There are about 8560 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 aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
During the last decades improvements in operative techniques and perioperative care have led to a steady decline in mortality after cardiac surgery. Good survival rates have been shown repeatedly although elderly patients have an increased risk for prolonged hospital stay and postoperative complications such as neurological and pulmonary problems. Post-operative cognitive decline (POCD) is common after cardiac surgery and although this cognitive decline can be subtle, in elderly vulnerable patients even a small decline can have important consequences such as a decreased quality of life and loss of independence. Recent studies among patients after coronary artery bypass grafting (CABG) found that the incidence of POCD varied between 30-60% depending on cognitive tests, time of assessment and patient populations. Cognitive and physical impairment frequently co-occur in older people. The association between cognitive impairment and functional disability has been investigated in several studies, which demonstrated that cognitive decline is associated with functional disability, also after cardiac surgery. One method for estimation of patients' physical performance is to evaluate sarcopenia. Sarcopenia is defined as a syndrome characterised by progressive and generalised loss of skeletal muscle mass and strength, leading to an increased risk of adverse outcomes such as physical disability, poor quality of life and death. Data on the prevalence of sarcopenia in community-dwelling residents or nursing-homes are widely available, but little is known on (elderly) hospitalized patients after cardiac surgery. The aim of this study is to evaluate the association between post-operative cognitive decline, quality of life (QoL) and sarcopenia in adult patients after coronary artery bypass grafting. The investigators hypothesize that a decreased postoperative QoL is mainly explained by POCD, therefore the primary research question of this study is: What is the influence of post-operative cognitive decline on QoL after CABG? The secondary research question is: Is there an association between postoperative sarcopenia and a decreased postoperative QoL?
Introduction: Venous thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is a frequent cause of morbidity and mortality. The population of critically ill patients is a heterogeneous group of patients with an overall high average risk of developing VTE. No prognostic model has been developed for estimation of this risk specifically in critically ill patients. The aim is to construct and validate a risk assessment model for predicting the risk of in-hospital VTE in critically ill patients. Methods: In the first phase of the study we will create a prognostic model based on a derivation cohort of critically ill patients who were acutely admitted to the intensive care unit. A point-based clinical prediction model will be created using backward stepwise regression analysis from a selection of predefined candidate predictors. Model performance, discrimination and calibration will be evaluated, and the model will be internally validated by bootstrapping. In the second phase of the study, external validation will be performed in an independent cohort, and additionally model performance will be compared with performance of existing VTE risk prediction models derived from, and applied to, general medical patients. Dissemination: This protocol will be published online. The results will be reported according to the Transparent Reporting of multivariate prediction models for Individual Prognosis Or Diagnosis (TRIPOD) statement, and submitted to a peer-reviewed journal for publication.
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.
Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the current practice of over-pressurizing the eye at the end of surgery. Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT) for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical protocol with current practice, where the eye is over-pressurized for a set period of time, in terms of surgical efficiency, clinical outcomes, and adverse events. Study design: International multicentre non-inferiority randomized clinical trial Study population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell dysfunction above the age of 18 years. Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients will be randomized for either the iOCT optimized surgical protocol or current standard surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups will be evaluated with iOCT at the end of surgery. Main study parameters/endpoints: The main study parameter is the rate of adverse events (particularly graft dislocations). Secondary parameters/endpoints are surgical time, the recovery of visual acuity and endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the extent/duration of surgical tissue manipulations. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of iOCT during surgery does not entail additional risk to the patient. Participants to this study will adhere to the standard of care after corneal transplant surgery. In addition, they will receive study specific measurements and questionnaires. The additional measurements and questionnaires will be combined with regular follow up moments.
The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases. Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and currently three alternatives are on the market. Clinical results of these devices are promising but loss of patency is not uncommon. The major difference between the two devices is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. Intermittent hinchpoints could also have an effect on stent integrity and stenosis. By evaluating endograft movement during the cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the endograft. This might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability. The choice for device is not part of this study.
Elevated levels of plasma triglycerides are increasingly recognized as an important causal risk factor for cardiovascular disease and associated pathologies. Lowering plasma triglycerides may therefore be a therapeutic target to lower cardiovascular disease risk. With this study the investigators want to examine the effects of fasting on adipose tissue metabolism in humans.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis when administered for 29 days in a cross-over design