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 purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.
The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod in measuring movement / physical activity in frail elderly.
This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years. Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System. Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™ AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac aneurysms. The results of this study will be used as supportive data for CE Marking submission in the European Union (EU). Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon™ AAA Stent graft System. Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance endpoints include successful delivery and deployment of the device; and absence of the following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration. Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices. Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic Aneurysm Stent graft System.
This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex with men) who were successfully treated for high grade AIN.
The formation of metastasis is responsible for as much as 90% of cancer-associated mortality. In spite of recent advances in oncologic therapy, approximately 50 % of the lung cancer patients have already overt disseminated cancer at diagnosis. Additionally, numerous patients with locoregional disease initially treated with curative intent develop (oligo)metastases during the course of disease. In both instances, these stage IV patients are generally considered to be incurable and mostly treated palliatively. Oligometastases, defined as 1-5 sites of active disease on whole body imaging, was coined to refer to isolated sites of metastasis resembling limited tumor metastatic capacity. The implication of this concept is that local cancer treatments are curative in a proportion of patients with metastases and that incorporating local therapy is a conceptually attractive approach. In several, but not all, academic centers the standard treatment of patients with oligometastases in good general health is standard chemotherapy followed by surgery or by Stereotactic Ablative Body Radiotherapy (SABR) with radical dose on the macroscopic visible tumors. The widespread introduction of SABR and of minimally invasive surgery has fuelled research in treating patients with oligometastases. Indeed, local control of metastases can be obtained in virtually all parts of the body with a low proportion of patients experiencing severe side effects. In the few prospective studies published to date, approximately 20% of patients remained free of recurrence several years after treatment when all sites of disease were targeted by radiation. Along with standard anti-cancer therapeutic modalities like chemotherapy and radiotherapy (RT), immunotherapy has recently gained a lot of attention. Angiogenesis is one of the hallmarks of cancer, and therefore, considerable efforts have been made to exploit this unique target for selective drug delivery. One of the appealing targets for both approaches is the splice variant of fibronectin containing extra domain B (EDB), which is abundantly expressed in vascular endothelial cells of a variety of primary tumors as well as metastases , but virtually absent in normal tissues. Recently, a human recombinant scFv fragment directed against EDB, designated L19, was developed and subsequently combined with the pro-inflammatory interleukin-2 (IL2), resulting in the immunocytokine L19-IL2. L19-IL2 delivers high doses of IL2 to the (metastatic) tumor site(s) exploiting the selective expression of EDB on newly formed blood vessels. Interleukin-2 (IL2) plays an essential role in the activation phases of both specific and natural immune responses. Even though it has no direct cytotoxic effects on cancer cells, it can induce tumor regression by stimulating a potent cell-mediated response. In summary, L19-IL2 is an immunocytokine which will stimulate immune response specifically in tumors with angiogenesis and tissue remodeling. Radiotherapy is a particularly interesting partner for immunotherapy, since it can be harnessed to specifically modify the immunogenicity of the primary tumors and their microenvironment, in the attempt to generate an in situ immunization of the host against a patient's own cancer. Our hypothesis is that three independent therapeutic approaches will synergize to improve dramatically survival in patients with oligometastases of solid tumors.
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.
In the present study, we want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during (single) human endotoxemia. In a future experiment we will investigate whether BCG-vaccination can reverse the tolerant state observed upon a second LPS administration. Our goal is to ultimately translate our results into clinic applications to reverse for example sepsis-induced immunoparalysis.
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still present. An additive strategy to further lower this residual risk may be via raising high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in cardiovascular disease (CVD) risk. To understand this it is important to know what are the targets and molecular mechanisms that underlie a shift to a HDL fraction with cardioprotective activities. There is increasing evidence that particularly the apoA-I proteins in the HDL fractions are atheroprotective. It is important to verify whether the effect of an intervention actually increases apoA-I production since that results in the formation of de-novo small pre-beta HDL particles that have full capacity to resorb cholesterol from the arterial wall and return this to the liver for secretion (reverse cholesterol transport). The investigators here propose to evaluate, in a double-blind human intervention study, the difference in intestinal apoA-I gene expression, of healthy subjects, after consumption of a high fat (HF) or low fat (LF) meal. Additionally the investigators propose to evaluate the effect of theobromine on intestinal apoA-I expression. Based on several studies, theobromine improved cardiovascular risk parameters among which an elevation in apoA-I and HDL cholesterol concentrations. It is however unknown whether this effect of theobromine originates from elevated apoA-I production, which suggest improved functionality, or decreased clearance, suggesting reduced functionality. The investigators therefore propose to also evaluate if the usage of theobromine is a better way to increase intestinal apoA-I mRNA and protein expression, than consumption of a HF meal. The investigators will do this in the same double-blind human intervention study. The theobromine will be added in a third arm in a LF condition. Study design: The proposed study will have a randomized, double-blind cross-over design. The total study duration will be 17 days, consisting of 3 experimental days with postprandial tests, each separated by a 1 week wash-out period. Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history of any gastrointestinal disorders or complaints. Intervention: During the three experimental days, subjects will consume a milkshake: one HF milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total follow-up during each of the postprandial tests is 5 hours.
Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.