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.
Frequent monomorphic premature ventricular complexes (PVCs) may cause a cardiomyopathy (CMP) that is reversible by suppression of the ectopic focus. This study investigates whether PVC suppression therapy can improve cardiac function and clinical condition of patients with idiopathic or ischemic CMP and frequent monomorphic PVCs. For this purpose, patients will be randomized to either one of two treatment strategies: 1) conventional heart failure therapy plus PVC suppression therapy, consisting of RFCA as primary treatment and Amiodarone as secondary treatment in case of unsuccessful RFCA, or 2) conventional heart failure therapy without PVC suppression therapy.
Rationale and objective: Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs. Study Design: The study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups. Study population: One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l). Intervention: During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study. Main study parameters/endpoints: Measurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.
The investigators hypothesize that certain mutations in the individual cancer genomes will predict response to Everolimus therapy. To identify possible genetic mutations that affect tumor response to Everolimus the investigators will obtain sequence analysis of tumors from all patients that will be treated with Everolimus in this study. Moreover, the investigators performed a systematic review of the currently available data to identify mutations that could be predictive for increased mTOR activity in cancer cells. These mutations have been described to lead to mTOR activation but their predictive value for response to Everolimus therapy remains unclear. The investigators will use the data generated in the investigators own prospective treatment study and the data from literature to select patients for entry into a second part of this trial. In this part the investigators want to test the hypothesis that selecting patients based on their specific genetic mutations increases the likelihood of response.
It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked. There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.
The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.
T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35% objective response rate, 44% stable disease, 18% progressive disease) in patients with advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and lapatinib. Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is "key" since the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the external domain of HER2. The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test which shows promise in measuring HER2 expression (extracellular domain) for the entire disease burden and which could identify non responding patients prior to TDM1 administration. Rationale II: As for many such agents, it is desirable to identify early on (here with the use of FDG-PET/CT) which patients are unlikely to benefit from the therapy
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and myocardial infarction. Several preclinical studies point towards promising effects of Danshen on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and hypertension. Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on hypertension. Further objectives are to determine its effect on endothelial function, oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.
This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus
The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.