Letteratura scientifica selezionata sul tema "Essai clinique multicentrique"
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Articoli di riviste sul tema "Essai clinique multicentrique":
Maggiori, L., E. Rullier, C. Meyer, F. Lazorthes, J. L. Faucheron e Y. Panis. "P.270 Essai clinique randomisé multicentrique sur les suintements séro-sanguinolents en chirurgie rectale". Gastroentérologie Clinique et Biologique 33, n. 3 (marzo 2009): A183. http://dx.doi.org/10.1016/s0399-8320(09)72961-6.
ONAISI, R., A. DUVIGNAUD, A. NGUYEN, J. DUPOUY, J. CHASTANG, J. LE BEL, R. LANDMAN et al. "ESSAI RANDOMISE POUR EVALUER L EFFICACITE ET LA SECURITE DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE - ESSAI COVERAGE FRANCE". EXERCER 32, n. 178 (1 dicembre 2021): 451–58. http://dx.doi.org/10.56746/exercer.2021.178.451.
Dominique, I., A. Ruffion, S. De Wachter, P. Van Kerrebroeck, M. Perrouin Verbe, R. Jairam, J. E. Terrier, B. Blok, F. Van Der Aa e S. Elneil. "Un système de neuromodulation sacré rechargeable pour le traitement de l’hyperactivité vésicale : résultats intermédiaires d’un essai clinique, prospectif, multicentrique". Progrès en Urologie 27, n. 13 (novembre 2017): 695–96. http://dx.doi.org/10.1016/j.purol.2017.07.051.
Blanc-Bisson, C., S. Blajezewski, E. Donois, V. Gilleron, G. Coureau, C. Germain, G. Chêne e I. Bourdel-Marchasson. "Analyse de faisabilité d’un essai clinique interventionnel ouvert randomisé multicentrique en oncologie gériatrique au moyen du PMSI. Étude Inogad". Revue d'Épidémiologie et de Santé Publique 57 (maggio 2009): S16. http://dx.doi.org/10.1016/j.respe.2009.02.057.
Pham-Scottez, A. "Impact d’une permanence téléphonique spécifique sur la prévention des tentatives de suicide des patients borderline adultes". European Psychiatry 30, S2 (novembre 2015): S24. http://dx.doi.org/10.1016/j.eurpsy.2015.09.074.
Escabasse, V., L. De Gabory, S. Morinière, N. Teissier, G. Mortuaire, P. Fayoux, O. Malard e G. De Bonnecaze. "Essai clinique multicentrique, randomisé évaluant l’efficacité de l’irrigation nasale chez les patients souffrant de mucoviscidose et présentant une rhinosinusite chronique". Revue des Maladies Respiratoires Actualités 12, n. 1 (gennaio 2020): 67–68. http://dx.doi.org/10.1016/j.rmra.2019.11.123.
Campion, C., R. Vatrinet, M. Bererd Camara, J. McCullough, K. Awuondo, Y. Sarro, E. Lhomme e L. Richert. "Gestion en temps réel d’une base de données biologiques centralisée pour un essai clinique vaccinal de phase II multicentrique en Afrique". Revue d'Épidémiologie et de Santé Publique 67 (maggio 2019): S129. http://dx.doi.org/10.1016/j.respe.2019.03.090.
Perrouin-Verbe, M., B. Blok, S. De Wachter, A. Ruffion, F. Van Der Aa, R. Jairam, S. Elneil e P. Van Kerrebroeck. "Nouveau système de neuromodulation des racines sacrées rechargeables pour le traitement de l’hyperactivité vésicale idiopathique : résultats à 12 mois d’un essai clinique, prospectif, multicentrique". Progrès en Urologie 28, n. 13 (novembre 2018): 705–6. http://dx.doi.org/10.1016/j.purol.2018.07.171.
Spaëth, D. "Époétine bêta dans le traitement de l'anémie liée à la chimiothérapie dans les tumeurs solides et les hémopathies malignes. Résultats d'un essai clinique, en ouvert, multicentrique". Bulletin du Cancer 97, n. 8 (agosto 2010): 969–78. http://dx.doi.org/10.1684/bdc.2010.1139.
Jaury, P., C. Buffel du Vaure, L. Bunge, E. Galam, M. E. Vincens, A. Catu-Pinault, C. Ghasarossian e C. Lemogne. "Groupes Balint de Formation à la Relation Thérapeutique chez les étudiants en 4e année de médecine. Effets sur l’empathie clinique par un essai randomisé multicentrique contrôlé". Psycho-Oncologie 12, n. 1 (marzo 2018): 8–12. http://dx.doi.org/10.3166/pson-2018-0030.
Tesi sul tema "Essai clinique multicentrique":
Mijoule, Guillaume. "Modélisation du processus d'inclusion de patients dans un essai clinique multicentrique". Toulouse 3, 2013. http://thesesups.ups-tlse.fr/2075/.
In this work, we investigate the statistical modeling of the patients' inclusion process in phase III of a multicentric clinical trial. We introduce empirical bayesian models similar to the Gamma-Poisson process that take into account uncertainty in the opening dates of centers or a time-dependent rate of inclusion. We show how to perform estimation and prediction based on an on-going study at some interim time. We extend these models to account for patients drop-out during screening process. Finally, a stochastic cost model is proposed
Nardi, Olivier. "Validation et intérêt thérapeutique de la mesure de la saturation musculaire en oxygène mesurée de manière non invasive au cours des syndromes septiques graves". Versailles-St Quentin en Yvelines, 2013. http://www.theses.fr/2013VERS0015.
Several manufacturers have put on the healthcare market medical devices intended for evaluation and monitoring of microcirculation. The technical performance of the medical device has to be separated from clinical benefit which is impacted by the performance of the device but also by the downstream consequences of using the device as a diagnostic tool. Among the devices intended for microcirculation monitoring, the Inspectra spectrometer uses near infrared technology to noninvasively illuminate the tissue below and to evaluate local haemoglobin oxygen saturation (StO2). Our aim was to evaluate the added value of StO2 monitoring for the management of severe sepsis and septic shock. We present our results regarding feasibility of multi-site StO2 monitoring and the impact of adrenergic support on StO2 in a first study. We then described the relationship between StO2 and ScvO2 in three observational studies. Finally the therapeutic interest of StO2 optimisation was assessed in two clinical controlled trials, one pilot trial including 30 patients and one European multicentric trial including 103 patients
Niangoran, Bessekon. "Apport du monitorage statistique des données dans la gestion des essais cliniques multicentriques en Afrique". Electronic Thesis or Diss., Bordeaux, 2023. http://www.theses.fr/2023BORD0436.
Data quality is a fundamental concern of clinical research. To ensure this quality, continuous data monitoring must be practiced. International drug regulatory bodies recommend that this monitoring be targeted, based on a risk analysis. From this recommendation emerged the concept of “centralized statistical monitoring” (CSM) which consists of detecting atypical distributions of variables in a center compared to other centers. This thesis identifies existing CSM methods, proposes new ones, and compares the performances of each. In the first part, we recall the interest of the subject, in a context marked by the increase in the number of clinical trials, the need to work increasingly remotely and the need for new monitoring paradigms. In the second part, we identify existing CSM methods, analyze their performances reported in the literature and draw two major observations: (i) the number of methods is limited; (ii) their assessments through simulation studies and applications on real data reported in the literature are also limited. In the third part we propose two new CSM methods to detect the distributions of atypical variables in multicenter trials, one for quantitative data which uses a standardized distance measure (Distance method) and the other for categorical data, which uses a hierarchical Bayesian beta-binomial (HBBB) model. We evaluate the performance of these methods using clinical trial simulations and then compare them to other CSM methods identified in the literature. For quantitative data, the Distance method has performances similar to the method proposed by Desmet et al., and superior to those of the two other existing methods. For categorical data, the HBBB method has similar performance to the only other existing method, also proposed by Desmet et al. For both methods, Distance and HBBB, the sensitivity is poor overall, but the specificity is excellent, including in many scenarios involving small sample sizes. The low sensitivity suggests that the CSM is an additional tool that can be used in addition to other conventional monitoring procedures, but does not replace them. The strong specificity and user-friendliness suggest that these methods can be routinely applied in all clinical trials, as their use will not be centrally time consuming and will not create unnecessary workload in investigational centers
DEGUIRAL, PHILIPPE. "Presentation et justification d'un essai clinique multicentrique, randomise, en double-aveugle, evaluant l'association granisetron-methylprednisolone avec ou sans alprazolam pour le controle des nausees et vomissements induits par les protocoles fec/fac". Nantes, 1994. http://www.theses.fr/1994NANT259M.
Olivier, François. "L'efficacité d'une méthode minimalement invasive pour l'administration du surfactant chez les prématurés de 32 0/7 à 36 6/7 semaines atteints de la maladie des membranes hyalines : un essai clinique randomisé multicentrique". Master's thesis, Université Laval, 2017. http://hdl.handle.net/20.500.11794/27525.
Background: Minimally invasive surfactant therapy (MIST) is used to avoid invasive mechanical ventilation (IMV) in respiratory distress syndrome (RDS) management. Objective: The primary aim of this study was to test MIST in moderate (32 – 33 weeks’ gestational age (GA)) and late preterm (34 - 36 weeks’ GA) infants affected by RDS to avoid IMV exposure and prevent pneumothorax. Methods: This is a randomized controlled trial including three Canadian neonatal intensive care units. Patients were randomized to standard management or to intervention (MIST). In the first day of life, patients from the intervention group received MIST immediately after randomization. The combined primary outcome included either exposure to IMV or occurrence of a pneumothorax requiring a chest tube insertion. Treatment failure criteria were used to prevent bias as the intervention was not blind. The analysis was made by intention to treat approach. Results: Among 45 randomized patients, 24 were assigned to MIST and 21 to the standard management group. All patients were included in the analysis. Eight infants (33%) in the intervention group presented with the primary outcome versus 19 (90%) in the standard management group (absolute risk reduction 0,57, 95% CI: 0,54-0,60). Seven patients from the intervention group reached the primary outcome for being exposed to IMV and one for presenting a pneumothorax. In the control group, 18 patients reached the primary outcome for being exposed to IMV and one for presenting a pneumothorax. In either group, none of the patients have reached the clinical failure criteria. Conclusion: Minimally invasive surfactant therapy was associated with a significant reduction in IMV exposure and pneumothorax occurrence in moderate and late preterm infants affected by RDS.
Kalfon, Pierre. "Contrôle glycémique informatisé en réanimation". Thesis, Paris 6, 2014. http://www.theses.fr/2014PA066150/document.
Stress-induced hyperglycemia is common in critically ill patients due to insulin resistance and increased hepatic output of glucose. The relationship between stress hyperglycemia and poor outcome for patients hospitalized in the intensive care unit (ICU) was already established when Van den Berghe et al demonstrated that tight glucose control (TGC) by intensive insulin therapy was associated with decreased mortality and rate of complications in surgical ICU patients. Because further randomized controlled studies have failed to replicate any mortality benefit and have even shown an increased mortality (the NICE -SUGAR study), the primary objective of this thesis was to test the hypothesis that TGC with a computerized decision-support system (CDSS) reduces the mortality in adult critically ill patients as compared to conventional glucose control targeting BG levels to <10 mmol/L (the CGAO-REA study). We discussed several aspects of glucose control in the ICU (integration in the clinical workflow, confounding issues in BG measurements, insulin resistance, glucose variability, impact of diabetic status) and reviewed existing computerized tools. Despite the negative result of the CGAO-REA study, the interest for CDSSs remains because meanwhile new therapeutic goals for glucose control in the ICU have emerged. The second objective of this thesis is to present ongoing developments. Based on research programs targeting an artificial pancreas for diabetic patients, in silico trials, multidisciplinary approaches integrating human factors, a computerized glucose control station could be developed to allow clinicians to achieve an optimized, individualized glucose control in the ICU
Robert, Sarah. "Santé et recours aux soins des jeunes en insertion socio-professionnelle : une recherche interventionnelle multicentrique Santé et recours aux soins des jeunes en insertion âgés de 18 à 25 ans suivis en mission locale Effects of systematically offered social and preventive medicine consultation on training and health attitudes of young people not in employment, education or training (NEETs) : an interventional study in France". Thesis, Sorbonne université, 2020. http://www.theses.fr/2020SORUS038.
In France, ‘‘Missions locales’’ are public assistance sites for young people aged 16–25 years who are not in employment, in education or training (NEET). More than 1.4 million NEETs – i.e. ten to fifteen percent of the youth – participate in these sites each year. The main goal of ‘‘Missions locales’’ is to enhance both professional and social insertion – since education, employment, housing and health issues are inseperable. Several international studies have shown that NEETs have poor health status. In France, there were very few quantitative studies on this topic until the PRESAJE survey in 2011, which took place in five ‘’Missions locales’’. Based on data from this survey, we showed that the overall social profile of the NEET population was diverse, with more difficult living conditions than in the general population. Health-related vulnerability factors identified were: low education level; social isolation; insufficient health insurance; low self-esteem; and, low level of trust in institutions. Some of their health indicators were remarkably poor compared to other youth of the same age: more often, they had chronic disease, were overweight or obese, and their mental health status was poor. Despite their poor health, NEETs had less access to health care than the youth of the same age in the general population. This work also has highlighted the importance of having health sites inside ‘‘Missions locales’’. Social and preventive medicine consultations that are fully integrated into the social services for NEETs have an impact on their access to training (and we hope subsequently on their employment), and contribute to changing some of their health-related behaviours