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Fecal calprotectin guided referral strategy in children in primary care

Point of care testing with Fcal POCT will reduce substantial the referral rate of children with chronic GI symptoms to the paediatrician.

Blind versus Ultrasound-guided Radius Reduction STudy

This multicentre randomised controlled trial aims to investigate whether PoCUS can be used as an adjunct to improve first attempt success rate in closed reductions of displaced distal radial fractures in adults in the ED.

Strong Teens and Resilient Minds: Depression and suicide prevention in secondary vocational education

One of the primary goals is to establish whether students in the first grade of secondary vocational education receiving the multimodal school-based stepped approach towards preventing suicidal behaviours and depression show a clinically significant…

A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome

This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).

Continuous versus Intermittent Nutrition in Paediatric Intensive Care: a Proof-of-concept

The main research objectives for the proof-of-concept study are to show the feasibility and safety of a daily cycle of feeding and fasting in critically ill children of different age-groups, that will trigger an adequate fasting response while…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome (NEPTUNE)

All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…

The Influence of Probiotics on the incidence of pediatric Antibiotic-associated Diarrhoea * IPAD study

The investigators aim to assess the effectiveness of a specific multispecies probiotic preparation (Winvloce 612) in reducing the incidence of AAD in children.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease

MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…

A Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of two doses of crizanlizumab versus placebo, with or without hydroxyureal/hydroxycarbamide therapy, in adolescent and adult sickle cell disease patients with vaso-occlusive crises (STAND)

This study has been transitioned to CTIS with ID 2023-508689-14-00 check the CTIS register for the current data. To compare the efficacy of 7.5 mg/kg of crizanlizumab versus placebo on the annualized rate of VOC leading to healthcare visit, in…

(Methyl)prednisolone and diazoxide in type 1 diabetes at onset

To examine the effects and safety of methylprednisolone combined with diazoxide on the progression of type 1 diabetes at the onset of disease

Paediatric Hepatic International Tumour Trial

This study has been transitioned to CTIS with ID 2024-516110-38-00 check the CTIS register for the current data. Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment…

A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

Primary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden in patients with PH (types 1 and 2)Key Secondary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden over time in patients with PHSecondary:1. To…

An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy

Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del
Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Primary objective: - To evaluate the efficacy of VX-445/TEZ/IVA in CF subjects who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).Secondary objectives: - To evaluate the safety of VX-445/TEZ/IVA- To…

A double blind, randomised, placebo-controlled trial to evaluate the dose-exposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease.

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…

Improving Adherence by Guiding Inhalation via Electronic Monitoring in children

The primary objective of this study is to improve asthma control in children with asthma by trying to improve therapy adherence and inhalation technique by providing them with qualitative feedback after their inhalation. This can be seen by the…

Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis

The Budesonide oral suspension is a new drug formulation especially developed for the treatment of eosinophile esophagitis in children and adolescents. The purpose of this clinical study is to investigate whether Budesonide oral suspension is…

The effect of Virtual Reality on post-surgical pain and recovery

Primary Objective: To investigate whether VR can reduce post-surgical pain, compared to a control condition.Secondary Objective(s): - To investigate the effect of VR on postoperative quality of recovery, compared to a control condition.- To…

Randomized, controlled growth hormone study in children and adolescents with a Prader-Willi-like phenotype, followed by a two year open-label growth hormone study - effects on body composition, growth, psychosocial development and quality of life

To investigate the effects of GH treatment on body composition, psychosocial development, psychomotor development, growth, glucose metabolism, serum lipids, cognition, behaviour, bone mineral density, quality of life and safety parameters in…