123 results
In this study, we hypothesize that the reference product (SalbR/Ventolin) is more effective than SalbG (Salbutamol Sandoz) atimproving the lungfunction in children with asthma, and that this difference increases alongside the severity of the airway…
Objective: To show the protective value and to measure cost effectiveness of higher Ig dosing on progression of lung disease in PAD.
Primary* The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Secondary* The secondary objective of this study is to evaluate the persistence of…
The purpose of this Phase 3 study is to evaluate the safety and clinical efficacy of ligelizumab 240 mg and 120 mg given subcutaneously (s.c.) every 4 weeks (q4w) to ensure protection against allergic reaction by decreasing the sensitivity to oral…
This study has been transitioned to CTIS with ID 2023-509694-22-00 check the CTIS register for the current data. Primary objective: • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely…
To investigate the effect of a cows-milk-based formula supplemented with synbiotics from t=0 to t=21, t=42 and t=84 days after amoxicillin or amoxicillin/clavulanic acid treatment in toddlers aged 1, 2 and 3 years old on: - change in proportion of…
The aim of the Mint study is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules in reducing abdominal pain intensity in these children. In addition, we investigate the effect of peppermint oil capsules compared…
Primary:To assess the effect of bilateral treatment with AAV5-hRKp.RPGR on functional vision as measured by vision-guided mobility assessment.Secondary:To assess changes after treatment administration in retinal function, functional vision, visual…
This study aims to evaluate the PK profile and IIV of drug exposure in plasma in children (aged 6-17 years) receiving (elexacaftor-)tezacaftor-ivacaftor. Secondary objectives are to evaluate the relationship between covariates and PK parameters that…
The primary objective is to examine whether changes over time in monitoring measures of cognition and behavior are associated with functional outcomes in pediatric oncology groups. Additional objectives are to examine trajectories, risk factors, and…
Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.
This study has been transitioned to CTIS with ID 2023-510160-12-00 check the CTIS register for the current data. To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall…
Primary objective:• Evaluate PK parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over.Secondary objectives:• Evaluate the safety of the oral suspension of temozolomide,• Evaluate the acceptability of the…
The overarching goal is to optimise the treatment of KD in children/adolescents across Europe.KD-CAAP will test the hypothesis that adding immediate adjunctive corticosteroid treatment to IVIGand aspirin will reduce CAA rates in unselected KD…
The main objective is to evaluate the effectiveness of three sessions of EMDR FF (targeting negative FF imagery related to youth*s most feared social situations) in treating social anxiety (lowering anxiety and avoidance related to those feared…
The aim of this PMCF study is to confirm the clinical safety and performance aspects of intracranial catheter placements forthe medical indications, hydrocephalus of any origin or ICP elevation. The study design requires determination of…
Through this research, we want to further investigate the concept of ear molding through the use of the EarWell Infant Corrective System, this time in the Dutch population. We hope to investigate the opinion on the treatment within the Dutch…
To collect long-term, real world data on safety and efficacy of gene therapy with voretigene neparvovec (Luxturna®).
the primary aim of this study is to evaluate the safety (adverse events and complaints) of submandibular duct ligation right after intraductal ethanol infusion into the submandibular salivary gland (Ethanol two-duct ligation [E-2DL] in order to…
Evaluation of the effect of different treatment thresholds in a clinical pathway for children with acute asthma who are treated with supplemental oxygen