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Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

2.1 Primary objectives2.1.1 Cross-sectional part• Technical evaluation of the functional and structural outcome measures to support a biomarker qualification by regulatory authorities and payers. 2.1.2 Longitudinal part • Assessment of prognostic…

Become Active in Beating osteoarthritiS (BABS): A randomized controlled trial on the effectiveness of a promotional campaign in improving the management of osteoarthritis and quality of care

An information campaign was developed targeting early-stage KHOA patients and healthcare professionals (HCPs) to optimise timing of referral to secondary care.

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…

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…

Effectiveness of Hospital Fit on physical activity of hospitalised patients: a stepped-wedge cluster-randomised clinical trial and process evaluation.

Primary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University…

PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery - PROTHOR: A randomized controlled trial

To compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic surgery under standardized one lung ventilation with low VT (5 mL/kg predicted body weight - PBW) in…

Evaluating the effect of Agaricus bisporus powder intake on the vaccination response to an influenza vaccine

The primary objective of this study is to demonstrate the effect of consuming daily 5 grams of Agaricus bisporus powder (10 capsules) on the vaccination response to an influenza vaccine in men and women aged 60 years or older during the influenza…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

Nutritional intake, nutritional status and physical activity level in people who have undergone a major dysvascular lower limb amputation

The primary objective of this study is to determine the nutritional intake, nutritional status, and physical activity level at various moments post-lower limb amputation (i.e., during hospital admission for amputation, at 5 weeks post-amputation, at…

Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.

The purpose of this clinical study is the assessment of the safety and effectiveness of the Flex II PFO Occluder in the treatment of subjects 18 years of age or older who have had a cryptogenic stroke due to a presumed paradoxical embolism as…

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…

Preoperative Intermittent Fasting versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial

The main objective is to investigate whether preoperative TRF improves perioperative insulin resistance compared to CHL and standard preoperative fasting.Our secondary objective is to investigate the feasibility of preoperative TRF in terms of…

Daily electrical stimulation to prevent recurring pressure ulcers in patients with a spinal cord injury compared to usual care

To investigate whether daily electrical stimulation of gluteal and hamstring muscles combined with usual care is more effective than only usual in individuals with chronic SCI who often have PU*s and/or are at high of recurring PU*s regarding: 1)…

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…

Assessment of cervical SofTening and the Prediction of Preterm birth

The aim of this study is to evaluate the predictive capacity of cervical softening and risk of PTB.

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…

Seasonal assessment of existing immunity for respiratory viruses in healthy volunteers to facilitate targeted vaccine development - a preparatory study

To assess existing background immunity for respiratory virus stems in the general population.

HPV infections and immune status in a cohort of girls who are eligible for national HPV immunization.

zie protocol

The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage

This study has been transitioned to CTIS with ID 2024-517783-37-00 check the CTIS register for the current data. The main objective is to assess the safety and feasibility of the direct omission of aspirin after PPCI with the continuation of…