BMJ open
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Randomized Controlled Trial Observational Study
Thresholds for clinically important deterioration versus improvement in COPD health status: results from a randomised controlled trial in pulmonary rehabilitation and an observational study during routine clinical practice.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires. ⋯ MCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings.
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Randomized Controlled Trial Multicenter Study
Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol.
Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences.Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG-70% isopropanol is more effective than 5% PVI-69% ethanol in reducing the incidence of reoperation after cardiac surgery. ⋯ This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
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Randomized Controlled Trial Multicenter Study
Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies.
New medications for anaemia associated with chronic kidney disease (CKD) are desirable, owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care. Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney. We report methodological details of three phase III trials, named MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI), designed primarily to investigate the efficacy of molidustat therapy in adults with renal anaemia and dialysis-dependent CKD. ⋯ The protocols were approved by ethics committees at all participating sites. The trials will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results arising from these studies will be published in peer-reviewed journal(s).
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Randomized Controlled Trial Multicenter Study
Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies.
Anaemia is a common complication of chronic kidney disease (CKD). Owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care, there is a need to develop new therapies. Hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitors might be a promising new treatment option. Molidustat is an oral HIF-PH inhibitor that stimulates the endogenous, predominantly renal, production of erythropoietin and was generally well tolerated in phase IIb clinical trials. Here, we report the design and rationale of two studies from the molidustat phase III programme: MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI). ⋯ The protocols were approved by ethics committees at all participating sites. These studies will be conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. Results arising from these studies will be published in peer-reviewed journal(s).
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Randomized Controlled Trial Multicenter Study
Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial.
Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year. ⋯ The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature.