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: Pelvic floor symptoms (PFS) are prevalent and often impair quality of life. They include micturition problems, defecation problems, pelvic organ prolapse, sexual problems and genito-pelvic pain. The pelvic floor is an anatomical and functional unit, and therefore different PFS may co-occur. However, literature on prevalence of clusters of PFS is scarce. Furthermore, PFS is understudied in the male population and when studies are performed in male subjects, studies do not assess the complete scope of possible PFS. Objective: To generate a cohort, which provides information on sex- and gender differences in: prevalence and incidence of (clinically relevant clusters of) PFS, risk factors and prognostic factors for PFS, factors that reveal the impact of PFS on daily life, help seeking behavior and use of health care. Study design: Prospective observational population-based cohort study with follow-up moments after 1 year and 2 years. Data of the questionnaire will be connected to medical record data from the participating general practitioners (GPs). A representative sample of female and male subjects with and without PFS will be invited for a physical examination to assess pelvic floor disorders and muscle function. Furthermore, a subsample of patients will be invited for a qualitative study consisting of semi-structured interviews on healthcare seeking behavior, including barriers and facilitators, preferences and satisfaction. Study population: female and male subjects, aged ≥16 years of age, from the general population will be included. Exclusion criteria are: terminal disease, or dementia, cognitive impairment or current psychological condition precluding informed consent, not suitable or too ill to participate based on the judgement of the GP. Main study parameters: To evaluate the sex- and gender difference in prevalence and incidence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, urogenital prolapse (females only), sexual functioning, and pain. Secondary study parameters are factors associated with the development of PFS ('risk factors'), factors that predict the course of PFS ('prognostic factors'), factors that reveal the impact of PFS on daily life, help seeking behavior, and health care use (consultations for PFS and consultation frequency, diagnostic tests, diagnoses, treatment, and referrals).
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: - 14 weeks of treatment with tralokinumab - a single dose of tralokinumab
The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.
Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.
A phase 2 study in two parts (A & B) designed to evaluate the effect of MEDI0382 on Hepatic Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 20 subjects will be enrolled in Part A and approximately 30 subjects in Part B.
The purpose of this study is to evaluate the safety of the combination of cetrelimab, with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of cetrelimab and apalutamide.
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.
Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels. Compared to patients with a normal metabolization function, for those with increased CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. For those with reduced CYP450 activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. Such evaluation is necessary before broad implementation of these guidelines can be advocated. In the present study 200 patients with sMDD who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). We hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.
Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.