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 study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol change whilst being dosed at the same time with daily miragebron.
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products or placebo.
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies. Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum. Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months). Patients will be followed for 2 years.
Rationale: evaluate the potential of the photonic needle (photonic needle technology) to discriminate tissues that are relevant to recognize during intraforaminal (transforaminal) epidural injection on lumbar level. Objective: The primary objective of this study is to investigate the potential of the photonic needle to discriminate between correct and incorrect placement of the needle tip in the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced fluoroscopy. The secondary objectives are to investigate the differences in the optical signals obtained with the photonic needle at a set of different pre-defined positions (M1, M2 and M3) encountered along the needle trajectory during above-mentioned procedures, and to detect potential intravascular positioning of the needle-tip at the target point (M4 - blood), Study design: this is a single blind observational study. Study population: Patients who have radicular pain on lumbar level, for example caused by disc herniation, and/or lateral recessus stenosis and/or radiculopathy eci. Main study parameters/endpoints: The main study parameters are: 1) successfully acquired diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the foramen (the target treatment location) as encountered during image-guided intraforaminal injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of contrast fluid (gold standard), 3) "Certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) will be provided by the physician. The type of tissue present at the needle tip will be based on the information available from imaging . The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered during image-guided intraforaminal injections on lumbar level, 2) successfully acquired diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above, 4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction angiography images after contrast injection at location M4, confirming vascular penetration (gold standard for vessel puncture), 6) "Certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging at M1 and at M4.
This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.
Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to the loss of functional capacity and an increased risk of developing chronic metabolic disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. It has become clear that amongst its many actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric oxide dependent vasodilation is physiologic and dose dependent. Recent data suggest that insulin's metabolic and vascular actions are closely linked. This also means that an increase in microvascular perfusion following food intake is more resistant to postprandial insulin release. This physiological process is brought into prominence with increasing age, and even more in type 2 diabetics, and contributes to diminishing glycaemic control. In the present study the investigators will investigate the impact of postprandial insulin release on microvascular recruitment in the oral cavity.
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo. Secondary Objectives: - Determine whether there are qualitative differences between the safety profiles of the 2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and the overall study population - Determine whether there are qualitative differences between the tolerability of the 2 dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population - Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1, Cohort 2, and the overall study population - Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic lipid levels in Cohort 2 compared to placebo - Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients with FH and inadequately controlled LDL-C who complete the primary efficacy assessment visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label Continuation Period
Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected for a minimum of 14 days following study drug administration. Safety and tolerability will be monitored throughout the study. A follow-up visit will occur 7-14 days after study drug administration.