Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial
This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled.The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery quest...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials
Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesConsidering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.Trial designThe study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.ParticipantsAll asymptomatic patients with ho...
Source: Trials - September 15, 2021 Category: Research Source Type: clinical trials
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
Conditions: Acute Coronary Syndrome; Myocardial Infarction, Acute Intervention: Other: Community education Sponsors: Monash University; National Heart Foundation, Australia; Department of Health, Victorian Government; Ambulance Victoria Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 9, 2021 Category: Research Source Type: clinical trials
Resiliency Engagement and Care in Health (REaCH): a telephone befriending intervention for upskilled rural youth in the context of COVID-19 pandemic —study protocol for a multi-centre cluster randomised controlled trial
This study aims to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilise social support from family, friends and significant others by using the telephonic befriending intervention.MethodsIn this article, we report the design and protocol of a multi-centre cluster randomised controlled trial. In total, 1440 participants aged 18 –35 years who have recently completed their course out of the DDU-GKY initiative will be recruited in the study from 12 project-implementing agencies (PIAs) across six geographical zones of India. Participants from 6 of these agencies will be assigned to the...
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials
A randomized open-label trial to evaluate the efficacy and safety of triple therapy with aspirin, atorvastatin, and nicorandil in hospitalised patients with SARS Cov-2 infection: A structured summary of a study protocol for a randomized controlled trial
AbstractObjectivesThe pathophysiology of SARS-Cov-2 is characterized by inflammation, immune dysregulation, coagulopathy, and endothelial dysfunction. No single therapeutic agent can target all these pathophysiologic substrates. Moreover, the current therapies are not fully effective in reducing mortality in moderate and severe disease. Hence, we aim to evaluate the combination of drugs (aspirin, atorvastatin, and nicorandil) with anti-inflammatory, antithrombotic, immunomodulatory, and vasodilator properties as adjuvant therapy in covid- 19.Trial designSingle-centre, prospective, two-arm parallel design, open-label random...
Source: Trials - July 15, 2021 Category: Research Source Type: clinical trials
Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treatment of Mild to Moderate COVID-19
KENILWORTH, N.J.--(BUSINESS WIRE) June 9, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482).... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 9, 2021 Category: Pharmaceuticals Source Type: clinical trials
Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial
AbstractObjectivesPrimary Objective• To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness.Secondary Objective• To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19Trial designMulti-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant.ParticipantsPatients of either se...
Source: Trials - June 3, 2021 Category: Research Source Type: clinical trials
