41 results
primary objective: To evaluate the long-term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF), homozygous or heterozygous for the F508del-cystic fibrosis transmembrane conductance regulator (…
To investigate the efficacy of a less intensive but more prolonged Cogmed © RM WMT (including active personalized coaching and feedback) in reducing behavioral symptoms and improving neurocognitive functioning and academic achievements in children…
Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent asthma,adequately controlled on twice-daily ICS/LABA. Secondary: Adverse…
Main objective: To assess the effect of Caphosol on the number of days of mucositis > grade ISecondary objective: to assess the effect of Caphosol on duration and degree of mucositis and pain, a possible influence on the occurrence of…
To investigate the short-term effectiveness of a 4 month manualized home-based behavioral treatment for referred children with ADHD, aged 6 to 13 years, who have responded insufficiently to first line treatment with medication or behavioral parent…
This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…
Primary: to compare the efficacy and safety of once daily (evening) administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >= 12 years of age with moderate to severe, persistent bronchial asthma over 12 weeks.Secondary:…
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 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 (…
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…
The objectives of this study are to determine the safety and efficacy of two doses of adalimumab versus MTX in paediatric subjects with chronic plaque psoriasis, to determine the time to loss of disease control and the ability to regain response…
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.
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal…
To evaluate the impact of electroencephalographic Narcotrend* Index (NI) monitoring on the speed of emergence and recovery from PPS for PGE.
This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…
Primary Objective: To investigate the effect of treatment with nebulized rhDNase targeted to the peripheral airways compared to rhDNase targeted to the central airways on FEF75 in children with CF who are on maintenance treatment with rhDNase.…
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
We hypothesize that nebulisation of ipratropiumbromide results in decreased production of sputum resulting in a better lung aeration (defined by an increase in EELV) and improved oxygenation (as defined by the PaO2/FiO2 ratio and the oxygenation…
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies with inhaled mannitol have demonstrated improvements in lung function, mucociliary…
To prove the efficacy and safety of ethanol lock solution in preventing catheter-related infections and subsequently venous thrombosis in children with a malignant disease who will have a tunnelled central venous catheter inserted.