296 results
The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…
The primary objective is to test the hypothesis that, after at least 15 weeks of daily administration (4 for titration, 7 of relatively stable dose, 4 at fixed doses; Study Period II), risperidone given orally in a dose of 0.25 - 3.0 mg/d depending…
1. To determine clinical symptoms of Dientamoeba fragilis infection. 2. To evaluate the efficacy and safety of clioquinol versus metronidazol in the treatment of Dientamoeba fragilis in children.3. To evaluate the duration of positive PCR…
The aim of this study is to find a succesful treatment for chronic abdominal pain and small intestinal bacterial overgrowth in children and at the same time improve the quality of life of these children. A second aim is to reduce the hospital visits…
The primary research inquiry being raised concerns anaesthesia related causes:Is it possible that adapting an amount of sevoflurane, from 1 MAC (minimum alveolar concentration) (2,5 vol%) to * MAC (1,25 vol%) in an MRI scan can reduce the frequency…
Primary objective of the study: 1. To report on the effectmodification by age of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniquesSecondary objectives:1. To report on the…
The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.
To test the hypothesis that The Transporters will show significant more improvement in contextual understanding of emotions and social functioning in children with ASD and BIF than a control intervention.
Primary: To measure the effect of a high protein diet on whole body protein synthesis and -breakdown, as well as on net whole body protein balance and production of urea in children after cardiac surgerySecondary: To measure the effect of a high…
Primary Objective:To evaluate the efficacy and safety of solifenacin succinate o.d. in children and adolescents with OABSecondary Objective:To perform population pharmacokinetics after multiple-dose administration.
2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…
The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second…
To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…
Primary: To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs. Key secondary: Ability to completely…
The objectives of this multi-centre, double-blind, randomized, 2-parallelgroups study are to investigate the efficacy, safety and tolerability of levetiracetam (LEV) monotherapy 15-60mg/kg/day versus valproic acid (VPA) monotherapy 10-40mg/kg/day in…
The objective of this study is to determine whether influencing the protein pathway thought to underlie TSC by Everolimus treatment will improve cognitive abilities in these children.
The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention. The secondary…
The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…
The primary objective of this study is to evaluate the efficacy of 2 dose levels of pregabalin (Level 1: 2.5 mg/kg/day; maximum 150 mg day and Level 2: 10 mg/kg/day; maximum 600 mg day) compared to placebo as an adjunctive treatment in reducing the…
The primary objective of this study is to test the hypothesis that risperidone given orally in a dose of 0.25 - 3.0 mg/d depending on body weight (eq. to approximately 0.01 - 0.04 mg/kg/d) for 12 weeks is superior to placebo in reducing disruptive…