{"doc_desc":{"title":"B\u00e9n\u00e9fice dans la gonarthrose d\u2019une cure thermale \u00e0 Saint-Lary Soulan","idno":"FRESH-PEF74119-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74119-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74119"},{"agency":"FReSH","code":"FRESH-PEF74119"}]},"title":"B\u00e9n\u00e9fice dans la gonarthrose d\u2019une cure thermale \u00e0 Saint-Lary Soulan","alternate_title":"LARYTHERM-Rhumato"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Patrick;BLIN","PILabo":"Universit\u00e9 de Bordeaux \/ BordeauxPharmacoEpi - Universit\u00e9 de Bordeaux - INSERM CIC1401","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-4005-7928","role":"pi id"},{"title":"IdRef","uri":"182433455","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Laure;CARCAILLON-BENTATA","PILabo":"Universit\u00e9 de Bordeaux \/ BordeauxPharmacoEpi - Universit\u00e9 de Bordeaux - INSERM CIC1401","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"263582779","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","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 SAINT LARY SOULAN","extlink":[{"title":"SIREN","uri":"216503888"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Cure thermale"},{"keyword":"cohorte"},{"keyword":"gonarthrose"},{"keyword":"incapacit\u00e9 fonctionnelle"},{"keyword":"douleur"},{"keyword":"fatigue"},{"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":"Arthrose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est d\u2019\u00e9valuer l\u2019efficacit\u00e9 comparative \u00e0 6 mois d\u2019une cure thermale \u00e0 Saint-Lary Soulan sur l\u2019incapacit\u00e9 fonctionnelle et la douleur (MCII : Minimal Clinical Important Improvement) dans la gonarthrose par rapport au groupe t\u00e9moin de l\u2019essai clinique randomis\u00e9 multicentrique Thermarthrose, recevant des soins standards.","abstract":"","coll_dates":[{"start":"2023-01-01","end":"2024-01-01"}],"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\": \" Patient pr\u00e9sentant des gonalgies dues \u00e0 une gonarthrose diagnostiqu\u00e9e depuis plus de 6 mois avec au moins trois des six crit\u00e8res cliniques d\u00e9finis par l\u2019American College of Rheumatology :            * \u00e2ge > 50 ans            * d\u00e9rouillage matinal < 30 minutes            * sensation de craquement lors des mouvements du genou            * genou globuleux par hypertrophie osseuse \u00e0 l\u2019examen physique           * douleur osseuse p\u00e9ri-articulaire \u00e0 l\u2019examen physique           * absence de chaleur locale \u00e0 la palpation - Patient ayant compl\u00e9t\u00e9 l\u2019Echelle Visuelle Analogique (EVA-D) pour l\u2019\u00e9valuation des gonalgies ressenties sur les huit derniers jours avec un score sup\u00e9rieur ou \u00e9gal \u00e0 3\\\/10 - Patient affili\u00e9 ou b\u00e9n\u00e9ficiant d'un r\u00e9gime de S\u00e9curit\u00e9 Sociale - 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 80 patients - maximum 171 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 et la commune de Saint-Lary Soulan."}},"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)"],"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 les m\u00e9decins thermaux et des auto-questionnaires remplis par les patients.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Patients recrut\u00e9s dans le d\u00e9partement des Hautes-Pyr\u00e9n\u00e9es, r\u00e9alisant une cure thermale \u00e0 Saint-Lary Soulan."},"dataTypes":{"clinicalDataDetails":"Genou(x) concern\u00e9(s) par la gonarthrose, anciennet\u00e9 de l'arthrose du genou, ant\u00e9c\u00e9dent de traumatisme du genou, date de la radiographie du ou des genou(x), score de s\u00e9v\u00e9rit\u00e9 de la gonarthrose, autre(s) localisation(s) arthrosique(s), \u00e9v\u00e8nement(s) ind\u00e9sirable(s)","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"}