| Document reference: 48077 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 28384 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48970 |
| Study title: A phase III, observer-blind, single-centre, randomized study to evaluate safety and immunogenicity of three lots of DTwPHib full liquid vaccine (Chiron Vaccines; now Novartis Vaccines) and of American Home Product (AHP-Wyeth) Tetramune (DTwPHib) vaccine administered to healthy infants 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): V38P2.xlsx |
| View full study record |
| Document reference: 49184 |
| 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 |
| View full study record |
| Document reference: 49190 |
| Study title: Diptheria booster vaccination one or two injections_1999Nicolay 1999, Vaccine 17 (1999) 2223-2228 |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): Nicolay_Diptheria booster vaccination one or two injections_1999.pdf |
| View full study record |
| Document reference: 49189 |
| Study title: Pilar 1983Please see report- sturdy report |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): Pilar 1983.pdf |
| View full study record |
| Document reference: 49188 |
| Study title: An open label, not randomized, age stratified trial to study safety and efficacy of the vaccine in subjects from 6 to 35 months of age.Please see report - study report |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): MEMUFL-95-001.xlsx |
| View full study record |
| Document reference: 49191 |
| Study title: Publication_8T-201RAPlease see report- sturdy report |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): Publication_8T-201RA.pdf |
| View full study record |
| Document reference: 49187 |
| Study title: Response to Diphtheria and Tetanus Booster Vaccination in pediatric renal transplantTransplantation, Issue: Volume 64(2),27 July 1997,pp 237-241, Enke |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49193 |
| Study title: Safety and immunogenicity of anew fully liquid DTPw-HepB-Hib combination vaccine in infantsKanra_et_al_2006_Publication |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): Kanra_et_al_2006_Publication.pdf |
| View full study record |
| Document reference: 49192 |
| Study title: open uncontrolled study to evaluate the acceptance and tolerance of flucloxacillin suspension.Lidgren. Clinical trial on flucloxacillin suspension in children. |
| Active substance: FLUCLOXACILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_2.xlsx |
| View full study record |
| Document reference: 49075 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27941 |
| Study title: EFFICACY AND SAFETY OF FLUCONAZOLE IN THE TREATMENT OF FUNGAL INFECTIONS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27663 |
| Study title: De Martini et al Clofoctol: microbiological, pharmacological and clinical aspects. Farmaci,1999,23(6)202-208 -aspetti microbiologici, farmacologici e clinici.Farmaci vol. 23 n.6-'99, De Martini Farmaci,1999,23(6)202-208 |
| Active substance: clofoctol |
| Study summary document link (including results): Art 45 EMA Chiesi Paediatric Studies.xls |
| View full study record |
| Document reference: 48991 |
| Study title: TEST ON TERATOGENIC EFFECT - RATS, ORAL ADMINISTRATION |
| Active substance: CLOMIPRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 24381 |
| Study title: Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11.Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11. |
| Active substance: CETIRIZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23670 |
| 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 |
| View full study record |
| Document reference: 49082 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49069 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39829 |
| Study title: Analysis of Physical and Mental Developmernt of Children With Aplasia, Hypoplasia and Ectopy of the Thyroid GlandEndocrine Reg 2006; 40: 7-14 Pniewska-Siark B., 2006 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48978 |
| Study title: Effect of long-term L-thyroxine treatment on bone mineral density in young adults with congenital hypothyroidismEur J Endocrinol 2004; 151: 689-694 Salerno M., 2004 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48984 |
| Study title: Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma Cancer2003; 98: 389-396 Van Santen HM., 2003 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48986 |
| Study title: Longitudinal Assessment of L-T4 Therapy for Congenital Hypothyroidism: Differences Between Athyreosis vs Ectopia and Delayed vs Normal Bone Age, Garcia MF 2000 J Pediatr Endocrinol Metab 2000; 13: 63-69 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48953 |
| Study title: Effects of Early High-Dose Levothyroxine Treatment on Auditory Brain Even-Related Potentials at School Entry in children with Congenital Hypothyroidism Marti S., 2006 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48955 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31137 |
| Study title: A Kr-81m inhalation method for detection of absence of uniform ventilation in asthma.Clin Nucl Med. 1981 Oct;6(10):463-7. Kawakami K 1981 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48561 |
| 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 |
| View full study record |
| Document reference: 48542 |
| Study title: Airway responses to repeated exercises detected by krypton-81m in asthmatic children.J Asthma. 1992;29(6):375-81.Obata T 1992 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48537 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25632 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25235 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45560 |
| Study title: Determination of right ventricular ejection fraction in children with cystic fibrosis.Pediatr Pulmonol. 1987 Jan-Feb;3(1):24-8. Piepsz A 1987 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48543 |
| Study title: Effect of posture on regional ventilation in children.Pediatr Pulmonol. 1992 Apr;12(4):227-32. Davies H 1992 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48536 |
| Study title: Effects of posture on the distribution of pulmonary ventilation and perfusion in children and adults.Thorax. 1989 Jun;44(6):480-4.Bhuyan U 1989 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48540 |
| Study title: Evaluation of the Accuracy of Steady-State Krypton-Sim Method for Calculating Right Ventricular Ejection FractionHamphrey R. Ham. Philipe R. Franken, Bernard Georges, Eric Delcourt, Marcel Guillaume, and Amnon Piepsz.J NucÃMed 27:593-601, 1986 |
| Active substance: krypton |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48531 |
| Study title: Krypton-81m ventilation and technetium-99m macroaggregated albumin perfusion scintigraphy for detection of pulmonary embolism: the first experience in Taiwan. |
| Active substance: krypton |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48532 |
| Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood.Kenney IJ 1993 |
| Active substance: krypton |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48533 |
| 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 |
| View full study record |
| Document reference: 48556 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42657 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42859 |
| Study title: Single-dose amoxicillin therapy with follow-up urine culture. Effective initial management for acute uncomplicated urinary tract infections. Savard-Fenton M, Fenton BW, Reller LB, Lauer BA, Byyny RL. Am J Med. 1982 Dec;73(6):808-13. |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48968 |
| Study title: Single-dose versus conventional therapy of urinary tract infections in female adolescents.Fine JS, Jacobson MS. Pediatrics. 1985 May;75(5):916-20. |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48967 |
| 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 |
| View full study record |
| Document reference: 49070 |
| Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Lerner et al. (Ann NY Acad Sci 145, 310-8, no 2 1967) |
| Active substance: BENZATHINE BENZYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_2.xlsx |
| View full study record |
| Document reference: 49071 |
| 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 |
| View full study record |
| Document reference: 49072 |
| Study title: A multicenter, open-label, pharmacokinetic/pharmacodynamic safety, and tolerability study of basiliximab (Simulect) in pediatric de novo renal transplant recipients.Offner G, Broyer M, Niaudet P, Loirat C, Mentser M, Lemire J, Crocker JF, Cochat P, Clark G, Chodoff L, Korn A, Hall M. Transplantation. 2002 Oct 15;74(7):961-6. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49257 |
| 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 |
| View full study record |
| Document reference: 48555 |
| Study title: [Results of lung perfusion and lung ventilation scintigraphy following surgery of diaphragmatic defects] [Article in German]Z Kinderchir. 1983 Feb;38(1):28-30. Hofmann U 1983 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48550 |
| Study title: Ventilation-perfusion scintigraphy in suspected pulmonary embolism: correlation with pulmonary angiography and refinement of criteria for interpretation.Radiology. 1986 May;159(2):383-90.Spies WG 1986 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48545 |
| Study title: Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report dateUchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31362 |
| Study title: Radionuclide assessment of the effects of chest physical therapy on ventilation in cystic fibrosis.Phys Ther. 1982 Jun;62(6):820-7. DeCesare JA 1982 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48552 |
| 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 |
| View full study record |
| Document reference: 24707 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45539 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45554 |
| Study title: Basiliximab: efficacy and tolerability in adults and children.Mocarquer A, Pinto V, Buckel E, Lagos E, Pefaur J, Ramirez K, Morales J, Rosatti P, Elberg A; Simulect Multicenter Study Group of Chile. Transplant Proc. 2003 Nov;35(7):2518-9. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49259 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48898 |
| 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 |
| View full study record |
| Document reference: 48618 |
| Study title: Pilot study of pimecrolimus in vitiligo treatment |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34109 |
| 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 |
| View full study record |
| Document reference: 49035 |
| Study title: Study the absorption of different salts of pc-V in syrup form and also to investigate whether gastrointestinal diseases, leading to malabsorption affects the absorption of pc in varying rates for different salts.Bolme et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_8.xlsx |
| View full study record |
| Document reference: 49039 |
| Study title: Study the effects of a twice a day dosage of penicillin V instead of three times a day.Nordbring et el |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_7.xlsx |
| View full study record |
| Document reference: 49038 |
| Study title: Study the effects of a twice a day dosage of potassium penicillin G, instead of three times a day.Vann et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_9.xlsx |
| View full study record |
| Document reference: 49040 |
| Study title: To evaluate the efficacy and safety of penicillin V in the treatment of acute tonsillitis in adults, when given as two or three daily doses.Mosbaek et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_16.xlsx |
| View full study record |
| Document reference: 49047 |
| Study title: To study the clinical efficacy of penicillin V given to children as a daily dosage of 50 mg/kg/day divided into two or three doses.Rundcrantz et al |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_17.xlsx |
| View full study record |
| Document reference: 49048 |
| Study title: Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34526 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45557 |
| Study title: Effect of early immunomodulator use in moderate to severe pediatric Crohn disease.Punati J, Markowitz J, Lerer T, Hyams J, Kugathasan S, Griffiths A, Otley A, Rosh J, Pfefferkorn M, Mack D, Evans J, Bousvaros A, Moyer MS, Wyllie R, Oliva-Hemker M, Mezoff A, Leleiko N, Keljo D, Crandall W; Pediatric IBD Collaborative Research Group. Inflamm Bowel Dis. 2008 Jul;14(7):949-54 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49284 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49216 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48606 |
| 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 |
| View full study record |
| Document reference: 48620 |
| Study title: Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30789 |
| 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 |
| View full study record |
| Document reference: 49239 |
| Study title: Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trialj. Pennat. Med, 24 (1996) 609-620, Giulio Bevilacqua1, |
| Active substance: PORACTANT ALFA |
| Study summary document link (including results): 50.00-CT-02-90 publication.pdf |
| View full study record |
| Document reference: 49228 |
| Study title: Infliximab for pediatric ulcerative colitis: a retrospective Italian multicenter study.Cucchiara S1, Romeo E, Viola F, Cottone M, Fontana M, Lombardi G, Rutigliano V, de'Angelis GL, Federici T. Dig Liver Dis. 2008 Jul;40 Suppl 2:S260-4 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49285 |
| 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): |
| View full study record |
| Document reference: 49286 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48614 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48613 |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 28274 |
| Study title: Retrospective survey for documentation of appllication and dosage of Gastricumeel (tablets) in children < 12 years of age [Bef-013] |
| Active substance: Gastricumeel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40006 |
| Study title: Randomized study to investigate the effects on growth and the safety of the treatment with recombinant growth hormone in 1 to 2-year-old children with growth retardation due to chronic kidney failure |
| Active substance: Somatropin |
| Study summary document link (including results): GHCRF-E-2_Norditropin.pdf |
| View full study record |
| Document reference: 41789 |
| Study title: Nabilone: an effective antiemetic in patients receiving cancer chemotherapy |
| Active substance: NABILONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32438 |
| Study title: Prospective randomized trial of azathioprine in cryopreserved valved allografts in children.Shaddy RE1, Lambert LM, Fuller TC, Profaizer T, Thompson DD, Baker SI, Osborne KA, Hawkins JA. Ann Thorac Surg. 2001 Jan;71(1):43-7; discussion 47-8. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49250 |
| 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 |
| View full study record |
| Document reference: 48593 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48617 |
| Study title: Evaluation of the efficacy and tolerance of RU51807 (cefpodoxime proxetil) in children with skin and soft tissue infections |
| Active substance: CEFPODOXIME |
| Study summary document link (including results): CEFPODOXIME STUDY FF8980740.xls |
| View full study record |
| Document reference: 47975 |
| Study title: Am J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi RAm J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi R |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44508 |
| Study title: The effect of long-term calcineurin inhibitor therapy on renal function in children after liver transplantation.Arora-Gupta N, Davies P, McKiernan P, Kelly DA. Pediatr Transplant. 2004 Apr;8(2):145-50. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49262 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48909 |
| 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 |
| View full study record |
| Document reference: 49196 |
| Study title: Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208. Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44831 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49064 |
| Study title: Evaluate the prophylactic efficacy of trimetoprim in urinary tract infections and its effect on the normal gastrointestinal and periurethral bacterial flora.Lidin-Janson et al |
| Active substance: TRIMETHOPRIM |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_3.xlsx |
| View full study record |
| Document reference: 49061 |
| Study title: Investigate the efficacy of trimethoprim administered once daily for three days.Ahlmén et al |
| Active substance: TRIMETHOPRIM |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_4.xlsx |
| View full study record |
| Document reference: 49062 |
| Study title: Investigate the efficacy of trimethoprim in the long-term treatment of urinary tract infections in children.Helle |
| Active substance: TRIMETHOPRIM |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_2.xlsx |
| View full study record |
| Document reference: 49060 |
| 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): |
| View full study record |
| Document reference: 44912 |
| 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): |
| View full study record |
| Document reference: 43110 |
| Study title: Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38486 |
| Study title: Pharmacokinetics of teicoplanin in children. - Tarral E, Jehl F, Tarral A et al. (1988) - Journal of Antimicrobial Chematherapy 21, Supplement A, 47-51. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44306 |
| 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 |
| View full study record |
| Document reference: 49063 |
| Study title: Effect of bacterial antigen lysate on IgG and IgA levels in children with recurrent infections and hypogamma-globulinemia |
| Active substance: Bacterial lysate |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41840 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49059 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48942 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mezereum-Homaccord (drops) [AWB-AT] |
| Active substance: Mezereum-Homaccord |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40071 |
| Study title: Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32177 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48959 |
| Study title: Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children.La Grutta S , Nicolini G, Capristo C, Bellodi SC, Rossi GA (Monaldi Arch Chest Dis. 2007 Mar;67:30-8.) |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): MC.PR.1400.003.01 publication.pdf |
| View full study record |
| Document reference: 49202 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48975 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48891 |
| Study title: Effect of continuous treatment with topical corticosteroid on episodic viral wheeze in preschool children (ages 8 months to 6 years). |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48432 |
| Study title: Single-dose caudal epidural morphine in children: safe, effective, and easy.J Clin Anesth 1991; 5: 386-90, Serlin S., 1991 |
| Active substance: MORPHINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48932 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26507 |
| Study title: |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLD40004.pdf |
| View full study record |
| Document reference: 28434 |
| Study title: Double-blind evaluation of effectiveness and safety of flunisolide aerosol for treatment of bronchial asthma in children.Piacentini G.L. et al, Allergy 1990,45, 612-616 |
| Active substance: FLUNISOLIDE |
| Study summary document link (including results): Published paper (Piacentini).pdf |
| View full study record |
| Document reference: 49212 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28890 |
| Study title: Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002.Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002. |
| Active substance: Foscarnet |
| Study summary document link (including results): Doutre MS et al 2002.pdf |
| View full study record |
| Document reference: 39636 |
| Study title: A randomized, double-blind trial to determine whether 1 g of erythromycin daily for a week is as a effective as the 2 g daily dose but without the adverse gastrointestinal effects associated with the larger dose.Linnemann et al. (Sexually transmitted diseases, Vol 14, No. 2) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_4.xlsx |
| View full study record |
| Document reference: 49052 |
| Study title: A single-blind trial to investigate the ethiology of bacterial respiratory tract infections and the efficacy of penicillin V (Kåvepenin) and erythromycin (Ery-Max) in these infections.Hovelius et al. (Clinical practice and Therapy, suppl 1, 1982) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_1.xlsx |
| View full study record |
| Document reference: 49049 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49050 |
| Study title: Double-blinded, randomized trial to evaluate the efficacy of early erythromycin treatment on the duration of fecal excretion and diarrhea associated with Campylobacter jejuni.Salazar-Lindo et al. (The Journal Of Pediatrics, Aug, 1986) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_6.xlsx |
| View full study record |
| Document reference: 49054 |
| Study title: Postoperative emesis after pediatric strabismus surgery. the effect of dixyrazine compared to droperidol |
| Active substance: DIXYRAZINE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49055 |
| Study title: Investigate how compliance among children may be related to form and dosage of the medicine.Norstedt |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_3.xlsx |
| View full study record |
| Document reference: 49051 |
| Study title: Investigate if Bordetella pertussis bacterias, that disappear after a couple of days of erythromycin treatment, returns after completed treatment.Quiding Boström Läkartidningen 1981 |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_10.xlsx |
| View full study record |
| Document reference: 49058 |
| Study title: Fucithalmic, chloramphenicol or no treatment after squint surgery in children. A single blind randomised study.Kearns P.P. 1992, Acta Ophthalmol, 70:132-134 |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48459 |
| Study title: A PROSPECTIVE SURVEY OF OPPORTUNISTIC INFECTIONS IN PATIENTS RECEIVING CHEMOTHERAPY FOR ACUTE LEUKEMIAS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27481 |
| Study title: CLINICAL EVALUATION OF FLUCONAZOLE (UK-49,858) IN IV DRIP ENJECTION FROM EFFICACY AND SAFETY IN PEDIATRIC SYSTEMIC MYCOSIS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27933 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27611 |
| Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS ON IVH |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27520 |
| Study title: SAFETY AND EFFICACY OF ORAL AND INTRAVENOUS FLUCONAZOLE IN PATIENTS WITH GASTRO-INTESTINAL CANDIDIASIS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28625 |
| Study title: Once daily aminoglycoside dosing in full term neonatesPediatr Infect Dis J 1995; 14: 71-72, Skopnik H., 1995 |
| Active substance: GENTAMYCIN |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48936 |
| Study title: An open uncontrolled study to evaluate the effect of treatment and tolerance of a flucloxacillin nsyrup.Price et al Flucloxacillin in the treatment of infectious conditions in children. |
| Active substance: FLUCLOXACILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_1.xlsx |
| View full study record |
| Document reference: 49076 |
| Study title: Investigate the bioavailability of 2 commercially available pediatric suspensions of erythromycin containing the stearate salt and the ethylsuccinate ester, respectively.Eriksson et al. (Scand J Infcect Dis 13: 211-215, 1981) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_9.xlsx |
| View full study record |
| Document reference: 49057 |
| Study title: Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady state intranasal levocabastine. Tran J Q, Di Cicco R A, Sheth S B, Tucci M, Peng L, Jorkasky D K, Hursting M J, Benincosa L J. Journal of clinical pharmacology, {May 1999, vol. 39, no. 5, p. 513 9. |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26441 |
| Study title: The effect of an infusion of doxapram on morphine analgesia. Gupta PK, Dundee JW. Anaesthesia. 1974 Jan;29(1):40-3. |
| Active substance: Doxapram |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48894 |
| Study title: Study the effect of erythromycin on diarrheal illnesses in a clinical trial among children at an orphanage in Bangkok, Thailand.Taylor et al. (Antimicrobial agents and chemotherapy, March 1987, p. 438-442) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_5.xlsx |
| View full study record |
| Document reference: 49053 |
| Study title: Study the epidemiology, natural history, treatment and prevention of perinatally aquired chlamydial infections.Grossman et al. (Elsevier biomedical press, 1982) |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_8.xlsx |
| View full study record |
| Document reference: 49056 |
| 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 |
| View full study record |
| Document reference: 49078 |
| Study title: A modified schedule for routine pertussis immunization |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40996 |
| Study title: A phase II, double blind, randomized, double center, controlled study to evaluate the safety and immunogenicity of four formulations of DTwPHib combined vaccine containing different concentrations of Hib conjugate in healthy infants at 3, 4, 5 months of age.Please see report- sturdy report |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): V45P1.xlsx |
| View full study record |
| Document reference: 49183 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 49185 |
| Study title: Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35208 |
| Study title: Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10 Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35203 |
| Study title: A controlled trial of aerosolized ribavirin in infants receiving mechanical ventilation for severe respiratory syncytial virus infectionA controlled trial of aerosolized ribavirin in infants receiving mechanical ventilation for severe respiratory syncytial virus infection |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35237 |
| Study title: Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47)Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47) |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35240 |
| Study title: Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency. Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30140 |
| Study title: Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood.Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30141 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46123 |
| Study title: The safety of Diprivan (propofol) anesthesia versus standard anesthetic techniques in pediatric subjects less than 36 months of age |
| Active substance: PROPOFOL |
| Study summary document link (including results): 0859US0046 Study Synopsis.pdf |
| View full study record |
| Document reference: 46126 |
| Study title: The safety, efficacy and pharmacokinetics of ZD0859#1 vs. Diprivan (propofol) injection when used for maintenance of anaesthesia in children. |
| Active substance: PROPOFOL |
| Study summary document link (including results): 0859IL0058 Study Synopsis.pdf |
| View full study record |
| Document reference: 46136 |
| 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 |
| View full study record |
| Document reference: 47082 |
| Study title: Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) |
| Active substance: PROTAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35084 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35231 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30351 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31136 |
| Study title: A Pilot Trial of Quetiapine (SEROQUEL¿) in Adolescents with the Spectrum of Psychotic Disorders (5077US/0018) DRAFT Clinical Study Report Synopsis |
| Active substance: QUETIAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45054 |
| Study title: A Study to Characterize the Steady-State Pharmacokinetics, Safety and Tolerability of Quetiapine Fumarate (SEROQUEL¿) in Children and Adolescents with Selected Psychotic Disorders |
| Active substance: QUETIAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45055 |
| Study title: Tolerability and Pharmacokinetics of Quetiapine (SEROQUEL¿) in Adolescents with Selected Psychotic Disorders |
| Active substance: QUETIAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45053 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45059 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47754 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47761 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34802 |
| Study title: Clinical laboratory data related to the safety of levocabastine eye drops and nasal spray. An evaluation based on 27 studies in 655 subjects (6-81 yrs) |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): LMD45257_Interventional_Levocabastine.xls |
| View full study record |
| Document reference: 31071 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34820 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34730 |
| Study title: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Subjects |
| Active substance: RABEPRAZOLE |
| Study summary document link (including results): Rabeprazole-E3810-A001-202 (synopsis).pdf |
| View full study record |
| Document reference: 35258 |
| Study title: Single and Multiple Dose Pharmacokinetics and Safety Study of Rabeprazole Sodium in 12 to 16 Year Old Subjects |
| Active substance: RABEPRAZOLE |
| Study summary document link (including results): Rabeprazole-E3810-A001-119 CSR synopsis.pdf |
| View full study record |
| Document reference: 35257 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34805 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35043 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41089 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34826 |
| Study title: Eakman GD et al. The effects of testosterone and dihydrotestosterone on hypothalamic regulation of growth hormone secretion. J Clin Endocrinol Metab. 1996 Mar;81(3):1217-23Eakman GD et al. The effects of testosterone and dihydrotestosterone on hypothalamic regulation of growth hormone secretion. J Clin Endocrinol Metab. 1996 Mar;81(3):1217-23 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35196 |
| Study title: Ghigo E et al. Arginine potentiates the GHRH- but not the pyridostigmine-induced GH secretion in normal short children. Further evidence for a somatostatin suppressing effect of arginine. Clin Endocrinol (Oxf). 1990 Jun;32(6):763-7Ghigo E et al. Arginine potentiates the GHRH- but not the pyridostigmine-induced GH secretion in normal short children. Further evidence for a somatostatin suppressing effect of arginine. Clin Endocrinol (Oxf). 1990 Jun;32(6):763-7 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35213 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35302 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35370 |
| Study title: Early ribavirin aerosol treatment of respiratory syncytial virus infection in high-risk children.Early ribavirin aerosol treatment of respiratory syncytial virus infection in high-risk children. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35239 |
| Study title: Early ribavirin treatment of respiratory syncytial viral infection in high-risk children.Early ribavirin treatment of respiratory syncytial viral infection in high-risk children. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35238 |
| Study title: Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure. Pediatric Critical Study Group. Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure. Pediatric Critical Study Group. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35233 |
| Study title: Follow-up of children with respiratory syncytial virus bronchiolitis in 1986 and 1987: potential effect of ribavirin on long term pulmonary function. The Bronchiolitis Study Group.Follow-up of children with respiratory syncytial virus bronchiolitis in 1986 and 1987: potential effect of ribavirin on long term pulmonary function. The Bronchiolitis Study Group. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35232 |
| Study title: Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo.Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35230 |
| Study title: Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis.Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35236 |
| Study title: Luna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseasesLuna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseases |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30145 |
| Study title: Malfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with IsoprinosineMalfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with Isoprinosine |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30146 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30147 |
| Study title: Minarro A, Linfante E, et alLa SemanaMedica {Argentina] Aug 91973;80(4379): 362-372 Results obtained using antiviral(NPl13) on diverse pediatric viral infections.Minarro A, Linfante E, et alLa SemanaMedica {Argentina] Aug 91973;80(4379): 362-372 Results obtained using antiviral(NPl13) on diverse pediatric viral infections. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30148 |
| Study title: Moroni P, Baratta L, Baratta B. Chron Dermatologica 1980;11:3-8. Cytologic effects in herpes zoster.Moroni P, Baratta L, Baratta B. Chron Dermatologica 1980;11:3-8. Cytologic effects in herpes zoster. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30150 |
| Study title: Ochocka M, Chmielewska D, Matysiak M. Folia Haematol Int Mag Klin Morphol Blutforsch. 1984;111(3):343-9 Isoprinosine in the treatment of herpes virus infections in children with leukaemia and malignant lymphoma.Ochocka M, Chmielewska D, Matysiak M. Folia Haematol Int Mag Klin Morphol Blutforsch. 1984;111(3):343-9 Isoprinosine in the treatment of herpes virus infections in children with leukaemia and malignant lymphoma. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30153 |
| Study title: Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). |
| Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35104 |
| Study title: Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. |
| Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35106 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35373 |
| Study title: Clinical Expert Statement for MA Renewal in Slovenial - Djebbar F. & Verdoncq B. - 12 July 2007 |
| Active substance: RIFAMPICIN/ISONIAZID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35378 |
| Study title: Clinical Certificate for MA Renewal in Slovenia - Verdoncq B. - 10 July 2007 (0703-CC-RIF+ISO+PYR-SLOVENIA-BV-10.07.07) |
| Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35379 |
| Study title: Referenced in Rifater Registration Dossier - Clinical Documentation - Update April 1998 : The use of fixed-dose combinations in antituberculosis chemotherapy. Rationale for their application in daily, intermittant and pediatric regimens. - Acoccella G. - 1990 (Bulletin of the Int. Union Against Tuberculosis and Lung Disease, 65, 2-3: 77-83) |
| Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35380 |
| Study title: Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977) Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977) |
| Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45141 |
| Study title: Compliance and tolerance of new antitubercular short-term chemopreventive regimens in childhood - a pilot project - Magdorf K, Arizzi-Rusche AF, Geiter LJ, O'Brien RJ et al - 1994 (Pneumologie, 48(10): 761 - 4)Compliance and tolerance of new antitubercular short-term chemopreventive regimens in childhood - a pilot project - Magdorf K, Arizzi-Rusche AF, Geiter LJ, O'Brien RJ et al - 1994 (Pneumologie, 48(10): 761 - 4) |
| Active substance: RIFAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35381 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34782 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30347 |
| Study title: Frequency, Management, and Outcome of Extravasation of Nonionic Iodinated Contrast Medium in 69 657 Intravenous InjectionsWang CL 2007. Radiology: Volume 243: Number 1-April 2007 |
| Active substance: IODIXANOL |
| Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
| View full study record |
| Document reference: 48198 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45075 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34809 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34877 |
| 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 |
| View full study record |
| Document reference: 35053 |
| Study title: Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34863 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30156 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35205 |
| Study title: Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35204 |
| Study title: Glikson M et al. The influence of pyridostigmine administration on human neuromuscular functions--studies in healthy human subjects. Fundam Appl Toxicol. 1991 Feb;16(2):288-98Glikson M et al. The influence of pyridostigmine administration on human neuromuscular functions--studies in healthy human subjects. Fundam Appl Toxicol. 1991 Feb;16(2):288-98 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35209 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35219 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35382 |
| Study title: Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995) Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995) |
| Active substance: RIFAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35383 |
| Study title: Poeta G. Rass Dermatol Sifilogr 1980;33:29-34 . Therapeutic use of methisoprinol in the treatment of herpes virus infectionsPoeta G. Rass Dermatol Sifilogr 1980;33:29-34 . Therapeutic use of methisoprinol in the treatment of herpes virus infections |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30157 |
| Study title: Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine®Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine® |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30161 |
| Study title: Salas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with IsoprinosineSalas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with Isoprinosine |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30163 |
| Study title: Santangelo G, Lombardo S, Randazzo S, Maccarrone N, Amato M. Aggiornamento Pediatrico; 1981; 32:1-24. Viruxan® in the treatment of viral infections in children. Therapeutic prospects for the treatment of recurrent viral infections in infants.Santangelo G, Lombardo S, Randazzo S, Maccarrone N, Amato M. Aggiornamento Pediatrico; 1981; 32:1-24. Viruxan® in the treatment of viral infections in children. Therapeutic prospects for the treatment of recurrent viral infections in infants. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30164 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30165 |
| Study title: "Marichy J. et al: The wound healing efffect of Solcoseyl oinment in the treatment of children with burns. Acta Therap. Brussels 10, 107-117 (1984) " "Marichy J. et al: The wound healing efffect of Solcoseyl oinment in the treatment of children with burns. Acta Therap. Brussels 10, 107-117 (1984) " |
| Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35095 |
| Study title: La Rifamycine SV dans les infections pulmonaires aigüe en pédiatrie - M. De Vriendt - 1967 (Brux. Méd., 47. 169 - 181) La Rifamycine SV dans les infections pulmonaires aigüe en pédiatrie - M. De Vriendt - 1967 (Brux. Méd., 47. 169 - 181) |
| Active substance: RIFAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35384 |
| Study title: Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) |
| Active substance: RIFAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35385 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47566 |
| Study title: De Castro; RIFAXIMIN TREATMENT FOR ACUTE RECURRENT DIARRHEA IN CHILDREN WITH GENITOURINARY DISORDERSDe Castro; RIFAXIMIN TREATMENT FOR ACUTE RECURRENT DIARRHEA IN CHILDREN WITH GENITOURINARY DISORDERS |
| Active substance: RIFAXIMIN |
| Study summary document link (including results): rifaximin-article-De Castro.pdf |
| View full study record |
| Document reference: 47564 |
| 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 |
| View full study record |
| Document reference: 47565 |
| 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 |
| View full study record |
| Document reference: 35389 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41499 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45067 |
| Study title: Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May 1995, vol. 171, no. 5, p. 303-4, ISSN: 0179-7158.Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May ... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34815 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35189 |
| Study title: Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35194 |
| Study title: Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4 Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35202 |
| Study title: Cook MR et al. Physiological and performance effects of pyridostigmine bromide in healthy volunteers: a dose-response study. Psychopharmacology (Berl). 2002 Jul;162(2):186-92Cook MR et al. Physiological and performance effects of pyridostigmine bromide in healthy volunteers: a dose-response study. Psychopharmacology (Berl). 2002 Jul;162(2):186-92 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35188 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34881 |
| Study title: Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONCOL}, 1994, Vol/Iss/Pg. 16/2 (138-142), ISSN: 0192-8562.Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONC... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34817 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 46137 |
| 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): |
| View full study record |
| Document reference: 35215 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rheuma-Heel (tablets) [AWB-AT] |
| Active substance: Rheuma-Heel/ Rhumeel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40154 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rhododendroneel S (drops) [AWB-AT] |
| Active substance: Rhododendroneel/ Rhododendroneel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40153 |
| Study title: Loche S et al. The effect of galanin on baseline and GHRH-induced growth hormone secretion in obese children. Clin Endocrinol (Oxf). 1990 Aug;33(2):187-92Loche S et al. The effect of galanin on baseline and GHRH-induced growth hormone secretion in obese children. Clin Endocrinol (Oxf). 1990 Aug;33(2):187-92 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35212 |
| Study title: Peino R. Acipimox-mediated plasma free fatty acid depression per se stimulates growth hormone (GH) secretion in normal subjects and potentiates the response to other GH-releasing stimuli. J Clin Endocrinol Metab. 1996 Mar;81(3):909-13Peino R. Acipimox-mediated plasma free fatty acid depression per se stimulates growth hormone (GH) secretion in normal subjects and potentiates the response to other GH-releasing stimuli. J Clin Endocrinol Metab. 1996 Mar;81(3):909-13 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
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| Document reference: 35197 |
| Study title: Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35199 |
| Study title: Ram Z et al. The effect of pyridostigmine on respiratory function in healthy and asthmatic volunteers. Isr J Med Sci. 1991 Nov-Dec;27(11-12):664-8 Ram Z et al. The effect of pyridostigmine on respiratory function in healthy and asthmatic volunteers. Isr J Med Sci. 1991 Nov-Dec;27(11-12):664-8 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35206 |
| Study title: Sueri L, Ielasi G, Del Massa M. (1979). Presented at del Convegno Internazionale sulla Isoprinosina; April 28, Rome, Italy; 87-93. Isoprinosine® in the treatment of some acute infectious diseases of viral origin: open and double-blind studySueri L, Ielasi G, Del Massa M. (1979). Presented at del Convegno Internazionale sulla Isoprinosina; April 28, Rome, Italy; 87-93. Isoprinosine® in the treatment of some acute infectious diseases of viral origin: open and double-blind study |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30172 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30177 |
| Study title: Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30178 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35107 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34702 |
| Study title: Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignant ependymomas of the CNS treated with eight drugs in 1 day: a report from the Childrens Cancer Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1994, vol. 12, no. 8, p. 1607-15, ISSN: 0732-183X.Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignan... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34720 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30367 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45072 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47649 |
| Study title: A double masked study on the effect of opthlamic levocabastine vs placebo on the signs and symptomsof allergic conjunctivitis |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31063 |
| Study title: Goldis-Gh. Clin. Pediat. 'Fundeni' IMF, Bucuresti, Romania. Children and the cancerous diseases (present general aspects in pediatric oncology). Pediatrie {PEDIATRIE}, 1982, Vol/Iss/Pg. 31/1 (3-14).Goldis-Gh. Clin. Pediat. 'Fundeni' IMF, Bucuresti, Romania. Children and the cancerous diseases (present general aspects in pediatric oncology). Pediatrie {PEDIATRIE}, 1982, Vol/Iss/Pg. 31/1 (3-14). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34724 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35294 |
| Study title: A therapeutic trial of the use of penicillin V or erythromycin with or without rifampin in the treatment of psoriasis. Vincent F, Ross JB, Dalton M, Wort AJ. Journal of the American Academy of Dermatology, Mar 1992, vol. 26, no. 3 Pt 2, p. 458−61. |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26479 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45083 |
| 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 |
| View full study record |
| Document reference: 35000 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30129 |
| Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987Report in Clinical documentation for Marketing Authorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44316 |
| Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Drug experience reports on 2 children receiving overdosage of teicoplaninReport in Clinical documentation for Marketing Authorisation Application (June 1987): Drug experience reports on 2 children receiving overdosage of teicoplanin |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44317 |
| Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY Gram positive - Del Favero.xls |
| View full study record |
| Document reference: 44318 |
| Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY Serious infections - Martino.xls |
| View full study record |
| Document reference: 44320 |
| Study title: Report in Clinical documentation for Marketing Authorisation Application (March 1987): European Multicentre open study of teicoplanin in Gram-positive infection ; 1987 sponsor summary - P.J. Lewis - 6 April 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY EG-87-42.xls |
| View full study record |
| Document reference: 44310 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY pharmacological.xls |
| View full study record |
| Document reference: 44315 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Concia E., Andreoni M., Suter F. - 4 March 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY DRC 357.DLI.1075.xls |
| View full study record |
| Document reference: 44296 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Dietrich H.A., Fell J.J., Pugnetti P. - 6 February 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY LP-SM-0025.xls |
| View full study record |
| Document reference: 44297 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY DRC 356.DLI.1074.xls |
| View full study record |
| Document reference: 44298 |
| Study title: Preventive effect of perindopril on the onset and progression of left ventricular dysfunction in subjects suffering from Duchenne Muscular Dystrophy. Double-blind multicentre, placebo-controlled study of 2 and 4 mg of perindopril in 60 subjects over a period of 3 years. |
| Active substance: PERINDOPRIL |
| Study summary document link (including results): perindopril_CL3-09490-123-FRA_publication_Duboc_2005.pdf |
| View full study record |
| Document reference: 45864 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47710 |
| Study title: A multicenter , non-interventional study about pimecrolimus 1 % cream, to measure the drug consumption and cosmetical tolerability in the treatment of mild or moderate atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CHU03 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34113 |
| Study title: A prospective, open label proof of concept study |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CBE01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 48117 |
| Study title: A randomized, double-blind, multicenter study of the blood concentrations, safety and efficacy of 1% SDZ ASM981 cream administered up to four times daily in adolescents and adults with atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CUS01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34138 |
| 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 |
| View full study record |
| Document reference: 34104 |
| Study title: A Retrospective Analysis of Elidel (pimecrolimus cream 1%) for the Treatment of Facial Vitiligo. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47708 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42754 |
| Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULPERAZONE IN THE TREATMENT OF INFECTIONS IN LEUKEMIC CHILDREN. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42869 |
| Study title: CLINICAL EVALUATION IF SULPERAZON (SP) FOR INFECTIONS WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42769 |
| Study title: CLINICAL EVALUATION OF SBT/CFP FOR RESPIRATORY TRACT INFECTIONS IN PREMATURE BORN BABIES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42760 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42791 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42797 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42798 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CEREBROVASCULAR DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42786 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42783 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42814 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42781 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42782 |
| Study title: A study to determine the effect of nifedipine (Adalat Retard) on early renal allograft function and cyclosoprin nephrotoxicity. |
| Active substance: NIFEPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32633 |
| Study title: British-Scandinavian co-operative headinjury study (HIT-I) |
| Active substance: NIMODIPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32649 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and safety of teicoplanin in the treatment of infections caused by Gram-positive cocci. A summary report of over 298 cases treated in France - Garaud J.J., Tarra -17/02/1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY EG-87.03.xls |
| View full study record |
| Document reference: 44299 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY Gram positive - Martinetto.xls |
| View full study record |
| Document reference: 44319 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): European Multicentre open study of teicoplanin in Gram-positive infection ; 1987 sponsor summary - P.J. Lewis - 6 April 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY EG-87-42.xls |
| View full study record |
| Document reference: 44300 |
| Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY Serious infections - Terragna.xls |
| View full study record |
| Document reference: 44321 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 44302 |
| Study title: Summary - Clinical documentation for Marketing Autorisation Application - June 1987Summary - Clinical documentation for Marketing Autorisation Application - June 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44322 |
| Study title: Summary of clinical studies of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections in the UK and Eire- Concia E., Andreoni M., Suter F. - 4 March 1987 ; Report in Clinical documentation for Marketing Autorisation Application - June 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44303 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 34102 |
| Study title: An investigator initiated study to explore the effectiveness of pimecrolimus cream 1% used twice daily (BID) for the treatment of facial vitiligo |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CUS28 Art45 listing 2011.xls |
| View full study record |
| Document reference: 48121 |
| Study title: Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609 |
| Active substance: OXYMETAZOLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33041 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42823 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR RESPIRATORY TRACT INFECTION (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42793 |
| Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR URINARY TRACT INFECTIONS (UTI) WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42803 |
| Study title: CLINICAL EVALUATION OF SULPERAZON AND PIPERACILLIN FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42838 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42822 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42830 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42831 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42832 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42836 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42841 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42842 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42844 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42827 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42845 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42819 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42816 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42811 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS WITH TOTAL PARENTAL NUTRITION (T.P.N.) PATIENTS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42776 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42771 |
| 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): |
| View full study record |
| Document reference: 42772 |
| Study title: Human pharmacokinetics of nitrazepam:effect of age and disease. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32661 |
| Study title: Infantile spasms. A retrospective study of 105 cases. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32658 |
| Study title: Prospective study of first-choice topiramate therapy in newly diagnosed infantile spasms. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32653 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32651 |
| 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): |
| View full study record |
| Document reference: 44326 |
| Study title: A 4-week repeated dose toxicity study of HMR3647 administered orally to young Beagle dogs followed by a 4-weeek recovery period |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41545 |
| Study title: A 4-week repeated dose toxicity study of HMR3647 administered to young rats |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41544 |
| Study title: Activity of telithromycin against erythromycin susceptible and resistant Streptococcus pyogenes and Streptococcus pneumoniae isolates from paediatric origin |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41572 |
| Study title: Evaluation of telithromycin on acute otitis media in an experimental animal model (chinchilla) |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41563 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41573 |
| Study title: Experimental studies of otitis media due to Streptococcus pneumoniae treated with HMR3647 |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41562 |
| Study title: HMR3647: Exploratory 7-day oral toxicity study in Sprague Dawley juvenile rats (from postnatal day 5) |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41546 |
| Study title: HMR3647: Single-dose toxicokinetic study in neonatal Sprague Dawley rats |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41543 |
| Study title: In vitro actibity of telithromycin (HMR3647) against Streptococcus pyogenes and Streptococcus pneumoniae clinical isolates from paediatric patients in Greece |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41552 |
| Study title: In vitro activity of antimicrobial agents against Streptococcus pyogenes in paediatrics : a Belgian multicenter study |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41556 |
| Study title: In vitro activity of telithromycin and multiple comparison antibiotics against recent clinical isolates from children |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41549 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33340 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33343 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTION (RTI) WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.) |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42768 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42792 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42817 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS COMPLICATED WITH STOMACH CANCER OR COLON CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42824 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH CEREBROVASCULAR DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42834 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42778 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42801 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42840 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42843 |
| 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): |
| View full study record |
| Document reference: 42837 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42828 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) WITH UNDERLYING DISEASE (COPD ETC.) |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42821 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42765 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASE, ETC. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42775 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH THE MALIGNANT DISEASES IN THE FIELD OF E.N.T. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42800 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS IN THE FIELD OF INTENSIVE CARE UNIT. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42810 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS COMPLICATED WITH DIGESTIVE SYSTEM MALIGNANT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42767 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42780 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42784 |
| Study title: Ou X, Li B, Du H. Clinical study: The effects of inhaling nitrous oxide for analgesia labor on pregnant women and fetus. Zhonghua Fu Chan Ke Za Zhi 2001 Jul;.36(7):399-401 Ou X, Li B, Du H. Clinical study: The effects of inhaling nitrous oxide for analgesia labor on pregnant women and fetus. Zhonghua Fu Chan Ke Za Zhi 2001 Jul;.36(7):399-401 |
| Active substance: NITROUS OXIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32668 |
| Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. |
| Active substance: NITROUS OXIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32671 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32673 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32677 |
| Study title: Berge TI. Acceptance and side effects of nitrous oxide oxygen sedation for oral surgical procedures. Acta Odontol Scand 1999 Aug;57(4):201-6. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32678 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41575 |
| Study title: macrolide-resistant streptococci among pediatric patients in Denmark, Luxemburg, The Netherlands and Turkey |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41557 |
| Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, after repeated oral administration of either of two doses, once daily, for 5 days or 7 to 10 days, in the treatment of respiratory tracts infections in children of 6 months to 12 years |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41569 |
| Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 20mg/kg once daily, for 5 days in the treatment of acute otitis media in children |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41570 |
| Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 15mg/kg twice daily, for 5 days in the treatment of acute otitis media in children |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41571 |
| Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with otitis media with effusion after multiple oral administration of 20mg/kg, once daily for 5 days or 15mg/kg twice daily for 4.5/5 days of telithromycin pediatric suspension |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41568 |
| 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): |
| View full study record |
| Document reference: 41567 |
| Study title: Pattern of killing of telithromycin and azithromycin against various strains of Streptococcus pneumoniae |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41561 |
| Study title: Pharmacokinetics of Telithromycin (HMR3647) in infants and children suffering from bacterial lower respiratory tract infections after single oral administration of 30mg/kg of a telithromyucin suspension (50mg/ml) |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41565 |
| 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): |
| View full study record |
| Document reference: 41555 |
| Study title: Telithromycin : epidemiological multicenter study on macrolide resistance of S.pneumoniae and S.pyogenes in the pediatric population in Germany, 2000- 2001 |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41550 |
| Study title: Telithromycin epidemiological survey in Austria isolates from paediatric patients |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41547 |
| Study title: U.S Survey of Telithromycin Activity against Streptococcus pyogenes |
| Active substance: telithromycin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41564 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33338 |
| Study title: Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537 |
| Active substance: PERPHENAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33900 |
| Study title: Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310)Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310) |
| Active substance: PERPHENAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33899 |
| Study title: Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158)Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158) |
| Active substance: PERPHENAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33901 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42802 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OR UROLOGY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42787 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF UROLOGY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42789 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42785 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE PERITONITIS THE FIELD OF GYNECOLOGIA |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42770 |
| Study title: CLINICAL EVALUATION OF SULPERAZON FOR UTI WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42764 |
| Study title: CLINICAL EVALUATION OF SULPERAZONE FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42833 |
| Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42807 |
| Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANCY DISEASES |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42804 |
| Study title: CLINICAL EVALUATION OF UNASYN-SIV IN THE TREATMENT OF PERFORATIVE PERITONITIS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42713 |
| Study title: CLINICAL EVALUATION SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDERS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42774 |
| Study title: CLINICAL STUDY OF SULBACTAM/CEFOPERAZONE IN CHILDREN WITH HEMATOLOGICAL DISORDERS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42761 |
| Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASE |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42763 |
| Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN/VANCOMYCIN FOR MRSA AND GRAM NEG RODS INFECTIONS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42766 |
| Study title: CLINICAL TRIAL OF SULPERAZON ALONE OR SULPERAZON PLUS DALACIN-S FOR INFECTIONS IN PATIENTS WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42825 |
| Study title: COMBINED THERAPY OF SBT/CFP AND CLINDAMYCIN (CLDM) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42773 |
| Study title: COMBINED THERAPY OF SULBACTAM/CEFOPERAZONE AND DOXYCYCLINE FOR MRSA RESPIRATORY TRACT INFECTIONS (RTI) |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42762 |
| Study title: COMBINED THERAPY OF SULPERAZON AND AMIKACIN (AMK) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42779 |
| Study title: COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR RESPIRATORY TRACT INFECTIONS (RTI) WITH UNDERLYING DISEASES (COPD ETC.). |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42806 |
| Study title: COMBINED THERAPY OF SULPERAZON AND PIPERACILLIN (OR AMIKACIN) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42777 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32685 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32697 |
| 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 |
| View full study record |
| 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: EVALUATIONS OF TOLERABILITY AND EFFICACY OF ORAL SF 86-327 IN CHILDREN TREATED FOR FUNGAL INFECTIONS. A SUMMARY OF DATA FROM EXPERIENCE OTHER THAN SPECIAL CLINICAL TRIALS IN CHILDREN |
| Active substance: TERBINAFINE |
| Study summary document link (including results): SFE700MR.xls |
| View full study record |
| Document reference: 44357 |
| Study title: Gupta et al, 2003 (overview article of studies) |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44341 |
| Study title: Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability. |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44342 |
| Study title: MULTICENTRIC, RANDOMIZED SINGLE-BLIND STUDY OF EFFICACY, SAFETY AND TOLERABILITY OF TERBINAFINE [LAMISIL(R)] TABLETS, ONCE DAILY, FOR 1, 2 OR 4 WEEKS IN THE TREATMENT OF TINEA CAPITIS IN CHILDREN |
| Active substance: TERBINAFINE |
| Study summary document link (including results): LASBR 06-22493MR.xls |
| View full study record |
| Document reference: 44349 |
| Study title: Nejjam et al, 1996: 12 children 5-11 years old |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44343 |
| Study title: OPEN STUDY TO DETERMINE THE EFFICACY OF 62.5 MG/D TERBINAFINE IN THE TREATMENT OF CHILDREN WITH TINEA CAPITIS. |
| Active substance: TERBINAFINE |
| Study summary document link (including results): SFE302 E-00 001MR.xls |
| View full study record |
| Document reference: 44352 |
| Study title: PILOT STUDY OF TERBINAFINE IN CHILDREN SUFFERING FROM TINEA CAPITIS: EVALUATION OF THE EFFICACY, SAFETY AND PHARMACOKINETICS SHORT TITLE: LAMISIL(R) _ EFFICACY, SAFETY, PHARMACOKINETICS IN CHILDREN |
| Active substance: TERBINAFINE |
| Study summary document link (including results): SFE 306MR.xls |
| View full study record |
| Document reference: 44353 |
| Study title: Study 1 - Gupta et al, 2003 (overview aricle of studies). |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44344 |
| Study title: Study 2 - Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability. |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44345 |
| Study title: Study 3 - Nejjam et al, 1996: 12 children 5-11 years old. |
| Active substance: TERBINAFINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44346 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42954 |
| Study title: TO DETERMINE THE SAFETY AND EFFICACY OF STM BID VS AUGMENTIN TID FOR THE TREATMENT OF RESPIRATORY TRACT OR UNCOMPLICATED URINARY TRACT INFECTIONS |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43018 |
| Study title: TO DETERMINE THE SAFETY AND EFFICACY OF SULTAMICILLIN FOR THE TREATMENT OF UPPER AND LOWER RESPIRATORY TRACT INFECTION AND UNCOMPLICATED URINARY TRACT INFECTION. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43048 |
| Study title: TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF 2.25 GM OF STM & PRABENECID 1 GM WITH AND WITHOUT PROBENECIDE IN THE TREATMENT OF GONORRHEA. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43062 |
| Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SBT/AMP/STM IN THE TREATMENT OF (RTI) RESPIRATORY TRACT INFECTIONS. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42951 |
| Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43012 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM (SBT/AMP) GIVEN ORALLY BID IN PEDIATRIC INFECTIONS. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42982 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM GIVEN ORALLY BID IN PEDIATRIC INFECTIONS. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42981 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF UTI. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43060 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN GIVEN ORALLY TWICE A DAY IN PEDIATRIC INFECTIONS. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42983 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN IN THE TREATMENT OF A VARIETY OF CHILDHOOD INFECTIONS, E.G., OTITIS MEDIA. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43061 |
| Study title: TO EVALUATE THE EFFICACY OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF BRONCHO-PNEUMONIA. |
| Active substance: SULTAMICILLIN |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42991 |
| Study title: COMBINED THERAPY OF SULPERAZON AND PIPERACILLIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42788 |
| Study title: COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN VS METRONIDAZOLE/GENTAMICIN IN COLORECTAL SURGERY PROPHYLAXIS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42676 |
| Study title: COMPARATIVE STUDY ON THE PROPHYLAXIS OF ABDOMINAL SURGERIES WITH INJECTABLE SULBACTAM - AMPICILLIN (UNASYN) VERSUS CEPHALOSPORINS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42658 |
| Study title: DETERMINATION OF AMPICILLIN/SULBACTAM IN HUMAN MILK |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42633 |
| Study title: DRUG TREATMENT VERSUS EXPECTANT MANAGEMENT OF PRETERM PREMATURE RUPTURE OF MEMBRANES |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42652 |
| 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): |
| View full study record |
| Document reference: 42733 |
| Study title: EFFICACY AND SAFETY OF SBT/AMP FOLLOWED BY ORAL SULTAMICILLIN IN THE TREATMENT OF OSTEOMYELITIS AND BONE/JOINT INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42749 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42695 |
| Study title: EFFICACY AND SAFETY OF SBT/AMP IN THE PERIOPERATIVE PROPHYLAXIS IN MAXILLOFACIAL SURGERY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42704 |
| Study title: EFFICACY AND SAFETY OF SBT/AMP IN THE TREATMENT OF DOCUMENTED COMMUNITY OR NOSOCOMIAL INFECTIONS IN GENERAL SURGERY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42706 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42703 |
| Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN ACUTE ENT INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42692 |
| Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN NEWBORN PATIENTS WITH SEVERE INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42702 |
| Study title: Houpt MI, Limb R, Livingston RL. Clinical effects of nitrous oxide conscious sedation in children. Pediatric Dentistry 2004;26(1);29-36 |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32700 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 32706 |
| Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. N Engl J Med 2003;349:45-50. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32709 |
| 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): |
| View full study record |
| Document reference: 41494 |
| Study title: In Vitro Evaluation of Allergic Reactions in hemophilia B Subjects who have Exhibited a Systemic Allergic Response after Exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX) |
| Active substance: NONACOG ALFA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41496 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41495 |
| Study title: An evaluation of the respiratory and cardiovascular effects of oral terbutaline in asthmatic pediatric children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44390 |
| Study title: UCR/96/001 A randomised,double-blind,placebo-controlled study of the safety & efficacy of 25mg,50mg, &100mg oral sumatriptan in adolescent migraine subjects. |
| Active substance: SUMATRIPTAN |
| Study summary document link (including results): Sumatriptan-SUMA2002-ICHE3.pdf |
| View full study record |
| Document reference: 43077 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Syzygium compositum (drops) [AWB-AT] |
| Active substance: Syzygium compositum-Heel - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40250 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 43082 |
| Study title: |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47775 |
| Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42742 |
| Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42743 |
| 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 SAFETY OF SULBACTAM/AMPICILLIN VS. CEFTAZIDIME IN CHILDREN WITH BACTERIAL INFECTIONS OF LOWER RESPIRATORY TRACT. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42705 |
| 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): |
| View full study record |
| Document reference: 42670 |
| Study title: EFFICACY AND TOLERATION OF SBT/AMP IN MILD SEVERE GYN-OB INFECTIONS (PID, ENDOMETRITIS, ETC.). |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42681 |
| Study title: EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IN PATIENTS WITH NON-SEVERE INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42709 |
| Study title: EFFICACY AND TOLERATION OF UNASYN IN TREATMENT OF INFECTIONS OF THE RESPIRATORY TRACT, GASTROINTESTINAL TRACT, SKIN AND SAFE TISSUES AND UROGENITAL TRACT |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42675 |
| Study title: EFFICACY OF SBT.AMP IN VARIOUS INFECTIONS IN CHILDREN. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42741 |
| Study title: EFFICACY OF UNASYN IN PATIENTS WITH ACUTE DISEASE OF THE LUNGS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 32721 |
| Study title: A 24-week open – label randomized cross-over study to monitor the plasma phenylalanine concentrations of subjects with phenylketonuria, aged 8 to 30 years, using Aminogran 1g tablets supplement to manage at least 50% of their protein substitute requirements or using standard diet supplement (Aminogran 1g tablets excluded) |
| Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32722 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40086 |
| Study title: Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594 Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594 |
| Active substance: Nystatin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45239 |
| 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): |
| View full study record |
| Document reference: 32728 |
| Study title: Freitag V.; Schumacher G.; Sternowsky H-J. Der Kinderarzt 1983; 14(2):177-178 Soor im Mund- und Windelbereich (Thrush in the mouth and nappy area) Freitag V.; Schumacher G.; Sternowsky H-J. Der Kinderarzt 1983; 14(2):177-178 Soor im Mund- und Windelbereich (Thrush in the mouth and nappy area) |
| Active substance: NYSTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45240 |
| Study title: Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13 |
| Active substance: NYSTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32727 |
| 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): |
| View full study record |
| Document reference: 32729 |
| 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: Effect of controlled-release terbutaline and budesonide alone and in combination in asthmatics. A multi-center study. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2167 Summary.pdf |
| View full study record |
| Document reference: 44399 |
| Study title: Effect of oral terbutaline on exercise-induced asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2589 interventional.xls |
| View full study record |
| Document reference: 44391 |
| Study title: Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45837 |
| Study title: Unusual complications of pentamidine in the treatment of Pneumocystis cariniii pneumonia. Wang, J.J., Freeman, A.I., Gaeta , J.F., and Sinks, L.F. (1970) Journal of Pediatrics 77:311-314Unusual complications of pentamidine in the treatment of Pneumocystis cariniii pneumonia. Wang, J.J., Freeman, A.I., Gaeta , J.F., and Sinks, L.F. (1970) Journal of Pediatrics 77:311-314 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45838 |
| Study title: A Phase 2, Randomized, Double-Blind Study To Evaluate the Dosing Concentration and Application Frequency of Tacrolimus Gel in the Treatment of Mild to Moderate Psoriasis in Pediatric and Adult subjects |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41599 |
| Study title: A Phase 3 Long-Term Open Label Study to Evaluate the Safety ofOnce Daily 0.3% Tacrolimus Gel in the Treatment of Psoriasis - |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41603 |
| 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): |
| View full study record |
| Document reference: 47773 |
| Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% FK506 Gel Versus Gel Vehicle in the Treatment of Psoriasis - |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41601 |
| Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% Tacrolimus Gel Versus Gel Vehicle in the Treatment of Psoriasis - |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41600 |
| Study title: An open-label study to evaluate the safety of topically applied tacrolimus ointment for the treatment of atopic dermatitis. |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47776 |
| 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: PRO-002 Final Statistical Report (18OCT2002)_Synopsis_Tacrolimus |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47774 |
| Study title: Tacrolimus ointment is effective for facial and intertriginous psoriasis ( J Am Acad Dermatol 2004;51:723-30.) - |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41602 |
| Study title: Tacrolimus Pharmacokinetics after Topical Administration of Tacrolimus Cream 0.01% and 0.03% to Pediatric Subjects with Atopic Dermatitis |
| Active substance: Tacrolimus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41604 |
| 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: PROCEDURE FOR THE STUDY OF UNASYN USED IN PROPHYLAXIS IN TREATMENT OF ABDOMINAL WOUND SURGERY |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42720 |
| 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: SAFETY AND EFFICACY OF SBT/AMP IN ADULTS WITH LOWER RESPIRATORY TRACT INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42718 |
| Study title: SBT/AMP - OPEN TRIAL. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42671 |
| Study title: SBT/AMP NON-COMPARATIVE OPEN TRIAL. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42665 |
| Study title: THE EVALUATION OF CLINICAL EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN (UNASYN) IN THE TREATMENT OF COMMUNITY-ACQUIRED INFECTIONS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42750 |
| Study title: THE NECESSITY FOR GRAM NEGATIVE ANTIMICROBIAL COVERAGE IN THE PREVENTION OF INFECTION FOLLOWING HEAD AND NECK SURGERY |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42628 |
| 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): |
| View full study record |
| Document reference: 32734 |
| Study title: Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307.Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307. |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41626 |
| Study title: Use of Octenisept for pre-operative skin and mucous membrane antisepsis and for supportive wound and suture treatment in small children and babies. UNIV-KLINIK FUR CHIRURGIE.1998. |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32737 |
| 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): |
| View full study record |
| Document reference: 42688 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (tablets) [AWB-AT] |
| Active substance: Oculoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40087 |
| Study title: Oral nystatin profilaxis to prevent invasive candidiasis in neonatal intensive care unit 2006 |
| Active substance: NYSTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41622 |
| Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
| Active substance: OBIDOXIME |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32732 |
| Study title: "Addendum to the clinical expert report, Local and systemic tolerability in babies and premature infants. Author: Priv. Doz. Dr. med. E. Sebastian Debus.2003. " |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32735 |
| Study title: "Experience report of the use of Octenisept in children prior to urological procedures. UNIVERSITY TEACHING HOSPITAL OF THE JOHANNES GUTENBERG UNIVERSITY, MAINZ. 1996. "Experience report of the use of Octenisept in children prior to urological procedures. UNIVERSITY TEACHING HOSPITAL OF THE JOHANNES GUTENBERG UNIVERSITY, MAINZ. 1996. |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32740 |
| Study title: Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957)Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957) |
| Active substance: NYSTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29021 |
| Study title: Observational study of the use of Octenisept on babies and neonates at the Pediatric Clinic of Gera Hospital.1996. |
| Active substance: OCTENIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32738 |
| Study title: Multicenter study of the effect of terbutaline in children with whooping cough. (Drs JA Gray, Edinburgh: WC Love, Glasgow: the United Kingdom) |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44389 |
| 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): |
| View full study record |
| Document reference: 45839 |
| Study title: Disposition of pentoxifylline in neonatal rats in relation to its pharmacological effect - Tabata - 2/05/1988 |
| Active substance: PENTOXYFILLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45843 |
| Study title: Group B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert reportGroup B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert report |
| Active substance: PENTOXYFILLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45844 |
| 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: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42794 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR P. AERUGINOSA RESPIRATORY TRACT INFECTIONS (RTI). |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42839 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.). |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42790 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RIP) COMPLICATED WITH MALIGNANT DISEASE. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42813 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42815 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) IN COMPLICATED LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42805 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) TO RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42799 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR FOR RESPIRATORY TRACT INFECTIONS COMPLICATED WITH LUNG CANCER. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42829 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42795 |
| Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42796 |
| Study title: TO ASSESS THE EFFICACY AND SAFETY OF A SINGLE DOSE OF STUDY MEDICATION IN TREATMENT OF URINARY TRACT INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42728 |
| Study title: TO ASSESS THE SAFETY AND EFFICACY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF DOCUMENTED INFECTIONS AFTER SURGICAL OPERATION IN THE ABDOMINAL REGION. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42700 |
| 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): |
| View full study record |
| Document reference: 42698 |
| Study title: THE USE OF CEFOPERAZONE PLUS SULBACTAM IN THE TREATMENT OF OSTEOMYELITIS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42631 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42727 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (eye drops) [AWB-099] |
| Active substance: Oculoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40089 |
| 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): |
| View full study record |
| Document reference: 41625 |
| Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58 |
| Active substance: OFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32757 |
| Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58 |
| Active substance: Ofloxacin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32767 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 32752 |
| Study title: Special Toxicity : Effects of orally administered DL-8280 on diarthric joints of immature dogs. - ONO - 30 Jan. 1984 (ofloxacin Daiichi Dossier) |
| Active substance: OFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32753 |
| Study title: Special Toxicity : Effects of orally administered DL-8280 on the knee and elbow joints of immature rats. - ONO - 26 Jul. 1982 (ofloxacin Daiichi Dossier) |
| Active substance: OFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32754 |
| Study title: The effect and side effects of terbutaline sustained release tablets in children exhibiting symptoms of nocturnal asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44401 |
| Study title: The effect of Bricanyl Turbuhaler and Bricanyl chlorofluorocarbon (CFC) inhaler on exercise-induced asthma in children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2178 interventional.xls |
| View full study record |
| Document reference: 44414 |
| Study title: The effect of Bricanyl Turbuhaler and Ventolin inhalation powder in Rotacaps on exercise induced asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2154 interventional.xls |
| View full study record |
| Document reference: 44418 |
| Study title: The effect of terbutaline 0.4 mg Turbuhaler (prototype) and salbutamol inhalation powder 0.2 mg in Rotacaps, on acute asthma bronchiale in children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2102 interventional.xls |
| View full study record |
| Document reference: 44407 |
| Study title: The effects of inhaled terbutaline sulfate and salbutamol on airway caliber, using the aerosol and dry powder systems of drug delivery. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44426 |
| 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 12-week open-label, multicenter, effectiveness and safety study of Elidel (pimecrolimus) cream 1% in subjects with atopic dermatitis. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CEG01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34098 |
| 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 |
| View full study record |
| 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 DOCUMENT THE EFFICACY AND SAFETY OF SBT/AMP IN MODERATE TO SEVERE PEDIATRIC INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42680 |
| Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERABILITY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF SKIN/SOFT TISSUE INFECTIONS OF BACTERIAL ETIOLOGY. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42746 |
| Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERATION OF UNASYN IM/IV IN VARIOUS INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42687 |
| 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 SAFETY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF GYNECOLOGICAL INFECTIONS OF BACTERIAL ETIOLOGY, INCLUDING, BUT NOT NECESSARILY LIMITED TO: PELVIC INFLAMMATORY DISEASE, ENDOMETRITIS, SALPINGITIS, BARTHELINITIS, ETC. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42716 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SBT/AMP GIVEN IM TWICE A DAY IN NON-SEVERE INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42724 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42708 |
| Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IM/IV IN THE TREATMENT OF SURGICAL INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42714 |
| Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IN THE TREATMENT OF MODERATE TO SEVERE SKIN/SOFT TISSUE OR BACTERIAL |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42748 |
| Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERATION OF SBT/AMP IN THE TREATMENT OF BACTERIAL INFECTIONS. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42747 |
| 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: TO STUDY THE EFFICACY AND SAFETY OF SBT/AMP IN THE TREATMENT OF INFECTIONS IN NEONATES. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42694 |
| 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: Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson tubes" Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson t... |
| Active substance: SULFACETAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42875 |
| 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: "Prophylaxis of Bacterial Infections after Bone Msrrow Transplantation - E. Gluckman, C. Roudet, I. Hirsch, A. Devergie, H. Bourdeau, C. Arlet - Chemotherapy 1991; 33 (suppl 1): 33-38" |
| Active substance: OFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32756 |
| Study title: A Multi-Center, Open-Label Study to Evaluate Omeprazole for the Treatment of Gastrointestinal Symptoms Associated with Acid-Related Disorders in Pediatric Subjects (Ages 2 through 16 years, Inclusive), 9 August 2000 |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32788 |
| Study title: Immuntherapie bei kindern mit hilfe eines multibakteriellen ribosomenpräparates |
| Active substance: Tetanus Vaccine (Adsorbed) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41393 |
| Study title: Effect of tetrabenazine on tics and Sleep of Gilles de la Tourette's Syndrome (Neurology 1984). Effect of tetrabenazine on tics and Sleep of Gilles de la Tourette's Syndrome (Neurology 1984). |
| Active substance: TETRABENAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44443 |
| Study title: Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173 |
| Active substance: OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45420 |
| Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589 |
| Active substance: OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45409 |
| Study title: A Multicenter, Retrospective Study to Evaluate the Effect of Multiple Doses of Omeprazole on Gastric or Esophageal pH in a Pediatric Population, 17 November 2000 |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32792 |
| Study title: A prospective study of a one-week nonbismuth quadruple therapy for childhood Helicobacter pylori infection. |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32784 |
| Study title: Effect of omeprazole in the treatment of refractory acid-related diseases in childhood: endoscopic healing and twenty-four-hour intragastric acidity |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32785 |
| Study title: Effect of omeprazole on the efficacy of amoxicillin and clarithromycin for the treatment of Helicobacter pylori associated gastritis in children, 22 February 2001 |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32793 |
| Study title: Low-dose ACTH therapy for West syndrome: initial effects and long-term outcomeLow-dose ACTH therapy for West syndrome: initial effects and long-term outcome |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44455 |
| 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 |
| View full study record |
| Document reference: 48142 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45770 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33249 |
| Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Eggenberger, Yverdon, Switzerland. 16.04.1985 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45243 |
| Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Herz, Basel/Switzerland. 01.05.1985 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45245 |
| Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Vich, Winterthur/ Switzerland. 01.05.1985 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45246 |
| Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report by Dr. D'Aruzzo, Mendrisio/Switzerland. 10.05.1985 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45247 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 45249 |
| Study title: Havas L: DOSAGE OF PHARMACEUTICALS IN CHILDREN B-0054340 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45251 |
| Study title: M. Sieniawska ,,Clinical evaluation of the prep. Biseptol 480 for i.v. use in children with bacterial infections" |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45242 |
| Study title: Reggiani G: PHARMACOKINETIC STUDIES OF TRIMETHOPRIM-SULFAMETHOXAZOLE IN CHILDREN WITH GASTROENTERITIS (MANUSCRIPT BY M.I. MARKS, M. KAZEMI, B. HALES AND A.H. NEIMS, ROCHE DEVELOPMENTAL PHARMACOLOGY UNIT, MCGILL UNIVERSITY, MONTREAL) |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45250 |
| 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): |
| View full study record |
| Document reference: 32773 |
| Study title: Treatment of irritable infants with omeprazole. A double bind placebo controlled prospective study (Australia) |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32776 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 47029 |
| Study title: Exercise induced asthma in children-protection with nedocromil sodium -In inflammation : Its clinical revelance in airways disease - JM. Henricksen - 1986 (RAI International Congress - Publication in Tilade CFC-Free metered dose inhaler nedocromil sodium-vol2 response to CSM questions references - no author - 09/ 1999 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47030 |
| 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 |
| View full study record |
| Document reference: 44445 |
| 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 |
| View full study record |
| Document reference: 44444 |
| Study title: Antitussive effect of carbetapentane (toclase) to infantile respiratory tract disturbances. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): ARCE92G0601 - Pentoxyverine.pdf |
| View full study record |
| Document reference: 45854 |
| Study title: Experimentation du sirop ucb 2543 expectorant chez l'enfant. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): DF68B006 - Pentoxyverine.pdf |
| View full study record |
| Document reference: 45856 |
| Study title: Expertise clinique du sirop "uc-2543 - expectorant" des laboratoires UCEPHA. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): ARCF99D1205 - Pentoxyverine.pdf |
| View full study record |
| Document reference: 45849 |
| Study title: Hustenbehandlung bei akuten und chronisch entzundlichen Erkrankungen der Atemwege im sauglings- und kindesalter mit Sedotussin Expectorans Sauglingszapfchen. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): DID88H112.pdf |
| View full study record |
| Document reference: 45858 |
| 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 |
| View full study record |
| Document reference: 45861 |
| Study title: Pentoxyverine effectively controls irritating cough in preschool children. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45853 |
| Study title: Tableau synoptique des essais avec le produit : "sirop expectoclase". |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45857 |
| Study title: Esteban F, Soldado L, Delgado M, Barrueco JC, Solanellas J. The usefulness of sucralfate in postoperative improvement of children's tonsillectomy. Anales O.R.L. Iber-Amer 2000, XXVII, 4, 393-404.Esteban F, Soldado L, Delgado M, Barrueco JC, Solanellas J. The usefulness of sucralfate in postoperative improvement of children's tonsillectomy. Anales O.R.L. Iber-Amer 2000, XXVII, 4, 393-404. |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42609 |
| 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): |
| View full study record |
| Document reference: 42608 |
| Study title: Long -term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group - no author -2000 ( N-Engl-J-Med) |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47033 |
| Study title: Long -term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group - no author -2000 ( N-Engl-J-Med) - Publication in Clinical Expert Statement - Renewal application for : Nedocromil-Sodium (all formulations) - DR. Rolf Ohlrogge - 08/12/2005 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47034 |
| 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): |
| View full study record |
| Document reference: 47001 |
| 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): |
| View full study record |
| Document reference: 47008 |
| Study title: Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44052 |
| 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 3-month open label, national, Quality of Life and safety study with Elidel (pimecrolimus) cream 1% in children (2-12 years) with atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CZA01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34119 |
| Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34133 |
| Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34134 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47706 |
| Study title: A 6-week open label, national, post-marketing surveillance program to obtain photographic documentation of mild to moderate atopic eczema lesions before and after treatment with Elidel (pimecrolimus) cream 1% in children from 2 years and above and adults with atopic ezcema |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34120 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42636 |
| 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): |
| View full study record |
| Document reference: 47012 |
| Study title: The protective effect of nedocromil sodium exercise-induced asthma - CP Bauer et al. - 1986 (European Journal of Respiratory disease vol 69) - Publication in Tilade CFC-Free metered dose inhaler nedocromil sodium-vol2 response to CSM questions references - no author - 09/ 1999 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47046 |
| Study title: Unusual bone scan of a child with osteogenesis imperfecta. Yurekli Y, Erdogan S, Cullu E. Clin Nucl Med. 2003 Feb;28(2):156. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43429 |
| Study title: A dermal embryo-fetal development study in rats |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34126 |
| 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: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589 |
| Active substance: OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45415 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42723 |
| Study title: Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47056 |
| Study title: Early bisphosphonate treatment in infants with severe osteogenesis imperfecta.(study published in 2006) |
| Active substance: NERIDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47061 |
| Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
| Active substance: TEGAFUR/URACIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44288 |
| Study title: A once a day antimicrobial therapy. Teicoplanin and ceftriaxone in the treatment of febrile neutropenic children with acute leukaemia. - Schaison, G ., Leverger, G ., Artel, G ., Pecking, D. -28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles 1988 ; 23-26 October : 33.A once a day antimicrobial therapy. Teicoplanin and ceftriaxone in the treatment of febrile neutropenic children with acute leukaemia. - Schaison, G ., Leverger, G ., Artel, G ., Pecking, D. -28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles 1988 ; 23-26 October : 33. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44323 |
| Study title: CES for MA renewal in Austria - Bruno Verdoncq - 28 February 2007 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44290 |
| Study title: Clinical and pharmacokinetic study of teicoplanin in children. - Kafetsis DA, Tspra H, Gianacopoulou C, Karamitsos S. -(Abstract) In: Abstract book of the 15th international congress of chemotherapy. Istanbul, 19-24 July 1987:322. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44304 |
| 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): |
| View full study record |
| Document reference: 44311 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33283 |
| 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): |
| View full study record |
| Document reference: 42686 |
| Study title: A PLACEBO-CONTROLLED DOUBLE-BLIND PROSPECTIVE STUDY OF THE EFFICACY OF UNASYN IN MANAGING PRETERM PREMATURE RUPTURE OF THE MEMBRANES |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42663 |
| Study title: A PROSPECTIVE, RANDOMIZED, EVALUATION OF AMPICILLIN/SULBACTAM VS CLINDAMYCIN/GENTAMICIN FOR TREATMENT OF CHORIOAMNIONITIS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42668 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42690 |
| Study title: AN OPEN EVALUATION OF SULBACTAM/AMPICILLIN IN THE MANAGEMENT OF CEREBRO-SPINAL MENINGITIS EMPIDERMICA. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42757 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42850 |
| Study title: Intravenous neridronate in children with osteogenesis imperfecta: a randomized controlled study. (study published in 2005) |
| Active substance: NERIDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47062 |
| Study title: Reduction of plasma taurine level in children affected by osteogenesis imperfecta during bisphosphonate therapy. (study published in 2007) |
| Active substance: NERIDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47060 |
| Study title: Retrospective survey for documentation of appllication and dosage of Nervoheel N (tablets) in children < 12 years of age [Bef-019] |
| Active substance: Nervoheel N |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40082 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 32618 |
| Study title: Contopoulos-Ioannidis et. Al ; PEDIATRICS Vol. 114 No. 1 July 2004 Extended-Interval Aminoglycoside Administration for Children: A Meta-analysis |
| Active substance: NETILMICIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32623 |
| Study title: Optimalisation of Netilmicin dosage based on therapeutic drug monitoring during the first days of life in very pre-term neonates (gestational age 23-32 weeks); MED.WIEKU ROZWOJ.,2009, XIII,4,252-259 |
| Active substance: NETILMICIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32621 |
| Study title: Sherwin, 2008;Individualising netilmicin dosing in neonates. Eur J Clin Pharmacol (2008) 64:1201–1208 DOI 10.1007/s00228-008-0536-0 |
| Active substance: NETILMICIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32620 |
| Study title: High levels of serum prostaglandin e2 in children with osteogenesis imperfecta are reduced by neridronate treatment. Not Available (study published in 2008) |
| Active substance: NERIDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47059 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Neuro-Injeel Ampullen (ampoules) [AWB-AT] |
| Active substance: Neuro-Injeel Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40083 |
| 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): |
| View full study record |
| Document reference: 32624 |
| Study title: Efficacy and tolerability of teicoplanin in treatment of Gram-positive infections in children - Kafetzis D.A., Romeo B. - 20 February 1987 ; Report in Clinical documentation for Marketing Autorisation Application (June 1987) |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): Teicoplanin STUDY DRC 359.DLI.1077.xls |
| View full study record |
| Document reference: 44291 |
| 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): |
| View full study record |
| Document reference: 44292 |
| Study title: Expert Report on the Clinical documentation for Marketing Authorisation Application - Peter J Lewis - 18 March 1986 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44293 |
| Study title: Expert Report on the Clinical documentation for Marketing Authorisation Application - Peter J Lewis - 9 March 1987 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44309 |
| Study title: Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44308 |
| Study title: Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44314 |
| Study title: Expert Report to amend therapeutic indications: Treatment of neonates - Haydn Clifford Cash - April 1992 amended July 1992 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44294 |
| Study title: Expert Report to amend therapeutic indications: Treatment of paediatric patients - Roscigno G. - 28 June 1991 |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44295 |
| Study title: Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259.Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44327 |
| Study title: Efficacy and safety of teicoplanin in the treatment of infections caused by gram-positive cocci. A summary of over 298 cases in France.Efficacy and safety of teicoplanin in the treatment of infections caused by gram-positive cocci. A summary of over 298 cases in France. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44312 |
| Study title: Open study on the efficacy and tolerability of teicoplanin in the treatment of Gram positive infection in children.Open study on the efficacy and tolerability of teicoplanin in the treatment of Gram positive infection in children. |
| Active substance: TEICOPLANIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44313 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 33339 |
| Study title: Liu JH et al. Enteric−coated peppermint−oil capsules in the treatment of irritable bowel syndrome: a prospective, randomized trial. J Gastroenterol 1997; 32(6): 765−8 |
| Active substance: Peppermint Oil 0.200 ml |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40116 |
| Study title: Clinical Expertise - Study N° ERI 175 - Pr. Bouletreau - Nov 83 |
| Active substance: PERFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45862 |
| Study title: Clinical Expertise - Study N° ERI 177 - Pefloxacin for infections intensive care - Pr Lhoste - Nov 84 |
| Active substance: PERFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45863 |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42740 |
| Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42719 |
| Study title: AN OPEN STUDY OF PARENTERAL SULBACTAM SODIUM/AMPICILLIN. |
| Active substance: SULBACTAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42752 |
| 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): |
| View full study record |
| Document reference: 47896 |
| Study title: 3. Numbers LC. Clinical experiences with tolnaftate. J Am Podiatry Assoc. 1967 . 3. Numbers LC. Clinical experiences with tolnaftate. J Am Podiatry Assoc. 1967 . |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44826 |
| Study title: 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6. 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44827 |
| Study title: Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275 Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275 |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44824 |
| Study title: Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70. Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44829 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25781 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45752 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45757 |
| Study title: Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. |
| Active substance: PENICILLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33838 |
| Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156 Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156 |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32995 |
| Study title: 39. Open-label, safety and efficacy, adjunctive or monotherapy study in asubjects ? 14 years of age with any seizure type. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44973 |
| Study title: 8. Phase 3, open-label, PK, safety, and tolerability study of TPM adjunctive therapy in pediatric subjects with Lennox-Gastaut syndrome |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44841 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33725 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44977 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33958 |
| Study title: Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292 |
| Active substance: PHENYTOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33969 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45821 |
| Study title: Cardiac arrest after intravenous pentamidine in an infant. Miller H.C. The pediatric infectious disease journal 1993 Aug, Vol :12 (8), p:694-6; ISSN : 0891-3668Cardiac arrest after intravenous pentamidine in an infant. Miller H.C. The pediatric infectious disease journal 1993 Aug, Vol :12 (8), p:694-6; ISSN : 0891-3668 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45822 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45825 |
| Study title: Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45826 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45760 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45765 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45827 |
| Study title: Publication in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 An evaluation of the effects of beclomethasone dipropionate aqueous nasal spray on long-term groqth in children - Rachelefsky GS - 1998 (J. Allergy Clin. Immunol. 101: S236) |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46834 |
| Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy |
| Active substance: PHLEUM PRATENSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34028 |
| Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy |
| Active substance: Phleum pratense |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40126 |
| 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): |
| View full study record |
| Document reference: 33957 |
| Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32924 |
| Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32946 |
| Study title: J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F.J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F. |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34075 |
| Study title: Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children. |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): Namazova_VSP_2-2010_pidotimod+ENG transl.pdf |
| View full study record |
| Document reference: 34071 |
| Study title: Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680). |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): Vargas Correa_2002_pidotimod.pdf |
| View full study record |
| Document reference: 34078 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981 0301-0301E1 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34081 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981 0315E1 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34082 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45828 |
| Study title: Pneumocystis carinii pneumonia and congenital hypogammaglobulinaemia. W.C. Marshall, H.J. Weston and Martin Bodian. Archives of Disease in Childhood, 1964, 39, 18.Pneumocystis carinii pneumonia and congenital hypogammaglobulinaemia. W.C. Marshall, H.J. Weston and Martin Bodian. Archives of Disease in Childhood, 1964, 39, 18. |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45829 |
| Study title: Pneumocystis carinii pneumonia associated with hypogammaglobulinaemia responding to pentamidine. Rodgers T.S., Haggie M.H.K. The Lancet, May 9, 1964, p.1042Pneumocystis carinii pneumonia associated with hypogammaglobulinaemia responding to pentamidine. Rodgers T.S., Haggie M.H.K. The Lancet, May 9, 1964, p.1042 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45830 |
| Study title: Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45831 |
| Study title: Pneumocystis carinii pneumonia in children with cancer. Diagnosis and treatment. Johnson, H.D. and Johnson, W.W. (1970). Journal of the American Medical Association 214 : 1067-1073Pneumocystis carinii pneumonia in children with cancer. Diagnosis and treatment. Johnson, H.D. and Johnson, W.W. (1970). Journal of the American Medical Association 214 : 1067-1073 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45832 |
| Study title: Rapport d'expert sur la documentation pharmacologie humaine et clinique : Dr. F. Pichon - Juin 1989Rapport d'expert sur la documentation pharmacologie humaine et clinique : Dr. F. Pichon - Juin 1989 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45833 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45834 |
| Study title: Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319 |
| Active substance: PENTAMIDINE ISETHIONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45835 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45836 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C1301 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34083 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44727 |
| Study title: Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44716 |
| Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32952 |
| Study title: Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45800 |
| Study title: Side effects of opiods during short-term administration:effect of age, gender and race. M. Soledad Clinical Pharmacology & Therapeutics Volu 74, (2), 102-112 including in the ex-ante documentationSide effects of opiods during short-term administration:effect of age, gender and race. M. Soledad Clinical Pharmacology & Therapeutics Volu 74, (2), 102-112 including in the ex-ante documentation |
| Active substance: PETHIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45869 |
| 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 |
| View full study record |
| Document reference: 34117 |
| Study title: An open-label, single-arm study to determine the efficacy of 1% Elidel (pimecrolimus) cream in the treatment of pityriasis alba. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34105 |
| Study title: An oral fertility and early embryonic development study in rats |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34124 |
| Study title: EFFECTIVE ELI – Evaluation of EFFECTIVEness of ELIdel in prevention of flares |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CSI01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34118 |
| Study title: Efficacy of Elidel in vitiligo vulgaris |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34108 |
| Study title: Elidel (pimecrolimus) cream 1% on drug consumption and drug utilization in subjects >2 years of age with mild to moderate atopic dermatitis using Elidel cream 1% in routine daily treatment practice |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CBE03 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34110 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 34114 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C1302 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34085 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C1303 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34086 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C1304 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34087 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C2313 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34088 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34121 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981W206-W206E1 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47701 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981W202 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47702 |
| Study title: |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47703 |
| Study title: 12-week, open-label, uncontrolled, non blinded, non randomized, single-arm, single-center, investigator-initiated study |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CUS11 Art45 listing 2011.xls |
| View full study record |
| Document reference: 48119 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34129 |
| Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32997 |
| 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): |
| View full study record |
| Document reference: 40106 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40109 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33612 |
| 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): |
| View full study record |
| Document reference: 33611 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45806 |
| 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): |
| View full study record |
| Document reference: 45810 |
| Study title: ELPASO-Elidel Patient Self-observation |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CDE11 Art45 listing 2011.xls |
| View full study record |
| 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: Exploratory, 2-week, double-blind, randomized |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CUS22 Art45 listing 2011.xls |
| View full study record |
| Document reference: 48120 |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48101 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48100 |
| Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32998 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 33568 |
| Study title: Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3 |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33930 |
| Study title: Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6 Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6 |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45103 |
| 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 |
| View full study record |
| Document reference: 45819 |
| 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 |
| View full study record |
| Document reference: 48341 |
| Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy |
| Active substance: PHLEUM PRATENSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34027 |
| Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy |
| Active substance: Phleum pratense |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40125 |
| 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 |
| View full study record |
| Document reference: 48098 |
| 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): |
| View full study record |
| Document reference: 33337 |
| 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): |
| View full study record |
| Document reference: 33300 |
| 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): |
| View full study record |
| Document reference: 30203 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Osteoheel S (tablets) [AWB-AT] |
| Active substance: Osteoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40090 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ovarium compositum (ampoules) [AWB-AT] |
| Active substance: Ovarium compositum |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40091 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40129 |
| Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448 |
| Active substance: PHOSPHOCREATINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34037 |
| Study title: Radu H, Keresztes L, Stenzel K. Effects of administration of phosphocreatine on the clinical, biochemical and electromyographic evolution of Duchenne's progressive muscular dystrophy. Minerva Med. 1968; 59 (99): 5524-29 |
| Active substance: PHOSPHOCREATINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34038 |
| Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32926 |
| Study title: Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371)Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45873 |
| Study title: Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352)Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45874 |
| Study title: En présence des angines de l'enfant - Carrier A. - 1976 (Méd. Gén. 2 (4) 33-36)En présence des angines de l'enfant - Carrier A. - 1976 (Méd. Gén. 2 (4) 33-36) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45875 |
| Study title: Essai clinique en pédiatrie d'une forme sirop de pénicilline: l'Oracilline sirop - Verger P. & Guillard J. M. - 1967 (J. Méd. Bordeaux, (12) 1903 - 1908)Essai clinique en pédiatrie d'une forme sirop de pénicilline: l'Oracilline sirop - Verger P. & Guillard J. M. - 1967 (J. Méd. Bordeaux, (12) 1903 - 1908) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45876 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 45889 |
| Study title: [A multicenter randomized study of fusidic acid ophthalmic gel and rifamycine eyedrops in acute conjunctivitis]. [Article in French]. Adenis J P, Arrata M, Gastaud P, Limon S, Massin M. J. Fr Ophtalmol 1989; 12(4): 317-322 |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
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| Document reference: 48449 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48461 |
| Study title: Effects of fusidic acid on staphylococcal keratitis. Tabbara. British jounal Ophthalmology, Vol 73, issue 2 1989 |
| Active substance: FUSIDIC ACID |
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| Document reference: 48462 |
| Study title: Efficacy and safety of Fucithalmic® compared with chloramphenicolHørven I |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
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| Document reference: 48460 |
| Study title: Efficacy and tolerability of Fucidin® eye dropThanpaichitra |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
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| Document reference: 48454 |
| Study title: Efficacy and tolerability of Fucithalmic®P. M. Møller |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48452 |
| 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): |
| View full study record |
| Document reference: 40100 |
| 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): |
| View full study record |
| Document reference: 40097 |
| 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): |
| View full study record |
| Document reference: 40093 |
| Study title: The Uninhibited Bladder in Children : Effect of Treatment on Recurrence of Urinary Infection and on Vesicoureteral Reflux Resolution - Koff A S and Murtagh D S. - J of Urology - 1983 ; (130: 1138-1141) - Publication in UK registration file - The Uninhibited Bladder in Children : Effect of Treatment on Recurrence of Urinary Infection and on Vesicoureteral Reflux Resolution - Koff A S and Murtagh D S. - J of Urology - 1983 ; (130: 1138-1141) - Publication in UK registration file - |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
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| Document reference: 32918 |
| 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 |
| View full study record |
| Document reference: 47515 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33354 |
| Study title: L'angine aiguë de l'enfant. Son traitement curatif et préventif. Boissiere H. - 1976 (Concours méd., 98 (46) 7437 - 7441)L'angine aiguë de l'enfant. Son traitement curatif et préventif. Boissiere H. - 1976 (Concours méd., 98 (46) 7437 - 7441) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45879 |
| Study title: L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45880 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32805 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48456 |
| Study title: Fusidic acid in infections of the external eye.Bijsterveld O.P. van 1987, Infection, 15: 16-19 |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48457 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28676 |
| Study title: Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: Effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatrics 1997;130:217-224.Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: Effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatrics 1997;130:217-224. |
| Active substance: HELIUM AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29088 |
| Study title: Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161)Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161) |
| Active substance: ITRACONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30810 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45725 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33546 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33616 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45731 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32809 |
| Study title: Effectiveness of Mass Oral Cholera Vaccination in Beira, Mozambique, published in New England Journal Med in Feb 2005 |
| Active substance: oral cholera vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41502 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45820 |
| 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): |
| View full study record |
| Document reference: 33841 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47658 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33383 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33628 |
| Study title: Etude clinique de Plewig et coll. 1971 |
| Active substance: TRETINOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46729 |
| Study title: Etude d'efficacité et tolérance biologique ouverte multicentrique 320 patients dont 31 de 15 ans et moins |
| Active substance: TRETINOIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46733 |
| 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 |
| View full study record |
| Document reference: 45389 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34068 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34047 |
| Study title: L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45890 |
| Study title: La scarlatine - Bastin R. & Pechere J. C. - 1966 (Presse méd., 74 (34) 1773.La scarlatine - Bastin R. & Pechere J. C. - 1966 (Presse méd., 74 (34) 1773. |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45878 |
| Study title: Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45881 |
| Study title: Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103)Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45882 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45872 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44700 |
| Study title: Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S. Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44702 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45885 |
| Study title: A phase IIIb, double-blind, randomized, placebo-controlled, multicentre study to assess the immunogenicity, safety and reactogenicity of 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus. |
| Active substance: oral live attenuated human rotavirus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45710 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45363 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38508 |
| Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11 |
| Active substance: TIZANIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38507 |
| Study title: 16. A placebo controlled 12 - week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodess in subjects with bipolar disorder i with an optionhal open -label extension. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44950 |
| Study title: 19. Antiepilepsy drug effectiveness in pediatric partial epilepsy. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47505 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33643 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45746 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45748 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45360 |
| Study title: 28. Retrospective chart review of patients diagnosed with infantile spasms and hypsarrythmia. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44963 |
| Study title: 3. Open-label, single center, safety, pharmacokinetics, and efficacy clinical trial in pediatric subjects with epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44836 |
| Study title: 30. Topiramate first add-on open label trial in pediatric subjects with inadequately controlled epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44879 |
| Study title: 30. Topiramate first add-on open label trial in pediatric subjects with inadequately controlled epilepsy. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44964 |
| Study title: 31. Prospective evaluation of epilepsy treatment with topiramate. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44965 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33641 |
| Study title: Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135 |
| Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33964 |
| Study title: Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987 Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987 |
| Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33961 |
| 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): |
| View full study record |
| Document reference: 33635 |
| 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: 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): |
| View full study record |
| Document reference: 33613 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46821 |
| Study title: Publication in CES - Ruuth E - 19/10/2001 Triamcinolone acetonide aqueous nasal inhaler and fluticasone propionate have no effect on short-term growth in children with allergic rhinitis - Skoner D - 2000 ( Allergy 2000; 55(Suppl 63): 184) |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46832 |
| Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448 |
| Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33960 |
| 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)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: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33965 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33955 |
| Study title: Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990 Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990 |
| Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33962 |
| Study title: Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32959 |
| 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 |
| View full study record |
| Document reference: 34077 |
| Study title: Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A.Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A. |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34070 |
| Study title: Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34072 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34076 |
| Study title: Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J.Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J. |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34073 |
| 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: 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45886 |
| Study title: Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352)Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45887 |
| Study title: Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165)Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165) |
| Active substance: PHENOXYMETHYLPENICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45888 |
| 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): |
| View full study record |
| Document reference: 33928 |
| Study title: Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44713 |
| Study title: Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32957 |
| Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32922 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45749 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33944 |
| Study title: Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40.Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40. |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33934 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45361 |
| Study title: Comparative evaluation of intravenous and oral ornidazole vs. clindamycin in acute infections due to anaerobic bacteria. |
| Active substance: ORNIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45375 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45374 |
| 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): |
| View full study record |
| Document reference: 40281 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT] |
| Active substance: Traumeel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40284 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40286 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009] |
| Active substance: Traumeel - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40278 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) in children aged up to 11 years old [AWB-090] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40265 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) in children aged up to 11 years old [AWB-091] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40274 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40275 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40264 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) [AWB-112]; |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40266 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT]; Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009]; |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40267 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT]; |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40272 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) [AWB-AT] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40273 |
| Study title: Retrospective survey for documentation of appllication and dosage of Traumeel S (ointment) in children < 12 years of age [Bef-023] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40276 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40271 |
| Study title: Experiencia clinica con el glutamate B6 en algunos deficits intelectuales infantilesM Knobel |
| Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): CL-GB6_M.KNOBEL.pdf |
| View full study record |
| Document reference: 48081 |
| Study title: High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Eston... |
| Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31488 |
| Study title: |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38491 |
| Study title: |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38492 |
| Study title: |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38496 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44644 |
| Study title: Expertise en pédiatrie du FLO 1347 soluté injectable - Fontaine G. - 02/02/73 |
| Active substance: TIAPRIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44744 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44670 |
| Study title: Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44676 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 31621 |
| Study title: Efficacy and tolerability of Meropenem 20 mg/kg tid in infants (3-12 months old) vs meropenem tid in children (1-14 years old) for the initial treatment of severe infections in hospitalised children. |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591IL9003.xls |
| View full study record |
| Document reference: 31622 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 31624 |
| Study title: Case-controlled, open study on the pharmacokinetics and treatment effect of 5-aminosalicylic acid in children with ulcerative colitis |
| Active substance: MESALAZINE |
| Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofallk enema_Dr Falk Pharma GmbH.xls |
| View full study record |
| Document reference: 31626 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27374 |
| Study title: A pharmacokinetic study |
| Active substance: TICARCILLIN |
| Study summary document link (including results): Study HP-83-14 Ticarcillin (Timentin).xls |
| View full study record |
| Document reference: 47676 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44804 |
| Study title: Efficacy of neuroprotectors in patients with tension headaches.Efficacy of neuroprotectors in patients with tension headaches. |
| Active substance: TINZANIDINE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44800 |
| Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2.Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. |
| Active substance: TINZANIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44787 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32024 |
| Study title: Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32026 |
| Study title: Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32028 |
| Study title: Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32030 |
| Study title: Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194)Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45018 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45020 |
| Study title: J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K. J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44610 |
| Study title: J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M, |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44614 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45003 |
| Study title: Eur Heart J. 1990 Oct;11(10):916-24. Influence of age and sex on left ventricular volumes and ejection fraction during upright exercise in normal subjects. Younis LT, Melin JA, Robert AR, Detry JM. Eur Heart J. 1990 Oct;11(10):916-24. Influence of age and sex on left ventricular volumes and ejection fraction during upright exercise in normal subjects. Younis LT, Melin JA, Robert AR, Detry JM. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44564 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44565 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44569 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40031 |
| Study title: Preparation H ointment (WH-66-228) repeated insult patch test |
| Active substance: Live Yeast Cell Derivative , Shark Liver Oil |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40030 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31380 |
| Study title: Clinical effects of Lomefloxacin ophthalmic solutionClinical effects of Lomefloxacin ophthalmic solution |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31343 |
| Study title: Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infectionsClinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31349 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44615 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38527 |
| Study title: An open label extension study of safety and efficacy of tiagabine in children with epilepsy |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38531 |
| Study title: An Open-Label Extension Study of Tiagabine HCl in the Treatment of Patients with Partial Seizures |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38528 |
| Study title: The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964)The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45036 |
| Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44984 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46708 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46718 |
| Study title: Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2. Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44825 |
| Study title: O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115. O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44830 |
| Study title: Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33. Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44832 |
| Study title: Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54. Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44833 |
| Study title: Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37. Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37. |
| Active substance: TOLNAFTATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44828 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonico-Injeel (ampoules) [AWB-AT] |
| Active substance: Tonico-Injeel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40261 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonsilla comp. Ampullen (ampoules) [AWB-AT] |
| Active substance: Tonsilla compositum-Heel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40277 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44877 |
| Study title: 15. Open-label extension study of the safety and efficacy of RWJ-17021-001 in subjects with bipolar i disorder who completed protocol TOPMAT-PDMD-002. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44949 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38526 |
| Study title: A compassionate Program of Tiagabine HCl in Treatment of Pediatric Patients with Partial Seizures |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38536 |
| Study title: Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39 |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38434 |
| Study title: Compassionate Use of Tiagabine HCl in Patients with Refractory Epilepsy |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38524 |
| Study title: Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44502 |
| Study title: Am J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron coAm J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron co |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44503 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44649 |
| Study title: A Phase IV Multicenter Randomized Double-blind study to assess the antibody response in healthy children aged 3 - 12 years after two vaccinations with FSME-IMMUN Inject |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41106 |
| Study title: A post-marketing study with FSME-IMMUN Inject to assess the rate of fever reactions in 190 healthy children aged 3 to 12 years |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41104 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44683 |
| Study title: Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al. Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44686 |
| Study title: A pilot study of topiramate in subjects with infantile spasms. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44853 |
| Study title: A pilot study of topiramate in subjects with infantile spasms. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44944 |
| Study title: A placebo controlled 12 - week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodess in subjects with bipolar disorder i with an optionhal open -label extension |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44856 |
| Study title: A retrospective chart review of infants with infantile spasm of which some were treated with Topamax |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44846 |
| Study title: A retrospective review of infants with infantile spasm of which some were treated with Topamax |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44924 |
| Study title: A pilot study of topiramate in subjects with infantile spasms |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44911 |
| Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44859 |
| Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44933 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44891 |
| Study title: Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF, Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF, |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44507 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28035 |
| Study title: Clinical investigation of the effect and safety of Tramal in paediatric postoperative administration |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45007 |
| Study title: Investigator's study (Dr. Rudolf Schosser): Post-authorisation observation Study, Booster Vaccination with FSME-IMMUN Adult und FSME-IMMUN 0,25ml Junior to achieve Protection if Irregular Vaccination scheme have occured in the vaccination history (duration: May 2005 - December 2006) |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41102 |
| Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987 |
| Active substance: TICLOPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44756 |
| Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date |
| Active substance: TICLOPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44758 |
| Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11 |
| Active substance: TINZANIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44791 |
| Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11 |
| Active substance: TINZANIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44803 |
| Study title: A PROSPECTIVE RANDOMIZED TRIAL OF FCA VS. AMPHOTERICIN B FOR EMPERIC ANTI-FUNGAL THERAPY OF THE NEUTROPENIC FEBRILE PATIENTS. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27986 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45027 |
| Study title: J Nucl Med. 1996 Sep;37(9):1444-8. Thallium-201 scintigraphy to assess effect of chemotherapy in osteosarcoma. Ohtomo K, Terui S, Yokoyama R, Abe H, Terauchi T, Maeda G, Beppu Y, Fukuma H. J Nucl Med. 1996 Sep;37(9):1444-8. Thallium-201 scintigraphy to assess effect of chemotherapy in osteosarcoma. Ohtomo K, Terui S, Yokoyama R, Abe H, Terauchi T, Maeda G, Beppu Y, Fukuma H. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44619 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44536 |
| Study title: Clin Med Res. 2003 Jul;1(3):233-8. Unsuspected widespread cardiac sarcoma in a child. Spieth ME, Kasner DI, Prasannan L. Clin Med Res. 2003 Jul;1(3):233-8. Unsuspected widespread cardiac sarcoma in a child. Spieth ME, Kasner DI, Prasannan L. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44538 |
| Study title: A CLINICAL STUDY ENTITLED TIOCONAZOL 6,5% SINGLE DOSE VAGINAL OINTMENT IN THE TREATMENT OF VAGINAL CANDIDASIS (DR. GRIGORIU ET ALL) (MULTICENTER STUDY) |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44807 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46737 |
| Study title: Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44725 |
| Study title: Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D. Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D. |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44720 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38504 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45038 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46719 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46710 |
| Study title: Study of the effects of hydrocortisone and hydrocortisone 17-butyrate ointments on plasma ACTH levels and Synacthen responses in children with eczemaStudy of the effects of hydrocortisone and hydrocortisone 17-butyrate ointments on plasma ACTH levels and Synacthen responses in children with eczema |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44466 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thalamus compositum (ampoules) [AWB-AT] |
| Active substance: Thalamus compositum-Heel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40254 |
| Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987 |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38476 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38523 |
| Study title: Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A. Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44661 |
| Study title: Open-label extension study of the safety and efficacy of rwj-17021-001 in subjects with bipolar i disorder who completed protocol topmat-pdmd-002 |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44855 |
| Study title: Open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjectswith Lennox-Gastaut syndrome |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44898 |
| Study title: Open-label, safety and efficacy, adjunctive or monotherapy study in asubjects ≥ 14 years of age with any seizure type. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44871 |
| Study title: Open-label, single center, safety, pharmacokinetics, and efficacy clinical trial in pediatric subjects with epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44894 |
| Study title: Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44512 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 24514 |
| Study title: Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. |
| Active substance: TIMOLOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44766 |
| Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86 |
| Active substance: TICLOPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44760 |
| Study title: Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M. Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44695 |
| Study title: A Multicentre Study for the Evaluation of the Clinical Efficacy and of Local and General Safety of Tioconazole in the Gynaecological Use |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): TCN-I-88-004 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48033 |
| Study title: A Multicentre Study on the Efficacy and Tolerability of 1% Tioconazole Cream in Dermatomycoses |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): TCN-I-88-004 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48034 |
| Study title: A NON COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 300MG VAGINAL OVULES FO THE SINGLE DOSE TREATMENT OF VAGINAL YEAST INFECTIONS |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 44810 |
| Study title: Efficacy and Safety of Tioconazole in the Treatment of Candidal Diaper Rash |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): TCN-TR-94-001B EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48037 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44808 |
| Study title: Efficacy and Tolerability of Dermatologic Tioconazole 1% Cream and Lotion vs Bifonazole 1% Cream and Lotion in the Treatment of Superficial Cutaneous Mycoses |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): TCN-I-86-004 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48032 |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44884 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44893 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44631 |
| Study title: Clin Nucl Med. 1988 Sep;13(9):629-31. The use and diagnostic significance of thallium-201 SPECT imaging in a case of anomalous left coronary artery. Petrozzo PJ, Woodard ML, Vitullo DA, Bekerman C, Blend MJ, Pinsky SM. Clin Nucl Med. 1988 Sep;13(9):629-31. The use and diagnostic significance of thallium-201 SPECT imaging in a case of anomalous left coronary artery. Petrozzo PJ, Woodard ML, Vitullo DA, Bekerman C, Blend MJ, Pinsky SM. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44543 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44545 |
| Study title: Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K. Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44546 |
| Study title: Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE. Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44549 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44814 |
| Study title: Treatment of Dermatomycosis with Tioconazole 2% Dermal Cream |
| Active substance: TIOCONAZOLE |
| Study summary document link (including results): TCN-MEX-87-001 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48035 |
| Study title: Heart Rhythm. 2006 Apr;3(4):424-32. Comment in: Heart Rhythm. 2006 Apr;3(4):433-4. QT peak dispersion, not QT dispersion, is a more useful diagnostic marker for detecting exercise-induced myocardial ischemia Masaki N, Takase B, Matsui T, Kosuda S, OHeart Rhythm. 2006 Apr;3(4):424-32. Comment in: Heart Rhythm. 2006 Apr;3(4):433-4. QT peak dispersion, not QT dispersion, is a more useful diagnostic marker for detecting exercise-induced myocardial ischemia Masaki N, Takase B, Matsui T, Kosuda S, O |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44578 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44579 |
| Study title: Int J Cardiol. 1994 Jan;43(1):1-9. Abnormal exercise electrocardiogram in an asymptomatic person--what next? Juneja R, Wasir HS. Int J Cardiol. 1994 Jan;43(1):1-9. Abnormal exercise electrocardiogram in an asymptomatic person--what next? Juneja R, Wasir HS. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44583 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44600 |
| Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
| Active substance: THIAMAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44735 |
| Study title: Efficacy of Thiobactin in the treatment of acute non tuberculosis lower respiratory tract infections in children |
| Active substance: THIAMPHENICOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44737 |
| Study title: EFFECT ON FETUSES AND NEWBORN YOUNG OF TORESTEN INJECTABLE SOLUTION ADMINISTERED TO PREGNANT ANIMALS |
| Active substance: THIETHYLPERAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44739 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44634 |
| Study title: Safety and Efficacy of Tiagabine HCl Monotherapy in the Treatment for Partial Seizures: High Dose versus Low Dose |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38530 |
| Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No dateStudies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38478 |
| Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86 |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38480 |
| 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 |
| View full study record |
| Document reference: 46699 |
| Study title: Evaluation of the effects of L.A.N.D., phenylephrine, and vehicle control nasal sprays in children with acute and chronic rhinitis due to coryza or allergy. |
| Active substance: TRAMAZOLINE |
| Study summary document link (including results): Tramazoline Hydrochloride_U70-0222_synopsis.pdf |
| View full study record |
| Document reference: 46700 |
| Study title: CLINICAL EVALUATION OF DIFLUCAN ON SEVERE CANDIDEMIA |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27536 |
| Study title: Levocabastine collyre dans le traitement de las conjonctivite allergique non infectieuse |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31062 |
| Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS IN ICU. |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27877 |
| Study title: To systematically document under practice conditions satisfactory tolerance, and accordingly the safety of therapy with Aspecton® Cough drops in accordance with the manufacturer’s dosage recommendations, in children with bronchitis or inflammatory bronchial disease with production of mucus. |
| Active substance: THYME |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47262 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40259 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thyreoidea compositum (ampoules) [AWB-AT] |
| Active substance: Thyreoidea compositum |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40260 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44485 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44489 |
| Study title: Safety and Efficacy of Three Dose Levels of Tiagabine HCl versus Placebo as Adjunctive Treatment for Complex Partial Seizures |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38521 |
| Study title: Safety and efficacy of Tiagabine HCl in the treatment of Pediatric Patients with Partial Seizures |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38534 |
| Study title: Unexpected side effects of tiagabine in five children with therapy resistant epileptic syndromes ; ABaumgarten-Walczak AStephani U Rabenhorst & U Stephani, U Stephani, Nervenheilkunde 1999, 18(6): 308-310Unexpected side effects of tiagabine in five children with therapy resistant epileptic syndromes ; ABaumgarten-Walczak AStephani U Rabenhorst & U Stephani, U Stephani, Nervenheilkunde 1999, 18(6): 308-310 |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38432 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44664 |
| Study title: Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44667 |
| Study title: Neurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, SoNeurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, So |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44668 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 44775 |
| 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): |
| View full study record |
| Document reference: 31140 |
| Study title: Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31128 |
| Study title: Phase 3, open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjects with Lennox-Gastaut syndrome. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44897 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44886 |
| 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-seizures (with or without secondarily genralized seizures) seizures. Open label extension study of the safety and efficacy of rwj-17021-001 in subjects with bipolar disorder who completed topmat-pdmd-002. A placebo-controlled 12-week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodes in subjects with bipolar disorder I with an optional open-label extension. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44914 |
| Study title: Prospective evaluation of epilepsy treatment with topiramate |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44869 |
| Study title: Retrospective, non-interventional evaluation of pharmacovigilance and clinical experiences with topiramate in the treatment of epilepsy in Slovakia |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44934 |
| 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 |
| View full study record |
| Document reference: 44774 |
| Study title: THE TREATMENT OF T VAGINALIS INFECTIONS IN CHILDREN |
| Active substance: TINIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44769 |
| Study title: Protective action of levocabastine PEG in antigen nasal challenge (17-32 yrs) |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31073 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31056 |
| 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): |
| View full study record |
| Document reference: 31058 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44603 |
| Study title: J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I. J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44605 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45035 |
| Study title: Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44638 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44553 |
| Study title: Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K. Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44555 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44557 |
| Study title: Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H. Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44558 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44560 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT] |
| Active substance: Traumeel - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40279 |
| Study title: Retrospective survey for documentation of appllication and dosage of Traumeel S (drops) in children < 12 years of age [Bef-022] |
| Active substance: Traumeel - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40280 |
| Study title: Effect of a new selective H1 receptor antagonist (levocabastine) in a nasal and conjunctival provocation test (11-44 yrs) |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31074 |
| Study title: Effecto de la soluci6n oftilmica de levocabastina (antagonista de receptores HI) en 10s sintomas de la conjunctivitis primaveral. Gaceta Medica de Mexico 130(6), p.481-486, 1994Effecto de la soluci6n oftilmica de levocabastina (antagonista de receptores HI) en 10s sintomas de la conjunctivitis primaveral. Gaceta Medica de Mexico 130(6), p.481-486, 1994 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31119 |
| Study title: Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31120 |
| Study title: EFFICACY AND SAFETY OF FLUCONAZOLE IN PATIENTS WITH OROPHARINGEAL CANDIDIASIS WITHOUT AIDS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27404 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34476 |
| Study title: Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32107 |
| Study title: EFFECT OF FELDENE CAP 10 MG IN ACUTE MUSCULOSKELETAL DISORDERS. AN OPEN MULTICENTER CLINICAL STUDY IN MOROCCO. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34412 |
| Study title: Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30.Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30. |
| Active substance: METHOZSALEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31715 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31716 |
| Study title: Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7. |
| Active substance: METHOZSALEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31714 |
| Study title: Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3.Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3. |
| Active substance: METHOZSALEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31723 |
| Study title: Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607.Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607. |
| Active substance: METHOZSALEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31718 |
| 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: Dynexan Mundgel. |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31225 |
| Study title: The effectiveness of a teething solution in infants. A clinical study. |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31224 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47999 |
| Study title: Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31967 |
| Study title: Metronidazole and anaerobic sepsis. |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): Metronidazole STUDY Anaerobic sepsis.xls |
| View full study record |
| Document reference: 48002 |
| Study title: Metronidazole FLAGYL injection 0.5% v/v. Adverse reactions. |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): Metronidazole STUDY Safety Review.xls |
| View full study record |
| Document reference: 48000 |
| 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 |
| View full study record |
| Document reference: 31301 |
| Study title: Effects of Lisuride and placebo on psychomotor instability syndrome in children in controlled study |
| Active substance: LISURIDE |
| Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_EXC008_study_synopsis.pdf |
| View full study record |
| Document reference: 31298 |
| Study title: Effects of lisuride hydrogen maleate in behaviorally disturbed children - double-blind controlled study with dexamphetamine sulphate |
| Active substance: LISURIDE |
| Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_HZI43_study_synopsis.pdf |
| View full study record |
| Document reference: 31300 |
| Study title: The treatment of dandruff and/or seborrhoeic dermatitits of the hair-covered scalp with 2% ketoconazole scalp gel |
| Active substance: KETOCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30835 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31602 |
| 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 |
| View full study record |
| Document reference: 31603 |
| Study title: Metronidazole in surgical infections. |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): Metronidazole STUDY Surgery.xls |
| View full study record |
| Document reference: 47998 |
| Study title: A double-blind comparison study of pivampicillin suspension and cefaclor suspension in the treatment of acute otitis media |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46062 |
| Study title: Efficacy, pharmacology, and safety of amdinocillin in treatment of neonatesEfficacy, pharmacology, and safety of amdinocillin in treatment of neonates |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46056 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46049 |
| Study title: Use of EMLA: is it an injection free alternative? |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31221 |
| Study title: Motala C, et al. Effect of loperamide on stool output and duration of acute infectious diarrhea in infants. J Pediatr 1990; 117: 467–471.Motala C, et al. Effect of loperamide on stool output and duration of acute infectious diarrhea in infants. J Pediatr 1990; 117: 467–471. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31437 |
| Study title: A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394)A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394) |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31303 |
| Study title: Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20)Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20) |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31306 |
| Study title: Loracarbef in acute maxiliary sinusitis |
| Active substance: LORACARBEF |
| Study summary document link (including results): Loracarbef - B9U-US-AZDE Synopsis with AE table.pdf |
| View full study record |
| Document reference: 31452 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 31456 |
| Study title: LY163892 vs Augmentin in otitis media - South Africa |
| Active substance: LORACARBEF |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31457 |
| Study title: LY163892 vs V-Cillin-K in streptococcal pharyngitis/tonsillitis |
| Active substance: LORACARBEF |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31458 |
| Study title: Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31968 |
| Study title: Publication 12 dans Rapport d'expertise clinique - Rôle thérapeutique du metronidazole dans les infections à bactéries anaérobies (A. Bertrand - 24 mars 1978): Treatment of a brain abscess due to Bacteroides fragilis with metronidazole - George R.H., Bint - 1976Publication 12 dans Rapport d'expertise clinique - Rôle thérapeutique du metronidazole dans les infections à bactéries anaérobies (A. Bertrand - 24 mars 1978): Treatment of a brain abscess due to Bacteroides fragilis with metronidazole - George R.H., Bint - 1976 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31969 |
| Study title: Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31970 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31971 |
| Study title: Schmör 1967 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47562 |
| Study title: Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985 |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31972 |
| Study title: The bacteriology and chemotherapy of otogenic cerebral abscesses. |
| Active substance: METRONIDAZOLE |
| Study summary document link (including results): Metronidazole STUDY Otogenic Cerebral Abcesses.xls |
| View full study record |
| Document reference: 48001 |
| Study title: Rapport d'expertise clinique - Professeur Pierre Benoît - 20/06/1969 |
| Active substance: METRONIDAZOLE AND SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31973 |
| Study title: Electrophysiological clinical evaluation of mexiletine |
| Active substance: MEXILETINE |
| Study summary document link (including results): Mexiletine hydrochloride_U85-0802_synopsis.pdf |
| View full study record |
| Document reference: 31979 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46061 |
| Study title: Mecillinam in cerebrospinal fluid in childrenMecillinam in cerebrospinal fluid in children |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46057 |
| Study title: Mecillinam in enteric feverMecillinam in enteric fever |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46054 |
| Study title: " The ""Berlin model"", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " The ""Berlin model"", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34661 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34680 |
| Study title: Open-label study; Children aged between 5 and 14 years with acute diarrhea due to viral infection or food allergy |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD5513_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31409 |
| Study title: REPRODUCTIVE STUDY, SEGMENT I - RAT EXPERIMENT. (EFFECT OF DRUG ON FERTILITY AND REPRODUCTIVE PERFORMANCE.; ORIGIN=PCS US / SU; CONTRACTOR=1; |
| Active substance: MAPROTILINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31528 |
| Study title: REPRODUCTIVE STUDY, SEGMENT III - RAT EXPERIMENT. (EFFECT OF DRUG ON LACTATION AND THE SUCKLING YOUNG); ORIGIN=PCS US / SU; CONTRACTOR=1; |
| Active substance: MAPROTILINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31529 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31548 |
| Study title: A new broad spectrum anthelminhtic. |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31544 |
| Study title: Pharmacokinetics of loracarbef in infants and children |
| Active substance: LORACARBEF |
| Study summary document link (including results): Loracarbef - B9U-MC-AZAN Summary.PDF |
| View full study record |
| Document reference: 31455 |
| Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LORATADINE |
| Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00677.pdf |
| View full study record |
| Document reference: 31464 |
| Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LORATADINE |
| Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00687.pdf |
| View full study record |
| Document reference: 31465 |
| Study title: Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205)Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205) |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31308 |
| Study title: Summary and comment on: Clinical study comparing the effects of Lisuride and placebo in hyperkinetic children |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31312 |
| Study title: EFFECT OF PRX CAP 10 MG IN ACUTE MUSCULOSKELETAL DISORDERS (A.M.D.) AN OPEN MULTICENTER CLINICAL STUDY IN TUNISIA |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34471 |
| Study title: EFFICACY AND TOLERANCE OF PIROXICAM IN THE TREATMENT OF POSTOPERATIVE ABDOMINAL PAIN IN CHOLECYSTECTOMIZED PATIENTS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34346 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31532 |
| Study title: Dose Range Study of Flubendazole in Children vith Ascaris lumbricoides and/ or Trichuris trichiura infections.1979 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31533 |
| Study title: Open trial of mebendazola in Trichuris trichiura and Hookworm Infections. 1972 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31543 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31720 |
| Study title: Volc-Platzer B. Photochemotherapy improves chronic cutaneous graft-versus-host disease, J Am Acad Dermatol. 1990 Aug;23(2 Pt 1):220-8.Volc-Platzer B. Photochemotherapy improves chronic cutaneous graft-versus-host disease, J Am Acad Dermatol. 1990 Aug;23(2 Pt 1):220-8. |
| Active substance: METHOZSALEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31721 |
| Study title: Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trialClinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31352 |
| Study title: Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection.Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection. |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31347 |
| Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Luffa compositum-Heel (tablets) and Luffa comp.-Heel (nose drops) in the treatment of hay fever [AWB-008] |
| Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40050 |
| Study title: Retrospective survey for documentation of appllication and dosage of Luffeel comp. (nose drops) in children < 6 years of age [Bef-017] |
| Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40051 |
| 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): |
| View full study record |
| Document reference: 31476 |
| Study title: Clinical safety and efficacy evaluation of oral lymecycline versus minocycline in the treatment of inflammatory acne - Mexico |
| Active substance: LYMECYCLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31475 |
| Study title: Efficacy and safety of Tetralysal 300mg compared to Vibramycin-D 100mg in subjects with acne vulgaris |
| Active substance: LYMECYCLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31477 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (tablets) [AWB-027] |
| Active substance: Lymphomyosot |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40053 |
| Study title: Retrospective survey for documentation of appllication and dosage of Lymphomyosot N (tablets) in children < 12 years of age [Bef-024] |
| Active substance: Lymphomyosot |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40052 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (ampoules) [AWB-AT] |
| Active substance: Lymphomyosot - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40054 |
| Study title: Bacillus clausii effects in children with allergic rhinitis. |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): ADPE05F0825.pdf |
| View full study record |
| Document reference: 31155 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31724 |
| 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 |
| View full study record |
| Document reference: 47245 |
| Study title: Control of epidemic meningococcal meningitis by mass vaccination. |
| Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47477 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31365 |
| 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): |
| View full study record |
| Document reference: 31360 |
| Study title: Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyesTherapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31345 |
| 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 |
| View full study record |
| Document reference: 47249 |
| 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 |
| View full study record |
| Document reference: 47250 |
| Study title: Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101)Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101) |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31645 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 32038 |
| Study title: Langer DH, Rapoport JL, Ebert MH, Lake CR, Nee LE. In: Greenhill, LL; Shopsin, B (Eds). The psychobiology of childhood; A Profile of current issues. Lancaster, MTP, 1984. P.197-210.Langer DH, Rapoport JL, Ebert MH, Lake CR, Nee LE. In: Greenhill, LL; Shopsin, B (Eds). The psychobiology of childhood; A Profile of current issues. Lancaster, MTP, 1984. P.197-210. |
| Active substance: MIANSERIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31989 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31379 |
| 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 + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31502 |
| Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders 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): |
| View full study record |
| Document reference: 31505 |
| Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - 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): |
| View full study record |
| Document reference: 31507 |
| 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): |
| View full study record |
| Document reference: 31549 |
| Study title: Therapeutical effectiveness and safety of 2% mebendazole syrup In various helminthiases. 1975 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31547 |
| Study title: Baume P. Mebeverine, an effective agent in the irritable colon syndrome.; Aust N Z J Med. 1972 Feb;2(1):34-6. |
| Active substance: MEBEVERINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31555 |
| Study title: Connell AM. Physiological and clinical assessment of the effect of the musculotropic agent mebeverine on the human colon.; Br Med J. 1965 Oct 9;2(5466):848-51. |
| Active substance: MEBEVERINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31556 |
| 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): |
| View full study record |
| Document reference: 32045 |
| Study title: Clinical study of a new synthetic antimicrobial agent, Lomeflox-acin ophthalmic solution in bacterial external eye infections.Clinical study of a new synthetic antimicrobial agent, Lomeflox-acin ophthalmic solution in bacterial external eye infections. |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31346 |
| Study title: Contrast of the effect of alomide and sodium cromoglycate in the treatment of allergic eye diseases. Zhang W, Lin Z. Yan Ke Xue Bao. 2000 Sep;16(3):214-6. Contrast of the effect of alomide and sodium cromoglycate in the treatment of allergic eye diseases. Zhang W, Lin Z. Yan Ke Xue Bao. 2000 Sep;16(3):214-6. |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31406 |
| Study title: Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eyeEfficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31353 |
| Study title: Efficacy of topical Lomefloxacin for external eye infectionEfficacy of topical Lomefloxacin for external eye infection |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31350 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31393 |
| Study title: Prospektiver vergleich von miconazol-gel und nystatin-suspension in der therapie des mundsoorsProspektiver vergleich von miconazol-gel und nystatin-suspension in der therapie des mundsoors |
| Active substance: MICONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31995 |
| 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 |
| View full study record |
| Document reference: 48310 |
| Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli |
| Active substance: MECILLINAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47882 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31366 |
| Study title: Kostromina V.P. et al: Estimation of detoxicational effects of antihomotoxic medicines in the treatment of children suffering from relapsing bronchitis and infected with mycobacteria. Biological Therapy (Ukraine), 2007, 3: 20-23 [IIT-publication] |
| Active substance: Lymphomyosot - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40060 |
| Study title: Kostromina V.P. et al: Estimation of detoxicational effects of antihomotoxic medicines in the treatment of children suffering from relapsing bronchitis and infected with mycobacteria. Biological Therapy (Ukraine), 2007, 3: 20-23 [IIT-publication] |
| Active substance: Lymphomyosot - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40061 |
| 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): |
| View full study record |
| Document reference: 40059 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (drops) [AWB-AT] |
| Active substance: Lymphomyosot - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40062 |
| 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): |
| View full study record |
| Document reference: 40057 |
| 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): |
| View full study record |
| Document reference: 40063 |
| Study title: Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children. La Grutta S , Nicolini G, Capristo C, Bellodi SC, Rossi GA (Monaldi Arch Chest Dis. 2007 Mar;67:30-8.) |
| Active substance: MADIPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31479 |
| 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): |
| View full study record |
| Document reference: 41410 |
| Study title: Van Hasselt et al. Pretreatment with [131I] metaiodobenzylguanidine and surgical resection of advanced neuroblastoma, European journal of pediatric surgery official journal of Austrian Association of Pediatric Surgery = Zeitschrift fur Kinderchirurgie (1996), 6(3), 155-8 |
| Active substance: META-IODOBENZYLGUANIDINE |
| Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
| View full study record |
| Document reference: 48328 |
| 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 |
| View full study record |
| Document reference: 47735 |
| Study title: EMLA cream 5% for removal of mollusca. A clinical study of plasma concentrations of lidocaine and prilocaine and analgesic effect in children. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 19_86EM13 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47239 |
| 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 |
| View full study record |
| Document reference: 47223 |
| Study title: Effect of inhaled azidocillin, mistabron and combination therapy in children with cystic fibrosis. |
| Active substance: MESNA |
| Study summary document link (including results): DE84H032C - Mesna.pdf |
| View full study record |
| Document reference: 31671 |
| Study title: Effect of inhaled azlocillin, mistabron and combination therapy in children with c.f. |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31673 |
| Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders 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 + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): Mg lactate_mg pidolate_pyridoxine chlorhydrate STUDY 246-6-004.xls |
| View full study record |
| Document reference: 31504 |
| Study title: Prevention of secondary cases of meningococcal disease in household contacts by vaccination. |
| Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
| Study summary document link (including results): link to document |
| View full study record |
| Document reference: 41274 |
| Study title: Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date.Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date. |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31382 |
| Study title: Evaluation of analgesic effect and tolerability of EMLA Cream 5% in the laser treatment of port wine stains. Multicentre, randomised, double-blind versus placebo. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 28_EM 9301 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47232 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47228 |
| 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): |
| View full study record |
| Document reference: 41523 |
| Study title: An international study on the treatment of NRTI-experienced HIV-infected children |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41526 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31135 |
| 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 |
| View full study record |
| Document reference: 31068 |
| Study title: The effect of levocabastine nasal spray in nasal provocation test (14-60 yrs) |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): LMD62438_Interventional_Levocabastine.xls |
| View full study record |
| Document reference: 31075 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47618 |
| Study title: Treatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisalTreatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisal |
| Active substance: MICONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31997 |
| Study title: Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52 |
| Active substance: MIDAZOLAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32004 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31385 |
| Study title: A multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of zafirlukast (Accolate) and loratadine in subjects with seasonal allergic rhinitis - 9188IL0126 |
| Active substance: ZAFIRLUKAST |
| Study summary document link (including results): 9188L0126 Summary.pdf |
| View full study record |
| Document reference: 45595 |
| Study title: HIV-NAT 017: Lopinavir with saquinavir in HIV-infected children: PK and 2-year treatment follow-up |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41525 |
| 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): |
| View full study record |
| Document reference: 31448 |
| Study title: Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9.Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9. |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41529 |
| Study title: Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children. |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41528 |
| 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 |
| View full study record |
| Document reference: 31567 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31369 |
| Study title: Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7. Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7. |
| Active substance: MIDAZOLAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32006 |
| Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated varicella vaccine (Oka-strain) when administered at the same time as routine MMR (measles, mumps, rubella) vaccine but at different injection sites. An open clinical study in healthy 15- to 18-month-old children. |
| Active substance: Live attenuated varicella vaccine (OKA strain) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47336 |
| Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41365 |
| Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41457 |
| 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 |
| View full study record |
| Document reference: 31708 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41621 |
| Study title: Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82.Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82. |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31928 |
| Study title: "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9." "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9." |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31930 |
| 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: Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection.Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. |
| Active substance: LOMEFLOXACIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31354 |
| 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): |
| View full study record |
| Document reference: 31357 |
| 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 + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31492 |
| Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirls |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47475 |
| Study title: Evaluation study of the side effects occumng after two RA27/3 strains of rubella vaccines in a population of schoolgirls. |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47476 |
| Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31483 |
| Study title: Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology 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 -Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31485 |
| Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis |
| Active substance: LEVOPROMAZINE |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31169 |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31283 |
| Study title: Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4 |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31647 |
| Study title: On teh mucolytic effect of Mistabron. |
| Active substance: MESNA |
| Study summary document link (including results): DE77K058 - Mesna.pdf |
| View full study record |
| Document reference: 31662 |
| Study title: On the mucolytic effect of mistabron. |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31664 |
| Study title: Clinical effect of an anti histaminic agent MQZ on perennial nasal allergy. A double blind study with clemastine fumarate |
| Active substance: MEQUITAZINE |
| Study summary document link (including results): Primalan L0013CPC44.xls |
| View full study record |
| Document reference: 31615 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mercurius-Heel S (tablets) [AWB-AT] |
| Active substance: Mercurius-Heel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40070 |
| Study title: Retrospective survey for documentation of appllication and dosage of Mercurius-Heel S (tablets) in children < 12 years of age [Bef-018] |
| Active substance: Mercurius-Heel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40069 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591IL0020 21 22.xls |
| View full study record |
| Document reference: 31625 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591IL0045.xls |
| View full study record |
| Document reference: 45255 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591US0001.xls |
| View full study record |
| Document reference: 45256 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591IL0062.xls |
| View full study record |
| Document reference: 45257 |
| 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): |
| View full study record |
| Document reference: 31227 |
| Study title: Four types of topical anaesthetic agents: evaluation of clinical effectiveness. |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31220 |
| Study title: A Study of the Effectiveness of Loperamide Vs. Bismuth Subsalicylate in the Symptomatic Treatment of Acute Diarrhea: Intention to Treat Analysis |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31415 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 31287 |
| Study title: Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41521 |
| Study title: Theralene pectoral bebe, rapport d'expertise clinique - Manciaux M. - 19/03/66 |
| Active substance: ALIMEMAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46440 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31114 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31145 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 3591US0013.xls |
| View full study record |
| Document reference: 45258 |
| Study title: |
| Active substance: MEROPENEM TRIHYDRATE |
| Study summary document link (including results): 1946600600.xls |
| View full study record |
| Document reference: 45259 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32007 |
| Study title: A survey of the side effects of midecamycin acetate (Miocamycin) dry syrup after marketing - T. Mayama, K. Maruyama, T. Nakazawa and M. Iida - International journal of clinical Pharmacology, therapy and toxicology, vol.28 nr6 - 1990 (245-250) |
| Active substance: MIDECAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32012 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32016 |
| Study title: Effect of Miocamycin on theophylline kinetics in children - N. Principi, J. Onorato, M.G. Guiliani, and A. Vigano - Eur. J. Clin Pharmacol (1987)31:701-704 |
| Active substance: MIDECAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32010 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32014 |
| Study title: Studio multicentrico sulla faringotonsillite in età pediatrica - P. Marchisio, A. Calanchi, J. Onorato, A. Plebani, E. Reali, L. Rancilio, E. Grasso, L. Magni, G. Caramia, et al. - Riv. Inf. Ped. (1989), 4, 239-249 |
| Active substance: MIDECAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32011 |
| Study title: Studio preliminare sulla Farmacocinetica della miocamicina nell'età pediatrica - L. Tarani, A. Teggi, L. Bruni, et al Riv. Inf. Ped. 1989, 4, 251-255 |
| Active substance: MIDECAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32013 |
| Study title: Upper respiratory tract infections in children: Antibiotic treatment - Marchisio P., Principi, N. - Drugs Exptl. Clin. Res. XIII(9) 585-588 (1987) |
| Active substance: MIDECAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32017 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32021 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41530 |
| Study title: van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66 |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41522 |
| Study title: Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10. Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10. |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41527 |
| 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): |
| View full study record |
| Document reference: 31459 |
| Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy |
| Active substance: LORACARBEF |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31453 |
| Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy |
| Active substance: LORACARBEF |
| Study summary document link (including results): Loracarbef - B9U-MC-AZAZ aCSR redacted.PDF |
| View full study record |
| Document reference: 31454 |
| Study title: Loracarbef concentration in sinus secretions/mucosa in children |
| Active substance: LORACARBEF |
| Study summary document link (including results): Loracarbef - B9U-MC-AZCX Synopsis.pdf |
| View full study record |
| Document reference: 31450 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 31364 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31394 |
| Study title: Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002)Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32022 |
| Study title: COMPARISON OF PIROXICAM VS PARACETAMOL IN PATIENTS WITH DENTAL SURGERY |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34433 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31521 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31707 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31367 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32739 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46069 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23934 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41833 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23479 |
| Study title: Short term treatment of acute urinary tract infection in girlsShort term treatment of acute urinary tract infection in girls |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46053 |
| Study title: Short term treatment with pivmecillinam in uncomplicated urinary tract infections in childrenShort term treatment with pivmecillinam in uncomplicated urinary tract infections in children |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46059 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34530 |
| Study title: "Viral inception of Asthma: Prospective study from infancy to early school age " |
| Active substance: PREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34683 |
| Study title: |
| Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34577 |
| Study title: Theralene pectoral, clinical expertise - Giraud - 06/01/65 |
| Active substance: ALIMEMAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46441 |
| Study title: A double blind, cross-over study to examine the effect of an inhaled corticosteroid (BUD) on the response to histamine challenge in a group of 12 mild asthmatics (aged 17 to 54 years) subjects |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48406 |
| Study title: A double blind, cross-over, randomized study with 2 periods of 2 weeks with 2weeks washout. To investigate the mechanisms for the clinical effects of budesonide on LAR, by measuring inflammatory cells and markers in bronchoalveolar lavage (BAL) fluid. Mean age (range): 24.5 years (17 - 30 years) |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48404 |
| Study title: A double-blind study to investigate whether prolonged corticosteroid therapy potentiates the effects of beta-2 agonist on pulmonary function in 14 asthmatic children (8-15 years). |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48407 |
| Study title: A double-blind, cross-over study to investigate the effects of inhaled BUD on wheezy infants <18 months of age (aged 4-17 months). |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48429 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48426 |
| Study title: A double-blind, randomized, cross-over studytTo determine whether the inhaled glucocorticoid BUD has any adverse effect on short-term linear growth in 15 children (6-13 years) with mild asthma. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48419 |
| Study title: A double-blind, placebo-controlled, randomized, cross-over study to determine whether BUD administered by the Nebuhaler was an effective prophylactic therapy for asthma in pre-school children aged 2-6 years. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48420 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48417 |
| Study title: A prospective, double-blind study to evaluate whether nebulised local steroid treatment is effective in the treatment of croup in infants and young children 3 months to 4.9 years. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48436 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48408 |
| Study title: A randomized, double-blind placebo controlled study to determine the effectiveness of nebulized budesonide in the treatment of acute bronchiolitis and in the prevention of postbronchiolitic wheezing in Infants with bronchiolitis < 12 months old. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48423 |
| 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 |
| View full study record |
| Document reference: 46112 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34688 |
| Study title: Clinical and EEG effects of piracetam in children with learning disorders. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ARCE04H1614 - Piracetam.pdf |
| View full study record |
| Document reference: 45909 |
| Study title: Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32072 |
| Study title: Massimino M et al, Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di, Ematologia-Oncologia Pediatrica) study, Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45 |
| Active substance: ETOPOSIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26826 |
| Study title: Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. |
| Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39934 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48421 |
| Study title: An open, prospective study to assess the long-term safety, as well as efficacy, of BUD in 52 asthmatic children aged 4-13 years (mean 9.6) whose asthma was not adequately controlled by their current therapy. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48413 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48418 |
| Study title: An open, randomised, cross over, active control study with two periods each of 2 weeks duration to investigate the stýstemic effects of low daily doses of ICS in 12 asthmatic children. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48415 |
| Study title: Tolerability of cetirizine in children. results of a prospective clinical observation study in 305 children suffering from allergic disorders of the upper respiratory tract and allergic pruritus. |
| Active substance: CETIRIZINE |
| Study summary document link (including results): SRCE92E2202 - Cetirizine.pdf |
| View full study record |
| Document reference: 23783 |
| Study title: Double-blind, randomized, placebo-controlled trial of the efficacy and safety of 5% minoxidil foam in the treatment of androgenetic alopecia in males |
| Active substance: MINOXIDIL |
| Study summary document link (including results): minoxidil A6221001.pdf |
| View full study record |
| Document reference: 32064 |
| Study title: Effect of methyldopa, propranolol, and propranolol plus minoxidil in the management of hypertension associated with renal disease in children. |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32063 |
| Study title: Effect of minoxidil on arterial blood pressure, cardiac index, nd plasma rennin activity in 6 severely hypertensive children |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32062 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32157 |
| Study title: Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32132 |
| Study title: Immunogenicity and safety study of two doses of Fluvirin (0.25 mL and 0.5 mL) with Vaxigrip (0.25 mL), in Healthy naive pediatric subjects aged 6 to 35 months. |
| Active substance: INFLUENZA VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48403 |
| Study title: An open, uncontrolled study with 3 periods, each of 3 weeks duration to assess the clinical efficacy of budesonide via nebilizer, 1000 mg bid, in chronically weezing infants, aged 2 to 12 months, and to evaluate any adrenal side-effects . |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48416 |
| Study title: Early detection of persistent trophoblastic tumour by serum human chorionic gonadotrophin monitoring after molar pregnancy. |
| Active substance: DACTINOMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25336 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34537 |
| Study title: Efficacy, pharmacology, and safety of amdinocillin in treatment of neonates; de Louvois et al, 1983, American Journal of medicine, 29 August, 119-124 Efficacy, pharmacology, and safety of amdinocillin in treatment of neonates; de Louvois et al, 1983, American Journal of medicine, 29 August, 119-124 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34533 |
| Study title: FL 1039, a new Semisynthetic Penicillin, Preliminary Report on Its Use in Enteric Fever ; B. Limson FL 1039, a new Semisynthetic Penicillin, Preliminary Report on Its Use in Enteric Fever ; B. Limson |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34527 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34536 |
| Study title: Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479 Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34534 |
| Study title: Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8.Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8. |
| Active substance: POLYMYXIN B AND TRIMETHOPRIM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34585 |
| Study title: Adler – Effective Treatment of Constipation and Encopresis with MOVICOL (Macrogol 3350 with electrolytes) in Children and Adolescents. |
| Active substance: POLIDOCANOL COMBINATIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34581 |
| Study title: Early postnatal effects of noopept and piracetam on declarative and procedural memory of adult male and female rats. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE06C0607 - Piracetam.pdf |
| View full study record |
| Document reference: 46044 |
| Study title: Effect of acupuncture in improving intelligence and language disorder of autistic children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPZ06C2119 - Piracetam.pdf |
| View full study record |
| Document reference: 46032 |
| 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 |
| View full study record |
| Document reference: 45901 |
| Study title: Effect of piracetam on the mean intrasplenic red cell transit time (MST) in sickle cell disease and sickle cell thalassaemia. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE88A153P - Piracetam.pdf |
| View full study record |
| Document reference: 45941 |
| Study title: Effect of pirazetam on brain development in newborn rats exposed to hypoxia. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE84G025P - Piracetam.pdf |
| View full study record |
| Document reference: 46036 |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48387 |
| Study title: An open label, single-center, pilot study to assess the safety, tolerability and immunogenicity of three injections of the HibCRM/AlPO4 vaccine, when given at 2, 3, 4 months of age to healthy infants. |
| Active substance: Influenza Vaccine (Split Virion, Inactivated) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48390 |
| Study title: Improved Acidosis Correction and Recovery of Mesothelial Cell Mass with Neutral-pH Bicarbonate Dialysis Solution among Children Undergoing Automated Peritoneal Dialysis, 2003 Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003 |
| Active substance: ISOTONIC SOLUTIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30757 |
| Study title: Effectiveness of a Vi capsular polysaccharide vaccine |
| Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41209 |
| Study title: Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587 Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34531 |
| Study title: Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95 Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34532 |
| Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175 Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34538 |
| Study title: Pivmecillinam in the treatment of recurrent urinary infection in girls; (Deasy P.F: and Lynch K., 1980, Irish Medical Journal, 73: 388-389 Pivmecillinam in the treatment of recurrent urinary infection in girls; (Deasy P.F: and Lynch K., 1980, Irish Medical Journal, 73: 388-389 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34535 |
| Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34539 |
| Study title: Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 |
| Active substance: PIVMECILLINAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34529 |
| Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp. |
| Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40132 |
| Study title: Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4)Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4) |
| Active substance: PRISTINAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46114 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46116 |
| Study title: Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493) |
| Active substance: PRISTINAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46117 |
| Study title: Effect of yizhi koufuye on intelligence structure in children with intelligence retardation. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE05J1308 - Piracetam.pdf |
| View full study record |
| Document reference: 46012 |
| Study title: Effectiveness of Nootropil treatment in children with inhibited expressive speech. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU90B131P - Piracetam.pdf |
| View full study record |
| Document reference: 45998 |
| Study title: Effects of nootropic drugs on some behavioural and bioche- mical changes after early postnatal hypoxia in the rat. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE87A291P - Piracetam.pdf |
| View full study record |
| Document reference: 46035 |
| Study title: Effects of piracetam administration to suckling rats on morphometry of neocortex and hippocampus. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE98J0910 - Piracetam.pdf |
| View full study record |
| Document reference: 46040 |
| Study title: Effects of piracetam in childbirth: anatomical aspects. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92K2710 - Piracetam.pdf |
| View full study record |
| Document reference: 45990 |
| Study title: Effects of piracetam in childbirth: clinical aspects. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92K2709 - Piracetam.pdf |
| View full study record |
| Document reference: 45961 |
| Study title: Effects of piracetam in children with learning disorders. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DS86C182P - Piracetam.pdf |
| View full study record |
| Document reference: 45927 |
| Study title: Effects of treatment based on piracetam on 30 neurologically damaged children of under one year old. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE77E091P - Piracetam.pdf |
| View full study record |
| Document reference: 45985 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34697 |
| Study title: The "Berlin model", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - The "Berlin model", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34574 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34575 |
| Study title: Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - 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): |
| View full study record |
| Document reference: 34576 |
| Study title: Dry and Itching Skin - therapy with a new preparation, containing urea and polidocanol. |
| Active substance: POLIDOCANOL AND UREA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34578 |
| Study title: Clinical observations with regard to the effects of UCB 6215 on some brain functions in schoollchildren. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE73C201 - Piracetam.pdf |
| View full study record |
| Document reference: 46017 |
| Study title: Comparison effects of vascular preparates in patients with cerebrovascular pathology. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE97C1402 - Piracetam.pdf |
| View full study record |
| Document reference: 46005 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32069 |
| Study title: Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32181 |
| Study title: Pratt CB et al. Treatment of unresectable or metastatic pediatric soft tissue sarcomas withsurgery, irradiation, and chemotherapy: a Pediatric Oncology Group study. Med Pediatr Oncol. 1998 Apr;30(4):201-9.Pratt CB et al. Treatment of unresectable or metastatic pediatric soft tissue sarcomas withsurgery, irradiation, and chemotherapy: a Pediatric Oncology Group study. Med Pediatr Oncol. 1998 Apr;30(4):201-9. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32185 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32082 |
| Study title: To study the effects of Fongitar (Polytar AF) in Pityriasis and squamous conditions of the scalp. |
| Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40133 |
| Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy |
| Active substance: Placenta compositum |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40136 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Placenta compositum (ampoules) [AWB-AT] |
| Active substance: Placenta compositum-Heel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40137 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Plantago-Homaccord (drops) [AWB-AT] |
| Active substance: Plantago-Homaccord |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39767 |
| 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 |
| View full study record |
| Document reference: 45976 |
| Study title: Clinical trial of the pneumococcal 23-valent vaccine in children with sickle cell disease or splenectomy (> 6 months-15 years old) |
| Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41324 |
| Study title: Safety and immunogenicity of the 23-valent pneumococcal vaccine after storage at 4°C for one year. (age 10-52 years old) |
| Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41325 |
| Study title: Safety and immunogenicity of the 23-valent vaccine in healthy children at increased risk of pneumococcal infection. (2-18 years old) |
| Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41323 |
| Study title: A Pilot Study of the Safety, Tolerability and Immunogenicity of Monovalent Pneumococcal Type 6B Conjugate Vaccine in Adults, Children and Infants |
| Active substance: Pneumococcal polysaccharides (serotypes 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C, 19F,20,22F,23F,33F) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47769 |
| Study title: A Multicenter, Open-Label Study of Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Healthy Infants |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41586 |
| Study title: A Phase II Randomized, Controlled Study to Determine the Safety and Immunogenicity of Two Combination Vaccines Containing Meningococcal C and Pneumococcal Capsular Polysaccharide-CRM197 Conjugates with or without PRP-CRM197 (HibTITER) in Healthy Infants |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41587 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41589 |
| Study title: EXPRES (EXacerbation PRevention with Elidel Survey) |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CNL01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34115 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47711 |
| Study title: Naturalistic, open-label, multicenter study of short-term management in early school-aged 6-10 years old) children with mild or moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CPL01 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34101 |
| Study title: Oncogenicity study by dermal administration to CD-1 mice for 52 weeks |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34128 |
| Study title: Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19. Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32174 |
| Study title: Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32172 |
| 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 |
| View full study record |
| Document reference: 28376 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41516 |
| Study title: Retrospective Review of Routine Prophylaxis and Inhibitor Treatment with Fanhdi (Bonn) |
| Active substance: HUMAN COAGULATION FACTOR VIII |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29147 |
| Study title: PMS: Pimecrolimus Cream 1% in childhood atopic dermatitis |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CHU02 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34112 |
| Study title: StabiEL Stabilisierung des Hautzustandes mit Elidel® (Pimecrolimus) – Post Marketing Surveillance Study. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CDE18 Art45 listing 2011.xls |
| View full study record |
| Document reference: 34097 |
| 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 |
| View full study record |
| Document reference: 34111 |
| Study title: Two prospective studies each conducted during 7 months in different locations: * with tacrolimus ointment 0.1%, a randomized, double-blind, placebo-controlled * with pimecrolimus cream 1%, a nonrandomized control study. |
| Active substance: PIMECROLIMUS |
| Study summary document link (including results): ASM981CBE02 Art45 listing 2011.xls |
| View full study record |
| Document reference: 48118 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32068 |
| Study title: Evolution of coma in children with chlorinated insecticides intoxication treated with piracetam. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE85G241P - Piracetam.pdf |
| View full study record |
| Document reference: 46010 |
| Study title: Gender differences in the effect of the nootropic medicine, noopept, in the model of early postnatal hypoxia. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE05L2910 - Piracetam.pdf |
| View full study record |
| Document reference: 46043 |
| Study title: Improvement of intellectual performance contribution of a specific cortical therapy. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE73G026 - Piracetam.pdf |
| View full study record |
| Document reference: 46019 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45734 |
| Study title: Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972 |
| Active substance: AMPICILLIN AND CLOXACILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46653 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32163 |
| Study title: Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52.Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32246 |
| Study title: Effect of Madecassol on healing of skin grafts among severely burned children |
| Active substance: Asiaticoside (Hydrocotyle Reconstituted Dry Extract (Centella Asiatica)) |
| Study summary document link (including results): Bayer CC_Asiaticoside_CC-02607_study_synopsis.pdf |
| View full study record |
| Document reference: 47908 |
| Study title: Einfachblinde, randomisierte, Verum-kontrollierte, monozentrische Studie zum Nachweis der Nicht-Unterlegenheit von Leukichtan Gel vs. Betaisodona Salbe in der Behandlung von Schnitt-, Schürfwunden und Verbrennungen |
| Active substance: ICHTASOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29767 |
| Study title: Effects of inhaled budesonide on serum markers of bone metabolism in children with asthma. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48431 |
| Study title: Study 1: An open label study to investigate whether BUD tehrapy given for four weeks could possibly potentiate the effect of terbutaline inhaled 15 minutes before exercise challenge in 14 children with exercise-induced asthma; Study 2: A double-blind, placebo controlled, cross-over study to investigate the effect of inhaled BUD on exercise-induced asthma in children in 14 asthmatic children (different from those in Study 1) |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48409 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48405 |
| Study title: Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802.Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32214 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41591 |
| Study title: A Randomized, Double Blind, Study of the Safety and Immunogenicity of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine in Healthy Infants at 2, 4, and 6 Months of Age. Amendment # 1: Safety and Immunogenicity of a Booster Dose of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine Administered Concurrently with MMR in Toddlers 12-15 Months of Age. |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41592 |
| Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41593 |
| Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41594 |
| Study title: An Open-Label Pilot Study to Evaluate the Safety Of Pneumococcal 7-Valent Conjugate Vaccine [Diphtheria Crm197 Protein] (Prevenar) in Healthy Adults and Children at 3 to 5 Years Old. |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41595 |
| Study title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar in Healthy Infants at 2, 4 and 6 months of age. |
| Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41597 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34545 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Podophyllum compositum (drops) [AWB-AT] |
| Active substance: Podophyllum compositum |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39768 |
| 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): |
| View full study record |
| Document reference: 46073 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27361 |
| Study title: COMPASSIONATE USE PROTOCOL FOR THE TREATMENT OF A THREE-YEAR OLD CHILD WITH SCEDOSPORIUM INFECTION |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 27788 |
| Study title: Hiddemann W et al. Antifungal treatment by amphotericin B and 5-fluorocytosine delays the recovery of normal hematopoietic cells after intensive cytostatic therapy for acute myeloid leukemia. Cancer. 1991 Jul 1;68(1):9-14 |
| Active substance: FLUCOCYTOSIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27303 |
| Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSES ASSOCIATED WITH DIGESTIVE MALIGNANCY |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27925 |
| 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 |
| View full study record |
| Document reference: 45910 |
| Study title: A preliminary report on piracetam in sickle cell anemia: a double blind cross over clinical trial and effect on erythrocyte survival. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE84B023P - Piracetam.pdf |
| View full study record |
| Document reference: 45978 |
| Study title: OPEN, NON-COMPARATIVE STUDY OF FLUCONAZOLE IN PATIENTS WITH COCCIDIOIDAL MENINGITIS |
| Active substance: FLUCONAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28052 |
| Study title: Antibiotics in Acute Osteomyelitis in Children;Blockey N J, McAllister T A J Bone Jt Surg Ser B 1972; 54(2): 299-309 |
| Active substance: FUSIDIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28707 |
| Study title: |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41160 |
| 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): |
| View full study record |
| Document reference: 29478 |
| Study title: Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473.Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473. |
| Active substance: FOSCARNET |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39593 |
| Study title: Use of gentamicin in chlildren with cystic fibrosis 6 Boxerbaum B. - 1971 (J. of Infectious Dis. Supl. 124:293) - Publication in Gentamicin Registration Dossier - 1978 - |
| Active substance: GENTAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28948 |
| 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 |
| View full study record |
| Document reference: 23570 |
| Study title: Effect of long-term treatment with the h 1 -receptor antagonist cetirizine in the prevention of urticaria in children with atopic dermatitis |
| Active substance: CETIRIZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23697 |
| Study title: Mecillinam in the treatment of neonatesMecillinam in the treatment of neonates |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46055 |
| Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio sppPivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46064 |
| Study title: Pivmecillinam in the treatment of childhood pyelonephritisPivmecillinam in the treatment of childhood pyelonephritis |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46058 |
| Study title: Pivmecillinam in the treatment of recurrent urinary infection in girlsPivmecillinam in the treatment of recurrent urinary infection in girls |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46060 |
| Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzaeRandomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46067 |
| Study title: Randomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infectionsRandomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infections |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46066 |
| 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): |
| View full study record |
| Document reference: 46065 |
| Study title: Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32180 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47214 |
| 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): |
| View full study record |
| Document reference: 34648 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44253 |
| 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): |
| View full study record |
| Document reference: 34383 |
| Study title: TO STUDY THE EFFECT, INCIDENCE, SEVERITY OF LOCAL AND SYSTEMIC SIDE EFFECTS OF INTERMUSCULAR PIROXICAM IN ACUTE MUSCULOSKELETAL DISEASE. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34355 |
| Study title: TO STUDY THE EFFICACY AND INCIDENCE IN THE SEVERITY OF LOCAL AND SYSTEMIC ADVERSE REACTIONS OF INTRAMUSCULAR PIROXICAM ADMINISTRATION IN ACUTE MUSCULOSKELETAL DISORDERS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34429 |
| 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): |
| View full study record |
| Document reference: 34393 |
| Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34410 |
| Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34434 |
| 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): |
| View full study record |
| Document reference: 35295 |
| Study title: TO STUDY THE PAIN-RELIEVING EFFECT OF PIROXICAM VS. BARALGIN AND FELDENE. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34344 |
| Study title: A comparison of Pondocillin® and Calcipen® in children with acute otitis media |
| Active substance: PIVAMPICILLIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46046 |
| Study title: Clinical and diagnostic features of osteomyelitis occurring in the first three months of life. Wong M, Isaacs D, Howman-Giles R, Uren R. Pediatr Infect Dis J. 1995 Dec;14(12):1047-53. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43574 |
| Study title: Maurer AH, Chen DC, Camargo EE, Wong DF, Wagner HN Jr, Alderson PO. Utility of three-phase skeletal scintigraphy in suspected osteomyelitis: concise communication. J Nucl Med. 1981 Nov;22(11):941-9. Maurer AH, Chen DC, Camargo EE, Wong DF, Wagner HN Jr, Alderson PO. Utility of three-phase skeletal scintigraphy in suspected osteomyelitis: concise communication. J Nucl Med. 1981 Nov;22(11):941-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44108 |
| Study title: Shi QX. [Bone imaging in the detection of skeletal metastasis] Zhonghua Zhong Liu Za Zhi. 1989 May;11(3):196-8. Chinese. Shi QX. [Bone imaging in the detection of skeletal metastasis] Zhonghua Zhong Liu Za Zhi. 1989 May;11(3):196-8. Chinese. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43786 |
| Study title: Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40. Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43686 |
| Study title: Vander Borght T, Laloux P, Maes A, Salmon E, Goethals I, Goldman S; Belgian Society for Nuclear Medicine.. Guidelines for brain radionuclide imaging. Perfusion single photon computed tomography (SPECT) using Tc-99m radiopharmaceuticals and brain metabolism positron emission tomography (PET) using F-18 fluorodeoxyglucose. The Belgian Society for Nuclear Medicine. [vander-borght-2001]Acta Neurol Belg. 2001 Dec;101(4):196-209. Vander Borght T 2001 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48708 |
| Study title: A Controlled Trial of Povidone–Iodine to Treat Infectious Conjunctivitis in ChildrenA Controlled Trial of Povidone–Iodine to Treat Infectious Conjunctivitis in Children |
| Active substance: POVIDONE IODINE |
| Study summary document link (including results): A controlled trial of povidone-iodine.pdf |
| View full study record |
| Document reference: 34611 |
| Study title: "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34673 |
| Study title: AWB-Rei/100797 2 March 1999: Post marketing surveillance for Betaisodona ointment in paediatrics |
| Active substance: POVIDONE IODINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34612 |
| Study title: AWB-TDG/BETA-LSG/220193, 07-Apr-1994, Anwendungsbeobachtung 1992/1993 Betaisodona. (Post marketing surveillance study 1992/1993 Betaisodona.) (Germany) |
| Active substance: POVIDONE IODINE |
| Study summary document link (including results): Povidone iodine - Option 1 Mundipharma IACs.xls |
| View full study record |
| Document reference: 45115 |
| Study title: Topical pranoprofen 0.1% is as effective anti-inflammatory and analgesic agent as diclofenac sodium 0.1% after strabismus surgery. Akyol-Salman I, Leçe-Sertöz D, Baykal O. J Ocul Pharmacol Ther. 2007 Jun;23(3):280-3.Topical pranoprofen 0.1% is as effective anti-inflammatory and analgesic agent as diclofenac sodium 0.1% after strabismus surgery. Akyol-Salman I, Leçe-Sertöz D, Baykal O. J Ocul Pharmacol Ther. 2007 Jun;23(3):280-3. |
| Active substance: PRANOPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46085 |
| Study title: Effects of combination therapy consisting of moderate-dose intravenous immunoglobulin G, pulses methylprednisolone and pravastatin in children with steroid resistant nephrosis |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46094 |
| Study title: Effects of pravastatin therapy on steroid hormone levels and pubertal development in children and adolescents with hypercholesterolemia |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46095 |
| Study title: Indications et resultats obtenus avec le Nootropyl dans les affections de l'oreille interne. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DF74J272P - Piracetam.pdf |
| View full study record |
| Document reference: 45944 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 34666 |
| Study title: "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34674 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34675 |
| Study title: Open study with HOE 777 0.1% emollient cream in children suffering from contact dermatitis, atopic dermatitis, seborrhoeic eczema or psoriasis |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): Prednicarbate STUDY Herz dermatitis.xls |
| View full study record |
| Document reference: 48012 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34678 |
| Study title: "RECOR with Dermatop Prednicarbate in the treatment of steroid sensitive skin disorders in children - No author - No date" "RECOR with Dermatop Prednicarbate in the treatment of steroid sensitive skin disorders in children - No author - No date" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34679 |
| Study title: Memory effects of a group of newly-synthesized pyrolidine derivatives with putative nootropic effect. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92G0605 - Piracetam.pdf |
| View full study record |
| Document reference: 46039 |
| Study title: New perspectives for the treatment of bronchial asthma by Nootrop (UCB Pharma). |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE98C2737 - Piracetam.pdf |
| View full study record |
| Document reference: 45979 |
| Study title: On the effects of nootropic substances on serum biochemical indexes in mentally retarded children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU84F041P - Piracetam.pdf |
| View full study record |
| Document reference: 46023 |
| Study title: Statistical report of a controlled trial of the effect of Nootropil in epileptic children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): CE75F041 - Piracetam.pdf |
| View full study record |
| Document reference: 45900 |
| Study title: The acute and chronic administrations of piracetam affect the movement related brain macropotentials. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE87F222 - Piracetam.pdf |
| View full study record |
| Document reference: 45893 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32161 |
| Study title: Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32116 |
| 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): |
| View full study record |
| Document reference: 34435 |
| 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): |
| View full study record |
| Document reference: 34439 |
| Study title: NA |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34440 |
| Study title: OPEN, NON-COMPARATIVE STUDY WITH FELDENE 20 MG CAPSULES IN PRIMARY DYSMENORRHEA. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34443 |
| 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 |
| View full study record |
| Document reference: 48699 |
| Study title: Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 |
| Active substance: MIZOLASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32274 |
| Study title: Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 |
| Active substance: MIZOLASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32275 |
| Study title: A 1-Year Open-Label, Flexible-Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hyponea Syndrome. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45277 |
| Study title: A 6-Month Open-Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hyponea Syndrome. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45278 |
| Study title: PIROXICAM FLASH IN UPPER RESPIRATORY TRACT INFECTIONS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34374 |
| Study title: PIROXICAM IN THE TREATMENT OF ACUTE LUMBAGO. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34426 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48014 |
| Study title: Quantitative scintigraphy of sacroiliac joints: effects of age, gender, and laterality. Vyas K, Eklem M, Seto H, Bobba VR, Brown P, Haines J, Krishnamurthy GT. AJR Am J Roentgenol. 1981 Mar;136(3):589-92. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44130 |
| Study title: Positive bone scan in cat-scratch disease. Walterspiel JN, Nimityongskul P. Pediatr Infect Dis J. 1987 Oct;6(10):944-5. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43843 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43443 |
| 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 |
| View full study record |
| Document reference: 48702 |
| 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): |
| View full study record |
| Document reference: 34641 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 34657 |
| Study title: An open study with HOE 777 0.25% emollient cream in children aged from 1 to 12 years with contact dermatitis, atopic dermatitis, seborrhoeic eczema or psoriasis |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): Prednicarbate STUDY Herz.xls |
| View full study record |
| Document reference: 34669 |
| Study title: An open study with HOE 777 0.25% emollient cream in children up to 1 year with seborrhoeic eczema |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): Prednicarbate STUDY Herz 1year.xls |
| View full study record |
| Document reference: 34676 |
| Study title: "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34670 |
| Study title: The effect of piracetam on intellectual abilities and performances in handicapped children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE85G231P - Piracetam.pdf |
| View full study record |
| Document reference: 45953 |
| 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 |
| View full study record |
| Document reference: 45919 |
| Study title: Evaluation of temporal and facial osteomyelitis by simultaneous In-WBC/Tc-99m-MDP bone SPECT scintigraphy and computed tomography scan. Weber PC, Seabold JE, Graham SM, Hoffmann HH, Simonson TM, Thompson BH. Otolaryngol Head Neck Surg. 1995 Jul;113(1):36-41. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43594 |
| Study title: Mandell GA, Contreras SJ, Conard K, Harcke HT, Maas KW. Bone scintigraphy in the detection of chronic recurrent multifocal osteomyelitis. J Nucl Med. 1998 Oct;39(10):1778-83. Mandell GA, Contreras SJ, Conard K, Harcke HT, Maas KW. Bone scintigraphy in the detection of chronic recurrent multifocal osteomyelitis. J Nucl Med. 1998 Oct;39(10):1778-83. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43523 |
| Study title: Extrinsic causes of vesical filling defects on scintigraphy.Mandell GA, Harcke HT. Clin Nucl Med. 1987 Mar;12(3):204-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43871 |
| Study title: The Value of 18F-FDG PET in the Detection of Stage M0 Carcinoma of the NasopharynxJ Nucl Med 2005; 46:405–410 .Tzu-Chen Yen, MD, PhD1; Joseph Tung-Chieh Chang, MD, MHA2; Shu-Hang Ng, MD3; Yu-Chen Chang, MD1; Sheng-Chieh Chan, MD1; Kun-Ju Lin, MD1; Wuu-Jyh Lin, PhD4; Ying-Kai Fu, PhD4; and Chen-Yu Lin2 |
| Active substance: Steripet |
| Study summary document link (including results): yen-2005-b.pdf |
| View full study record |
| Document reference: 48748 |
| Study title: Piracetam effect on rat reproductive function and sexual maturation of the offspring. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU87H122P - Piracetam.pdf |
| View full study record |
| Document reference: 46042 |
| Study title: Piracetam for the treatment of breath-holding spells [selected summaries]. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE99G2323 - Piracetam.pdf |
| View full study record |
| Document reference: 45946 |
| Study title: Kushner BH et al How effective is dose-intensive/myeloablative therapy against Ewing'ssarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review J Clin Oncol. 2001 Feb 1;19(3):870-80. ReviewKushner BH et al How effective is dose-intensive/myeloablative therapy against Ewing'ssarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review J Clin Oncol. 2001 Feb 1;19(3):870-80. Review |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32097 |
| Study title: Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44026 |
| Study title: Graham ML et alPhase II trial of mitoxantrone in acute lymphoblastic leukemia of childhood. A Pediatric Oncology Group studyInvest New Drugs. 1991 Aug;9(3):263-7. Erratum in: Invest New Drugs 1991 Nov;9(4):383. Wilkerson RW [corrected to Wilkerson RW].Graham ML et alPhase II trial of mitoxantrone in acute lymphoblastic leukemia of childhood. A Pediatric Oncology Group studyInvest New Drugs. 1991 Aug;9(3):263-7. Erratum in: Invest New Drugs 1991 Nov;9(4):383. Wilkerson RW [corrected to Wilkerson RW]. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32071 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34427 |
| Study title: Unsuspected muscular radionuclide uptake due to chronic muscular injury contracted during sports activity. Roland J, Houben L, Vandevivere J. Clin Nucl Med. 1997 Sep;22(9):632-3. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43544 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34382 |
| Study title: TO EVALUATE CLINICAL EFFICACY AND SAFETY OF PIROXICAM IN THE TREATMENT OF PRIMARY DYSMENORRHEA. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34444 |
| Study title: TO EVALUATE THE ANALGESIC AND ANTIINFLAMATORY EFFECT OF PIROXICAM IN PATIENTS WITH GONBARTHROSIS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34479 |
| Study title: TO EVALUATE THE EFFECT OF PIROXICAM IN THE COURSE OF TREATMENT ASSOCIATED WITH SYMPTOMATIC VIRAL PHARYNGITIS |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34480 |
| Study title: TO EVALUATE THE EFFECTIVENESS AND SAFETY OF INJECTABLE PIROXICAM IN THE MANAGEMENT OF POST-OPERATIVE PAIN. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48013 |
| Study title: "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005" "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34671 |
| 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 |
| View full study record |
| Document reference: 34090 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34642 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34647 |
| Study title: "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (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): |
| View full study record |
| Document reference: 34672 |
| Study title: Determination of the efficacy and safety of prednicarbate 0.25% solution for dermatoses sensitive to topical corticosteroids |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): Prednicarbate STUDY Drebinger topical 313DT.xls |
| View full study record |
| Document reference: 34659 |
| 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: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34660 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48011 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44159 |
| Study title: Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5. Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43712 |
| Study title: Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24. Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43373 |
| Study title: Piracetam: effects on reading achievement and evoked potentials in dyslexics. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE88A294P - Piracetam.pdf |
| View full study record |
| Document reference: 45931 |
| Study title: Pyramen. effect on the intellectual mnestic activity in mentally retarded schoolchildren in a double blind experiment. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE88H027P - Piracetam.pdf |
| View full study record |
| Document reference: 46020 |
| Study title: Safe and effective use piritramide following sevoflurane anesthesia in children. Anesthesiology 91 (3A), p.A1280. 1999 Safe and effective use piritramide following sevoflurane anesthesia in children. Anesthesiology 91 (3A), p.A1280. 1999 |
| Active substance: PIRITRAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34303 |
| Study title: The value of FDG-PET in the detection, grading and response to therapy of soft tissue and bone sarcomas; a systematic review and meta-analysis. CANCER TREATMENT REVIEWS (2004) 30, 83–101. E. Bastiaanneta, H. Groenb, P.L. Jagerc, D.C.P. Cobbenc, W.T.A. van der Graafd, W. Vaalburgc, H.J. Hoekstraa,* |
| Active substance: Steripet |
| Study summary document link (including results): bastiaannet-2004.pdf |
| View full study record |
| Document reference: 48726 |
| Study title: Grier HE et al Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone N Engl J Med. 2003 Feb 20;348(8):694-701Grier HE et al Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone N Engl J Med. 2003 Feb 20;348(8):694-701 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32091 |
| Study title: Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32104 |
| 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): |
| View full study record |
| Document reference: 32196 |
| 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): |
| View full study record |
| Document reference: 32118 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34462 |
| Study title: TO INVESTIGATE THE EFFECT OF A LOADING DOSE OF PIROXICAM 40MG/D FOLLOWED BY 20 MG/D IN THE TREATMENT OF SYMPTOMS ASSOCIATED WITH URTI. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34389 |
| Study title: Cranial osteomyelitis: diagnosis and follow-up with In-111 white blood cell and Tc-99m methylene diphosphonate bone SPECT, CT, and MR imaging. Seabold JE, Simonson TM, Weber PC, Thompson BH, Harris KG, Rezai K, Madsen MT, Hoffman HT. Radiology. 1995 Sep;196(3):779-88. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44260 |
| 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): |
| View full study record |
| Document reference: 34428 |
| Study title: EFFICACY OF PIROXICAM VS INDOMETHACIN IN ACUTE LOCOMOTOR AFFECTIONS LINKED WITH SPORTS ACTIVITY. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34379 |
| Study title: EFFICACY OF PIROXICAM VS. NAPROXEN IN PATIENTS WITH RHEUMATIOD ARTHRITIS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34441 |
| 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): |
| View full study record |
| Document reference: 34369 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 34430 |
| Study title: Evaluación del efecto de una vacuna polivalente neumocócica en la incidencia de la carga nasofaríngea de S.pneumoniae y de Otitis media aguda . (U.S) |
| Active substance: Vacuna conjugada (adsorbida) frente al oligosacárido meningocócico del serogrupo C |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40296 |
| 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 |
| View full study record |
| Document reference: 47355 |
| Study title: A randomised, double-blind, multicentre study to evaluate the efficacy of valaciclovir in episodic treatment of recurrent facial herpes simplex virus (HSV) infection. |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Study HS240011 Valaciclovir.xls |
| View full study record |
| Document reference: 45428 |
| Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Valaciclovir-HS210915-ICHE3.pdf |
| View full study record |
| Document reference: 45424 |
| 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 |
| View full study record |
| Document reference: 47304 |
| Study title: McEvoy C et al. Acute effects of vecuronium on pulmonary function and hypoxemic episodes in preterm infants. Pediatr Int 2007;49:631-6McEvoy C et al. Acute effects of vecuronium on pulmonary function and hypoxemic episodes in preterm infants. Pediatr Int 2007;49:631-6 |
| Active substance: VECURONIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45532 |
| Study title: Discontinued administration (6 months a year) of growth hormone to children with very short stature and having suffered from intrauterine growth retardation: safety and effect on growth of long-term therapy |
| Active substance: Somatropin |
| Study summary document link (including results): GHRETARD-F-2-F_Norditropin.pdf |
| View full study record |
| Document reference: 41777 |
| Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42263 |
| Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42295 |
| Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42327 |
| Study title: Follow-Up Screening to Investigate the Occurrence of Long-Term Retinal Effects in Children Exposed to Vigabatrin Treatment and in Subjects Exposed to Vigabatrin In Utero. |
| Active substance: VIGABATRIN |
| Study summary document link (including results): Vigabatrin-Study 3.pdf |
| View full study record |
| Document reference: 39389 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47305 |
| Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Valaciclovir-HS210916-ICHE3.pdf |
| View full study record |
| Document reference: 45425 |
| Study title: Evaluation of Growth Promoting Effect and Safety of Growth Hormone in Achondroplasia |
| Active substance: Somatropin |
| Study summary document link (including results): Somatropin - B9R-JE-6001 CTR Summary.pdf |
| View full study record |
| Document reference: 41635 |
| Study title: EXAMINATION OF EFFECTS ON GROWTH PROMOTING AND SAFETY OF PNU- 180307 IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE WITHOUT EPIPHYSEAL CLOSING |
| Active substance: Somatropin |
| Study summary document link (including results): 307-MET-0021-002 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41642 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41665 |
| 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 |
| View full study record |
| Document reference: 41779 |
| Study title: Randomised study to investigate the effects on growth, on gonadal function and on the safety of recombinant hGH treatment in pubertal children with growth retardation secondary to chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41793 |
| Study title: Randomised study to investigate the effects on growth, on uraemic toxins profile and on the safety of recombinant human growth hormone treatment in very young children with growth retardation secondary to chronic renal insufficiency (CRI). |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41791 |
| Study title: Randomised Study to Investigate the Effects on Growth, on Uremic Toxins Profile and on Renal Function of Recombinant Human Growth Hormone Treatment in Very Young Children With Growth Retardation Secondary To Chronic Renal Insufficiency. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41790 |
| Study title: To estimate the survival of bone marrow transplant (BMT) subjects randomized to receive cytomegalovirus (CMV) prophylaxis with intravenous (IV) acyclovir (ACV) followed by either oral valaciclovir (VACV) or IV ganciclovir (GCV). |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Study 123-039 (HS2A3005) Valaciclovir.xls |
| View full study record |
| Document reference: 47356 |
| Study title: Francis AJ, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties in children with intellectual deficits: randomised trial. Phytomedicine. 2002 May;9(4):273-9. |
| Active substance: Valeriana dry extract |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40299 |
| Study title: Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children. Phytomedicine. 2006 Jun;13(6):383-7. Epub 2006 Feb 17. |
| Active substance: Valeriana dry extract |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40298 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Valerianaheel (drops) [AWB-AT] |
| Active substance: Valeriana Heel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39769 |
| Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection |
| Active substance: VALGACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45433 |
| Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection |
| Active substance: VALGACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45434 |
| 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): |
| View full study record |
| Document reference: 45436 |
| 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): |
| View full study record |
| Document reference: 45543 |
| Study title: RECOMBINANT SOMATROPIN (GENOTONORM (REGISTERED)) GIVEN SUBCUTANEOUSLY AS DAILY INJECTIONS OR AS CONTINUOUS INFUSION TO GROWTH HORMONE DEFICIENT CHILDREN. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41731 |
| 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 EVALUATING THE EFFECT OF GENOTROPIN IN PREPUBERTAL SHORT NORMAL CHILDREN |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41740 |
| 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): |
| View full study record |
| Document reference: 41755 |
| Study title: Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30 Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42201 |
| Study title: Benton D, Roberts G. Effect of vitamin and mineral supplementation on intelligence on a sample of schoolchildren. Lancet, 1988:1;140-3.Benton D, Roberts G. Effect of vitamin and mineral supplementation on intelligence on a sample of schoolchildren. Lancet, 1988:1;140-3. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45576 |
| Study title: Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45569 |
| 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): |
| View full study record |
| Document reference: 35569 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 35550 |
| Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42247 |
| Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42279 |
| Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42311 |
| Study title: Arpino C et al. Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). Epilepsia 2000;41(11):1436-43. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45449 |
| Study title: Linday LA, Tapia-Mendoza J, Shindledecker, RD, et al. Effect of daily cod liver oil and a mutlivtamin-mineral supplement with selenium on upper respiratory tract pediatric visits by young, inner-city, Latino children: randomized pediatric sites. Ann Otol Rhinol Laryngol, 2004:113;891-901.Linday LA, Tapia-Mendoza J, Shindledecker, RD, et al. Effect of daily cod liver oil and a mutlivtamin-mineral supplement with selenium on upper respiratory tract pediatric visits by young, inner-city, Latino children: randomized pediatric sites. Ann Otol Rhinol Laryngol, 2004:113;891-901. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45575 |
| 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 |
| View full study record |
| Document reference: 45230 |
| Study title: A single blind study of the efficacy and tolerance of roxithromycin (25mg bid) and erythromycin ethylsuccinate (1OOmg bid) in children with chlamydia! conjunctivitis |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): Roxithromycin STUDY S8796508a.xls |
| View full study record |
| Document reference: 48008 |
| Study title: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35588 |
| Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42248 |
| Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42280 |
| Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42312 |
| 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: Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42.Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45574 |
| 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): |
| View full study record |
| Document reference: 40309 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT] |
| Active substance: Vomitusheel - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40308 |
| 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): |
| View full study record |
| Document reference: 40310 |
| 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: 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): |
| View full study record |
| Document reference: 45241 |
| Study title: Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42188 |
| 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 EFFECT OF GENOTROPIN ON GLOMERULAR FILTRATION RATE IN PREPUBERTAL CHILDREN AFTER RENAL TRANSPLANTATION. |
| Active substance: Somatropin |
| Study summary document link (including results): 90-054 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41721 |
| Study title: THE EFFECT OF GENOTROPIN ON GLOMERULAR FILTRATION RATE IN PUBERTAL CHILDREN AFTER RENAL TRANSPLANTATION. |
| Active substance: Somatropin |
| Study summary document link (including results): 90-055 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41720 |
| Study title: The effects of early postnatal onset recombinant hGH therapy in newborn infants with IUGR |
| Active substance: Somatropin |
| Study summary document link (including results): GHRETARD-NL-1-NL_Norditropin.pdf |
| View full study record |
| Document reference: 41783 |
| Study title: The growth promoting effect of NN-798 in children with chronic renal failure on conservative therapy. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41797 |
| Study title: The growth promoting effect of NN-798 in children with chronic renal failure treated on hemodialysis or peritoneal dialysis. |
| Active substance: Somatropin |
| Study summary document link (including results): GHCRF-J-1-J_Norditropin.pdf |
| View full study record |
| Document reference: 41796 |
| Study title: Do seizures in children cause intellectual deterioration ? - Ellenberg JH et al. - N Engl J. Med 1986; 314:1085-88. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45473 |
| 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 |
| View full study record |
| Document reference: 48050 |
| Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42255 |
| Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42287 |
| Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42319 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42320 |
| Study title: Trial to explore efficacy, kinetics and safetyKosmidis et al |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_7.xlsx |
| View full study record |
| Document reference: 42447 |
| 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 |
| View full study record |
| Document reference: 41775 |
| 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): |
| View full study record |
| Document reference: 41756 |
| Study title: Treem WR. Infant colic: A pediatric gastroenterologist's perspective. Pediatr Clin North Am. November 11, 1994, 1121-38Treem WR. Infant colic: A pediatric gastroenterologist's perspective. Pediatr Clin North Am. November 11, 1994, 1121-38 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42195 |
| Study title: Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42208 |
| 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: An Open Multicentre Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Chronic Invasive Aspergillosis and Candidiasis |
| Active substance: VORICONAZOLE |
| Study summary document link (including results): A150-303 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48052 |
| Study title: An Open-Label, Intravenous to Oral Switch, Multiple Dose, Multi- Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to < 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infection |
| Active substance: VORICONAZOLE |
| Study summary document link (including results): A1501037 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 48056 |
| Study title: An Open, Intravenous Multiple Dose, Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Toleration of Voriconazole in Children Aged 2-12 Years Who Require Treatment for the Prevention of Systemic Fungal Infection |
| Active substance: VORICONAZOLE |
| Study summary document link (including results): A1501007 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48055 |
| Study title: An Open, Multicentre, Dose Escalating Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Acute Invasive Aspergillosis |
| Active substance: VORICONAZOLE |
| Study summary document link (including results): 150-304 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48048 |
| Study title: An Open, Single Intravenous Dose, Multicentre Study to Investigate the Pharmacokinetics, Safety and Toleration of Voriconazole in Immunocompromised Children Aged 211 Years |
| Active substance: VORICONAZOLE |
| Study summary document link (including results): 150-249 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 48047 |
| Study title: Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. - Ohtsuka Y et al. - Epilepsia 1999;40 (Suppl 2):296 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45474 |
| Study title: Effect size of lithium, divalproex sodium, and carbamazepine in children and adolescents with bipolar disorder - Kowatsch RA. and al. - 2000 ( J Am Acad Child Adolesc Psychiatry 2000, 39 (6) : 713-720 - Publication in expert report on the clinical documentation - Grunze H. - 04/2003 - |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45475 |
| 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: 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48004 |
| Study title: Effect of RU 28965 administered orally for 10 days on bone tissue in infant dogs |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35477 |
| Study title: Effects of RU 28 965 (RXM) on toothformation in infant beagle dogs - Sasaki T. - 29/10/94 |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35479 |
| Study title: Effects of RU 28 965 administered orally for 10 days on bone tissue in infant dogs - Tateta C. and al. - 22/12/94 |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35480 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 35482 |
| 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): |
| View full study record |
| Document reference: 35602 |
| Study title: A pilot single centre, randomised, double-blind crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7 15 years. Report No. GM2003/00237/00; |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35591 |
| Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Sameterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Sympotmatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2002/00268/00; |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35596 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 35595 |
| Study title: Solcoseryl Eye Gel: an effective adjunct in the treatment of chronic ulcers of the cornea. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35586 |
| 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): |
| View full study record |
| Document reference: 35589 |
| Study title: Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42207 |
| Study title: On topical application of fluorides and its inhibiting effect on caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42394 |
| Study title: On topical application of fluorides and its inhibiting effect on caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42507 |
| Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42265 |
| Study title: Effects of valproate in 100 children with special reference to weight. - Egger J et al. - Br Med J 1981;283:577-81. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45476 |
| Study title: Ellenberg JH et al. Do seizures in children cause intellectual deterioration ? N Engl J. Med 1986; 314:1085-88. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45477 |
| 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): |
| View full study record |
| Document reference: 45486 |
| Study title: Evaluation of the efficacy and tolerance of roxithromycin 5-8 mg/kg/day taken B.I.D. and clarithromycin 11-21 mg/kg/day taken B.I.D. in a 5 to 10 days treatment of lower respiratory tract infections in children. |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): FF9496564.pdf |
| View full study record |
| Document reference: 45229 |
| Study title: Roxithromycin 1OOmg paediatric tablet - Multicenter clinical trial |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): Roxithromycin STUDY FFR8796523.xls |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48006 |
| Study title: Study in children and young adults of the diffusion of roxithromycin (RU 28965) into tonsillar tissue following administration of 2 or 3 doses. |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): Roxithromycin STUDY Begue &Cotin.xls |
| View full study record |
| Document reference: 48009 |
| Study title: Study of the diffusion of Roxithromycin (RU 28 965) in the middle ear secretions of children after repeated oral administration |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): Roxithromycin STUDY FFR869652.xls |
| View full study record |
| Document reference: 48005 |
| Study title: Growth hormone treatment of prematures with chronic lung disease (CLD) receiving dexamethasone treatment. A double blind, placebo controlled trial, evaluating whether treatment with growth hormone will reduce the negative effects of Dexamethasone treatmen |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41799 |
| 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): |
| View full study record |
| Document reference: 41803 |
| Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42297 |
| Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42329 |
| 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 |
| View full study record |
| 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: Michel O et al. The value of Ems Mineral Salts in the treatment of rhinosinusitis in children: Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children. Int J Pediatr Otorhinolaryngol 2005; 69(10):1359-1365 |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45632 |
| Study title: Otten and Grote: Otitis media with effusion and chronic upper respiratory tract infection in children: a randomized, placebo-controlled clinical study. Laryngoscope. 1990 Jun;100(6):627-33 |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Otten_1990.xls |
| View full study record |
| Document reference: 47924 |
| Study title: Petruson B. et al. (1985) Study in acute infectious rhinitis in children. Larkartidningen 82, 26-27. |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Petruson_1985.xls |
| View full study record |
| Document reference: 45652 |
| Study title: An open, randomised, mulicenter, 2-period crossover trial, evaluating the acceptance and compliance of Norditropin® SimpleXxTM/NordiPenTM versus Norditropin®/Nordiject® |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41812 |
| Study title: Assessment of satisfaction with growth hormone treatment in children born small for gestational age: benefits of galenic form of the product. Prospective, multi-centre, open, non-randomised trial. |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1670_Norditropin.pdf |
| View full study record |
| Document reference: 41817 |
| Study title: INVESTIGATION OF THE CARDIOVASCULAR EFFECTS OF BIOSYNTHETIC GROWTH HORMONE (GENOTROPIN) IN CHILDREN WITH SHORT STATURE |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41725 |
| 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): |
| View full study record |
| Document reference: 42210 |
| Study title: de la Portilla F et al. Improved quality of anorectal endoluminal ultrasonography using emulsion of dimethicone. Dis Colon Rectum. 2003 Oct;46(10):1436-7de la Portilla F et al. Improved quality of anorectal endoluminal ultrasonography using emulsion of dimethicone. Dis Colon Rectum. 2003 Oct;46(10):1436-7 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42206 |
| Study title: Friis H. Dimethicone in lactulose-induced dyspepsia. Effect on H2 production and Symptoms. Ugeskr Laeger. 1993 Oct 18;155(42):3378-80Friis H. Dimethicone in lactulose-induced dyspepsia. Effect on H2 production and Symptoms. Ugeskr Laeger. 1993 Oct 18;155(42):3378-80 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42213 |
| Study title: Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42198 |
| 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): |
| View full study record |
| Document reference: 42057 |
| Study title: Maternal use of antiepileptic drugs and the risk of major congenital malformations: a joint European prospective study of human teratogenesis associated with maternal epilepsy. - Samren EB et al. - Epilepsia 1997;38(9):981-90. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45498 |
| Study title: Ohtsuka Y et al. Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. Epilepsia 1999;40 (Suppl 2):296 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45503 |
| Study title: Prospective, double-blind, randomised, active-controlled multicentre |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A2_1973.xls |
| View full study record |
| Document reference: 48045 |
| 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 |
| View full study record |
| 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: 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: 42321 |
| Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42392 |
| Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42505 |
| Study title: Effect of a fluoride-containinglacquer on dental caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42362 |
| Study title: Effect of a fluoride-containinglacquer on dental caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42475 |
| Study title: Effect of a preventive program based on professional toothcleaning and fluoride application on caries and gingivitis. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42374 |
| Study title: Effect of a preventive program based on professional toothcleaning and fluoride application on caries and gingivitis. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42487 |
| Study title: Effect of annual application of polyurethane lacquer containing silane-fluoride. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42436 |
| Study title: Effect of annual application of polyurethane lacquer containing silane-fluoride. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42549 |
| Study title: Effect of different carriers preventive measures in children highly infected with mutans streptococci. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42381 |
| Study title: Effect of different carriers preventive measures in children highly infected with mutans streptococci. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42494 |
| Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42437 |
| 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): |
| View full study record |
| Document reference: 42219 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (drops) [AWB-AT] |
| Active substance: Spigelon |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40243 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (tablets) [AWB-AT] |
| Active substance: Spigelon |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40244 |
| 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 |
| View full study record |
| Document reference: 42225 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41386 |
| 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 |
| View full study record |
| Document reference: 45604 |
| Study title: A Dose-ranging, Safety, and Efficacy Trial with Zafirlukast (ACCOLATE)in the Treatment of Pediatric Subjects with Mild-to-moderate Asthma; Up toa 52-week Open Label Safety Extension |
| Active substance: ZAFIRLUKAST |
| Study summary document link (including results): 9188IL0139 CSR Summary.pdf |
| View full study record |
| Document reference: 45606 |
| 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 |
| View full study record |
| Document reference: 45609 |
| Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42550 |
| Study title: Effect of fluoride brushing on the dental treatment requirement in a group of junior elementary school students. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42413 |
| Study title: Effect of fluoride brushing on the dental treatment requirement in a group of junior elementary school students. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42526 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42515 |
| Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42425 |
| Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42538 |
| Study title: Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42396 |
| Study title: Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42509 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40157 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Sabal-Homaccord (ampoules) [AWB-AT] |
| Active substance: Sabal-Homaccord - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40161 |
| Study title: 16. The probiotic effect of Saccharomyces boulardii in a pediatric age group; Journal of Tropical Pediatrics, 2004 ; 50 (4) :234-236 |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40170 |
| 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: 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42031 |
| Study title: Sequestration studies with chromium-51 labeled red cells as criteria for splenectomy.Isr J Med Sci. 1967 Nov-Dec;3(6):832-7. |
| 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: 48288 |
| Study title: Post-treatment effect of fluoride varnishes in children with a high prevalence of dental caries in a community with fluoridated water. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42534 |
| 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: Prospective study of development of infants born to mothers with epilepsy. - James FH et al. - J Neurol Neurosurg Psychiatry 2002;72:135. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45511 |
| Study title: Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). - Arpino C et al. - Epilepsia 2000;41(11):1436-43. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45515 |
| Study title: 22. Effect of Saccharomyces boulardii in children with acute gastroenteritis and its relationship to the immune response.; BMJ. 2007 Aug 18;335:340. |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40176 |
| Study title: Efecto del Saccharomyces boulardii en ninos con diarreas infecciosas agudas.; Annales de Pédiatrie 1994 ; 41 (6) : 397 - 400. |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40166 |
| 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): |
| View full study record |
| Document reference: 40165 |
| Study title: METABOLIC EFFECTS OF GROWTH HORMONE (GENOTONORM) IN GIRLS WITH TURNER SYNDROME. |
| Active substance: Somatropin |
| Study summary document link (including results): 95-8121-001 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41670 |
| 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: Progression of approximal caries in primary molars and the effect of Duraphat treatment. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42399 |
| Study title: Progression of approximal caries in primary molars and the effect of Duraphat treatment. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42512 |
| 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, 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: 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 |
| View full study record |
| Document reference: 41759 |
| 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 |
| View full study record |
| Document reference: 42152 |
| Study title: A randomised, placebo controlled, doubly blind study of the effect of sibutramine on the treatment of obese adolescents with a recommended diet and exercise plan followed by a sibutramine-free period (SB116) |
| Active substance: SIBUTRAMINE |
| Study summary document link (including results): Sibutramine-SB116.pdf |
| View full study record |
| Document reference: 47620 |
| 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 |
| View full study record |
| Document reference: 41664 |
| Study title: Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42211 |
| Study title: Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42217 |
| Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with pediatric 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): Salmeterol-Xinafoate-102095-ICHE3.pdf |
| View full study record |
| Document reference: 42018 |
| Study title: Effect of four week regular Salmeterol treatment on cardiovascular autonomic balance in asthmatic children. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Study SMS40094-Salmeterol Xinafoate-Serevent Rotadisks.xls |
| View full study record |
| Document reference: 42060 |
| 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): |
| View full study record |
| Document reference: 45537 |
| Study title: Use of injectable valproic acid in status epilepticus - Giroud M. and al. - 1993 ( Drug Invest 1993 ; 5 : 154-9 ) Publication 2 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45525 |
| 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): |
| View full study record |
| Document reference: 45528 |
| Study title: Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF solution: results from a demonstration program after four school years. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42406 |
| Study title: Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF solution: results from a demonstration program after four school years. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42519 |
| Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42351 |
| Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42464 |
| Study title: Effects of fluoride and chlorhexidine on the microflora of dental root surfaces and progression of root-surface caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42410 |
| Study title: Effects of fluoride and chlorhexidine on the microflora of dental root surfaces and progression of root-surface caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42523 |
| Study title: Effects of self-applied topical fluoride preparations in orthodontic patients. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42448 |
| Study title: Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42209 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42326 |
| 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): |
| View full study record |
| Document reference: 45565 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Veratrum-Homaccord (drops) [AWB-AT] |
| Active substance: Veratrum-Homaccord |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40300 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) in children aged up to 11 years old [AWB-089] |
| Active substance: Vertigoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40303 |
| Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Vertigoheel (tablets) in the treatment vertigo [AWB-114] |
| Active substance: Vertigoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40304 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) [AWB-AT] |
| Active substance: Vertigoheel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40302 |
| Study title: Higher frequency of early local side effects with aqueous versus depot immunotherapy for Hymenoptera venom allergy |
| Active substance: VESPULA SPP |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39384 |
| 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): |
| View full study record |
| Document reference: 39385 |
| Study title: Open, multicentric, post marketing surveillance study of GlaxoSmithKline Biologicals’ Vi polysaccharide typhoid vaccine (TYPHERIXÔ) injected in healthy children and adults according to the Indian prescribing information. |
| Active substance: Vi polysaccharide of Salmonella typhi |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47496 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of agitation (with and without fever) by children aged up to 11 years with Viburcol (suppositories) [AWB-097] |
| Active substance: Viburcol |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40306 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Viburcol (suppositories) [AWB-AT] |
| Active substance: Viburcol |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40305 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of acute feverish infects by children aged up to 11 years with Viburcol N (suppositories) [AWB-118] |
| Active substance: Viburcol N |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40307 |
| 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): |
| View full study record |
| Document reference: 39158 |
| Study title: Treatment of acne with a yeast preparation;Fortschr Med. 1989 Sep 10; 107(26):563-6. German. |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40184 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41772 |
| Study title: A study to evaluate the effectivity and safety of introducing biosynthetic human growth hormone (Norditropin PenSet) for treatment of children with growth hormone deficiency in Bulgaria |
| Active substance: Somatropin |
| Study summary document link (including results): GHD-ROV-5-BU_Norditropin.pdf |
| View full study record |
| Document reference: 41760 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43181 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43191 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43201 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43215 |
| Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42363 |
| Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42476 |
| Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42407 |
| Study title: A small risk canot be excluded, but a high risk of congenital anomalies in the children of women who are treated with spiramycin during pregnancy is unlikely (article retrieved from Micromedx online database) |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42585 |
| 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): |
| View full study record |
| Document reference: 42576 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42579 |
| Study title: Intérêt de la Rovamycine Sirop en pédiatrie - H. Batellier, PS Jouk - 1982 (Tome XIII N° 1) |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42580 |
| Study title: A polarized light and scanning electron microscope study of the effect of Duraphat treatment on in vivo caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42370 |
| Study title: A polarized light and scanning electron microscope study of the effect of Duraphat treatment on in vivo caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42483 |
| Study title: An Exploratory, phase 2, open, two-arm, match-control, randomised and stratified pilot study assessing the prevention of the adverse effects of long-term high-dose glucocorticoid therapy by Growth Hormone (NutropinAq) administered by sub-cutaneous route i |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41754 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42119 |
| Study title: Prospective multicentric observational study/long term use |
| Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et... |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39756 |
| Study title: Prospective observational study |
| Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et... |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39757 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Selenium-Homaccord (drops) [AWB-AT] |
| Active substance: Selenium-Homaccord/Selenium-Homaccord - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40190 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43225 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43235 |
| Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42520 |
| Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42303 |
| Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42335 |
| Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42241 |
| Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42273 |
| Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42305 |
| Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42242 |
| Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42274 |
| Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42306 |
| Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42243 |
| Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42275 |
| Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42307 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42317 |
| Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42254 |
| Study title: Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German. Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43559 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47463 |
| Study title: A study to test the efficacy of E45 Cream on nappy rash |
| Active substance: SOFT PARAFFIN |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42562 |
| 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): |
| View full study record |
| Document reference: 40232 |
| 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, Eucalyptus oil, Turpentine oil, Camphor |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40234 |
| Study title: The caries-preventive effect of a fluoride varnish in the fissures of the first permanent molar. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42482 |
| Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42343 |
| Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42456 |
| Study title: The clinical effect of application of a urethane lacquer containing silane fluorine. A one-year study. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42376 |
| Study title: The clinical effect of application of a urethane lacquer containing silane fluorine. A one-year study. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42489 |
| Study title: The clinical effect of application of fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42438 |
| Study title: The clinical effect of application of fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42551 |
| Study title: The effect of Duraphat lacquer on the condition of the permanent teeth in children consuming fluoridated table salt. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42386 |
| Study title: The effect of Duraphat lacquer on the condition of the permanent teeth in children consuming fluoridated table salt. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42499 |
| Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42372 |
| Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42485 |
| Study title: The effect of prophylactic measures on the gingival health of school children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42345 |
| 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): |
| View full study record |
| Document reference: 40200 |
| Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42286 |
| Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42318 |
| Study title: PK in adolescent subjects with rizatriptan 5 mg |
| Active substance: RIZATRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47417 |
| 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): |
| View full study record |
| Document reference: 35453 |
| Study title: Uncontrolled, pharmacokinetic, efficacy and safety study using a dose rate of 0.2 mg/kg/h in 0 to 180-day-old infants and 0.4 mg/kg/h infants over 181 days old. The epidural infusion was preceeded by a bolus injection of 1-2 mg/kg (0.5-1 mL/kg of 2 mg/mL solution). Continuous epidural infusion. 0-12 months. |
| Active substance: ROPIVACAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35457 |
| Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety |
| Active substance: ROSUVASTATIN CALCIUM |
| Study summary document link (including results): Study 4522IL0054_CSR Synopsis.pdf |
| View full study record |
| Document reference: 47886 |
| Study title: 10 day oral toxicity study in the young dog - Thien - Aubert and al. - 31/12/95 |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35461 |
| Study title: 28 day oral toxicity study and recovery study of RU 28 965 in infant beagle dogs - Moriya A. And al. - 31/07/90 |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35463 |
| Study title: " Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
| Active substance: PREDNICARBATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34663 |
| Study title: Effectiveness of piracetam in the treatment of toxic comas. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE75L051 - Piracetam.pdf |
| View full study record |
| Document reference: 46007 |
| Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood. Kenney IJ, Lenney W, Lutkin JE, Gordon I. Br J Radiol. 1993 Nov;66(791):1031-4. |
| 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: 48271 |
| 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 |
| View full study record |
| Document reference: 48278 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41662 |
| Study title: Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818.Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43119 |
| 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: 42063 |
| Study title: Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7. Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43665 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43245 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43318 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43336 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43346 |
| Study title: Post-treatment effect of fluoride varnishes in children with a high prevalence of dental caries in a community with fluoridated water. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42421 |
| 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): |
| View full study record |
| Document reference: 43660 |
| Study title: Transient ureteral dilatation associated with infantile infectious sacroiliitis. Dejter SW, Eggli DF, Gibbons MD. J Urol. 1989 May;141(5):1154-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43785 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42582 |
| Study title: Spiramycin versus penicillin V in the empiric treatment of bacterial tonsillitis - L Manolopoulos et al. - 1989 - BJCP (43 (3): 94-96)Spiramycin versus penicillin V in the empiric treatment of bacterial tonsillitis - L Manolopoulos et al. - 1989 - BJCP (43 (3): 94-96) |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42583 |
| 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): |
| View full study record |
| Document reference: 42584 |
| 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): |
| View full study record |
| Document reference: 42472 |
| Study title: The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43301 |
| Study title: The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43261 |
| 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): |
| View full study record |
| Document reference: 43268 |
| Study title: Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1998; 62(1):77-82.Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1998; 62(1):77-82. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43151 |
| Study title: Lackner H, Urban C, Kerbl R, Schwinger W, Beham A. Noncytotoxic Drug Therapy in Children with Unresectable Desmoid Tumors. Cancer 1997;80(2):334-340 1997;(2):334-340.Lackner H, Urban C, Kerbl R, Schwinger W, Beham A. Noncytotoxic Drug Therapy in Children with Unresectable Desmoid Tumors. Cancer 1997;80(2):334-340 1997;(2):334-340. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43115 |
| Study title: Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76.Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43095 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43098 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43118 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43131 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43189 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43199 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43209 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43214 |
| Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42336 |
| Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42449 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42359 |
| Study title: The effect of prophylactic measures on the gingival health of school children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42458 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43796 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43238 |
| Study title: The effect of topical fluoride treatment on enamel fluoride uptake and the tensile bond strength of an orthodontic bonding resin. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42350 |
| Study title: The effect of topical fluoride treatment on enamel fluoride uptake and the tensile bond strength of an orthodontic bonding resin. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42463 |
| Study title: Three-year study of the effect of fluoride varnish (Duraphat) on proximal caries progression in teenagers. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42387 |
| Study title: Three-year study of the effect of fluoride varnish (Duraphat) on proximal caries progression in teenagers. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42500 |
| Study title: Topical application of fluoride varnish for dental caries prevention in ollectives following a 3-year testing period][Article in German |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42385 |
| Study title: Topical application of fluoride varnish for dental caries prevention in ollectives following a 3-year testing period][Article in German |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42498 |
| Study title: Trials - results - conclusions. Duraphat - Fluor Protector |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42340 |
| Study title: Trials - results - conclusions. Duraphat - Fluor Protector |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42453 |
| Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42271 |
| Study title: Epstein JS, Ganz WI, Lizak M, Grobman L, Goodwin WJ, Dewanjee MK. Indium 111-labeled leukocyte scintigraphy in evaluating head and neck infections. Ann Otol Rhinol Laryngol. 1992 Dec;101(12):961-8. Epstein JS, Ganz WI, Lizak M, Grobman L, Goodwin WJ, Dewanjee MK. Indium 111-labeled leukocyte scintigraphy in evaluating head and neck infections. Ann Otol Rhinol Laryngol. 1992 Dec;101(12):961-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43683 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48274 |
| 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 |
| View full study record |
| Document reference: 48273 |
| Study title: A multi-location clinical study of the effects of biosynthesized 191 AA (rhGH) Growth Hormone in the Treatment of Pituitary Dwarfism |
| Active substance: Somatropin |
| Study summary document link (including results): 86-075 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41742 |
| Study title: A MULTICENTER, RANDOMIZED, DOUBLEBLIND PLACEBO-CONTROLLED TRIAL EVALUATING THE METABOLIC AND RESPIRATORY EFFECTS OF SOMATROPIN IN CHILDREN WITH CYSTIC FIBROSIS |
| Active substance: Somatropin |
| Study summary document link (including results): 307-MET-9002-026 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41746 |
| Study title: A multicentre study of the acceptability and convenience of administering growth hormone treatment by means of an injection pen delivery system (NordiJect) |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41807 |
| Study title: Gynecomastia - clinical and therapeutic aspects. [Serbian]. Gynecomastia - clinical and therapeutic aspects. [Serbian]. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43306 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44146 |
| Study title: Imaging of non-central nervous system primitive neuroectodermal tumours: diagnostic features and correlation with outcome. Dick EA, McHugh K, Kimber C, Michalski A. Clin Radiol. 2001 Mar;56(3):206-15. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43457 |
| Study title: Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5. Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44036 |
| Study title: Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6. Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43834 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42598 |
| Study title: A Multicenter, Double–Blind, Vehicle Controlled Study of Topical 5% Spironolactone Cream in the Treatment of Nodulocystic Acne |
| Active substance: SPIRONOLACTONE |
| Study summary document link (including results): S84-89-02-016 EMEA Paediatric Web Synopsis.pdf |
| View full study record |
| Document reference: 42601 |
| Study title: Relazione clinica sull'impiego dello spironolattone quale agente sodiuretico. |
| Active substance: SPIRONOLACTONE |
| Study summary document link (including results): Spironolactone STUDY Dallavolta.xls |
| View full study record |
| Document reference: 47995 |
| Study title: ACTG 338 Week 48 Analysis Report, A Phase II Rolling Arm Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV- Infected Children |
| Active substance: stavudine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41614 |
| Study title: Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212.Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43122 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43224 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43234 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43244 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43326 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137 |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43333 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43344 |
| Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43354 |
| Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42373 |
| Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42486 |
| Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42423 |
| Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42536 |
| Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42445 |
| Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42558 |
| Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42252 |
| Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42284 |
| Study title: Auvert-Colin L, Couret I, Fajon O, Rossi M. [Scintigraphy with radiolabeled granulocytes for the detection of peripheral septic osteoarticular sites] Rev Rhum Ed Fr. 1993 Dec;60(12):871-8. French. Auvert-Colin L, Couret I, Fajon O, Rossi M. [Scintigraphy with radiolabeled granulocytes for the detection of peripheral septic osteoarticular sites] Rev Rhum Ed Fr. 1993 Dec;60(12):871-8. French. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43645 |
| Study title: Banovac K. The effect of etidronate on late development of heterotopic ossification after spinal cord injury. J Spinal Cord Med. 2000 Spring;23(1):40-4. Banovac K. The effect of etidronate on late development of heterotopic ossification after spinal cord injury. J Spinal Cord Med. 2000 Spring;23(1):40-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43486 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 35390 |
| Study title: Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta -F.Glorieux (abstract available) Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta -F.Glorieux (abstract available) |
| Active substance: RISEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35388 |
| Study title: 6-week, prospective, randomized, double-blind, placebo-controlled trial. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-NED-9_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 47260 |
| 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 |
| View full study record |
| Document reference: 35410 |
| Study title: Data of 80 subjects aged between 13 and 17 years of age with schizophrenia and who used risperidone for at least one year are to be collected. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35407 |
| Study title: Multicenter, multinational retrospective analysis on the safety of Risperdal in adolescent subjects with schizophrenia (13-17 yrs) |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-SCH-4083_Non-interventional_Risperidone.xls |
| View full study record |
| Document reference: 35391 |
| Study title: Open label, 6-month, multicenter study in adolescents with schizophrenia. Subjects entered from RIS-USA-231 or RIS-SCH-302 or entered directly. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-SCH-302_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35406 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43575 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 44240 |
| Study title: Tc-99m MAA total-body imaging to detect intrapulmonary right-to-left shunts and to evaluate the therapeutic effect in pulmonary arteriovenous shunts. Lu G, Shih WJ, Chou C, Xu JY. Clin Nucl Med. 1996 Mar;21(3):197-202. |
| 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: 48255 |
| 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: 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48217 |
| Study title: A MULTICENTRE STUDY ON GROWTH AND METABOLIC EFFECTS OF HIGH DOSE OF GENOTONORM IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): A6281201 (94-0201-001) PhRMA Clinical Study Synopsis.pdf |
| View full study record |
| Document reference: 41676 |
| 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 |
| View full study record |
| Document reference: 41745 |
| 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 |
| View full study record |
| Document reference: 41788 |
| Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE IN GIRLS WITH TURNER'S SYNDROME |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41682 |
| Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE TREATMENT IN CHILDREN WITH THALASSEMIA MAJOR |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41684 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43094 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43123 |
| Study title: Dubowitz DJ, Miles KA. Technical note: bone SPECT of the wrist. Br J Radiol. 1994 Sep;67(801):890-3. Dubowitz DJ, Miles KA. Technical note: bone SPECT of the wrist. Br J Radiol. 1994 Sep;67(801):890-3. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43616 |
| Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE IN CHILDREN WITH GROWTH HORMONE DEFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41687 |
| Study title: The effect of salmeterol (50mcg bd) and sustained release theophylline (uniphyllin 200mg bd) on night-time symptoms and sleep quality in children aged 5-16 years with nocturnal asthma. Report No. GRP/95/036 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Study SLPT06- SMS30014-Salmeterol Xinafoate-Serevent Rotadisks.xls |
| View full study record |
| Document reference: 42047 |
| Study title: The effect of salmeterol (50mcg bd) and sustained release theophylline (uniphyllin 200mg bd) on night-time symptoms and sleep quality in children aged 5-16 years with nocturnal asthma. Report No. GRP/95/036 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42067 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Schwef-Heel (drops) [AWB-AT] |
| Active substance: Schwef-Heel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40185 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Schwef-Heel (drops) [AWB-042] |
| Active substance: Schwef-Heel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40186 |
| Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43139 |
| Study title: Multicentre, randomised, double-blind, cross-over trial to evaluate the tolerance of Salmeterol protective effect in the asthma of effort. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SMS30078-ICHE3.pdf |
| View full study record |
| Document reference: 42035 |
| Study title: Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119.Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43091 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 43276 |
| Study title: Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. International Journal of Gynecology and Obstetrics 1998;62(1):77-82 1998;(1):77-82.Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. International Journal of Gynecology and Obstetrics 1998;62(1):77-82 1998;(1):77-82. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43293 |
| Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42316 |
| Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42452 |
| Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42432 |
| Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42545 |
| Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42430 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42455 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40224 |
| 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): |
| View full study record |
| Document reference: 43353 |
| Study title: Open-label, 6-month, multicenter study in adolescents with schizophrenia. Subjects entered from RIS-USA-231 or RIS-SCH-302 or entered directly |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-USA-231_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35395 |
| Study title: Risperidone in adolsecents, effects on tolerability and quality of life, open pilot trial |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35409 |
| Study title: Risperidone in the traztment of behavioural disturbances in mentally retarded children and adolescents: a double-blind placebo-controlled pilot trial. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35429 |
| Study title: Risperidone in the treatment of disruptive behavior disorders in children with intellectual limitations. One-year continuation study. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-CAN-20_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35430 |
| 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): |
| View full study record |
| Document reference: 43370 |
| Study title: Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4. Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43835 |
| Study title: Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70. Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43595 |
| 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): |
| View full study record |
| Document reference: 40225 |
| Study title: Retrospective survey for documentation of appllication and dosage of Spigelon (tablets) in children < 12 years of age [Bef-026] |
| Active substance: Spigelon |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40245 |
| 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: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929 Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43 |
| Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40239 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43613 |
