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","availabilityStatus":"The data is not available for download directly via DataverseNL but is available on request if the request is compliant with the Terms of Access.","contactForAccess":"Contact dataset owner","fileAccessRequest":false,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: the LDN Crohn study."},{"typeName":"alternativeTitle","multiple":true,"typeClass":"primitive","value":["LDN Crohn Study"]},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"van der Woude C.J."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"van de Pol, N."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"https://orcid.org/0000-0002-4699-6662"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Paulides, E"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Wolfhagen, F."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/028xtgx62","expandedvalue":{"scheme":"http://www.grid.ac/ontology/","@type":"https://schema.org/Organization"}}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Tielemans, M."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/05564wx43"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Bartelink, M."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/05w8df681"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"West, R.L."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/007xmz366"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Holster, I.L."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/01n0rnc91"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Verweij, K.E."},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"https://ror.org/01n0rnc91"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"van der Woude, C.J."},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"van de Pol, N."},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"Crohn's disease (CD) is an inflammatory bowel disease (IBD). Several drugs exist to induce and maintain remission, but a significant part of the patients is refractory to current IBD drugs or experiences side effects. Whether low-dose naltrexone (LDN) is a safe and easily accessible alternative treatment option for these patients needs to be investigated. The aim of this study is to assess the efficacy of LDN for the induction of remission in patients with mild to moderate CD.\n\nThe LDN Crohn study is a randomised, double-blinded, placebo-controlled multicentre trial. Patients with CD are randomised 1:1 to receive treatment with either LDN 4.5 mg once daily or placebo for 12 weeks. The primary objective is endoscopic remission at week 12, defined as Simple Endoscopic Score-CD≤2 and ulcerated surface subscore ≤1 in all five segments. Secondary aims include clinical and endoscopic response, changes in laboratory measures of inflammation, adverse events and patient-reported outcomes."}}]},{"typeName":"subject","multiple":true,"typeClass":"controlledVocabulary","value":["Medicine, Health and Life Sciences"]},{"typeName":"keyword","multiple":true,"typeClass":"compound","value":[{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"Crohn's disease"}}]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"Paulides E, Lie MRKL, van der Woude CJ. Low-dose naltrexone for the induction of remission in patients with mild to moderate Crohn's disease: protocol for the randomised, double-blinded, placebo-controlled, multicentre LDN Crohn study. BMJ Open. 2022 Apr 8;12(4):e058358. doi: 10.1136/bmjopen-2021-058358. PMID: 35396307; PMCID: PMC8996009."},"publicationIDType":{"typeName":"publicationIDType","multiple":false,"typeClass":"controlledVocabulary","value":"pmid"},"publicationIDNumber":{"typeName":"publicationIDNumber","multiple":false,"typeClass":"primitive","value":"35396307"},"publicationURL":{"typeName":"publicationURL","multiple":false,"typeClass":"primitive","value":"https://doi.org/10.1136/bmjopen-2021-058358"}}]},{"typeName":"notesText","multiple":false,"typeClass":"primitive","value":"The data are sensitive since they involve personal information of patients. There are restrictions on use by commercial parties and on sharing openly, based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available upon signing a Data Transfer Agreement (see Terms of Access)."},{"typeName":"language","multiple":true,"typeClass":"controlledVocabulary","value":["English"]},{"typeName":"producer","multiple":true,"typeClass":"compound","value":[{"producerName":{"typeName":"producerName","multiple":false,"typeClass":"primitive","value":"van der Woude, C.J."},"producerAffiliation":{"typeName":"producerAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"},"producerAbbreviation":{"typeName":"producerAbbreviation","multiple":false,"typeClass":"primitive","value":"CJW"}}]},{"typeName":"productionDate","multiple":false,"typeClass":"primitive","value":"2024-06-06"},{"typeName":"productionPlace","multiple":true,"typeClass":"primitive","value":["Gemstracker","SPSS","Excel"]},{"typeName":"contributor","multiple":true,"typeClass":"compound","value":[{"contributorType":{"typeName":"contributorType","multiple":false,"typeClass":"controlledVocabulary","value":"Data Collector"},"contributorName":{"typeName":"contributorName","multiple":false,"typeClass":"primitive","value":"van de Pol, N."}},{"contributorType":{"typeName":"contributorType","multiple":false,"typeClass":"controlledVocabulary","value":"Data Collector"},"contributorName":{"typeName":"contributorName","multiple":false,"typeClass":"primitive","value":"Paulides, E."}},{"contributorType":{"typeName":"contributorType","multiple":false,"typeClass":"controlledVocabulary","value":"Project Leader"},"contributorName":{"typeName":"contributorName","multiple":false,"typeClass":"primitive","value":"van der Woude, C.J."}}]},{"typeName":"grantNumber","multiple":true,"typeClass":"compound","value":[{"grantNumberAgency":{"typeName":"grantNumberAgency","multiple":false,"typeClass":"primitive","value":"ZonMW"},"grantNumberValue":{"typeName":"grantNumberValue","multiple":false,"typeClass":"primitive","value":"848082001"}}]},{"typeName":"distributor","multiple":true,"typeClass":"compound","value":[{"distributorName":{"typeName":"distributorName","multiple":false,"typeClass":"primitive","value":"van de Pol, N."},"distributorAffiliation":{"typeName":"distributorAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"},"distributorAbbreviation":{"typeName":"distributorAbbreviation","multiple":false,"typeClass":"primitive","value":"NP"}},{"distributorName":{"typeName":"distributorName","multiple":false,"typeClass":"primitive","value":"van der Woude, C.J."},"distributorAffiliation":{"typeName":"distributorAffiliation","multiple":false,"typeClass":"primitive","value":"erasmusmc.nl"},"distributorAbbreviation":{"typeName":"distributorAbbreviation","multiple":false,"typeClass":"primitive","value":"CJW"}}]},{"typeName":"depositor","multiple":false,"typeClass":"primitive","value":"van de Pol, Natasja"},{"typeName":"dateOfDeposit","multiple":false,"typeClass":"primitive","value":"2024-12-06"},{"typeName":"dateOfCollection","multiple":true,"typeClass":"compound","value":[{"dateOfCollectionStart":{"typeName":"dateOfCollectionStart","multiple":false,"typeClass":"primitive","value":"2021-01-14"},"dateOfCollectionEnd":{"typeName":"dateOfCollectionEnd","multiple":false,"typeClass":"primitive","value":"2024-03-31"}}]},{"typeName":"kindOfData","multiple":true,"typeClass":"primitive","value":["Survey data","Clinical data"]},{"typeName":"series","multiple":true,"typeClass":"compound","value":[{"seriesName":{"typeName":"seriesName","multiple":false,"typeClass":"primitive","value":"LDN Crohn Study"}}]},{"typeName":"software","multiple":true,"typeClass":"compound","value":[{"softwareName":{"typeName":"softwareName","multiple":false,"typeClass":"primitive","value":"SPSS"},"softwareVersion":{"typeName":"softwareVersion","multiple":false,"typeClass":"primitive","value":"28"}}]}]},"dansDataVaultMetadata":{"displayName":"Data Vault Metadata","name":"dansDataVaultMetadata","fields":[{"typeName":"dansDataversePid","multiple":false,"typeClass":"primitive","value":"doi:10.34894/OBSIAZ"},{"typeName":"dansDataversePidVersion","multiple":false,"typeClass":"primitive","value":"1.0"},{"typeName":"dansBagId","multiple":false,"typeClass":"primitive","value":"urn:uuid:9023909f-227f-4c20-9d59-b130b5cee467"},{"typeName":"dansNbn","multiple":false,"typeClass":"primitive","value":"urn:nbn:nl:ui:13-5d2de8c6-0179-4a74-b8a9-a4548b17e1ed"}]}},"files":[]}}}