Articles: outcome-assessment-health-care.
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Randomized Controlled Trial
Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.
Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. ⋯ US National Institutes of Health, the Cathy Donnellan, Albert E Einstein, and Birdie W Einstein Fund, and the William Merz Professorship.
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Randomized Controlled Trial
The Dose-Dependent Effects of Ketoprofen on Dynamic Pain after Open Heart Surgery.
Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce postoperative pain, in both static (i.e., at rest) and dynamic contexts (e.g., during coughing or mobilization), and reduced doses could improve their efficacy/tolerance balance. ⋯ Although we failed to demonstrate any analgesic effects with low doses of ketoprofen, we confirmed the good efficacy/tolerance balance with this propionic NSAID of intermediate COX2-selectivity. Lower doses of NSAIDs, potentiated by a loading dose, should be tested in the future.IRB approval: CPP Sud-Est VI (Clermont-Ferrand, France), on 12/23/2013.Clinical trial registry: EudraCT (2013-003878-27); ClinicalTrials.gov (NCT02180087).Key words: Non-steroidal anti-inflammatory drugs, ketoprofen, cyclooxygenase, pain, postoperative, sternotomy, postoperative rehabilitation, analgesia, side effects.
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Journal of neurotrauma · Sep 2017
Randomized Controlled TrialRed blood cell transfusion guided by near infrared spectroscopy in neurocritically ill patients with moderate or severe anaemia.
In neurocritically ill patients (NCPs), the use of hemoglobin level as the sole indicator for red blood cell transfusion (RBCT) can result in under- or over-transfusion. This randomized controlled trial was conducted to ascertain whether a transcranial oxygen saturation (rSO2) threshold, as measured by near-infrared spectroscopy, reduces RBCT requirements in anemic NCPs (closed traumatic brain injury, subarachnoid, or intracerebral hemorrhage), compared with a hemoglobin threshold alone. Patients with hemoglobin 70-100 g/L received RBCTs to attain an rSO2 > 60% (rSO2 arm) or to maintain hemoglobin between 85 and 100 g/L (hemoglobin arm). ⋯ There were no differences between the study arms regarding the percentage of transfused patents (59% vs. 71%; relative risk 0.83 [95% CI 0.62-1.11]), stay on neurocritical care unit (21 vs. 20 days), unfavorable Glasgow Outcome Scale scores on hospital discharge (57% vs. 71%), in-hospital mortality (6% vs. 10%), or 1 year mortality (24% vs. 24%). Among NCPs with hemoglobin concentrations of 70-85 g/L, withholding transfusion until rSO2 is <60% may result in reduced RBCs requirements compared with routinely transfusing to attain a hemoglobin level >85 g/L. Further studies are required to confirm this finding and its possible impact on clinically significant outcomes.
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Randomized Controlled Trial
Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial.
Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. ⋯ French Ministry of Health.
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The lancet oncology · Aug 2017
Randomized Controlled Trial Multicenter Study Comparative StudyNivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial.
Patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options and poor prognosis. Nivolumab significantly improved survival of this patient population when compared with standard single-agent therapy of investigator's choice in Checkmate 141; here we report the effect of nivolumab on patient-reported outcomes (PROs). ⋯ Bristol-Myers Squibb.