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.
Even though internet-based interventions have been used in treatment of forensic psychiatric outpatients for over ten years, no robust research into their effectiveness has taken place. Multiple potential benefits and barriers have been observed in clinical practice, such as the possibility to increase a patient's treatment readiness, self-efficacy and thus reduce undesired behaviour such as reactive aggression. However, therapists indicate that these interventions do not seem to work for all forensic psychiatric patients, and that uptake is generally quite low. There is an urgent need to evaluate if and how these internet-based interventions are of added value for treatment of forensic psychiatric outpatients. The main goal of this study is to investigate whether the addition of the existing internet-based intervention 'Aggression' to treatment as usual of forensic psychiatric outpatients leads to better treatment outcomes than treatment as usual that is delivered solely in-person. This study uses a multicentre mixed methods randomized controlled trial (RCT) design, with four participating Dutch forensic psychiatric outpatient care organizations. Patients are included if they receive outpatient treatment for aggression regulation problems and will be randomized into an experimental condition, in which the internet-based intervention is added to treatment as usual (TAU), or a control condition, with only TAU. Participants are assessed four times: at baseline (T0), halfway during the 10-week intervention (T1), after completing the intervention (T2), and after three months (T3). Primary outcome measures are regulatory emotional self-efficacy, treatment readiness, and aggression, assessed via validated self-report questionnaires. Secondary outcome measures are the number of in-person treatment sessions during the data collection, and dynamic risk factors. Adherence to and engagement will be studied as potential predictors for effectiveness via respectively log data and a self-report questionnaire. Perceived benefits, barriers and points of improvement will be identified via qualitative interviews with participating patients and therapists. This will be the first experimental study to investigate an internet-based intervention in a forensic psychiatric outpatient sample. By using a mixed-methods design and by adding adherence and engagement as potential predictors, this study can not only answer questions about if, but also why and for whom this intervention works. Consequently, this study will answer an important question from clinical practice: are these types of interventions - which have been used in practice for over ten years - actually of added value for treatment?
Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Plant-derived proteins can be produced on a more sustainable scale, but are generally considered lower quality protein sources compared to animal-based sources because of incomplete essential amino acid profiles, resulting in lower anabolic properties for skeletal muscle building. Blending different plant-derived proteins can be a solution, but will never match the profile of other high-quality animal-derived proteins, likely necessitating the fortification of such plant-based protein blends with essential amino acids such as leucine. Objective: To assess post-prandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine compared to (gold standard) whey protein and compared to the plant protein blend without additional leucine. Study design: randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial. Study population: 45 healthy (BMI 18.5-35 kg/m2) older males (age: 60-85 y inclusive). Intervention: Subjects will consume a beverage containing 20g whey protein isolate, 20g of a plant protein blend or the same plant protein blend fortified with 2g leucine. Continuous intravenous stable isotope amino acid tracer infusions will be applied, with plasma and muscle samples collected at different time points throughout the experimental test day. Main study parameters/endpoints: The primary outcome will be postprandial (0-4h) muscle protein synthesis rates following beverage ingestion.
Rationale: Diabetes mellitus is a chronic disease that is often associated with long-term macrovascular and microvascular complications and decreased life expectancy. Approximately 70% of patients with type 2 diabetes mellitus (DM2) are overweight or obese. Weight loss benefits several aspects of DM2, such as improved glycemic control, increased insulin sensitivity and reduced fasting insulin. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery. Bariatric surgery is indicated at a body mass index (BMI) > 35 kg/m², in combination with other comorbidities. It is associated with better glycemic control and more weight reduction, compared to intensive medical treatment alone. For patients with not adequately controlled DM2 who are not eligible for surgery (i.e., BMI of < 35 kg/m²), there is a therapeutic gap, which could be filled by one of the currently available endoscopic therapies aiming to reduce weight. One of these therapies is endoscopic sutured gastroplasty (ESG), performed with the endomina device (EndoTools Therapeutics S.A.). There is however a paucity of data showing the effect of ESG on metabolic comorbidities including DM2. We hypothesize that ESG with the endomina device will improve glycemic control in patients with DM2 and obesity. Objective: To evaluate the efficacy of ESG with the endomina device on glycemic control, in obese insulin treated type 2 diabetic patients. Study design: This is a prospective, randomized controlled trial. Study population: 58 subjects (29 in each group) with a BMI between 30 and 40 kg/m² and DM2, treated with insulin therapy. Intervention (if applicable): The intervention group will receive ESG performed with the endomina device. The control group will receive standard diabetic care. Main study parameters/endpoints: The primary endpoint is the proportion of patients with a clinically relevant reduction of insulin dose. Secondary endpoints include among others reduction in HbA1c, remission of diabetes, weight loss, quality of life and (serious) adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An ESG with the endomina device is known to have only minor adverse events (transient abdominal cramps, nausea, vomiting), and a serious adverse event rate of <1% (no surgical intervention needed, no mortality).
The goal of this food-effect study on Alectinib pharmacokinetics is to learn about the food effect of alectinib. The main question aims to answer is: • To determine the food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC) and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach. Participants will take alectinib-d6 (microtracer) with and without food on different days.
Allergic rhinitis (AR) is a disorder that affects more than 500 million people worldwide. Nasal congestion is one of the most general and bothersome symptoms in rhinitis, which affects the quality of life (QOL). Current medications are undesirable due to their side-effects. Acupuncture for AR in general can be considered as safe and can be seen as a potential therapeutic intervention for nasal congestion. Evidence supported that acupuncture is clinically used for signs and symptoms of nose disorders, such as nasal congestion, with effectiveness, but whether acupuncture has immediate, post-treatment and long-term effects on nasal congestion in AR is not verified by strictly designed clinical study. The ANCAR trial uses a standard treatment protocol with a fixed set of acupuncture points - to be as scientific as possible from Western medical viewpoint - to open the nose and affect underlying energetic imbalance and immunity at the same time, to maintain its nose opening effect. This novel acupuncture treatment protocol can be seen as a solid and profound approach from which every AR patient may benefit.
The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.
This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B
This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects up to 10% of the reproductive-aged women worldwide. The etiology is still unknown and treatment therefore remains symptomatic. Studies indicate a possible role of the gut microbiome in the pathology of PCOS. PCOS women have a disturbed gut microbiome, with certain species associated with the PCOS characteristics:hyperandrogenism, ovarian dysfunction, obesity, glucose intolerance and insulin resistance. Although differences have been found in gut microbiome composition between PCOS and healthy women, the literature is inconclusive regarding the difference in gut microbiome biodiversity. Studies examining the vaginal microbiome in PCOS women show consistent results with specific species in the vaginal microbiome. However, there are only few studies on the vaginal microbiome in PCOS women and no studies have yet investigated the correlation between sex-specific hormones and PCOS characteristics. More research is needed to understand the function of the microbiome in the pathophysiology of PCOS, so that this can offer perspectives in future therapies.
Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial. The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.