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.
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
Rationale: Food intake stimulates muscle protein synthesis rates. The magnitude of the anabolic response to feeding forms a key factor in regulating muscle mass maintenance. Ingestion of animal-derived proteins generally leads to a greater stimulation of muscle protein synthesis when compared to the ingestion of plant-derived proteins. What is often neglected is that the anabolic properties of protein isolates do not necessarily reflect the anabolic response to the ingestion of the whole-foods from which those are derived. This discrepancy is due to the presence or absence of other components normally found within whole-food matrices, which influence protein digestion and amino acid absorption from animal based and plant based protein sources. A rapid and robust post-prandial release of food-derived amino acids is of particular relevance for older individuals, who typically show a blunted muscle protein synthetic response to feeding Objective: To compare the post-prandial muscle protein synthetic response following ingestion of a whole-food meal (560 kilo calorie (kCal); ~36 g protein total, ~0.45 g/kg body weight) containing ~100 g lean ground beef (~30 g protein) versus the ingestion of an isonitrogenous, isocaloric whole-food meal containing only plant-based protein sources (561 kCal; ~36 g protein total) in vivo in healthy, older men and women. Study design: randomized, counter-balanced, cross-over design, researchers and participants are not blinded, analysts are blinded. Study population: 16 healthy older (65-85 y) men and women (1:1 ratio of men:women) Intervention: Participants will undergo 2 test days. On one test day participants will consume a whole-food meal containing meat as the primary source of protein (~36 g, ~0.45 g/kg body weight). On the other day, participants will consume a whole-food meal containing only plant-based foods as the source of protein (~36 g or ~0.45 g/kg body weight). In addition, a continuous intravenous tracer infusion will be applied, and blood an muscle samples will be collected in order to assess the muscle protein synthetic response. Main study parameters/endpoints: The primary endpoint will be mixed muscle protein synthesis rates over the full 6h post-prandial period following meal ingestion.
This is a randomized, cross over, experimental trial in which carotid body function will be evaluated in 35 healthy subjects during partial muscle relaxation and after recovery from muscle relaxation
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Depression is a debilitating psychiatric disorder with a recurrent and progressive course. Around 25% of depressive patients has experienced moderate to severe levels of childhood trauma (CT), resulting in earlier onset and more severe and recurrent depressions. There is currently no targeted treatment for CT-related depression. This is problematic as patients with CT-related depression respond poorly to standard depression treatments. The RESET-psychotherapy study proposes an innovative, targeted disease-modifying treatment strategy for CT-related depression. The main objective is to investigate the effectiveness of trauma-focused therapy (TFT), as an addition to regular depression treatment ('treatment as usual'; TAU), in reducing depression symptom severity in patients with CT-related depression. 158 adult patients will be randomized to receive a 12-week treatment with 1) TAU or 2) TFT in combination with TAU. The primary outcome measure is defined as depression symptom severity after 12 weeks treatment (post-treatment), measured with the Inventory of Depressive Symptomatology - Self Rated (IDS-SR).
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Local hemodynamics might play a key role in the pathogenesis of AAA, as it is associated with aneurysmal growth, intraluminal thrombus formation and rupture risk. Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture. Consequently, this may improve risk assessment and provide patient-specific therapy guidance. Nowadays, endovascular aneurysm repair (EVAR) is the preferred treatment modality in most patients with an infrarenal AAA. However, EVAR is associated with a relatively high reintervention rate. It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli. These unfavourable flow conditions might be related to various complications after EVAR, such as limb occlusion, renal dysfunction, and the persistence of type II endoleaks. Visualizing local blood flow profiles after EVAR might provide insight in these (un)favourable conditions. In vivo blood flow quantification is a great challenge, particularly in the abdomen. Advanced ultrasound based techniques, incorporating ultrasound contrast agents and plane wave imaging, proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers. Objective: The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry (echoPIV) measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair. Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI (PC MRI) based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV. Furthermore, changes in blood flow velocity profiles after placement of a stent graft will be evaluated.
The NESCIO-trial is a multicenter, randomized, open-label, three-arm phase II trial investigating different combinations of neoadjuvant immunotherapy in patients with primary, resectable, intermediate to high-risk, clear-cell renal cell carcinoma. In this trial patients will be randomized 1:1:1 to receive either 2 cycles of nivolumab 360mg every 3 weeks (arm A), 2 cycles of ipilimumab 1 mg/kg + nivolumab 3 mg/kg every 3 weeks (arm B) or 2 cycles of relatlimab 360mg + nivolumab 360mg every 3 weeks (arm C), prior to surgery at week 7. After 42 patients (14 per arm) have been recruited, an interim analysis will be performed to evaluate the observed efficacy and toxicity within each arm and either allow for early discontinuation of the treatment or continuing recruitment for the second stage. As the primary endpoint, the pathological response (decrease in tumor) will be evaluated. If at most one pathologic response in the primary tumor is observed, the treatment arm will be closed for insufficient activity on the primary tumor. If at least 2 pathologic responses are observed, 9 additional patients will be included to a total of 23 patients per cohort. A maximum of 69 patients will be recruited for this study. Follow up will start at week 12 with a CT-scan according to the national/center's standard. Patients will be evaluated every 3 months by physical examination and lab testing for up to two years, thereafter according to institutional guidelines up to 5 years following surgery.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI. Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life. The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation. Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education. Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)