There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
A controlled before-after study is performed in order to gain insights into the effectiveness of the CMyLife platform in terms of medication compliance, guideline adherence, quality of life, information provision and patient empowerment. Participants who agreed to use the CMyLife platform for at least 6 months, were enrolled in the treatment group and participants who did not agree to use the platform were enrolled in the control group. After signing informed consent, participants received a baseline questionnaire by mail. Upon completion of the baseline questionnaire, participants used (intervention group) or did not use (control group) the CMyLife platform for at least 6 months, after which they were asked to complete the post-intervention questionnaire.
Rationale: Improving dietary behaviours in view of optimising risk factors of metabolic syndrome requires behaviour change strategies. Tailored dietary advice, i.e. recommendations offered as a guide to action, can support behaviour change. In the current study we aim to learn how to better help consumers in their daily life to make lifestyle choices that better match their personal health target than their usual choices by providing personalised advice and feedback. In this study we target consumers at risk of metabolic syndrome (MetS) that are highly motivated to change their dietary behaviour in view of improving health. Objective: The primary objective is to investigate the potential of personalised dietary advice and feedback for initiating and maintaining dietary changes by consumers at risk of MetS. In addition we want to evaluate understanding, applicability and personal benefit of personalised dietary advice and feedback by the target population to be able to further optimize the personalisation in future studies. The secondary objective is to explore potential effects of personalised dietary advice and feedback on subjective health and metabolic health parameters. Study design: The study follows a one group pre-test post-test design with a duration of 16 weeks after the first advice is provided to the participants. Study population: In total 40 adult men and women at risk of metabolic syndrome will be recruited from the consumer databases of Wageningen Food & Biobased Research. Consumers are eligible for study participation when they are highly motivated to change dietary behaviour, willing to use technology, willing to share food purchase data as registered on a customer card of the supermarket, and in possession of a smart-phone. Intervention: The intervention consists of personalised dietary advice and feedback on actual behaviour and health status that will be provided to study participants at set time points throughout the study period. The content of the advice will be generated partly automated based on dietary intake and parameters of metabolic health using knowledge rules that are developed for this study. During a consultation with the dietician, the advice is then translated in a dietary behaviour change strategy by taking into account individual preferences through motivational interviewing. Main study parameters/endpoints: Primary outcomes of the study are the adequacy of intake of fruits, vegetables, whole grain products, dairy, fish, fats & oils, red meat, processed meat, and sweetened beverages & fruit juices as estimated by the online tool Eetscore. Furthermore consumer experiences and individual benefits of the provided personalised dietary advice are monitored on a weekly basis throughout the intervention period.
Rationale: Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical activation of the ventricles, and may cause pacing-induced cardiomyopathy and heart failure. Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing that can possibly overcome the adverse effects of RVP. Study design and hypotheses: The LEAP trial is a multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study that compares LVSP with conventional RVP. A total of four hundred seventy patients with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage >20% will be randomized 1:1 to LVSP or RVP. The primary endpoint is a composite endpoint of all-cause mortality, hospitalization for heart failure and a more than 10% decrease in left ventricular ejection fraction (LVEF) in absolute terms leading to a LVEF below 50% at one year follow-up. LVSP is anticipated to result in improved outcomes. Secondary objectives are to evaluate whether LVSP is cost-effective and associated with an improved quality of life (QOL) as compared to RVP. Quality of life is expected to improve with LVSP and reduced healthcare resource utilizations are expected to ensure lower costs in the LVSP group during follow-up, despite initial higher costs of the implantation. Study design: Multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study. Study population: Adult patients with a bradycardia-pacing indication because of AV conduction disorders with an expected ventricular pacing percentage of ≥ 20% and a left ventricular ejection fraction (LVEF) >/= 40%. Four hundred seventy patients will be randomized 1:1 to LVSP or RVP. Intervention: LVSP vs RVP. Main study parameters/endpoints: The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up. Secondary endpoints are: - Time to first occurrence of all cause mortality or hospitalization for heart failure. - Time to first occurrence of all cause mortality. - Time to first occurrence of hospitalization for heart failure. - Time to first occurrence of atrial fibrillation (AF) de novo. - The echocardiographic changes in LVEF at one year. - The echocardiographic changes in diastolic (dys-)function at one year. - The occurrence of pacemaker related complications. - Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA). The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year.
The outcome of irresectable oesophaguscancer is poor, despite the fact that curative treatment with definitive chemoradiation is possible. The outcome of treatment can possibly be improved by combining chemoradiation with immunotherapy such as bintrafusp alfa, a combined TGF-β and PD-L1 inhibitor. In this study investigators investigate the feasibility of combining bintrafusp alfa with definitive chemoradiation in patients with irresectable squamous cell carcinoma of the esophagus.
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
To investigate the effectiveness of percutaneous nephrostomy catheter placement versus retrograde double J catheter placement in patients with symptoms of obstructive kidney disease (with either infection and/or pain and/or kidney function deterioration) caused by urolithiasis.
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking. The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation. The secondary hypothesis is that INTELLiVENT-ASV improves the quality of breathing.
Rationale: Diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care. Objective: To determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis. Study design: Observational study - Prospective clinical non-intervention measurement study. Study population: Adult ASA 1-2 patients, scheduled for open upper GI surgery Intervention (if applicable): Not applicable. We will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia. Main study parameters/endpoints: Femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after Trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). A fluid bolus will be performed as part of standard care (goal-directed fluid therapy). The vasopressor and Trendelenburg position time points are optional measurements. We will also measure (continuous) invasive femoral blood pressure (SBP, DBP, MAP), non-invasive blood pressure, SVV, central venous pressure (when available), heart rate, SpO2, PFI, etCO2.