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.
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied. The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
Rationale: Plant stanols are well known for their effects on lowering intestinal cholesterol absorption ultimately resulting in 10-15% reduced serum LDL cholesterol concentrations in humans. In addition we have also shown that serum triacylglycerol (TG) concentrations may be lowered in subjects with elevated baseline concentrations. Till now, there is little evidence for plant stanol effects other than improving lipid profiles. However, we have very recently found strong indications in ex vivo models using isolated human peripheral mononuclear blood cells (PBMCs) from healthy volunteers that plant stanols have the capacity to improve immune function. More into detail, plant stanols shifted the differentiation of naive T-cells into the Th1 direction by activating a specific receptor present on the Antigen presenting cells (APCs) and T-cells. This effect might ultimately be helpful in situations in which the Th1/Th2 cell balance is disturbed into a Th2 over-responsiveness. By activating the Th1 response, the disturbed balance may be restored. This is for example a possibility in the treatment or prevention of asthma, food allergies or HIV in susceptible subjects. In addition, very recently (MEC 08-3-051) in a pilot study we also showed these ex vivo Th1 stimulating effects of plant stanols specifically in PBMCs isolated from asthma patients, as said, a condition characterized by a Th2 dominant immune response. Objective: The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients. Study design: A double-blind randomized placebo-controlled human intervention study in which 90 patients with clinically proven asthma will participate: 45 in the intervention group receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt without added plant stanols. At the end of the run-in period as well as at the end of the experimental period blood will be sampled to isolate PBMCs. These cells are used to evaluate effects on cytokine production, phagocytic capacity of neutrophils, and the activity of NK cells. In addition, the golden standard to show improvements in immune function is by showing an elevated Immunoglobulin response to a vaccine. Therefore, during the experimental period all subjects receive a vaccination against Hepatitis A Virus. After 1, 2, 3, and 4 weeks blood will be sampled to monitor specific immunoglobulin titers to HAV. Study population: 90 people with clinically proven asthma, who are not carrier of hepatitis A, B or C and have not been vaccinated against hepatitis A in the past. Also, these participants do not have any other immune-related pathology Main study parameters/endpoints: primary: Specific anti-HAV antibody titers after vaccination; secondary: Phagocytic capacity of neutrophils; NK-cell activity; Th1 and Th2 cytokine production profiles by PHA stimulated PMBCs. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the study, 9 blood samples (each 20 or 50 mL) will be taken. Total time investment for the subjects will be 160 min. Occasionally, a heamatoma or bruise can occur during venipuncture. After the vaccination a heamatoma or a sore arm can occur. These side effects should disappear within 4-5 days. Other common side effects related to the vaccination are headache, loss of appetite, and fatigue, which usually will disappear within 24 hours. The results of this study will show whether consumption of plant stanol enriched yogurts is able to restore the disturbed th1/Th2 balance in asthma patients. Ultimately, this is expected to reduce asthmatic exacerbations, as the Th2 dominant immune response seems causal to asthmatic symptoms, however these clinical improvements are not verified in this relatively short term intervention study.
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
The main objective of the study is to determine whether an intensive web-based titration system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].
The purpose of this study is to determine whether the quantitative detection of circulating tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard qualitative method - cytology both in the cerebrospinal fluid of patients, clinically suspected for leptomeningeal metastases.
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.