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Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement.
Front Med (Lausanne)
January 2025
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.
View Article and Find Full Text PDFHigher monomeric C-reactive protein levels are associated with premature coronary artery disease.
Front Immunol
January 2025
Laboratory of Cell Hemostasis, Chazov National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.
Introduction: Chronic inflammation is a major risk factor for coronary artery disease (CAD). Currently, the inflammatory cardiovascular risk is assessed via C-reactive protein (CRP) levels measured using a high-sensitivity assay (hsCRP). Monomeric CRP (mCRP) is a locally produced form of CRP that has emerged as a potential biomarker of inflammation.
View Article and Find Full Text PDFCD56 CD16 cells represent a distinct mature NK cell subset with altered phenotype and are associated with adverse clinical outcome upon expansion in AML.
Front Immunol
January 2025
Team Immunity and Cancer, Cancer Research Center of Marseille (CRCM), Inserm U1068, CNRS UMR7258, Paoli-Calmettes Institute, University of Aix-Marseille UM105, Marseille, France.
Introduction: Acute myeloid leukemia (AML) is a rare haematological cancer with poor 5-years overall survival (OS) and high relapse rate. Leukemic cells are sensitive to Natural Killer (NK) cell mediated killing. However, NK cells are highly impaired in AML, which promote AML immune escape from NK cell immune surveillance.
View Article and Find Full Text PDFOptimizing care for gastric cancer with overt bleeding: Is systemic therapy a valid option?
World J Clin Oncol
January 2025
Department of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA 30303, United States.
Gastric cancer (GC) and gastroesophageal junction cancer (GEJC) represent a significant burden globally, with complications such as overt bleeding (OB) further exacerbating patient outcomes. A recent study by Yao evaluated the effectiveness and safety of systematic treatment in GC/GEJC patients presenting with OB. Using propensity score matching, the study balanced the comparison groups to investigate overall survival and treatment-related adverse events.
View Article and Find Full Text PDFA novel machine learning based framework for developing composite digital biomarkers of disease progression.
Front Digit Health
January 2025
Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, NJ, United States.
Background: Current methods of measuring disease progression of neurodegenerative disorders, including Parkinson's disease (PD), largely rely on composite clinical rating scales, which are prone to subjective biases and lack the sensitivity to detect progression signals in a timely manner. Digital health technology (DHT)-derived measures offer potential solutions to provide objective, precise, and sensitive measures that address these limitations. However, the complexity of DHT datasets and the potential to derive numerous digital features that were not previously possible to measure pose challenges, including in selection of the most important digital features and construction of composite digital biomarkers.
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