{"doc_desc":{"title":"\u00c9tude de s\u00e9curit\u00e9 et de pharmacocin\u00e9tique en pratique r\u00e9elle de Pylera\u00ae en France : l'\u00e9tude SAPHARY","idno":"FRESH-PEF73260-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73260-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73260"},{"agency":"FReSH","code":"FRESH-PEF73260"}]},"title":"\u00c9tude de s\u00e9curit\u00e9 et de pharmacocin\u00e9tique en pratique r\u00e9elle de Pylera\u00ae en France : l'\u00e9tude SAPHARY","alternate_title":"SAPHARY"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Patrick;BLIN","firstname":"Patrick","lastname":"BLIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"patrick.blin@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de Bordeaux \/ Bordeaux PharmacoEpi - Universit\u00e9 de Bordeaux - Service de Pharmacologie m\u00e9dicale - CIC Bordeaux CIC 1401","isContact":true}],"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":"ALLERGAN INDUSTRIE","extlink":[{"title":"SIREN","uri":"344097902"}]}]},"distribution_statement":{"contact":[{"name":"Patrick;BLIN","lastname":"BLIN","firstname":"Patrick","type":"contact","email":"patrick.blin@u-bordeaux.fr","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":"effet ind\u00e9sirable neurologique"},{"keyword":"infection \u00e0 Helicobacter Pylori"},{"keyword":"Bismuth"},{"keyword":"Pylera"},{"keyword":"Bordeaux PharmacoEpi"},{"keyword":"Service de Pharmacologie m\u00e9dicale"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Codes d'extension","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/979408586","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"L'objectif principal de l'\u00e9tude est de v\u00e9rifier l'absence d'accumulation de bismuth chez les sujets \u00e0 qui l'on a prescrit Pylera\u00ae, par une approche pharmacocin\u00e9tique en vie r\u00e9elle.","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2016-01-01"}],"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            \"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\": \" Hommes et femmes \u00e2g\u00e9s de 18 ans et plus ayant re\u00e7u une prescription de l'investigateur pour un traitement par Pylera\u00ae. - Capacit\u00e9 mentale et l\u00e9gale de donner un consentement \u00e9clair\u00e9 \u00e9crit et jug\u00e9 par l'investigateur capable de suivre les proc\u00e9dures d\u00e9crites dans le protocole.  \",\n    \"clusion_E\": \"Femmes enceintes ou allaitantes - Inqui\u00e9tude de l'investigateur quant \u00e0 la s\u00e9curit\u00e9 de la participation du sujet \u00e0 l'\u00e9tude ou toute autre raison pour laquelle l'investigateur consid\u00e8re que le sujet n'est pas apte \u00e0 participer \u00e0 l'\u00e9tude\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['Codage MedDRA pour les \u00e9v\u00e9nements ind\u00e9sirables neurologiques et non neurologiques (SOC et PT) ; code ATC']","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\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;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":"< 500 individus","response_rate":"200"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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 est d\u00e9finie dans un accord-cadre \u00e9tabli entre le promoteur, l&#x27;universit\u00e9 de Bordeaux et l&#x27;ADERA (association \u00e0 but non lucratif)"}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"04-11-2015","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Cahiers d'observation (Case Report Form, CRF) sur papier est rempli par l'investigateur \u00e0 chaque visite de suivi.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Dossiers m\u00e9dicaux, dossiers cliniques, notes des infirmi\u00e8res, correspondance m\u00e9dicale concernant le patient, notes d'\u00e9volution concernant le patient, rapports de pathologie, rapports de laboratoire, feuilles de travail de l'\u00e9tude, dossier patient informatis\u00e9.","biologicalDataDetails":"Concentration de bismuth dans le sang total et le plasma avant le d\u00e9but du traitement par Pyelra\u00ae et \u00e0 la fin du traitement de 10 jours par Pylera\u00ae.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}