{"doc_desc":{"title":"Registre clinico-biologique de l'endocardite infectieuse au CHU de Nancy et mise en place d\u2019une sp\u00e9cimenoth\u00e8que","idno":"FRESH-PEF60189-fr","producers":[{"name":"Fran\u00e7ois ALLA","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60189-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60189"},{"agency":"FReSH","code":"FRESH-PEF60189"}]},"title":"Registre clinico-biologique de l'endocardite infectieuse au CHU de Nancy et mise en place d\u2019une sp\u00e9cimenoth\u00e8que","alternate_title":"EI-TH\u00c8QUE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;ALLA","PILabo":"CIC-EC INSERM CHU","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-5793-7190","role":"pi id"},{"title":"IdRef","uri":"035115424","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"francois.alla@u-bordeaux.fr","isContact":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : ICE","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;ALLA","email":"francois.alla@u-bordeaux.fr","type":"contact","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":"intervention chirurgicale valvulaire"},{"keyword":"hospitalisation"},{"keyword":"d\u00e9c\u00e8s"}],"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":"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":"Endocardite infectieuse aig\u00fce ou subaig\u00fce","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/512128824","title":"CIM-11"}]}],"purpose":"Enrichir la banque de donn\u00e9es cliniques et biologiques des patients pris en charge pour endocardite infectieuse au CHU de Nancy depuis 1991 ; Enrichir de fa\u00e7on prospective cette banque par de nouveaux items recouvrant de fa\u00e7on pr\u00e9cise les diff\u00e9rents aspects \u00e9volutifs et th\u00e9rapeutiques de la maladie ; Constituer une sp\u00e9cimenoth\u00e8que (s\u00e9roth\u00e8que et plasmath\u00e8que) afin de pouvoir r\u00e9pondre rapidement aux futures probl\u00e9matiques h\u00e9matologiques (marqueur du risque embolique par exemple).","abstract":"","coll_dates":[{"start":"1991-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est']","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\": \"Patient lorrains hospitalis\u00e9s au CHU de Nancy depuis 1991 pour EI.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques. Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou retour vers un tiers. Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi. R\u00e9alisation d\\'audit qualit\u00e9 interne annuellement. Proc\u00e9dure qualit\u00e9 POS (Proc\u00e9dures Op\u00e9ratoires Standardis\u00e9es). Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"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":"['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)\"}","{\"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":"[1000-5000[."},"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\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation non possible des donn\u00e9es par des industriels","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":"Non","contributorName":"Fran\u00e7ois ALLA","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\/24914062"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Examens cliniques : saisie manuscrite. Examens biologiques : saisie manuscrite.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Lorraine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Pr\u00e9l\u00e8vement de sang et de plasma.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}