Nctid:
NCT00001390
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012466", "term"=>"Salivary Gland Diseases"}], "ancestors"=>[{"id"=>"D000009059", "term"=>"Mouth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M15285", "name"=>"Salivary Gland Diseases", "asFound"=>"Salivary Gland Diseases", "relevance"=>"HIGH"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>173}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-10-26"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2018-09-20", "completionDateStruct"=>{"date"=>"2018-09-20"}, "lastUpdateSubmitDate"=>"2018-09-21", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2018-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Saliva", "Parotid", "Lip Biopsy", "Health", "Exocrine", "Normal Volunteer"], "conditions"=>["Healthy", "Salivary Gland Disease"]}, "referencesModule"=>{"references"=>[{"pmid"=>"32939030", "type"=>"DERIVED", "citation"=>"Tanaka T, Warner BM, Odani T, Ji Y, Mo YQ, Nakamura H, Jang SI, Yin H, Michael DG, Hirata N, Suizu F, Ishigaki S, Oliveira FR, Motta ACF, Ribeiro-Silva A, Rocha EM, Atsumi T, Noguchi M, Chiorini JA. LAMP3 induces apoptosis and autoantigen release in Sjogren's syndrome patients. Sci Rep. 2020 Sep 16;10(1):15169. doi: 10.1038/s41598-020-71669-5."}, {"pmid"=>"31095438", "type"=>"DERIVED", "citation"=>"Burbelo PD, Ferre EMN, Chaturvedi A, Chiorini JA, Alevizos I, Lionakis MS, Warner BM. Profiling Autoantibodies against Salivary Proteins in Sicca Conditions. J Dent Res. 2019 Jul;98(7):772-778. doi: 10.1177/0022034519850564. Epub 2019 May 16."}, {"pmid"=>"23982860", "type"=>"DERIVED", "citation"=>"Yin H, Cabrera-Perez J, Lai Z, Michael D, Weller M, Swaim WD, Liu X, Catalan MA, Rocha EM, Ismail N, Afione S, Rana NA, Di Pasquale G, Alevizos I, Ambudkar I, Illei GG, Chiorini JA. Association of bone morphogenetic protein 6 with exocrine gland dysfunction in patients with Sjogren's syndrome and in mice. Arthritis Rheum. 2013 Dec;65(12):3228-38. doi: 10.1002/art.38123."}]}, "descriptionModule"=>{"briefSummary"=>"Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation.\n\nSome of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands.", "detailedDescription"=>"* Objective: To obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction.\n* Study population: Healthy volunteers aged 18-70 years old\n* Design: Observational\n* Outcome measures: Clinical and basic science data to serve as controls for comparisons with subjects presenting with salivary gland dysfunction\n\nSaliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation.\n\nSome of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands.\n\nThe outcome measurement for this study is to determine those healthy subjects whose data and specimens can be used as control comparison for our patient subjects in our Sj(SqrRoot)(Delta)gren s syndrome studies (15-D-0051, 99-D-0070, 11-D-0094 and/or 11-D-0172)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n* Healthy male or female volunteers from 18 to 70 years old.\n* Ability to understand and sign an informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Known pregnancy.\n* Chronic medical illness, other than well-controlled hypertension or hyperlipidemia.\n* Chronic use of medications, with the exception of oral contraceptives, hormone replacement therapy, antihypertensives and antilipemics.\n* Have problems with dry mouth and/or dry eyes.\n* NIH employees who are subordinates/relatives/co-workers of investigators."}, "identificationModule"=>{"nctId"=>"NCT00001390", "briefTitle"=>"Salivary Evaluation in Healthy Volunteers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Salivary Evaluation in Healthy Volunteers", "orgStudyIdInfo"=>{"id"=>"940018"}, "secondaryIdInfos"=>[{"id"=>"94-D-0018"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Blake M Warner, D.D.S.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Dental and Craniofacial Research (NIDCR)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Dental and Craniofacial Research (NIDCR)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
