Trials
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Chronic obstructive pulmonary disease (COPD) not only affects pulmonary function but also leads to skeletal muscle dysfunction. The various characteristics of different forms of traditional Chinese exercise lead to inconsistent clinical effects in COPD patients. Hence, the present study carefully combined and rearranged liuzijue, wuqinxi, baduanjin, and yijinjing into a pulmonary exercise program targeting COPD patients. ⋯ The results of this study will compensate for the current inadequate understanding of prescribed pulmonary exercise and may provide a new, simple, convenient, and effective home-based exercise intervention for COPD patients.
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The objective of the Dutch Sildenafil therapy in dismal prognosis early onset fetal growth restriction (STRIDER) randomised clinical trial is to assess the beneficial and harmful effects of sildenafil versus placebo on fetal and neonatal mortality in pregnant women with severe early-onset fetal growth restriction. The objective of this detailed statistical analysis plan is to minimize the risks of selective reporting and data-driven analysis. ⋯ This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data and updated after stopping of the trial at interim analysis.
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Physical rehabilitation is required to enhance functional outcomes and overall recovery following total knee arthroplasty (TKA). However, there are no universally accepted clinical guidelines available to consistently structure rehabilitation for TKA patients. A common method is rehabilitation provided in an outpatient setting, on a one-to-one treatment basis. This method is resource-intensive and outcomes must be compared to less costly alternatives such as home-based rehabilitation. The current study will analyse a novel home-based rehabilitation program. The Maxm skate is a portable, lower-limb, postoperative, rehabilitation exercise device for individual use in a hospital or home-based setting. This study was developed to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation program to standard rehabilitative care following TKA. The primary outcome is the range of motion (ROM) achieved by patients who received the Maxm Skate program compared to standard care at three months post TKA. Secondary outcomes include patient-reported outcomes, costs and functional evaluations which will be collected at multiple time-points up to 12 months after TKA. ⋯ This RCT will be the first to investigate the safety, efficacy and cost-effectiveness of the home-based Maxm Skate Rehabilitation program, in comparison to standard rehabilitative care following primary TKA.
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The insertion of a laryngeal mask airway (LMA) is difficult in children due to the unique features of their airways. Muscle relaxants have been reported to facilitate LMA insertion in adults; however, there is a lack of evidence supporting this in children. This trial is designed to assess the feasibility of LMA insertion with and without the use of muscle relaxants in pediatric patients under general anesthesia. ⋯ We will compare the OLPs to determine whether the muscle relaxant provides better conditions for the manipulation of the LMA. This is the first randomized controlled trial to investigate whether muscle relaxants are beneficial to the clinical performance of LMA insertion in pediatric patients under general anesthesia. This trial will be a resource for improving the process and safety of pediatric LMA insertion under general anesthesia.
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Selective fetal growth restriction in monochorionic twin pregnancies is associated with an increased risk of perinatal mortality and morbidity and represents a clinical dilemma. Interventions include expectant management with early preterm delivery if there are signs of fetal compromise, selective termination of the compromised twin, fetoscopic laser coagulation of the communicating placental vessels or termination of the whole pregnancy. Previous studies evaluating interventions have reported many different outcomes and outcome measures. Such variation makes comparing, contrasting, and combining results challenging, limiting ongoing research on this uncommon condition to inform clinical practice. We aim to produce, disseminate, and implement a core outcome set for selective fetal growth restriction research in monochorionic twin pregnancies. ⋯ The development, dissemination, and implementation of a core outcome set for selective fetal growth restriction should ensure that future research protocols select, collect, and report outcomes and outcome measures in a standardized manner. Data synthesis will be possible on a broad level and rigorous implementation should advance the quality of research studies and their effective use in order to guide clinical practice, improve patient care, maternal, short-term perinatal outcomes, and long-term neurodevelopmental outcomes.