There are about 13446 clinical studies being (or have been) conducted in Belgium. 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.
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
BACKGROUND Demographic trends coupled with a rise in chronic diseases mean that the population of patients requiring palliative and end-of-life care is ageing. Due to the ageing population palliative care for older people has been identified as one of the worldwide public health priorities. A majority of elderly patients die in hospital. Studies from the United Kingdom and other countries have shown that many older persons dying in hospital experience suboptimal care. The Care Programme for the Last Days of Life has been developed to improve the quality of end-of-life care in acute geriatric hospital wards. The programme is based on existing end-of-life care programmes but modeled to the acute geriatric care setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and the effects that may be achieved in patients dying in an acute geriatric hospital setting are unknown. The aim of this study is to evaluate the effectiveness of the Care Programme for the Last Days of Life in improving the quality of care and quality of life during the last 48 hours of life of patients dying in acute geriatric hospital wards in Flanders as compared to usual care. METHODS In order to contribute substantially to the increase of evidence for the effect of the Care Programme for the Last Days of Life in patients dying in acute geriatric hospital wards, a cluster randomized controlled trial will be conducted. Ten hospitals with one or more acute geriatric wards will conduct a one-year baseline assessment during which care will be provided as usual. For each patient dying in the ward, a questionnaire will be filled in by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals will be randomized to receive intervention (implementation of the Care Programme) or no intervention. Subsequently, the Care Programme will be implemented in the intervention hospitals over a six-month period. A one-year post-intervention assessment will be performed immediately after the baseline assessment in the control hospitals and after the implementation period in the intervention hospitals. Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life. DISCUSSION This will be the first cluster randomized controlled trial to evaluate the effect of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The results will enable us to evaluate whether implementation of the Care Programme has positive effects on end-of-life care during the last days of life in this patient population and which components of the Care Programme contribute to improving the quality of end-of-life care.
Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients. The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation. The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.
Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction. Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.
The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).
This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-ascending dose JNJ-54861911 which is currently being developed for the treatment of Alzheimer's disease.
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.