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A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreichâ¤*s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…

The efficacy of night splinting in children with cerebral palsy, a randomised controlled trial

1) To evaluate the efficacy of knee-ankle-foot orthoses (worn by night) in preventing a decrease of range of motion to ankle dorsiflexion in children with cerebral palsy (Clinical part). 2) To evaluate the effect of night-worn knee-ankle-foot…

Secondary prevention of asthma in overweight/obese children by a combined dietary-behavioural-physical activity intervention

The current proposal studies the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of overweight/obese children with asthma. Also the underlying mechanism of these…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multinational Clinical Study to Evaluate the Efficacy and Safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…

Effectiveness and safety of parecoxib in children undergoing scoliosis surgery compared to placebo: a double-blinded randomised controlled trial

Assessing the effectiveness and safety of parecoxib compared to placebo in pain relief children undergoing scoliosis surgery

"Inside the mirror"
A pilot study on the effects of dance movement intervention on interpersonal non-verbal attunement in adolescents with autism spectrum disorders.

The project aims at contributing some empirical evidence of treatment effects of DMT with ASD. We expect i) to replicate similar results in a series of individual treatment processes and ii) to find contrasting results in a series of individual…

Reduction of asthma exacerbation rate in children by non-invasive monitoring of inflammatory markers in exhaled breath (condensate): the RASTER study

The purpose of the present proposal is to improve care to children with asthma by including regular assessments of non-invasive inflammatory markers during the management of asthma. In this case, treatment is also guided by inflammatory markers (…

Modification of cognitive interpretation bias by training in adolescents with obsessive compulsive disorder

The goal of the present study is twofold. The first one is to develop a Recogntion Task for adolescents with OCD analogue to the Recognition Task for adults. This Revised Recognition Task can afterwards be used for measurement of the effectiveness…

*Working memory training in children with neuropsychiatric disorders and borderline intellectual functioning*

1. To investigate the efficacy of Cogmed working memory training in reducing behavioral symptoms in children with neuropsychiatric disorders and borderline intellectual functioning.2. To investigate whether WM training improves neurocognitive…

Hyperactivity and inattentive behaviour in the classroom.

This project aims (I) to examine the effectiveness of the teacher training 'Hyperactivity and inattentive behaviour in the Classroom', and (II) to implement this training into Dutch regular primary schools.

A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy (DMD114044)

Primary: to assess efficacy of subcutaneous 6 mg/kg GSK2402968 versus placebo administered over 48 weeks in ambulant subjects with DMD. Secondary: Safety, tolerability, PK, quality of life.

A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with…

A randomised controlled trial examining the effects of a cognitive behavioural treatment for bereaved children combined with parental support

This proposed randomised controlled trial seeks to examine the effect of "GriefHelp" - a cognitive behavioural treatment for children with emotional problems following the death of a loved one. Participants are randomly assigned to two…

Using nicotine patches to support smoking cessation among adolescents.

The main aim of this study is to determine the effectiveness and safety of nicotine replacement therapy (NRT) in achieving long-term smoking cessation among young smokers aged 12 up to and including 18 years. Other aims of this study are to…

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"I really want to, but I can't." An effect measurement of 20 neurofeedback treatments on intermediate vocational training students who fall under the theta/beta protocol, as measured by changes in the Bourdon-Wiersma Test, The Outcome Rating Scale, and the tendency of obtained marks.

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A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…

Cost-effectiveness of laser Doppler imaging in burn care in the Netherlands

To gain insight in the effects and cost-effectiveness of the introduction of laser Doppler imaging in burn care.

A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…

A study on the effects of a behavioral-management strategy on the efficiency in Special Education

The main goal of this study is to test the effects of a classroom-based behavior-management strategy (Taakspel) on the emotional and behavioral functioning of the students, the wellbeing and perceived efficacy of the teachers, and the teacher-…