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2. Les psychobiotiques. Études chez l'Homme.
- Author
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Lecerf, J. M.
- Abstract
Copyright of Phytothérapie is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2018
- Full Text
- View/download PDF
3. Les temps forts de Chicago 2017.
- Author
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Grazziotin-Soares, D. and Lotz, J.
- Abstract
Copyright of Oncologie (Tech Science Press) is the property of Tech Science Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2017
- Full Text
- View/download PDF
4. Les essais cliniques : leur apport dans le parcours de soins des patientes traitées pour un cancer du sein.
- Author
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Saghatchian, M., Pistilli, B., Ghouadni, A., André, F., and Delaloge, S.
- Subjects
BREAST cancer patients ,CLINICAL trials ,MEDICAL care ,BREAST cancer diagnosis ,MEDICAL literature reviews ,METASTASIS - Abstract
Copyright of Oncologie (Tech Science Press) is the property of Tech Science Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2016
- Full Text
- View/download PDF
5. Quelques éléments en faveur d’une réflexion psychopathologique sur la psychopathie : seconde partie
- Author
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Englebert, Jérôme
- Subjects
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ANTISOCIAL personality disorders , *PATHOLOGICAL psychology , *PSYCHOPATHY , *MANIA , *CLINICAL trials , *COMPARATIVE studies - Abstract
Abstract: Objectives: The objectives of this study are to offer some clinical and semiological considerations for a psychopathological conception of psychopathy. In the first part, the author provides a history of this diagnosis (see Introduction of this paper) and a description of the current trends in the international literature: the contributions of R.D. Hare and the PCL-R, D.J. Cooke and the Comprehensive Assessment of Psychopathic Personality (CAPP) and T.H. Pham for French-speaking validations (subtitle 2 of this paper). After that, the author proposes a definition of psychopathology in the sense of Minkowski and Jaspers proposals (i.e. these latter come from the principles of the continental phenomenology) (subtitle 3 of this paper). Patients and methods: This theoretical essay is improved by clinical situations. The psychopaths were interviewed in prison or in forensic centers. The method used was a psychopathological analysis from the clinical material, as well as references to the phenomenological psychopathology (continental phenomenology) and the philosophy of J.-P. Sartre, M. Foucault and P. Ricœur. Results: This study shows that it is useful to consider a psychopathological reflection on psychopathy and this approach gives a framework for the clinical investigations. Regarding that, the author proposes a first comparison between the binswangerian conception of mania and the psychopathic functioning (subtitle 4 of this paper). By this way, we can understand why many studies show a positive correlation between the scoring in the PCL-R and the scale of the MMPI mania. The behavior is similar but the difference is about the dialectic between the “ego” and the “alter ego”. The maniac has a fundamental crisis of the “ego”, which the psychopath does not have. A second finding of our investigations concerns emotions and the dimension of the adaptive psychopathic disorder (subtitle 5 of this paper). An epistemological discussion of the concept of emotions allows us to say that the psychopath is competent in the management of emotional stimuli, which confers a psychological advantage to him. In addition, fundamental research on the management of the emotional stimuli in the psychopath seems to confirm our hypothesis of an adaptive dimension for the psychopathic disorder. The last point we discuss is about “morality” and “ethics” for the psychopath (these notions are from the concepts of empathy and sympathy). On the basis of Foucault''s distinction between these two concepts, it becomes possible to study these dimensions and integrate them in the practice of psychopathology. This proposal enables to introduce the concept of narrativity. This observation prompts the clinician to listen to the patient and to pay attention to how he has to tell himself. Conclusions: Our contribution shows that it is possible to conduct a study about the psychopathology of psychopathy. Our study is not intended to be complete and irrefutable. Our goal is rather to give some evidence for a psychopathological consideration on psychopathy (as indicated by the title of this paper). Finally, we offered some thoughts on the practice of psychotherapy by integrating the adaptive dimension of this disorder which, when it is missed, can lead to a psychotherapeutic stalemate. [Copyright &y& Elsevier]
- Published
- 2013
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6. Détection de la négation : corpus français et apprentissage supervisé.
- Author
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Dalloux, Clément, Grabar, Natalia, and Claveau, Vincent
- Subjects
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PATIENT selection , *DATA mining , *MEDICAL protocols , *INFORMATION storage & retrieval systems , *CLINICAL trials , *SUPERVISED learning - Abstract
Automatic detection of negated content is often a pre-requisite in information extraction systems, especially in the biomedical domain. This paper proposes two main contributions in this field. It first introduces a corpus built with excerpts from clinical trial protocols in French, describing the inclusion criteria for patient recruitment. The corpus is manually annotated for marking up the negation cues and their scope. Secondly, two supervised learning approaches are proposed for the automatic detection of negation. Besides, one of the approaches is validated on English data from the state of the art: the approach shows very good results and outperforms existing approaches, and it also yields comparable results on the French data. Finally, we propose several experiments with different vector representations of words. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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- View/download PDF
7. Réimaginer des communautés? Le traitement précoce contre le VIH / sida en Côté d'Ivoire.
- Author
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BRIVES, CHARLOTTE and LE MARCIS, FRÉDÉRIC
- Abstract
Copyright of Terrain is the property of Mission Patrimoine Ethnologiq and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2015
- Full Text
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8. ETAT DES LIEUX DE LA REGLEMENTATION DES ESSAIS CLINIQUES AU MALI.
- Author
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Sangho, Aboubacar, Kaloga, Assitan dite Pendourou, Sangho, Oumar, Teguera, Rabiéta Kouboura, Sangho, Fanta, Maïga, Saïbou, Sanogo, Rokia, and Semdé, Rasmané
- Abstract
Copyright of Mali Médical is the property of Mali Medical, Faculte de Medecine, de Pharmacie et d'Odonto-stomatologie and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
9. Entre responsabilité et liberté : la place fondamentale de l’éthique en temps de crise.
- Author
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Remaud, Émilie, Bouguet, Morgan, and Marignac, Geneviève
- Subjects
MEDICAL triage ,CLINICAL trials ,LIBERTY ,DEMOCRACY ,COVID-19 - Abstract
Copyright of Canadian Journal of Bioethics / Revue canadienne de bioéthique is the property of Ecole de Sante Publique de l'Universite de Montreal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
- Full Text
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10. Système sémantiquement interopérable de sélection semi-automatique des patients éligibles aux essais thérapeutiques en cancérologie.
- Author
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Cuggia, M., Dufour, J.-C., Zekri, O., Gibaud, I., Garde, C., Bohec, C., Duvauferrier, R., Fieschi, D., Besana, P., Charlois, L., Bourde, A., Garcelon, N., Laurent, J., Fieschi, M., and Dameron, O.
- Subjects
CLINICAL trials ,AUTOMATION ,ELECTRONIC health records ,ONCOLOGY ,DECISION support systems ,MEDICAL technology - Abstract
Copyright of IRBM is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2012
- Full Text
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11. Macrolane®, une indication dans l’augmentation mammaire trop prématurée. Mise au point sur les connaissances actuelles du produit
- Author
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Chaput, B., De bonnecaze, G., Tristant, H., Garrido, I., Grolleau, J.-L., and Chavoin, J.-P.
- Subjects
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AUGMENTATION mammaplasty , *HYALURONIC acid , *BREAST cancer , *MAMMOGRAMS , *BREAST implants , *BIOMEDICAL materials , *CLINICAL trials - Abstract
Summary: Study Purpose: For ten years the market for resorbable fillers has seen a large increase. A CE mark is sufficient for its placing on the market, they do not require AMM because they are not considered drugs. The Macrolane® is a hyaluronic acid NASHA gel-based technology, available on the French market since 2007 as filler used in all areas of the body except face and breasts. It is highly crosslinked, which slows its resorption, leaving in place long-term waste. At end of 2008, Macrolane® received a CE mark for breast augmentation. The aim of this paper is to review current scientific knowledge on the Macrolane™ and list the many uncertainties regarding its recent breast indication. Materials and methods: We reviewed the PubMed literature and study levels of evidence on Macrolane®. All AFFSAPS communication and correspondence with the SOFCPRE on hyaluronic acids and particularly Macrolane™ were collected. Results: At the moment there is no scientific study of high level of evidence which has studied the effects of Macrolane® on breast parenchyma in terms of carcinogenesis or the disruption of radiological monitoring of the breast. The subglandular method of injection remains complex and uncertain especially about the risk of wrong passage. Conclusions: The Macrolane® is proposed as an alternative less invasive than breast implants. Nevertheless the lack of scientific data on this product led to its non approval by the Food and Drug Administration in the United States. Currently there remains too much uncertainty on this filler for reasonable use plebiscite. It would therefore be preferable to return to the manufacturer the burden of proof of Macrolane® safety and security and limit its use in clinical trials yet. [ABSTRACT FROM AUTHOR]
- Published
- 2011
- Full Text
- View/download PDF
12. Place actuelle de la kinésithérapie respiratoire dans la prise en charge de la bronchiolite aiguë du nourrisson hospitalisé
- Author
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Bailleux, S., Lopes, D., Geoffroy, A., Josse, N., Labrune, P., and Gajdos, V.
- Subjects
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CLINICAL trials , *PHYSIOLOGICAL therapeutics , *PEDIATRIC respiratory diseases , *BRONCHIOLE diseases , *HOSPITAL care - Abstract
Summary: This article updates the respiratory physiotherapy technique used in France, and the rationale for its use. This paper reports the results of a recent randomized clinical trial that did not show any efficiency of respiratory physiotherapy (using increased expiratory acceleration) in infants hospitalized for a first episode of bronchiolitis. Further trials are necessary for evaluating this technique in infants who are not hospitalized. [Copyright &y& Elsevier]
- Published
- 2011
- Full Text
- View/download PDF
13. Impact clinique de la durée de conservation des globules rouges avant transfusion
- Author
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Lacroix, J. and Tucci, M.
- Subjects
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BLOOD collection , *CLINICAL medicine , *BLOOD transfusion , *ERYTHROCYTES , *IMMUNOREGULATION , *HEALTH outcome assessment , *HEMOLYSIS & hemolysins , *CLINICAL trials - Abstract
Abstract: Presently, red blood cell units are stored up to 42days in France and Canada. Length of storage of red blood cell units is not based on clinical outcomes: it is rather based on a decision made by some experts in the 1940s that red blood cell units can be stored as long as the average hemolysis is lower than 1% and the proportion of red blood cells still alive 24hours post-transfusion is higher than 70%. Data reported recently suggest that transfusion with older red blood cell units may jeopardize the outcome of severely ill patients. In this paper, we comment the data already published on this question, and we summarize the randomized clinical trials presently on-going that were undertaken to address the relationship between length of storage of red blood cell units and outcomes of transfused patients. [Copyright &y& Elsevier]
- Published
- 2011
- Full Text
- View/download PDF
14. La recherche clinique en nutrition – Méthodologie et réglementation des essais cliniques
- Author
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Meunier, Nathalie, Roth, Hubert, Ferrand, Loïc, Laville, Martine, and Cano, Noël
- Subjects
- *
CLINICAL trials , *RESEARCH methodology , *NUTRITION , *MEDICAL laws , *HEALTH policy , *MEDICAL research - Abstract
Abstract: What is the regulation of clinical research? Which administrative steps must be carried out? Who are the different actors and what are their responsibilities in the management of biomedical research? What are the characteristics of clinical research in nutrition? Which methodology should be used? The objective of this paper is to answer these questions, keeping in mind that the rules are regularly modified, and that the elements described today will not apply tomorrow. Moreover, the law does not always respond to all situations and to all questions. [ABSTRACT FROM AUTHOR]
- Published
- 2010
- Full Text
- View/download PDF
15. Développement d’une innovation technologique en santé : le cycle CREPS Concept – Recherche – Essais – Produit – Soins.
- Author
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Moreau-Gaudry, A. and Pazart, L.
- Subjects
TECHNOLOGICAL innovations ,MEDICAL technology ,MEDICAL care ,RESEARCH funding ,CLINICAL trials ,DIMENSIONAL analysis - Abstract
Copyright of IRBM is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2010
- Full Text
- View/download PDF
16. Quel pharmaconutriment choisir en réanimation ?
- Author
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Coëffier, Moïse, Tamion, Fabienne, and Déchelotte, Pierre
- Subjects
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RESUSCITATION , *CRITICALLY ill , *CLINICAL trials , *INTENSIVE care units , *GLUTAMINE , *ARGININE , *FATTY acids , *ANTIOXIDANTS - Abstract
Abstract: Thanks to a better knowledge of specific metabolic needs in the critically ill patient, clinical trials have been performed to assess the clinical efficacy of supplementation with specific substrates used as pharmaconutrients. Main pharmaconutrients of potential interest in the ICU are glutamine, arginine, n-3 polyinsaturated fatty acids and anti-oxidants. Their clinical usefulness, which varies according to the dose, the route of supplementation, and to patients categories (surgical, trauma, burned, septic...), and their underlying mechanisms of action are now better defined. After reviewing the main pathophysiological targets of each pharmaconutrient in the critically ill patient, this paper summarizes for each substrate their validated or potential indications. Beyond nutritional support, pharmaconutrition appears nowadays as a true therapeutic means in the critically ill patient. [Copyright &y& Elsevier]
- Published
- 2009
- Full Text
- View/download PDF
17. Pneumonies aiguës communautaires : analyse critique des essais cliniques
- Author
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Chidiac, C.
- Subjects
- *
ANTIBIOTICS , *COMMUNITY-acquired pneumonia , *DRUG resistance in microorganisms , *AMOXICILLIN , *CLINICAL trials - Abstract
Abstract: Optimal antibiotic treatment of community-acquired pneumonia (CAP) remains controversial. The clinical impact of S. pneumoniae resistance to macrolides is well documented. By contrast high dosage amoxicillin (1 g tid) remains active against such strains and no failure has been reported. The aim of this paper was to review clinical trials in community-acquired pneumonia, published from January 1, 1999, to December 31, 2005. One hundred seventy-three articles were collected, using Medline, 35 of which were analyzed, and 16 finally used. Telithromycin and pristinamycin may be used in mild to moderate CAP. Anti-pneumococcal fluoroquinolones such as levofloxacin and moxifloxacin may be used in at risk patients, but levofloxacin has only been investigated in patients with severe CAP and patients with Legionnaire''s disease. Amoxicillin 1 g tid remains the drug of choice for pneumococcal CAP. [Copyright &y& Elsevier]
- Published
- 2006
- Full Text
- View/download PDF
18. Prévention de la dépendance des personnes âgées : étude randomisée dans la communauté: Prevention of Dependency in Elderly Persons: A Randomised Study in the Community.
- Author
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Cornu, Catherine, Carré, Corinne, Guetemme, Gilles, Ravis, Brigitte, Sandrine Thérond, Gueyffier, François, and Bonnefoy, Marc
- Subjects
MEDICAL care for older people ,EXERCISE ,PROTEINS ,HEALTH facilities ,CLINICAL trials ,PUBLIC health - Abstract
Le nombre des personnes de plus de 85 ans doublera en 2020. Prévention de la dépendance et maintien à domicile sont des enjeux majeurs. L’exercice physique et l’amélioration de l’apport protéique sont des mesures préventives possibles ; nous décrivons l’organisation d’un essai en cours, évaluant leur effet sur 102 personnes âgées randomisées en deux groupes, l’un recevant programme d’exercices et suppléments alimentaires protéinés, l’autre pas. L’étude s’appuie sur les responsables d’associations de maintien à domicile, et des aides à domicile (AD) sélectionnées. Leur rôle était de recruter des personnes âgées, de les stimuler pour les exercices et la prise des protéines, d’informer l’équipe de recherche de tout problème. Cette organisation a apporté l’aide attendue, mais la supervision des AD devrait être renforcée. Ce réseau offre un potentiel important, comportant des travailleurs stables (14 ans d’ancienneté en moyenne dans cette étude), offrant des possibilités d’évaluation de futures mesures de prévention. Mots clés : prévention de la dépendance, domicile, essai clinique contrôlé, personnes âgées Abstract The number of elderly people aged >85 years will double by the year 2020. Helping the elderly to live independently at home is a major challenge for society. Physical exercise and protein energy intake might both be effective in preventing dependency. This paper describes the organisation of an ongoing study aimed at evaluating the preventive effect of such measures, involving 102 elderly persons randomised into two groups, one receiving preventive measures but not the other. The study organisation was based on representatives and selected workers from associations involved in home assistance for elderly. Their role consisted in recruiting persons for participation in the trial, encouraging them to perform exercises and take dietary supplements, and notifying the research team of all health-related events. This organisation has reached its objectives, even though the supervision of the domestic workers needs to be improved. This network, comprising stable workers (14 years of work experience on average in this study) offers the potential for future research in the community to evaluate preventive measures. Keywords: prevention of dependency, home care, randomised clinical trial, elderly Texte reçu le 28 février 2003 ; accepté le 29 juillet 2003 [ABSTRACT FROM AUTHOR]
- Published
- 2003
- Full Text
- View/download PDF
19. Apport du numérique dans la prise en charge médicale des patients souffrant de douleurs chroniques.
- Author
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Kerckhove, N., Corteval, A., and Eschalier, A.
- Abstract
Copyright of Douleur et Analgésie is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2021
- Full Text
- View/download PDF
20. Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial
- Author
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James S. Khan, Lindsay A. Jibb, Jason W. Busse, Ian Gilron, Stephen Choi, James E. Paul, Michael McGillion, Sean Mackey, D. Norman Buckley, Shun Fu Lee, and P. J. Devereaux
- Subjects
pain ,perioperative ,clinical ,clinical trials ,randomized controlled trials ,Medicine (General) ,R5-920 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18–75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P
- Published
- 2019
- Full Text
- View/download PDF
21. Spécificités et recherches méthodologiques pour l’évaluation en soins de support en oncologie
- Author
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Paillard, M. -J., Pulido, M., Metges, J. -P., Almont, T., Heutte, N., and Bonnetain, F.
- Published
- 2017
- Full Text
- View/download PDF
22. Les métamorphoses de la preuve dans le champ psychiatrique
- Author
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Saraga, Michael
- Subjects
épistémologie ,clinical trials ,ensayo clínico ,epistemología ,psychotropes ,epistemology ,sicotrópicos ,medicina basada en evidencia ,essais cliniques ,evidence-based medicine ,psychotropic drugs - Abstract
Cet article est une contribution à l’étude des transformations contemporaines du champ de la psychiatrie à partir d’une lecture de la recherche en psychopharmacologie reposant sur l’analyse de la structure et des styles des publications dans le domaine. Il met en évidence trois moments principaux : (1) l’âge d’or des découvertes majeures (lithium, chlorpromazine, imipramine), documentée par une description clinique au cas par cas ; (2) la montée en puissance de l’essai randomisé contrôlé et l’accent mis sur une méthodologie devant permettre d’éviter l’incertitude et les biais de la clinique ; (3) les années récentes, marquées par une concurrence entre molécules, le développement des approches méta-analytiques et une opacité croissante des articles pour le lecteur clinicien. Cette contribution s’inscrit dans le cadre d’une épistémologie historique des pratiques cliniques. This paper contributes to the study of psychiatry’s contemporary transformations by analyzing the structure and form of the scientific literature in the field psychopharmacology. It highlights three main periods: (1) the “golden age” of the major discoveries (lithium, chlorpromazine, imipramine), which are reported through case-by-case clinical descriptions; (2) the emergence of the randomized controlled trial and the growing importance of a strict methodology attempting to avoid the uncertainty and biases of the clinical work; (3) the recent years, characterized by a competition between similar molecules, the development of meta-analytical methods and a growing opacity of the published literature for the clinician-reader. This contribution is part of a wider historical epistemology of clinical practice. Este artículo es una contribución al estudio de las transformaciones contemporáneas en el campo de la psiquiatría a partir de un análisis de la investigación en psicofarmacología basado en el análisis de la estructura y de los estilos de publicaciones en este campo. En él se destacan tres etapas principales: (1) la edad de oro de los grandes descubrimientos (litio, clorpromazina, imipramina), documentada por una descripción clínica en cada caso, (2) el incremento del ensayo aleatorio controladoy del foco puesto en una metodología para evitar la incertidumbre y los sesgos clínicos, (3) los últimos años, marcados por la competencia entre las moléculas, el desarrollo de métodos meta-analíticos y el aumento de la opacidad de los artículos para el lector clínico. Esta contribución se inscribe en el contexto de una epistemología histórica de las prácticas clínicas.
- Published
- 2020
23. GERICO: dix ans de recherche clinique en oncogériatrie.
- Author
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Girre, V., Orsini, C., and Brain, E.
- Subjects
GERIATRIC oncology ,OLDER patients ,CANCER patients ,TOXICITY testing ,CLINICAL trials ,QUALITY of life ,LIFE expectancy - Abstract
Copyright of Oncologie (Tech Science Press) is the property of Tech Science Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2011
- Full Text
- View/download PDF
24. Nécessité d'approches alternatives dans les stratégies d'évaluation des nouveaux antibiotiques antibactériens
- Author
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Trémolières, F., Garraffo, R., and Lortholary, O.
- Subjects
- *
ANTIBIOTICS , *MOLECULES , *PHARMACEUTICAL industry , *SCIENCE , *CLINICAL trials - Abstract
Abstract: The golden age of antibacterial antibiotics extend from year 1941 to the 1990s decade. At that time, something like an earth quake occurred: from the thirty molecules or so whose development was being achieved or was already marketed, only three were put on the French market, and faced the greatest difficulties to be prescribed by practicians, because: [-] the knights of good practice want a strict limitation of their use to precise indications; [-] the pharmaceutical companies find that the return on investment is almost impossible; [-] the prescribers are stunned by the inconsistency between the MAs, the advances in science and the health economic authorities advices which claim that these products are not very interesting; [-] the research for new antibiotics is stalling; [-] thus, for the first time in 60 years, an iconoclastic question arises: do we need new antibiotics? However, while the debate is raging, many of us think “yes we do”, as it is a duty to anticipate today the consequences of tomorrow''s bacterial resistances. This paper presents three types of propositions to optimise the development of future molecules: [-] sharpening of the data concerning preclinical security for a better predicting both the activity and the toxicity; [-] improvement in performances and organization of clinical trials, which implicates to reconsider some of the present methodological rules; [-] inclusion in the evaluation data of some relevant and new features measuring the anti-bacterial activity while taking into account the present and future bacterial resistances. The development of new concepts to develop new drugs which would be active against tomorrow''s bacteria compels us to manage in a new fashion today''s systems, which have reached their own limits. [Copyright &y& Elsevier]
- Published
- 2005
25. Fréquentation du registre français des essais cliniques en cancérologie et information recherchée par les patients et proches
- Author
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Pauporté, I., Manach, E., Bachouche, N., Duperrey, M., and Hommais, A.
- Published
- 2011
- Full Text
- View/download PDF
26. Probiotiques et prévention de l’allergie: quel intérêt ?
- Author
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Waligora-Dupriet, A. -J., Rodriguez, B., and Butel, M. -J.
- Published
- 2011
- Full Text
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27. Cancer épithélial évolué de l’ovaire de la patiente âgée: quel état des lieux suite à la Conférence internationale de Vancouver?
- Author
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Lestrade, L.
- Published
- 2011
- Full Text
- View/download PDF
28. Les essais cliniques de médicaments de thérapie innovante: quel avenir pour la réglementation européenne?
- Author
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Mahalatchimy, Aurélie, de Grove-Valdeyron, Nathalie, Droits International, Comparé et Européen (DICE), Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS), Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC) (DICE / CERIC), Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS), Institut de Recherche en Droit Européen, International et Comparé (Toulouse) (IRDEIC), Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Centre National de la Recherche Scientifique (CNRS)-Université de Toulon (UTLN)-Université de Pau et des Pays de l'Adour (UPPA)-Aix Marseille Université (AMU), Centre National de la Recherche Scientifique (CNRS)-Université de Toulon (UTLN)-Université de Pau et des Pays de l'Adour (UPPA)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-Université de Toulon (UTLN)-Université de Pau et des Pays de l'Adour (UPPA)-Aix Marseille Université (AMU), Université Toulouse Capitole (UT Capitole), and Université de Toulouse (UT)-Université de Toulouse (UT)
- Subjects
Advanced therapy medicinal products ,clinical trials ,flexibilité ,droit de l’Union européenne ,concurrence ,compassionate use ,usage compassionnel ,essais cliniques ,flexibility ,exemption hospitalière ,hospital exemption ,[SHS.DROIT]Humanities and Social Sciences/Law ,competition ,European Union law ,Médicaments de thérapie innovante - Abstract
International audience; In relation to the “hot” topic of regenerative medicine, European Union law established a specific legal framework for advanced therapy medicinal products, manufactured from human or animal genes, cells or tissues. However, these medicinal products do not have always to be submitted to clinical trials as legal requirements vary according to the intended use: market of the whole of Member States, compassionate use, and hospital exemption. Moreover, specificities of these medicinal products make clinical trials difficult to be conducted. This paper highlights the consecutive competition between regulations and products that takes roots in the tension between the challenges of patients’ safety and quick access to innovative treatments. It also shows the regulatory flexibility currently favored to ensure the necessary balance between safety and availability, is not without limits.; Dans le contexte très discuté de la médecine régénératrice, le droit de l’Union a adopté un cadre juridique spécifique pour les médicaments de thérapie innovante, fabriqués à partir de gènes, cellules ou tissus d’origine humaine ou animale. Pourtant, ces médicaments ne sont pas toujours soumis à des essais cliniques car les exigences règlementaires diffèrent selon l’utilisation envisagée : marché de l’ensemble des Etats membres, usage compassionnel, exemption hospitalière. De même, les essais cliniques obligatoires sont difficiles à mettre en œuvre en raison des spécificités de ces médicaments. Cet article souligne la concurrence de réglementations et de produits qui en résulte et qui s’ancre dans la tension existante entre les enjeux de sécurité des patients et d’accès rapide à des traitements innovants. Il démontre également que la flexibilité réglementaire, à ce jour privilégiée pour garantir un équilibre indispensable entre sécurité et disponibilité, n’est pas sans présenter certaines limites.
- Published
- 2018
29. La recherche clinique dans le domaine du cancer du sein: état des lieux et perspectives
- Author
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Gligorov, J., Azria, D., Belkacemi, Y., Spielmann, M., and Namer, M.
- Published
- 2009
- Full Text
- View/download PDF
30. Nouvelles thérapeutiques dans la maladie d’Alzheimer: vers un traitement visant à ralentir la progression de la maladie
- Author
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Piau, A., Hein, C., Nourhashémi, F., and Vellas, B.
- Published
- 2009
- Full Text
- View/download PDF
31. Syndrome de l’intestin irritable : pourquoi est-il si difficile de trouver un traitement efficace ?
- Author
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Duracinsky, M. and Chassany, O.
- Published
- 2007
- Full Text
- View/download PDF
32. Les essais cliniques sur les médicaments antalgiques dans l’attente d’innovations méthodologiques ?
- Author
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Dubray, C.
- Published
- 2007
- Full Text
- View/download PDF
33. Quelle évaluation gérontologique faut-il utiliser pour les essais multicentriques?
- Author
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Chaladaj, A., Terret, C., Albrand, G., Courpron, P., and Droz, J. -P.
- Published
- 2007
- Full Text
- View/download PDF
34. Attractivité de la France pour la recherche clinique à promotion industrielle
- Author
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Magistrali, Léa, Université Paris Descartes - Paris 5 (UPD5), Université Paris Descartes, Annick Tibi, and Magistrali, Léa
- Subjects
clinical trials ,Jardé Law ,[SHS.DROIT] Humanities and Social Sciences/Law ,advanced therapy products ,JEL: O - Economic Development, Innovation, Technological Change, and Growth/O.O3 - Innovation • Research and Development • Technological Change • Intellectual Property Rights ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,[SHS.ECO]Humanities and Social Sciences/Economics and Finance ,pharmaceutical industry ,[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences ,[SHS.DROIT]Humanities and Social Sciences/Law ,industriels du médicament ,oncologie ,oncology ,médicaments de thérapie innovante ,Jardé ,recherche ,[SHS.ECO] Humanities and Social Sciences/Economics and Finance - Abstract
France is a major actor of clinical research at international level. Still, its participation in industrial research is declining. In Europe for example, France was involved in 36% of industrial clinical trials in 2014 but only in 26% in 2016. Human and economical stakes of clinical research are crucial. In order to identify action levers to reinforce France attractiveness, this paper highlights actual features attracting clinical trials promoters. Clinical trials in oncology and for advanced therapy medicinal products are today majors drivers of French industrial clinical research and there is a large margin of improvement to attract more clinical trials, as: increasing recognition of special skills of investigation centers, improving patients recruitment speed and optimizing work practices. Furthermore, special attention should be paid to maintain a national legal framework enabling a reactive research of quality to remain attractive on the international scene., La France compte parmi les grands acteurs mondiaux de la recherche clinique à promotion industrielle mais elle perd désormais du terrain. En Europe notamment, la France participait en 2014 à 36% des essais cliniques promus par des industriels du médicament et à seulement 26% de ces essais en 2016. Les enjeux humains et économiques liés à la réalisation de ces essais cliniques sont majeurs. Afin d’identifier des leviers d’actions qui renforceront l’attractivité de la France auprès des industriels du médicament, ce travail analyse les caractéristiques françaises qui permettent aujourd’hui d’attirer les essais cliniques. Les essais cliniques en oncologie et sur les médicaments de thérapies innovantes représentent aujourd’hui deux domaines dans lesquels les compétences françaises sont reconnues. La France a réussi à s’élever au rang de leader européen dans la réalisation de ces essais cliniques grâce, entre autres, à une expertise scientifique forte et à un effort de mise en avant des acteurs de la recherche dans ces domaines. La France dispose d’un potentiel important pour renforcer son attractivité auprès des promoteurs. Des améliorations sont possibles pour augmenter la visibilité des compétences des centres investigateurs auprès des promoteurs, pour améliorer la vitesse de recrutement des patients au sein des essais cliniques ou encore, pour harmoniser et optimiser les pratiques professionnelles des investigateurs. Une attention particulière doit être portée au maintien d’un cadre juridique national favorable à la réalisation des essais cliniques et ce, afin de garantir une recherche clinique française réactive, de qualité et attractive sur la scène internationale
- Published
- 2017
35. Attractiveness of France for industrial clinical research
- Author
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Magistrali, Léa, Magistrali, Léa, Université Paris Descartes - Paris 5 (UPD5), Université Paris Descartes, and Annick Tibi
- Subjects
clinical trials ,Jardé Law ,[SHS.DROIT] Humanities and Social Sciences/Law ,advanced therapy products ,JEL: O - Economic Development, Innovation, Technological Change, and Growth/O.O3 - Innovation • Research and Development • Technological Change • Intellectual Property Rights ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,[SHS.ECO]Humanities and Social Sciences/Economics and Finance ,pharmaceutical industry ,[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences ,[SHS.DROIT]Humanities and Social Sciences/Law ,industriels du médicament ,oncologie ,oncology ,médicaments de thérapie innovante ,Jardé ,recherche ,[SHS.ECO] Humanities and Social Sciences/Economics and Finance - Abstract
France is a major actor of clinical research at international level. Still, its participation in industrial research is declining. In Europe for example, France was involved in 36% of industrial clinical trials in 2014 but only in 26% in 2016. Human and economical stakes of clinical research are crucial. In order to identify action levers to reinforce France attractiveness, this paper highlights actual features attracting clinical trials promoters. Clinical trials in oncology and for advanced therapy medicinal products are today majors drivers of French industrial clinical research and there is a large margin of improvement to attract more clinical trials, as: increasing recognition of special skills of investigation centers, improving patients recruitment speed and optimizing work practices. Furthermore, special attention should be paid to maintain a national legal framework enabling a reactive research of quality to remain attractive on the international scene., La France compte parmi les grands acteurs mondiaux de la recherche clinique à promotion industrielle mais elle perd désormais du terrain. En Europe notamment, la France participait en 2014 à 36% des essais cliniques promus par des industriels du médicament et à seulement 26% de ces essais en 2016. Les enjeux humains et économiques liés à la réalisation de ces essais cliniques sont majeurs. Afin d’identifier des leviers d’actions qui renforceront l’attractivité de la France auprès des industriels du médicament, ce travail analyse les caractéristiques françaises qui permettent aujourd’hui d’attirer les essais cliniques. Les essais cliniques en oncologie et sur les médicaments de thérapies innovantes représentent aujourd’hui deux domaines dans lesquels les compétences françaises sont reconnues. La France a réussi à s’élever au rang de leader européen dans la réalisation de ces essais cliniques grâce, entre autres, à une expertise scientifique forte et à un effort de mise en avant des acteurs de la recherche dans ces domaines. La France dispose d’un potentiel important pour renforcer son attractivité auprès des promoteurs. Des améliorations sont possibles pour augmenter la visibilité des compétences des centres investigateurs auprès des promoteurs, pour améliorer la vitesse de recrutement des patients au sein des essais cliniques ou encore, pour harmoniser et optimiser les pratiques professionnelles des investigateurs. Une attention particulière doit être portée au maintien d’un cadre juridique national favorable à la réalisation des essais cliniques et ce, afin de garantir une recherche clinique française réactive, de qualité et attractive sur la scène internationale
- Published
- 2017
36. Cancers rares : des entités différentes, des problématiques communes
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Marty, M. and Rheims, N.
- Published
- 2008
- Full Text
- View/download PDF
37. Chimiothérapie néo–adjuvante: justificatif historique et expérimental
- Author
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Pouillart, P.
- Published
- 2004
- Full Text
- View/download PDF
38. Clinical studies, the interests and limits of using dabigatran in atrial fibrillation
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Male ,Clinical Trials as Topic ,Monitoring ,Platelet Aggregation ,Antidotes ,Phase II as Topic ,Anticoagulants ,Phase III as Topic ,Stroke ,Thromboembolism ,Atrial Fibrillation ,beta-Alanine ,Humans ,Benzimidazoles ,Clinical Trials ,Female ,Warfarin ,Physiologic ,Anti-Arrhythmia Agents ,Aged - Abstract
Atrial fibrillation (AF) is the most frequent cardiac arrhythmia, especially in older people. This condition is associated with an increased risk of stroke, and long-term anticoagulation treatment is therefore needed. Vitamin K antagonists are effective in reducing the risk of stroke but optimal use of these drugs remains difficult. The development of new oral anticoagulant drugs is therefore highly relevant. Dabigatran is an oral direct thrombin inhibitor. Its prodrug, dabigatran etexilate, is marketed under the name of Pradaxa and was initially approved for the prevention of thromboembolic events in major orthopedic surgery. It has been recently approved for stroke prevention in patients with AF. The purpose of this paper is to review--in light of current knowledge--the interests and limits of using dabigatran etexilate in AF. Briefly, dabigatran etexilate is not inferior to warfarin in AF. However many questions remain unanswered, including questions related to the concomitant use of dabigatran etexilate and acetylsalicylic acid, the possible increased risk of myocardial infarction and the need for drug monitoring.
- Published
- 2012
39. Réimaginer des communautés ?
- Author
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Brives, Charlotte and Marcis, Frédéric Le
- Subjects
hiv/Aids ,clinical trials ,biosocialités ,antirétroviraux ,vih/sida ,Abidjan ,biosociality ,essais cliniques ,antiretrovirals - Abstract
En 1990, l’introduction des antirétroviraux (ARV) a constitué un changement majeur dans la lutte contre l’épidémie de VIH sur le continent africain, modifiant les rapports entre les individus et le virus dont ils étaient porteurs. Si les individus séropositifs se vivaient ou étaient perçus comme victimes de la pandémie ou des violences structurelles, la médicalisation de la prévention depuis 2008 apparaît comme une autre évolution importante car elle implique la mise sous traitement précoce de patients pourtant asymptomatiques. Cette configuration nouvelle, productrice de relations inédites entre le corps, le virus, soi et les autres n’est dans l’immédiat observable que dans le cadre précis des essais cliniques. Cet article, en prenant pour objet l’analyse des conditions et des conséquences de la participation de sujets d’un pays du Sud, infectés par le VIH, à un essai portant sur la mise sous traitement précoce, permet de réinterroger à nouveaux frais la question de la vie avec le virus, et de documenter les conséquences globales d’un changement biotechnologique majeur dans les relations entre les humains et les virus. The introduction of anti retrovirus drugs in the 1990 caused a major change in the fight against the epidemic of the HIV virus on the African continent. This modified relations between individual people and their relation to the virus they were carrying. If previously seropositive individuals saw themselves, or were seen by others, as victims of the pandemic or of structural violence, the medicalisation of prevention from 2008 onwards brought about a major change since it implies the giving of early treatment to apparently a-symptomatic patients. This new situation which causes new relations between the body, the virus, the self and others is, at first, only visible within the narrow framework of clinical trials. This paper focuses on the analysis of the conditions and consequences of participation by carriers of the virus in a country of the South to a trial of a form of early treatment. This study enables the re-examination of questions concerning what life with the virus is like and enables documenting the global consequences of a major biotechnological shift in the relations of humans and the virus.
- Published
- 2015
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