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.
Rationale: Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints. A number of non-randomised trials show a favourable outcome of early surgery: in the study of Enriquez-Sarano et al. for instance, the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality, and decreased morbidity compared with the conservative management [1]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population (50% at 10 years follow-up according to Rosenhek et al [2]), it has proven to be eventually associated with good perioperative and postoperative outcome when careful follow-up is being carried out [2]. Objective: To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function. Study design: Multicenter, registry trial. Study population: 250 Asymptomatic patients (18-75 years old) with severe organic MV regurgitation and preserved left ventricular function. The current European Society of Cardiology (ESC) guidelines on Valvular Heart Disease will be applied [3]. These guidelines are also used in the Netherlands. Accordingly, patients with an indication for MV surgery will not be included. Intervention: Intervention will be early MV repair compared to a watchful waiting strategy.
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Rationale: Prolongation of the electrocardiographic PR interval (PR interval > 200ms; also known as first-degree atrioventricular block) is frequently encountered in clinical practice and is generally considered as a benign sign. However, there is increasing evidence that a prolonged PR interval results in poor hemodynamic performance with elevated left ventricular (LV) end-diastolic pressures evidenced by diastolic mitral regurgitation. Previous studies have also associated a prolonged PR interval with a substantially increased risk of future atrial fibrillation (AF) and pacemaker-implantation, and increased risk of heart failure (HF) hospitalization and death. These risks stress the importance of proper atrioventricular (AV) coupling. Shortening of the PR interval may be especially important in heart failure patients and can be obtained by atrioventricular pacing. A possible adverse effect of ventricular pacing is that it results in ventricular dyssynchrony which may lead to worsening cardiac function. This effect may be prevented by applying atrio-biventricular pacing. Data from several previous (sub)studies have suggested this. Objective: The purpose of this study is to investigate the acute hemodynamic effects of restoration of atrioventricular coupling by atrio-biventricular pacing in patients with heart failure and prolonged PR interval. Study design: This study will be a multi-center, exploratory, prospective interventional, nonrandomized acute hemodynamic study, using patients as their own controls. Study population: The study will enroll 26 patients with symptomatic heart failure, reduced left ventricular ejection fraction (LVEF) (< 35%) and prolonged PR interval (>230ms), but without seriously prolonged QRS duration (<150ms) or left bundle branch block (LBBB) QRS pattern, who are candidates for an implantable cardioverter defibrillator (ICD) device according to current guidelines. Main study parameters/endpoints: The main study parameter will be the acute hemodynamic change in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing. Secondary parameters will be the acute hemodynamic changes in left ventricular dP/dt|max and left ventricular stroke volume (SV) by invasive measurements and in left ventricular stroke volume, diastolic mitral regurgitation and left ventricular diastolic filling time by echocardiography during atrioventricular optimization by atrio-biventricular pacing. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients are candidates for an ICD device in whom cardiac resynchronization therapy (CRT) can be considered according to current guidelines. Patients in the present study will receive a CRT-defibrillator (CRT-D). The risk and/or complications of the CRT-D implantation are not additional for this study. After the implantation, acute invasive hemodynamic measurements will be performed with a pressure-volume catheter, which is inserted via the femoral artery and adds approximately 30 minutes to the standard procedure. An extra radiation dose of approximately 50mGy is needed to place the pressure volume catheter in the LV cavity. Local vascular complications of femoral artery puncture like bleeding or damage to the vessel wall may occur but are rare. The non-invasive echocardiographic protocol one to two weeks after implantation will add approximately 45 minutes to the routine outpatient clinic visit. The patients do not have to visit the clinic outside the routine outpatient clinic visits before and after a CRT-D implantation. The patients will have the potential direct benefit from the procedure, by finding the patient's specific optimal (atrioventricular) settings and thereby reducing above described risks of a prolonged PR interval. In case of a worse hemodynamic performance due to the procedure, the CRT-D will be programmed to back up pacing and there is no harm for the patient outside the above subscribed extra measurements.
The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer.
The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.
The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.
A functioning vascular access provides a lifeline for patients requiring haemodialysis but vascular access dysfunction remains one of the leading causes of excessive morbidity, mortality and healthcare costs in this group. Despite increasing numbers of vascular access trials, successful interventions to improve vascular access function have been sparse and compromised by highly variable, often selectively reported outcome measures of limited relevance to patients and health professionals. Through engagement of all relevant stakeholders including patients and caregivers, vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis, has been identified as one of the most critically important outcome measures for trials in haemodialysis. This prospective, multi-centre, multinational validation study aims to assess the accuracy and feasibility of measuring vascular access function part of routine clinical practice and across different clinical settings to ensure successful global implementation of this core outcome measure in future trials in haemodialysis.