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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.

Tackling defective epigenetic assembly in psychopathology:
Towards personalized intervention in Kleefstra syndrome

We aim to prevent or reverse developmental regression in patients with Kleefstra syndrome. We hypothesise that the regression we observed is the result of a psychotic disorder, which isnot properly recognised by clinicians and often not treated…

*Trauma-informed approach for unaccompanied refugee minors: a multiple baseline case series*

The primary objective of this study is to measure the effectiveness of the TFT for URMs living in the Netherlands. The research question is as follows: is this TFT effective in decreasing symptoms of posttraumatic stress and depression in URMs…

Core elements of Cognitive Behavioural Therapy in treatment of depression in youth: does the type and sequence of elements matter

Primary Objective: The primary objective is to establish the differential and sequential effectiveness of cognitive restructuring (CR) and behavioral activation (BA) (and the optimal sequence of these elements) on depressive symptoms (PHQ-2 at post…

Corrective osteotomy with virtual planning of malunited forearm fractures with and without the use of patient specific guides: a randomized controlled trial

With this study we try to answer the following question:What is the clinical outcome after a corrective osteotomy of a forearm malunion when we virtually plan the correction preoperatively and whether or not use patient-specific guides…

A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy

This study is being conducted to collect additional data to describe the safety and tolerability of multiple cycles of IV administration of fosaprepitant daily for 3 consecutive days, concomitantly with a 5-HT3 antagonist, with or without…

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…

Effects of nicotinamide riboside (vitamin B3) in patients with Ataxia Telangiectasia

The purpose of this research is to investigate whether treatment with nicotinamide riboside (vitamine B3) has a positive effect on the disease course of patients with ataxia telangiectasia.

Optimizing timing of glucocorticoid treatment in children with congenital adrenal hyperplasia

To study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.

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…

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (study 208467)

This study has been transitioned to CTIS with ID 2024-513032-14-00 check the CTIS register for the current data. Primary:To evaluate the efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02…

A phase 3b, prospective, open-label, uncontrolled, multicenter study on long-term safety and efficacy of rVWF in pediatric and adult subjects with severe von Willebrand disease (VWD)

To evaluate the efficacy of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in adult and pediatric / adolescent subjects (aged 12 to <18 years) during the…

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.…

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Main objective:To explore the impact of setmelanotide on obesity in patients with various specific rare genetic mutations.Secondary objective:To assess the effects of setmelanotide on:* Safety and tolerability-Hunger* Waist circumferenceOptional sub…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on PFS and ORR in subjects with RAI-refractory DTC who have progressed after prior VEGFR-targeted therapy.

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 1/2 trial on the safety, tolerability, pharmacokinetics,
pharmacodynamics and exploratory efficacy of DYN101 in patients >= 16
years of age with centronuclear myopathies caused by mutations in DNM2
or MTM1

Primary Objective• To assess the safety and tolerability of 3 single ascending dose (SAD) levels and 3 MAD levels of DYN101.Secondary Objectives• To assess the PK of SAD and MAD of DYN101.• To explore target engagement in muscle of DYN101.…

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…

A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)

The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…