Articles: human.
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Randomized Controlled Trial Multicenter Study
Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
Cardiosphere-derived cells (CDCs) ameliorate skeletal and cardiac muscle deterioration in experimental models of Duchenne muscular dystrophy. The HOPE-2 trial examined the safety and efficacy of sequential intravenous infusions of human allogeneic CDCs in late-stage Duchenne muscular dystrophy. ⋯ Capricor Therapeutics.
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Randomized Controlled Trial Comparative Study
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known. ⋯ First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).
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Randomized Controlled Trial
Prevention of violence against women and girls: A cost-effectiveness study across 6 low- and middle-income countries.
Violence against women and girls (VAWG) is a human rights violation with social, economic, and health consequences for survivors, perpetrators, and society. Robust evidence on economic, social, and health impact, plus the cost of delivery of VAWG prevention, is critical to making the case for investment, particularly in low- and middle-income countries (LMICs) where health sector resources are highly constrained. We report on the costs and health impact of VAWG prevention in 6 countries. ⋯ We demonstrate that investment in established community-based VAWG prevention interventions can improve population health in LMICs, even within highly constrained health budgets. However, several VAWG prevention interventions require further modification to achieve affordability and cost-effectiveness at scale. Broadening the range of social, health, and economic outcomes captured in future cost-effectiveness assessments remains critical to justifying the investment urgently required to prevent VAWG globally.
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Randomized Controlled Trial
A group-based mental health intervention for Tanzanian youth living with HIV: Secondary analysis of a pilot trial.
Youth living with human immunodeficiency virus (YLWH) are vulnerable to incomplete adherence to antiretroviral therapy in the context of stigma, decreased hope for future, and mental health challenges. Despite these challenges, few mental health interventions have been developed to support YLWH. Previous randomized results from the Sauti ya Vijana (SYV; "The Voice of Youth") mental health intervention were indicative of the intervention's benefits in promoting virologic suppression. ⋯ Despite the small sample size, findings from this study demonstrate that mental wellbeing may be an important pathway to improved HIV outcomes for YLWH. The same trend toward virologic suppression pre- to postintervention was demonstrated in the randomized pilot trial and suggests that SYV holds promise to improve HIV outcomes. Data from this analysis support the fully powered trial that is now underway.
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Randomized Controlled Trial
EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge.
Respiratory syncytial virus (RSV) infection causes substantial morbidity and mortality among infants, older adults, and immunocompromised adults. EDP-938, a nonfusion replication inhibitor of RSV, acts by modulating the viral nucleoprotein. ⋯ All EDP-938 regimens were superior to placebo with regard to lowering of the viral load, total symptom scores, and mucus weight without apparent safety concerns. (ClinicalTrials.gov number, NCT03691623.).