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 aim of the present study is to compare the outcomes of standard care to the effects of exercise alone, and exercise combined with nutrition counseling, on post-transplantation weight gain and quality of life in renal transplant recipients (RTR). The primary outcome is subdomain physical functioning of quality of life, (SF-36 PFS). Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Additionally it is planned to study data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness.
The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.
This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.
Rituximab is a monoclonal antibody with proven efficacy in WM but responses are slow. Bortezomib has shown significant and rapid activity in WM. Combinations of bortezomib with rituximab nad dexamethasone with rituximab have shown synergistic activity in laboratory studies and clinical trials. This is a Phase II multicenter study designed to evaluate the safety and efficacy of the combination of Bortezomib , Rituximab and dexamethasone (BDR). BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv will be administered. A total of 8 infusions of rituximab will be administered. Subsequently patients rated as CR, PR, MR or SD will be followed without any treatment until there is evidence of progressive disease.
Primary Objective: - To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC). Secondary Objectives: - To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks; - To assess Progression-free survival (PFS) and the overall survival (OS); - To assess the safety profile of each schedule of iniparib; - To assess the biological activity in tumor tissue (substudy); - To evaluate the pharmacokinetic (PK) profile of iniparib (substudy); - To characterize molecular and biological profile of tumors (substudy); - To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone. Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.
Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease. Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions. Study design: Randomized, double blind, placebo controlled intervention study. Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.