Trials
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Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience.
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Letter Multicenter Study
Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada.
Primary Objective: To determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily reduces microbiologically confirmed COVID-19 among front line health care workers at high risk for SARS-CoV-2 exposure. Secondary Objectives: To compare the following between study arms: adverse events; symptomatic COVID-19; duration of symptomatic COVID-19; days hospitalized attributed to COVID-19; respiratory failure attributable to COVID-19 requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; mortality attributed to COVID-19, number of days unable to work attributed to COVID-19, seroconversion (COVID-19 negative to COVID-19 positive over the study period); ability of participant plasma to neutralize SARS-CoV-2 virus in vitro; To describe short-term psychological distress associated with risk of COVID-19 exposure at 1, 60, 120 days of the study. To explore laboratory markers within participants with confirmed COVID-19: including circulating markers of host immune and endothelial activation in participant plasma and their correlation with disease severity and outcome TRIAL DESIGN: The HEROS study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), placebo controlled, participant and investigator-blinded, multi-site superiority trial of oral HCQ 400 mg taken once daily for 90 days as PrEP to prevent COVID-19 in health care workers at high risk of SARS-CoV-2 exposure. At 90 days, there is an open label extension wherein all participants are offered a one-month course of HCQ 400mg once daily for PrEP of COVID-19. ⋯ All participants, research coordinators, technicians, clinicians and investigators will be blinded to the participant allocation group. Numbers to be randomised (sample size) N=988, randomised into two groups of 494 patients.
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Delirium is an acute status of brain dysfunction that commonly occurs in patients who have undergone cardiac surgery, and increases morbidity and mortality. It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia. Dexmedetomidine infusion might exert a neuroprotective effect. However, the effect of perioperative administration of dexmedetomidine on the incidence of postoperative delirium (POD) in patients undergoing cardiac or non-cardiac surgery is yet controversial. The present study aimed to reveal the effect of intraoperative dexmedetomidine administration on the incidence of delirium in adult patients following cardiac surgery. ⋯ This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180). The results will be disseminated at academic conferences and submitted to peer-reviewed publications. Either positive or negative results will provide guidance for clinical practice.
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Primary Objective • To evaluate the effect of ravulizumab, a long-acting complement (C5) inhibitor plus best supportive care (BSC) compared with BSC alone on the survival of patients with COVID-19. Secondary Objectives • Number of days free of mechanical ventilation at Day 29 • Duration of intensive care unit stay at Day 29 • Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 29 • Change from baseline in peripheral capillary oxygen saturation/ fraction of inspired oxygen (SpO2 /FiO2) at Day 29 • Duration of hospitalization at Day 29 • Survival (based on all-cause mortality) at Day 60 and Day 90 Safety • Incidence of treatment-emergent adverse events and treatment-emergent serious adverse events. PK/PD/Immunogenicity • Change in serum ravulizumab concentrations over time • Change in serum free and total C5 concentrations over time • Incidence and titer of anti-ALXN1210 antibodies Biomarkers • Change in absolute level of soluble biomarkers in blood associated with complement activation, inflammatory processes, and hypercoagulable states over time Exploratory • Incidence of progression to renal failure requiring dialysis at Day 29 • Time to clinical improvement (based on a modified 6-point ordinal scale) over 29 days • SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores at Day 29 (or discharge), Day 60, and Day 90 • EuroQol 5-dimension 5-level (EQ-5D-5L) scores at Day 29 (or discharge), Day 60, and Day 90 TRIAL DESIGN: This is a multicenter Phase 3, open-label, randomized, controlled, study. The study is being conducted in acute care hospital settings in the United States, United Kingdom, Spain, France, Germany, and Japan. ⋯ Patients will be randomized in a 2:1 ratio (ravulizumab plus BSC:BSC alone). Randomization will be stratified by intubated or not intubated on Day 1. Computer-generated randomization lists will be prepared by a third party under the direction of the sponsor. Investigators, or designees, will enrol patients and then obtain randomization codes using an interactive voice/web response system. The block size will be kept concealed so that investigators cannot select patients for a particular treatment assignment. Blinding (masking): This is an open-label study. Numbers to be randomised (sample size): Approximately 270 patients will be randomly assigned in a 2:1 ratio to ravulizumab plus BSC (n=180) or BSC alone (n=90).
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The proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater reliance on in-home services, hospitalization, institutionalization, and premature mortality. The purpose of this study is to determine the effects of an intervention with high-protein diet alone or in combination with power training in pre-frail and frail old adults. ⋯ The finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.