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DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients

The DAPARHT trial is designed to assess effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) weight, ii) glucose…

Synbiotics and Conditioned Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis.

Primary objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules to reduce NASH in patients with fibrotic NASH…

TOLERANCE: a 3 arm randomized study on healTh-related quality Of Life of EldeRly pAtients with advaNced soft tissue sarComa undergoing doxorubicin every three weeks or doxorubicin weekly or cyclophosphamide plus predniso(lo)ne treatment

Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…

A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and
bleeding in patients with cancer associated VTE (ASTER)

This study has been transitioned to CTIS with ID 2023-509569-19-00 check the CTIS register for the current data. The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6…

A phase 2, 12-week, randomized, double-blind, placebo-controlled study of DS-1211b in individuals with pseudoxanthoma elasticum

Primary:To assess the safety and tolerability of DS-1211b compared with placebo in subjects with PXE.To assess the dose response by assessing the treatment changes in PD endpoints.

A phase 1, first-in-human, 2-part, randomized, double-blind, placebo
controlled, single ascending dose and sequential, open-label, multiple
ascending dose study to evaluate the safety, tolerability,
pharmacodynamics, and pharmacokinetics of VIS171 in healthy
participants and participants with autoimmune disease(s)

The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…

A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

Primary Objective:Double-blind period : Evaluate the effect of SRP-4045 and SRP-4053 (combined-active group) compared to placebo on ambulation, endurance, and muscle function, as measured by the 6MWTSecondary Objectives:- Double-blind period:…

Evaluation of adhesions formation using conventional third generation endometrial ablation with and without postoperative application of an intrauterine adhesion barrier film

Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier

A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC.This study aims to explore whether blockade of Transforming…

Double-blind, placebo-controlled phase 1 trial of nizaracianine administered in three divided doses to healthy volunteers

Primary• To assess the safety and tolerability in healthy volunteers of nizaracianine administered IV in three divided dosesSecondary• To perform pharmacokinetic analyses of blood and urine• To determine if bolus injection of nizaracianine enables…

Surgery and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomised controlled trial.

Zie het onderzoeksprotocol 2: "Objectives".

Efficacy of the Myosuit for increasing daily life gait performance in the home and community setting and gait capacity in people with incomplete spinal cord injury

Part A:The primary objective is to test the efficacy of the Myosuit, a soft exosuit, for increasing daily life gait performance in the home and community setting in people with iSCI. Secondary, the efficacy of the Myosuit program on gait capacity…

Effect of cyclic versus continuous enteral nutrition on circadian rhythms in critical illness: the CIRCLES study

The primary objective is to evaluate whether cyclic daytime enteral feeding can decrease the disruption of circadian rhythms in critically ill patients compared to continuous enteral feeding. Secondary objectives are to evaluate the effect of cyclic…

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Determine the Pharmacodynamics and Pharmacokinetics of OPC-214870 Following Repeated Oral Administration to Healthy Subjects

- To assess the CNS functional effects of OPC-214870 following dosing using Neurocart test battery

What is the optimal antithrombotic strategy in patients with atrial fibrillation having acute coronary syndrome or undergoing percutaneous coronary intervention?

This study has been transitioned to CTIS with ID 2022-502140-13-00 check the CTIS register for the current data. 1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients…

ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)

This study has been transitioned to CTIS with ID 2024-516770-29-00 check the CTIS register for the current data. The objective of this study is to evaluate the clinical efficacy, biological effects and safety of anifrolumab treatment in pSS.

A double-blind, randomised, placebo-controlled study to evaluate the pharmacokinetics, safety and pharmacodynamics of ascending single and fixed repeat intravenous doses of DMT in healthy subjects

This study has been transitioned to CTIS with ID 2024-518020-68-00 check the CTIS register for the current data. Primary:Part A: To assess the safety and tolerability of single ascending doses of DMT in healthy subjects, when given by IV infusion.…

The effect of Virtual Reality on pain in patients undergoing lumbar puncture. A randomized controlled trial

The aim of this study is to determine whether VR used during lumbar puncture will significantly reduce pain and anxiety perception.

A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, Parallel-Group Study to Evaluate the Effect of LMTM on the Response to an Oral Tyramine Challenge and to Determine the Multiple-Dose Pharmacokinetics of LMTM.

Part 1:The purpose of this study is to determine whether LMTM inhibits monoamine oxidase (MAO). MAO is an enzyme (protein involved in reactions in the body) which breaks down tyramine. By giving participants tyramine which raises the blood pressure…

The effectiveness of the Wim Hof Method on the physical and mental health of people with a spinal cord injury

The primary objective of this trial is to assess the effects of WHM, involving breathing exercises, mindset (and cold exposure), on health-related quality of life in people with SCI. The secondary objectives are to assess the effects of WHM,…