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.
Safety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS). Indication: Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%). Hypotheses: The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.
The leading cause of disease burden across the globe is cardiovascular disease (CVD). Important modifiable behavioral CVD risk factors include, amongst others, smoking and low physical activity (PA). Individuals with a low socioeconomic position (SEP) often have a less favorable profile of risk factors, resulting in a higher disease burden and premature death. There is a need for cost-effective multi-behavior interventions that target one or more risk factors. eHealth applications are increasingly being used to offer behavior change interventions. Potential benefits include accessibility, scalability, cost-effectiveness, and increased disease self-management. However, eHealth interventions are often static and thereby less effective, and also frequently developed without (sufficiently) engaging end-users. Involving end-users, including those from lower SEP groups, and other relevant stakeholders can help to optimize the adoption and adherence to the eHealth intervention and result in the maintenance of healthy behavior. The Perfect Fit intervention is the result of interdisciplinary collaboration, and the personalized eHealth intervention supports adult smokers to stop smoking and increase their PA using a virtual coach. We primarily aim to examine the feasibility, acceptability and preliminary effectiveness of the Perfect Fit intervention. A mixed-method single-arm pre-post intervention study will be used. The intervention, delivered through a virtual coach, has a personalized duration and intensity, but will last on average 16 weeks.
The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
INTRODUCTION A variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. The idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. However, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. As these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius OBJECTIVE The objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures. STUDY DESIGN This is a prospective, randomized, controlled multicenter study. Patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/CT scans will be made. STUDY POPULATION All patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction. INTERVENTION Surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting. USUAL CARE Open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest. OUTCOME MEASURES Primary outcomes: complications and quality of life. Secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.
Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).
Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area.Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.
The goal of this clinical trial is to assess the effect of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic tromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH). The main question[s] it aims to answer are: - What is the effect of BPA on quality of life, measured with the PEmb-QoL-questionnaire, in patients with CTEPD without PH? - What is the effect of is the effect of BPA on exercise capacity in patients with CTEPD without PH? This study is a randomised clinical trial with cross-over design. Participants will be randomised in an intervention and a control group. At baseline, questionnaires and exercise tests will be perfomed in all patients. The intervention group will first receive BPA-treatment. After 6 months, all patients will fill in the questionaires and undergo the exercise tests. At this point the control group will also receive BPA-treatment. After 12 months the study outcomes will be measured in all participants with the same questionnaires and exercise tests. The total follow-up is 24 months.
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
This randomized control trial aims to evaluate the effect of transcutaneous auricular vagal nerve stimulation in patients with irritable bowel syndrome. The intervention will be 8 weeks of treatment with a vagal nerve stimulator. The main objectives are: - To evaluate the clinical response, defined as a decrease of at least 50 points on the IBS-SSS questionnaire, of the treatment. - To ascertain whether the autonomic-vagal neurosignature, derived from pre-treatment registration of symptom profiles, autonomic responses and imaging of neuronal activity as a reaction to stress is able to predict therapeutic response to tVNS accurately. - To evaluate the effect of treatment on quality of life - To evaluate the effect of treatment on depression - To evaluate the effect of treatment on anxiety Participants will be asked to wear a wearable (Fitbit) and fill out a daily questionnaire for one week. Thereafter, a functional brain MRI will be performed. In the intervention group patients will receive transcutaneous nerve stimulation for 8-weeks at home. The comparison group will receive the same device but with a non-conducting electrode. Patients fill out weekly questionnaires during the treatment period and at follow-up moments 3 and 6 months after finishing the treatment period.