{"doc_desc":{"title":"Cohort on Predictive Exacerbation Factors in Severe Asthmatics","idno":"FRESH-PEF8817-en","producers":[{"name":"Antoine MAGNAN","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8817-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8817"},{"agency":"FReSH","code":"FRESH-PEF8817"}]},"title":"Cohort on Predictive Exacerbation Factors in Severe Asthmatics","alternate_title":"EXPRESA - EXacerbation PREdictive factors in Severe Asthma"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Antoine;MAGNAN","PILabo":"CHU Nantes ; Institut national de la sant\u00e9 et de la recherche m\u00e9dicale - \/ UMR 915: l'Institut du thorax","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"075645300","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"201220396X","role":"labo id"}],"email":"a.magnan@hopital-foch.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Antoine;MAGNAN","email":"a.magnan@hopital-foch.com","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"marker"},{"keyword":"lymphocyte population"},{"keyword":"predictive factors"}],"topics":[{"topic":"Allergology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Asthma","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1656445230","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"To validate exacerbation prediction in certain lymphocyte populations by comparing markers already identified (NO, EEI), based on factors that do or do not cause infection.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Male and female; - Adult; - Severe asthmatic.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"45"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"06-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","contributorName":"Antoine MAGNAN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Samples are taken, respiratory function is assessed and questionnaires are completed during each visit. Immunomonitoring is systematically carried out. Exacerbations caused by viral infections shall be documented by testing for main causal viruses. Identifying predictive exacerbation markers in severe asthmatics may subsequently allow the relevance of treatment based on these markers to be tested, with the aim to prevent exacerbations.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Pays de la Loire - 6 centres."},"dataTypes":{"clinicalDataDetails":"Measurement of respiratory function.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}