Cepharanthine (CEP) is a natural remedy that potently inhibits SARS-CoV-2 activity both in vitro and in vivo. To evaluate the efficacy and safety of CEP compared with placebo in adults with asymptomatic or mild coronavirus disease 2019 (COVID-19), we conducted a proof-of-concept, double-blind, randomized, placebo-controlled trial. Patients were randomized to receive 120 mg/day of CEP, 60 mg/day CEP or placebo for 5 days.
View Article and Find Full Text PDFObjectives: This study aimed to evaluate the therapeutic effect of suraxavir marboxil (GP681, abbreviated as suraxavir) in adults with uncomplicated influenza.
Methods: We conducted a multi-centre randomized, double-blind, placebo-controlled phase 2 trial in 18 Chinese centres. Participants had to be aged 18 to 65 years with a positive influenza test, presenting with at least one influenza systemic and respiratory symptom in at least moderate severity within 48 hours of onset.
Background: Ovarian cancer (OC) is a heterogeneous malignancy with multiple histological subtypes, showing global variability in incidence. Temporal changes in diagnostic criteria and risk factors might influence the incidence and distribution of OC and its subtypes.
Methods: This study analyzed incidence patterns (2013-2017) and trends (1988-1992 to 2013-2017) of OC and its subtypes across 65 and 40 countries, respectively.
This paper aims to present a Statistical Analysis Software (SAS) macro %BBIplus, offering estimation and visualisation methods for the Bang's Blinding Index (BBI) for randomised controlled trials (RCTs) with various designs. We developed the SAS macro programme %BBIplus to facilitate the implementation of BBI. This user-friendly programme allows for easy and rapid estimation and visualisation of BBI across different scenarios, including pairwise comparison RCTs with two arms, double-dummy design RCTs with three arms and factorial design RCTs with four arms.
View Article and Find Full Text PDFBackground: Burns carries a high risk of severe physical damage, prolonged recovery, and mental health implications for both patients and their caregivers. While distress among caregivers of burn patients has been studied, less attention has been given to potential positive psychological changes. This study focuses on the prevalence, temporal dynamics, and predictors of posttraumatic growth (PTG) among caregivers.
View Article and Find Full Text PDFBackground: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed.
View Article and Find Full Text PDFPurpose: To evaluate the safety and efficacy of a next-generation, all-suture anchor in patients undergoing arthroscopic repair of rotator cuff tears, compared with that of an established solid suture anchor.
Methods: Between April 2019 and January 2021, a prospective, comparative, randomized controlled noninferiority study conducted on people with Chinese ethnicity at 3 tertiary hospitals enrolled patients (18-75 years) requiring arthroscopic treatment for rotator cuff tears. Patients were randomized into 2 cohorts receiving either all-suture anchor or solid suture anchor and followed for 12 months.
Background: Medication nonadherence is a significant public health problem as it contributes to poor clinical outcomes and increased healthcare costs. Older patients with multimorbidity and polypharmacy often have low medication adherence. These patients also have a high prevalence of potentially inappropriate medication (PIM) use.
View Article and Find Full Text PDFBackground: Delirium is a common and serious postoperative complication, especially in the elderly. Epidural anesthesia may reduce delirium by improving analgesia, reducing opioid consumption, and blunting stress response to surgery. This trial therefore tested the hypothesis that combined epidural-general anesthesia reduces the incidence of postoperative delirium in elderly patients recovering from major noncardiac surgery.
View Article and Find Full Text PDFSignal Transduct Target Ther
February 2021
Treatment of severe Coronavirus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage.
View Article and Find Full Text PDFImportance: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, And Participants: Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020.
: Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. : A prospective, randomized, open-label clinical trial was performed to compare the geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies elicited by the inactivated vaccines Healive and Havrix.
View Article and Find Full Text PDFBlind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group.
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