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.
Vitamin D deficiency is common in older persons, in particular in residents of nursing homes. This is mainly explained by the fact that older persons do not often go outside in the sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to supplement vit D in order to correct the deficiency. The advised daily dose of vit D supplementation is 800 IU. Several studies showed that with this dose the required serum 25(OH)D levels will not be reached. primary objective of this study is: - to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a day. - to determine the best consolidation treatment. Secondary objective - is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in residents of nursing homes. - is there a relation between the increase in serum 25(OH)D level and muscle strength (handgrip strength). - is there a relation between the increase in serum 25(OH)D level and mobility (2 minute walk test). Study design: Randomised trial with 3 study groups: - Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy. - Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy. - Group 2. 800 IU vit D3/ dag. Study population: Vitamine D deficient residents of nursing homes, 65 years or older.
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
The purpose of this study is to determine the effect of gastric banding or gastric bypass on hypothalamic morphology and function, gut hormones and systems biology in obese subjects with and without type 2 diabetes.
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.
The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.
The main objective of the study is to observe the OXN treatment of patients with moderate to severe non-malignant pain in daily clinical practise with respect to pain relief and bowel function. Patients who have insufficient pain relief and/or unacceptable side effects with the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can be included in the study.
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC.