Nephrology
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Randomized controlled clinical trials represent the gold standard of research into health-care interventions but conducting a randomized trial requires careful planning, structures and procedures. The conduct of a clinical trial is a collaborative effort between investigators, participants and a range of professionals involved both centrally and locally in the coordination and execution of the study. In this article, the key steps to conducting a randomized controlled trial are summarized.
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Determining the number of subjects required for a study is a critical component when planning a research project. An adequate number of patients are needed in order to be able to answer the research question of interest with a degree of certainty. ⋯ The primary aim is to demystify the sample size section in published clinical trials. Some of the difficulties in determining the sample size correctly are also highlighted and some good practices recommended.
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Clinical Trial
Benefit and cost from the long-term use of cyclosporine-A in idiopathic membranous nephropathy.
Idiopathic membranous nephropathy (IMN), the most common cause of nephrotic syndrome in adults, is usually treated by cyclosporin A (CsA). Estimation of the effectiveness of long-term use of CsA in the remission and relapse rate of nephrotic syndrome along with histological changes in repeat renal biopsies was the aim of the study. ⋯ Low doses of CsA with prednisolone induce remission of nephrotic syndrome in most idiopathic membranous nephropathy patients. Although typical features of CsA nephrotoxicity are not observed, significant deterioration of histological lesions occurs with time, even in patients with remission. Long-term use of CsA should be examined with caution.