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A policy framework for leveraging generative AI to address enduring challenges in clinical trials.
NPJ Digit Med
January 2025
Center for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Copenhagen, Denmark.
Can artificial intelligence improve clinical trial design? Despite their importance in medicine, over 40% of trials involve flawed protocols. We introduce and propose the development of application-specific language models (ASLMs) for clinical trial design across three phases: ASLM development by regulatory agencies, customization by Health Technology Assessment bodies, and deployment to stakeholders. This strategy could enhance trial efficiency, inclusivity, and safety, leading to more representative, cost-effective clinical trials.
View Article and Find Full Text PDFWell-designed effective interventions promoting sustainable diets are urgently needed to benefit both human and planetary health. This study evaluated the feasibility, acceptability, and potential impact of a pilot blended digital intervention aimed at promoting sustainable diets. We conducted a series of ABA n-of-1 trials with baseline, intervention, and follow-up phases over the course of a year, involving twelve participants.
View Article and Find Full Text PDFMorphological study of the anterior dentition in Raoellidae (Mammalia, Artiodactyla), new insight on their dietary habits.
J Anat
January 2025
Institut des Sciences de l'Évolution de Montpellier (ISEM), Univ Montpellier, CNRS, IRD, Montpellier, France.
Raoellidae are small artiodactyls from the Indian subcontinent closely related to stem cetaceans. They bring crucial information to understand the early phase of the land-to-water transition in Cetacea. If they are considered to be partly aquatic, the question of their dietary habits remains partly understood due to their "transitional" morphology.
View Article and Find Full Text PDFPatient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial.
J Med Internet Res
January 2025
Indiana University, Indianapolis, IN, United States.
Background: Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored.
View Article and Find Full Text PDFBruton's tyrosine kinase inhibitor for multiple sclerosis: new hope or false dawn.
J Neurol
January 2025
Institute of Psychological Medicine and Clinical Neuroscience, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, UK.
The first of several phase 3 trials examining efficacy in relapsing MS has not been able to demonstrate a significant benefit and has also raised important safety concerns. More results are on their way and it will be important to understand whether the safety signals identified are drug- or class-specific and whether other BTKi also fail to reach their endpoints for relapsing MS. However, as reported in preliminary data for another BTKi, it may be that they will have more of a role in progressive disease as hinted by the unraveling of relevant molecular mechanisms and pathways.
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