{"doc_desc":{"title":"Etude cas-t\u00e9moins sur les facteurs de risque de la narcolepsie suite \u00e0 une exposition aux vaccins anti-H1N1","idno":"FRESH-PEF73060-fr","producers":[{"name":"Antoine PARIENTE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73060-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73060"},{"agency":"FReSH","code":"FRESH-PEF73060"}]},"title":"Etude cas-t\u00e9moins sur les facteurs de risque de la narcolepsie suite \u00e0 une exposition aux vaccins anti-H1N1","alternate_title":"NarcoFluVF"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Yves;DAUVILLIERS","firstname":"Yves","lastname":"DAUVILLIERS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id"},{"title":"SIREN","uri":"263400160","role":"organisation id"}],"email":"y-dauvilliers@chu-montpellier.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","PILabo":"Montpellier University Hospital \/ National Reference Centre for Narcolepsy\/Sleep Laboratory","isContact":true},{"name":"Antoine;PARIENTE","firstname":"Antoine","lastname":"PARIENTE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"antoine.pariente@u-bordeaux.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Inserm, Bordeaux University Hospital \/ Pharmacoepidemiology","isContact":true}],"oth_id":[{"name":"Projet Europ\u00e9en VAESCO","type":"collaboration"}],"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"},{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00s9v1h75"}]}]},"distribution_statement":{"contact":[{"name":"Yves;DAUVILLIERS","lastname":"DAUVILLIERS","firstname":"Yves","type":"contact","email":"y-dauvilliers@chu-montpellier.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id","title":"ROR"},{"uri":"263400160","role":"organisation id","title":"SIREN"}]},{"name":"Antoine;PARIENTE","lastname":"PARIENTE","firstname":"Antoine","type":"contact","email":"antoine.pariente@u-bordeaux.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":"Narcolepsie"},{"keyword":"H1N1"},{"keyword":"Grippe"},{"keyword":"vaccins"},{"keyword":"exposition"}],"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":"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":"Narcolepsie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1201727099","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":"L\u2019objectif principal de l\u2019\u00e9tude \u00e9tait de d\u00e9terminer les facteurs de risques de la narcolepsie, en particulier d\u2019\u00e9tudier le r\u00f4le potentiel de la grippe, de l\u2019infection \u00e0 H1N1, des vaccinations (notamment contre la grippe pand\u00e9mique H1N1). Cette \u00e9tude devait ainsi pouvoir contribuer \u00e0 l\u2019\u00e9tude europ\u00e9enne coordonn\u00e9e par le consortium VAESCO et ayant b\u00e9n\u00e9fici\u00e9 d\u2019un financement de l\u2019ECDC. L\u2019objectif secondaire \u00e9tait de comparer les caract\u00e9ristiques des cas expos\u00e9s et des cas non expos\u00e9s. Le r\u00f4le potentiel de pr\u00e9dispositions g\u00e9n\u00e9tiques n\u2019est pas d\u00e9crit dans le pr\u00e9sent rapport final (d\u00e9pendant des analyses qui seront potentiellement r\u00e9alis\u00e9es ult\u00e9rieurement sur les pr\u00e9l\u00e8vements stock\u00e9s).","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2012-01-01"}],"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\": \"Enfance (6 \u00e0 12 ans)\",\n \"concept\": {\n \"vocab\": \"MeSH\",\n \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n }\n },\n {\n \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n \"concept\": {\n \"vocab\": \"MeSH\",\n \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n }\n },\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 \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n \"concept\": {\n \"vocab\": \"MeSH\",\n \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n }\n }\n ],\n \"level_type_clusion_I\": \"Patients\",\n \"level_type_clusion_other\": \"\",\n \"clusion_I\": \"Les cas \u00e9taient d\u00e9finis comme des patients avec un diagnostic de narcolepsie, valid\u00e9 et class\u00e9 selon les crit\u00e8res de la d\u00e9finition \u00e9tablie par la Brighton Collaboration par un Comit\u00e9 de Validation, dont la date index principale \u00e9tait comprise entre le 01\\\/04\\\/2009 et le 30\\\/04\\\/2011, et dont la date d\u2019apparition de la somnolence diurne excessive (SDE) \u00e9tait post\u00e9rieure au 31\\\/12\\\/2004. Les t\u00e9moins : Patients de m\u00eame age, de m\u00eame sexe et pris en charge dans le m\u00eame centre qu'un cas. Soins sans rapport avec la narcolepsie et une vaccination anti-H1N1\",\n \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"Patient\/Case : 85 t\u00e9moins\/Controls : 202"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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":"","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":"05-05-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2016","isContributorPI":false,"contributorName":"Antoine PARIENTE","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=narcoflu"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (Europe)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"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":"Questionnaire face \u00e0 face pour les cas et par t\u00e9l\u00e9phone pour les cas et les t\u00e9moins","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"14 centres \u00e0 travers la France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Pr\u00e9levement sanguin (typage HLA, DBQ1, analyses g\u00e9n\u00e9tiques et analyses d'anticorps)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}