Articles: disease.
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Randomized Controlled Trial
Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: a randomised, double-blind, phase 2b trial.
Bordetella pertussis epidemics persist as transmission remains unabated despite high acellular pertussis vaccination rates. BPZE1, a live attenuated intranasal pertussis vaccine, was designed to prevent B pertussis infection and disease. We aimed to assess the immunogenicity and safety of BPZE1 compared with the tetanus-diphtheria-acellular pertussis vaccine (Tdap). ⋯ ILiAD Biotechnologies.
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Randomized Controlled Trial
Effect of summer acupoint application treatment (SAAT) on gut microbiota in healthy Asian adults: A randomized controlled trial.
Acupoint application has served as an important complementary and adjunctive therapy in China. The purpose of this study is to explore the impact of summer acupoint application treatment (SAAT) on the abundance and biological structure of gut microbiota in healthy Asian adults. Based on the CONSORT guidelines, 72 healthy adults were included in this study, randomly divided into 2 groups, receiving either traditional (acupoint application within known relevant meridians, Group A) or sham (treated with placebo prepared by mixing the equal amount of starch and water, Group B) SAAT. ⋯ At the genus level, the relative abundance of Faecalibacterium and Subdoligranulum species in the 2 groups were all significantly increased (P < .05). In addition, a significant reduction in the relative abundance of Blautia, Bacteroides, and Dorea in Group A (P < .05) and Eubacterium hallii group and Anaerostipes (P < .05) in Group B was observed after treatment. Our findings indicated SAAT substantially influenced the bacterial community structure in the gut microbiota of healthy Asian adults, which might serve as potential therapeutic targets for related diseases, and provided a foundation for future studies aimed at elucidating the microbial mechanisms underlying SAAT for the treatment of various conditions such as obesity, insulin resistance, irritable bowel syndrome.
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Randomized Controlled Trial
Phase I cardiac rehabilitation with 5-phase music after emergency percutaneous coronary intervention for acute myocardial infarction: A prospective randomized study.
Five-phase music therapy was reported to be effective in the treatment and rehabilitation of several diseases. This study explored the effect of phase I cardiac rehabilitation combined with 5-phase music in acute myocardial infarction (AMI) patients after emergency percutaneous coronary intervention. ⋯ Phase I cardiac rehabilitation combined with 5-phase music could alleviate anxiety and depression and improve sleep quality.
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Randomized Controlled Trial Multicenter Study
Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection.
Although symptom and viral rebound have been reported after nirmatrelvir-ritonavir treatment, the trajectories of symptoms and viral load during the natural course of COVID-19 have not been well described. ⋯ National Institute of Allergy and Infectious Diseases.
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Randomized Controlled Trial Multicenter Study
A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part).
Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies of ensitrelvir have demonstrated promising results in treating mild-to-moderate COVID-19, evaluation of its clinical efficacy due to shifting vaccination status and emergence of the Omicron variant represents significant challenges. Here, we describe the protocol for a phase 3 study designed to evaluate the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19, regardless of risk status or vaccination history. ⋯ In a post hoc analysis of the phase 2b study, compared with placebo, ensitrelvir demonstrated a reduced time to resolution of 5 symptoms in patients with mild-to-moderate COVID-19. Through this study, we intend to validate and establish the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19.