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.
The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments. - patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation) - the tumor will get a higher dose - androgen deprivation therapy will be reduced as much al possible preventing side effects Researchers will compare oncological outcome and toxicity.
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: - What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of [89Zr]Zr-DFO-APAC? - What is the biodistribution and internal radiation dosimetry of the tracer dose of [89Zr]Zr-DFO-APAC? - What is the binding and retention time of [89Zr]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the [89Zr]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.
Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints. Eligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents. The potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.
This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
The 32 million Alzheimer's disease (AD) and 69 million prodromal AD patients worldwide contribute to a large economic burden. Effective and safe therapies that slow or prevent the progression from mild cognitive impairment (MCI) to AD are therefore of high priority. Transcranial alternating current stimulation (tACS) is a safe and patient-friendly non-invasive brain stimulation technique that serves as a potential candidate for reducing and/or slowing cognitive impairment. Application of tACS in the gamma frequency range, specifically around 40 Hz, has been studied in patients with AD and MCI due to AD. In these patients, a single session of 40 Hz tACS at the precuneus showed to improve episodic memory and to increase gamma power, as measured with electroencephalography. These findings will be replicated in the current study in patients with MCI due to AD, using magnetoencephalography (MEG) recorded before, during and after tACS. In this way, brain activity and network changes that underlie this improvement in episodic memory can be studied with greater temporal and spatial detail.
The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.
Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinically effective in preventing invasive pneumococcal disease, but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate, but not purified polysaccharide vaccine. However, these differences remain scantly studied. Lymph node fine needle aspiration (FNA) has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines. Insight into the underlying immune mechanisms of vaccines could improve future vaccine design, e.g. by refining dosing intervals. Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination. Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells (BGC) in lymph node aspirates at various time points after vaccination, as measured by spectral flow cytometry. Both total BGC cells and S. pneumoniae polysaccharide-specific BGC frequencies will be determined. Trial design Pilot intervention study without a comparator. Trial population Healthy individuals between the age of 20 - 40 Interventions Subjects will be vaccinated once with Prevenar13. FNA of the draining lymph node will be performed and blood will be drawn at baseline, followed by weekly collection during the first four weeks, every other week between weeks 4 - 8 and a final collection time point after 12 weeks, resulting in a total of 8 sampling time points over the course of three months. Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study.
The goal of this clinical trial is to integrate genomic (WES/WGS) and other -omics technologies in order to find the genetic causes, in 500 patients (children and adults) with an unexplained metabolic phenotype in whom standard care (genetic and metabolic evaluation) did not provide a diagnosis. The overall aim of this study is to diagnose patients with an unknown metabolic phenotype. In addition, we want to provide evidence that the combination of approaches and techniques used in this study will increase diagnostic yield compared to current separated approaches. All participants will undergo a multi-omics(WES, WGS and metabolomics) approach to solve the unsolved genetic basis of their metabolic phenotype.
To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.