Nctid:
NCT00001890
Payload:
{"FullStudy"=>{"Rank"=>472675, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000003141", "ConditionMeshTerm"=>"Communicable Diseases"}, {"ConditionMeshId"=>"D000011014", "ConditionMeshTerm"=>"Pneumonia"}, {"ConditionMeshId"=>"D000003586", "ConditionMeshTerm"=>"Cytomegalovirus Infections"}, {"ConditionMeshId"=>"D000002690", "ConditionMeshTerm"=>"Chlamydia Infections"}, {"ConditionMeshId"=>"D000018410", "ConditionMeshTerm"=>"Pneumonia, Bacterial"}, {"ConditionMeshId"=>"D000050197", "ConditionMeshTerm"=>"Atherosclerosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000012141", "ConditionAncestorTerm"=>"Respiratory Tract Infections"}, {"ConditionAncestorId"=>"D000008171", "ConditionAncestorTerm"=>"Lung Diseases"}, {"ConditionAncestorId"=>"D000012140", "ConditionAncestorTerm"=>"Respiratory Tract Diseases"}, {"ConditionAncestorId"=>"D000001161", "ConditionAncestorTerm"=>"Arteriosclerosis"}, {"ConditionAncestorId"=>"D000001157", "ConditionAncestorTerm"=>"Arterial Occlusive Diseases"}, {"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000002318", "ConditionAncestorTerm"=>"Cardiovascular Diseases"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000002694", "ConditionAncestorTerm"=>"Chlamydiaceae Infections"}, {"ConditionAncestorId"=>"D000016905", "ConditionAncestorTerm"=>"Gram-Negative Bacterial Infections"}, {"ConditionAncestorId"=>"D000001424", "ConditionAncestorTerm"=>"Bacterial Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}, {"ConditionAncestorId"=>"D000015231", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Bacterial"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13594", "ConditionBrowseLeafName"=>"Pneumonia", "ConditionBrowseLeafAsFound"=>"Pneumonia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6481", "ConditionBrowseLeafName"=>"Cytomegalovirus Infections", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M25878", "ConditionBrowseLeafName"=>"Atherosclerosis", "ConditionBrowseLeafAsFound"=>"Atherosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20219", "ConditionBrowseLeafName"=>"Pneumonia, Bacterial", "ConditionBrowseLeafAsFound"=>"Pneumonia, Bacterial", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5624", "ConditionBrowseLeafName"=>"Chlamydia Infections", "ConditionBrowseLeafAsFound"=>"Chlamydia Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M22390", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14668", "ConditionBrowseLeafName"=>"Respiratory Tract Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10858", "ConditionBrowseLeafName"=>"Lung Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14667", "ConditionBrowseLeafName"=>"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4159", "ConditionBrowseLeafName"=>"Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4155", "ConditionBrowseLeafName"=>"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9333", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7132", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4412", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18939", "ConditionBrowseLeafName"=>"Gram-Negative Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11826", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4411", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15248", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17625", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Bacterial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1720", "ConditionBrowseLeafName"=>"Cytomegalic Inclusion Disease", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T1303", "ConditionBrowseLeafName"=>"Chronic Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}, {"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004967", "InterventionMeshTerm"=>"Estrogens"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000006728", "InterventionAncestorTerm"=>"Hormones"}, {"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7806", "InterventionBrowseLeafName"=>"Estrogens", "InterventionBrowseLeafAsFound"=>"Some", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M13935", "InterventionBrowseLeafName"=>"Progesterone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9478", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"80"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2000", "CompletionDateStruct"=>{"CompletionDate"=>"March 2001"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Cellular Immunity", "Cytokines", "Estrogen", "Humoral Immunity", "Progesterone", "Chlamydia Pneumoniae", "Human Cytomegalovirus", "Postmenopause"]}, "ConditionList"=>{"Condition"=>["Atherosclerosis", "Chlamydia Infections", "Cytomegalovirus Infections", "Pneumonia, Bacterial", "Postmenopause"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8479518", "ReferenceType"=>"background", "ReferenceCitation"=>"Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0."}, {"ReferencePMID"=>"9259669", "ReferenceType"=>"background", "ReferenceCitation"=>"Danesh J, Collins R, Peto R. Chronic infections and coronary heart disease: is there a link? Lancet. 1997 Aug 9;350(9075):430-6. doi: 10.1016/S0140-6736(97)03079-1."}, {"ReferencePMID"=>"8613369", "ReferenceType"=>"background", "ReferenceCitation"=>"Gaydos CA, Summersgill JT, Sahney NN, Ramirez JA, Quinn TC. Replication of Chlamydia pneumoniae in vitro in human macrophages, endothelial cells, and aortic artery smooth muscle cells. Infect Immun. 1996 May;64(5):1614-20. doi: 10.1128/iai.64.5.1614-1620.1996."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Hardening of the arteries (atherosclerosis) and heart disease are much more common in men than in women. However, as women grow older, especially after menopause the incidence of atherosclerosis and heart disease increases. These findings suggest that estrogen may be protective and help in preventing heart disease.\n\nStudies of large groups of post-menopausal women suggest that hormone replacement therapy (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable changes in particles that carry cholesterol in the blood stream and improves function of blood vessels. Estrogen may also stimulate the immune system's ability to fight off infections that may lead to or contribute to atherosclerosis.\n\nResearchers believe two specific infectious agents (Chlamydia pneumoniae and human cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation and the development of atherosclerosis.\n\nThe purpose of this study is to determine if estrogen treatment can change how the immune system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in postmenopausal women.", "DetailedDescription"=>"The incidence of atherosclerotic cardiovascular disease in women does not approach rates seen in men until approximately a decade following menopause, suggesting that estrogen is vasculoprotective. Infectious pathogens such a Chlamydia pneumoniae (C. pneumoniae) and human cytomegalovirus (hCMV) have been implicated in the pathogenesis of atherosclerosis. Experimental studies in cultured lymphocytes and animals suggest that estrogen stimulates cell-mediated immune responsiveness, observations that are potentially relevant to the eradication of intracellular pathogens including C. pneumoniae and hCMV. The purpose of this study is to determine whether estrogen therapy augments cell-mediated immune responsiveness in estrogen-deficient postmenopausal women who have serologic evidence of chronic infection with C. pneumoniae and/or hCMV. A comparison will be made between seropositive and seronegative women. We propose that estrogen therapy will stimulate a more efficient cell-mediated response to these chronically persistent infectious intracellular pathogens, resulting in eradication of these organisms that are of potential importance in atherogenesis."}, "EligibilityModule"=>{"Gender"=>"Female", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Must be a postmenopausal woman 65 years of age or younger.\n\nTime since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml.\n\nWomen must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG.\n\nMust not have used hormone replacement therapy within past 6 months.\n\nMust not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed.\n\nMust not have a history of alcoholism or binge-drinking.\n\nMust not have diabetes mellitus or known abnormal glucose intolerance test.\n\nMust not have a history of stroke, angina or myocardial infarction.\n\nMust not have a history of deep venous thrombosis/pulmonary embolism.\n\nMust not have a history of cancer (except for treated squamous cell and basal cell carcinomas).\n\nMust not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal).\n\nMust not have impaired renal function (creatinine greater than 1.6 mg/dl).\n\nMust not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease).\n\nMust not have a history of intermittent vaginal bleeding.\n\nMust not have serum triglycerides greater than 400 mg/dL."}, "IdentificationModule"=>{"NCTId"=>"NCT00001890", "BriefTitle"=>"Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection", "OrgStudyIdInfo"=>{"OrgStudyId"=>"990100"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"99-H-0100"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Estrogen therapy", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Heart, Lung and Blood Institute (NHLBI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
