Nctid:
NCT00002293
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D002177", "term"=>"Candidiasis"}, {"id"=>"D002180", "term"=>"Candidiasis, Oral"}], "ancestors"=>[{"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D009059", "term"=>"Mouth Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M5437", "name"=>"Candidiasis", "asFound"=>"Candidiasis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M5440", "name"=>"Candidiasis, Oral", "asFound"=>"Candidiasis, Oral", "relevance"=>"HIGH"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009761", "term"=>"Nystatin"}], "ancestors"=>[{"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D007476", "term"=>"Ionophores"}, {"id"=>"D049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M12697", "name"=>"Nystatin", "asFound"=>"Lipid emulsion", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M10509", "name"=>"Ionophores", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "statusVerifiedDate"=>"2007-10", "lastUpdateSubmitDate"=>"2007-10-01", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2007-10-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Nystatin", "AIDS-Related Opportunistic Infections", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Candidiasis, Oral"], "conditions"=>["Candidiasis, Oral", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8757423", "type"=>"BACKGROUND", "citation"=>"MacPhail LA, Hilton JF, Dodd CL, Greenspan D. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 15;12(5):470-6. doi: 10.1097/00042560-199608150-00005."}]}, "descriptionModule"=>{"briefSummary"=>"To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or IV, CDC classification)"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.\n* Systemic or oral antibiotics.\n\nPatients must have AIDS or AIDS-related syndromes (HIV infection:\n\n* Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.\n* Patients can be entered into the study who have:\n* Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.\n* A positive or negative oral culture for Candida.\n* Must be able to follow instructions regarding the use of a pastille.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.\n* Suspected or proven candidal esophagitis.\n\nPatients with the following are excluded:\n\n* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.\n* Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.\n* Not expected to survive for at least 6 months.\n* Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.\n* Known hypersensitivity to nystatin.\n* Suspected or proven candidal esophagitis.\n\nPrior Medication:\n\nExcluded within 72 hours of study entry:\n\n* Any oral or intravenous antifungal agent."}, "identificationModule"=>{"nctId"=>"NCT00002293", "briefTitle"=>"A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Bristol-Myers Squibb"}, "officialTitle"=>"Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes", "orgStudyIdInfo"=>{"id"=>"026B"}, "secondaryIdInfos"=>[{"id"=>"5"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nystatin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Birmingham Veterans Administration Med Ctr / Univ of Alabama", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"085434000", "city"=>"Princeton", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Bristol - Myers Squibb Co", "geoPoint"=>{"lat"=>40.34872, "lon"=>-74.65905}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}}}}
