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PreventPAP trial

To compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients receiving a lower extremity amputation with standard neurectomy versus those who received targeted muscle reinnervation.

Defeating Fear with Exposure therapy delivered by mental health nurses in primary care for Anxiety Disorders in older adults - a cluster-randomized controlled trial

The primary objective of this study is to evaluate the (cost-)effectiveness of ET for late-life anxiety disorders delivered by trained MHNs in primary care, in terms of anxiety and quality of life, compared to UC. UC is not restricted, and the GP…

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation VISTA

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of moderate or greater TR.

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

The purpose of the pivotal study is to determine the safety and efficacy of IMPEDE-FX RapidFill for increasing the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label EVAR stent graft…

NEW characterizing rate of progression in USHer syndrome (NEW-USH) study
a natural history study in patients with Usher syndrome

The study will help us to determine 1. the necessary type of (combined) examinations and 2. the sample size that is essential to evaluate (future) genetic therapy in Usher syndrome type 2 and USH2A associated nsRP.

Testing a tailored Home Exercise program to Gain insight into performance fatigability and
Reduce pain and fatigue In Patients with FSHD: THE GRIP on FSHD study

Primary objectives1. To determine the effect of a tailored exercise program by using the widely implemented exercise app *Physitrack* on experienced pain and fatigue in patients with FSHD.2. To investigate the relationship between perceived pain…

Sequential imaging for suspicion of Prostate cancer Reducing Overdiagnosis and Unnecessary biopsy with Timely diagnosis of significant cancer

The primary objectives of this study are to evaluate the safety and effectiveness of a novel diagnostic approach applying PSA-density and MRI-imaging-based monitoring, as opposed to immediate prostate biopsy, in men with an intermediate risk of…

Prospective, non-randomized, multicentre clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)

The objective of this trial is to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. The only notable difference between the existing,…

IMPROVING GASTROINTESTINAL FUNCTION IN HIGH-RISK NEWBORNS BY STIMULATION OF THE ENTERIC NERVOUS SYSTEM

Primary objective: determine whether HAPTOS intervention results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (postmenstrual age) compared to standard care. Secondary objectives: To determine whether…

PeRcutaneous cOronary intervention of native Coronary arTery versus venous bypass graft in patients with prior cORonary artery bypass graft surgery - the PROCTOR trial

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.

Single use vs reusable catheters in intermittent CatheterizatiOn for treatment of urinary retention: a Multicenter, Prospective, RandomizEd controlled, non-inferiority trial (COMPaRE)

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 prospective data collection initiative on on small bowel, colorectal and anal cancer - a prospective observational cohort study.

The main objectives of this project are:- To start a prospective observational cohort study of patients who have been diagnosed with CRC, small bowel and anal cancer and follow them from time of diagnosis until death.- To prospectively collect data…

Study on Prognosis of Acutely Ruptured intracranial Aneurysms

The goal of this study is to investigate which treatment(-s) lead to the best outcome by using existing variation of practice.

Hitting the Mark: Introducing state-of-the-art MRI for precision radiotherapy of glioblastoma

Primary objective:• To demonstrate that the probability for reduced coverage of the recurrence volume by a radiotherapy plan based on a CTVbio, compared to the clinical radiotherapy plan (1.5-cm CTV), is lower than 0.20.Secondary objectives:&…

The DRAIHA study: Data Registry of AutoImmune Hemolytic Anemia, to improve diagnostic testing for the development of personalized treatment protocols in AIHA patients

Primary objective1. The primary aim of the study is to answer the question whether specification of a positive direct antiglobulin test and/or red blood cell autoantibody specification is correlated with the clinical course in patients with AIHA.…

Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

To evaluate cost effectiviness of the SENS-U (continuous ultrasonic bladder monitoring) in urotherapy for children with functional daytime urinary incontinence.

An exploratory, multi-centre, two-part study to describe chronic induced urticaria characteristics and explore novel biomarkers with a multimodal patient profiling approach by comparing CIndU patients to chronic spontaneous urticaria patients and healthy volunteers

The objective of this study is to deep phenotype CIndU (subtype SD and ColdU) and detect novel biomarkers for diagnosis and treatment response as well as establish methodologies for (non-) invasive monitoring of treatment effects in chronic…

Model Informed preciSion doSIng tO iNdividualise and optimize pharmacotherapeutic treatment (MISSION) - Appendix 1: Prospective evaluation of Model informed precision dosing (MIPD) for tacrolimus and mycophenolic acid in paediatric patients with a kidney disease

Overall objective:To improve the existing drug prescribing and treatment monitoring process.Objective appendix 1: To prospectively evaluate the predictive performance of the MIPD strategy for tacrolimus and mycophenolic acid in paediatric patients…

The beneficial value of 18F FDG PET/CT in the follow-up of stage III non-small cell lung cancer patients

Primary Objective The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance. Secondary…

A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS

To compare the objective response rate between patients with metastatic non-small cell lung cancer characterized by PDL-1 TPS<50% and low TMB and either actionable mutation, inactivating STK11, KEAP1 or NFE2L2 mutations, treated by…