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A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER*S DISEASE

The primary objective of this secondary prevention study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of gantenerumab, an anti-amyloid antibody, in amyloid-positive, cognitively unimpaired participants at risk for or…

CONvalescence of FUnCtional outcomes after ICU Stay by oral protein supplementation
The CONFUCIUS oral protein supplementation trial

The primary objective is to investigate the effect of 6 weeks porcine protein supplementation versus an isocaloric carbohydrate (maltodextrin) on the composite endpoint of physical recovery.

The effect of mealworm protein on muscle damage in active vital elderly

To investigate the impact of the daily consumption of a mealworm- and whey protein supplement on muscle damage upon physical exercise in vital active elderly.

Adaptability training for individuals after stroke

1. To evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke in an RCT. 2. To identify patient characteristics…

Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study

Objective: We want to determine the effectiveness of rTMS in patients with bipolar depression who did not respond to two or more adequately dosed medication trials, using an adequately powered pragmatic RCT. We hypothesize that active rTMS, compared…

Self-management as a first-line treatment prior to GP consultation for men with lower urinary tract symptoms

To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-lineintervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU).

The effect of (chemo- or bio)radiation on functional capacity, fatigue and quality of life in patients with head and neck cancer: a trial within cohorts, the VITAL study.

Primary Objective: - To determine and compare physical performance in patients with HNC with and without an exercise intervention.Secondary Objective(s): - To determine and compare muscle strength in patients with HNC with and without an exercise…

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…

Digital, blended lifestyle intervention program for remission and improved management of type 2 diabetes

Primary Objective: 1. To determine the effectiveness of a personalised, holistic 24-week digital lifestyle programme in achieving diabetes type 2 (T2DM) remission independence from blood glucose-lowering medications, in a Dutch population, in…

IBIS: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-IminoBiotin in acute Ischemic Stroke due to large vessel occlusion

This study will be a prospective, placebo controlled, randomised phase 2 single centre study with the primary objective to evaluate the safety and tolerability of 2-IB when administered to patients with AIS due to LVO, treated with IVT and/or EVT.…

Feeling Safe-Netherlands: recovery-oriented cognitive behaviour therapy to promote wellbeing and feeling safer.

Primary Objective: To test whether the Feeling Safe-NL programme is more effective in improving wellbeing over time than CBTp (from baseline to 18-month follow-up).Secondary objectives: To test whether the Feeling Safe-NL programme is more effective…

A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

To establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve (THV) in subjects with moderate, calcific aortic stenosis (AS)

Diaphragm PARAlysis : Surgery Or mechanicaL ventilation?

The following questions will be addressed in the PARASOL study• Is the proposed study design feasible?,We will set up the study as a randomized pilot study to evaluate if patients are willing and able to participate in a randomized trial, i.e. are…

ProMIO 2.0; a powerful lifestyle intervention for older adults from ethnic minorities

Primary Objective: - To investigate the effectiveness of the ProMIO lifestyle intervention (targeting protein intake and exercise behavior) on physical functioning in older adults from ethnic minorities (Turkish, Moroccan and Surinamese). Secondary…

Pulsed radiofrequency for hand osteoarthritis pain

To assess the efficacy of transcutaneous pulsed radiofrequency therapy (tPRF) as a treatment for pain in hand OA.

Impact of Triglyceride-Lowering on Inflammatory Activity in Patients with Hypertriglyceridemia

To study the impact of AKCEA-APOCIII-LRx on lipid and inflammatory measurements in the fasting and postprandial phase.

Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial

This study has been transitioned to CTIS with ID 2024-517230-17-00 check the CTIS register for the current data. To determine the effect of anakinra on the development of perihematomal oedema, compared to standard medical management. In an…

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease

The primary objective of the trial is:To assess whether a non-surgical, fractional flow reserve (FFR) and optical coherence tomography (OCT)-guided treatment strategy* has a comparable outcome (MACE) with surgical revascularization of significant…

A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)

The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…