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A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

Primary Objective: • To compare efficacy of once-weekly KRd (56 mg/m2 ) to twice-weekly KRd (27 mg/m2) in subjects with RRMM with 1 to 3 prior lines of therapyKey Secondary Objectives: • To compare progression-free survival (PFS) between treatment…

MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women with Polycystic Ovary Syndrome: a multicentre double-blind randomised controlled trial

The primary objective of this study is to assess the effectiveness of myo-inositol supplementation to prevent pregnancy complications in women with PCOS. Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and…

Medium and long term outcomes after modern radiotherapy for IDH mutated glioma

Objectives: • To report treatment outcomes and radiation-induced toxicity from a prospective, multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy,• To intergrate radiotherapeutic dose distributions, imaging…

The reliability of the 13C-phenylalanine breath test for phenylketonuria patients: a pilot study

To establish the test-retest reliability of the 13C-PBT for measuring Phe hydroxylation in patients with PKU.

Reduction of listening effort with speech enhancement strategies in cochlear implant users

There are 2 main limbs to this study:1. Create a benchmark, in which we will assess the three most commonly used Dutch speech-in-noise tests, namely the LIST, Matrix, DIN and Plomp for their associated LE in noise. This is necessary as pupillometry…

A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren*s Syndrome (TWINSS)

The purpose of this trial is to- determine the dose-response of iscalimab in a population of patients with moderate-to-severe Sjögren*s Syndrome (SjS), defined by ESSDAI >=5and ESSPRI >=5 (Cohort 1)- evaluate the preliminary efficacy…

Coagulation monitoring to prevent hemostatic complications in kids on extracorporeal membrane oxygenation

The primary objectives of this study are:1. to investigate the association between both conventional and alternative coagulation tests, and hemostatic complications, including bleeding and clotting complications in pediatric ECMO patients2. to…

Synaptic density and tau pathology in Alzheimer's disease

This study has been transitioned to CTIS with ID 2024-517636-22-00 check the CTIS register for the current data. The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([18F]SynVesT-1 PET),…

Safer & More Efficient Closure of Trocar Wounds; Manual vs. Automated, a Pilot Trial

Primary objectivesTime needed for proper closure of the trocar wounds with the automated deviceSecondary objectivesDemonstrate user-friendliness of the Mediclose System

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…

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…

The hypoxic challenge test in preterm infants with or without bronchopulmonary dysplasia: a test for pulmonary and pulmonary vascular function?

The primary objective is to assess the hypoxic challenge test, combined with echocardiography, as a function test for the pulmonary and pulmonary vascular system in preterm born children with and without bronchopulmonary dysplasia. Secondary…

Validation of the Wet Bulb Globe Temperature criteria (ISO 7243) and Predicted Heat Strain (ISO 7933) for older adults

The aim of the current study is to investigate if the reference values of the WBGT in ISO 7243 should be adjusted for older adults. Also, the calculated PHS will be compared with the measured core temperature, sweat rate and exposure time.

Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy

This study has been transitioned to CTIS with ID 2024-511252-41-00 check the CTIS register for the current data. The aim of the current study is to extend the time to develop new disease progression in prostate cancer patients with recurrent disease…

Psychopathology and cognition in CNV disorders

The objective of this study is to describe cognitive profile and dimensions of psychopathology in subjects with CNV disorders.

A randomized, open-label, parallel group, two arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.

The purpose of this study is to ascertain the efficacy, safety, tolerability and pharmacokineticsof LNP023 over a 24-week treatment period compared with rituximab in subjects with MN.

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenia

This study has been transitioned to CTIS with ID 2023-509397-39-00 check the CTIS register for the current data. Part A: Safety:• To characterize the safety and tolerability of up to four dose levels of rilzabrutinibin patients with ITPEfficacy:• To…

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

This study has been transitioned to CTIS with ID 2024-515914-41-00 check the CTIS register for the current data. The primary objective of this study is to assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter
Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-
Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

Main objective:To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.Secondary objectives:• To assess the efficacy of…

The relation between memory and exam performance - modulation with Methylphenidate

The present study aims to examine whether memory improvement, caused by Ritalin (MPH) intake, has a positive effect on exam performance.