Trials
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Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. Although several factors have been reported to predict mortality in AKI patients, fluid overload (FO) during CRRT is a well-known predictor of patient survival. However, FO has been mostly quantified as an arithmetical calculation and determined on the basis of the physicians' perception. Even though such quantification and assessment provides an easy evaluation of a patient's fluid status and is a simple method, it is not applicable unless a detailed record of fluid monitoring is available. Furthermore, the method cannot differentiate excess water in individual water compartments but can only reflect excess total body water. Bioimpedance analysis (BIA) has been used to measure the nutritional component of body composition and is a promising tool for the measurement of volume status. However, there has been no prospective interventional study for fluid balance among CRRT-treated AKI patients using BIA. Therefore, we will investigate the usefulness of fluid management using the InBody S10 (InBody®, Seoul, Korea), a BIA tool, compared with that of generally used quantification methods. ⋯ This will be the first clinical trial to investigate the effect of using BIA-guided fluid management to achieve euvolemia in CRRT-treated AKI patients.
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Randomized Controlled Trial Comparative Study
Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study.
Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1 mg lidocaine and 2 mg CPC. Single-agent lozenges containing 8 mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This study compared a new lozenge formulation, containing 8 mg lidocaine and 2 mg CPC, with the currently marketed lozenge for the treatment and relief of sore throat symptoms in subjects diagnosed with a sore throat due to an upper respiratory tract infection (URTI). ⋯ The modest difference in the pattern of effectiveness between the two treatments observed in this study does not support use of the 8 mg lidocaine + 2 mg CPC lozenge.
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Elderly people have high rates of functional decline, which compromises independence, self-confidence, and quality of life (QoL). Physical exercise leads to significant improvements in strength, balance, functional mobility, and QoL, but there is still reduced access to this therapeutic strategy due to difficulties in locomotion to training centers or lack of adaptation to the exercise environment. ⋯ The lack of scientific evidence demonstrating the benefits of semi-supervised home exercise on functional mobility and QoL in elderly people represents an obstacle to the development of guidelines for clinical practice and for policy-makers. The World Health Organization highlighted the importance of musculoskeletal health programs for elderly people, and the exercise program described in this protocol was designed to be viable, easy to implement, and inexpensive, and could be performed at the home of elderly subjects after receiving only guidelines and follow-up via periodic visits. Based on these facts, we hope that this study will demonstrate that a well-structured, home-based exercise program can be effective in improving functional mobility and QoL of sedentary elderly people, even without constant supervision during exercise.
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Randomized Controlled Trial
Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial.
We investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale randomized controlled trial on this topic. ⋯ This pilot study has provided basic data for a larger clinical trial to demonstrate the efficacy and safety of TEA for chronic LBP.
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Trial participants in placebo groups report experiencing adverse events (AEs). Existing systematic reviews have not been synthesized, leaving questions about why these events occur as well as their prevalence across different conditions unanswered. ⋯ AEs in trial placebo groups are common and cannot be attributed entirely to natural history. Trial methodologies that reduce AEs in placebo groups while satisfying the requirement of informed consent should be developed and implemented.