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From Paper to Digital: Evaluating Electronic Medical Records and their Compliance with EMA Guidelines in European Clinical Trials.
Rev Recent Clin Trials
January 2025
Dipartimento Patologia e Cura del Bambino, Regina Margherita AOU Città della Salute e della Scienza di Torino, Presidio Infantile Regina Margherita, Turin, Italy.
Background: Over the past decade, there has been a significant shift from paper-based to digital medical record management, driven largely by advances in digital technology. This transition has led to widespread adoption of Electronic Medical Records (EMRs), with the expectation that paper documentation will soon be fully replaced. In response, the European Medicines Agency's "Guideline on Computerised Systems in Clinical Trials" outlines essential criteria for validated EMR systems to ensure data integrity and security, and sets standards for electronic source documents in clinical trials.
View Article and Find Full Text PDFOrganosulfur Compounds in Garlic for Gastric Cancer Treatment: Anticancer Effects, Overcoming Drug Resistance, and Mechanisms.
Recent Pat Anticancer Drug Discov
January 2025
Tianjin Key Laboratory for Modern Drug Delivery & High-Efficiency, School of Pharmaceutical Science and Technology, Faculty of Medicine, Tianjin University, Tianjin, 300072, P.R. China.
Garlic has been consumed globally as a functional food and traditional medicine for various ailments. Its active organosulfur compounds (OSCs) have demonstrated significant anticancer properties, particularly against gastric cancer. However, a comprehensive review of these effects and the underlying molecular mechanisms, including their role in overcoming drug resistance, is currently lacking.
View Article and Find Full Text PDFEvaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with Amyotrophic Lateral Sclerosis (ALS) by Investigating Patient's Specific microRNAs as Novel Biomarkers: A Clinical Trial Study.
Curr Stem Cell Res Ther
January 2025
Department of Immunology, Immunology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Background: Since there is currently no cure for amyotrophic lateral sclerosis (ALS), it is essential to search for diagnostic biomarkers and novel treatments to reduce the severity of this disease. One of these treatment approaches is stem cell transplantation.
Objective: This study aims to evaluate the safety and efficacy of repeated transplantation of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with ALS by analyzing clinical and molecular data.
Challenges for switching central nervous system and psychiatric medication products: A review of the literature.
J Psychopharmacol
January 2025
Department of Psychiatry, McGill University, Montreal, QC, Canada.
Background: Switching between versions of medication products happens commonly despite challenges in achieving bioequivalence and therapeutic equivalence. Central nervous system and psychiatric drugs, especially those that are technically demanding to manufacture and have complex pharmacokinetic properties, such as long-acting injectables (LAIs), pose particular challenges to bioequivalence and safe and efficacious drug switching.
Aims: To assess whether drugs deemed "bioequivalent" are truly interchangeable in drug switching.
Effect of Social Restriction Due to the COVID-19 Pandemic on Activity of Daily Living and Disease Severity of Patients With Alzheimer Disease: Sub-analysis of a Double-blinded Noninferiority Study of Donepezil Patches and Donepezil Tablets.
Alzheimer Dis Assoc Disord
January 2025
Teikoku Seiyaku, Higashikagawa, Japan.
Background: We previously reported that social restrictions due to the COVID-19 pandemic led to a decline in cognitive function in patients with Alzheimer disease (AD). Here, we assessed the effects of COVID-19 restrictions on the activities of daily living (ADL) and disease severity in patients by comparing them to a control group.
Methods: We examined the impact on ADL, evaluated using disability assessment for dementia (DAD), and disease severity, evaluated using the ABC dementia scale, in patients with mild-to-moderate AD.
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