- Trials with a EudraCT protocol (1,787)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (216)
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: J Nucl Med. 2005 Apr;46(4):560-6. Characterization of hyperinsulinism in infancy assessed with PET and 18F-fluoro-L-DOPA. Ribeiro MJ, De Lonlay P, Delzescaux T, Boddaert N, Jaubert F, Bourgeois S, Dollé F, Nihoul-Fékété C, Syrota A, Brunelle F. |
Active substance: FLUDEOXYGLUCOSE |
Study summary document link (including results): |
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Document reference: 28106 |
Study title: Diabetes Care. 2001 Mar;24(3):555-60. Blood pressure does not rise before the onset of microalbuminuria in children followed from diagnosis of type 1 diabetes. Oxford Regional Prospective Study Group. Schultz CJ, Neil HA, Dalton RN, Konopelska Bahu T, Dunger DB; Oxford Regional Prospective Study Group. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28171 |
Study title: An open-label, multicenter, single-dose study to evaluate the pharmacokinetics of glimepiride (Amaryl®) in pediatric patients with type 2 diabetes mellitus - Sponsor Sanofi - 26/02/2004 |
Active substance: GLIMEPIRIDE |
Study summary document link (including results): Glimepiride-Study 2.pdf |
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Document reference: 28971 |
Study title: Glimipiride versus Metformin as Monotherapy in Paediatric Subject with Type 2 Diabetes Mellitus : A Single Bind Comparaison Study - sponsor sanofi - 15/11/2004 |
Active substance: GLIMEPIRIDE |
Study summary document link (including results): Glimepiride-Study 1.pdf |
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Document reference: 28972 |
Study title: Effects of renal failure and metabolic diseases upon bone scanning in children.Schumichen C. Annales de Radiologie 1983 26(6):498-504 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48758 |
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): |
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Document reference: 22596 |
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 |
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Document reference: 23155 |
Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants |
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
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Document reference: 40152 |
Study title: A randomized double-blind study of safety and efficacy of SMOF 20% vs. Intralipid 20% in infants and children requiring long-term parenteral nutrition |
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
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Document reference: 40151 |
Study title: Acid-Base status in dietary treatment of phenylketonuria |
Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
Study summary document link (including results): |
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Document reference: 32725 |
Study title: Are tablets a practical source of protein substitute in phenylketonuria? |
Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
Study summary document link (including results): |
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Document reference: 32726 |
Study title: Mineral and trace – metal Balances in Children receiving normal and synthetic diets |
Active substance: NUTRIENTS WITHOUT PHENYLALANINE |
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Document reference: 32723 |
Study title: A randomised, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity |
Active substance: OCTREOTIDE |
Study summary document link (including results): Novartis Octreotide_Sandostatin LAR Study B2403_31Aug2011.xls |
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Document reference: 32741 |
Study title: A randomized, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity |
Active substance: OCTREOTIDE |
Study summary document link (including results): Novartis Octreotide_Sandostatin LAR Study B2403E1_31Aug2011.xls |
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Document reference: 32742 |
Study title: A randomized, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity |
Active substance: OCTREOTIDE |
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Document reference: 32743 |
Study title: "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr5.xls |
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Document reference: 47718 |
Study title: "Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44"Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr4.xls |
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Document reference: 47717 |
Study title: Appendix I to Ephynal (dl-α-tocopherol) NDA pharmacokinetic profile (for Vitamin E) in premature neonated following intramuscular administration |
Active substance: TOCOPHEROL |
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Document reference: 47788 |
Study title: Kalra V. Vitamin E Administration and Reversal of Neurological Deficits in Protein-Energy Malnutrition. Journal of Tropical Pediatrics 2001; 47: 39-48. Kalra V. Vitamin E Administration and Reversal of Neurological Deficits in Protein-Energy Malnutrition. Journal of Tropical Pediatrics 2001; 47: 39-48. |
Active substance: TOCOPHEROL |
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Document reference: 44822 |
Study title: Pharmacokinetic profile for vitamin E in premature neonated following intramuscular administration |
Active substance: TOCOPHEROL |
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Document reference: 44823 |
Study title: Tolerability and acceptability of Ro 01-4065/342, EPHYNAL effervescent tablets |
Active substance: TOCOPHEROL |
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Document reference: 47790 |
Study title: "Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206"Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr8.xls |
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Document reference: 47721 |
Study title: "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr7.xls |
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Document reference: 47720 |
Study title: "The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251"The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr6.xls |
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Document reference: 47719 |
Study title: |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33954 |
Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31482 |
Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur... |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31489 |
Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31501 |
Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31502 |
Study title: |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31503 |
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 |
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Document reference: 31504 |
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) |
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Document reference: 31491 |
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) |
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Document reference: 31485 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31481 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31499 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31500 |
Study title: Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764. |
Active substance: BIOTIN |
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Document reference: 22625 |
Study title: J.A.R. Calderon: Uso de Pantogar en la terapia contra la caida difusa del cabello y danos estructurales del mismo, 2003 |
Active substance: VITAMIN COMBINATIONS |
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Document reference: 39401 |
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 |
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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 |
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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 |
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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 |
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Document reference: 45570 |
Study title: Geltman PL, Meyers AF, Mehta SD, et al. Daily multivitamins with iron to prevent anemia in high-risk infants: A randomized clinical trial. Pediatrics, 2004:114;86-93.Geltman PL, Meyers AF, Mehta SD, et al. Daily multivitamins with iron to prevent anemia in high-risk infants: A randomized clinical trial. Pediatrics, 2004:114;86-93. |
Active substance: VITAMINS |
Study summary document link (including results): |
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Document reference: 45572 |
Study title: Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82.Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82. |
Active substance: VITAMINS |
Study summary document link (including results): |
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Document reference: 45568 |
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 |
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Document reference: 45575 |
Study title: Ozkan B, Bereket A, Turan S. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr, 2004:163:738-741.Ozkan B, Bereket A, Turan S. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr, 2004:163:738-741. |
Active substance: VITAMINS |
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Document reference: 45573 |
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 |
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Document reference: 45574 |
Study title: The use of multivitamin-preparations in paediatricsThe use of multivitamin-preparations in paediatrics |
Active substance: VITAMINS |
Study summary document link (including results): |
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Document reference: 45566 |
Study title: Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik |
Active substance: VITAMINS |
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Document reference: 45567 |
Study title: A 12-Month Study to Assess the Safety and Efficacy of Meridia® (sibutramine hydrochloride monohydrate) 10 and 15 mg in Obese Adolescents |
Active substance: SIBUTRAMINE |
Study summary document link (including results): Sibutramine-SB238.pdf |
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Document reference: 47621 |
Study title: A randomised, placebo controlled, doubly blind study of the effect of sibutramine on the treatment of obese adolescents with a recommended diet and exercise plan followed by a sibutramine-free period (SB116) |
Active substance: SIBUTRAMINE |
Study summary document link (including results): Sibutramine-SB116.pdf |
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Document reference: 47620 |
Study title: An open-label, single dose, pharmacokinetic study of sibutramine and its metabolites in obese adolescents. |
Active substance: SIBUTRAMINE |
Study summary document link (including results): Sibutramine-SB240.pdf |
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Document reference: 47622 |
Study title: Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes |
Active substance: SIBUTRAMINE |
Study summary document link (including results): sibutramine-danielsson.xls |
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Document reference: 48136 |
Study title: Use of Sibutramine in Obese Mexican Adolescents: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial |
Active substance: SIBUTRAMINE |
Study summary document link (including results): sibutramine-garciamorales.xls |
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Document reference: 48137 |
Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety |
Active substance: ROSUVASTATIN CALCIUM |
Study summary document link (including results): Study 4522IL0054_CSR Synopsis.pdf |
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Document reference: 47886 |
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 |
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Document reference: 47885 |