Articles: human.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study.
Mirikizumab, a humanised monoclonal antibody that inhibits IL-23p19, is effective in moderate-to-severe ulcerative colitis. We aimed to evaluate the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease. ⋯ Eli Lilly and Company.
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Randomized Controlled Trial Multicenter Study Comparative Study
Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer.
Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy. ⋯ Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.).
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The lancet oncology · Dec 2024
Multicenter StudyValemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study.
Few treatment options exist for patients with non-Hodgkin lymphoma, and outcomes remain poor for relapsed or refractory disease. We evaluated the safety and preliminary clinical activity of valemetostat, a novel inhibitor of EZH2 and EZH1, in patients with relapsed or refractory non-Hodgkin lymphomas. ⋯ Daiichi Sankyo.
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Anesthesia and analgesia · Nov 2024
Multicenter StudyContribution of Coordination Theories to the Determination of Human Factors Associated With Operating Room Perceived Performance.
The efficient and fluid organization of surgical interventions in an operating room (OR) and operating suite (OS) is important as these are among the most expensive units to run in medical-surgical facilities. The complexity of OS organization requires careful coordination, defined here as the directing of individuals' efforts toward achieving common and explicitly recognized goals. There is currently sparse literature on OS coordination, especially in the French context. This study aimed to respond to this gap by reporting on the coordination mechanisms associated with the perceived performance of OS across 4 facilities in an urban setting in France. ⋯ Based on existing literature on multi-team systems (as represented in the OS organization), this study identifies success factors influencing OS coordination. These include the OS manager's leadership skills; the identification of formal system objectives; and professional differentiation between stakeholders (absence/decrease of a sense of belonging to a multi-team system). This differentiation was related to the high degree of specialization within OS teams, each bringing different norms, cultures, and contingencies that induce dissonance in organization and task performance. Interventions targeting these success factors might improve coordination, and thus performance, in the OS.
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Randomized Controlled Trial Multicenter Study Comparative Study
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women.
There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women. ⋯ No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.).