Articles: disease.
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Randomized Controlled Trial
Drug-coated balloon versus drug-eluting stent in acute myocardial infarction: A protocol for systematic review and meta-analysis.
Previous studies comparing the published literature on drug-eluting stents (DES) and drug-coated balloon (DCB) have drawn divergent conclusions, as these studies are limited by small sample sizes. To overcome these limitations, we thus conducted a high-quality systematic review and meta-analysis to assess the efficacy and safety of DCB versus DES for patients with acute myocardial infarction (AMI). It was hypothesized that DCB use at the AMI is associated with decreased risk of cardiovascular disease and death. ⋯ 10.17605/OSF.IO/AVTYW.
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Randomized Controlled Trial
The development of the cure of the functional intestinal disorder based on the differences of gut microbiota in aged patients: A randomized clinical trial.
Constipation, which is not an organic disease in the lower gastrointestinal tract, is a gastrointestinal symptom characteristic of elderly patients. Complaints of dyschezia increase with age, and it is difficult to treat in many cases. This study aimed to determine the appropriate treatment and its effects on intestinal immunity in elderly patients experiencing chronic constipation. ⋯ The results indicated that the improvement of intestinal flora was somewhat achieved by relieving constipation. Because intestinal bacteria significantly influence intestinal immunity and, thus, systemic immunity of the entire body, the development of better treatments for constipation would help to improve both the intestinal environment and immune function in the elderly.
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Randomized Controlled Trial Multicenter Study
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.
At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported. ⋯ The mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).
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Randomized Controlled Trial Multicenter Study
Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial.
The optimal dose and duration of oral amoxicillin for children with community-acquired pneumonia (CAP) are unclear. ⋯ Among children with CAP discharged from an emergency department or hospital ward (within 48 hours), lower-dose outpatient oral amoxicillin was noninferior to higher dose, and 3-day duration was noninferior to 7 days, with regard to need for antibiotic re-treatment. However, disease severity, treatment setting, prior antibiotics received, and acceptability of the noninferiority margin require consideration when interpreting the findings.
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Randomized Controlled Trial
Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study.
Alagille syndrome is a rare genetic disease that often presents with severe cholestasis and pruritus. There are no approved drugs for management. Maralixibat, an apical, sodium-dependent, bile acid transport inhibitor, prevents enterohepatic bile acid recirculation. We evaluated the safety and efficacy of maralixibat for children with cholestasis in Alagille syndrome. ⋯ Mirum Pharmaceuticals.