Nctid:
NCT00002041
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002177", "term"=>"Candidiasis"}, {"id"=>"D004941", "term"=>"Esophagitis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D004935", "term"=>"Esophageal Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D005759", "term"=>"Gastroenteritis"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M8091", "name"=>"Esophagitis", "asFound"=>"Esophagitis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M5437", "name"=>"Candidiasis", "asFound"=>"Candidiasis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M5440", "name"=>"Candidiasis, Oral", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M8875", "name"=>"Gastroenteritis", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000666", "term"=>"Amphotericin B"}, {"id"=>"C068538", "term"=>"Liposomal amphotericin B"}], "ancestors"=>[{"id"=>"D000563", "term"=>"Amebicides"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}], "browseLeaves"=>[{"id"=>"M4002", "name"=>"Amphotericin B", "asFound"=>"9 months", "relevance"=>"HIGH"}, {"id"=>"M255436", "name"=>"Liposomal amphotericin B", "asFound"=>"9 months", "relevance"=>"HIGH"}, {"id"=>"M3904", "name"=>"Amebicides", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "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"=>["AIDS-Related Opportunistic Infections", "Esophagitis", "Acquired Immunodeficiency Syndrome", "Amphotericin B", "Candidiasis, Oral"], "conditions"=>["Candidiasis, Esophageal", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.\n\nPatients with the following are excluded:\n\n* Documented Candida fungemia.\n* Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.\n* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.\n* Patient refusal to enter study.\n\nPatient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.\n\n* Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.\n* Informed consent must be signed and obtained."}, "identificationModule"=>{"nctId"=>"NCT00002041", "briefTitle"=>"Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Bristol-Myers Squibb"}, "officialTitle"=>"Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients", "orgStudyIdInfo"=>{"id"=>"001A"}, "secondaryIdInfos"=>[{"id"=>"875-10"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Amphotericin B", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"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"}}}}
