Articles: adult.
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Randomized Controlled Trial Multicenter Study
Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Healthy Children and Adults in Dengue-Endemic Regions: A Randomized, Placebo-Controlled Phase 2 Study.
A safe, effective tetravalent dengue vaccine is a global health priority. The safety and immunogenicity of a live attenuated, recombinant tetravalent dengue vaccine candidate (TDV) were evaluated in healthy volunteers from dengue-endemic countries. ⋯ TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure.
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Randomized Controlled Trial Multicenter Study
Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.
The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. ⋯ Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group. (AUSTRI ClinicalTrials.gov number, NCT01475721.).
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Randomized Controlled Trial
Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh.
A single-dose regimen of the current killed oral cholera vaccines that have been prequalified by the World Health Organization would make them more attractive for use against endemic and epidemic cholera. We conducted an efficacy trial of a single dose of the killed oral cholera vaccine Shanchol, which is currently given in a two-dose schedule, in an urban area in which cholera is highly endemic. ⋯ A single dose of the oral cholera vaccine was efficacious in older children (≥5 years of age) and in adults in a setting with a high level of cholera endemicity. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT02027207.).
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Randomized Controlled Trial
Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture.
Topical anesthetics are used to decrease procedural pain such as venipuncture. Advantages of vapocoolants include rapid onset, ease of application, low cost, and lack of associated pain of injection and other needlestick-related risks. We hypothesized that the pain of venipuncture would be reduced by at least 1.8 points on a 10-point numerical rating scale after application of a vapocoolant compared with placebo. ⋯ The vapocoolant significantly decreased venipuncture pain in adults compared with placebo and was well tolerated with minor adverse effects that resolved quickly. There were no significant differences in VS and no visible skin changes documented at the site by photographs taken within 5 to 10 minutes postspray/venipuncture.
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Randomized Controlled Trial Multicenter Study
Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential.
To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology. ⋯ Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.