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.
Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive. With this, we want to confirm that the chances of getting pregnant while using this contraceptive are very small. We also want to demonstrate that the use of mifepristone is safe, and it does not lead to any severe health problems. We expect fewer side effects compared to other frequently used contraceptives with hormones. Mifepristone does not contain these hormones. It is important to know how people experience that use of one tablet a week.
The serious digital game, SugarVita, is a collaborative effort between the Máxima Medical Centre (MMC) and Eindhoven University of Technology (TUe), intending to enhance self-management for individuals with diabetes. As a mobile application available on smartphones and tablets, SugarVita emerged from cooperative design sessions involving patients diagnosed with diabetes. The average age of type 2 diabetes patients in the Netherlands exceeds 50 years. Following extensive discussions with these patients, the decision was made to model SugarVita after a digital board game, reminiscent of the classic board game 'ganzenbord' (Game of the Goose). In SugarVita, players experience a day in the life of an individual with diabetes, making choices regarding dietary habits, physical activity, and medication intake. Throughout this simulated day, the blood glucose level serves as a central theme. Players earn points by effectively managing their blood glucose levels. SugarVita can be played together with relatives or friends. The game aims to give people with diabetes more control over their chronic condition. Self-care is now seen as the primary approach to diabetes, which is a complex multi-faceted task where training and education are crucial. Importantly, SugarVita recognizes that a conventional 'dry' explanation may not resonate with everyone.
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.
Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound. Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of 'EUS-negative' IAP. Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization. Study population: Adults with a first episode of 'EUS-negative' IAP. Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment. Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.
Oesophageal and gastric scintigraphy evaluates the function of the gastrointestinal system including variables such as oesophageal transit and gastric emptying (GE). Some variables are known to change after bariatric surgery. In patients that have symptoms of pain or nausea after bariatric surgery, oesophageal and gastric scintigraphy plays an important role in determining the nature of symptoms and is necessary for adequate treatment. However, literature on reference values in the bariatric population are scarce. At this moment, quantitative evaluation of the scintigraphy cannot be performed and conclusions are based on visual interpretation. There is a need for a standardised scintigraphy protocol for the population that underwent bariatric surgery taking into account the changed anatomy and physiology. Then, reference values that describe the oesophageal transit and GE assessed using scintigraphy have to be determined.
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed. The aim of this prospective study is to evaluate the use and experiences of the card set and website designed to aid the physiotherapist in decision making with regards to motor learning. The following research question is central to this evaluation: How are the developed card set and website used and experienced by physiotherapists in primary care during the treatment of patients with neurological or geriatric conditions?
The Rhea-study is a multicenter prospective diagnostic proof-of-concept study There is an unquestionable need for improved diagnostic approaches for (incidental) SVT. The researchers plan to evaluate the MRDTI technique, that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis, for the notoriously challenging diagnosis of incidental SVT. This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future, i.e. the possibility of assessment of the age of the thrombus in patients with incidental SVT, which is of utmost importance for determination of the indication for anticoagulant therapy. If this hypothesis is proven true, i.e. sensitivity of MRDTI for SVT is indeed >90%, the investigators will proceed with performing a randomized controlled outcome study in which patients with possible/probable chronic SVT with normal MRDTI test results and no other indications for anticoagulant therapy. These patients will be randomized between active therapeutically dosed anticoagulation versus no anticoagulation, to compare clinical outcome with regard to the occurrence of venous thromboembolism and/or Progressive symptomatic SVT as well as major bleeding.
This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group. The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores.
The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.