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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis. SELECT-GCA

This study has been transitioned to CTIS with ID 2023-505476-29-00 check the CTIS register for the current data. This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week…

Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma

This study has been transitioned to CTIS with ID 2024-516125-31-02 check the CTIS register for the current data. Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended…

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…

Effectiveness and cost-effectiveness of MicroShunt (MS) implantation versus standard trabeculectomy (TE)

The objective of this project is to aid in deciding on the use of the MicroShunt in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open-angle glaucoma (POAG), pigment dispersion syndrome or ocular…

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…

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…

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…

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…

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.

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 effectiveness of EMDR in young children (1,5 to 8 years) with PTSD

It is investigated whether EMDR is effective in reducing post-traumatic stress reactions in young children (1.5 to 8 years), reducing co-morbid emotional and behavioral problems and whether the results will be maintained 3 months after treatment. In…

A stratified approach integrated with eHealth in primary care physiotherapy for patients with neck and/or shoulder complaints: a cluster randomized controlled trial

To assess the (cost-)effectiveness of the Stratified Physiotherapeutic (Blended) Care approach versus usual physiotherapy in primary care patients with neck and/or shoulder complaints.

Microvascular Recovery in Acute MI, a multi center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI).

To compare the relative efficacy of sonothrombolysis in the acute management of STEMI following primary percutaneous coronary intervention [PCI] in patients with persistent ST elevation compared with standard of care.

A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The primary objective of the study is:• To evaluate the clinical efficacy of rozanolixizumab as a treatment for subjects with CIDPThe secondary objectives of the study are:• To evaluate the safety and tolerability of rozanolixizumab sc infusion in…

The effect of polyethylene glycol treatment on gut health in Cystic Fibrosis, a pilot study

Main objective: to assess the effects of PEG treatment on bile acid homeostasis in cystic fibrosis patients. Secondary objective: to assess the effects of PEG treatment on gastrointestinal symptoms and quality of life, and on gut health-related…