44 results
The primary objective is to determine the efficacy of a disease specific cognitive behavioral therapy program in adolescents with IBD and increased symptoms of depression or anxiety on reducing symptoms of depression. Secondary objectives are to…
Main objective:To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.Secondary objectives:1…
To evaluate the ability of ataluren to improve pulmonary function relative to placeboTo determine the effect of ataluren on:1. Pulmonary symptoms2. General well-being3. Health-related Quality Life (HRQL)
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
The study aims to answer the following research questions:1. How high/low are levels of symptomatology of depression and/or PTSD in traumatised refugee children in ASC?2. Do symptom levels decrease after a short-term trauma-focused intervention?3.…
Primary Objectives:Safety Run-in PartTo establish a safe and tolerable dose of azacitidine to be used in the randomized part of thestudy.Randomized PartTo evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after…
In this research study we compare two approaches that can be used to give breathing support to prematurely born babies. Both techniques are currently used in different countries over the world. However, at this moment we don*t know which methods is…
Primary objective is to investigate whether delineation of the epileptogenic tissue during aECoG-guided surgery guided by HFOs instead of epileptiform spikes, will not lead to a worse outcome with respect to post-operative seizure freedom. Secondary…
To assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in reducing the proportion of patients who experience a major bleed or death up to study day 28.
We aim to determine the effects of a face to face and a blended parent training program (i.e., two formats of Behavioral Parent Training Groningen; BPTG) on behavior problems for children 4 through 12 years old with ASD and behavior problems.…
Primary:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…
The comparison of the effects (and cost effectiveness) of mindfulness training for the child + Mindful Parenting for the parents versus medication (Methylphenidate) in a randomized controlled trial (RCT) in children with ADHD, aged 9-18.
To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency. The dose response…
The primary objective is to study the effect of paediatric pelvic physiotherapy in addition to conventional therapy on the number of patients with treatment success in children aged 4-17 years presenting in primary care with functional constipation…
The primary objective is to compare the efficacy and safety of SD-101-6.0vs. SD- 101-0.0 (placebo) in patients with Simplex, RecessiveDystrophic, or Junctional non Herlitz Epidermolysis Bullosa.The primary endpoint is the complete closure of the…
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 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…
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…
The primary objective of the clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to…
To investigate the direct effect of caffeine on the respiratory effort of the preterm infant at birth.