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 purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
This study examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.
The goal of this clinical trial is to compare conservative wait-and-see management to elective surgical intervention, in asymptomatic Congenital Pulmonary Airway Malformation (CPAM) children. Children assigned to the intervention group will undergo surgical resection of the CPAM between 6 and 9 months of age. Children assigned to the control group will be monitored conservatively. The follow-up scheme will be uniform for both treatment groups and last for 5 years. The primary outcome is the difference in maximal endurance at five years of age between the surgical and conservative group. Secondary outcome measures are molecular genetic diagnostics, validated questionnaires - on parental anxiety, quality of life and health care consumption -, repeated imaging, and pulmonary morbidity during follow-up, as well as surgical complications and histopathology.
Background of the study: Major depressive disorder is a severe neuropsychiatric condition that affects approximately 15% to 18% of people worldwide during their lifetime (Malhi & Mann, 2018). Selection of the optimal treatment is difficult. A certain correlation (functional / structural, vascular or a mix of both) is expected between clinical data (obtained from psychometric tests such as the HDRS and psychiatric evaluations) and MRI parameters (functional activity, structural connectivity, anatomical variations, perfusion / diffusion etc.). Objective of the study: Identification of MRI-based biomarkers to predict clinical outcome of major depressive disorder in comparison with healthy controls. Outcome is defined by level of depressive and cognitive symptomatology and related comorbidity. Study design: An independent treating physician will inform a potentially eligible patient and ask whether he/she is interested in voluntary participation in the study. If he/she is interested, the independent treating physician will refer the patient to one of the clinicians from the GGz who is also involved in the Neurotrend study for further steps such as providing the information letter / informed consent and scheduling an intake interview at least one week after receiving all necessary information. Healthy controls will be recruited through public advertisement and via the website www.neurotrend.nl. Pilot subjects will be recruited from the Eindhoven University community and via the website www.neurotrend.nl. Both groups, healthy controls and pilot subjects, will have at least one week to consider and decide on participation. One week later an intake session will take place in which the inclusion and exclusion criteria will be checked. During this session, patients can also ask questions about the study and the informed consent will be signed if the participant is willing to participate voluntarily in the study. Subsequently at the end of the intake session, a starting (baseline) date will be planned for this participant . The actual participation starts at baseline. In total, 120 depressed patients and 60 healthy controls will participate in the study. Each participant visits Kempenhaeghe twice, whereby each session, is dedicated to complete questionnaires and cognitive tests, such as memory tasks and eye tracking. In the last hour, the participant will be scanned (MRI). Two weeks before each visit, the participant has to fill in some questionnaires that have been sent to the participant. Study population: 120 patients with major depressive disorder and 60 healthy controls*. * Inclusion of up to 30 healthy "pilot" participants for technical evaluation. See above. Primary study parameters/outcome of the study: - Hamilton Depression Rating Scale (HDRS) scores - Treatment / medication usage - MRI metrics (varies per MRI modality, an example is volume per region for a T1-weighted scan and fractional anisotropy for diffusion-weighted scans). Secondary study parameters/outcome of the study (if applicable): - Scores of psychometric assessments (e.g. STAI-DY1 - anxiety score) - Scores of cognitive assessments (e.g. average response time for the eye-tracking task) Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The participant burden is low and is divided into an intake session and two research sessions. The MRI scan is non-invasive, and subjects can indicate that they want to stop the scan at any time during the scan by squeezing a type of balloon that will lie next to the subject in the case that they feel uncomfortable or for any other reason. Subjects with MRI contraindications (e.g. claustrophobia, pregnancy or implants not suitable for MRI) are already excluded in advance and will therefore not participate in the study at all. Mostly, the subjects will lie still during the scan, except for one affective task in which they will be asked to match different emotional faces for about 5 minutes.The cognitive tests will only consist of memory, reaction speed, attention, and processing speed tasks which in total, do not last more than 30 minutes. The risks of the MRI scanner (CE-marked) are minimal.
The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).
[18F]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in [18F]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).
This is a two-center open-label non-randomized proof of principle study consisting of a dose-finding part (phase I) and phase II study with Simon two-stage design investigating the anti-tumor activity of the combination of capecitabine and galunisertib in patients with colorectal cancer with peritoneal metastases.
This prospective multicenter observational cohort study is designed to study the diagnostic performance of acute-setting angiography-based FFR (e.g. vFFR) for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR and acute-setting NHPR (e.g. RFR) as the reference standards.
This is a multicentre retrospective and prospective cohort study with the goal to develop a well-characterised multimodal image database of eyes with intermediate AMD with and without early atrophy. The main objectives are: 1. Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy. 2. Grading of these images to explore imaging markers of progression. 3. Develop predictive models as a secondary analysis of our dataset. This study will recruit around 1.000 eyes in 6 months. All consenting patients who have had at least 3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria will be included in the study for retrospective data collection. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.
The goal of this pilot study is to evaluate the feasibility of an eHealth intervention for cardiac patients during their waiting period before their rehabilitation. The main questions it aims to answer are: - What is the feasibility of an eHealth intervention designed for cardiac patients with a low socio-economic position during the waiting period before their cardiac rehabilitation. - What is the potential effect of this intervention on patient activation and feelings of certainty and guidance. Participants will: - Be randomised in either intervention or control group - Fill in a questionnaire at the start of their waiting period (after release from the hospital) - Use the eHealth intervention during their waiting period (usually 2 to 6 weeks)(intervention group only) - Fill in a questionnaire at the start of their rehabilitation Researchers will compare intervention and control group to see if the intervention has improved patient activation and feelings of certainty and guidance.