{"doc_desc":{"title":"\u00c9tude transversale sur des patients migraineux consultant en m\u00e9decine de ville","idno":"FRESH-PEF73242-fr","producers":[{"name":"Fran\u00e7oise RADAT","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73242-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73242"},{"agency":"FReSH","code":"FRESH-PEF73242"}]},"title":"\u00c9tude transversale sur des patients migraineux consultant en m\u00e9decine de ville","alternate_title":"SMILE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Fran\u00e7oise;RADAT","firstname":"Fran\u00e7oise","lastname":"RADAT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id"},{"title":"SIREN","uri":"263305823","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","PILabo":"CHU Pellegrin \/ 33076 Bordeaux Cedex","isContact":false},{"name":"Gilles;GERAUD","firstname":"Gilles","lastname":"GERAUD","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"organisation id"},{"title":"SIREN","uri":"263100125","role":"organisation id"}],"email":"geraud.g@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","PILabo":"Groupe Hospitalier Rangueil-Larrey","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UCB PHARMA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01n6t9x28","role":"sponsor id"},{"title":"SIREN","uri":"562079046","role":"sponsor id"}],"role":"sponsor"},{"name":"","role":"sponsor"}],"funding_agencies":[{"name":"UCB PHARMA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01n6t9x28"},{"title":"SIREN","uri":"562079046"}]}]},"distribution_statement":{"contact":[{"name":"Gilles;GERAUD","lastname":"GERAUD","firstname":"Gilles","type":"contact","email":"geraud.g@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Migraine"},{"keyword":"troubles de l'humeur"},{"keyword":"comportements d'adaptation"},{"keyword":"pratique de soins primaires"},{"keyword":"prise en charge m\u00e9dicale"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Migraine","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/669367341","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Les objectifs de l'\u00e9tude SMILE \u00e9taient d'\u00e9valuer l'anxi\u00e9t\u00e9, le stress, la d\u00e9pression, l'impact fonctionnel et les comportements d'adaptation chez les patients migraineux consultant en en m\u00e9decine de ville en France","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2006-01-01"}],"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\": \"Chaque m\u00e9decin participant devait inclure les quatre premiers patients cons\u00e9cutifs consultant pour une migraine,  \u00e2g\u00e9s de plus de  18 ans et actuellement non trait\u00e9 avec une substance connue pour \u00eatre dot\u00e9e de propri\u00e9t\u00e9s prophylactiques migraine (utilis\u00e9es sp\u00e9cifiquement pour la pr\u00e9vention des migraines ou pour d'autres raisons)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"6109"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","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":"07-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"14-09-2017","isContributorPI":false,"contributorName":"Gilles GERAUD","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18039338"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie","Priv\u00e9 \u00e0 but non lucratif"],"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":"Par les m\u00e9decins participant","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Tests psychom\u00e9triques (score HAD, stress (PSS4), Migraine-Specific Quality of life) \u00c9valuation de l'efficacit\u00e9 de traitement aigu","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}