Plos One
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Randomized Controlled Trial
Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study.
Continuous renal replacement therapy (CRRT) is considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care units (ICUs). However, the role of heparin anticoagulation, which is used to maintain circuit patency, is equivocal due to the risk of bleeding and morbidity. Among various alternative anticoagulants, nafamostat mesilate has been shown to be an effective anticoagulant in patients prone to bleeding. Hence, we conducted a prospective, randomized controlled study investigating the effect of nafamostat mesilate on mortality, CRRT filter life span and adverse events in patients with bleeding tendency. Seventy-three Patients were randomized into either the futhan or no-anticoagulation group. Thirty-six subjects in the futhan group received nafamostat mesilate, while thirty seven subjects in the no-anticoagulation group received no anticoagulants. Baseline characteristics and appropriate laboratory tests were taken from each group. The mortality between the two groups was not significantly different. Nevertheless, between the futhan group and the no-anticoagulation group, the overall number of filters used during CRRT (2.71 ± 2.12 vs. 4.50 ± 3.25; p = 0.042) and the number of filters changed due to clots per 24 hours (1.15 ± 0.81 vs. 1.74 ± 1.62; p = 0.040) were significantly different. When filter life span was subdivided into below and over 12 hours, the number of filters functioning over 12 hours was significantly higher in the futhan group than in the no-anticoagulation group (p = 0.037, odds ratio 1.84). There were no significant differences in transfusion, mortality, or survival between the two groups, and no adverse events related to nafamostat mesilate were noted. Hence, nafamostat mesilate may be used as an effective and safe anticoagulant, without increasing the risk of major bleeding complications, in patients prone to bleeding.
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Randomized Controlled Trial
Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial.
abstract summary error
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Randomized Controlled Trial
Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.
To evaluate the effects of study participation per se at the beginning of a sleep extension trial between screening, randomization, and the run-in visit. ⋯ Improvements in biochemical and behavioral parameters between screening and randomization changed the "true" study baseline, thereby potentially affecting outcome. While regression to the mean and placebo effect were considered, these findings are most consistent with the "Hawthorne effect", according to which behavior measured in the setting of an experimental study changes in response to the attention received from study investigators. This is the first time that biochemical changes were documented with respect to the Hawthorne effect. The findings have implications for the design and conduct of clinical research.
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Randomized Controlled Trial
Sleep dissolves illusion: sleep withstands learning of visuo-tactile-proprioceptive integration induced by repeated days of rubber hand illusion training.
Multisensory integration is a key factor in establishing bodily self-consciousness and in adapting humans to novel environments. The rubber hand illusion paradigm, in which humans can immediately perceive illusory ownership to an artificial hand, is a traditional technique for investigating multisensory integration and the feeling of illusory ownership. However, the long-term learning properties of the rubber hand illusion have not been previously investigated. ⋯ A significantly greater reduction in galvanic skin response was observed after wakefulness compared to after sleep. Our results suggest that although repetitive rubber hand illusion training facilitates multisensory integration and physiological habituation of a multisensory incongruent environment, sleep corrects illusional integration and habituation based on experiences in a multisensory incongruent environment. These findings may increase our understanding of adaptive neural processes to novel environments, specifically, bodily self-consciousness and sleep-dependent neuroplasticity.
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Randomized Controlled Trial
Effects of 1-year intervention with a Mediterranean diet on plasma fatty acid composition and metabolic syndrome in a population at high cardiovascular risk.
Metabolic syndrome (MetS) has become an important public concern due to its increasing prevalence. An altered fatty acid composition has been associated with MetS, but the Mediterranean diet has been shown to have a protective effect. The aim of the present study was to analyze the influence of a Mediterranean dietary pattern, as assessed by the biomarkers of food supplied, on the plasma fatty acid composition and its relation with MetS after 1 year of intervention. ⋯ The nut and olive oil diets induced a fatty acid composition that has been shown to be beneficial in the face of MetS. Therefore, a Mediterranean diet rich in fats of vegetable origin may be a useful tool for the management of MetS without the need for concerns over weight gain due to its high fat content.