1062 results
Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…
The aim of this study is to demonstrate which is the most effective operation for neonates with necrotizing enterocolitis (NEC): intestinal resection with stoma formation or intestinal resection with primary anastomosis.
The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…
Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
To compare one dose of the short acting tropicamide combined with one dose of the longer acting cyclopentolate (c+t) with a double dose of the longer acting cyclopentolate (c+c). To develop a cycloplegics protocol that garantees optimal refractieve…
Primary: Longterm safety and tolerability of 2 dosages of ambrisentan. Secundary: Supportive efficacy data.
The goal of this trial is to find the best available conservative treatment, based on subjective pain scores, for children with Sever*s disease. Our primary objective is to score the possible decrease of pain experienced by the subjects. This will…
The study described in this protocol is designed to determine the pharmacokinetics of cefotaxime and its metabolite, desacetyl-cefotaxime, in children on continuous intravenous infusion of cefotaxime. Using these data we will be able to delineate…
The objective of the study is to improve the trained as wel as other executieve functions. Also the aim of this study is that these functions will improve in everyday life and generalize to other domains, resulting in improvement in behavior,…
Hypothesis:A substantial proportion of the JIA patients in remission (according to the Wallace criteria) will be able to discontinue etanercept successfully.Goals:To investigate in a randomized controlled trial:- which proportion of JIA patients in…
This project aims to develop an evidence based effective and "safe" dosing regimen for commonly used life saving medicationsused in the treatment of asphyxiated, critically ill newborns, undergoing therapeutic hypothermia.To this aim the…
The study will include 100 children with HFASD aged 8 to 12 years old. During 8 one-hour weekly group meetings children are trained on precursors of Theory of Mind (perception, imitation, emotion recognition, pretence), elementary Theory of Mind…
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
To create a registry for paediatric patients with iris-fixated or posterior IOL*s, and the assessment of the long-term effects of implanted, artificial lenses in children.
Measuring specific antibody titers against influenza A (subtype H1N1 and / or seasonal vaccine) in DS children. DS anti-influenza antibody titers will be compared with controls available from the same laboratory.
Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…
To compare neonatal mortality and short-term (advanced MRI indices of structural brain injury at 40 weeks* GA) and long-term neurodevelopmental outcomes (Bayley scales of infant development III [BSID-III] at 24 months) between two groups of very…
To evaluate the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in preterm infants with a birth weight from 800 g to less than 1500 g and with a gestational age from 25 weeks…
The objective of this study is to test the safety of the research study drug, MK-0462 (rizatriptan) and to test the ability of study drug to relieve or reduce migraine for the study population.