Lancet
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial.
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. ⋯ Pfizer Inc.
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Randomized Controlled Trial Multicenter Study
Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial.
Organ preservation is a concept proposed for patients with rectal cancer after a good clinical response to neoadjuvant chemotherapy, to potentially avoid morbidity and side-effects of rectal excision. The objective of this study was to compare local excision and total mesorectal excision in patients with a good response after chemoradiotherapy for lower rectal cancer. ⋯ National Cancer Institute of France, Sanofi, Roche Pharma.
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Lifelong antiplatelet treatment is recommended after ischaemic vascular events, on the basis of trials done mainly in patients younger than 75 years. Upper gastrointestinal bleeding is a serious complication, but had low case fatality in trials of aspirin and is not generally thought to cause long-term disability. Consequently, although co-prescription of proton-pump inhibitors (PPIs) reduces upper gastrointestinal bleeds by 70-90%, uptake is low and guidelines are conflicting. We aimed to assess the risk, time course, and outcomes of bleeding on antiplatelet treatment for secondary prevention in patients of all ages. ⋯ Wellcome Trust, Wolfson Foundation, British Heart Foundation, Dunhill Medical Trust, National Institute of Health Research (NIHR), and the NIHR Oxford Biomedical Research Centre.
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Randomized Controlled Trial Multicenter Study
Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.
Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABAA) receptors, for the treatment of post-partum depression. ⋯ Sage Therapeutics, Inc.
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According to life history theory, increased investment in reproductive function (physiology and behaviour) at different times throughout the life course affects the risk of many diseases and, ultimately, longevity. Although genetic factors contribute to interindividual and interpopulation variation in reproductive traits, the dominant source of variability is phenotypic plasticity during development and adult life. ⋯ Conversely, increased investment in reproductive function might compromise somatic investment in health, such that faster sexual maturation and higher parity increases risk of diabetes and cardiovascular disease. An evolutionary perspective on reproductive biology could improve the efficacy of public health efforts to reduce the risk of hormone-sensitive cancers and other non-communicable diseases.