{"doc_desc":{"title":"Etude longitudinale sur des patients trait\u00e9s par benfluorex ayant une fuite aortique","idno":"FRESH-PEF8761-fr","producers":[{"name":"Mahmoud ZUREIK","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8761-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8761"},{"agency":"FReSH","code":"FRESH-PEF8761"}]},"title":"Etude longitudinale sur des patients trait\u00e9s par benfluorex ayant une fuite aortique","alternate_title":"REFLEX"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Mahmoud;ZUREIK","firstname":"Mahmoud","lastname":"ZUREIK","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"mahmoud.zureik@ansm.sante.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Institut national de la sant\u00e9 et de la recherche m\u00e9dicale - \/ U1152 Physiopathologie et \u00e9pid\u00e9miologie des maladies respiratoires\u00c9quipe\/activit\u00e9 :- \u00c9pid\u00e9miologie respiratoire: de l'\u00e9tiologie de l'asthme et de la BPCO au pronostic de la transplantation pulmonaire","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Mahmoud;ZUREIK","lastname":"ZUREIK","firstname":"Mahmoud","type":"contact","email":"mahmoud.zureik@ansm.sante.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Recherche"},{"keyword":"benfluorex"},{"keyword":"effets secondaires"},{"keyword":"post"},{"keyword":"autorisation de mise sur le march\u00e9"},{"keyword":"AMM"},{"keyword":"effets ind\u00e9sirables"},{"keyword":"\u00e9tude"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"Maladies de l'appareil circulatoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/426429380","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"\u00c9tudier l'\u00e9volution \u00e9chographique des atteintes valvulaires (r\u00e9gression, stabilit\u00e9 ou progression) chez les patients ayant \u00e9t\u00e9 trait\u00e9s par benfluorex. Comparer l\u2019\u00e9volution des atteintes valvulaires potentiellement li\u00e9es au benfluorex \u00e0 celles non li\u00e9es au benfluorex. - Chez tous les patients et chez ceux avec atteintes valvulaires potentiellement li\u00e9es au benfluorex, \u00e9tudier l\u2019\u00e9volution en fonction : - de l\u2019indication(s), de la dur\u00e9e de l\u2019exposition au benfluorex et la dur\u00e9e depuis l\u2019arr\u00eat du m\u00e9dicament. - de l\u2019\u00e2ge et du sexe - du diab\u00e8te et de sa prise en charge m\u00e9dicamenteuse. - de l\u2019existence de pathologies cardiaques et non cardiaques. - des traitements actuels et des traitements ayant \u00e9t\u00e9 pris simultan\u00e9ment avec le benfluorex.","abstract":"","coll_dates":[{"start":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" homme et femme - 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