60 results
Objective: This protocol describes a framework that will be used to create different studies. The general primary and secondary objectives of this protocol are stated below:Primary objective: Investigate the effect of surgery on the position and…
The primary objective is to demonstrate efficacy of an extended remote monitoring intervention, including a TM app, HF nurse guided home care and multidisciplinary network collaboration using the Virtual Ward platform, on top of standard HF care…
Primary objective: - To develop an automatic segmentation algorithm using artificial intelligence for real-time intra-operative vessel segmentationSecondary objectives: - Post-operative evaluating the accuracy of…
This intervention study investigates the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise training for 3 months on bone and muscle health, and quality of life in older adults recovering from an acute…
Evaluation of the effect of different treatment thresholds in a clinical pathway for children with acute asthma who are treated with supplemental oxygen
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 (…
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.
The primary objective of this clinical Research is: • The objective of the study is to investigate concept and feasibility of view automation for SHD interventions. The study will explore the contribution of (semi) automatic views based procedural…
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…
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…
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 -…
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…
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…
Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
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…
To compare the clinical and angiographic outcomes of a strategy of native vessel PCI with SVG PCI in patients with prior CABG presenting with SVG failure and a clinical indication for repeat revascularization, as determined by the local Heart Team.
The main objective of this trial is to determine whether reusable catheters are not less efficient as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, urethral damage/…
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…
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)…
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…