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MUSCLE study - Mitochondrial dysfUnction: a key player in chemotherapy-induced Skeletal and Cardiac muscLE damage?

To demonstrate the ability of using non-invasive 31P-MRS to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles (i.e., skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio)…

Neural plasticity and recovery after early and intensive upper extremity motor training in people with cervical spinal cord injury.

This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT)…

High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease. (HicaP)

To assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.

Multi-parametric MRI in patients suspected for muscle invasive bladder cancer: a new local staging paradigm

The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or…

Real-time use of artificial intelligence (CAD EYE) in the colorectal cancer surveillance of Lynch syndrome patients - an international multicenter trial

Primary Objective:- To compare adenoma detection rate (ADR) with versus without real-time automated detection (CAD EYE, Fujifilm)Secondary Objectives:- To compare the size, morphology and histology of adenomas detected and resected in both arms of…

Calcium Reduction by Orbital Atherectomy in Western Europe: the CROWN study

To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…

SIMBA study: Imaging study of Cognitive Outcomes after Treatment for Pediatric Brain Tumor

The primary objective is to examine relationships between neurocognitive performance and MRI parameters of brain vasculature, metabolism, and white matter diffusion in children who have been treated for posterior fossa tumor. Secondary objectives…

Non-invasive fetal electrocardiography and speckle tracking echocardiography in the second trimester, 16 until 28 weeks gestational age: a prospective cohort study.

The primary objective of this study is to generate reference values for NFMS parameters as well as for 2D-STE parameters during the second trimester, 16 until 28 weeks gestational age. The secondary objective is to investigate the diagnostic…

Autonomous Blood Drawing Optimization and Performance Testing

This study has several objectives, in different (subsequent) study phases:• A1. Optimize and validate the technology of the VD to reach non-inferiority• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking• B2. Demonstrate…

Randomized controlled clinical trial on the application of Heli-FX EndoAnchors in conjunction with the Endurant II/IIs endograft in infrarenal aortic aneurysms with a wide infrarenal neck

The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions foruse (IFU) conditions in aneurysms with a wide neck is superior to treatment with…

A prospective, multi-centre, repeated measures, traditional feasibility study investigating neural health correlates with outcomes and evaluating focused multipolar implementation in the Phoenix Research System for newly implanted adult cochlear implant recipients.

This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…

Comparison Of reduced DAPT followed by P2Y12 inhibitor Monotherapy with Prasugrel vs stAndard Regimen in STEMI patients treated with OCT-guided vs aNgio-guided completE revascularization.

This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…

Transcatheter Aortic Valve Replacement
With the Medtronic Transcatheter Aortic Valve Replacement System
In Patients at Low Risk for Surgical Aortic Valve Replacement

Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…

Aerobic fitness or Muscle mass training to Improve Colorectal cancer Outcomes (AMICO): to study safe and feasible exercise dosages (phase 2) and the effects of exercise on chemotherapy dose modifications and progression free survival (phase 3) in patients with metastatic colorectal cancer.

Phase 2 pilot-study: to examine feasible exercise dosages in patients with mCRC and collect data on preliminary effects on clinical outcomes.Phase 3 trial: to collect data on the efficacy of exercise on 1) chemotherapy dose modifications and 2)…

Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and
Reduced Left Ventricular Function: The PROTECT IV Trial

The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…

MARS study- Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to limit the Rate of Incisional Hernia ( IH) Occurrence

The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…

Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System

This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.

Joint distraction in the treatment of haemophilic ankle arthropathy: clinical and structural efficacy, a pilot study

This study is designed to gather prospective data on a) the clinical effectiveness, b) the tissue structure changes, and c) the short term costs of ankle joint distraction (AJD) in 10 patients with HAA during 10 years follow-up.

Exploring Metabolic Maturation in the Extremely Preterm Brain at Term Equivalent Age: EMMA study.

We will combine four 7 Tesla MRI markers in extremely preterm infants (MRSI; SWI; PC-MRI; ihMT) to assess (1) if they can predict outcome until 2 years of age; (2) if they are of added value to 3 Tesla prematurity (Kidokoro et al., 2013) and (3) if…

Evaluation of different treatment thresholds in a clinical pathway for children with acute asthma

Evaluation of the effect of different treatment thresholds in a clinical pathway for children with acute asthma who are treated with supplemental oxygen