{"doc_desc":{"title":"Registre des cas d'insuffisance surr\u00e9nalienne et\/ou de syndrome de Cushing chez des patients trait\u00e9s par cortico\u00efdes inhal\u00e9s","idno":"FRESH-PEF2932-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2932-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2932"},{"agency":"FReSH","code":"FRESH-PEF2932"}]},"title":"Registre des cas d'insuffisance surr\u00e9nalienne et\/ou de syndrome de Cushing chez des patients trait\u00e9s par cortico\u00efdes inhal\u00e9s","alternate_title":"CORINES"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Mathieu;MOLIMARD","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0002-4346-8346","role":"pi id"},{"title":"IdRef","uri":"080590144","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"mathieu.molimard@u-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Nicholas;MOORE","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-1212-2817","role":"pi id"},{"title":"IdRef","uri":"077852877","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"nicholas.moore@u-bordeaux.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"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":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"Mathieu;MOLIMARD","email":"mathieu.molimard@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Nicholas;MOORE","email":"nicholas.moore@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Insuffisance surr\u00e9nalienne"},{"keyword":"syndrome de Cushing"},{"keyword":"cortico\u00efdes inhal\u00e9s"},{"keyword":"cohorte r\u00e9trospective"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"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":"Les objectifs \u00e9taient de recenser les cas d\u2019insuffisance surr\u00e9nalienne et\/ou de syndrome de Cushing chez des patients sous cortico\u00efdes inhal\u00e9s au cours des ann\u00e9es 2000 \u00e0 2005 et de d\u00e9crire les circonstances de survenue de ces \u00e9v\u00e8nements afin de formuler des recommandations pour les pr\u00e9venir.","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\": \"Nourrisson (28j \u00e0 2 ans)\",\n \"concept\": {\n \"vocab\": \"MeSH\",\n \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n }\n },\n {\n \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n \"concept\": {\n \"vocab\": \"MeSH\",\n \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n }\n },\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\": \"Enfants ou adultes trait\u00e9s par cortico\u00efdes inhal\u00e9s ; Ayant pr\u00e9sent\u00e9 une symptomatologie \u00e9vocatrice d\u2019une insuffisance surr\u00e9nalienne et\\\/ou d\u2019un syndrome de Cushing au cours des ann\u00e9es 2000 \u00e0 2005 ; Premiers sympt\u00f4mes apparus au cours du traitement ou au plus tard 3 mois apr\u00e8s son arr\u00eat ; Patients sans insuffisance surr\u00e9nalienne et\\\/ou le syndrome de Cushing connus avant la mise sous traitement par des cortico\u00efdes inhal\u00e9s.\",\n \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","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\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"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":"70 patients \u00e9ligibles dont 32 patients inclus 70 eligible patients, of whom 32 patients included"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La propri\u00e9t\u00e9 des donn\u00e9es de l'\u00e9tude a fait l'objet d'une convention entre l'Universit\u00e9 Bordeaux Segalen, le CHU de Bordeaux et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"10-06-2011","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"Non","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18707191"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les m\u00e9decins d\u00e9claraient \u00e0 l\u2019aide d'un questionnaire tous les patients r\u00e9pondant aux crit\u00e8res d\u2019inclusion. Pour chaque cas ainsi d\u00e9clar\u00e9, un second questionnaire \u00e9tait envoy\u00e9 au m\u00e9decin. Ce questionnaire \u00e9tait destin\u00e9 \u00e0 recueillir tous les traitements pris par le patient y compris les traitements par cortico\u00efdes syst\u00e9miques, ainsi que les \u00e9l\u00e9ments cliniques et biologiques susceptibles de pr\u00e9ciser le diagnostic et les circonstances de survenue de ces \u00e9v\u00e8nements.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Pneumologues, p\u00e9diatres, endocrinologues, m\u00e9decins r\u00e9animateurs en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}