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 SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.
Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. However, these young patients and their doctors don't know which increase in physical activity can be expected. Objective: To measure the difference in physical activity before and after THA. Study design: Longitudinal prospective single center observational study. Study population: 87 patients who have primary THA under the age of 50 years. Excluding patients with an underlying oncologic disease which results in THA. Intervention: N.a. Main study parameters/endpoints: The first primary endpoint is physical activity in minutes per day. The other primary endpoint is MVPA in minutes per day. Secondary endpoints are difference of TUG outcomes in seconds and the difference of 6MWT outcomes in meters. For the patients experience, the COPM total scores and NRS pain scores will be measured. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study requires three outpatient clinic visits. These visits will coincide with regular outpatient clinic visits, so patients will not have to come in extra for this study. During the preoperative and 1 year postoperative visit, the patients will complete the COPM. The patient will wear a PA monitor for 7 days after each visit. Patients might experience confronting feelings while being exposed to their PA activity profile after the study or experience mild discomfort while wearing the PA monitor since it will be worn 24 hours per day for 7 days. Also, filling in the questionnaires will take some time (5-10 minutes per questionnaire series). There are no significant physical risks associated to this study.
Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. TRAP-2 aims to address these needs by investigating whether addition of trastuzumab and pertuzumab to standard of care improves survival of patients with resectable HER2 positive esophageal adenocarcinoma (HER2+ EAC). Patients with HER2+ EAC will be randomised to neoadjuvant chemoradiation according to the CROSS regimen or CROSS + TRAstuzumab and Pertuzumab. Primary outcome is overall survival.
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation. This study is a national multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (< 2 cm2) in the human knee. The product aims at functional repair of cartilage defects in the knee and regeneration of cartilage. The objective of this clinical investigation is to demonstrate the clinical safety and performance of the Hy2Care Injectable hydrogel. Data from this clinical investigation will be used to support a CE marking application for the Hy2Care Injectable hydrogel. Sites will be selected based on a documented site qualification procedure. The Principal Investigator at each site will be selected based on confirmed expertise in the orthopaedic field. Each site will have a designated Principal Investigator and one or more study coordinators collectively responsible for the study data collection, inclusive of screening, enrolment, evaluation and documentation, in accordance with the International Organization for Standardization (ISO) 14155 guidelines for Good Clinical Practice. Per site, one physician will be assigned as Principal Investigator. Other physicians will be referred to as 'sub-investigators'.
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib.
In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates. 160 patients that will undergo re-resection in the GLOW study will be presented with WGS results leading to added treatment options.
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the neurologist, radiologist and neurosurgeon. This intervention will make curative-intent treatment possible where this could otherwise not be given and is a non-invasive and non-competitive alternative to epilepsy surgery. It is expected that the health costs for this curative treatment will not exceed standard treatment, such as lifelong medication and neuromodulation.
Rationale: Survival rates of patients with critical illness have increased due to improved facilities and treatment methods in the intensive care unit (ICU). However, surviving critical illness does not mean these patients are cured. In general, ICU-admission is associated with decreased physical performance and perceived physical health, impaired mental health and quality of life (QoL), reflecting in an impaired long-term recovery. Long-term health problems can partly be contributed to prolonged muscle weakness and malnutrition. Improving physical performance and perceived physical health may play a key role in boosting recovery after ICU-admission. Mono-interventions focusing on improving physical performance or nutritional intake have limited effect on long term functioning and QoL. A lifestyle intervention encompassing physical therapy and optimisation of caloric and protein intake may improve wellbeing and QoL in these patients. Previous studies found that interventions focused on mobilization and physical rehabilitation are feasible within the ICU and outpatient programs. Additionally, promising results were found in personalized healthcare and lifestyle programs for other patient groups with long-term health problems, such as cancer survivors and patients with diabetes or mental health problems. Based on this, the investigators hypothesized that a lifestyle intervention program may improve wellbeing and quality of life in long-term ICU-survivors. Objective: Evaluation of the effects of a integrative lifestyle intervention program on physical performance and perceived physical health, mental health and health related quality of life after ICU-admission. Study design: Randomised controlled trial Study population: Long-term ICU patients (length of stay ICU ≥48h) Intervention: The intervention group will be part of a 12-week combined lifestyle intervention encompassing group physical therapy twice a week and improvement of dietary caloric and protein intake by means of nutritional advice and, if applicable, caloric and/or protein supplementation. The control group will be subject to follow up meetings with research staff to assess physical and mental health and quality of life. Main study parameters/endpoints: Physical functioning (RAND-36 subscale-score) at the end of the 12 week intervention period. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants have two additional appointments where they participate in an interview and perform physical tests (bioimpedance measurements, ultrasound of the upper thigh muscles, hand grip strength test, Morton mobility index test, and the six-minute walking test with pulse oximetry). At baseline and week 12 of the program, all participants complete a combination of questionnaires on mental health and quality of life. The intervention group will additionally be subject to supervised group training sessions twice a week for the duration of the intervention (12 weeks). Further, two meetings with a professional about their diet will be organised. If a patient has a deficit in caloric and/or protein intake, dietary supplements with daily intake instructions will be provided. The risks and disadvantages of this intervention are minimal. However, this study requires considerable time investment and physical and mental effort. The extent of this study is crucial to clarify the effect of a combined intervention program on recovery after critical illness.