{"doc_desc":{"title":"B\u00e9n\u00e9fice d\u2019une cure thermale \u00e0 Cast\u00e9ra-Verduzan dans la gonarthrose","idno":"FRESH-PEF73998-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73998-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73998"},{"agency":"FReSH","code":"FRESH-PEF73998"}]},"title":"B\u00e9n\u00e9fice d\u2019une cure thermale \u00e0 Cast\u00e9ra-Verduzan dans la gonarthrose","alternate_title":"CASTHERM-Rhumato"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Pauline;BOSCO-LEVY","PILabo":"","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0001-9763-5974","role":"pi id"},{"title":"IdRef","uri":"188371400","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"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":"COMMUNE DE CASTERA VERDUZAN","extlink":[{"title":"SIREN","uri":"213200835"}]},{"name":"DEPARTEMENT DU GERS","extlink":[{"title":"SIREN","uri":"223200015"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Cure thermale"},{"keyword":"gonarthrose"},{"keyword":"incapacit\u00e9 fonctionnelle"},{"keyword":"douleur"},{"keyword":"cohorte"},{"keyword":"qualit\u00e9 de vie"}],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Maladies du syst\u00e8me musculosquelettique ou du tissu conjonctif","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1473673350","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"L'objectif principal est d'\u00e9valuer l\u2019effet d\u2019une cure thermale \u00e0 Cast\u00e9ra-Verduzan sur l\u2019am\u00e9lioration fonctionnelle \u00e0 6 mois dans la gonarthrose.","abstract":"","coll_dates":[{"start":"2021-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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 (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\": \" Patient \u00e2g\u00e9 de 50 ans ou plus - Patient pr\u00e9sentant des gonalgies dues \u00e0 une gonarthrose diagnostiqu\u00e9e depuis plus de 6 mois, confirm\u00e9e par une imagerie du genou (radiographie du genou de face\\\/schuss et d\u00e9fil\u00e9 f\u00e9moro-patellaire r\u00e9alis\u00e9e dans les 6 mois pr\u00e9c\u00e9dant l\u2019inclusion) - Patient ayant compl\u00e9t\u00e9 l\u2019Echelle Visuelle Analogique (EVA) pour l\u2019\u00e9valuation des gonalgies ressenties sur les huit derniers jours avec un score strictement sup\u00e9rieur \u00e0 3\\\/10 - Patient acceptant de participer \u00e0 l\u2019\u00e9tude, ayant compl\u00e9t\u00e9 et sign\u00e9 le Formulaire de consentement expr\u00e8s libre et \u00e9clair\u00e9 du Patient\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Les diff\u00e9rents questionnaires de l\\'\u00e9tude seront monitor\u00e9s par un Attach\u00e9 de Recherche Epid\u00e9miologique afin de v\u00e9rifier la coh\u00e9rence des donn\u00e9es. Ce dernier pourra solliciter le m\u00e9decin thermal en cas de questionnaires non renvoy\u00e9s ou de pr\u00e9cisions sur les donn\u00e9es compl\u00e9t\u00e9es. Un contr\u00f4le des donn\u00e9es recueillies sur site pourra \u00e9galement \u00eatre effectu\u00e9 par un Attach\u00e9 de Recherche Epid\u00e9miologique.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"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":"minimum 50 patients - maximum 100 patients"},"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 et l&#x27;acc\u00e8s aux donn\u00e9es de l&#x27;\u00e9tude ont fait l&#x27;objet d&#x27;une convention entre l&#x27;Universit\u00e9 de Bordeaux, l&#x27;ADERA SAS, le d\u00e9partement du Gers et la commune de Cast\u00e9ra-Verduzan."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"07-03-2023","isContributorPI":"Non","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"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":"Les donn\u00e9es d'\u00e9tude sont recueillies par des questionnaires papiers standardis\u00e9s : des questionnaires m\u00e9dicaux remplis par le m\u00e9decin thermal et des auto-questionnaires remplis par les patients.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Patients r\u00e9alisant une cure thermale \u00e0 Cast\u00e9ra-Verduzan dans le d\u00e9partement du Gers."},"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"}