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.
The population is aging worldwide, concomitant frailty is increased in older age groups. Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby negatively influencing quality of life and health care costs. Prevention or delay of onset of frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may have beneficial effects on microbiota composition and health outcome parameters. As microbiota composition and function may be altered in elderly compared to younger adults, it will investigated whether the effects of GOS on selected parameters of microbiota and gut health differ between elderly versus younger adults. The primary objective of this study is to compare the effects of four weeks GOS supplementation on intestinal microbiota composition and activity in elderly versus younger adults. Further, this study has four secondary objectives. The study conforms to a randomized double-blind placebo-controlled cross-over design per age-group. Study populations are human volunteers (male and female), healthy young adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily for four weeks. The other intervention period subjects will receive isocaloric placebo supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end of each intervention period, several measurements will take place. There will be a washout period of four to five weeks between intervention periods. The main study parameter is the change in microbial composition and activity induced by GOS intervention, in younger adults and elderly.
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.
This is a single centre prospective data registry. In this study atrial conduction characteristics of extended surface Electrocardiograms (esECG), biomarkers and genetic analysis will be performed before ablation, before discharge and 3 months after catheter ablation of atrial fibrillation (AF) and compared to routine clinical follow-up data. The objective of this registry is to establish a data registry of patients undergoing ablation of AF. Supplementary to the routine clinical diagnostic an esECG and an analysis of biomarkers will be performed and compared to clinical and outcome data.
SUNNIFORECAST (Standard of Care vs. Nivolumab + Ipilimumab as First line treatment of renal cell cancer of non-clear cell subtypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC).
Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI, from a microbiota perspective, is as relevant as the large intestine. There are indications that microbiota composition is different in lean and obese subjects, and is related to insulin resistance. However, these indications are mainly based on the analysis of fecal samples. Therefore, analysis of the microbiota composition in the more proximal part of the gastrointestinal (GI) tract may provide new insights into the microbial species that are involved or related to metabolic homeostasis at that location. The IntelliCap® CR system offers a minimally invasive tool that is able to collect reliable samples in the SI, as was shown by NIZO in a clinical validation study. The main aim of the current study is to explore and compare the upper GI microbiota composition in lean and obese subjects, in order to generate new leads for development of products that may target the upper GI microbiota community or specific species thereof, which may impact the maintenance of metabolic homeostasis. This may provide new opportunities for the treatment, reduction or prevention of overweight and/or obesity or insulin resistance.
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.
Objective: To investigate the effect of 5 weeks dapagliflozin 10 mg once daily treatment on glucose and lipid fluxes in patients with type 2 diabetes. Study design: Single center single arm (mechanistic) intervention trial. Study Population: Male or postmenopausal female patients with type 2 diabetes BMI > 25 kg/m2and more than 12 weeks a stable dose of metformin treatment > 1500mg, HbA1C ≥6.5% - <8.5%, Fasting Plasma Glucose (FPG) <13.2 mmol/l, LDL cholesterol >2.5 mmol/l, willing to switch to rosuvastatin 10mg once daily for 4 weeks, and then receive 10 mg dapagliflozin once daily orally, for 5 weeks. Treatment: After a statin washout fase of 4 weeks, baseline cholesterol synthesis will be measured (2H3 Leucine, 2H2O deuterated water). Then, treatment with rosuvastatin 10mg for 4 weeks will be initiated after which, patients will undergo glucose (2H2enriched glucose) and lipid flux (2H3 Leucine, 2H2O deuterated water and oral 1,2,3,4-13C16 - palmitate enrichment measurements) followed by 5 weeks treatment with dapagliflozin 10mg once daily. In the final week glucose/lipid flux measurements will be repeated. Sample Size: 12 DM2 subjects. Outcome measures: The primary endpoint is effect of 5 weeks Sodium-Glucose Linked co-transporter (SGLT) 2 inhibition on LDL cholesterol synthesis in patients with DM2. Secondary endpoints are effect of SGLT2 inhibition on triglyceride and cholesterol fluxes as well as (hepatic and peripheral) insulin sensitivity and energy expenditure. Finally, effect of SGLT2 inhibition on dietary intake, liver fat content (MRI liver) and fecal microbiome will be studied at these timepoints.
During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord. Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in "delayed paraparesis". In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days). The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients. The following candidate tests will be examined: 1. Long loop reflexes (LLR) consisting of F-waves. 2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).
A Double-blind randomised placebo-controlled pilot study as well as a reversed translational part To investigate whether two faecal transplantations from either allogeneic (healthy) or autologous (own) donor, administered through a nasoduodenal tube, has beneficial effects on irritable bowel syndrome (IBS) symptoms such as abdominal pain frequency and severity. Secondary objective is to study microbiota changes in faeces samples.
General cognitive impairment is highly prevalent in chronic obstructive pulmonary disease (COPD) patients. Domain-specific cognitive impairments include deficits in domains such as cognitive flexibility, verbal memory, working memory, planning, and psychomotor speed; which in general are associated with poor health behaviours, such as infrequent exercising and poor diet. Additional cognitive training may reverse these effects. Recent evidence suggests that working memory training is linked to self-control and, indirectly, to improved lifestyle behaviour including increased physical activity. The investigators hypothesise that enhancing cognitive performance through administering specific working memory training not only improves cognitive function but that it facilitates better adherence to a more active lifestyle and a healthier diet in COPD patients.