- Trials with a EudraCT protocol (4,071)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (4,787)
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: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45270 |
| Study title: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 BA-RP1 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47847 |
| Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA) |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45271 |
| Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA) |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 SP PD2 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47848 |
| Study title: Serum Concentrations of Flurbiprofen in Children After a Single Oral Dose of 22.5 mg or 27 mg of the Drug, following a Multidose Regime |
| Active substance: FLURBIPROFEN |
| Study summary document link (including results): flurbiprofen-dm7620.pdf |
| View full study record |
| Document reference: 48075 |
| Study title: Acute osteomyelitis in children: combined Tc-99m and Ga-67 imaging. Lewin JS, Rosenfield NS, Hoffer PB, Downing D. Radiology. 1986 Mar;158(3):795-804. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43915 |
| 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: 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: 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: Scintigraphic evaluation of extremity pain in children: its efficacy and pitfalls. Park HM, Rothschild PA, Kernek CB. AJR Am J Roentgenol. 1985 Nov;145(5):1079-84. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43930 |
| Study title: [Algodystrophy, a little known disease in children. General review apropos of 4 cases] French. Labenne M, Bertrand AM, Wendling D, Onimus M, Laurain JM, Amsallem D. Ann Pediatr (Paris). 1987 Oct;34(8):603-8. Review. French. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43850 |
| 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 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: 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: FLU9705: a multi-centre, parallel group, randomised, double-blind study to investigate the efficacy of fluticasone propionate 100 mcg MDI bd versus placebo MDI bd both via Babyhaler™ spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 months study period. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FMS40256-ICHE3.pdf |
| View full study record |
| Document reference: 28395 |
| Study title: Nebulised Fluticasone propionate in an upper respiratory tract inflammatory disorder (rhinopharyngitis): a multicentre, randomised, blinded, parallel group study of the efficacy and safety of nebulised fluticasone propionate 0.5mg daily compared with nebulised beclomethasone dipropionate 0.8mg daily in children suffering from acute rhinopharyngitis. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FLIC09-ICHE3.pdf |
| View full study record |
| Document reference: 28422 |
| Study title: Prevention of Otitis media in children." 6) "A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients." |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FNM40083-ICHE3.pdf |
| View full study record |
| Document reference: 28367 |
| 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: A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children (aged 5-12, inclusive) with persistent asthma evaluating the safety, efficacy and pharmacokinetics of Foradil (formoterol fumarate) 10 mg bid delivered b |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 0604 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47797 |
| 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: 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 6 months comparison of the safety and efficacy profiles of OXIS (formoterol) Turbuhaler as needed and BRICANYL (terbutaline) Turbuhaler as needed in children with asthma on anti-inflammatory treatment. |
| Active substance: FORMOTEROL |
| Study summary document link (including results): SD-037-0695 Study Synopsis.pdf |
| View full study record |
| Document reference: 47802 |
| 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: A RANDOMISED, DOUBLE-BLIND, CROSS-OVER, MULTI-CENTRE STUDY COMPARING THE EFFICACY AND TOLERABILITY OF FORMOTEROL 12 UG INHALED TWICE DAILY WITH SALBUTAMOL 100 UG INHALED FOUR TIMES DAILY IN THE TREATMENT OF ASTHMA IN CHILDREN |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 NBG 8937 Art45 Listing.xls |
| View full study record |
| Document reference: 47805 |
| Study title: A randomized double-blind, cross-over comparison of inhaled formoterol 12 ug and salbutamol 200 ug in children with exercise induced asthma |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 FO-DK1Art45 listing 2011.xls |
| View full study record |
| Document reference: 47807 |
| Study title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIPLE DOSE (1 WEEK) FINDING, MULTICENTER, CROSSOVER STUDY IN CHILDREN AGED 5 TO 12 WITH PERSISTENT ASTHMA COMPARING 4 DOSES (5, 10, 15 AND 30 UG) OF FORMOTEROL BID ADMINISTERED FROM THE MULTIPLE DOSE DRY |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 0602 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47808 |
| Study title: MULTI-CENTRE, OPEN LABEL, NON COMPARATIVE STUDY OF MULTIPLEDOSES OF 12 MYG FORMOTEROL METERED DOSE AEROSOL IN CHILDREN WITH BROCHIAL ASTHMA |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 BA-RP1F Art45 listing 2011.xls |
| View full study record |
| Document reference: 47849 |
| Study title: ONSET OF ACTION IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DFORC3 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47851 |
| Study title: OPEN LONG TERM TRIAL ON FORMOTEROL METERED DOSE AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DFORE6 - D 042 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47852 |
| Study title: Open, 12-month, follow-up of a 3-month, comparative, multi-centre, double-blind trial to assess the long-term tolerability and efficacy of formoterol 12 ug dry powder capsules in children with reversible obstructive airways diseases |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DP-PD2F Art45 listing 2011.xls |
| View full study record |
| Document reference: 47853 |
| Study title: PLACEBO-CONTROLLED, DOSE-FINDING, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL OF DIFFERENT DOSES OF INHALED FORMOTEROL DRY POWDER (6, 12, 24 UG) AND 400 UG INHALED SALBUTAMOL DRY POWDER IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DP-PD6 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47858 |
| Study title: PREVENTIVE EFFECT AND TOLERABILITY OF FORMOTEROL COMPARED WITH THAT OF SALBUTAMOL IN CHILDREN WITH EXERCISE-INDUCED ASTHMA |
| Active substance: FORMOTEROL |
| Study summary document link (including results): |
| 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: Generalized soft tissue calcification in children and adolescents with end stage renal failure. van Diemen-Steenvoorde R, Donckerwolcke RA, de Haas G. Eur J Pediatr. 1986 Sep;145(4):293-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43893 |
| Study title: [Osteomyelitis in children: sometimes hard to recognize] Dutch. te Pas AB, Feith SW, Wit JM. Ned Tijdschr Geneeskd. 2002 Aug 17;146(33):1547-50. Dutch. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43438 |
| Study title: Clinical impact and prognostic value of metaiodobenzylguanidine imaging in children with metastatic neuroblastoma. Perel Y, Conway J, Kletzel M, Goldman J, Weiss S, Feyler A, Cohn SL. J Pediatr Hematol Oncol. 1999 Jan-Feb;21(1):13-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43514 |
| Study title: Comparison of radiographic and radionuclide skeletal surveys in battered children. Pickett WJ, Faleski EJ, Chacko A, Jarrett RV. South Med J. 1983 Feb;76(2):207-12. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44049 |
| Study title: The diagnostic importance of a quantitative evaluation of gamma scintigraphy in Perthes' disease in children.Dmitrienkov BN, Fed in AV, Zhvaniia TG, Subbotina EN. Med Radiol1989 Jul;34(7):19-23. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48477 |
| Study title: Technetium 99m-methylene diphosphonate bone scans in children with reflex neurovascular dystrophy. Laxer RM, Allen RC, Malleson PN, Morrison RT, Petty RE. J Pediatr. 1985 Mar;106(3):437-40. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43956 |
| 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 multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4-11 years with asthma |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40012-ICHE3.pdf |
| View full study record |
| Document reference: 28443 |
| 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: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with Seretide(tm) 50/100mcg |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM3802-ICHE3.pdf |
| View full study record |
| Document reference: 28442 |
| Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”) |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30018-ICHE3.pdf |
| View full study record |
| Document reference: 28451 |
| Study title: Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric) |
| Active substance: FLUTICASONE AND SALMETEROL |
| Study summary document link (including results): Fluticasone-Propionate-Sameterol-ADERE-PEDIATRIC-1-ICHE3.pdf |
| 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: The role of radioisotopic methods in imaging of intervertebral disc inflammation in children. Pilecki S, Gierach M, Drobik P, Kurylak A, Trzcinska I, Hagner W, et al. Nucl Med Rev Cent East Eur. 2006;9(1):72-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43375 |
| Study title: [Early diagnosis of bone infarction in children with sickle cell anemia by MDP 99m Tc scanning] Koren A, Fedchteyn S, Katsuni E. Harefuah. 1982 Mar 1;102(5):182-5. Hebrew. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44090 |
| Study title: The role of bone scintigraphy in predicting femoral head collapse following cervical fractures in children. Mortensson W, Rosenborg M, Gretzer H. Acta Radiol. 1990 May;31(3):291-2. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43763 |
| Study title: A SINGLE CENTRE, DOUBLE-BLIND, WITHIN-PATIENT COMPARATIVE TRIAL WITH CUMULATIVE DOSES OF FORMOTEROL AND SALBUTAMOL METERED DOSE AEROSOLS IN CHILDREN WITH ASTHMA.INTEGRATED STUDY REPORT (CLINICAL AND STATISTICAL) |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 GS 19 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47812 |
| Study title: A single dose study evaluating peak inspiratory flow rate and forced inspiratory vital capacity in children and adults with asthma of differing severity after administration of a placebo capsule for inhalation when using the aerolizer device |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 0061 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47813 |
| 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: BIOMETRIC REPORT ON A CLINICAL STUDY WITH FORMOTEROL (TWO 6-UG PUFFS) VERSUS FENOTEROL (TWO 0.2-MG PUFFS) IN CHILDREN WITH REVERSIBLE DISEASES OF THE AIRWAYS |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DFORB5 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47822 |
| Study title: Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7 |
| Active substance: CYCLOPHOSPHAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25142 |
| Study title: [Osteoscintigraphy in the evaluation of a bone transplant in cranioplasty in children] Russian. Mytnikov AM, Smirnov IuN, Ivanov LB, Eshankulov GS, Bukhanov VE. Med Radiol (Mosk). 1989 Apr;34(4):46-9. Russian. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43790 |
| 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: STATISTICAL REPORT ON AN OPEN, NON-COMPARATIVE STUDY WITH FORMOTEROL-METERED DOSE AEROSOL (2 X DAILY 12 MCG) IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE DISEASES OF THE RESPIRATORY TRACT |
| Active substance: FORMOTEROL |
| Study summary document link (including results): FOR258 DFORC5 Art45 listing 2011.xls |
| View full study record |
| Document reference: 47866 |
| Study title: 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: Tolerability of high dose formoterol vs. high dose terbutaline in asthmatic children after inhalation via Turbuhaler |
| Active substance: FORMOTEROL |
| Study summary document link (including results): SD-037-0738 Study Synopsis.pdf |
| View full study record |
| Document reference: 47870 |
| Study title: A double blind, double dummy, crossover study to compare the systemic pharmacodynamic effects and safety of inhaled fluticasone propionate Nebules™ 1mg bd with oral prednisolone administered for 7 days to children aged 4 to 16 years with asthma |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FLTB3055-ICHE3.pdf |
| View full study record |
| Document reference: 28421 |
| Study title: A double blind, double dummy, placebo controlled trial of Fluticasone propionate aqueous nasal spray and oral Ketotifen in children with perennial rhinitis aged between 2 and 4 years. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FLNQ12-ICHE3.pdf |
| View full study record |
| Document reference: 28364 |
| 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 multi-centre, randomised, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of fluticasone propionate 400μg daily with budesonide 400μg daily in children with asthma. |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FMS30037-ICHE3.pdf |
| View full study record |
| Document reference: 28426 |
| Study title: Gallium-67 and technetium-99m-methylene diphosphonate skeletal scintigraphy in determining prognosis for children with stage IV neuroblastoma. Macdonald WB, Stevens MM, Dalla Pozza L, Bergin M, Menser MA, Howman-Giles R, Uren RF. J Nucl Med. 1993 Jul;34(7):1082-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43662 |
| 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: Bone infarction in children with sickle cell disease: early diagnosis and differentiation from osteomyelitis. Koren A, Garty I, Katzuni E. Eur J Pediatr. 1984 Jun;142(2):93-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43995 |
| Study title: The imaging diagnosis of nonpyogenic discitis in children.Grünebaum M, Horodniceanu C, Mukamel M, Varsano I, Lubin E. Pediatr Radiol. 1982;12(3):133-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44102 |
| Study title: Baldini G. et al Controlled clinical study on the activity of a new formulation of Ambroxol in asthma-like bronchitis in children.MinervaPed,1989,Baldini |
| Active substance: AMBROXOL |
| Study summary document link (including results): MinervaPed,1989,Baldini.pdf |
| View full study record |
| Document reference: 48876 |
| Study title: Magnetic resonance imaging in children with acute hip pain. Ranner G, Ebner F, Fotter R, Linhart W, Justich E. Pediatr Radiol. 1989;20(1-2):67-71. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43799 |
| 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: Jones MM, Moore WH, Brewer EJ, Sonnemaker RE, Long SE. Radionuclide bone/joint imaging in children with rheumatic complaints. Skeletal Radiol. 1988;17(1):1-7. Jones MM, Moore WH, Brewer EJ, Sonnemaker RE, Long SE. Radionuclide bone/joint imaging in children with rheumatic complaints. Skeletal Radiol. 1988;17(1):1-7. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43832 |
| Study title: Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43822 |
| Study title: Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43386 |
| Study title: "Fluoxetine vs. Placebo in the Acute Treatment of Major Depressive Disorder in Children and Adolescents |
| Active substance: FLUOXETINE |
| Study summary document link (including results): fluoxetine B1Y-MC-X065 Clinical Study Synopsis.pdf |
| View full study record |
| Document reference: 28343 |
| 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: Impact Of Fluoxetine On Growth In Children And Adolescents |
| Active substance: FLUOXETINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28330 |
| 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: A Randomized, Double-Blind, Double Dummy, Parallel Group Comparison of Fluticasone Propionate Inhalation Powder (50mcg BID) via DiskusTM with Oral Montelukast (5mg QD) Chewable Tablets in Children 6–12 years of Age with Persistent Asthma |
| Active substance: FLUTICASONE |
| Study summary document link (including results): Fluticasone-Propionate-FPD40012-ICHE3.pdf |
| View full study record |
| Document reference: 28389 |
| 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: 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: 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: symptomatic treatment of migraine in children: a systemic review of medications trials |
| Active substance: CHLORPHENAMINE AND PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 24048 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
| Active substance: CODEINE_AND_PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 24563 |
| Study title: Experience with rnebendazol in children with multiple intestinal helminthiasis. 1974 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31553 |
| 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: Children With Congenital Hypothyroidism and Their Siblings: Do They Really Differ?Rovet JF., 2005 Horm Res 2006; 66: 240-248 Pediatrics 2005; 1145 (1): e52-e57 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48956 |
| Study title: Cognition and Behaviour at School Entry in Children With Congenital Hypothyroidism Treated Early With High-Dose LevothyroxineJ Pediatr 2004; 144: 747-752 Simoneau-Roy J., 2004 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48980 |
| Study title: Investigate the clinical use of Lactulose as laxative in constipated children.Bush |
| Active substance: LACTULOSE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_3.xlsx |
| View full study record |
| Document reference: 49068 |
| Study title: To compare lactulose with standardized senna syrup in treatment of constipated children.Perkin |
| Active substance: LACTULOSE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_1.xlsx |
| View full study record |
| Document reference: 49066 |
| 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: Pyridostigmine and metoclopramide do not restore the TSH response to TRH-inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest 2000; 23: 744-747, Radetti G., 2000 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48952 |
| 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: Multicentre, randomised, comparative double-blind and double placebo study in two parallel groups, of the efficacy and safety of ketoprofen (0.5 mg/kg/dose), versus paracetamol (15 mg/kg/dose), in repeated doses, in the treatment of febrile conditions in children aged 6 months to 6 years. |
| Active substance: KETOPROFEN |
| Study summary document link (including results): Ketoprofen-Study 4.pdf |
| View full study record |
| Document reference: 30864 |
| Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41242 |
| 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: Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975) |
| Active substance: DANTROLENE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25533 |
| Study title: Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25938 |
| Study title: Clinical applications of radionuclide lung scanning in infants and children.Br J Radiol. 1981 Jul;54(643):576-85. Gordon I 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: 48553 |
| 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 esophageal transit in children and in infants by means of Krypton-81m.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985 |
| 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: 48548 |
| Study title: Krypton-81m: a better radiopharmaceutical for assessment of regional lung function in children.Radiology. 1979 Mar;130(3):741-7. Li DK 1979 |
| 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: 48558 |
| Study title: Provocation test for children with bronchial asthma monitored by 81mKr ventilation and perfusion lung scans.Eur J Nucl Med. 1985;10(1-2):81-3. Uchiyama G 1985 |
| 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: 48547 |
| Study title: Pulmonary ventilation and perfusion studies in infants and children.J Thorac Imaging. 1986 Oct;1(4):49-56. Gainey MA 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: 48544 |
| Study title: [Pulmonary ventilation studies of asthmatic children with Kr-81m (author's transl)] [Article in Japanese]Nippon Igaku Hoshasen Gakkai Zasshi. 1979 May 25;39(5):499-505.Uchiyama G 1979 |
| Active substance: krypton |
| Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
| View full study record |
| Document reference: 48557 |
| Study title: Quantitative approach to the study of regional lung function in children using krypton 81m.Br J Radiol. 1980 Oct;53(634):950-9. Ciofetta G 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: 48554 |
| 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: INTRAVENOUS FOSPHENYTOIN AND INTRAMUSCULAR FOSPHENYTOIN IN CHILDREN WITH SEIZURES. |
| Active substance: FOSPHENYTOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28604 |
| Study title: USE OF GABAPENTIN FOR SYMPTOM CONTROL IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER - A PILOT STUDY. (PELLOCK/WATEMBERG) |
| Active substance: GABAPENTIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28798 |
| Study title: An Open-Label, Dose-Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children with Attention-Deficit/Hyperactivity Disorder |
| Active substance: ATOMOXETINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21979 |
| Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. (Jan 1988) |
| Active substance: IBUPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29380 |
| Study title: James LP, Stowe CD, Farrar HC, Menendez AA, Argao EA. The pharmacokinetics of oral ranitidine in children and adolescents with cystic fibrosis. J Clin Pharmacol. 1999 Dec;39(12):1242-7.James LP, Stowe CD, Farrar HC, Menendez AA, Argao EA. The pharmacokinetics of oral ranitidine in children and adolescents with cystic fibrosis. J Clin Pharmacol. 1999 Dec;39(12):1242-7. |
| Active substance: RANITIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35279 |
| Study title: Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534.Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34836 |
| Study title: To determine if systemic absorption of (pyrvinium pamoate) C1-316 occures in children following single oral doses of 5 mg/kg.Heffelfinger |
| Active substance: PYRVINIUM |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Pyrvin embonate_1.xls |
| View full study record |
| Document reference: 49077 |
| Study title: Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488).Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34736 |
| 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: Combinant human growth hormone improves growth in children receiving glucocorticoid treatment after liver transplantation.Sarna S, Sipilä I, Rönnholm K, Koistinen R, Holmberg C. J Clin Endocrinol Metab. 1996 Apr;81(4):1476-82. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49217 |
| Study title: Comparison of three different methods of estimating the glomerular filtration rate in children after renal transplantation.al-Harbi N, Lireman D. Am J Nephrol. 1997;17(1):68-71. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49219 |
| Study title: A Single Dose, Randomized, Open-Label, Single Center, Two-Way Crossover Pharmacokinetic Study of Advil® Cold & Sinus Tablets in Children |
| Active substance: IBUPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29539 |
| Study title: Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures; Paediatr Anaesth 2002, 12(7):594-9 |
| Active substance: FENTANYL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27190 |
| 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: 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: Statistical report: the dose response curve of fenoterol in the range 3 mcg - 1000 mcg in asthmatic children. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30615 |
| 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: 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: Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, |
| Active substance: VERAPAMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45534 |
| Study title: Differences between children and adults in thiopurine methyltransferase activity and metabolite formation during thiopurine therapy: possible role of concomitant methotrexate.Pettersson B1, Almer S, Albertioni F, Söderhäll S, Peterson C. Ther Drug Monit. 2002 Jun;24(3):351-8. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49254 |
| Study title: Efficacy and tolerability at 3 and 6 months following use of azathioprine for recalcitrant atopic dermatitis in children and young adults.Hon KL, Ching GK, Leung TF, Chow CM, Lee KK, Ng PC. J Dermatolog Treat. 2009;20(3):141-5. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49287 |
| 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: Follow-up of children with autoimmune hepatitis treated with cyclosporine.Cuarterolo M, Ciocca M, Velasco CC, Ramonet M, González T, López S, Garsd A, Alvarez F. J Pediatr Gastroenterol Nutr. 2006 Nov;43(5):635-9. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49277 |
| Study title: Altiay et al. 99mTc-HMPAO brain perfusion single-photon emission computed tomography in children with Down syndrome: relationship to epilepsy, thyroid functions, and congenital heart diseaseJournal of child neurology (2006), 21(7) 610-4. altiay s 2006 |
| Active substance: CERETEC |
| Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
| View full study record |
| Document reference: 48605 |
| Study title: Cerebral Perfusion in Children With Alice in Wonderland SyndromeYung-Ting Kuo, MD*†, Nan-Chang Chiu, MD†, Ein-Yiao Shen, MD†, Che-Sheng Ho, MD†, and Ming-Che Wu, MD‡ PEDIATRIC NEUROLOGY Vol. 19 No. 2 |
| Active substance: CERETEC |
| Study summary document link (including results): kuo yt 1998.pdf |
| View full study record |
| Document reference: 48594 |
| 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: Charron et al. Temporal correlation of the erythrocyte sedimentation rate with Tc-99m WBC uptake on children with inflammatory bowel diseasesClin Nucl Med. 2003 Nov; 28(11):905-7. charron m 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: 48622 |
| 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: Differences in 99mTc-HMPAO brain SPET perfusion imaging between Tourette’s syndrome and chronic tic disorder in childrenNan-Tsing Chiu1, Ying-Chao Chang2, Bi-Fang Lee1, Chao-Ching Huang3, Shan-Tair Wang4. European Journal of Nuclear Medicine Vol. 28, No. 2, February 2001 |
| Active substance: CERETEC |
| Study summary document link (including results): nan-tsing chiu 2001.pdf |
| View full study record |
| Document reference: 48597 |
| Study title: Infliximab heals intestinal inflammatory lesions and restores growth in children with Crohn's disease.Borrelli O, Bascietto C, Viola F, Bueno de Mesquita M, Barbato M, Mancini V, Bosco S, Cucchiara S. Dig Liver Dis. 2004 May;36(5):342-7. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49264 |
| Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49263 |
| Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49270 |
| Study title: Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden.Schmidt S, Mellström D, Norjavaara E, Sundh SV, Saalman R. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49290 |
| Study title: Monitoring 6-thioguanine nucleotide concentrations in Japanese children and adolescents with inflammatory bowel disease.Ohtsuka Y, Arai K, Aoyagi Y, Fujii T, Yamakawa Y, Ohtani K, Ikuse T, Baba Y, Inage E, Kudo T, Suzuki R, Nagata S, Shimizu T. J Gastroenterol Hepatol. 2010 Oct;25(10):1626-30 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49294 |
| Study title: Monitoring azathioprine metabolite levels and thiopurine methyl transferase (TPMT) activity in children with inflammatory bowel disease.Paerregaard A, Schmiegelow K. Scand J Gastroenterol. 2002 Mar;37(3):371-2. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49252 |
| Study title: Myasthenia gravis in children: a longitudinal study.Ashraf VV, Taly AB, Veerendrakumar M, Rao S. Acta Neurol Scand. 2006 Aug;114(2):119-23. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49273 |
| Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part I).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49281 |
| Study title: Griffiths et al. 99mTechnetium HMPAO imaging in children with the Sturge- Weber syndrome: a study of nine cases with CT and MRI correlationNeuroradiology (1997), 39(3), 219-24. Griffiths pd 1997 |
| Active substance: CERETEC |
| Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc |
| View full study record |
| Document reference: 48611 |
| Study title: Improving the diagnosis of acute appendicitis in children with atypical clinical findings using the technetium-99m hexamethylpropylene amine oximelabelled white-blood-cell abdomen scan.Pediatr Radiol. 2002 Sep;32(9):663-6. yan dc 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: 48621 |
| 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: Diler et al. Pharmacotherapy and regional cerebral blood flow in children with obsessive compulsive disorder.Yonsei Med J. 2004 Feb 29; 45(1):90-9 diler rs 2004 |
| 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: 48609 |
| 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: "Long-Term Efficacy of Anticholinergic and Alpha-blocking Drugs in the Detrusor of Children with Myelomeningocele - Bouchot O et al. - Journal d'Urologie - 1988 (94(2): 83-86) - Publication in UK registration file - " "Long-Term Efficacy of Anticholinergic and Alpha-blocking Drugs in the Detrusor of Children with Myelomeningocele - Bouchot O et al. - Journal d'Urologie - 1988 (94(2): 83-86) - Publication in UK registration file - " |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32983 |
| Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41709 |
| Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part II).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49282 |
| Study title: Normal thiopurine methyltransferase levels do not eliminate 6-mercaptopurine or azathioprine toxicity in children with inflammatory bowel disease.Kader HA, Wenner WJ Jr, Telega GW, Maller ES, Baldassano RN. J Clin Gastroenterol. 2000 Jun;30(4):409-13. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49233 |
| Study title: Oral tacrolimus treatment of severe colitis in children.Bousvaros A1, Kirschner BS, Werlin SL, Parker-Hartigan L, Daum F, Freeman KB, Balint JP, Day AS, Griffiths AM, Zurakowski D, Ferry GD, Leichtner AM. J Pediatr. 2000 Dec;137(6):794-9. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49249 |
| 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: Short-term cyclosporine induces a remission of autoimmune hepatitis in children.Alvarez F, Ciocca M, Cañero-Velasco C, Ramonet M, de Davila MT, Cuarterolo M, Gonzalez T, Jara-Vega P, Camarena C, Brochu P, Drut R, Alvarez E. J Hepatol. 1999 Feb;30(2):222-7. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49226 |
| Study title: The relationship between 99mTc-HMPAO brain SPECT and the scores of real life rating scale in autistic childrenMeryem Kayaa,*, Serap Karasalihog˘lub, Funda U¨ stu¨na, Aziz Gu¨ltekina, Tevfik Fikret C¸ ermika, Yes¸im Fazlıog˘lub, Mevlu¨t Tu¨rec, O¨ mer N. Yig˘itbas¸ıa, S¸ akir Berkardaa. Brain & Development 24 (2002) 77–81 |
| Active substance: CERETEC |
| Study summary document link (including results): kaya m 2002.pdf |
| View full study record |
| Document reference: 48593 |
| Study title: Transient Posterior Encephalopathy Induced by Chemotherapy in ChildrenRocı´o Sa´nchez-Carpintero, MD, PhD*, Juan Narbona, MD, PhD*, Reyes Lo´pez de Mesa, MD*, Javier Arbizu, MD‡, and Luis Sierrasesu´maga, MD, PhD†. Pediatr Neurol 2001;24:145-148. |
| Active substance: CERETEC |
| Study summary document link (including results): Sanchez r 2001.pdf |
| View full study record |
| Document reference: 48600 |
| Study title: Usefulness of Tc-99m HMPAO-labeled WBC heart scan to predict impaired ventricular function and coronary artery dilation in children with Kawasaki diseaseHsiu-Bao Hsua, Yun-Ching Fub,c,*, Shih-Chuan Tsaid, Ruoh-Fang Yene, Betau Hwangc,f. International Journal of Cardiology 92 (2003) 65– 69 |
| Active substance: CERETEC |
| Study summary document link (including results): hsiu-bao h 2003.pdf |
| View full study record |
| Document reference: 48591 |
| 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: Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4. |
| Active substance: CETIRIZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23659 |
| 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: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/Internal Report, Strenge-Hesse, March 1996 |
| Active substance: Silibinine dihydrogen succinate, disodium |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39873 |
| Study title: GM2002/00081/00 A double blind, placebo controlled two way cross over study investigating the efficacy of sumatriptan nasal spray in children's migraine. |
| Active substance: SUMATRIPTAN |
| Study summary document link (including results): sumatriptan-SUM40019-ICHE3.pdf |
| View full study record |
| Document reference: 43074 |
| Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part III).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49283 |
| Study title: Tacrolimus and steroids versus ciclosporin microemulsion, steroids, and azathioprine in children undergoing liver transplantation: randomised European multicentre trial.Kelly D1, Jara P, Rodeck B, Lykavieris P, Burdelski M, Becker M, Gridelli B, Boillot O, Manzanares J, Reding R. Lancet. 2004 Sep 18-24;364(9439):1054-61. |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49265 |
| 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: Treatment of small vessel primary CNS vasculitis in children: an open-label cohort study.Hutchinson C, Elbers J, Halliday W, Branson H, Laughlin S, Armstrong D, Hawkins C, Westmacott R, Benseler SM. Lancet Neurol. 2010 Nov;9(11):1078-84 |
| Active substance: Azathioprine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 49295 |
| 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: Analyse critique des études cliniques Abbott, contains study 75-030 of Depakene syrup in epileptic children - Canlorbe P. - 03/04/1981 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45447 |
| 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: Topical stannous fluoride as a caries preventive for preschool children1962-Burgess |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): 1962-Burgess-Topical stannous fluoride as a caries preventive for preschool children.pdf |
| View full study record |
| Document reference: 49142 |
| 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: 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: Assessment of Efficacy and Systemic Safety of a New Chlorofluorocarbon-Free Formulation of Inhaled Beclomethasone Dipropionate in Asthmatic ChildrenPEDIATRIC ASTHMA, ALLERGY & IMMUNOLOGY, Volume 15, Number 3, 2002 |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): DM-RS-3303-05-00 pubblication.pdf |
| View full study record |
| Document reference: 49208 |
| Study title: Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma. Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24. |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): MC.PR.1400.001.98 publication.pdf |
| View full study record |
| Document reference: 49203 |
| Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in, in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 mg of nebulized beclomethasone dipropionate or 750mg of nebulized Pulmicort® twice a day.study synopsis. Please see report |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc |
| View full study record |
| Document reference: 49206 |
| Study title: Evidence of adequacy of the performance of the Pulvinal by measuring through-device Peak Inspiratory Flow Rate in severe airways obstruction in adults and children.Dal Negro et al, J.Aerosol Med 2001, 14(3) 343-349 |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): Published Paper (Dal Negro).pdf |
| View full study record |
| Document reference: 49200 |
| Study title: Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955. |
| Active substance: BIOTIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 22596 |
| Study title: An open study to investigate the clinical efficacy of Triamcinolone hexacetonide in diseases of the ear in children.Larras-Martenot (Les Cahier d´O.R.L. 14(4): 415-416, 1979) |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48964 |
| Study title: A multicentre study for open assessment of the efficacy and safety of TILADE (Nedocromil sodium) QID in the management of Asthma in children - H. Eigen et al. - 1990 - 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: 46994 |
| Study title: "A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study. J Biederman, et al., Journal of Clinical Psychiatry 2006, 67(5): 727-35. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45291 |
| 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: Do inhaled steroids change the response to inhaled ß-agonists in children? |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-3001 Study Synopsis.pdf |
| View full study record |
| Document reference: 44403 |
| Study title: Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999 Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45019 |
| Study title: Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981 |
| Active substance: TROSPIUM |
| Study summary document link (including results): 14532838.pdf |
| View full study record |
| Document reference: 46886 |
| 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: Open Randomized Parallel Group Design Trial Investigating the Efficacy and Tolerability of Beclomethasone Dipropionate (100 mcg qid) Dry Powder Delivered from Two Different Powder Inhalers (Chiesi and Glaxo) in the Treatment of Chronic Asthma in ChildrenJOURNAL OF AEROSOL MEDICINE, Volume 13, Number 1, 2000 |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): 15.02-CT-92-Pubblication.pdf |
| View full study record |
| Document reference: 49201 |
| Study title: Short-term growth and adrenal function in children with asthma treated with inhaled beclomethasone dipropionate hydroflouroalkane-134aPEDIATRIC ALLERGY AND IMMUNOLOGY, Pediatr Allergy Immunol 2006: 17: 613–619 |
| Active substance: BECLAMETHASONE |
| Study summary document link (including results): DM-PR-3303-004-03-publication.pdf |
| View full study record |
| Document reference: 49207 |
| 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 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: Efficacy and tolerability of morniflumate in the treatment of acute pharyngotonsillitis in children. Clinica,anno XXIX, 77-84, gennaio-giugno 1990R.Riondino et al, 1990. Clinica Europea 1990, Riondino |
| Active substance: MORNIFLUMATE |
| Study summary document link (including results): Clinica Europea 1990, Riondino.pdf |
| View full study record |
| Document reference: 48878 |
| Study title: Clinical pharmacokinetics and pharmacodynamics of opioid analgesics in infants and childrenOlkkola KT, Hamunen K, Maunuksela EL., 1995, Clin Pharmacokinet 1995; 5: 385-404 |
| Active substance: MORPHINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48931 |
| Study title: Recommended use of morphine in neonates, infants and children based on a literature review: Part 2 - Clinical use.Paediatr Anaesth 1997; 2: 93-101, Kart T, Christrup LL, Rasmussen M., 1997 |
| Active substance: MORPHINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48929 |
| 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: Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. |
| Active substance: CALCIUM CARBONATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 23155 |
| Study title: Bisoprolol treatment in children with hyperkinetic heart syndromeEur J Echocardiography 1999; Suppl: S66, Jurko A., 1999 |
| Active substance: Bisoprolol |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48905 |
| Study title: β-Blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial.Pediatr Nephrol 2002; 17: 345-350; Sorof JM., 2002 |
| Active substance: BISOPROLOL AND HYDROCHLOROTHIAZIDE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48907 |
| Study title: Corticosteroids administered by nebulization to children with bronchial asthma.Terzano C, Barkai L, Cremonesi G., Adv Ther. 2001 Nov-Dec;18:253-60. |
| Active substance: FLUNISOLIDE |
| Study summary document link (including results): MC-PR-3502-001-99 publication.pdf |
| View full study record |
| Document reference: 49211 |
| 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: Gentamicin in the treatment of acute and chronic pyelonephritis in childrenMed Klinik 1970; 65 (12): 552-557, Kienitz M., 1970 |
| Active substance: GENTAMYCIN |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48933 |
| Study title: PHARMACOKINETICS OF VOLTAREN IN CHILDRENPHARMACOKINETICS OF VOLTAREN IN CHILDREN |
| Active substance: DICLOFENAC |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26072 |
| 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: 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 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: 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: 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: 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: Janka-G-E, Lau-B-M, Haas-R-J, et-al. Dept. Haematol. Oncol., Child. Hosp., Univ. Munich, Germany. Combination chemotherapy and radiotherapy for Hodgkin's disease in children. European Journal of Pediatrics {EUR-J-PEDIATR}, 1978, Vol/Iss/Pg. 127 /4 (287-292).Janka-G-E, Lau-B-M, Haas-R-J, et-al. Dept. Haematol. Oncol., Child. Hosp., Univ. Munich, Germany. Combination chemotherapy and radiotherapy for Hodgkin's disease in children. European Journal of Pediatrics {EUR-J-PEDIATR}, 1978, Vol/Iss/Pg. 127 /4 (287-292). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34747 |
| Study title: Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34841 |
| Study title: Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647).Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34843 |
| Study title: Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X.Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34844 |
| Study title: Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35216 |
| 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: Kynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in childrenKynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in children |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30135 |
| 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: 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: Therapeutic equivalence of a deep propofol sedation in children aged 1 month to 8 years undergoing magnet resonance imaging |
| Active substance: PROPOFOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46120 |
| 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: Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1988, vol. 6, no. 12, p. 1845-50, ISSN: 0732-183X.Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol},... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34704 |
| Study title: Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532.Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34705 |
| Study title: Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34706 |
| Study title: Ekert-H. Treatment of childhood Hodgkin's disease with chemotherapy alone. Experiences from the Royal Children's Hospital, Melbourne. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 241-6, ISSN: 0927-3042. Ekert-H. Treatment of childhood Hodgkin's disease with chemotherapy alone. Experiences from the Royal Children's Hospital, Melbourne. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 241-6, ISSN: 0927-3042. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34707 |
| Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31116 |
| Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31126 |
| Study title: A 3-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL¿) Immediate-release Tablets in Daily Doses of 400 mg and 600 mg Compared with Placebo in the Treatment of Children and Adolescents with Bipolar I Mania |
| Active substance: QUETIAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45051 |
| 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: Risk of peripartal transmission of hepatitis B in children born to Hepatitis B positive mothers. |
| Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47765 |
| Study title: Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X.Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34709 |
| Study title: Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, 1992, Vol/Iss/Pg. 8/4 (215-218), ISSN: 0256-7040.Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, ... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34801 |
| Study title: Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1987, vol. 5, no. 8, p. 1221-31, ISSN: 0732-183X.Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34804 |
| Study title: Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. Current Medical Research and Opinion 14(3), p. 161-170,1998Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. Current Medical Research and Opinion 14(3), p. 161-170,1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31134 |
| 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: Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34823 |
| Study title: Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, Villejuif, France. Postoperative chemotherapy without irradiation for ependymoma in children under 5 years of age: a multicenter trial of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, 1 Mar 2001, vol. 19, no. 5, p. 1288-96, ISSN: 0732-183X.Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, ... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34727 |
| Study title: Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34728 |
| Study title: Haglund-U, Hayder-S, Zech-L. Dept. Med. Cell Genet., Med. Nobel Inst., Karolinska Inst., S-104 01 Stockholm, Sweden. Sister chromatid exchanges and chromosome aberrations in children after treatment for malignant lymphoma. Cancer Research {CANCER-RES}, 1980, Vol/Iss/Pg. 40/12 (4786-4790).Haglund-U, Hayder-S, Zech-L. Dept. Med. Cell Genet., Med. Nobel Inst., Karolinska Inst., S-104 01 Stockholm, Sweden. Sister chromatid exchanges and chromosome aberrations in children after treatment for malignant lymphoma. Cancer Research {CANCER-RES}, 1980, Vol/Iss/Pg. 40/12 (4786-4790). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34731 |
| Study title: Spiller HA, et all. Skin breakdown and blisters from senna-containing laxatives in young children. Ann Pharmacother. 2003 May;37(5):636-9. |
| Active substance: Rabarbar + senna |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40149 |
| Study title: Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1990, vol. 18, no. 4, p. 265-72, ISSN: 0098-1532.Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without la... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34748 |
| Study title: Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960.Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34749 |
| Study title: Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34751 |
| 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: Phase IV, compassionate use program of rasburicase for treatment of hyperuricemia in children and adolescent patients with tumor lysis syndrome |
| Active substance: rasburicase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47278 |
| Study title: Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children .Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children . |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30142 |
| Study title: A randomized double-blind study of safety and efficacy of SMOF 20% vs. Intralipid 20% in infants and children requiring long-term parenteral nutrition |
| Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40151 |
| Study title: Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34824 |
| Study title: Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Klinische Paediatrie, {Klin-Padiatr}, May-Jun 1986, vol. 198, no. 3, p. 137-46, ISSN: 0300-8630.Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Kl... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34826 |
| Study title: Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534.Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34827 |
| 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: Pegylated Interferon with and without ribavirin for children with HCV (PEDS – C) [112 children and adolescents aged 5-18 years with CHC (all genotypes) that are able to swallow tablets] |
| Active substance: RIBAVIRIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35303 |
| 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: Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street. |
| Active substance: PROMETHAZINE |
| Study summary document link (including results): Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street.pdf |
| View full study record |
| Document reference: 35049 |
| 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: Efficacy and safety of aerosolized ribavirin in young children hospitalized with influenza: a double-blind, multicenter, placebo-controlled trial. Efficacy and safety of aerosolized ribavirin in young children hospitalized with influenza: a double-blind, multicenter, placebo-controlled trial. |
| Active substance: PYRITINOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35235 |
| 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: 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: 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: Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34783 |
| Study title: Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p. 211-4, ISSN: 0390-5616.Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34711 |
| Study title: Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34712 |
| Study title: Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34713 |
| Study title: Evaluation of a coronary-cameral fistula: benefits of coronary dual-source MDCT angiography in childrenLerner CB 2008. Pediatr Radiol (2008) 38:874–878 |
| 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: 48201 |
| Study title: Iodixanol Pharmacokinetics in ChildrenJohnson WH 2001 Pediatr Cardiol 22:223–227, 2001 |
| 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: 48196 |
| Study title: Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34768 |
| 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: McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Summer 1990, vol. 12, no. 2, p. 147-54, 29 refs, ISSN: 0192-8562.McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/o... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34785 |
| Study title: McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1990, Vol/Iss/Pg. 12/2 (147-154), ISSN: 0192-8562.McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Jo... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34784 |
| Study title: Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations Office, 199 North Lake Ave, Pasadena, CA 91101, United States. Efficacy and toxicity of 12 courses of ABVD chemotherapy followed by low-dose regional radiation in advanced Hodgkin's disease in children: A report from the Childrens Cancer Study Group. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/12 (1971-1980), ISSN: 0732-183X.Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34714 |
| 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: Leventhal-B-G. Johns Hopkins Oncology Center, Baltimore, MD, United States. Management of stage I-II Hodgkin's disease in children. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/7 (1123-1124), ISSN: 0732-183X.Leventhal-B-G. Johns Hopkins Oncology Center, Baltimore, MD, United States. Management of stage I-II Hodgkin's disease in children. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/7 (1123-1124), ISSN: 0732-183X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34771 |
| Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34773 |
| Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34772 |
| Study title: Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566).Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34774 |
| Study title: Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for the treatment of childhood and adolescent Hodgkin disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 2001, vol. 23, no. 2, p. 84-8, ISSN: 1077-4114.Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for ... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
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| Document reference: 34732 |
| Study title: Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34733 |
| Study title: Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34735 |
| Study title: Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber experience. Pediatric hematology and oncology, {Pediatr-Hematol-Oncol}, Oct-Nov 2003, vol. 20, no. 7, p. 497-504, ISSN: 0888-0018.Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34737 |
| Study title: Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
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| Document reference: 34879 |
| Study title: Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 1996, vol. 18, no. 1, p. 76-80, ISSN: 1077-4114.Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hem... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34880 |
| Study title: Ghigo E et al. Growth hormone responses to pyridostigmine in normal adults and in normal and short children. Clin Endocrinol (Oxf). 1987 Dec;27(6):669-73Ghigo E et al. Growth hormone responses to pyridostigmine in normal adults and in normal and short children. Clin Endocrinol (Oxf). 1987 Dec;27(6):669-73 |
| Active substance: PYRIDOSTIGMINE |
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| Document reference: 35217 |
| Study title: Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6.Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6. |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35221 |
| Study title: van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004, vol. 42, no. 3, p. 210-5, ISSN: 1545-5009.van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004,... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34864 |
| Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1994, vol. 5 Suppl 2, p. 113-5, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official j... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34829 |
| Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, Sep 1992, vol. 3 Suppl 4, p. 73-6, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34830 |
| Study title: Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51, |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34831 |
| Study title: Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34832 |
| 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: Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35192 |
| 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: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -) |
| Active substance: PROPAFENONE |
| Study summary document link (including results): propafenone-m03681.pdf |
| View full study record |
| Document reference: 35059 |
| 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: 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: "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: 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: 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: Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21.Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21. |
| Active substance: RIMEXOLONE |
| Study summary document link (including results): Ocular-hypertensive and anti-inflammatory response to rimexo.pdf |
| View full study record |
| Document reference: 35387 |
| Study title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children ≥ 4 to < 16 Years Old with Osteogenesis Imperfecta |
| Active substance: RISEDRONIC ACID |
| Study summary document link (including results): Risedronate sodium - Study 1.pdf |
| View full study record |
| Document reference: 35389 |
| Study title: Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34715 |
| Study title: Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754.Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34716 |
| Study title: Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34718 |
| Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in children |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30357 |
| Study title: Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30358 |
| Study title: Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30361 |
| 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: Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45).Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34792 |
| Study title: Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34793 |
| Study title: Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X.Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34719 |
| 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: van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34867 |
| Study title: Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34738 |
| Study title: Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34740 |
| Study title: Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis, TN 38101, United States. Efficacy and toxicity of multiagent chemotherapy and low-dose involved- field radiotherapy in children and adolescents with Hodgkin's disease. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1993, Vol/Iss/Pg. 11/1 (100-108), ISSN: 0732-183X.Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34741 |
| Study title: Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34742 |
| Study title: Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16). |
| Active substance: PROCARBAZINE |
| 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: Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0370-4106.Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34883 |
| Study title: "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." |
| Active substance: PROCHLOPERAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34969 |
| Study title: A comparison of Diprivan (propofol) and thiopentone for induction of anaesthesia in children. |
| Active substance: PROPOFOL |
| Study summary document link (including results): 035868_0208 Study Synopsis.pdf |
| View full study record |
| Document reference: 46131 |
| Study title: A comparison of the characteristics of propofol and methohexitone for induction and maintenance of anaesthesia in children. |
| Active substance: PROPOFOL |
| Study summary document link (including results): 035868_0248 Study Synopsis.pdf |
| View full study record |
| Document reference: 46134 |
| 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 study to assess the pharmacokinetics of propofol in young children after a single dose for induction of anaesthesia. |
| Active substance: PROPOFOL |
| Study summary document link (including results): 035868_0243 Study Synopsis.pdf |
| View full study record |
| Document reference: 46130 |
| Study title: Remifentanil/Propofol versus Desflurane/N2O in general surgery, opthalmic surgery and ENT surgery in children |
| Active substance: REMIFENTANIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35286 |
| Study title: An open-label dose-finding trial of low molecular weight heparin LU 47311 (Clivarine®) for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
| Active substance: REVIPARIN |
| Study summary document link (including results): Reviparin-CL057.pdf |
| View full study record |
| Document reference: 35289 |
| Study title: An open-label, multicenter, randomized trial comparing low molecular weight heparin (reviparin) to standard of care for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
| Active substance: REVIPARIN |
| Study summary document link (including results): Reviparin-CL055.pdf |
| View full study record |
| Document reference: 35290 |
| Study title: Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thiemann-M, Schwarze-E-W. Department of Pediatric Hematology and Oncology, University Children's Hospital, Germany. schellon@uni-muenster.de. High cure rates and reduced long-term toxicity in pediatric Hodgkin's disease: the German-Austrian multicenter trial DAL-HD-90. The German- Austrian Pediatric Hodgkin's Disease Study Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1999, vol. 17, no. 12, p. 3736-44, ISSN: 0732-183X.Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thi... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34834 |
| Study title: Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34835 |
| Study title: Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34838 |
| Study title: Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630.Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34839 |
| Study title: Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35207 |
| Study title: Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35214 |
| 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: Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685 Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35220 |
| Study title: Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35184 |
| Study title: Radetti G et al. Pyridostigmine and metoclopramide do not restore the TSH response to TRH inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest. December 1, 2000, 744-7Radetti G et al. Pyridostigmine and metoclopramide do not restore the TSH response to TRH inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest. December 1, 2000, 744-7 |
| Active substance: PYRIDOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35180 |
| Study title: EEG during intravenous anaesthesia with propofol in children |
| Active substance: PROPOFOL |
| Study summary document link (including results): 0859FC-0018 Study Synopsis.pdf |
| View full study record |
| Document reference: 46127 |
| Study title: 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 |
| Active substance: PYRVINIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39567 |
| Study title: Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30170 |
| Study title: Spicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic childrenSpicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic children |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30171 |
| Study title: Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30174 |
| 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: Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30363 |
| Study title: Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989).Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34699 |
| Study title: Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34700 |
| Study title: Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X.Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34701 |
| 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: Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34703 |
| 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: Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34721 |
| Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenAJR Am J Roentgenol. 1991 Feb;156(2):345-50 Comparison of iohexol with barium in gastrointestinal studies of infants and children. Cohen MD, Towbin R, Baker S, Davis S, Becker C, Eggleston DE, Kehler M, Smith JA, Cory DA, White SJ. |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30365 |
| Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenJ Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. |
| Active substance: IOHEXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30379 |
| 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: Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620).Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34799 |
| Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31059 |
| Study title: Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130).Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34723 |
| 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: Placebo-controlled comparison of levamisole, pyrantel pamoate, thiabendazole, piperazine citrate, and varlaus dosages of mebendazole in the treatment of ascariasis and trichuriasis in children. 1975 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31539 |
| Study title: Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34777 |
| Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
| Active substance: LARATADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31016 |
| Study title: The effectiveness of the homeopathic remedy Rhinital in the out-patient treatment of children suffering from perennial and seasonal rhinitis |
| Active substance: Luffa operculata, Cardiospermum halicacabum, Galphimia glauca |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39743 |
| 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: Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1998, vol. 16, no. 3, p. 897-906, ISSN: 0732-183X.Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD i... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34744 |
| Study title: Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532.Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34745 |
| Study title: Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34746 |
| Study title: Acute poisoning in a children's hospital A 2-year experience |
| Active substance: PROMETHAZINE |
| Study summary document link (including results): Acute poisoning in a children's hospital A 2-year experience.pdf |
| View full study record |
| Document reference: 35052 |
| Study title: Adverse reactions in children |
| Active substance: PROMETHAZINE |
| Study summary document link (including results): Adverse reactions in children.pdf |
| View full study record |
| Document reference: 35038 |
| Study title: Annotation The use of psychotropic medications in children A British view |
| Active substance: PROMETHAZINE |
| Study summary document link (including results): Annotation The use of psychotropic medications in children A British view.pdf |
| View full study record |
| Document reference: 35029 |
| Study title: Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11).Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34725 |
| Study title: Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1994, Vol/Iss/Pg. 28/2 (381-386), ISSN: 0360-3016.Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34818 |
| Study title: Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30132 |
| Study title: Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. |
| Active substance: INOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30133 |
| Study title: Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An analysis of the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania experience. University of Pennsylvania experience. Cancer, {Cancer}, 1 Jun 1992, vol. 69, no. 11, p. 2755-60, ISSN: 0008-543X.Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An ... |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34779 |
| Study title: Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39).Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34780 |
| Study title: Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34869 |
| Study title: Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23).Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23). |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34870 |
| 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 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: 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: Open, non controlled, non randomised, unicenter pilot study to investigate the long-term efficacy of Adalat® drops and Adalat® retard 10 mg tablets in children with pulmonary hypertension and with peripheral pulmonary stenosis |
| Active substance: NIFEPIDINE |
| Study summary document link (including results): Bayer Pharma_Nifedipine_1555_study_synopsis.pdf |
| View full study record |
| Document reference: 32632 |
| Study title: The management of acute diarrhea in children: oral rehydratation, maintenance, and nutritiaonal therapy - Duggan C. et al. - 1992 (Morb. Mortal. Wkly. Rep., 1992, 41 (RR-16): 1-20)The management of acute diarrhea in children: oral rehydratation, maintenance, and nutritiaonal therapy - Duggan C. et al. - 1992 (Morb. Mortal. Wkly. Rep., 1992, 41 (RR-16): 1-20) |
| Active substance: NIFUROXAZIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47063 |
| Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , |
| Active substance: PACLITAXEL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33044 |
| Study title: Deaths in young children receiving nitrazepam. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32660 |
| Study title: Improvement of mental retardation plus epilepsy in children following management. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32654 |
| Study title: Seizures with clonazepam: Discontinuation and suggestions for safe discontinuation rates in children. |
| Active substance: NITRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32657 |
| Study title: Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. |
| Active substance: NITROUS OXIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32663 |
| Study title: Goldman LJ. Anesthetic uptake of sevoflurane and nitrous oxide during an inhaled induction in children. Anesthesia and Analgesia. 2003; 96(2):400-6 Goldman LJ. Anesthetic uptake of sevoflurane and nitrous oxide during an inhaled induction in children. Anesthesia and Analgesia. 2003; 96(2):400-6 |
| Active substance: NITROUS OXIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32666 |
| 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: 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: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp011.pdf |
| View full study record |
| Document reference: 48096 |
| Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp012.pdf |
| View full study record |
| Document reference: 48097 |
| Study title: A Phase 2, Open-Label, Prospective, Safety and pK Study to Assess the Extended Use of Synagis (Seven Injections) in Infants and Children with or without CLD |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-w00-350.pdf |
| 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 III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33336 |
| Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33335 |
| Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992.A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| 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: 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: Baskett PJF, Hyland J, Deane M, Wray G. Analgesia for burns dressing in children. A dose-finding study for phenoperidine and droperidol with and without 50 per cent nitrous oxide and oxygen. Br J Anaesth 1969 Aug;41(8):684-8. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32676 |
| Study title: Beh T, Splinter W, Kim J. In children, nitrous oxide decreases pain on injection of propofol mixed with lidocaine.Can J Anesth 2002;49(10);1061-1063 |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32677 |
| 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: 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: 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: A double blind, parallel, multicenter comparison of tenoxicam with naproxene in the treatment of children and adolescents suffering from Juvenile Chronic Arthritis (JCA). |
| Active substance: TENOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44339 |
| Study title: Open-label 40 weeks extension of study S-12159 to follow-up the long-term tolerability and efficacy of tenoxicam in children and adolescents suffering from juvenile rheumatoid arthritis (JRA) treated for up to one year. |
| Active substance: TENOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44338 |
| Study title: Open-label short-term study to find the adequate dosage tenoxicam for the treatment of children and adolescents suffering from juvenile rheumatoid arthritis. |
| Active substance: TENOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44337 |
| 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: A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33325 |
| Study title: Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307) |
| Active substance: PERPHENAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33898 |
| 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: AWB Petadolex for long term prophylaxis of migraine in children and aldolescents |
| Active substance: Petasitidis extr. e rad. spiss. (28 – 44 :1); extraction solvent: CO2 (HERB)* |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40124 |
| 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: 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: 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: Constant I, Abbas M, Boucheseiche S, Laude D, Murat I. Non-invasive assessment of cardiovascular autonomic activity induced by brief exposure to 50% nitrous oxide in children. Br J Anaesth 2002;88(5):637-43. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32683 |
| Study title: Dunn-Russell T, Adair SM, Sams DR, Russell CM, Barenie JT. Oxygen saturation and diffusion hypoxia in children following nitrous oxide sedation. Pediatr Dent 1993 Mar-Apr;15(2):88-92. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32684 |
| Study title: Evans JK, Buckley SL, Alexander AH, Gilpin AT. Analgesia for the reduction of fractures in children: A comparison of nitrous oxide with intramuscular sedation. J Pediatr Orthop 1995 Jan-Feb;15(1):73-7. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32687 |
| Study title: Frampton A, Browne GJ, Lam LT, Cooper MG, Lane LG. Nurse administered relative analgesia using high concentration nitrous oxide to facilitate minor procedures in children in an emergency department. Emerg Med J 2003;20:410-413. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32691 |
| Study title: Gall O, Annequin D, Benoit G, Van Glabeke E, Vrancea F, Murat I. Adverse events of premixed nitrous oxide and oxygen for procedural sedation in children. Lancet 2001;358:1514-15. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32692 |
| 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: Hennrikus WL, Shin AY, Klingelberger CE. Self-administered nitrous oxide and a haematoma block for analgesia in the Outpatient reduction of fractures in children. J Bone Joint Surg 1995;77A(3);335-339 |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32698 |
| Study title: Single dose pharmacokinetic study of tenoxicam in children and adolescents ruffering from Juvenile Rheumathoid Arthritis (JRA). |
| Active substance: TENOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44340 |
| 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: 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 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: A comparison in children with chronic asthma, of terbutaline sulphate administered either as a metered aerosol with Nebuhaler(TM) or as a nebulised solution. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2104 Study Synopsis.pdf |
| View full study record |
| Document reference: 44385 |
| Study title: A comparison of Bricanyl Turbuhaler to Ventolin Inhaler in asthmatic children currently using Ventolin Inhaler. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44429 |
| Study title: A comparison of terbutaline Turbuhaler® and salbutamol Rotahaler in asthmatic pre-school children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44427 |
| Study title: A comparison of the Bricanyl Turbohaler and Ventolin Rotahaler in asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2131 interventional.xls |
| View full study record |
| Document reference: 44416 |
| 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: 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: Jackson D. A trial of premixed nitrous oxide and oxygen in dental anaesthesia in children. Brit J Anaesth 1975;39;161-164 |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32701 |
| Study title: Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Annals of Emergency Medicine 2001;37(1):20-27. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32707 |
| Study title: Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, crossover clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. British Journal of Anaesthesia 2003 Dec;91(6):850-856. |
| Active substance: NITROUS OXIDE AND OXYGEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32711 |
| Study title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age With Severe Hemophilia B |
| Active substance: NONACOG ALFA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41493 |
| Study title: A comparison of the efficacy of terbutaline delivered via Turbuhaler® and pressurised metered dose inhaler (pMDI) plus Nebuhaler® in the treatment of moderate to severe acute asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44428 |
| Study title: A comparison of the efficacy of terbutaline sulphate, inhaled via Turbuhaler and via nebulization, in the management of acute severe asthma in small children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2200 Summary.pdf |
| View full study record |
| Document reference: 44412 |
| Study title: A cumulative dose-response study of terbutaline in asthmatic children. A comparison between Turbuhaler and metered dose inhaler (MDI) |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2129 interventional.xls |
| View full study record |
| Document reference: 44408 |
| Study title: A comparison of Bricanyl Turbuhaler and Berotec dry powder inhaler in asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): CSR 01-2135.pdf |
| View full study record |
| Document reference: 44417 |
| Study title: A twelve-week, double-blind, randomized study to assess safety and efficacy of Bricanyl Turbuhaler in asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2212 Summary.pdf |
| View full study record |
| Document reference: 44404 |
| Study title: An assessment of small children's ability to use Bricanyl Turbuhaler according to age. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): CSR 01-2191.pdf |
| View full study record |
| Document reference: 44425 |
| 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: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with Ventolin Rotahaler. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2159 interventional.xls |
| View full study record |
| Document reference: 44420 |
| Study title: Clinical Trial to evaluate the efficacy of terbutaline in preventing exercise induced asthma when administered to children via the spacer aerosol. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): CSR 01-6032.pdf |
| View full study record |
| Document reference: 44435 |
| Study title: Comparison of Bricanyl depot tablets 5 mg and ordinary tablets 2.5 mg in children with bronchial asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44395 |
| Study title: GM2002/00080/00 Single centre, placebo controlled, double blind randomised crossover, single attack study evaluating the efficacy and tolerability of sumatriptan nasal spray 10mg for the acute treatment of migraine in children suffering from refractory migraine |
| Active substance: SUMATRIPTAN |
| Study summary document link (including results): Sumatriptan-SUM30009-ICHE3.pdf |
| View full study record |
| Document reference: 43072 |
| 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: 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 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: 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: Mineral and trace – metal Balances in Children receiving normal and synthetic diets |
| Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32723 |
| Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44394 |
| Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44432 |
| Study title: Comparison of Bricanyl(R) depot tablets 5 mg b.i.d. with ordinary oral ß-agonist treatment b.i.d. in children with bronchial asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44396 |
| Study title: Determination of the efficacy of Bricanyl in children using the Turbuhaler (DEBUT). |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2110 interventional.xls |
| View full study record |
| Document reference: 44431 |
| Study title: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with nebuhaler. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2155 Study Synopsis.pdf |
| View full study record |
| Document reference: 44419 |
| Study title: Dose response study of subcutaneous terbutaline and epinephrine in children with acute asthma. (N B! Study code fictitious: allocated for Clint pusposes) |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2550 interventional.xls |
| View full study record |
| Document reference: 44382 |
| Study title: Efficacy and safety of Bricanyl Turbuhaler in children. A dose-response study in steady state. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2209 Study Synopsis.pdf |
| View full study record |
| Document reference: 44402 |
| Study title: Efficacy and safety of Bricanyl Turbuhaler in children. A dose-response study in steady state. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2207 Study Synopsis.pdf |
| View full study record |
| Document reference: 44434 |
| 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: 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: 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: 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: "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: Long-acting terbutaline administered by mouth to children aged 8 - 14 years with chronic asthma. A comparison with Theo-Dur. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2092 Summary.pdf |
| View full study record |
| Document reference: 44398 |
| Study title: 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: Optimal inhalation flow rate for Bricanyl(R) Turbuhaler powder inhaler 0.25 mg/dose in asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2110 interventional.xls |
| View full study record |
| Document reference: 44406 |
| Study title: Optimal inhalation technique for Bricanyl Turbuhaler in children with asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2157 interventional.xls |
| View full study record |
| Document reference: 44409 |
| Study title: Progressive hearing loss in hearing impaired children: immediate results of antiphlogistic-rheologic infusion therapy. Michael Streppel, Claus Wittekindt, Hasso von Wedel, Martin Walger, Hans Jakob Schondorf, Olaf Michel, Eberhard Stennert. International Journal of Pediatric Otorhinolaryngology 57 (2001) 129-136 |
| Active substance: PENTOXYFILLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45848 |
| 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 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: Pharmacokinetics of terbutaline in asthmatic children after intravenous administration. (N B! Study code fictitious: allocated for Clint pusposes) |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-2611 interventional.xls |
| View full study record |
| Document reference: 44383 |
| Study title: Pilot study of Bricanyl retard in asthmatic children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): CSR 01-9073.pdf |
| View full study record |
| Document reference: 44400 |
| Study title: Terbutaline in the acute treatment of children with bronchial asthma. (N B! Study code fictitious: allocated for Clint pusposes) |
| Active substance: TERBUTALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44384 |
| 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 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 efficacy of terbutaline in children with cough. A double-blind placebo controlled study. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2172 Summary.pdf |
| View full study record |
| Document reference: 44388 |
| Study title: The use of Nebuhaler(TM) in children with acute asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): Terbutaline Bricanyl 01-6063 interventional.xls |
| View full study record |
| Document reference: 44387 |
| Study title: The use of the Nebuhaler in acute asthma in children. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): CSR 01-2638.pdf |
| View full study record |
| Document reference: 44386 |
| Study title: Use and acceptability of the Bricanyl Turbuhaler in children with bronchial asthma. |
| Active substance: TERBUTALINE |
| Study summary document link (including results): 01-2176 Summary.pdf |
| View full study record |
| Document reference: 44423 |
| 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: 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: Long-Term Open-Label Trial of Olanzapine in Children with Childhood Onset of Schizophrenia |
| Active substance: OLANZAPINE |
| Study summary document link (including results): Olanzapine - F1D-MC-HGCT Synopsis redacted batch numbers.pdf |
| View full study record |
| Document reference: 32760 |
| Study title: Open-Label Study of Olanzapine in Children with Pervasive Developmental Disorder |
| Active substance: OLANZAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32761 |
| Study title: Dose-Ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents with Hypertension |
| Active substance: OLMESARTAN MEDOXOMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32764 |
| Study title: Adrenal function improves in asthmatic children on inhaled steroids: a longitudinal studyAdrenal function improves in asthmatic children on inhaled steroids: a longitudinal study |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44463 |
| Study title: Children's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pkChildren's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pk |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44469 |
| Study title: Children's Hospital, University of Helsinki, FinlandChildren's Hospital, University of Helsinki, Finland |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44477 |
| Study title: Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836 |
| Active substance: SULFASALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42877 |
| Study title: Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis.Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis. |
| Active substance: SULFASALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42886 |
| Study title: Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis. |
| Active substance: SULFASALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42887 |
| 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: Evaluation of the role of acidic and non-acidic reflux in recurrent respiratory and chronic ear, nose,and throat (ENT) diseases in children by using multichannel intraluminal impedance (MII) apparatus |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32778 |
| Study title: Histologic findings in children treated with long-term proton pump inhibitors (PPIs) |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32782 |
| Study title: Omeprazole in children with reflux esophagitis-an open dose finding study and an evaluation of the safety and efficacy during maintenance treatment. Interim report 1996 |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32794 |
| Study title: Pharmacokinetics and pharmacodynamics of the infusion formulation of omeprazole in children when treatment is not possible |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32780 |
| Study title: PK/PD study on omeprazole in children with gastro-esophageal reflux |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32771 |
| Study title: Characteristics of Children Receiving Proton Pump Inhibitors Continously for up to 11 years duration |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32781 |
| Study title: Department of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.grDepartment of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.gr |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44462 |
| Study title: Department of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jpDepartment of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jp |
| Active substance: TETRACOSACTIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44454 |
| Study title: Open study to assess efficacy and safety of Tetracaine in children undergoing venepuncture or cannulation1992 |
| Active substance: TETRACAINE |
| Study summary document link (including results): Tetracaine_Amegel199201.xls |
| View full study record |
| Document reference: 48144 |
| 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: Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45771 |
| Study title: Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288)Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288) |
| Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33291 |
| 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. Salzberg, Birsfelden/ Switzerland. 26.04.1985 |
| Active substance: Sulfamethoxazole trimethoprim |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45244 |
| 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: Study about relationship between asthma and GERD in children (NO) |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32772 |
| Study title: The impact of omeprazole on children with cystic fibrosis who require high dose pancreatic enzymes. |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32777 |
| Study title: Therapy control in children <1 year of age treated with omeprazole (SE) |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32779 |
| 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: Use of magnesium omeprazole (MOPRAL) for treating pathological gastroesophagael reflux in children (Mexico) |
| Active substance: OMEPRAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32775 |
| Study title: Cough,wheeze and astma diagnosis in children - KP. Jones - 1993 (Clin Exp Allergy) - 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: 47002 |
| Study title: Cough,wheeze and astma diagnosis in children - KP. Jones - 1993 (Clin Exp Allergy) - 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: 47027 |
| Study title: Cromolyn sodium in the treatment of children with severe, perennial asthma - BA. Berman et al. - 1975 (Pediatrics vol 55) - 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: 47028 |
| 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: Il Nedocromil sodium nel trattamento dell'asma cronico infantile. Studio in doppio cieco vs placebo - A. Corrias et al. - 1990 (Ped Med Chir (Med Surg Ped) vol 12) - 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: 47031 |
| Study title: Inhibition of exercise -induced asthma (EIA) by nedocromil sodium and sodium cromoglycate in children - E. Novembre et al. - 1993 ( J Allergy Clin Immunol vol 91) - 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: 47032 |
| Study title: Clinical study;Administration of Sedotussin to infants and young children. Final evaluation and expert report involving 5,024 patients. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): ARCE94C1701(2) - Pentoxyverine.pdf |
| View full study record |
| Document reference: 47360 |
| Study title: Final report of the study of the possible relation between pentoxyverin dispensing and respiratory depression in children. |
| Active substance: PENTOXYVERINE |
| Study summary document link (including results): DE85C261 - Pentoxyverine.pdf |
| View full study record |
| Document reference: 45852 |
| 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: Arguelles-Martin F. Sucralfate versus cimetidine in the treatment of reflux oesophagitis in children. Am J Med 1989; 86 (suppl 6A): 73-76. Arguelles-Martin F. Sucralfate versus cimetidine in the treatment of reflux oesophagitis in children. Am J Med 1989; 86 (suppl 6A): 73-76. |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42602 |
| Study title: Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42607 |
| Study title: Dr. Kuwabara's study reported in 1987 13 Children (11 boys and 2 girls, from 1-year-old to 14-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate) and/or Gastrozepin (Pirenzepine)Dr. Kuwabara's study reported in 1987 13 Children (11 boys and 2 girls, from 1-year-old to 14-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate) and/or Gastrozepin (Pirenzepine) |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42610 |
| Study title: Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate)Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate) |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42611 |
| 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: Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602. Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602. |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42604 |
| 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: Lopriore. Ventilator-associated pneumonia and upper airway colonization with Gram negative bacilli: the role of stress ulcer prophylaxis in children. Intensice Care Med 2002; 28: 763-767. Lopriore. Ventilator-associated pneumonia and upper airway colonization with Gram negative bacilli: the role of stress ulcer prophylaxis in children. Intensice Care Med 2002; 28: 763-767. |
| Active substance: SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42605 |
| 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: Multicentre double-blind group comparative study assess the efficacy of substituting nedocromil sodium (Tilade) 8 mg daily and sodium cromoglycate (Intal) 20 mg daily in paediatric patients currently maintained on sodium cromoglycate 20 mg daily - D. Hilde et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47005 |
| Study title: Nedocromil sodium (TILADE) in the treatment of the severe forms of asthma in children - V. Petru et al. - 1991 (Cesk Pediatr vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47035 |
| Study title: Nedocromil sodium (TILADE) in the treatment of the severe forms of asthma in children - V. Petru et al. - 1991 (Cesk Pediatr vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47038 |
| Study title: Nedocromil sodium for chronic asthma in children. - A-V. Sridhar et al. - 2006 (Cochrane database of systematics review vol 3) - Publication in Nedocromil Sodium CFC-free Inhaler Corporate Data Sheet - no author - 25/06/2003 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47039 |
| Study title: Nedocromil sodium vs sodium cromoglycate pressurised aerosol in the prevention of bronconstriction induced by ultrasonic nebulized distilled water in asthmatic children - E. Spezia et al. - 1993 -Pediatr Pulmonol vol 16) - 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: 47041 |
| Study title: Prevalence of asthma in Melbourne schoolchildren : changes over 26 years - CF. Robertson et al. - 1991 (BMJ vo l 302) - 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: 47024 |
| 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: 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, 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, 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: Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000 |
| Active substance: SUFENTANYL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42621 |
| 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: Report of a double-blind group comparative trial comparing nedocromil sodium (2 mg four times a day) and placebo in the management of bronchial asthma in children - R. Ronchetti - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47009 |
| Study title: Report of an open assessment of nedocromil sodium (4 mg given four times a day) in the management of bronchial asthma in children - L. Businco - 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: 47010 |
| Study title: Report on a double-blind crossover study to compare the efficacy and duration of action of nedocromil sodium (4 mg) and placebo, Given by pressurised aerosol exercise-induced asthma in children, carried out - M. Silvermann - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47011 |
| Study title: Report on a matched-pairs double-blind comparative study on the effects of nedocromil sodium (4mg * 4) with placebo on non-specific bronchial reactivity changes in asthmatic children when re-exposed to allergen (House Dust Mite) in a natural environment - Prof. Boner - 1987 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47012 |
| Study title: Sodium nedocromil modifies bronchial hyperreactivity in asthmatic children - BM. Ricci et al. - 1993 (Eur Respi J vol 6 suppl 17) - 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: 47043 |
| Study title: Spacing devices and metered-dose inhalers in childhood asthma - H. Levinson et al. - 1983 (J Pediatrics vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47044 |
| Study title: Summary of the Pharmacokinetics of Nedocromil Sodium in children - MG. Neale - 1994 - 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: 47014 |
| Study title: Tratamiento con nedocromil sodico en ninos con asma cronica grave. Estudio preliminar - JL. Madrazo et al. - 1991 ( Rev Esp Alergol Immunol Clin suppl 2 vol 6) - 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: 47047 |
| Study title: Twelve month open assessment study of the safety and acceptability of flavoured nedocromil sodium (4 mg, QID) in the management of paediatric asthma - J. Cater et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
| Active substance: NEDOCROMIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47015 |
| 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: Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children.Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children. |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47050 |
| Study title: Dose-response relationships for neostigmine antagonism of rocuronium-induced neuromuscular block in children and adults.Dose-response relationships for neostigmine antagonism of rocuronium-induced neuromuscular block in children and adults. |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47051 |
| Study title: Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47052 |
| Study title: Gwinnutt CL, Walker RW, Meakin G.: Antagonism of intense atracurium-induced neuromuscular block in children. Br J Anaesth. 1991 Jul;67(1):13-6.Gwinnutt CL, Walker RW, Meakin G.: Antagonism of intense atracurium-induced neuromuscular block in children. Br J Anaesth. 1991 Jul;67(1):13-6. |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47053 |
| Study title: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47054 |
| 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: Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children.Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children. |
| Active substance: NEOSTIGMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47057 |
| 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: 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: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
| Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33285 |
| Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33331 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33317 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33332 |
| 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: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication] |
| Active substance: Nervoheel - Tabletten |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40081 |
| 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: 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: 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: 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: 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: 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: 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: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33334 |
| Study title: Kline RM et al. Enteric−coated, pH−dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J PEDIATR 2001; 138(1): 125−128 |
| Active substance: Peppermint Oil 0.200 ml |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40117 |
| Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415 |
| Active substance: Peppermint Oil 0.200 ml |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21225 |
| Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415 |
| Active substance: Peppermint Oil 0.200 ml |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40113 |
| Study title: Study of the efficacy of the oral drop formulation in children and adolescents. Dr F. Larbre, Hopital Debrousse (Lyon), 05/1964 - Study mentioned in the summary report - |
| Active substance: PERICIAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33894 |
| 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 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: 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: Open-label, cross-over, randomized, reference-controlled, multicenter study to investigate the parents’ preference for Creon for children over Creon 12000 U in infants with pancreatic exocrine insufficiency due to cystic fibrosis |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-S245-3118.pdf |
| View full study record |
| Document reference: 47669 |
| Study title: Randomized, open-label, cross-over study comparing the efficacy and tolerance of Creon® Forte and Cotazym S Forte® in children and young adults with cystic fibrosis |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-K224-5010.pdf |
| View full study record |
| Document reference: 45111 |
| Study title: 11.) Systemic en- zyme therapy in the treatement of supra- condylar fractures of the humerus in Children |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40103 |
| Study title: 12.) Influence of Wobenzym treat- ment in children with increased sickness rate |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40104 |
| Study title: 14.) Oral Enzyme Therapy of Re- current Respiratory Inflammations in Children |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40105 |
| Study title: Efficacy and safety of Ciprofloxacin Ophthalmic Ointment versus TOBREX Ophthalmic Ointment for treating bacterial conjunctivitis in children (C9129), |
| Active substance: TOBRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44816 |
| Study title: An open trial to assess the acceptability and tolerance of Lonarid mono syrup in children. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): Paracetamol_U96-0101_synopsis.pdf |
| View full study record |
| Document reference: 45778 |
| Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results). |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45776 |
| Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks - 12 months results. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45777 |
| Study title: Comparison of the antipyretic activity of ibuprofen and paracetamol in children with pyrexia. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45802 |
| Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84.Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84. |
| Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33642 |
| Study title: Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45753 |
| Study title: Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3 Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45756 |
| 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: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85 Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85 |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32996 |
| Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84. |
| Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33723 |
| Study title: J Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou PJ Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou P |
| Active substance: PIDOTIMOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34074 |
| Study title: Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45762 |
| Study title: Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45763 |
| Study title: Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21)Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45764 |
| Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45768 |
| 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: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640) |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46836 |
| Study title: Publication in Response Document of MRP type II variation - Banerji D - 16/05/2000 A long-term (1 year) safety study of triamcinolone acetonide (TAA) HFA oral inhaler in asthmatic children - Weinberg EG - 1999 (European Respiratory Journal 14 (S30) abstract P361, p42s) |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46839 |
| Study title: A randomised, double-blind, placebo-controlled, multi-centre, Phase I trial investigating the safety of Grazax® in children aged 5-12 years with grass pollen induced rhinoconjunctivitis (with/without asthma) |
| Active substance: Phleum pratense |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40130 |
| Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
| Active substance: PHLEUM PRATENSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34030 |
| Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
| Active substance: Phleum pratense |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40128 |
| 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: 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: 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: Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1.Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1. |
| Active substance: PILOCARPINE |
| Study summary document link (including results): Eyedrop instillation for reluctant children.pdf |
| View full study record |
| Document reference: 34079 |
| Study title: Long term double blind controlled studies in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutynin STUDY Marion 012-059.xls |
| View full study record |
| Document reference: 33002 |
| 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: 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: 271/87: Steady-state pharmcokinetics and phamacodynamics of theophylline, in asthmatic children of 9 - 13 years, after unequal twice-daily dosing of the oral sustained-release formulation BY158K |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): Study report 271-87 Theopyhlline -synopsis.pdf |
| View full study record |
| Document reference: 44730 |
| Study title: Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44722 |
| Study title: Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44723 |
| Study title: Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44719 |
| Study title: Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02 |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44724 |
| Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32962 |
| Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45792 |
| Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children |
| Active substance: PARACETAMOL |
| Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf |
| View full study record |
| Document reference: 45798 |
| Study title: Double-blind comparison of the taste of children's anacin-3 liquid vs. children tylenol liquid in normal children |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45786 |
| Study title: Comparison of IM pethidine, diazepam and flunitrazepam as premedicants in children undergoing otolaryngological surgery - L Lindgren Br J. - 1979 (Anaesth 1979, 51 321-327) - Publication in expert report DOL01VOL2 - |
| Active substance: PETHIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45868 |
| 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: 18.) Prophylaxis and treatment chronic hepatitis 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: 40107 |
| Study title: 19.) Efficacy of oral enzyme therapy in the complex treat- ment of atopic dermatitis in children |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| 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 single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988.A single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33604 |
| Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33600 |
| Study title: A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33611 |
| Study title: Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3 |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33577 |
| Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile of oral tramadol hydrochloride in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-007; Phase 2) |
| Active substance: PARACETAMOL AND TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45808 |
| Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
| Active substance: PARACETAMOL AND TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45806 |
| Study title: Evaluation of the safety profile of oral tramadol for the treatment of painful conditions in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-008; Phase 2) |
| Active substance: PARACETAMOL AND TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45809 |
| Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-001 and TRAM-PEDS-006; Phase 2) |
| Active substance: PARACETAMOL AND TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45805 |
| 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 I Study of the Safety, Tolerance and Phannacokinetics of Reconstituted Lyophilized MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Administered Intravenously at 15 mg/kg and 30 mg/kg in Children with a History of Prematurity or Bronchopulmonary Dysplasia |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp045.pdf |
| View full study record |
| Document reference: 48104 |
| Study title: A Phase I/II study of the safety, tolerance and pharmacokinetics of MED 493 conducted in otherwise healthy hospitalised children with Respiratory Syncytial Virus Infection |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp009.pdf |
| 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: A Phase II, Randomized, Double-Blind, Two-Period, Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palivizumab (MEDI-493, Synagis®), a Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children with a History of Prematurity |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp097.pdf |
| View full study record |
| Document reference: 48106 |
| 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: Bartoszek M, Brenner AM, Szefler SJ. Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy. Clin Pharmacol Ther. 1987 Oct;42(4):424-32.Bartoszek M, Brenner AM, Szefler SJ. Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy. Clin Pharmacol Ther. 1987 Oct;42(4):424-32. |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33931 |
| 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: Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54. |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33940 |
| Study title: de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3.de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3. |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33933 |
| Study title: A 16 Week Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Tolerability of Paroxetine in the Treatment of Children and Adolescents with Social Anxiety Disorder/Social Phobia |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-676-fullCSR.pdf |
| View full study record |
| Document reference: 48342 |
| Study title: A 38-Week, Two Phase, Multicenter Study to Investigate the Safety and Effectiveness of Paroxetine (10-60 mg/day) in the Treatment of Children and Adolescent Outpatients with Obsessive-Compulsive Disorder |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-453-fullCSR.pdf |
| View full study record |
| Document reference: 48341 |
| Study title: A Multicenter Study to Assess the Pharmacokinetics of Paroxetine Following Repeat Dose Administration in Children and Adolescents with Obsessive- Compulsive Disorder (OCD) and/or Depression |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-715-fullCSR.pdf |
| View full study record |
| Document reference: 48345 |
| Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study) |
| Active substance: PHLEUM PRATENSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34029 |
| Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study) |
| Active substance: Phleum pratense |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40127 |
| Study title: A Phase III/IV Multicenter Evaluation ofthe Immunogenicity ofPalivizumab (Synagis®) in Children who Previously Received Palivizumab (Synagis®) Prophylaxis and Children Receiving the Drug for the First Time |
| Active substance: palivizumab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47445 |
| 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 Phase IV study of fie safety of Synagis (Palivizumabib) for Prophylaxis of Respiratory Syncytial Virus Disease in Children with Cystic Fibrosis |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-ma001.pdf |
| View full study record |
| Document reference: 48107 |
| Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
| Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33326 |
| 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: An open-label, multicentre, 8-12 week open-label study in children aged 1-11 years with erosive oesophagitis and / or intra-oesophageal pH<4 greater than 4.2% of the time. |
| Active substance: LANSOPRAZOLE |
| Study summary document link (including results): Lansoprazole_M97-808-Synopsis.pdf |
| View full study record |
| Document reference: 47611 |
| Study title: A double blind, multiple dose study of the antipyretic activity and tolerability of ibuprofen and paracetamol in burns pyrexia in children. |
| Active substance: IBUPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29457 |
| Study title: An Open-Label Study of the Safety of an Ibuprofen-Pseudoephedrine HCl Suspension in Children. Sep 1999.An Open-Label Study of the Safety of an Ibuprofen-Pseudoephedrine HCl Suspension in Children. Sep 1999. |
| Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46244 |
| Study title: Green M. Double-blind study of nasal decongestion with oxymetazoline and phenylephrine in asthmatic children with rhinitis. Rev Allergy 1966; 20(9):863-8 Green M. Double-blind study of nasal decongestion with oxymetazoline and phenylephrine in asthmatic children with rhinitis. Rev Allergy 1966; 20(9):863-8 |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45104 |
| Study title: "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 |
| Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
| Study summary document link (including results): Ossopan nr7.xls |
| View full study record |
| Document reference: 47720 |
| Study title: "The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251"The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251 |
| Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
| Study summary document link (including results): Ossopan nr6.xls |
| View full study record |
| Document reference: 47719 |
| 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: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32917 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
| Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33430 |
| Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991. |
| Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33439 |
| Study title: Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130)Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) |
| Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33386 |
| Study title: Phase IV study to evaluate the safety and efficacy of Phenobarbitone in children |
| Active substance: PHENOBARBITAL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45871 |
| Study title: Double-blind, randomized, multi-centre, crossover, placebo-controlled pilot study OXC is indicated for use in treatment of partial seizures in adults and pediatric patients ≥6 years of age. This is a pilot study to assess its efficacy in outpatient children and adoloscents with behavioural disorders |
| Active substance: OXACARBAZEPINE |
| Study summary document link (including results): oxacarbazepine-TRI476BES04 Art45 Listing 2011.xls |
| View full study record |
| Document reference: 45121 |
| Study title: Cetirizine vs oxatomide in the treatment of children suffering from seasonal allergic rhinitis. |
| Active substance: OXATOMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45381 |
| Study title: Comparison of cetirizine and oxatomide in preschool children with perennial allergic rhinitis. A multicenter study. |
| Active substance: OXATOMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45380 |
| Study title: Double-blind multicenter study on the efficacy and tolerability of cetirizine compared with oxatomide in chronic idiopathic urticaria in preschool children |
| Active substance: OXATOMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45382 |
| Study title: Efficacy and safety of cetirizine and oxatomide in young children with perennial allergic rhinitis : a 10-day, multicenter, double-blinded, randomised, parallel-group study. |
| Active substance: OXATOMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45379 |
| Study title: Influence of therapy by Woben-zym on immune and metabolic parametrs at children with chronic hepatitis B |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40112 |
| Study title: Oral Enzyme Therapy of Re- current Respiratory Infections in Children |
| Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40093 |
| Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32928 |
| Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32930 |
| 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): |
| View full study record |
| 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: K.L.I.P.S. (ketoprofen lysine salt: an Italian pediatric study). Multicentre, randomised, double-blind clinical study aimed at assessing antiphlogistic, antipyretic and pain-killing efficacy of ketoprofen lysine salt suppositories in children suffering... |
| Active substance: PARACETAMOL |
| Study summary document link (including results): Paracetamol_U97-0250_synopsis.pdf |
| View full study record |
| Document reference: 45775 |
| Study title: Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45729 |
| 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: Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79 |
| Active substance: ONDASETRON |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32806 |
| Study title: Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17 |
| Active substance: ONDASETRON |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32808 |
| 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: Open clinical study in MRI of intracranial and spinal tumors and other lesion of the CNSAJR Am J Roentgenol. 1998 Feb;170(2):478-80. Non-breath-hold gadolinium-enhanced MR angiography of the thoracoabdominal aorta: experience in 18 children. Lam WW, Chan JH, Hui Y, Chan F. |
| Active substance: GADODIAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28811 |
| Study title: Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985 |
| Active substance: KETOPROFEN AND SUCRALFATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30892 |
| Study title: Clinical and spirometric evaluation of ipratropium bromide and salbutamol in children with bronchitis and preceding asthma. |
| Active substance: IPRATROPIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30548 |
| Study title: A Blinded, Single-Dose, Parallel Study Comparing the Anitpyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45783 |
| Study title: Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477) |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33546 |
| Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33555 |
| Study title: Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45733 |
| Study title: Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84) |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45735 |
| Study title: Paracetamol for treating fever in children. {Cochrane Database Syst Rev}, 2002, no. 2 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45801 |
| Study title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Longterm Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD) |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-716-fullCSR.pdf |
| View full study record |
| Document reference: 48346 |
| Study title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Obsessive-Compulsive Disorder (OCD) |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-704-fullCSR.pdf |
| View full study record |
| Document reference: 48344 |
| Study title: A Randomized, Multicenter, 8-Week, Double-blind, Placebo-Controlled Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder |
| Active substance: PAROXETINE |
| Study summary document link (including results): Paroxetine-29060-701-fullCSR.pdf |
| View full study record |
| Document reference: 48343 |
| 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: A Phase IV, Case-Matched, Cohort Surveillance Study in Preterm Children Who Receive SYNAGIS@ Prophylaxis in the First Year of Life Versus Preterm Children Without RSV Prophylaxis: Incidence of RSV Hospitalization and Assessment of Disease Severity in the Season Following Prophylaxis |
| Active substance: palivizumab |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41608 |
| Study title: A Study of the Safety, Tolerance, and Efficacy of Palivizumab (MEDI-493, Synagis®) for Prophylaxis of Respiratory Syncytial Virus in Children with Congenital Heart Disease |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp048.pdf |
| View full study record |
| Document reference: 48105 |
| Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Northern Hemisphere |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-w98-271-northern-hemisphere.pdf |
| View full study record |
| Document reference: 48110 |
| Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Southern Hemisphere |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-w98-271-southern-hemisphere.pdf |
| View full study record |
| Document reference: 48111 |
| Study title: Compassionate Use of MEDI-493, a Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Severe RSV Disease in Children With Lung Disease Who Are Intolerant to RespiGam® Infusions |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp041.pdf |
| View full study record |
| Document reference: 48103 |
| Study title: Evaluation of immunogenicity of IM MED-493 in children who previously received IM MED-493 prophylaxis and children receiving IM MED-493 for the first time |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-mi-cp036.pdf |
| View full study record |
| Document reference: 48102 |
| Study title: Safety and Efficacy Study of Palivizumab in Children with Congenital Heart Disease (Phase III Clinical Trial) |
| Active substance: palivizumab |
| Study summary document link (including results): palivizumab-m03-637.pdf |
| View full study record |
| Document reference: 48091 |
| Study title: J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ. J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44589 |
| Study title: Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586 |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33938 |
| Study title: Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92.Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92. |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33932 |
| Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Multicenter study in children under 14 years suffering from seasonal allergic rhinitisBauer 2001 |
| Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE |
| Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Bauer_2001.xls |
| View full study record |
| Document reference: 48026 |
| 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: 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: 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: Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4 |
| Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33361 |
| Study title: Treosulfan-based conditioning regimens for hematopoietic stem cell transplantation in children with primary immunodeficiency: United Kingdom experience Treosulfan-based conditioning regimens for hematopoietic stem cell transplantation in children with primary immunodeficiency: United Kingdom experience |
| Active substance: TREOSULFAN |
| Study summary document link (including results): 21325599.pdf |
| View full study record |
| Document reference: 47628 |
| Study title: Efficacy and Safety by Children and Adolescents (5-17 yrs and 2 months) with Autictic Disorders |
| Active substance: TRETINOIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46730 |
| Study title: A Phase III multicenter, open-label, long term safety study of Triamcinolone acetonide forte HFA-134a oral inhaler treatment in moderate to severe asthmatic children, involving 250 patients - No author - No date |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46822 |
| Study title: Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44697 |
| Study title: Tolerability and efficacy of VIBROCIL paediatric drops: multicentric, open trial, in children aged between 1 and 6 years, suffering from nasal congestionVerhegge 1994 |
| Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE |
| Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Verhegge_1994.xls |
| View full study record |
| Document reference: 48029 |
| Study title: Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58 |
| Active substance: PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33939 |
| Study title: Oxatomide in children with allergic rhinoconjuctivitis. Comparison of two different dosage schemes. |
| Active substance: OXATOMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45378 |
| 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: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369) |
| Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33391 |
| Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33605 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33591 |
| 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: 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: Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR. Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44703 |
| Study title: Semin Pediatr Neurol. 1999 Dec;6(4):267-77. Neurocysticercosis and acquired cerebral toxoplasmosis in children. Mitchell WG. Semin Pediatr Neurol. 1999 Dec;6(4):267-77. Neurocysticercosis and acquired cerebral toxoplasmosis in children. Mitchell WG. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44704 |
| Study title: A Blinded, Single-Dose, Parallel Study Comparing the Antipyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45784 |
| Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45791 |
| Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45797 |
| Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil Suspension (10 mg/kg), acetaminophen (15 mg/kg), and a vehicle control in the relief of sore throat pain in children |
| Active substance: PARACETAMOL |
| Study summary document link (including results): Ibuprofen-WM-375A.pdf |
| View full study record |
| Document reference: 45790 |
| Study title: Determination of dose-response curve for nebulised oxitropium-bromide in asthmatic preschool children using the Forced Oscillation Technique in a double blind randomized trial design. |
| Active substance: OXITROPIUM BROMIDE |
| Study summary document link (including results): oxitropium bromide_U98-0119_synopsis.pdf |
| View full study record |
| Document reference: 27100 |
| Study title: Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45737 |
| Study title: Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45740 |
| 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: Determination of the safety and efficacy of Alupent syrup administered to children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): Orciprenaline sulphate_U76-0070_synopsis.pdf |
| View full study record |
| Document reference: 45371 |
| 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: 18. Topiramate for the prophylactic treatment of cyclic vomiting syndrome in children. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44952 |
| 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: Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45741 |
| Study title: Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45743 |
| Study title: Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45744 |
| Study title: Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202.Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45745 |
| Study title: Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556) |
| Active substance: PARACETAMOL |
| 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: Report on an efficacy and dosage study in children with bronchial asthma. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): Orciprenaline sulphate_U85-0455_synopsis.pdf |
| View full study record |
| Document reference: 45372 |
| Study title: Study to determine the safety of long term administration of Alupent syrup for the treatment of bronchial asthma in children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45368 |
| Study title: An open, multicenter, long-term study to assess the efficacy and tolerance of Kreon® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis in comparison with a historical control group of healthy children. |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-KREO-584.pdf |
| View full study record |
| Document reference: 47656 |
| Study title: Double-blind, double-placebo controlled study comparing Creon® with Pancrex V Forte® tablets in the management of children with cystic fibrosis. |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-KREON-8402.pdf |
| View full study record |
| Document reference: 47661 |
| Study title: 32. Safety and Efficacy of Topamax in Monotherapy or Combined Therapy in Children & Adult Patients with Epilepsy, in an Observational Study with Medium Duration of 8 Months. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44966 |
| Study title: A placebo-controlled, double-blind study of the safety and efficacy of Nasacort AQ nasal spray in children with perennial allergic rhinitis - Simpson BE - 07/08/1996 - Report in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 - |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): Triamcinolone Acetonide-Study 3.pdf |
| View full study record |
| Document reference: 46824 |
| Study title: Efficacy of Sinubid (Sinutab® SA) in children. Research Report 932-0040. |
| Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
| Study summary document link (including results): paracetamol_pseudoephedrine RR932-0040.pdf |
| View full study record |
| Document reference: 47416 |
| 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: Double-blind, randomized, cross-over study comparing the efficacy and tolerance of Creon® and Pancrease® in children and young adults with cystic fibrosis |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-KREON-586.pdf |
| View full study record |
| Document reference: 47660 |
| Study title: Open single-center study to investigate the pharmacodynamics of Creon® 25 000 minimicrospheres measured by 13C.triglyceride breath test and gastric emptying measured by 13C_octanoate breath test in cystic fibrosis patients using healthy children not receiving Creon® 25 000 minimicrospheres as controls |
| Active substance: Pancreatin |
| Study summary document link (including results): Pancreatin-S248-2001.pdf |
| View full study record |
| Document reference: 47671 |
| Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33606 |
| Study title: A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33613 |
| Study title: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33608 |
| Study title: A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| 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: A randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of Nasacort AQ 110 μg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): Triamcinolone Acetonide-Study 1.pdf |
| View full study record |
| Document reference: 46825 |
| Study title: Controlled clinical study comparing the efficacy of twice daily applications of westcort (hydrocortisone valerate) cream 0,2% and Kenalog (triamcinolonacetonide) cream 0,1% in the treatment of children with atopic dermatitis. |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46820 |
| Study title: A Phase III multicenter, parallel group, randomized, open study of Triamcinolone acetonide HFA 75µg oral inhaler, compared to Beclomethasone dipropionate in mild symptomatic to moderate asthmatic children, involving 280 patients - No author - No date |
| Active substance: TRIAMCINOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46823 |
| 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: 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: Five medium term double blind controlled trials in children comparing Ditropan with placeboFive medium term double blind controlled trials in children comparing Ditropan with placebo |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32921 |
| 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):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: DOXERGAN (OXOMEMAZINE)- Tablet 10mg, Syrup 01%.. Summary document. France validation dossier 17/06/1988. Clinical information. Reference to clinical Expert report from LARBRE F., Lyon 12/07/1962. Children 5months-13 years treated from 4 to 21 days. (French language) |
| Active substance: OXOMEMAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32974 |
| Study title: A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33614 |
| Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33610 |
| Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children. 94-406, Unpublished Report CSR204. May 1997. |
| Active substance: PARACETAMOL AND PHENYLEPHRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33609 |
| Study title: 214/92: Efficacy of BY158K vs. terbutaline on the oscillatory resistance in children aged 2 to 5 years suffering from bronchial asthma |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): Study report 214-92 Theopyhlline - synopsis.pdf |
| View full study record |
| Document reference: 44731 |
| Study title: Clinical and microbiological study comparing CILOXAN Ophthalmic Solution to TOBREX Ophthalmic Solution for treating bacterial conjunctivitis in children (C9174), |
| Active substance: TOBRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44817 |
| Study title: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85 |
| Active substance: OXITRIPTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32923 |
| Study title: A phase III multiple dose use study of APAP extended release pediatric chewable tablets compared to Children’s Tylenol® chewable tablets in the treatment of febrile children. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): paracetamol 93-341.pdf |
| View full study record |
| Document reference: 47511 |
| Study title: A phase III multiple dose use study of APAP extended release pediatric suspension compared to Children’s Tylenol® elixir in the treatment of febrile children. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): paracetamol 94-406.pdf |
| View full study record |
| Document reference: 47512 |
| Study title: A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994.A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994. |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 33437 |
| Study title: Clinical investigation I : Enuresis with diurnal micturitional trouble in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutinin STUDY Debat 1.xls |
| View full study record |
| Document reference: 48016 |
| Study title: Clinical investigation I continued: Enuresis with diurnal micturitional trouble in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutinin STUDY Debat 2.xls |
| View full study record |
| Document reference: 48017 |
| Study title: Five medium term double blind controlled trials in children comparing Ditropan with placebo Five medium term double blind controlled trials in children comparing Ditropan with placebo |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32994 |
| Study title: Long term double blind controlled studies in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutynin STUDY Marion 012-022.xls |
| View full study record |
| Document reference: 33000 |
| Study title: Long term double blind controlled studies in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutynin STUDY Marion 012-031.xls |
| View full study record |
| Document reference: 33001 |
| Study title: Long term double blind controlled studies in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutynin STUDY Marion 012-069.xls |
| View full study record |
| Document reference: 33003 |
| Study title: Long term double blind controlled studies in children |
| Active substance: OXYBUTYNIN |
| Study summary document link (including results): Oxybutynin STUDY Marion 012-019.xls |
| View full study record |
| Document reference: 32999 |
| 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: Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11 |
| Active substance: PARACETAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45750 |
| 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 determine the safety and efficacy of long term administration of Alupent syrup for the treatment of bronchial asthma in children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45367 |
| Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup for the treatment of bronchial asthma in children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45364 |
| Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup for the treatment of bronchial asthma in children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45365 |
| Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup to children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45366 |
| 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: To determine the safety and efficacy of Alupent Syrup administered to children. |
| Active substance: ORCIPRENALINE |
| Study summary document link (including results): Orciprenaline sulphate_U76-0064_synopsis.pdf |
| View full study record |
| Document reference: 45370 |
| Study title: Marsden CD The treatment of severe dystonia in children and adults. J.Neurol.Neurosurg.Psych. 1984;47:1166-1173.Marsden CD The treatment of severe dystonia in children and adults. J.Neurol.Neurosurg.Psych. 1984;47:1166-1173. |
| Active substance: ORPHENADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32901 |
| 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: Oberbaum, M et al.: A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer 2001;92(3):684-690 [IIT-publication] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40268 |
| 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: 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: Tsymbal, I.N.; Plahuta, T.G.; Vdovin, V.V. u.a.: Traumeel S in treatment of intramuscular hematomas in children with hemophilia. Thromb Haemostasis 1997;(suppl246):PS-1007 [IIT-publication] |
| Active substance: Traumeel S |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40263 |
| 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: Am Heart J. 1988 Oct;116(4):1028-33. ECG findings after myocardial infarction in children after Kawasaki disease. Nakanishi T, Takao A, Kondoh C, Nakazawa M, Hiroe M, Matsumoto Y. Am Heart J. 1988 Oct;116(4):1028-33. ECG findings after myocardial infarction in children after Kawasaki disease. Nakanishi T, Takao A, Kondoh C, Nakazawa M, Hiroe M, Matsumoto Y. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44498 |
| 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: Clinical trial. Drops. Infants and Children - Larbre F. - 23/06/1973 |
| Active substance: TIAPRIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44750 |
| 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: A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO DETERMINE THE PHARMACOKINETICS OF MESALAMINE FOLLOWING ADMINISTRATION OF 30 MG/KG/DAY, 60 MG/KG/DAY, AND 90 MG/KG/DAY AS 400 MG DELAYEDRELEASE TABLETS GIVEN EVERY 12 HOURS FOR 28 DAYS TO CHILDREN AND ADOLESCENTS WITH ACTIVE ULCERATIVE COLITIS |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31644 |
| Study title: A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92 |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31635 |
| Study title: B.S. Kirschner. Diagnosis and medical management of Crohn`s disease and ulcerative colitis in children. Problems in General Surgery 1993;10:16-32.B.S. Kirschner. Diagnosis and medical management of Crohn`s disease and ulcerative colitis in children. Problems in General Surgery 1993;10:16-32. |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31641 |
| Study title: Bioavailibility of 5-ASA from slow release 5-ASA drug and sulfasalazine in normal children; Christensen LA et al, Dig. Diseases and Sci., 1993, 38(10):1831-6 |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31628 |
| 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: Efficacy of mesalazine 500 mg tablets in preventing relapses of quiescent Crohn’s disease in children |
| Active substance: MESALAZINE |
| Study summary document link (including results): Pentacomp9001_mesalazine_synopsis_EMA.pdf |
| View full study record |
| Document reference: 47387 |
| Study title: A comparison of single dose caudal tramadol, tramadol plus bupivacaine and bupivacaine administration for postoperative analgesia in children - Gunduz M, Ozengiz D, Ozbek H, Isik G - 2001 (Paediatric Anaesthesia, 2001; 11: 323-326) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45015 |
| Study title: A double-blind, randomised, placebo-controlled clinical study to investigate the efficacy and safety of Tramal ® drops and midazolam in children undergoing dental extraction under general anaesthesia |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45009 |
| Study title: - A double-blind, randomised, placebo-controlled clinical study to investigate the efficacy and safety of Tramal ® drops and midazolam in children undergoing dental extraction under general anaesthesia - Treatment of postoperative pain with tramadol HCl in children - Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen |
| Active substance: TRAMADOL |
| Study summary document link (including results): Tramadol HCL STUDY 02-27.xls |
| View full study record |
| Document reference: 45013 |
| Study title: A randomised, double-blind, multicenterclinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children - Habre W (Multicenter) - 2002 |
| Active substance: TRAMADOL |
| Study summary document link (including results): Tramadol HCL STUDY PCP1.xls |
| View full study record |
| Document reference: 45016 |
| Study title: A randomised, double-blind, multicentre clinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45004 |
| Study title: An open multicenter study on the efficacy and safety of tramadol HCl (Tramal®) in the management of postoperative pain and other acute pain conditions in children - Lenkiewicz T - May 2, 1996 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45017 |
| Study title: An open, multicenter study on the efficacy and safety of tramadol hydrochloride (Tramal ®) in the management of postoperative pain and other acute pain conditions in children |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45002 |
| Study title: Tiapridal treatment of extrapyramidal motor disorders in children - Klepel H. Gebelt H. - 04/1986 |
| Active substance: TIAPRIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44747 |
| Study title: Tiapridal treatment of tic disease in children - Herbaut M. - No date |
| Active substance: TIAPRIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44748 |
| Study title: A Phase I open-label single center (historically controlled) study to evaluate the safety, tolerability and immunogenicity using three doses of polygeline free tick-borne encephalitis (TBE) vaccine in children. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48395 |
| Study title: A Phase III multicenter, open label extension study of the safety and immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48402 |
| Study title: a Phase III multicenter, single-blind, randomized, historically controlled-study of a new polygeline-free TBE vaccine in healthy children ages 1 to 11 years. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48401 |
| 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: Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6)Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32025 |
| 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: 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: 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: Study of the live attenuated Rubella vaccine among children and adolescent |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21212 |
| 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: Rubella vaccine in school Children |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41364 |
| Study title: Rubella vaccine in school Children |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41456 |
| 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 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: Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8. |
| Active substance: TRAXENAMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46720 |
| 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: Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9)Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9) |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38467 |
| 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 phase IV, single-blind, multi-centre, randomized, controlled study to evaluate the safety, tolerability and immunogenicity of two Tick-Borne Encephalitis (TBE) vaccines: Novartis Vaccines's Encepur® Kinder and "licensed comparator" vaccine (Baxter's FSME Immun® Junior) administered according to two different schedules in children. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48385 |
| 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: Am J Cardiol. 1992 Mar 1;69(6):673-6. Estimation of right ventricular pressure in children by thallium-201 myocardial imaging using single-photon emission computed tomography. Akiba T, Yoshikawa M, Otaki S, Nakasato M, Suzuki H, Sato S, Sato T. Am J Cardiol. 1992 Mar 1;69(6):673-6. Estimation of right ventricular pressure in children by thallium-201 myocardial imaging using single-photon emission computed tomography. Akiba T, Yoshikawa M, Otaki S, Nakasato M, Suzuki H, Sato S, Sato T. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44506 |
| Study title: Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45023 |
| Study title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approximately Three Years After a Booster Vaccination with FSME-Immun 0.25 ml Junior in Children (Follow-up to Study 146A and 180) |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41103 |
| Study title: A phase III, controlled, open-label, randomized, multicenter study in children: evaluating the immunogenicity and safety of Novartis pediatric Tick Borne Encephalitis (TBE) vaccine using three different immunization schedules. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48396 |
| Study title: phase III, controlled, randomized, observer-blind, multicenter study in healthy, TBE negative children ages ≥1 to <12 years of age. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48382 |
| Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48399 |
| Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
| Active substance: Tick-Borne Encephalitis Virus |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48400 |
| Study title: Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44534 |
| Study title: Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602.Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602. |
| Active substance: TRIENTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46734 |
| Study title: Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45024 |
| Study title: Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45025 |
| 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: 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: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days’administration of 450 mg theophylline (BY158K) per day. |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf |
| View full study record |
| Document reference: 21676 |
| Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days` administration of 450 mg theophylline (BY158K) per day |
| Active substance: THEOPHYLLINE |
| Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf |
| View full study record |
| Document reference: 44729 |
| Study title: Tramadol iv vs nalbuphine iv, 47 children aged 1 to 10 years old. IIS on tramadol in children undergoing endoscopic surgery for reflux oesophagitis. One-year double-blind comparison of post-op tramadol (bolus of 2 mg/kg BW + infusion of 8 mg/kg BW over 24 h) vs nalbuphine. |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45011 |
| Study title: Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45038 |
| Study title: Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45039 |
| Study title: Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45040 |
| Study title: Treatment of postoperative pain with tramadol HCl in children |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44993 |
| Study title: - Treatment of postoperative pain with tramadol HCl in children - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45014 |
| Study title: Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45041 |
| Study title: Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9. |
| Active substance: TRAXENAMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46714 |
| 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: 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: Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44511 |
| Study title: Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44653 |
| Study title: Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, Sébahoun S, de Pontual L, Maunoury C. Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, Sébahoun S, de Pontual L, Maunoury C. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44690 |
| Study title: Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL. Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44694 |
| Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase ii |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44851 |
| Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44909 |
| Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44942 |
| Study title: Evaluation of the population pharmacokinetic properties of tramadol (T) and Odemethyltramadol (M1) in children and the relation between exposure to T and M1 and different measurements of efficacy, based on data coming from study WIS-AL-TRA-PCP1 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45005 |
| 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: Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. |
| Active substance: TIMOLOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44765 |
| 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: Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45031 |
| Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile or oral tramadol HCl in children and adolescents aged seven to sisteen years - Multicenter - 2000 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45028 |
| Study title: Nalbuphine vs. Tramadol. Efficacy and safety of nalbuphine in postoperative pain after surgery in children |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45008 |
| Study title: J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR. J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR. |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44630 |
| 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: Jpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, HashiguJpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, Hashigu |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44635 |
| Study title: Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31)Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45042 |
| 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: Final report on the additional trials of K 41 - KB 227 in children (in response to the question of reversing the age related recommendation of the Bundesgesundheitsamtes. |
| Active substance: TRAMAZOLINE |
| Study summary document link (including results): Tramazoline Hydrochloride_U93-0588_synopsis.pdf |
| View full study record |
| Document reference: 46704 |
| Study title: Final report on the test of K 41 - KB 227 in children. |
| Active substance: TRAMAZOLINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46695 |
| Study title: Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): LMD40441_Interventional_Levocabastine.xls |
| View full study record |
| Document reference: 31070 |
| Study title: Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31123 |
| 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: 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: Tiapride treatment of tics in children and adolescents - J. Daléry, J. Maillet, R. de VillardTiapride treatment of tics in children and adolescents - J. Daléry, J. Maillet, R. de Villard |
| Active substance: TIAGABINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 38468 |
| 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: Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9) |
| Active substance: TIAPRIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44743 |
| Study title: Levocabastine nasal spray in the treatment of rhinitis in asthmatic children: a double-blind comparison with placebo (6-15 yrs) |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): LMD62485_Interventional_Levocabastine.xls |
| View full study record |
| Document reference: 31077 |
| Study title: Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996 |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31130 |
| Study title: Multicentre study of levocabastine in children - interim report |
| Active substance: LEVOCABASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31067 |
| Study title: Safety & efficacy of tpm in children (aged 12 years and younger) with difficult to treat epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44864 |
| Study title: Safety and efficacy of Topamax in monotherapy or combined therapy in children and adult patient with epilepsy in an observational study with medium duration of 6 months. |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44925 |
| Study title: Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery |
| Active substance: TRAMADOL |
| Study summary document link (including results): Tramadol STUDY 86-04-95.xls |
| View full study record |
| Document reference: 44995 |
| Study title: OPEN CLINICAL STUDY ON THE ANALGESIC EFFICACY OF TRAMADOL (TRAMAL) IN CHILDREN WITH POST-OPERATIVE PAIN AFTER ABDOMINAL SURGERY |
| Active substance: TRAMADOL |
| Study summary document link (including results): synopsis-wis-al-tra86-04-95.pdf |
| View full study record |
| Document reference: 45006 |
| Study title: Open randomized clinical trial study to compare the efficacy and safety of Tramadol 2mg/Kg to pethidine 1 mg/Kg and to nalbuphine 0,1 mg/Kg in children with postoperative pain after lower abdominal surgery |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44998 |
| Study title: THE TREATMENT OF AMOEBIASIS IN CHILDREN |
| Active substance: TINIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44771 |
| Study title: THE TREATMENT OF AMOEBIC LIVER ABSCESS IN CHILDREN |
| Active substance: TINIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44772 |
| Study title: THE TREATMENT OF GIARDIASIS IN CHILDREN |
| Active substance: TINIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44770 |
| 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: Clin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, BClin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, B |
| Active substance: THALLIUM 201T1 CHLORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44552 |
| Study title: Safety and efficacy of tpm in children (aged 12 years and younger) with difficult to treat epilepsy |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44921 |
| Study title: Topiramate for the prophylactic treatment of cyclic vomiting syndrome in children |
| Active substance: TOPIRAMATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44858 |
| Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged between seven to sixteen years - Multicenter - 2000 |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45032 |
| Study title: Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349)Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45033 |
| Study title: Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42) Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42) |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45034 |
| 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: Serum concentrations and pharmacokinetics of tramadol and its metabolite M1 in children after intravenous or extradural caudal administration of tramadol HCl |
| Active substance: TRAMADOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45001 |
| Study title: Serum concentrations of tramadol and its metabolite M1 in children after intravenous or caudal extradural administration of tramadol HCl |
| Active substance: TRAMADOL |
| Study summary document link (including results): synopsis-fo-pk401.pdf |
| View full study record |
| Document reference: 45000 |
| 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: 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: The role of Mesna in teh tretment of status asthmaticus in children. |
| Active substance: MESNA |
| Study summary document link (including results): DE79G271P - Mesna.pdf |
| View full study record |
| Document reference: 31674 |
| Study title: The role of mesna in the treatment of status asthmaticus in children. |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31676 |
| Study title: Treatment of recurrent sarcomas in children and young adults : the use of a multimodality approach including ifosfamide and etoposide (Miser.J. Et al. - Proc. Ann,.Meet. Am. Soc. Clin.Oncol. 7 - 1988-Abstr.999)Treatment of recurrent sarcomas in children and young adults : the use of a multimodality approach including ifosfamide and etoposide (Miser.J. Et al. - Proc. Ann,.Meet. Am. Soc. Clin.Oncol. 7 - 1988-Abstr.999) |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31650 |
| Study title: 131(I)-meta-iodobenzylguanidine treatment of 32 children with therapyrefractory neuroblastomaBerthold 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: 48311 |
| Study title: Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32093 |
| 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: Painless dental extraction in children. |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31222 |
| 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 intraoral use of EMLA cream in children: a clinical investigation. |
| Active substance: LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31217 |
| Study title: Social functioning in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. |
| Active substance: METOPIMAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31964 |
| 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: 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: 107.208 - A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
| Active substance: MELOXICAM |
| Study summary document link (including results): Meloxicam_U03-1727_synopsis.pdf |
| View full study record |
| Document reference: 31592 |
| Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
| Active substance: MELOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31594 |
| Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
| Active substance: MELOXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31595 |
| Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis. |
| Active substance: MELOXICAM |
| Study summary document link (including results): Meloxicam_U03-1429_synopsis.pdf |
| View full study record |
| Document reference: 31596 |
| Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results). |
| Active substance: MELOXICAM |
| Study summary document link (including results): Meloxicam_U00-1093_synopsis.pdf |
| View full study record |
| Document reference: 31593 |
| Study title: Comparative study of Ibuprofen syrup and Paracetamol syrup in soft-tissue injuries in children |
| Active substance: IBUPROFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 29425 |
| Study title: Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32158 |
| 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: 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: Double-blind, randomised, placebo-control study.; Male and female children with acute infantile diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD57014_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31436 |
| Study title: Infants and children with acute and chronic diarrhoea |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD11242_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31443 |
| Study title: Open label ; Infants and young children with acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD11203_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31446 |
| Study title: A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54)A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54) |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31302 |
| 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 concentrations in sinus secretions/mucosa in children |
| Active substance: LORACARBEF |
| Study summary document link (including results): Loracarbef - B9U-MC-AZCT Synopsis.PDF |
| View full study record |
| Document reference: 47386 |
| 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: 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: 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: 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: " 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: Open-label Children with acute diarrhoea were enrolled. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD5600_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31410 |
| Study title: Open-label The study was conducted to evaluate the loperamide solutions since, it was found that the capsule form was not suitable for children on account of age. Children from 9 days to 2 years of age, hospitalised in a general paediatric assistance service for acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD10146_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31428 |
| Study title: Open-label study in children with acute and chronic diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD5507_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31407 |
| 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: Open-label study; Male and female children with acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD5508_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31408 |
| Study title: Open-label study; Male and female children with moderately severe or severe diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD8741_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31418 |
| Study title: Open-label study.; Male and female children suffering from acute or sub-acute diarrhoea for 1 day to 3 weeks were included in the study. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD8742_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31419 |
| Study title: Open-label, placebo-control study.; Male children between the age of 6 and 36 months with a history of diarrhoea who were at least 5% dehydrated clinically. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD67655_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31435 |
| 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: 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 loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
| Active substance: LORATADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31466 |
| Study title: LORATADINE SYRUP FOR CHILDREN 2 - 5 YEARS OLD |
| Active substance: LORATADINE |
| Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C98566.pdf |
| View full study record |
| Document reference: 31461 |
| Study title: Safety of Loratadine Syrup in children 6 months - 2 Years Old. |
| Active substance: LORATADINE |
| Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00256.pdf |
| View full study record |
| Document reference: 31463 |
| Study title: Intraoperative tolerance of lormetazepam I.V. (intravenous) in infants, children and adolescents |
| Active substance: LORMETAZEPAM |
| Study summary document link (including results): Bayer Pharma_Lormetazepam_80011_study_synopsis.pdf |
| View full study record |
| Document reference: 31468 |
| Study title: Double-blind studies with mefloquine and in combination with sulfadoxine-pyrimethamine in 120 adults and 120 children with falciparum malaria in Vietnam. Leimer R*,Anh T K,Kim N V,Arnold K,Chien V V,Bich N N,Thoa K,Ladinsky J |
| Active substance: MEFLOQUINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31585 |
| Study title: Single dose pharmacokinetics of sulfadoxine, pyrimethamine and mefloquine in thai children following administration of one tablet Fansimef, Schwartz D E*,Weidekamm E,Heizmann P,Chongsuphajaisiddhi T,Portmann R |
| Active substance: MEFLOQUINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31586 |
| Study title: Melatonine in ADHD children |
| Active substance: MELATONIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31588 |
| 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: Update on lithium carbonate therapy in children and adolescents. - Alessi N, Naylor MW, Ghaziuddin M, Zubieta JK - ( J A Child Adolesc Psychiatry, 1994 Mar Apr; 33(3)291-304Update on lithium carbonate therapy in children and adolescents. - Alessi N, Naylor MW, Ghaziuddin M, Zubieta JK - ( J A Child Adolesc Psychiatry, 1994 Mar Apr; 33(3)291-304 |
| Active substance: LITHIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31310 |
| Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41232 |
| Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41368 |
| Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41240 |
| 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: Clinical trial with mebendazole in schoolchildren 1972 |
| Active substance: MEBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31542 |
| Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension |
| Active substance: LOSARTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31470 |
| Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants |
| Active substance: LOSARTAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31471 |
| Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension |
| Active substance: LOSARTAN POTASSIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46656 |
| Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants |
| Active substance: LOSARTAN POTASSIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46657 |
| 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: 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: Klingebiel et al. Initial experiences in the treatment of children with metastatic and recurrent neuroblastoma using meta-iodobenzylguanidine Klinische Padiatrie (1986), 198(3), 230-6 |
| Active substance: META-IODOBENZYLGUANIDINE |
| Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
| View full study record |
| Document reference: 48320 |
| Study title: Lashford et al. Phase I/II study of iodine 131 metaiodobenzylguanidine in chemoresistant neuroblastoma: a United Kingdom Children's Cancer Study Group investigationJournal of clinical oncology : official journal of the American Society of Clinical Oncology (1992), 10(12), 1889-96 |
| Active substance: META-IODOBENZYLGUANIDINE |
| Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
| View full study record |
| Document reference: 48321 |
| Study title: The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72 |
| Active substance: LEVOCARNITINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31142 |
| Study title: A non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/mL oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years. |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): A00315 - Levocetirizine - RRCE03C1301.pdf |
| View full study record |
| Document reference: 47308 |
| 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: Bioavailability of methylphenidate hydrochloride from a 20mg sustained release tablet in children (1980) |
| Active substance: METHYLPHENIDATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31727 |
| Study title: Analgesia for the surgical removal of molluscum contagiosum in children: a double-blind, placebo-controlled, time-repsonse study of EMLA(R) (lidocaine/prilocaine) cream. Astra Report 802-10 AC 082-1, February 05, 1990. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 06_86EM25 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47251 |
| Study title: A double-blind cross-over trial of sodium 2-mercaptoethane sulphonate (mistabron) in children with cystic fibrosis. |
| Active substance: MESNA |
| Study summary document link (including results): DPL78F061 - Mesna.pdf |
| View full study record |
| Document reference: 31660 |
| Study title: Berezniuk V.V., Lamza H.B: Application of composite antihomotoxic preparations in the treatment of children suffering from acute sinusites. Biological Therapy (Ukraine), 2006, 2: 26-29 [IIT-publication] |
| Active substance: Lymphomyosot - Tropfen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40064 |
| Study title: Assessment of the immunogenicity and safety of a meningococcal A/C diptheria conjugate vaccine administered in two-year old children in comparison with a licensed meningococcal A/C polysaccharide vaccine. |
| Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41268 |
| Study title: Levocetirizine: pharmacokinetics and pharmacodynamics in children age 6 to 11 years. |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): ADPE05F0305.pdf |
| View full study record |
| Document reference: 31156 |
| Study title: Pharmacokinetic evaluation and ex vivo serum protein binding. levocetirizine dihydrochloride (ucb 28556). a non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/ml oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years. |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): ARVD04B1001 - Levocetirizine.pdf |
| View full study record |
| Document reference: 31151 |
| Study title: The early prevention of asthma in atopic children (EPAAC(TM)) study. a multi-country, double blind, placebo-controlled, randomized, parallel group trial: evaluation of the efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for 18 months in preventing the onset of asthma in 12 to 24 months old children who suffer from atopic dermatitis and are sensitized to grass pollen and / or house dust mite allergens. |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31154 |
| 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: Astra Report No 802 10 AC 093-1 A Clinical Study On A Single Unit Dose Package of Emla (Emla Patch) and Emla 5% Cream Used to Reduse Pain From Venupuncture in Children. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 24_89 EM 04 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47236 |
| Study title: Astra Report No. 802-10 AC 094 Clinical Study On Two Single Unit Dose Packages (Emla Patch) and Emla 5 % Cream Used to Reduce Pain at I.V Cannulation in Children |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 29_88EM01 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47231 |
| 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: Double-blind evaluation of a lidocaine-prilocaine cream (EMLA) for venous cannulation pain in children |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 31_83-P029 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47229 |
| Study title: Open-label; Children aged between 1 month and 7 years with acute or chronic diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD10145_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31427 |
| Study title: Open-label; Children between the ages of 4 and 12 years with acute diarrhoea and the duration of diarrhoea prior to treatment should not have been more than 48 hours. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD15843_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31438 |
| Study title: Open-label; Children with acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD5720_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31411 |
| Study title: Open-label; Children with acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD9535_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31421 |
| Study title: Use of Positron Emission Tomography for Presurgical Localization of Eloquent Brain Areas in Children with Seizures.Pediatr Neurosurg 1997;26:144-156. Jolznily D. Dtlncane, S. David h foss a, Daniel J. Baiidy, Kiln rManwaringa, Allen Af. Kaplan, Eric AL Rei~nalt, Kewei Cheizd, Michael A. La~son, David L. CVodrichc. |
| Active substance: Steripet |
| Study summary document link (including results): duncan-1997.pdf |
| View full study record |
| Document reference: 48727 |
| 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: Open-label; Children with acute or sub-acute diarrhoea |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD8740_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31417 |
| Study title: Open-label; Hospitalised infants and young children with acute diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD12173_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31442 |
| Study title: Open-label; Male and female children with acute and chronic diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD9658_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31423 |
| Study title: Open-label; Male and female children with acute and chronic diarrhoea. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD9659_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31424 |
| Study title: Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32.Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31440 |
| Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41246 |
| Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41382 |
| Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41375 |
| Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children . |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41247 |
| Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children . |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41383 |
| Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41238 |
| Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41376 |
| Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41378 |
| Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41374 |
| Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41235 |
| Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41371 |
| Study title: MEBEVERINE SUSPENSION. AMULTICENTRE BASELINE CONTROLLED STUDY IN CHILDREN WITH FUNCTIONAL DISORDERS OF THE GASTRO-INTESTINAL TRACT. |
| Active substance: MEBEVERINE |
| Study summary document link (including results): Mebeverine-H.103.5002M.pdf |
| View full study record |
| Document reference: 31560 |
| Study title: LEVINSON H.N. Dramatic favorable responses of children with learning disabilities or dyslexia and attention deficit disorder to antimotion sickness medications : four case reports. PERCEPT.MOT.SKILLS 1991. 73/3 PT 1,723-738 |
| Active substance: MECLIZINE HYDROCHLORIDE |
| Study summary document link (including results): Levinson.xls |
| View full study record |
| Document reference: 47884 |
| 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: "Corticosteroids improve survival of children with AIDS and Pneumocystis carinii pneumonia - Sleasman JW - 1993 (Am J Dis Child 147 30-34) - Publication in CER - Simons G - July 1997 -" Clinical Expert Report July 1997 |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31922 |
| 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: Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192 Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192 |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31632 |
| Study title: Study to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in childrenStudy to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in children |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31629 |
| Study title: Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781 |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31631 |
| Study title: V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989 V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989 |
| Active substance: MESALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31634 |
| Study title: A phase II, open, case-controlled clinical study to assess the immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age |
| Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47877 |
| 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: Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma. (Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24.) |
| Active substance: MADIPIDINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31480 |
| 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: Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 - |
| Active substance: METAMIZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31711 |
| Study title: The prolongation of the EPAAC(TM) trial (early prevention of asthma in atopic children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (lctz-lctz, lctz-plc and plc-plc): evaluating the long term efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the epaactm trial (A00309). |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): ARVD02J2302 - Levocetirizine.pdf |
| View full study record |
| Document reference: 31150 |
| Study title: The prolongation of the EPAAC™ trial (Early Prevention of Asthma in Atopic Children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluating the long term efficacy and safety of levocetirizine (5 mg/mL oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the EPAAC™ trial (A00309) |
| Active substance: LEVOCETIRIZINE |
| Study summary document link (including results): A00384 - Levocetirizine - RPCE04B0203.pdf |
| View full study record |
| Document reference: 47307 |
| 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: Sarna S, Hoppu K, Holmberg C . (1996) . Relation of methylprednisolone pharmacokinetics to adrenal suppression in children with liver transplants . Horm Res 46 :90 Sarna S, Hoppu K, Holmberg C . (1996) . Relation of methylprednisolone pharmacokinetics to adrenal suppression in children with liver transplants . Horm Res 46 :90 |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31927 |
| 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: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part I: Full term infants. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 22_85-EM15 (Part I) CSR Synopsis.pdf |
| View full study record |
| Document reference: 31239 |
| Study title: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part II: Full term infants. |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 23_85-EM15 (Part II) CSR Synopsis.pdf |
| View full study record |
| Document reference: 47222 |
| 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: Humoral antibody responses to a biannual multiantigen vaccination: report of a field trial on children in Sudan. |
| Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41262 |
| Study title: Incidence of reactions to meningococcal A + C vaccine among U. K. school children. |
| Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41255 |
| Study title: A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have RecUlTent and/or Persistent Acute Otitis Media |
| Active substance: Levofloxacin |
| Study summary document link (including results): LO FBO-OTMD-002.pdf |
| View full study record |
| Document reference: 45233 |
| Study title: A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting |
| Active substance: Levofloxacin |
| Study summary document link (including results): LOFBIV-PCAP-003.pdf |
| View full study record |
| Document reference: 45231 |
| Study title: An Open-Label Single Oral Dose Study to Evaluate the Safety and Pharmacokinetics of Levofloxacin Suspension Formulation in Infants and Children (~ 16 Years of Age) |
| Active substance: Levofloxacin |
| Study summary document link (including results): LOFBO-PHI-l10.pdf |
| View full study record |
| Document reference: 45235 |
| Study title: An Open-Label Study of Levofloxacin to Evaluate Bacteriologic Outcome in the Treatment of Children Who are at Risk for Acute Otitis Media That is Difficult to Treat |
| Active substance: Levofloxacin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45232 |
| Study title: Pharmacokinetics and Middle Ear Fluid Penetration of Levofloxacin in Children Undergoing Tympanostomy Tube Placement for Serious Otitis Media |
| Active substance: Levofloxacin |
| Study summary document link (including results): LOFBO-PHI-I09.pdf |
| View full study record |
| Document reference: 45234 |
| 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: Open clinical investigation of plasma levels of prilocaine and lidocaine after the dermal application of EMLA to children aged between 2 and 3 years |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 18_86EM16 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47240 |
| Study title: Topical analgesia with EMLA cream for curettage of molluscum contagiosum in children. 85-EM24 |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 30_85EM24 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47230 |
| 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: Influence of mistabron on the viscoelasticity of tracheo- bronchial secretions in children with cystic fibrosis |
| Active substance: MESNA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31665 |
| Study title: Intensive therapy of status asthmaticus in children |
| Active substance: MESNA |
| Study summary document link (including results): DE77K187P - Mesna.pdf |
| View full study record |
| Document reference: 31679 |
| Study title: An exploratory unblinded trail of Levovist (SH U 508A) used in B-mode sonography in comparison with radiologically monitored voiding cystourethrography in diagnosis of vesicoureterorenal reflux in children (with subsequent blinded reading of the results) |
| Active substance: MICROPARTICLES OF GALACTOSE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31999 |
| Study title: Dorman, M.L., et al., Is intravenous conscious sedation for surgical orthodontics in children a viable alternative to general anaesthesia?--a case review. Br Dent J, 2007. 202(11): p. E30. Dorman, M.L., et al., Is intravenous conscious sedation for surgical orthodontics in children a viable alternative to general anaesthesia?--a case review. Br Dent J, 2007. 202(11): p. E30. |
| Active substance: MIDAZOLAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32002 |
| 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: Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. |
| Active substance: MIDAZOLAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32005 |
| 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: Jullien V, Urien S, Hirt D, Delaugerre C, Rey E, Teglas JP, Vaz P, Rouzioux C, Chaix ML, Macassa E, Firtion G, Pons G, Blanche S, Tréluyer JM. Population analysis of weight-, age-, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years.Antimicrob Agents Chemother. 2006; Nov;50(11):3548-55. Epub 2006 Aug 28. |
| Active substance: lopinavir / ritonavir |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21187 |
| 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: An evaluation of antiemetic agents in the control of vomiting in children. |
| Active substance: MECLOZINE |
| Study summary document link (including results): DE76M282P.pdf |
| View full study record |
| Document reference: 31563 |
| 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: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. |
| Active substance: MEDROXYPROGESTERONE ACETATE |
| Study summary document link (including results): MPAASC-0012-277 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 31568 |
| Study title: A phase III, open, randomised, controlled multicentre study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu- OKA) given to healthy children 4 to 6 years of age previously primed with one dose of measles-mumpsrubella vaccine (either Priorix™ or M-M-R II™) in their second year of life and presumed seronegative for varicella. |
| Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47878 |
| Study title: A phase III, open, randomized, controlled study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children of 4 to 6 years of age previously primed with one dose of measles-mumps-rubella vaccine (GlaxoSmithKline Biologicals’ PriorixÔ or Merck & Co.’s M-M-R IIÔ) |
| Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47876 |
| Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children. |
| Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47879 |
| Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children. |
| Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47880 |
| Study title: A controlled clinical study to assess the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ varicella vaccine in children aged between 1 and 12 years with a known history of neurodermatitis. |
| Active substance: Live attenuated varicella vaccine (OKA strain) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47335 |
| 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: A double-blind, randomised, controlled multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old children. |
| Active substance: Live attenuated varicella virus [Oka/ Merck strain] |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47287 |
| Study title: Use of Oka/Merck Varicella Vaccine in Children With Acute Lymphocytic Leukemia in Remission |
| Active substance: Live attenuated varicella virus [Oka/ Merck strain] |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47286 |
| Study title: Clinical and immunological evaluation of the live attenuated RA27/3 rubella vaccine in seronegative children and adults in Switzerland |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41359 |
| Study title: Clinical and serological evaluation of the live attenuated RA27/3 strain rubella vaccine in a population of susceptible children in France |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41363 |
| Study title: Clinical evaluation of the live attenuated rubella vaccine, RA27/3 on seronegative children in Dakar (Senegal) |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41358 |
| Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
| Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31513 |
| Study title: "Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -" |
| Active substance: METAMIZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31712 |
| Study title: Metamizole (dipyrone) drops versus paracetamol suppositories in the treatment of fever in children. Mexico |
| Active substance: METAMIZOLE |
| Study summary document link (including results): Metamizol STUDY X107-4028 MEXICO.xls |
| View full study record |
| Document reference: 47987 |
| Study title: Metamizole (dipyrone) suppositories versus paracetamol suppositories in the treatment of fever in children. Final clinical and statistical report No.X107/4037 respectively X107/4/M/T/401/FI-Thailand, Hoechst AG, Frankfurt. Simasathien S. et al.;1995 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 - |
| Active substance: METAMIZOLE |
| Study summary document link (including results): Metamizol STUDY X107-4037 THAILAND.xls |
| View full study record |
| Document reference: 31708 |
| Study title: Pharmacokinetics and therapeutic study with Nimesulide suppositories in children with postoperative pain and inflammation - SCHARLI - No date |
| Active substance: METAMIZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31693 |
| 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: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. |
| Active substance: MEFENAMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31578 |
| Study title: Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6 |
| Active substance: MEFENAMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31572 |
| Study title: Tönschoff B, Haffner D, Mehls O et al . (1993) . Efficacy and safety of growth hormone treatment in short children with renal allografts : three year experience . Kidney Int 44 :199-207Tönschoff B, Haffner D, Mehls O et al . (1993) . Efficacy and safety of growth hormone treatment in short children with renal allografts : three year experience . Kidney Int 44 :199-207 |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31929 |
| 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: Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - 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: 31491 |
| 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: Rubella vaccination in school Children |
| Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47474 |
| 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: 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: Pharmacokinetics and pharmscodynamics of levosimendan in Children with Congenital Heart Disease |
| Active substance: LEVOSIMENDAN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31170 |
| Study title: Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8. |
| Active substance: METHYLPREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31932 |
| Study title: Physiological assessment of therapy of children with profuse retention of secretion in the bronchi. |
| Active substance: MESNA |
| Study summary document link (including results): DE77F241P - Mesna.pdf |
| View full study record |
| Document reference: 31670 |
| Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
| Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31495 |
| Study title: Clinical and biological tolerance of long term (3 months) of children with Mequitazine |
| Active substance: MEQUITAZINE |
| Study summary document link (including results): primalan L0013SOC003.xls |
| View full study record |
| Document reference: 31617 |
| Study title: Tolerance of Primalan in children (21 days) |
| Active substance: MEQUITAZINE |
| Study summary document link (including results): Primalan L0013SOC002.xls |
| View full study record |
| Document reference: 31618 |
| 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: Tümer L. et al., Bone minaral density and metabolism in children treated with L-Thyroxine Tümer L. et al., Bone minaral density and metabolism in children treated with L-Thyroxine |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31174 |
| 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: A placebo-controlled, double-blind study;Children hospitalised with acute gastro-enteritis with diarrhea, necessitating intravenous rehydration. |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): LMD15027_Interventional_Loperamide Hydrochloride.xls |
| View full study record |
| Document reference: 31441 |
| Study title: Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18 |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31422 |
| Study title: Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7 |
| Active substance: LOPERAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31425 |
| Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. (Protocol 115) and An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension |
| Active substance: LISINOPRIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31291 |
| Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. |
| Active substance: LISINOPRIL |
| Study summary document link (including results): US No. 115_116 CSR Synopsis.pdf |
| View full study record |
| Document reference: 31290 |
| Study title: A multicenter, open-label, single-dose study to investigate the phamacokinetics of lisinopril in hypertensive children and infants. |
| Active substance: LISINOPRIL |
| Study summary document link (including results): US No. 114_117 CSR Synopsis.pdf |
| View full study record |
| Document reference: 31296 |
| Study title: Treatment of needle punlcture pain in children with a new topical lidocaine/prilocaine preparation |
| Active substance: LIDOCAINE AND PRILOCAINE |
| Study summary document link (including results): 05_81-P008 CSR Synopsis.pdf |
| View full study record |
| Document reference: 47227 |
| 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: L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. |
| Active substance: LEVOCARNITINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31141 |
| Study title: ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51) |
| Active substance: LEVOCARNITINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31146 |
| Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ... |
| Active substance: LEVOCARNITINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31145 |
| Study title: Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701..Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701.. |
| Active substance: MIDAZOLAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32007 |
| 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: 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: Clinical trial for efficacy and safety of miglitol ( Bay m 1099) in insulin - dependent diabetic children - Petzinna D. and al. - 16/06/1994 Miglitol Initial Registration Dossier - 1995 - Part IV Vol 294 |
| Active substance: MIGLITOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32018 |
| Study title: Clinical trial to assess the efficacy and tolerability of Bay m 1099 (Miglitol) in insulin-dependent diabetic children - H Schulz and al. - 27/11/1990 Migliotl Initial Registration Dossier - 1995 - Part IV Vol 292 |
| Active substance: MIGLITOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32019 |
| Study title: Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300)Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300) |
| Active substance: MILRINONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32021 |
| Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
| Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31517 |
| 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: 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: ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 |
| Active substance: LEVOCARNITINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31144 |
| 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: Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70 |
| Active substance: MEFENAMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 31582 |
| Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children |
| Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41239 |
| Study title: Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32208 |
| Study title: Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5 Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32080 |
| Study title: Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30.Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32218 |
| 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: Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328 |
| Active substance: POLIDOCANOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46071 |
| 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: The influence of a synthetic antihistamine upon the bodyweight and height in children |
| Active substance: Buclizine |
| Study summary document link (including results): CE70A063-translation.pdf |
| View full study record |
| Document reference: 42014 |
| 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: "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -" "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -" |
| Active substance: PREDNISOLONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45113 |
| Study title: A twelve week, double-blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with specific written language difficulties (dyslexia). |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE84G047 - Piracetam.pdf |
| View full study record |
| Document reference: 45895 |
| Study title: Efficacy and tolerability of dimethindene maleate solution (DMM; Fenistil drops) in two different concentrations vs. placebo in children suffering from chicken-pox. |
| Active substance: DIMETINDENE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26159 |
| Study title: EFFICACY AND SAFETY OF CIPROFLOXACIN VS TOBRAMYCIN AND CEFTAZIDIME IN THE TREATMENT OF CHILDREN AND JUVENILES SUFFERING FROM ACUTE PULMONARY EXACERBATION OF CYSTIC FIBROSIS (AMENDMENT NO.3/09.MARCH 95) |
| Active substance: CIPROFLOXACIN |
| Study summary document link (including results): Bayer Pharma_Ciprofloxacin_1310_study_synopsis.pdf |
| View full study record |
| Document reference: 24219 |
| Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - SOUTH AMERICA |
| Active substance: Hepatitis A Vaccine for Children (80 U/dose) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40915 |
| 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, placebo-controlled study to compare different treatments for acute wheezy bronchitis in 123 children aged 1.5-18 months. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48430 |
| 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 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 randomised cross-over study of two consecutive week treatment periods to compare the ease of handling and application by the parents and the acceptability by the child of two spacer devices, NebuChamber® and Babyhaler®, in the treatment of young children aged 6 – 59 months with symptoms of asthma. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48424 |
| Study title: Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361 |
| Active substance: PREDNISONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34689 |
| Study title: Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157 |
| Active substance: PREDNISONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34688 |
| Study title: Safety and tolerability of Kiddi Pharmaton Fizz effervescent tablets, comparing the marketed formula with an improved one with a reduced mineral amount, and a comparator product: A double-blind, controlled, randomised, three arm cross-over study in children. |
| Active substance: MINERALS AND VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32039 |
| Study title: Add-on treatment with non-antiepileptic drugs in children with epilepsy. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE99L2306 - Piracetam.pdf |
| View full study record |
| Document reference: 46000 |
| Study title: Amine oxidase activity in blood serum of children with mental deficiency. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU88L281P - Piracetam.pdf |
| View full study record |
| Document reference: 45981 |
| Study title: Clinical and biological tolerance of piracetam in children treated for 8 weeks at 3.3 g daily. |
| Active substance: PIRACETAM |
| Study summary document link (including results): CE80L141 - Piracetam.pdf |
| View full study record |
| Document reference: 45914 |
| 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: Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32108 |
| Study title: A randomized, double-blind study to test the hypothesis that treatment with an inhaled anti-inflammatory drug (BUD) but not an inhaled beta-agonist (terbutaline) would reduce bronchial responsiveness in children with asthma ad with minimal or no bronchoconstriction in 19 children (7-16 years) with allergic asthma and minimal or no bronchoconstriction attending an outpatient respiratory clinic. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48411 |
| Study title: A randomized, double-blind to compare the long-term effect in children (7-16 years) of regular bronchodilator plus antiinfalmmatory treatment using inhaled corticosteroids with regular bronchodilator treatment alone |
| Active substance: BUDESONIDE |
| 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, 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: Comparision of equal dose of budesonide inhaled from a Nebuhaler (aerosol) and from a Turbuhaler (powder) in a 4-weeks cross-over study in asthmatic children 10 - 15 years old |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48435 |
| 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: Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32053 |
| Study title: Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32056 |
| 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: Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32168 |
| Study title: Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32202 |
| Study title: Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32176 |
| Study title: Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9.Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32245 |
| Study title: Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32149 |
| Study title: Edick MJ et al, Pharmacokinetics and pharmacodynamics of oral etoposide in children with relapsed or refractory acute lymphoblastic leukemia, J Clin Oncol. 2003 Apr 1;21(7):1340-6 |
| Active substance: ETOPOSIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26881 |
| Study title: Wells RJ et al, Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study, J Clin Oncol. 1994 Nov;12(11):2367-77 |
| Active substance: ETOPOSIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26910 |
| Study title: Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671 |
| Active substance: DEXAMETHASONE AND DIPHENHYDRAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 25720 |
| Study title: Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32207 |
| 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: 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: Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6.Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6. |
| Active substance: POLYMYXIN B AND TRIMETHOPRIM |
| Study summary document link (including results): Results of a survey of children with acute bacterial conjunc.pdf |
| View full study record |
| Document reference: 34586 |
| 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: Dyslexia: diagnosis and treatment in children with piracetam on an out-patient basis. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE84D277 - Piracetam.pdf |
| View full study record |
| Document reference: 45982 |
| 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: Multicenter, double-blind, multiple-dose, placebo-controlled dose-response study of ebastine in children with seasonal ragweed allergy |
| Active substance: EBASTINE |
| Study summary document link (including results): RP-64305X-106_Ebastine_EUdraCT_reduced datafields-CP-Almirall.xls |
| View full study record |
| Document reference: 48069 |
| Study title: A phase II, controlled, single-center study to assess safety and immunogenicity of a primary vaccination course with one dose of Haemophilus influenzae type b (Hib) conjugate vaccine containing Aluminum Phosphate (Hib/AlPO4 vaccine), given alone or concomitantly with Measles, Mumps and Rubella Vaccine (MMR, Morupar®, licensed by Chiron, now Novartis Vaccines and Diagnostics), in healthy children 12-15 months of age. |
| Active substance: Influenza Vaccine (Split Virion, Inactivated) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48391 |
| 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: 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: 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 - 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 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: Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32212 |
| 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: Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32051 |
| Study title: Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32058 |
| Study title: Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32059 |
| Study title: Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32060 |
| 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: 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: Clinics and treatment of nocturnal enuresis in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU85L073P - Piracetam.pdf |
| View full study record |
| Document reference: 45964 |
| Study title: Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996. Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996. |
| Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 30965 |
| Study title: Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5 |
| Active substance: MINOXIDIL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32061 |
| Study title: A multicenter, randomized, double−blind, placebo−controlled, efficacy and safety study of Remeron in outpatient children and adolescents with major depressive disorder |
| Active substance: MIRTAZAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32065 |
| Study title: A single dose, pharmacokinetic trial of Remeron (mirtazipine) in children and adolescents with major depression |
| Active substance: MIRTAZAPINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32066 |
| Study title: Wofford MM et al. Treatment of occult or late overt testicular relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. J Clin Oncol. 1992 Apr;10(4):624-30Wofford MM et al. Treatment of occult or late overt testicular relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. J Clin Oncol. 1992 Apr;10(4):624-30 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32225 |
| Study title: Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9.Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32222 |
| Study title: Yock TI et al. Local control in pelvic Ewing sarcoma: analysis from INT-0091--a report from the Children's Oncology Group. J Clin Oncol. 2006 Aug 20;24(24):3838-43.Yock TI et al. Local control in pelvic Ewing sarcoma: analysis from INT-0091--a report from the Children's Oncology Group. J Clin Oncol. 2006 Aug 20;24(24):3838-43. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32175 |
| 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: Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82 |
| Active substance: CYCLOPHOSPHAMIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 24947 |
| Study title: Clinical evaluation of perphenazine, triflupromazine, and hydroxyzine for postoperative sedation in children |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE92B0408.pdf |
| View full study record |
| Document reference: 29255 |
| Study title: Fluoxetine Versus Placebo in the Treatment of Children and Adolescents with Obsessive-Compulsive Disorder |
| Active substance: FLUOXETINE |
| Study summary document link (including results): fluoxetine B1Y-MC-HCJW Clinical Study Summary.pdf |
| View full study record |
| Document reference: 47359 |
| 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: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
| Active substance: Plantago Ovata Tinnevelly Senna Pods |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40138 |
| Study title: Evaluation of efficacy of piracetam in add-on treatment of partial epilepsy in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE98L2605 - Piracetam.pdf |
| View full study record |
| Document reference: 46014 |
| 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 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: 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: Conclusions regarding the influence of Piracetam upon the cognitive learning symptoms of children with learning disabilities. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE75G011 - Piracetam.pdf |
| View full study record |
| Document reference: 47899 |
| 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 Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42Bisogno G et al Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32090 |
| 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: Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32169 |
| Study title: Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32221 |
| Study title: Evaluation of the results of a study in children with unprogressive syndromes of CNS disturbances and simultaneous retarded mental development, treated with Nootropil. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE76C096 - Piracetam.pdf |
| View full study record |
| Document reference: 46022 |
| 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: Experience with piracetam for cerebral lesions in children and adults. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92K2615 - Piracetam.pdf |
| View full study record |
| Document reference: 45987 |
| Study title: Experiences with piracetam in children with cerebral insufficiency. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE79G023 - Piracetam.pdf |
| View full study record |
| Document reference: 46002 |
| Study title: Experimental education of mentally retarded children. Organization and preliminary results. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU81B232P - Piracetam.pdf |
| View full study record |
| Document reference: 45972 |
| Study title: Improvement of acupuncture on independent walking ability in children with cerebral paralysis. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE05B0306 - Piracetam.pdf |
| View full study record |
| Document reference: 45969 |
| Study title: Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32241 |
| Study title: Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301) Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301) |
| Active substance: ADENOSINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46302 |
| Study title: Final medical report Acceptance study with Mucosolvan 15 mg and 30 mg in children. |
| Active substance: AMBROXOL |
| Study summary document link (including results): Ambroxol Hydrochloride_U87-0438_Synopsis.pdf |
| View full study record |
| Document reference: 46537 |
| Study title: ZANNINO L, et al. CONTROLLED CLINICAL STUDY ON A NEW MUCOLYTIC AGENT - AMBROXOL HYDROCHLORIDE - IN HYPERSECRETORY BRONCHIALDISEASE IN CHILDREN. “La Clinica Pediatrica” Vol. 64 - Number 4 - 1982 |
| Active substance: AMBROXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48437 |
| Study title: Arndt C et al A feasibility, toxicity, and early response study of etoposide, ifosfamide, andvincristine for the treatment of children with rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS) IV pilot study J Pediatr Hematol Oncol. 1997 Mar-Apr;19(2):124-9Arndt C et al A feasibility, toxicity, and early response study of etoposide, ifosfamide, andvincristine for the treatment of children with rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS) IV pilot study J Pediatr Hematol Oncol. 1997 Mar-Apr;19(2):124-9 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32156 |
| Study title: Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41.Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32219 |
| Study title: Rosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in textRosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in text |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32099 |
| 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: Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32200 |
| Study title: Cairo MS et al. FAB LMB96 International Study Committee. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents. Blood. 2007 Apr 1;109(7):2736-43.Cairo MS et al. FAB LMB96 International Study Committee. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents. Blood. 2007 Apr 1;109(7):2736-43. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32199 |
| Study title: Castleberry RP et al.Phase II investigational window using carboplatin, iproplatin, ifosfamide, and epirubicin in children with untreated disseminated neuroblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1994 Aug;12(8):1616-20.Castleberry RP et al.Phase II investigational window using carboplatin, iproplatin, ifosfamide, and epirubicin in children with untreated disseminated neuroblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1994 Aug;12(8):1616-20. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32243 |
| Study title: Winick NJ et al. Treatment of CNS relapse in children with acute lymphoblastic leukemia: A Pediatric Oncology Group study. J Clin Oncol. 1993 Feb;11(2):271-8Winick NJ et al. Treatment of CNS relapse in children with acute lymphoblastic leukemia: A Pediatric Oncology Group study. J Clin Oncol. 1993 Feb;11(2):271-8 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32224 |
| 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: Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186 |
| Active substance: BENZENTHONIUM AND LIDOCAINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 22285 |
| 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: Nebulized budesonide for children with mild-to-moderate croup. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48439 |
| Study title: One-year follow-up of young children hospitalized for wheezing: the influence of early anti-inflammatory therapy and risk factors for subsequent wheezing and asthma. |
| Active substance: BUDESONIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 48438 |
| 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: Sadowitz PD et al. Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 1993 Feb 1;81(3):602-9.Sadowitz PD et al. Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 1993 Feb 1;81(3):602-9. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32223 |
| Study title: Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32145 |
| 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: Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32079 |
| Study title: Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32087 |
| Study title: Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32159 |
| 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: A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4 |
| Active substance: POLIDOCANOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46070 |
| Study title: Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 |
| Active substance: POLIDOCANOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46068 |
| Study title: Gallet JP, Dicetel capsules, report of the clinical expert evaluation (in children), report no 20, May 7, 1975. |
| Active substance: PINAVERIUM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34139 |
| Study title: A 36-week, double blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with developmental reading disorder (dyslexia). |
| Active substance: PIRACETAM |
| Study summary document link (including results): RRCE92E1404 - Piracetam.pdf |
| View full study record |
| Document reference: 45915 |
| Study title: A clinical investigation of piracetam in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE73J051 - Piracetam.pdf |
| View full study record |
| Document reference: 46026 |
| Study title: Craft A et al Ifosfamide-containing chemotherapy in Ewing's sarcoma: The Second United Kingdom Children's Cancer Study Group and the Medical Research Council Ewing's Tumor Study J Clin Oncol. 1998 Nov;16(11):3628-33Craft A et al Ifosfamide-containing chemotherapy in Ewing's sarcoma: The Second United Kingdom Children's Cancer Study Group and the Medical Research Council Ewing's Tumor Study J Clin Oncol. 1998 Nov;16(11):3628-33 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32101 |
| Study title: Culbert SJ Remission induction and continuation therapy in children with their first relapse of acute lymphoid leukemia. A Pediatric Oncology Group study.Cancer. 1991 Jan 1;67(1):37-42.Culbert SJ Remission induction and continuation therapy in children with their first relapse of acute lymphoid leukemia. A Pediatric Oncology Group study.Cancer. 1991 Jan 1;67(1):37-42. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32228 |
| Study title: A multicenter study of pharmacokinetics of oral fexofenadine hydrochloride administered as granulation powder in applesauce in children from 6 months to 2 years of age (MO164559/1123) |
| Active substance: FEXOFENADINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27266 |
| Study title: Comparison of oral transmucosal fentanyl citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair; Annals of Emergency Medicine 1996, 28(4): 385-90 |
| Active substance: FENTANYL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 27140 |
| Study title: Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32197 |
| Study title: Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32193 |
| Study title: A double-blind, parallel group, study to compare the efficacy and safety of piracetam with placebo in children with specific learning disabilities. |
| Active substance: PIRACETAM |
| Study summary document link (including results): RAE91A102 - Piracetam.pdf |
| View full study record |
| Document reference: 45902 |
| Study title: Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32153 |
| Study title: Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32237 |
| Study title: Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32215 |
| Study title: Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
| Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34564 |
| 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: AN OPEN-LABEL EXTENSION STUDY OF GABAPENTIN IN CHILDREN WITH EPILEPSY WHO HAVE PARTICIPATED IN THE DOUBLE-BLIND STUDY 945-186 |
| Active substance: GABAPENTIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 28763 |
| Study title: The dry, nonproductive cough in children. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE91C2858.pdf |
| View full study record |
| Document reference: 29286 |
| Study title: Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91 |
| Active substance: BLEOMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 22797 |
| 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: 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, 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: 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: 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: Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562. |
| Active substance: PROCARBAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34778 |
| Study title: Abdominal masses in children: multiorgan imaging with 99mTc methylene diphosphonate. Siddiqui AR, Cohen M, Moran DP. AJR Am J Roentgenol. 1982 Jul;139(1):35-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44079 |
| Study title: Nuclear medicine studies in evaluation of skeletal lesions in children with histiocytosis X. Siddiqui AR, Tashjian JH, Lazarus K, Wellman HN, Baehner RL. Radiology. 1981 Sep;140(3):787-9. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44111 |
| 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: Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41. Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41. |
| Active substance: PRALIDOXIME |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46084 |
| Study title: A randomized crossover trial of combination pharmacologic therapy in children with familial hypercholesterolemia |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46091 |
| 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: Long-term safety of Pravastatin in children with familial hyper-cholesterolaemia |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46096 |
| Study title: Inefficacy of piracetam in the prevention of painful crises in children and adolescents with sickle cell disease. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE05H2932 - Piracetam.pdf |
| View full study record |
| Document reference: 45917 |
| Study title: Response to prophylactic treatment of benign headache in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPS98J0907 - Piracetam.pdf |
| View full study record |
| Document reference: 45945 |
| 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: "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: Lipid peroxidation and oxidative hemolysis of erythrocytes in healthy children and in small children with iron-deficiency anemia at high altitudes. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE91J1101 - Piracetam.pdf |
| View full study record |
| Document reference: 46021 |
| Study title: Movement related potentials of learning disabled children treated with piracetam. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE97C1306 - Piracetam.pdf |
| View full study record |
| Document reference: 45929 |
| 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 clinical study regarding the influence of piracetam upon the symptoms presented by children with learning disabilities. |
| Active substance: PIRACETAM |
| Study summary document link (including results): CE75F171 - Piracetam.pdf |
| View full study record |
| Document reference: 45903 |
| 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: Summary of SK&F 38462 retarded children study. |
| Active substance: PIRACETAM |
| Study summary document link (including results): RAE90L214 - Piracetam.pdf |
| View full study record |
| Document reference: 45897 |
| Study title: The clinical investigation of piracetam (UCB 6215, Nootropil) in treatment of mentally delayed children with hyperactivity. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU85G241P - Piracetam.pdf |
| View full study record |
| Document reference: 45920 |
| Study title: Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32238 |
| Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32074 |
| Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32084 |
| Study title: Felgenhauer J et al Very intensive, short-term chemotherapy for children and adolescents withmetastatic sarcomas Med Pediatr Oncol. 2000 Jan;34(1):29-38Felgenhauer J et al Very intensive, short-term chemotherapy for children and adolescents withmetastatic sarcomas Med Pediatr Oncol. 2000 Jan;34(1):29-38 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32160 |
| Study title: Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32125 |
| Study title: Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32109 |
| Study title: Sood S, Chugani HT.. Epub 2006 Jun 24. Functional neuroimaging in the preoperative evaluation of children with drugresistant epilepsy. [sood-2006]Childs Nerv Syst. 2006 Aug;22(8):810-20. Sood S 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: 48700 |
| Study title: Optimisation of the experimental design for the population pharmacokinetic analysis of mizolastine solution in children, submitted to J. Pharmacokin. Biopharm - Mentré F, Dubruc C., Thénot J.P.- No date.Optimisation of the experimental design for the population pharmacokinetic analysis of mizolastine solution in children, submitted to J. Pharmacokin. Biopharm - Mentré F, Dubruc C., Thénot J.P.- No date. |
| Active substance: MIZOLASTINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32271 |
| Study title: Pharmacokinetic study of myzolastine paediatric syrup in allergic children aged 6 to 12 years. |
| Active substance: MIZOLASTINE |
| Study summary document link (including results): Mizolastine-Study 3.pdf |
| View full study record |
| Document reference: 32270 |
| 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: Short-term efficacy and safety of pravastatin in 72 children with familial hypercholesterolemia |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46103 |
| 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: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " |
| Active substance: PRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34643 |
| Study title: our experience with piracetam (Nootropil UCB) treatment in children from high-risk pregnancies with subsequent minimal brain dysfunction. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92K2736 - Piracetam.pdf |
| View full study record |
| Document reference: 45993 |
| Study title: Piracetam (UCB 6215) in the reeducation of children with speech disorders. |
| Active substance: PIRACETAM |
| Study summary document link (including results): CE71K081 - Piracetam.pdf |
| View full study record |
| Document reference: 45912 |
| 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: 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 question of correlations between biological and clinical indices in children with mental deficiency. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU82G141P - Piracetam.pdf |
| View full study record |
| Document reference: 45940 |
| 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: The value of the use of piracetam (UCB 6215) in adjustment disturbances of children |
| Active substance: PIRACETAM |
| Study summary document link (including results): CE72B281 - Piracetam.pdf |
| View full study record |
| Document reference: 45937 |
| Study title: [Extraosseous tumor uptake of 99m technetium methylendiphosphonate in children with neuroblastoma (author's transl)] Italian Mancini AF, Turba E, Vallicelli R, Vitelli A, Fini A, Rosito P. Pediatr Med Chir. 1981 Nov-Dec;3(6):535-9. Italian. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44189 |
| Study title: Piracetam for the treatment of sickle cell disease in children - a double blind test. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE98G1611 - Piracetam.pdf |
| View full study record |
| Document reference: 45938 |
| Study title: Piracetam in learning and behaviour disorders in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE79A153 - Piracetam.pdf |
| View full study record |
| Document reference: 45892 |
| Study title: Piracetam in learning and behaviour disorders in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE79D171 - Piracetam.pdf |
| View full study record |
| Document reference: 47900 |
| Study title: Piracetam in learning and behaviour disorders in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE79D172 - Piracetam.pdf |
| View full study record |
| Document reference: 47901 |
| Study title: Piracetam in primarily anaemic and cytotoxic hypoxic coma in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): PDEE92K2701 - Piracetam.pdf |
| View full study record |
| Document reference: 46009 |
| Study title: Piracetam in the treatment of children with acute neuroleptic intoxication. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ARCP92F2523 - Piracetam.pdf |
| View full study record |
| Document reference: 45908 |
| Study title: Piracetam in treatment of children with school problems. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DP90J101P - Piracetam.pdf |
| View full study record |
| Document reference: 46024 |
| Study title: Use of piracetam in the treatment of children with severe drug poisoning. |
| Active substance: PIRACETAM |
| Study summary document link (including results): RAE90K295S - Piracetam.pdf |
| View full study record |
| Document reference: 46008 |
| Study title: Use of piracetam in the treatment of children with the infantile brain-damage syndrome. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE84D278 - Piracetam.pdf |
| View full study record |
| Document reference: 46004 |
| Study title: Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32205 |
| Study title: Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32213 |
| Study title: Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32233 |
| Study title: Green DM et al. Treatment of children with clear-cell sarcoma of the kidney: a report from theNational Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2132-7Green DM et al. Treatment of children with clear-cell sarcoma of the kidney: a report from theNational Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2132-7 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32253 |
| Study title: Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52.Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32252 |
| Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, fixed-dosage (340 or 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, Including a 2-Week (Blined) Withdrawel Period. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45282 |
| Study title: MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71.MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32231 |
| Study title: Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34.Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34. |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32250 |
| Study title: Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32112 |
| Study title: Acute epiphyseal osteomyelitis in children. Rosenbaum DM, Blumhagen JD. Radiology. 1985 Jul;156(1):89-92. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43939 |
| Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45281 |
| Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. |
| Active substance: MODAFINIL |
| Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
| View full study record |
| Document reference: 45283 |
| Study title: Kremens B et al High-dose chemotherapy with autologous stem cell rescue in children with nephroblastoma Bone Marrow Transplant 2002 Dec;30(12):893-8 |
| Active substance: ETOPOSIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 26727 |
| Study title: Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296. |
| Active substance: PRAZEPAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34637 |
| 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: Therapeutisch Erprobung - 2.6.4: Indikation nephrotisches syndrom (pages 1307 to 1380) - Studie 65 : Clinical assessment of HOE118 in children with nephrotic syndrom - Grünberg J - No date |
| Active substance: PIRETANIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34300 |
| Study title: Piracetam therapy does not enhance cognitive functioning in children with Down syndrome. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE01D1801 - Piracetam.pdf |
| View full study record |
| Document reference: 45970 |
| Study title: Prognostic factors of sudden hearing loss in children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): ADPE01K1615 - Piracetam.pdf |
| View full study record |
| Document reference: 46003 |
| Study title: Pyramem. treatment of children with minimal brain dysfunction (preliminary data). |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE90C052P - Piracetam.pdf |
| View full study record |
| Document reference: 45930 |
| 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: Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 |
| Active substance: PIRITRAMIDE |
| Study summary document link (including results): pothmann_piritramide.pdf |
| View full study record |
| Document reference: 34302 |
| Study title: On-demand analgesia with piritramide in children. A study on dosage specification and safety. European Journal of Pediatric Surgery 7, p.38-41, 1997 On-demand analgesia with piritramide in children. A study on dosage specification and safety. European Journal of Pediatric Surgery 7, p.38-41, 1997 |
| Active substance: PIRITRAMIDE |
| Study summary document link (including results): petrat_piritramide.pdf |
| View full study record |
| Document reference: 34301 |
| 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: Variant pathogenetic therapy in the acute phase of hypoxic-traumatic brain damage in immature children. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DRU87G074P - Piracetam.pdf |
| View full study record |
| Document reference: 46018 |
| Study title: The irritable hip. Scintigraphy in 192 children. Royle SG, Galasko CS. Acta Orthop Scand. 1992 Feb;63(1):25-8. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43706 |
| Study title: Green DM et al. Treatment of children with stages II to IV anaplastic Wilms' tumor: a report fromthe National Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2126-31Green DM et al. Treatment of children with stages II to IV anaplastic Wilms' tumor: a report fromthe National Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2126-31 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32254 |
| 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: McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32242 |
| Study title: Meyer WH et al Carboplatin/ifosfamide window therapy for osteosarcoma: results of the St Jude Children's Research Hospital OS-91 trial J Clin Oncol. 2001 Jan 1;19(1):171-82Meyer WH et al Carboplatin/ifosfamide window therapy for osteosarcoma: results of the St Jude Children's Research Hospital OS-91 trial J Clin Oncol. 2001 Jan 1;19(1):171-82 |
| Active substance: MITOXANTRONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32134 |
| Study title: TO MEASURE THE ELIMINATION HALF-LIFE (T1/2) OF PIROXICAM AFTER ITS STEADY KINETIC STATE HAS BEEN ACHIEVED IN CHILDREN WITH JRA. VALUES FOR VOLUME OF DISTRIBUTION AND CLEARANCE CAN THEN BE CALCULATED. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34466 |
| Study title: (99m)Tc-MDP scintigraphic findings in children with leukemia: value of early and delayed whole-body imaging. Shalaby-Rana E, Majd M. J Nucl Med. 2001 Jun;42(6):878-83. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43452 |
| Study title: Turner CD, Chi S, Marcus KJ, MacDonald T, Packer RJ, Poussaint TY, et al.. Epub 2006 Sep 22. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. [turner-2007]J Neurooncol. 2007 Mar;82(1):95-101. Turner CD 2007 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48705 |
| Study title: Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 |
| Active substance: URINARY CONCREMENT SOLVENTS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39154 |
| Study title: A study to investigate the steady state pharmacokinetics of oral Valaciclovir (Valtrex) in immunocompromised children |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Valaciclovir-HS2B4005-ICHE3.pdf |
| View full study record |
| Document reference: 45429 |
| 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 parallel group study comparing oral adjuctive vigabatrin with placebo in children with uncontrolled complex partial seizures - Valentine C, Mettert N, Mosier M, Michon AM, and the Vigabatrin protocol 221 investigative cohort - 1998 (Epilepsia In press (abstract) 1998) Publication in Consolidated Responses to Questions raised in Article 12 Referral Procedure - 11/1998" |
| Active substance: VIGABATRIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39386 |
| Study title: A Preliminary Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Venlafaxine in Children and Adolescents with Conduct Disorder |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600A-126-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47930 |
| Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents with Generalized Anxiety Disorder |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600B2-396-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47935 |
| Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents With Generalized Anxiety Disorder397 |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600B2-397-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47936 |
| Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents With Major Depression |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600B1-382-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47932 |
| Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents with Major Depressive Disorder |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600B1-394-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47933 |
| Study title: Open-Label Long-Term Safety Study of Venlafaxine ER in Children and Adolescents with Major Depressive Disorder |
| Active substance: Venlafaxine |
| Study summary document link (including results): 0600B1-395-US EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 47934 |
| Study title: A comparison of intravenous salbutamol, aminophylline and the combination in the treatment of acute severe asthma in children. Report No. GPM/85/008 |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35567 |
| Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/001 |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35547 |
| Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/007 |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35568 |
| 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: EFFICACY AND SAFETY OF GENOTONORM IN CHILDREN WITH FAMILIAL SHORT STATURE |
| Active substance: Somatropin |
| Study summary document link (including results): 90-076 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41715 |
| Study title: EFFICACY AND SAFETY OF THE AUTHENTIC RECOMBINANT HUMAN SOMATROPIN GENOTROPIN IN CHILDREN WITH FAMILIAL SHORT STATURE |
| Active substance: Somatropin |
| Study summary document link (including results): 89-050 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41728 |
| Study title: EFFICACY OF GENOTONORM IN PREPUBERTAL CHILDREN WITH SHORT STATURE SECONDARY TO A NEUROSECRETORY DYSFUNCTION. COMPARISON OF EFFICACY ON GROWTH WITH GROWTH HORMONE DEFICIENT CHILDREN AND CONSTITUTIONAL SHORT STATURE CHILDREN |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41677 |
| Study title: A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SLGB3019-ICHE3.pdf |
| View full study record |
| Document reference: 42050 |
| Study title: A Multicentre, Randomised, Double-Blind, Parallel-Group Study Comparing Pressurised Inhaler and Dry Powder Formulations of Salmeterol Xinafoate 50μg bd in Children With Reversible Airways Obstruction |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SLPT03-ICHE3.pdf |
| View full study record |
| Document reference: 47697 |
| Study title: A multicentre, randomised. double-blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50mcg twice daily from the diskhaler) compared with placebo (from the diskhaler) with salbutamol (200mcg to use 'as required' from the diskhaler) in children with asthma. Report No. GRP/95/011 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SMS30013-ICHE3.pdf |
| View full study record |
| Document reference: 42048 |
| Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf |
| View full study record |
| Document reference: 42041 |
| Study title: Dose-modification study of vigabatrin in children with refractory epilepsy.-Farr IN, Beaumont D. , Projekt Report: WIN 90-67, 1990 |
| Active substance: VIGABATRIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39395 |
| Study title: Dose-modification study of vigabatrin in children with refractory epilepsy.-Farr IN, Beaumont D. , Projekt Report: WIN 90-67, 1990 |
| Active substance: VIGABATRIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39397 |
| 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: 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: A phase II study of vinorelbine tartrate in children with Recurrent or Refractory Malignancies. |
| Active substance: VINORELBINE |
| Study summary document link (including results): A09705.pdf |
| View full study record |
| Document reference: 39400 |
| Study title: "Safety of inactivated split-virion influenza vaccine administered by the intradermal route in healthy children" |
| Active substance: Virus de la gripe fraccionados |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45261 |
| 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: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children. |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Valaciclovir-HS210914-ICHE3.pdf |
| View full study record |
| Document reference: 45423 |
| Study title: Evaluation of knee-mometry as a method of growth velocity control in growth retarded children undergoing one year of growth hormone treatment |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41782 |
| 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: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Internal Report, Strenge-Hesse, March 1996 |
| Active substance: Silibinine dihydrogen succinate, disodium |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40194 |
| Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf |
| View full study record |
| Document reference: 47699 |
| Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf |
| 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: Placebo controlled trial of growth hormone therapy for short children with steroid dependent nephrotic syndrome |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41795 |
| 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: PROTOCOL FOR THE STUDY OF GROWTH HORMONE IN GENETICALLY SHORT CHILDREN |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41737 |
| 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: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox. |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): Valaciclovir-HS2101951-ICHE3.pdf |
| View full study record |
| Document reference: 45422 |
| Study title: Pharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), SimonPharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), Simon |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45421 |
| Study title: Pharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, EksborgPharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, Eksborg |
| Active substance: VALACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45430 |
| Study title: Post-marketing surveillance trial evaluating efficacy and tolerability of a valerian root extract in 55 children. |
| Active substance: Valerian root extract 6.15:1 (HERB) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40297 |
| 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: 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: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children. |
| Active substance: VALGACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45432 |
| Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox. |
| Active substance: VALGACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45431 |
| Study title: A clinical study of 57 children with fetal anticonvulsant syndromes. - Moore et al. - J Med Genet 2000;37:489-497. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45435 |
| 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: "Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease" |
| Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41459 |
| Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease |
| Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41460 |
| Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42276 |
| Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42308 |
| Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42400 |
| Study title: Recombinant Growth Hormone (rhGH) in Growth hormone deficient children |
| Active substance: Somatropin |
| Study summary document link (including results): 86-001 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41744 |
| 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: 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: Final report of the study a double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX in healthy 12 to 15 month-old children, X04-VAR-402. : |
| Active substance: virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45265 |
| Study title: Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610.Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45571 |
| 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: Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94. Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94. |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45570 |
| Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42513 |
| Study title: Fluoride clearance of whole saliva in young school children after topical application. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42397 |
| Study title: Fluoride clearance of whole saliva in young school children after topical application. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42510 |
| Study title: An open cross-over comparison of controlled release salbutamol tablets (4mg bd) with individually titrated slow release theophylline (Theodur) in the management of chronic reversible airways obstruction in children (ST 388). Report No. GRP/88/013 |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35573 |
| Study title: - Application and efficacy of the multi-dose powder inhaler, Easyhaler, in children with asthma |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35551 |
| Study title: Long-term use of fluoride lacquer in preventive care of school children in area of basic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42384 |
| Study title: Adab et al. Additional educational needs in children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2001;70:15-21. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45443 |
| Study title: Additional educational needs in children born to mothers with epilepsy. -Adab et al. - J Neurol Neurosurg Psychiatry 2001;70:15-21. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45444 |
| Study title: An open-label trial of divalproex in children and adolescents with bipolar disorder - Wagner KD. - 2002 ( J Am Acad Child Adolesc Psychiatry 2002, 41 (10) : 1224-1230 ) |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45446 |
| Study title: Antiepileptic drug-induced worsening of seizures in children. - Guerrini R. et al. - Epilepsia 1998; 39 (suppl. 3): S2-S10 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45448 |
| Study title: Baumann RJ. et al. Treatment of children with simple febrile convulsions: the AAP practice parameter. Pediatr Neurol 2000; 23:11-17. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45451 |
| 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: AN MULTI-LABELLED, RANDOMIZED MULTI-CENTER STUDY EVLUATING THE EFFICACY OF A LOW DOSE OF RHGH (SOMATOTROPIN) IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 91-039 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41703 |
| Study title: An Open label, Randomized, Crossover, Patient/Parent Preference Trial of Norditropin® SimpleXx™ versus Humatrope®, Nutropin-AQ® and Genotropin™ in Children with Growth Hormone Deficiency |
| Active substance: Somatropin |
| Study summary document link (including results): hGH-2060_Norditropin.pdf |
| View full study record |
| Document reference: 41819 |
| Study title: An open randomised multicentre, 2-period crossover trial evaluating in GHD children the acceptance of the new liquid Norditropin® Simplexx™ versus the freeze-dried Norditropin® 4 I.U. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41811 |
| Study title: AN OPEN SINGLE CENTRE TRIAL EVALUATING THE EFFICACY AND SAFETY OF GENOTROPIN IN SHORT CHILDREN WITH PRADER-WILLI SYNDROME |
| Active substance: Somatropin |
| Study summary document link (including results): 94-8129-007 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41671 |
| Study title: Beclometasone Dipropionate inhalation powder in chronic asthma in children. Riv.Ital.Ped., 1981 ,7, 429Grzincich G.L. et al, Riv.Ital.Ped. 1981, Grzincich |
| Active substance: SALBUTAMOL AND BECLOMETHASONE DIPROPIONATE |
| Study summary document link (including results): Riv.Ital.Ped. 1981, Grzincich.pdf |
| View full study record |
| Document reference: 47303 |
| Study title: Non-interventional study on the use of Sophtal-POS® N in children |
| Active substance: SALICYLIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35575 |
| Study title: GENOTONORM IN SHORT CHILDREN WITH A BACKGROUND OF INTRAUTERINE GROWTH RETARDATION |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41679 |
| Study title: GENOTROPIN IN CHILDREN SHORT FOR GESTATIONAL AGE |
| Active substance: Somatropin |
| Study summary document link (including results): CTN 90-079 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41716 |
| Study title: GENOTROPIN IN CHILDREN WITH GROWTH HORMONE DEFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 90-033 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41722 |
| Study title: GENOTROPIN IN CHILDREN WITH INTRAUTERINE GROWTH RETARDATION. AN OPEN, MULTICENTER, COMPARATIVE, RANDOMISED, NATIONAL STUDY |
| Active substance: Somatropin |
| Study summary document link (including results): 93-8122-008 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41678 |
| Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE |
| Active substance: Somatropin |
| Study summary document link (including results): 91-045 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41702 |
| Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) |
| Active substance: Somatropin |
| Study summary document link (including results): 89-070, 89-071 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41729 |
| Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE. A LONG TERM STUDY IN BELGIUM |
| Active substance: Somatropin |
| Study summary document link (including results): CTN 90-080-98-8122-011 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41667 |
| Study title: Long-term use of fluoride lacquer in preventive care of school children in area of basic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42497 |
| 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: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease. |
| Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45577 |
| Study title: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease. |
| Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45580 |
| Study title: An Open-label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10 mg (Recombinant Somatropin) administered by ZomaJet Vision X Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner’s |
| Active substance: Somatropin |
| Study summary document link (including results): 1 CS-002 Synopsis.pdf |
| View full study record |
| Document reference: 41753 |
| Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41710 |
| Study title: A multicenter 10-week randomized double-blind, Placebo-controlled flexible dose outpatient study of Sertraline in children and adolescents with major depressive disorder. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42130 |
| Study title: A multicenter 10-week randomized double-blind, placebo-controlled flexible dose outpatient study of sertraline in children and adolescents with major depressive disorder. (Strength: 25, 50mg; Pharmaceutical form: tablet) |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42143 |
| Study title: A multicenter 24-week open-label extension study of Sertraline in children and adolescent outpatients previously diagnosed with major depressive disorder. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42131 |
| Study title: A multicenter 24-week open-label extension study of sertraline in children and adolescent putpatients previously diagnosed with major depressive disorder. (Strenght: 50mg; Pharmaceutical form: tablet) |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42144 |
| Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE. A TWOYEAR FOLLOW UP TRIAL WITHOUT TREATMENT COMPRISING THE PATIENTS FROM THE FORMER TWO TREATMENT ARMS. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41714 |
| Study title: GENOTROPIN IN SHORT CHILDREN WITH PRADER-WILLI SYNDROME |
| Active substance: Somatropin |
| Study summary document link (including results): 91-019 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41706 |
| Study title: GENOTROPIN IN SHORT CHILDREN WITH SILVER-RUSSELL SYNDROME |
| Active substance: Somatropin |
| Study summary document link (including results): 89-070, 89-071 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41730 |
| Study title: GENOTROPIN IN THE TREATMENT OF CHILDREN WITH SHORT STATURE |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-080 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41734 |
| Study title: Genetics and Neuroendocrinology in Children with Growth Hormone Deficient |
| Active substance: Somatropin |
| Study summary document link (including results): Somatropin - B9R-IT-GDFT CTR Summary.pdf |
| View full study record |
| Document reference: 41632 |
| Study title: Bartel DR et al. Sclerodermalike esophageal disease in children of mothers with silicone breast implants. J Am Med Assoc. September 20, 1994, 767-70Bartel DR et al. Sclerodermalike esophageal disease in children of mothers with silicone breast implants. J Am Med Assoc. September 20, 1994, 767-70 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42196 |
| 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 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: Clinical comparative assessment of efficacy, tolerance and toxicity of Dipromal and Depakina in the treatment of epilepsy in children |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45460 |
| Study title: Comparative clinical and pharmacokinetic study of a new slow release versus conventional preparations of valproic acid in children with intractable epilepsy - Braisn and Development, 1992, 14 (5), p.304-308 - Imaizumi T., Izumi T., Fukuyama Y. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45467 |
| Study title: Dean JCS et al. Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:251-9. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45469 |
| 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, long-term evaluation of Sertraline in children and adolescents with obsessive compulsive disorder or depression. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42129 |
| 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: Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42174 |
| Study title: Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42179 |
| Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42426 |
| Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42539 |
| Study title: To evaluate the effect of two years of treatment with three different dose regimens of Norditropin® SimpleXx® on height in children with intrauterine growth retardation ages 3 to <8 years at start of treatment; a randomized, parallel, multinational trial |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1424_Norditropin.pdf |
| 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: TREATMENT WITH ECOMBINANT HUMAN GROWTH HORMONE (GENOTONORM(REGISTERED)) IN PREPUBERTAL CHILDREN WITH SHORT STATURE SECONDARY TO CORTICOID THERAPY. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41673 |
| 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, 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: Oral anticoagulation therapy in children. 2006 Oral anticoagulation therapy in children. 2006 |
| Active substance: WARFARIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39419 |
| 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: 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: 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 Multicentre, Randomised, Double-blind, Double-dummy, Parallel Group Comparison of Three Treatments: 1) Seretide (50/100 mcg Strength)bd via Diskus/Accuhaler Inhaler, 2) Fluticasone Propionate 200 mcg bd via Diskus Inhaler, 3) Fluticasone Propionate 100mcg bd via Diskus/Accuhaler Inhaler in Children Aged 4-11 Years with Asthma. Report No. BP1999/00102/00 |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35594 |
| 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: 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: Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents. EB Posner. Cochrane database Syst Rev. 2005;(4):CD003032 in CES EXPCRC-CES733-EN-E01. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45479 |
| Study title: Guerrini R. et al. Antiepileptic drug-induced worsening of seizures in children. Epilepsia 1998; 39 (suppl. 3): S2-S10 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45484 |
| Study title: Initiation and tolerance of intravenous valproate in children (abstract), Thomas AB, Wheless JW, Willmore LJ, Galan JA, Curtis VL, Martinez H. Epilepsia 1993; 34 (suppl. 6): 81-2 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45489 |
| 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: 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: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41711 |
| Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41712 |
| Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal and pubertal children on dialysis |
| Active substance: Somatropin |
| Study summary document link (including results): 91-005 and 91-006 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41708 |
| Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal children with chronic renal insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 92-8123-003 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41749 |
| Study title: AN OPEN-LABELLED MULTI-CENTRE STUDY EVALUATING THE SAFETY AND EFFICACY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 95-8123-016 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41669 |
| Study title: AN OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFUCUENCY (HUNGARY) |
| Active substance: Somatropin |
| Study summary document link (including results): 91-094 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41694 |
| Study title: An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children with GH Deficiency |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1315_Norditropin.pdf |
| View full study record |
| Document reference: 41815 |
| Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35600 |
| Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal” |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35599 |
| Study title: Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction |
| Active substance: SALMETEROL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35601 |
| Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/016 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42026 |
| Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/018 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42034 |
| Study title: GROWTH HORMONE THERAPY IN SHORT CHILDREN AFTER RENAL TRANSPLANTATION FOR CHRONIC RENAL FAILURE IN GERMANY |
| Active substance: Somatropin |
| Study summary document link (including results): 94-8123-015 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41672 |
| Study title: Growth hormone treatment in children after renal transplantation. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41787 |
| Study title: GROWTH HORMONE TREATMENT IN SHORT CHILDREN BORN SMALL FOR DATE (GENOTONORM) |
| Active substance: Somatropin |
| Study summary document link (including results): 89-041 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 41727 |
| Study title: Growth hormone treatment of children after intrauterine growth retardation (IUGR). |
| Active substance: Somatropin |
| Study summary document link (including results): GHRETARD-BPD-14-20-21-NL_Norditropin.pdf |
| View full study record |
| Document reference: 41774 |
| Study title: Growth hormone treatment of short stature in children with chronic renal failure |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41784 |
| Study title: Growth hormone treatment of short stature in children with chronic renal failure |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41785 |
| 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: Pharmacokinetics of fluoride gels in children and adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42357 |
| Study title: Pharmacokinetics of fluoride gels in children and adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42470 |
| Study title: A Single-Centre Study to Determine the Pharmacodynamics and Duration of Action of Single Doses of Salmeterol Xinafoate 50mcg and 100ug as the Dry Powder Formulation Over a 12 Hour Period and to Further Assess the Tolerability of Salmeterol Xinafoate 50mcg BD in Children with Moderate to Severe Asthma. Report No. GRP/95/020 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42052 |
| 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: 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: Otten F.W:A. and Grote J.J. (1988) Treatment of chronic maxillary sinusitis in children. Int. J. Pediat. Otorhinolaryngology, 15, 269-278 |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Otten_1988.xls |
| View full study record |
| Document reference: 45651 |
| 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, multi-centre trial evaluating acceptance of the new liquid growth hormone formulation - Norditropin® SimpleXx® in children with GH deficiency |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1515_Norditropin.pdf |
| View full study record |
| Document reference: 41816 |
| Study title: An open, randomised multicentre crossover trial evaluating the acceptance of the new Liquid Norditropin® formulation versus the freeze-dried powder Norditropin® in treatment naïve Turner Syndrome children. |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-3338_Norditropin.pdf |
| View full study record |
| Document reference: 41818 |
| 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: Open follow-up study of Sertraline in children and adolescents with obsessive compulsive disorder. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42128 |
| Study title: Sertraline in the treatment of obsessive compulsive disorder (O.C.D) in children and adolescents. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42132 |
| Study title: Tolerance and Pharmacokinetics of Sertraline after single and multiple dosing in children and adolescents with obsessive compulsive disorder or depression. |
| Active substance: SERTRALINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42127 |
| Study title: High dose growth hormone administration over the first 18 months of treatment in children with GHD |
| Active substance: Somatropin |
| Study summary document link (including results): GHD-F-3-F_Norditropin.pdf |
| View full study record |
| Document reference: 41762 |
| Study title: GROWTH HORMONE THERAPY IN PUBERTAL SHORT CHILDREN, OR PREPUBERTAL ADOLESCENTS OLDER THAN 16 YEARS, WITH RENAL FAILURE. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41726 |
| 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: A single-centre, randomised, double-blind, placebo controlled, parallel group study to evaluate the efficacy of salmeterol (50mcg BD via the diskhaler) in children aged 6-16 years who have asthma that is difficult to control. Report No. GRP/95/024; |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Study SLPX01- SMS30029-Salmeterol Xinafoate-Serevent Rotadisks.xls |
| View full study record |
| Document reference: 42062 |
| Study title: A two centre study to assess the ease of handling and efficacy of salmeterol 50mcg twice daily delivered via a multidose powder inhaler compared with terbutaline sulphate 500mcg three times daily delivered via a turbohalerTM in children aged 6-11 years with reversible airways disease. Report No. GRP/95/017 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Study SMDT07-SLGB4005-Salmetrol Xinafoate (Serevent Diskus).xls |
| View full study record |
| Document reference: 42032 |
| Study title: A two-centre, double-blind, placebo controlled three way cross-over study to determine the duration of action of salmeterol 25mcg and 50mcg administered via Diskhaler against exercise induced bronchoconstriction in children with asthma. Further to compare the effect of salmeterol 50mcg x 2 and salbutamol 200mcg x 2 administered via adiskhaler for 6 weeks, on bronchial hyperreactivity in two parallel groups. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42057 |
| Study title: Treatment with human recombinant growth hormone of children with chronic renal failure |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41792 |
| Study title: TREATMENT WITH RECOMBIANT HUMAN GROWTH HORMONE(GENOTONORM(REGISTERED)) IN CHILDREN WITH SHORT STATURE SECONDARY TO A LONG TERM CORTICOID THERAPY A STUDY OF EFFICACY AND SAFETY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41647 |
| Study title: TREATMENT WITH RECOMBINANT HUMAN GROWTH HORMONE (GENOTONORM) IN CHILDREN WITH SHORT STATURE SECONDARY TO A LONG TERM CORTICOID THERAPY |
| Active substance: Somatropin |
| Study summary document link (including results): A6281217 (96-8123-018) PhRMA Clinical Study Synopsis.pdf |
| View full study record |
| Document reference: 41668 |
| Study title: TREATMENT WITH RECOMBINANT HUMAN GROWTH HORMONE IN SHORT CHILDREN AFTER RENAL TRANSPLANTATION FOR CHRONIC RENAL FAILURE IN SPAIN. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41732 |
| Study title: Lee WL et al. Management of epilepsy in children. In: the treatment of epilepsy. S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45492 |
| Study title: Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. - Dean JCS et al. - J Med Genet 2002;39:251-9. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45493 |
| Study title: Management of epilepsy in children. In: the treatment of epilepsy. - Lee WL et al. - S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45497 |
| Study title: Monotherapiy in children with epilepsy: a preliminary report advances in epileptology - Mc Gowan and al. - 1983 (XIVth Epilepsy International symposium, 1983, 283-290) |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45500 |
| Study title: Normal intelligence in children with prenatal exposure to carbamazepine. - Gaily E et al. - Neurology 2004;62:28-32. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45502 |
| 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: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42259 |
| Study title: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42291 |
| 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 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: 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: 17. Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial; Aliment Pharmacol Ther. 2005 ; 21 (5) : 583-590 |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40171 |
| 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: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42323 |
| Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42260 |
| Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42292 |
| Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42324 |
| Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42261 |
| Study title: A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50μg (from a Diskhaler) after a single dose and after treatment with 50μg twice daily, for 28 days in children and adolescents with asthma. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SLGB4003-ICHE3.pdf |
| 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: A double-blind, three-way crossover study assessing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd and 100mcg bd compared with salbutamol 200mcg qds for the treatment of severe chronic asthma in children 5-16 years old. Report No. GRP/95/019 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42049 |
| Study title: Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766, Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766, |
| Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42236 |
| 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: Prognosis in children with febrile convulsions. - Nelson KB et al. - Pediatrics 1978; 61: 720-727. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45510 |
| Study title: Specific cognitive dysfunction in children with epileptic mothers. - Gaily et al. - Dev Med Child Neurol 1990;32-403-414. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45512 |
| Study title: Status Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 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: 45513 |
| Study title: The longer term outcome of children born to mothers with epilepsy. - Adab et al. - J Neurol Neurosurg Psychiatry 2004;75:1575-83. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45517 |
| Study title: Treatment of children with simple febrile convulsions: the AAP practice parameter. - Baumann RJ. et al. - Pediatr Neurol 2000; 23:11-17. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45521 |
| 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: 23. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. |
| Active substance: Saccharomyces boulardii |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40177 |
| Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Belgium. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-043 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41657 |
| Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in France. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-047 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41656 |
| Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Spain. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-158 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41654 |
| Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Sweden/Finland. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-051 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41655 |
| Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in UK. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 88-033 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41658 |
| Study title: A Multi-centre, Randomised, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Dry Powder Formulations of Salmeterol Xinafoate 25μg and 50μg Twice Daily With Salbutamol 200μg Twice Daily Given in Children With Reversible Airways Obstruction |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SLPT02-ICHE3.pdf |
| View full study record |
| Document reference: 42071 |
| Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41801 |
| Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41802 |
| Study title: Long term tolerance study in children with renal insufficiency treated with somatropin over 1 year |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41820 |
| Study title: Multicentre clinical trial on the safety and efficacy of recombinant human growth hormone, Norditropin®, in growth retarded children with chronic renal failure. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41786 |
| Study title: NN-701 early phase 2 clinical trial – early phase 2 clinical trial in short stature children with intrauterine growth retardation |
| Active substance: Somatropin |
| Study summary document link (including results): GHRETARD-J-3-J_Norditropin.pdf |
| View full study record |
| Document reference: 41778 |
| Study title: Clinical trial using Genotropin in diet-treated children with chronic renal failure in Australia. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 89-023 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41653 |
| Study title: Concentration control trial of Norditropin SimpleXx in children with growth hormone deficiency: A two year, open-label, randomized, multi-center trial |
| Active substance: Somatropin |
| Study summary document link (including results): HGH-2051_Norditropin.pdf |
| View full study record |
| Document reference: 41758 |
| Study title: Controlled study to evaluate the efficacy and safety of the treatment with liquid Norditropin which will be started randomly at the ages of 2 to 5, in children diagnosed of intrauterine growth retardation |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41780 |
| Study title: Norditropin® and Norditropin® cartridges: An open-label, randomized, comparative safety and efficacy trial in children with growth hormone deficiency |
| Active substance: Somatropin |
| Study summary document link (including results): HGH-2124_Norditropin.pdf |
| View full study record |
| Document reference: 41757 |
| Study title: Norditropin® in children with growth failure associated with IGF deficiency: A 12 months open-label, randomized, parallel group study. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41798 |
| Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41800 |
| Study title: Nutritional status of children with chronic renal failure receiving recombinant human growth hormone therapy. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 89-031 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41652 |
| 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: Clinical study of salmeterol xinafoate (SN408) dry powder. Bioequivalency study between salmeterol xinafoate aerosol in children with bronchial asthma by single dose crossover method. Report No. JJA/93/011; |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Study SMS40086-SD102-Salmeterol Xinafoate-Serevent Rotadisks.xls |
| View full study record |
| Document reference: 42043 |
| Study title: Clinical study of Salmeterol xinafoate dry powder. Bioequivalency study between Salmeterol xinafoate aerosol in children with bronchial asthma by a single dose, cross-over method. Report No. JJA/93/011 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42059 |
| 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: Efficacy and safety of long-term inhaled salmeterol and beclomethasone dipropionate in corticosteroid-naïve children with mild to moderate, chronic, stable asthma. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SMS40065-ICHE3.pdf |
| View full study record |
| Document reference: 42051 |
| 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: Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes |
| Active substance: SIBUTRAMINE |
| Study summary document link (including results): sibutramine-danielsson.xls |
| View full study record |
| Document reference: 48136 |
| Study title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study of intravenous Sidenafil in the treatment of children, aged 0 to 17 with pulmonary hypertension. |
| Active substance: sildenafil |
| Study summary document link (including results): A1481134 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41605 |
| Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children. |
| Active substance: Silibinine dihydrogen succinate, disodium |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39872 |
| Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children.Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/ |
| Active substance: Silibinine dihydrogen succinate, disodium |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40193 |
| 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: McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42177 |
| Study title: Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83 |
| Active substance: SIMETICONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42181 |
| Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42293 |
| Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42325 |
| 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: 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 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: Endo et al. The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808) |
| Active substance: URINARY CONCREMENT SOLVENTS |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39157 |
| Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42377 |
| Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42490 |
| Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9 |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42244 |
| Study title: Wong VC, Sun JG, Yeung DW. Pilot study of efficacy of tongue and body acupuncture in children with visual impairment. [wong-2006-b]J Child Neurol. 2006 Jun;21(6):463-73. Wong VC 2006 |
| Active substance: Steripet |
| Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
| View full study record |
| Document reference: 48713 |
| Study title: The long-term safety and efficacy of Risperdal® in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 14 years. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35423 |
| Study title: The long-term safety and efficacy of Risperdal® in conduct disorders in mild, moderate and borderline mentally retarded children- a follow up trial of RIS-INT-41 |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-INT-41_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35424 |
| Study title: The safety and efficacy of open-label risperidone in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-USA-97_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35431 |
| Study title: A STUDY OF FACTORS DETERMINING GROWTH IN A POPULATION OF SHORT SLOWLY OR NORMALLY GROWING CHILDREN AND POTENTIAL MANAGEMENT OPTIONS INCLUDING GROWTH HORMONE |
| Active substance: Somatropin |
| Study summary document link (including results): 88-007 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41736 |
| 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: Cassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid ArthritisCassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid Arthritis |
| Active substance: SULFASALAZINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42881 |
| 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: 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 view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30 |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42586 |
| Study title: Acceptability and tolerability of the new liquid Norditropin® SimpleXx® formulation in combination with the new pen system NordiPenTM, with or without NordiPenmateTM: An open multicentre trial in adults and children with Growth Hormone Deficiency and chi |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1230_Norditropin.pdf |
| View full study record |
| Document reference: 41814 |
| Study title: Evaluation of the efficacy and safety of a single dose of secnidazole suspension (30 mg/kg) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingano - 1988 (registration dossier) |
| Active substance: SECNIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42115 |
| Study title: Evaluation of the efficacy and tolerance of a suspension of secnidazole in the treatment of acute uncomplicated amoebic dysentery in children (Study n° SZ 80002) - Dr J.M. Cardo-Salles, Dr Tall, Bobo Di Oulasso, Dr Josseran, Prof R. Lenoble - 1987 to 1988 (registration dossier) |
| Active substance: SECNIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42116 |
| 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: 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: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42249 |
| Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42281 |
| Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42313 |
| Study title: A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)] |
| Active substance: SERRAPEPTASE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42124 |
| Study title: Serrapeptase vs. Diclofenac - Postoperative treatment of children. Controlled study. (Comparative study) |
| Active substance: SERRAPEPTASE |
| Study summary document link (including results): 2011-08-30 Serrapeptase AN02_89 Synopsis.pdf |
| View full study record |
| Document reference: 42121 |
| 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: 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: 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: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication] |
| Active substance: Solidago compositum-Heel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40199 |
| 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 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 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: Kaladze N.N., Titova E.V.: Antihomotoxic preparations in the combined treatment of secondary osteopenia in children suffering from chronic pyelonephritis. Therapy (Ukraine), 2007, 3: 15-19 [IIT-publication] |
| Active substance: Solidago compositum-Heel - Ampullen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40198 |
| 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: The safety and efficacy of risperidone versus placebo in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35426 |
| Study title: Pharmacokinetics of Rosuvastatin in Children and Adolescents with Heterozygous Familial Hypercholesterolemia (4522IL/0086) |
| Active substance: ROSUVASTATIN CALCIUM |
| Study summary document link (including results): Study 4522IL0086_CSR Synopsis.pdf |
| View full study record |
| Document reference: 47885 |
| Study title: Optimization of aerosol deposition by pressure support in children with cystic fibrosis: an experimental and clinical study. Fauroux B, Itti E, Pigeot J, Isabey D, Meignan M, Ferry G, Lofaso F, Willemot JM, Clément A, Harf A. Am J Respir Crit Care Med. 2000 Dec;162(6):2265-71. |
| 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: 48230 |
| Study title: A MULTICENTER TRIAL OF GENOTROPIN TREATMENT OF CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA): EVALUATION OF PREDICTORS OF/CORRELATES WITH FIRST YEAR GROWTH RESPONSE |
| Active substance: Somatropin |
| Study summary document link (including results): 307-MET-0021-004 PhRMA Clinical Study Synopsis.pdf |
| View full study record |
| Document reference: 41644 |
| 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: A MULTI CENTRE, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROTH HORMONE THERAPY IN SHORT PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS. |
| Active substance: Somatropin |
| Study summary document link (including results): 91-032 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41704 |
| Study title: A multi-center open-labeled study evaluating the efficacy and safety of growth hormone therapy in short pubertal and prepubertal children with chronic renal insufficiency undergoing chronic peritoneal dialysis or hemodialysis |
| Active substance: Somatropin |
| Study summary document link (including results): 90-059 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41717 |
| Study title: A MULTI-CENTER, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS |
| Active substance: Somatropin |
| Study summary document link (including results): 91-031 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41705 |
| Study title: A MULTI-CENTRE PILOT STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE IN SHORT CHILDREN WITH CYSTINOSIS |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41701 |
| Study title: A MULTI-INDEPENDENT, OPEN LABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 92-8123-009 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41686 |
| Study title: Bone mineral density and bone scintigraphy in children and adolescents with osteomalacia. El-Desouki M, Al-Jurayyan N. Eur J Nucl Med. 1997 Feb;24(2):202-5. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43554 |
| 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: Rovamycine infant 0.375MIU, children 0.750MIU,older children 1.5 MIU - Spiramycin granules in sachets - part IV A.2.1 |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42591 |
| 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: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42594 |
| Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42599 |
| 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: 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: 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: 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: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43107 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43128 |
| Study title: The trace efficacy of dental caries prevention in children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42429 |
| Study title: The trace efficacy of dental caries prevention in children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42542 |
| 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: Bone scintigraphy in preschool children with lower extremity pain of unknown origin. Englaro EE, Gelfand MJ, Paltiel HJ. J Nucl Med. 1992 Mar;33(3):351-4. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43702 |
| Study title: Acute haematogenous osteomyelitis in children - the reliability of skeletal scintigraphy. Erasmie U, Hirsch G. Z Kinderchir. 1981 Apr;32(4):360-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44127 |
| 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: A MULTI-INDEPENDENT, OPEN LABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 90-057 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41718 |
| Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PREPUBERTAL CHILDREN WITH |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41697 |
| Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41698 |
| Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41699 |
| Study title: A MULTI-INDEPENDENT, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41693 |
| Study title: A MULTI-INDEPENDENT, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 90-056 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41719 |
| Study title: A MULTI-INDEPENDENT, OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41700 |
| Study title: A MULTI-INDEPENDENT, OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 91-009 and 91-010 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41707 |
| Study title: A MULTI-INDEPENDENT,OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY. |
| Active substance: Somatropin |
| Study summary document link (including results): TRN 91-109 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41692 |
| Study title: A MULTICENTER TRIAL EVALUATING THE EFFICACY AND SAFETY OF SOMATROPIN IN SHORT CHILDREN BORN SMALL-FOR GESTATIONAL AGE |
| Active substance: Somatropin |
| Study summary document link (including results): 307-MET-0021-001 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41641 |
| 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: 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: Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7.Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7. |
| Active substance: SPIRAMYCIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42596 |
| 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: Bone pain palliation with strontium-89 in children. Giammarile F 1998 Med Pediatr Oncol. 1998 Mar; 30(3):199-200 F Giammarile et al. |
| Active substance: STRONTIUM 89 |
| Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
| View full study record |
| Document reference: 48213 |
| Study title: Pain palliation with strontium-89 in children with metastatic disease Charron M 1996 Med Pediatr Oncol. 1996 Jun; 26(6):393-6 |
| Active substance: STRONTIUM 89 |
| Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
| View full study record |
| Document reference: 48212 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43167 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43172 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43178 |
| 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 prevention with fluoride varnishes among preschool children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42344 |
| Study title: Caries prevention with fluoride varnishes among preschool children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42457 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43186 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43196 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43206 |
| Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43147 |
| 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: A double-blind , placebo-controlled study of risperidone in children and adolescents with autistic disorder |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-USA-150_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35418 |
| Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-INT-79_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35427 |
| Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-INT-84_Interventional_Risperidone.xls |
| View full study record |
| Document reference: 35433 |
| Study title: Children and adolescents (5-17 yrs) with conduct or other OBD. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35414 |
| Study title: Determination of the pharmacokinetics and safety of risperidone at steady state in children and adolescents 5 to less than 18 years of age. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35434 |
| Study title: Efficacy and safety of risperidone in the treatment of children with autistic disorder and other pervasive developemental disorders: A canadian, multicenter , double-blind, placebo controlled-study. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35420 |
| Study title: Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43961 |
| Study title: The contribution of perfusion scintigraphy in the evaluation of children suffering from recurrent localized pneumonia. Hardoff R, Rivlin J, Front A. Eur J Nucl Med. 1990;17(3-4):152-5. |
| 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: 48284 |
| 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 MULTICENTRE TRIAL EVALUATING THE EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN SHORT FOR GESTATIONAL AGE |
| Active substance: Somatropin |
| Study summary document link (including results): 93-8122-003 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41680 |
| Study title: A MULTICENTRE, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS |
| Active substance: Somatropin |
| Study summary document link (including results): 92-8123-010 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41685 |
| Study title: A MULTICENTRE, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL, PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41696 |
| Study title: A multicentre, open, clinical trial with duration of 12 months, evaluating the efficacy and safety of Norditropin® SimpleXx®, starting from 4 years of age until onset of puberty in SGA children due to IUGR |
| Active substance: Somatropin |
| Study summary document link (including results): GHLiquid-1523_Norditropin.pdf |
| View full study record |
| Document reference: 41781 |
| 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 SINGLE CENTER, OPEN-LABELED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERPY IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): 90-109 EMA Pediatrics Web Synopsis.pdf |
| View full study record |
| Document reference: 41713 |
| Study title: A SIX-MONTH STUDY OF EFFICACY OF GENOTROPIN 36 IU IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41689 |
| 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: Kelly KM. Complementary and alternative medical therapies for children with cancer. European Journal of Cancer 2004; 40(14):2041-2046.Kelly KM. Complementary and alternative medical therapies for children with cancer. European Journal of Cancer 2004; 40(14):2041-2046. |
| Active substance: TAMOXIFEN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43138 |
| 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: 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: Serevent VS Placebo : Paediatric asthma, exercise-induced. A multicentre, double-blind. parallel group study to assesss the efficacy of serevent 50mcg.bd vs placebo.bd (via the accuhaler) on the prevention of exercise induced asthma in children. A real-life situation. Report No. SLGB4021R |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42027 |
| 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: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42110 |
| Study title: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42111 |
| Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42107 |
| Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42108 |
| Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42109 |
| Study title: To establish the pharmacokinetic properties of scopolamine in children |
| Active substance: SCOPOLAMINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42112 |
| 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: One year treatment with either inhaled corticosteroid or a long acting beta-2-agonist in asthmatic children. Report No. GM1996/00022/00 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol Xinafoate-SLGB4015-ICHE3.pdf |
| View full study record |
| Document reference: 42054 |
| Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y) |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42038 |
| Study title: Efficacy and tolerance evaluation of secnidazole suspension single dose (30 mg/kg/day) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingans - No date |
| Active substance: SECNIDAZOLE |
| Study summary document link (including results): Secnidazole STUDY Cimerman.xls |
| View full study record |
| Document reference: 42113 |
| Study title: Clinical evaluation of Duraphat varnish in the prevention of dental caries in children and in the control of cervical hypersensitivity in adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42443 |
| Study title: Clinical evaluation of Duraphat varnish in the prevention of dental caries in children and in the control of cervical hypersensitivity in adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42556 |
| Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y) |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-102095-ICHE3.pdf |
| View full study record |
| Document reference: 42066 |
| Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y) |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42070 |
| Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y) |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
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| Document reference: 42073 |
| Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y) |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): |
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| Document reference: 42075 |
| Study title: Placebo controlled study during one year comparing the addition of Salmeterol with an increase of the dose of the inhaled corticosteroid in asthmatic children already on treatment with inhaled corticosteroids. Report No. GM1998/00044/00 |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol Xinafoate-SLGB4014-ICHE3.pdf |
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| Document reference: 42053 |
| Study title: Salmeterol dry powder 50mcg bd versus usual treatment in children with moderate asthma. |
| Active substance: SALMETEROL (XINAFOATE) |
| Study summary document link (including results): Salmeterol-Xinafoate-SMS40069-ICHE3.pdf |
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| Document reference: 42029 |
| 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): |
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| Document reference: 40224 |
| Study title: Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. |
| Active substance: TAMOXIFEN |
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| Document reference: 43284 |
| Study title: Pharmacokinetics and safety of risperidone in children with autistic disorder after a single oral dose of risperidone. Part I: Pharmackinetics and prolactin response. Part II: Tolerability, cardiovascular safety and laboratory safety. |
| Active substance: RISPERIDONE |
| Study summary document link (including results): |
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| Document reference: 35422 |
| Study title: Randomized, double-blind, placebo-controlled multicenter 3-week study in children and adolescents (ages 10-17 years) with acute mania in Bipolar I disorder |
| Active substance: RISPERIDONE |
| Study summary document link (including results): RIS-BIM-301_Interventional_Risperidone.xls |
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| Document reference: 35392 |
| 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 |
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| 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 |
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| Document reference: 35430 |
| Study title: Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study. Sengespeik HC et al., Arzneimittelforschung, 1998: 990-4. |
| Active substance: Spike oil |
| Study summary document link (including results): |
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| Document reference: 40225 |
| Study title: Retrospective survey for documentation of appllication and dosage of Spigelon (tablets) in children < 12 years of age [Bef-026] |
| Active substance: Spigelon |
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| Document reference: 40245 |
| Study title: Acute hematogenous osteomyelitis of children: assessment of skeletal scintigraphy-based diagnosis in the era of MRI. Connolly LP, Connolly SA, Drubach LA, Jaramillo D. Treves ST. J Nucl Med 2002 Oct;43(10):1310-6. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
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| Document reference: 48472 |
