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.
Rationale: Lifestyle changes in diet and exercise can reverse type 2 diabetes (T2D), also referred to as T2D remission. Although combined lifestyle interventions for T2D remission are promising, not all persons react similarly to such 'one-size-fits-all' interventions. Research has shown that as a result of differences in T2D pathophysiology between individuals, different subgroups of T2D can be identified, that differ in which diet is most beneficial in the recovery of pancreatic beta-cell function. TNO and partners work on the development of the Diabetyping Lifestyle Intervention (DLI) for T2D subtypes that tailors the combined lifestyle intervention based on organ dysfunction (liver, muscle and/or pancreatic beta cell function) by using the Oral Glucose Tolerance Test (OGTT). Current diabetyping is invasive, needs to take place in a clinical setting, and therefore is not suited for scaling to application in the large T2D population of more than 1 million people. Therefore, less invasive, scalable alternatives are warranted. Objective: The main objective of the 2DIAREM study is to develop minimally invasive alternatives of diabetyping. Two alternative sampling methods will be evaluated, finger pricks and continuous glucose monitoring (CGM). Data collected through these technologies may be used to predict OGTT indices and diabetypes to guide personalized lifestyle interventions for T2D patients. Furthermore, the investigators aim to develop and evaluate the minimally invasive diabetyping technology with algorithms based on finger prick sampling and multi-day CGM upon a standardized snack or multi-day CGM only under real-world conditions. Study design: The study will be an observational study, lasting 20 days and consisting of three mornings with measurements. Study population: A heterogenous group of people with overweight/(pre)diabetes type 2. The investigators aim for equal distribution among overweight/prediabetes, mild diabetes, and severe diabetes in the study population. Intervention (if applicable): During the 20 days of monitoring participants are asked to undergo one OGTT and consume two times a standardized snack (Snelle Jelle (naturel 65 gram)) after an overnight fast. In between participants are asked to follow their usual lifestyle. Main study parameters/endpoints: Continuously measured subcutaneous glucose, as well as, glucose and insulin, and c-peptide collected via capillary sampling for the development of algorithms predicting the different diabetypes and the underlying indices based on venous blood glucose and insulin. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of this study consists of the application and removal of the continuous glucose monitor device, and the consumption of a sweet beverage (OGTT) and two standardized snacks and undergoing several capillary blood draws. The risks associated with participation can be considered negligible, and are mainly associated with the glucose sensor and the OGTT. The glucose sensor provides a small risk of adverse events including skin irritation, skin infection, and skin colouring. The OGTT poses a small risk of hypo- or hyperglycaemia and can lead to nausea. However, experienced medical professionals are present at the clinic and will closely monitor well-being and health status of the study participants. Benefits include that data collected through the technologies may be used to predict OGTT indices and diabetypes much less invasively and scalable to guide personalized lifestyle interventions for T2D patients.
Study aim: To determine the effectiveness of the RISE intervention on reducing sedentary behaviour after discharge from acute hospital care in community dwelling people with a first-ever stroke, who have a sedentary movement behavioural pattern (so called 'sedentary prolongers' and 'sedentary movers') in comparison to usual care, at the end of the intervention period (T1). Who can participate? People aged over 18, who return home after acute care with a first-ever stroke, who are independent in walking with or without a walking aid, will be included in the RISE intervention study. What does the study involve? In this clinical randomized controlled trial, participants with first-ever stroke and a sedentary movement pattern will be included and randomly assigned to either the experimental group who will receive RISE intervention and usual care or the control group who will receive usual care. Primary and secondary outcome will be measured at baseline, post-treatment and six, nine and 12 months post-randomisation.
Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure. The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.
The goal of this observational study is to learn about the presence of extracutaneous manifestations in patients with congenital ichthyosis. The main question it aims to answer is: - Do patients with congenital ichthyosis experience extracutaneous manifestations? Participants will fill in questionnaires in which the investigators will explore whether patients experience extracutaneous manifestations, and if so what these manifestations entail. Examples of such questions are whether patients experience (joint) pain or whether they experience hindrance due to their complaints.
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB.
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).
The aim of this pilot study is to develop a feasible and quantifiable ultrasonographic method to grade the severity of adenomyosis and to determine the interobserver variation.