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Coaching On Lifestyle

Hypotheses are that the long-term supervision of the CooL intervention will be related to beneficial changes in the participants¡¯ energy-balance related behaviours, body composition, and quality of life. Besides, the goal of the intervention is to…

The effect of head cooling on cognitive functioning in kickboxing; a pilot study.

The goal of the present study is to investigate the effect of head cooling after kickboxing matches on cognitive functioning amongst both amateur and professional kickboxers. Based on the above mentioned studies, it is hypothesized that head cooling…

Safety and tolerability of controlled Human Urine Transfusion for Urinary tract infection Prevention (SHUTUP): a pilot study

To investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI*s.

Prevention of Suicide Mortality in Noord-Brabant: The Effect of Implementation of a Regional Suicide Prevention system. A staggered implementation stepped wedge trial design.

The aim of this study is to lower suicide rates in Noord-Brabant with 20% by establishing a chain of care and a suicide prevention system in this regional network of chain partners. To this end, two sub-objectives are: (1) to evaluate the effect of…

Carotid Artery ImPlant for Trapping UpstReam Emboli
(CAPTURE) for Preventing Stroke in Atrial Fibrillation
Patients

To assess the safety, feasibility, and tolerability of the Vine* Embolic Protection System and implantation procedure in atrial fibrillation (AF) patients at high stroke risk who are unsuitable for oral anti-coagulants (OAC).

Clinical Evaluation of the Safety of a Local Osteo-Enhancement Procedure (LOEP) Intended to Increase Bone Strength in the Proximal Femur of Women in Europe with Osteoporosis.

To conform the procedural safety of the OSSURE LOEP Kit in the specific clinical setting of use in the femoral neck in patients with osteoporosis. Secondary objective: To evaluate the post-market clinical performance of the OSSURE LOEP Kit.

A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of
TEV-48125 for the Prevention of Cluster Headache

As of 15 June 2018, only patients from the ECH study (Study TV48125 CNS 30056) will enroll in this study for active treatment. As of 15 June 2018, all CCH patients included in this study have been asked to discontinue treatment, and are encouraged…

A randomised, double-blind, controlled, parallel-group, multi-country study to investigate the effect of a partially hydrolysed infant formula with added synbiotics on gut microbiota composition and clinical effectiveness in infants at high risk of developing allergy.

The aim of the present study is therefore to investigate the bifidogenic effect of a hypoallergenic formula (based on partially hydrolysed whey protein) supplemented with a specific combination of prebiotics and probiotics (synbiotics) compared to…

Renoprotective effects of potassium supplementation in chronic kidney disease

To study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4 or estimated glomerular filtration rate [eGFR] 15 - 44 ml/min/1.73 m2).

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…

Explaining the underlying factors of moderate to severe fatigue in patients with chronic obstructive pulmonary disease (COPD)

To identify physical, systemic, psychological, and behavioural factors that precipitate and/or perpetuate fatigue in patients with clinically stable COPD and to identify the impact of exacerbation-related hospitalizations on fatigue and its…

Double blind, randomized, 2-way cross-over, placebo controlled study to evaluate the therapeutic and preventive effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model in healthy male subjects

PrimaryTo assess the preventative effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model using HPTol upon multiple dosing of GLPG1205 versus placebo.SecondaryTo further assess the preventative effect…

Investigating cardiovascular adverse events related to cancer treatment: a study of extreme toxicity using induced pluripotent stem cells

To identify the pathophysiology and predictors of study (extreme) cancer treatment -induced cardiovascular toxicity in cancer patients, by in vitro investigation of cardiovascular toxicity in patient-derived cardiomyocytes (iPSC-CMs) and endothelial…

Pilot Randomized-controlled phase-IIa trial on the prevention of comorbid Depression and Obesity in Attention-deficit / Hyperactivity disorder

Primary objective: To assess the prevention of depressive symptoms by 10-weeks BLT and 10-weeks AEI vs. TAU, and to establish feasibility and effect sizes of these two kinds of interventions in combination with a m-Health app based reinforcement in…

Is preventing hypothermia in patients undergoing a primairy Total Knee Prosthesis or Total Hip prosthesis with the Barrier Easywarm as effective as with Forced-Air Warming.

If there is comparable Efficacy in preventing hypothermia we can start using the barrier easywarm instead of the BairHugger. With the Bair hugger there is a disruption in airflow in the operatieon theatre which might bring a higher risk of infection…

Increased training load in athletes

The main objective of this study is to test whether the adapted training protocol induces underperformance (>2% increase in time) in trained cyclists and triathletes.

Body composition in renal cell cancer: associations with survival outcomes, tumour characteristics, lifestyle habits, and circulating biomarkers

The primary objective is to get a comprehensive insight in the role of body composition features in RCC, and how these are related to patient-, tumour- and lifestyle-related factors, circulating biomarkers, and recurrence and survival.The research…

Lactobacillus casei Shirota for influencing the microbiome of patients with Barrett's esophagus.

Primary objectivesTo study if LcS can colonize the esophagus of BE patients.To study the effect of LcS colonization on the Gr+ (except for LcS)/ Gr- bacterial ratio of the esophagus.Secondary objectivesTo quantify the number of specific pathogenic…

Safety and protective efficacy of genetically modified Plasmodium berghei (Pb(PfCS@UIS4)) malaria parasites in healthy volunteers

Phase 1Primary objective:To determine the safety and tolerability of administration of Pb(PfCS@UIS4) to healthy volunteers delivered by infectious mosquito bites.Secondary objective:Immunogenicity of Pb(PfCS@UIS4) as assessed by ELISA and IFA.…

Cast-OFF trial: One versus four-five weeks cast immobilization for non reduced distal radius fractures. A randomized clinical trial. A feasibility study.

The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. This feasibility study will be used to…