Download or read book Processus de conception et de validation d un outil d intelligence artificielle pour la conciliation m dicamenteuse dans les essais cliniques written by Domitille Oddon and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Afin de sécuriser le parcours thérapeutique des patients en essais cliniques et d'assurer la qualité des données recueillies, le pharmacien hospitalier réalise une conciliation médicamenteuse (CM) pour chaque nouveau patient inclus dans un protocole d'essai clinique émettant des listes de médicaments interdits ou à surveiller (MIS), à risque d'interaction avec le médicament expérimental. La réalisation du bilan médicamenteux et l'analyse pharmaceutique avec recherche de MIS doivent être réalisées rapidement avant l'inclusion des patients et selon les informations émises par les promoteurs. D'autres problématiques concernant la reproductibilité inter-pharmaciens et la multitude des sources utilisées pour l'analyse pharmaceutique ont soulevé le besoin de créer un outil numérique capable d'agréger ces multiples sources et d'harmoniser les pratiques. A travers une collaboration entre les pharmaciens d'un Centre de Lutte Contre le Cancer et les pharmaciens d'une startup spécialisée dans le domaine de l'intelligence artificielle (IA) appliquée à la santé, les processus de conception et de validation d'un outil d'IA pour la CM dans les essais cliniques ont été mis en place. Le pharmacien responsable du processus de conception a rédigé des spécifications pour la construction d'algorithmes de données permettant aux pharmaciens de construire des groupes de médicaments intégrant les MIS de chaque essai clinique, automatiquement détectés lors de l'analyse pharmaceutique. Il a également été spécifié la création d'un module de recherche rapide pour les demandes d'avis pharmaceutiques, la constitution d'un tableau de bord avec différents indicateurs de suivi (ex. : nombre de conciliations, nombre de MIS) et d'autres fonctionnalités. Devant ce projet de généralisation de la CM aux essais cliniques, deux protocoles de recherche ont été élaborés pour valider la méthode de détection automatisée des MIS et pour évaluer les performances de l'outil en vie réelle auprès de plusieurs centres.
Download or read book Le rapport d tude clinique written by Bérengère Thouroude and published by . This book was released on 2010 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le rapport d’étude clinique décrit la méthodologie et les résultats obtenus au cours d’un essai clinique. Il doit être complet, sans ambiguïté et facile à analyser par les agences réglementaires. Le développement d’un médicament est un processus long et coûteux. Pour réduire les délais, la Conférence Internationale d’Harmonisation a été mise en place. Elle est en charge d’établir des recommandations réglementaires valables dans les 3 zones suivantes: Etats-Unis, Europe et Japon. En 1996, la recommandation ICH E3 décrivant le format et le contenu des rapports d’études cliniques a été mise en place. Au sein du Département de Rédaction des Rapports d’Etudes Cliniques du laboratoire Servier, la Recommandation ICH E3 a été adaptée dans une procédure opératoire standard. Une maquette est annexée à cette procédure pour guider les rédacteurs. Un rapport d’étude clinique est composé de 5 parties principales: introduction, méthodologie, résultats, conclusion et annexe. Les annexes sont composées de documents unitaires qui doivent être compilés lors de la génération de la version électronique du rapport grâce à des outils de gestion électronique des documents. Les versions successives du rapport d’étude clinique font l’objet d’un circuit de validation qui est décrit dans une procédure opératoire standard. La version finale du rapport d’étude clinique est aussi validée par l’investigateur principal de l’étude. Les rapports d’études cliniques de toutes les études réalisées lors du développement d’un nouveau médicament sont placés dans le module 5 du dossier d’autorisation de mise sur le marché.
Download or read book L analyse du type d tudes ayant permis la formulation de l hypoth se test e dans un essai clinique randomis permet elle d en pr dire l issue written by Nathan Vigneron and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans une époque où "l'Evidence Based Medecine" prime, les essais cliniques de phases 3 sont le gold standard dans la quête de preuve. Cependant leurs réalisations étant très contraignantes sans garanti de succès, nous avons souhaité observer si certains types d'études réalisées en amont et citées dans l'argumentaire pouvait augmenter les probabilités d'avoir une confirmation de l'hypothèse testée. Nous avons retenu un échantillon de 150 essais cliniques médicamenteux randomisés de phase 3 à critère de jugement unique ou composite, publiés avant l'apparition du COVID, dans trois des grands journaux scientifiques (LANCET, JAMA, NEJM). Nous avons extrait de chacun des essais inclus, qu'il soit confirmant ou non, chaque étude justifiant sa réalisation, qu'elles soient uniques ou multiples, et les avons classées dans 13 catégories, afin d'observer s'il existe un lien entre ces derniers et l'issue de l'hypothèse testée dans les essais inclus. La description de cet échantillon a permis d'observer un lien potentiel entre la présence d'études biologiques (p : 0.0007), ainsi que l'absence d'études transversales (p : 0.0488), et de méta analyses épidémiologiques (p : 0.0116) dans l'argumentaire des essais inclus, et la confirmation de l'hypothèse qui en a découlé. Ces associations, bien que statistiquement significatives, sont faibles, et confirment l'idée qu'il est illusoire de vouloir s'affranchir de la nécessité de la confirmation par un ECR de phase 3. Notre travail présente plusieurs limites. Notamment, l'échantillon n'a pas été calculé en fonction d'une puissance statistique préalablement établie, l'absence de distinction entre nouvelle molécule thérapeutique et molécule thérapeutique en repositionnement, aucune sélection quant à la qualité des ECR inclus, et nous n'avons pas apprécié le caractère cliniquement pertinent des critères de jugement principal des ECR inclus. Ce travail descriptif et exploratoire présente trop de limites pour mettre en évidence ou réfuter avec conviction l'existence d'un certain type d'études ou une certaine combinaison de type d'études, permettant de préciser de manière fiable la probabilité de succès des ECR de phase 3.
Download or read book Adjuvant Therapy for Breast Cancer written by Monica Castiglione and published by Springer Science & Business Media. This book was released on 2009-07-11 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adjuvant treatment is administered prior to or as follow up to surgical procedures for breast cancer. Proven success in using medical therapies allowing for breast conserving procedures or reducing risk of occurrence. Although there has been much progress towards a cure, including the introduction of new targeted therapies, metastasizing cancer remains highly incurable.
Download or read book Transient Ischemic Attack and Stroke written by Sarah T. Pendlebury and published by Cambridge University Press. This book was released on 2009-02-19 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accessible handbook covering the investigation, diagnosis and management of transient ischemic attacks and minor strokes.
Download or read book Mitochondrial Replacement Techniques written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-04-17 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.
Download or read book Behavioural Inattention Test written by Barbara A. Wilson and published by . This book was released on 1987 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cerebral Small Vessel Disease written by Leonardo Pantoni and published by Cambridge University Press. This book was released on 2014-05 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Up-to-date discussion of the etiology, diagnosis, treatment, and prevention of this common cause of stroke and cognitive impairment.
Download or read book The Cognitive and Neural Bases of Spatial Neglect written by Hans-Otto Karnath and published by Oxford University Press, USA. This book was released on 2002 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spatial neglect is a disorder of space-related behaviour. It is characterized by failure to explore the side of space contralateral to a brain lesion, or to react or respond to stimuli or subjects located on this side. Research on spatial neglect and related disorders has developed rapidly inrecent years. These advances have been made as a result of neuropsychological studies of patients with brain damage, behavioural studies of animal models, as well as through functional neurophysiological experiments and functional neuroimaging.The Cognitive and Neural Bases of Spatial Neglect provides an overview of this wide-ranging field of scientific endeavour, providing a cohesive synthesis of the most recent observations and results. As well as being a fascinating clinical phenomenon, the study of spatial neglect helps us tounderstand normal mechanisms of directing and maintaining spatial attention and is relevant to the contemporary search for the cerebral correlates of conscious experience, voluntary action and the nature of personal identity itself.The book is divided into seven sections covering the anatomical and neurophysiological bases of the disorder, frameworks of neglect, perceptual and motor factors, the relation to attention, the cognitive processes involved, and strategies for rehabilitation.Chapters have been written by a team of the leading international experts in this field.This will be essential reading for neuropsychologists, neurologists, neurophysiologists, cognitive neuroscientists and psychologists.
Download or read book Early Breast Cancer written by J. Zander and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: March 23 and 24, 1983 saw the fIrst international symposium held under the auspices of the Wilhelm Vaillant Foundation for the Advancement of Pro phylactic Medicine in the I. Frauenklinik der Ludwig Maximilians Univer sitiit Miinchen. This symposium was concerned with Advances in Early Detection and Treatment of Breast Cancer and brought together patholo gists, gynecologists, and radiologists from Denmark, England, France, Italy, Sweden, Switzerland, the German Democratic Republic, and the Federal Republic of Germany. The fIrst session dealt with problems concerned with the biology, patho genesis, and histopathology of early carcinoma of the breast, with special reference to the clinical aspects. The second session was taken up with topi cal developments in the early diagnosis of breast carcinoma and indicated the present limitations of early diagnosis. In the third session the latest results of the experiences by groups working on the treatment of early carci noma of the breast in France, the United Kingdom, Italy, the United States of America, and the Federal Republic of Germany were discussed. The main emphasis lay on conservative treatment methods with complete or partial preservation of the breast. These vary quite widely. Some of the conclusions presented on the basis of long-term clinical studies must be regarded as signifIcant breakthroughs, and at the stage these have reached they must no longer be overlooked. The symposium has highlighted numerous unsolved problems and made it clear that conflicting opinions abound.
Download or read book Community Management of Opioid Overdose written by World Health Organization and published by . This book was released on 2015-09-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 69000 people die each year from opioid overdose. Opioid overdose is easily reversed with the opioid antidote naloxone and with basic life support. Such care is generally only available in medical settings, however. These guidelines recommend that people who are likely to witness an opioid overdose, including people who use opioids, and their family and friends should be given access to naloxone and training in its use so that they can respond to opioid overdose in an emergency if a medical response is not available. Naloxone can be injected or administered intra-nasally and has minimal effects in people who have not used opioids. While naloxone administered by bystanders is a potentially life-saving emergency interim response to opioid overdose, it should not be seen as a replacement for comprehensive medical care.
Download or read book Entertainment Computing ICEC 2015 written by Konstantinos Chorianopoulos and published by Springer. This book was released on 2015-09-24 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 14th International Conference on Entertainment Computing, ICEC 2015, held in Trondheim, Norway, in September/October 2015. The 26 full papers, 6 short papers, 16 posters, 6 demos and 6 workshops/tutorial descriptions presented were carefully reviewed and selected from 106 submissions. The multidisciplinary nature of Entertainment Computing is reflected by the papers. They focus on computer games; serious games for learning; interactive games; design and evaluation methods for Entertainment Computing; digital storytelling; games for health and well-being; digital art and installations; artificial intelligence and machine learning for entertainment; interactive television and entertainment.
Download or read book Free and Fair Elections written by Guy S. Goodwin-Gill and published by Inter-Parliamentary Union. This book was released on 2006 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Download or read book Facial Oral Tract Therapy F O T T written by Ricki Nusser-Müller-Busch and published by Springer Nature. This book was released on 2020-11-07 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book offers a comprehensive approach to the assessment and treatment of disturbances in facial expression, oral movement, swallowing, breathing, voice and speech production caused by developmental and acquired neurological conditions. The principles outlined are used in patients with different etiologies (e.g. stroke, tumors, traumas). F.O.T. T., developed by Kay Coombes, is a hands-on approach based on an understanding of neurological functions and the way we learn from experience. The approach aims to give the patient experience of physiological posture and movement using facial-oral functions in normal activities of daily living (ADL). Rather than mere “exercises”, F.O.T.T involves meaningful activities aiming to promote participation, according to ICF criteria. Four main areas are covered: nutrition, oral hygiene, nonverbal communication and speech. Each chapter summarises the problems of severely ill patients and shows the clinical reasoning behind the solutions offered. Separate chapters discuss tracheostomy management and the training of the carers involved, including relatives. The chapter authors are experienced specialists (physio-, occupational- and speech-language therapists and physicians), whose contributions aim to provide interdisciplinary perspectives and translate latest research into clinical practice.
Download or read book Clinical Systems Neuroscience written by Kenji Kansaku and published by Springer. This book was released on 2015-01-28 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: The impaired brain has often been difficult to rehabilitate owing to limited knowledge of the brain system. Recently, advanced imaging techniques such as fMRI and MEG have allowed researchers to investigate spatiotemporal dynamics in the living human brain. Consequently, knowledge in systems neuroscience is now rapidly growing. Advanced techniques have found practical application by providing new prosthetics, such as brain–machine interfaces, expanding the range of activities of persons with disabilities, or the elderly. The book’s chapters are authored by researchers from various research fields such as systems neuroscience, rehabilitation, neurology, psychology and engineering. The book explores the latest advancements in neurorehabilitation, plasticity and brain–machine interfaces among others and constitutes a solid foundation for researchers who aim to contribute to the science of brain function disabilities and ultimately to the well-being of patients and the elderly worldwide.
Download or read book Essentials of WISC IV Assessment written by Dawn P. Flanagan and published by John Wiley & Sons. This book was released on 2004-11-11 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: A successor to the extremely popular Essentials of WISC-III/WPPSI-R Assessment(0-471-34501-6), Essentials of WISC-IV Assessment provides beginning and seasoned clinicians comprehensive guidelines to administering, scoring, and interpreting the latest revision of the Wechsler Intelligence Scales for Children. Featuring the popular Essentials format of call-out boxes, Test Yourself questions and step-by-step instructions, this handy resource also includes strengths and weaknesses of the instrument, practical clinical applications, and illustrative case reports. This detailed guide to using this immensely popular measure of intelligence is a must-have for anyone involved in the psychological testing of children.
