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The trustworthiness of registered randomised control trials on hysteroscopy.
Eur J Obstet Gynecol Reprod Biol
December 2024
Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia; Monash Women's, Monash Health, Clayton, Victoria, Australia; Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK. Electronic address:
Introduction: The objective of this study was to assess the publication status of RCTs studying hysteroscopy registered on clinical trial registries, and the trustworthiness of these studies.
Material And Methods: We systematically searched 23 clinical trial registries and MEDLine for studies on hysteroscopy registered between March 2012 and 25 March 2022. Published RCTs were assessed for trustworthiness using the Trustworthiness in RAndomised Controlled Trials (TRACT) checklist.
Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000-20: a retrospective analysis.
Lancet
January 2025
Centre for Health System Sustainability, School of Public Health, Brown University, Providence, RI, USA.
Background: Health systems experience difficult trade-offs when paying for new drugs. In England, funding recommendations by the National Institute for Health and Care Excellence (NICE) for new drugs might generate health gains, but inevitably result in forgone health as the funds cannot be used for alternative treatments and services. We aimed to evaluate the population-health impact of NICE recommendations for new drugs during 2000-20.
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Bone Marrow Transplant
December 2024
Servicio de hematologia, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS)/CSIC, Universidad de Sevilla, Sevilla, Spain.
Ruxolitinib has been approved for the treatment of adults and pediatric patients ≥12 years with steroid refractory graft-versus-host disease (GvHD). However, real-life studies are needed to confirm the results of clinical trials and further assess its efficacy in special populations. We performed a descriptive, retrospective, multi-center study of 352 adults and 42 pediatric patients treated with ruxolitinib for steroid-refractory acute or chronic GvHD.
View Article and Find Full Text PDFBarnidipine as a potential alternative treatment for Raynaud's phenomenon secondary to systemic sclerosis: a retrospective pilot study.
Clin Rheumatol
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Rheumatology Unit, Department of Medicine, University of Verona, P.le L.A. Scuro 10, 37134, Verona, Italy.
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Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.
Clin Pharmacol Ther
November 2024
Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.
New drug applications (NDAs) in Japan are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA). Those that pass the review are subsequently subject to deliberation by the Ministry of Health, Labour and Welfare Pharmaceutical Affairs and Food Sanitation Councils (MHLW-PAFSC), and the MHLW legislatively grants approval based on its positive opinions. However, little is known regarding the relationship between the PMDA review and the MHLW decision.
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