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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 PDFLong-Term Blood Pressure Trends After a Remote Hypertension Intervention: A Secondary Analysis of the Digital Care Transformation: Remotely Delivered Hypertension Management Program.
Hypertension
January 2025
Accelerator for Clinical Transformation, Brigham and Women's Hospital, Boston, MA. (S.H., A.J.B., D.Z., S.K., K.W., D.G., C.P.C., B.M.S.).
Background: Hypertension is a major cardiovascular risk factor, yet traditional care often results in suboptimal blood pressure (BP) control at the population level. We implemented a remote hypertension management program that monitored home BP and titrated medications per algorithm. This study assessed the program's long-term effects by examining participants' office BP up to 42 months post-enrollment.
View Article and Find Full Text PDFClinicopathologic Features and Viral Status of Low-risk HPV6 and HPV11-Associated Squamous Cell Carcinoma of the Uterine Cervix and Vulva.
Am J Surg Pathol
January 2025
Department of Pathology.
Despite being designated as "noncarcinogenic" human papillomavirus (HPV) types, mono-infection with HPV6 or HPV11 has been found in squamous cell carcinomas (SCCs) at specific sites, including the larynx, penis, anus, and rarely, the lower female genital tract. The association between clinicopathologic features, viral status, and the carcinogenic mechanisms related to these low-risk HPVs remains unclear. The current study characterizes a series of low-risk HPV6 and HPV11-associated SCCs of the uterine cervix (6 cases) and vulva (2 cases).
View Article and Find Full Text PDFOccupational Performance in the Discipline of Occupational Therapy During COVID-19 at a Public University in KwaZulu-Natal.
Occup Ther Int
January 2025
Discipline of Occupational Therapy, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.
The application of the person-environment-occupation-performance (PEOP) model in occupational therapy education offers valuable insights into the interaction between person, environment, and occupational factors and how these elements influenced the strategies used to adapt and navigate the transformation of health professions education during the COVID-19 pandemic. This study explored how individual characteristics, contextual demands, and the nature of educational occupations shaped the adaptation and performance of educators and students. The study used a qualitative, exploratory research design at a public higher education institution (HEI) in South Africa, focusing on the occupational therapy program.
View Article and Find Full Text PDFA bibliometric study on the impact of gut microbiota on the efficacy of immune checkpoint inhibitors in cancer patients: analysis of the top 100 cited articles.
Front Immunol
January 2025
School of Basic Medicine, Zhejiang Chinese Medical University, Hangzhou, China.
Background: Immune checkpoint inhibitors (ICIs) have transformed oncological treatment by modulating immune responses against tumors. However, their efficacy is subject to inter-patient variability and is associated with immune-related adverse events (irAEs). The human gut microbiota, a complex microbial ecosystem, is increasingly implicated in modulating responses to ICIs.
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