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.
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and accounts for a considerable part of health care costs. Herbal supplements are used in many cultures for the prevention and treatment of many different conditions. Due to lack of scientific proof, the application in western cultures are minimal. Animal studies have shown that many constituents of such herbal supplements may have beneficial effects on several important parameters known to be affected in T2D. Still, no scientific proof in humans is available. We therefore aim to investigate the effect of 4-week herbal supplementation on glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with increased fasting glucose levels or a decreased glucose tolerance. Objective: The primary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on blood glucose levels and glucose tolerance. The secondary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and during an OGTT test. Study design: This study is a randomized, double-blind, placebo controlled cross-over trial in which two different treatments will be evaluated e.g. an intervention with the herbal mixture and a placebo. Each person will obtain both treatments in random order for four weeks with a wash out period of four weeks in-between. Fasting blood samples will be collected and subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation. Furthermore, after 4-week supplement intake we will collect a urine sample and collect an adipose tissue biopsy. The whole trial will last three months. Study population: 26 overweight males and females 50-75yrs old with an increased fasting glucose or with an impaired glucose tolerance. Intervention: Two intervention periods of 4-weeks in which participants will take three times a day a supplement of 500mg herbal or placebo. Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA, adipose tissue an white blood cell gene expression and markers of inflammation . Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects that will participate in the study will invest a total of 16.5 hours. Blood collection by vena punctures/insertion of the venflon and the collection of an adipose tissue biopsy can occasionally cause a local hematoma or bruise and some participants may report pain or discomfort. The herbal supplements contain small amounts St. John's wort, which may affect the function of liver enzymes. We will therefore monitor liver function parameters during the supplementation period. Furthermore, subjects are excluded if they use medication known to be affected by St. John's wort. Participant will donate 284ml of blood, dispersed over 12 weeks.
A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness. With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study. The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.
The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.
Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV. Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients