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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…

A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of BIIB132 Administered Intrathecally to Adults With Spinocerebellar Ataxia 3

To evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via IT injection to participants with SCA3.

Pregnancy and the human brain: a window of neuroplasticity

Beyond mapping the pregnancy-related neural plasticity in structure and function, this project is designed to reveal functional and behavioral implications of the transformations impacting a woman*s brain across this major transitional stage. The…

FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

The primary study objective is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed…

A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)

This study has been transitioned to CTIS with ID 2024-510947-71-00 check the CTIS register for the current data. Primary:To assess the tolerability of asciminib versus nilotinib with respect to the time to discontinuation of study treatment due to…

Changes in gut- and vaginal microbiome composition in association with PCOS clinical phenotypes

The main objectives of this study is to analyze differences in the gut and vaginal microbiome between healthy and PCOS women and investigate whether these differences correlate with PCOS characteristics. In addition, we want to look at a possible…

The Franciscus Obesity NASH Study

To evaluate NAFLD/NASH changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery.To establish the correlation between histology (liver biopsy) and transient elastography measurement in a…

Efficacy of Adductor Channel Block for anterior cruciate ligament surgery: A prospective double blinded randomized controlled trial

The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor channel block to the standard pain regiment after anterior cruciate ligament surgery.

Examination of (handgrip) exercise to triggers coronary vasoconstriction in patients who are referred for a coronary function test

Main research question: Does (handgrip) exercise provoke vasoconstrictive responses of the coronary arteries in patients with suspected ANOCA with clinically indicated coronary function test including acetylcholine provocation test?Secondary…

Individualisation of management with novel upfront therapy enzalutamide in newly diagnosed metastasized prostate cancer using (PSMA)PET/CT imaging

To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.

A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)

This study has been transitioned to CTIS with ID 2024-512244-36-00 check the CTIS register for the current data. The objectives of this are to establish the safety, tolerability, and efficacy of VRDN-001, and the pharmacokinetic (PK) and…

A Phase 1 Study to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C-ASTX029 in Healthy Volunteers

Primary objectives:To identify and quantify the excretion pathways of oral ASTX029, including the mass balance and the excretions in urine and feces (Period 1).To determine the absolute oral bioavailability (F) of ASTX029 under fasting conditions (…

A Study to Evaluate the Safety, Tolerability, and Effects on NSAID-Induced Small Bowel Pathology of K-196 in Healthy Volunteers.

Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…

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…

Decoding personalized nutritional, microbiome and host patterns impacting clinical and prognostic features in Crohn*s disease

By means of this study we want to find out whether there are certain characteristics that can influence or predict the course of Crohn's disease. We want to do this by collecting data on diet, inflammation levels in the blood, complaints and…

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 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PRAX-628 in Healthy Participants.

Part A (Single Ascending Dose):Primary: To assess the safety and tolerability of single oral doses of PRAX-628 Secondary: To evaluate the pharmacokinetics (PK) of single oral doses of PRAX-628 Part B (Multiple Ascending Dose):Primary: To assess the…

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.

Biomarker identification of radionuclide therapy-induced radiation responses.

This is a pilot study to validate the possibility of determining the effect of PRRT with 177Lu-DOTATATE on transcriptional regulation and DNA damage induction in PBMCs and how this is related to the radiation dose.We will also want to explore if we…

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…