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A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine - the REBUILD-2

This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

Using a complex carbohydrate mixture added to a high-protein DIet to STeer fermentation to improve metabolic, gut and brain heALth

Primary Objective: The main goal of this study is to provide evidence that steering saccharolytic/proteolytic fermentation by a specific indigestible fibre mixture supplemented against the background of a high-protein diet optimizes beneficial and…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Primary:- To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.Secondary:- To evaluate the safety of a single IV dose of suvratoxumab.- To evaluate the effect of suvratoxumab on reducing the incidence of…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

The aim of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin in preventing new arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to…

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…

Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and Medication Overuse Headache

This study has been transitioned to CTIS with ID 2024-510729-24-00 check the CTIS register for the current data. Primary Objective• To evaluate the efficacy of eptinezumab as add-on to BI for the prevention of migraine and treatment of MOHSecondary…

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.

The effect of intradialytic supplementation in chronic hemodialysis patients; a pilot study

The primary objective of this pilot study is the feasibility of prolonged intra-dialytic creatine supplementation. The secondary objectives of this pilot study are to study the safety of prolonged intra-dialytic creatine supplementation for dialysis…

Reduction of blood loss in pediatric osteotomies around the hip
- A randomized placebo-controlled trial with tranexamic acid -

This study has been transitioned to CTIS with ID 2024-516324-34-01 check the CTIS register for the current data. To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a…

Effect of protein supplementation on fat free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial.

The main aim of this study is to assess whether protein supplementation could prevent excessive fat free mass loss during the first year after bariatric surgery.

Coadministration of genetically attenuated Plasmodium falciparum *mei2 (GA2) sporozoites with adjuvants - a proof of principle study

This study has been transitioned to CTIS with ID 2024-516488-99-00 check the CTIS register for the current data. Primary objectives: 1. To assess the effect of experimental immunization with GA2 sporozoites by mosquito bite with and without co-…

Evaluating the effect of different daily plant stanol ester intakes on the vaccination response to an influenza vaccine

The primary objective of this study is to demonstrate the effect of consuming different daily amounts of plant stanols (2.0, 3.0, or 4.0 gr stanols; delivered via products enriched with plant stanol esters) on the vaccination response to an…

Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (<= 45%) After Myocardial Infarction (HF-REVERT)

This study has been transitioned to CTIS with ID 2023-507569-24-00 check the CTIS register for the current data. This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess theefficacy and safety of CDR132L in…

A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

This study has been transitioned to CTIS with ID 2023-503794-38-00 check the CTIS register for the current data. - To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic…

Combined effect of Pregabaline and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers
the POLO study

The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.

Effect of pasteurized Akkermansia muciniphila on maintenance of body weight after a low caloric diet

In this project we intends to study the efficacy of pasteurized A. muciniphila for protection against weight regain in individuals with overweight/obesity, and aims to address the following key objectives: 1. To investigate the effects of…

Effects of recreational nitrous oxide use on psychomotor functioning related to driving performance

Primary Objective: To answer the question: How long after the use of a typical recreational dose of nitrous oxide (4 liters, 100%, bolus administration via inhalation) is there a measurable negative impact on psychomotor functioning?Secondary…

A randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel + aspirin) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty

To assess whether and to what extent dual therapy clopidogrel 75 mg/acetylsalicylic acid 80 mg daily is superior to monotherapy clopidogrel 75 mg daily, in reducing the combined endpoint all-cause death and cardiovascular adverse events after one-…