{"doc_desc":{"title":"Etude transversale sur des patients infect\u00e9s par le VIH trait\u00e9s par antir\u00e9troviraux : pr\u00e9valence de la lipoatrophie faciale - FRAN08-005","idno":"FRESH-PEF115-fr","producers":[{"name":"Isabelle COHEN-CODAR","affiliation":"ABBVIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF115-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"115"},{"agency":"FReSH","code":"FRESH-PEF115"}]},"title":"Etude transversale sur des patients infect\u00e9s par le VIH trait\u00e9s par antir\u00e9troviraux : pr\u00e9valence de la lipoatrophie faciale - FRAN08-005","alternate_title":"PREFACE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Isabelle;COHEN-CODAR","firstname":"Isabelle","lastname":"COHEN-CODAR","type":"investigator","extlink":[{"title":"SIREN","uri":"750775660","role":"organisation id"}],"email":"","affiliationName":"ABBVIE","PILabo":"ABBVIE","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64","role":"sponsor id"},{"title":"SIREN","uri":"602950206","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"},{"title":"SIREN","uri":"602950206"}]},{"name":"REGION AUVERGNE RHONE ALPES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"effet secondaire"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"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":"D\u00e9crire la pr\u00e9valence de la lipoatrophie faciale chez les patients infect\u00e9s par le VIH et trait\u00e9s par antir\u00e9troviraux. D\u00e9crire la pr\u00e9valence des lipoatrophies et des syndromes lypodistrophiques mixtes. Evaluer \u00e0 l\u2019aide de l\u2019autoquestionnaire patient multidimensionnel et sp\u00e9cifique ABCD \u00ab Assessment of Body Change and Distress \u00bb le score de qualit\u00e9 de vie.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2009-12-31"}],"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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient infect\u00e9 par le VIH, trait\u00e9 par antir\u00e9troviraux depuis au moins 1 an et se pr\u00e9sentant \u00e0 la consultation dans son centre de prise en charge habituel pour le suivi de son infection par le VIH, durant la p\u00e9riode de l\u2019\u00e9tude, obtention du consentement \u00e9crit pour la collecte et l\u2019exploitation des donn\u00e9es personnelles.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non 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d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-07-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Fiches 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Autoquestionnaire ABCD compl\u00e9t\u00e9 par le patient et remis au m\u00e9decin sous enveloppe cachet\u00e9e puis envoy\u00e9 \u00e0 la soci\u00e9t\u00e9 en charge de la gestion des donn\u00e9es.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"suivi biologique de l'infection par VIH","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}