Articles: function.
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Randomized Controlled Trial
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population. We aimed to substantiate this post-hoc result and assess safety and efficacy of edaravone in a phase 3 trial that focused on patients with early stage ALS who met the post-hoc analysis inclusion criteria. ⋯ Mitsubishi Tanabe Pharma Corporation.
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Randomized Controlled Trial
Goal-directed Fluid Therapy Does Not Reduce Primary Postoperative Ileus after Elective Laparoscopic Colorectal Surgery: A Randomized Controlled Trial.
Inadequate perioperative fluid therapy impairs gastrointestinal function. Studies primarily evaluating the impact of goal-directed fluid therapy on primary postoperative ileus are missing. The objective of this study was to determine whether goal-directed fluid therapy reduces the incidence of primary postoperative ileus after laparoscopic colorectal surgery within an Enhanced Recovery After Surgery program. ⋯ Intraoperative goal-directed fluid therapy compared with fluid therapy based on traditional principles does not reduce primary postoperative ileus in patients undergoing laparoscopic colorectal surgery in the context of an Enhanced Recovery After Surgery program. Its previously demonstrated benefits might have been offset by advancements in perioperative care.
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Randomized Controlled Trial Multicenter Study Comparative Study
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial.
The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. ⋯ The BaSICS trial will provide robust evidence on whether a balanced crystalloid, compared with saline, improves important patient outcomes in critically ill patients. BaSICS will also provide relevant information on whether bolus infusion rate affects outcomes in this population.
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Randomized Controlled Trial
Mindfulness-based Intervention does not Influence Cardiac Autonomic Control or Pattern of Physical Activity in Fibromyalgia During Daily Life: An Ambulatory, Multi-measure Randomized Controlled Trial.
Fibromyalgia (FM) is a syndrome characterized by severe pain, fatigue and sleep disturbance. There is evidence of central hyper-responsiveness to sensory stimulation and impaired cardiovascular autonomic control. Laboratory investigations suggest that mindfulness-based stress reduction (MBSR) may improve autonomic functioning in FM. However, these findings may not reflect what occurs during naturalistic conditions, and MBSR studies during real-life functioning are lacking. We conducted a randomized controlled, 3-armed study with 168 female FM patients. This report describes cardiac, respiratory, and physical activity findings. ⋯ MBSR did not produce cardiac autonomic benefits or changes in daily activity in FM. Furthermore, the lack of an association between patient-experienced clinical improvement and objective physiological measures suggests that subjective changes in the wellbeing of FM patients over time are not related to alterations in the cardiorespiratory autonomic function or activity levels.
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Randomized Controlled Trial Multicenter Study
A tailored guided internet-based cognitive-behavioral intervention for patients with rheumatoid arthritis as an adjunct to standard rheumatological care: Results of a randomized controlled trial.
For patients with chronic pain conditions such as rheumatoid arthritis (RA), who experience elevated levels of distress, tailored-guided internet-based cognitive-behavioral treatment may be effective in improving psychological and physical functioning, and reducing the impact of RA on daily life. A multicenter, randomized controlled trial was conducted for RA patients with elevated levels of distress as assessed by a disease-specific measure. The control group (n = 71) received standard care and the intervention group (n = 62) additionally received an internet-based tailored cognitive-behavioral intervention. ⋯ No effects were found for the impact of RA on daily life, except for the intervention group experiencing fewer role limitations due to emotional problems (P < 0.001, d = 0.53). Offering guided internet-based cognitive-behavioral therapy is a promising development to aid patients with psychological distress particularly in improving psychological functioning. Further research on adherence and specific intervention ingredients is warranted.