233 results
To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.
To determine if maintenance therapy with AZN will provide significant improvements in PCD lung disease, compared to placebo: reduction in respiratory system exacerbations and improvement in lung function, ventilation inhomogeneity, improvement in…
Primary Objectives:* For the European Union (EU) regulatory assessment, the primary objective of Period 1 is to evaluate theefficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatricPAH patients through…
Primary outcome parameter is the amount of intra- and postoperative transfusions required. Secondary outcome parameters include intra- and postoperative blood loss, operation time, and postoperative complications and the outcome of…
To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.
To assess the efficacy, safety, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) (based on subject body weight at baseline) as compared to matching placebo BID, when administered orally for 12 weeks in…
To evaluate the effects of intranasal oxytocin compared to placebo administration on appetite, satiety and food intake.Also effects on social behavior, BMI, body composition, IGF-I levels and genetic differences (deletion / mUPD). To assess oxytocin…
Primary objective: To evaluate the efficacy of GWP42003-P as adjunctive treatment inreducing the number of drop seizures when compared with placebo, inpatients with LGS.Drop seizure is defined as an attack or spell (atonic, tonic or tonic-clonic)…
Primary objectiveTo assess whether the use of alimemazine improves symptoms of allergic diseases and ADHD, as scored by the parents using standardized questionnaires (Sample Snap IV rating scales)
To determine whether computerized training procedures can lead to a decrease of aggression-related attention andinterpretation, and whether this reduces aggressive behaviors.
Primary objective: To investigate the effectiveness of ongoing treatment with methylphenidate as prescribed in clinical practice beyond two years in children and adolescents. Secondary objectives:(1) to investigate the effects of discontinuation of…
To compare the EEG pattern after administration of cyclopentolate with the EEG pattern after placebo eye-drops.Primary outcomeEEG pattern changes after administration of two drops of cyclopentolate1% compared with placebo.Secondary outcomes- Pattern…
Determine efficiency and safety of two different doses of pregabalin as compared to placebo.
Primary Efficacy Objective* The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1…
Primary Objectives:The primary objectives are to evaluate in infants who are hospitalized with RSV infection:- the pharmacokinetics of JNJ-53718678 after multiple oral doses;- the safety and tolerability of JNJ-53718678 when administered for 7 days.…
The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…
Primary objective:The purpose of this study is to evaluate the short term effect of a patellar strap on symptoms and sports participation in children with Osgood-Schlatter disease.Secondary objective: The second objective of this study is to…
To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the…
Specific AimsAs reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood…
The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…