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.
This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products with varying proportions of whey protein and caseins, and different processing conditions.
Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.
Some dietary fibres, including wheat fibres, have shown to increase fecal bulk and improve stool. In previous studies, this effect on fecal bulk was especially studied for intact wheat fibers. Moreover, in most studies, the wheat fiber was offered daily as a single dose in cereals. In this study, we investigate whether an increased intake of extracted wheat fiber, implemented at several time points in a normal daily dietary pattern, can also increase fecal bulk and improve stool frequency and consistency. Here we want to demonstrate that an increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and that the enhanced wheat fiber intake will also increase stool frequency and consistency. The study is a double-blind crossover design in which the intervention is based on products enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched intervention will last for 10 days with a wash-out period of at least 4 days. The study will be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons will be assigned to the intervention groups. In one of the intervention periods participants receive 'control boxes' with products low in wheat fiber and in the other period they will receive boxes with products enriched with VITACEL Wheat Fiber. During an intervention period of 10 days participants will receive 10 boxes, one for each day. In the last 5 days of the intervention + 1 additional day after the intervention (so in total 6 days), participants will collect their fecal samples to analyse fecal bulk. Daily also a diary has to be kept and questionnaires have to be completed to check compliance to the intervention and assess stool consistency, gut-related complaints.
Rationale: Ipilimumab, a monoclonal antibody targeting CTLA-4, is approved for the treatment of metastatic melanoma and significantly increases median overall survival. However, use of this drug is associated with immune related adverse events (IRAEs) like colitis, hepatitis, dermatitis, alveolitis and hypophysitis in 10-40% of the patients. In general IRAEs are manageable by cessation of ipilimumab in combination with treatment with corticosteroids or TNF-alpha blockade but they can be severe or even life-threatening. In addition, treatment with ipilimumab is expensive. Because of the high costs and the potential serious toxicity of ipilimumab, it is of great importance to identify biomarkers that correlate with clinical activity and can be used to select patients that will benefit from CTLA-4 blockade therapy. The investigators hypothesize that differences in response to treatment with ipilimumab are due to variability in the pharmacodynamics and -kinetics of the antibody. It is hypothesized that patients who do not respond to treatment with ipilimumab have lower drug levels in tumor tissues as compared to patients with a good response to therapy. In addition, the investigators hypothesize that IRAEs are associated with high drug levels in the affected tissue. To visualize molecular interactions a novel technique is used in which positron emission tomography (PET) is combined with labeled monoclonal antibodies. Because ipilimumab induces activation of T-lymphocytes it is hypothesized that uptake of 89Zr-ipilimumab in tumor lesions and normal tissue is different (i.e. higher) after the second administration of ipilimumab (3 weeks after first injection). Therefore immuno-PET scans will be performed after the first and after the second injection of ipilimumab. Objective: Part one: The primary objective is: 1. To assess uptake (visual and quantitative) of 89Zr-ipilimumab in tumor lesions and biodistribution at two timepoints (at start of ipilimumab therapy and after the second injection 3 weeks later). The secondary objectives are: 1. To determine the correlation between tumor targeting of ipilimumab and response to therapy. 2. To assess uptake (visual and quantitative) of 89Zr-ipilimumab in normal tissues. 3. To determine de correlation between organ targeting and toxicity
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.
This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).
The primary objective is to determine the safety, performance and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in treatment naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.
Study design: A national, multi-center, patient-blinded, randomized clinical trial. Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing Delayed Bleeding (DB). Intervention: PC will be compared to standard care (no PC). Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma recurrence and risk factors for DB.