Nctid:
NCT00000530
Payload:
{"FullStudy"=>{"Rank"=>474365, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000014652", "ConditionMeshTerm"=>"Vascular Diseases"}, {"ConditionMeshId"=>"D000011928", "ConditionMeshTerm"=>"Raynaud Disease"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000090122", "ConditionAncestorTerm"=>"Livedoid Vasculopathy"}, {"ConditionAncestorId"=>"D000013927", "ConditionAncestorTerm"=>"Thrombosis"}, {"ConditionAncestorId"=>"D000016769", "ConditionAncestorTerm"=>"Embolism and Thrombosis"}, {"ConditionAncestorId"=>"D000016491", "ConditionAncestorTerm"=>"Peripheral Vascular Diseases"}, {"ConditionAncestorId"=>"D000017445", "ConditionAncestorTerm"=>"Skin Diseases, Vascular"}, {"ConditionAncestorId"=>"D000012871", "ConditionAncestorTerm"=>"Skin Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafAsFound"=>"Vascular Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14462", "ConditionBrowseLeafName"=>"Raynaud Disease", "ConditionBrowseLeafAsFound"=>"Raynaud's Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2751", "ConditionBrowseLeafName"=>"Livedoid Vasculopathy", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16376", "ConditionBrowseLeafName"=>"Thrombosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7474", "ConditionBrowseLeafName"=>"Embolism", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18818", "ConditionBrowseLeafName"=>"Embolism and Thrombosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M28903", "ConditionBrowseLeafName"=>"Peripheral Arterial Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18584", "ConditionBrowseLeafName"=>"Peripheral Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15364", "ConditionBrowseLeafName"=>"Skin Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19404", "ConditionBrowseLeafName"=>"Skin Diseases, Vascular", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3486", "ConditionBrowseLeafName"=>"Livedoid Vasculopathy", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000009543", "InterventionMeshTerm"=>"Nifedipine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000002121", "InterventionAncestorTerm"=>"Calcium Channel Blockers"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000077264", "InterventionAncestorTerm"=>"Calcium-Regulating Hormones and Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000014665", "InterventionAncestorTerm"=>"Vasodilator Agents"}, {"InterventionAncestorId"=>"D000015149", "InterventionAncestorTerm"=>"Tocolytic Agents"}, {"InterventionAncestorId"=>"D000012102", "InterventionAncestorTerm"=>"Reproductive Control Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12173", "InterventionBrowseLeafName"=>"Nifedipine", "InterventionBrowseLeafAsFound"=>"Over 60", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5071", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5088", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5074", "InterventionBrowseLeafName"=>"Calcium Channel Blockers", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17102", "InterventionBrowseLeafName"=>"Vasodilator Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17559", "InterventionBrowseLeafName"=>"Tocolytic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Channel Blockers", "InterventionBrowseBranchAbbrev"=>"ChanBlk"}, {"InterventionBrowseBranchName"=>"Vasodilator Agents", "InterventionBrowseBranchAbbrev"=>"VaDiAg"}, {"InterventionBrowseBranchName"=>"Reproductive Control Agents", "InterventionBrowseBranchAbbrev"=>"Repr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1992"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 2004", "CompletionDateStruct"=>{"CompletionDate"=>"June 1998"}, "LastUpdateSubmitDate"=>"April 14, 2016", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 15, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Heart Diseases", "Raynaud's Disease", "Vascular Diseases"]}}, "ReferencesModule"=>{"AvailIPDList"=>{"AvailIPD"=>[{"AvailIPDId"=>"RTS", "AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/rts/", "AvailIPDType"=>"Individual Participant Data Set", "AvailIPDComment"=>"NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement."}, {"AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/rts/", "AvailIPDType"=>"Study Protocol"}, {"AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/rts/", "AvailIPDType"=>"Study Forms"}]}, "ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"10431945", "ReferenceType"=>"background", "ReferenceCitation"=>"Jennings JR, Maricq HR, Canner J, Thompson B, Freedman RR, Wise R, Kaufmann PG. A thermal vascular test for distinguishing between patients with Raynaud's phenomenon and healthy controls. Raynaud's Treatment Study Investigators. Health Psychol. 1999 Jul;18(4):421-6. doi: 10.1037//0278-6133.18.4.421."}, {"ReferencePMID"=>"10789602", "ReferenceType"=>"background", "ReferenceCitation"=>"Comparison of sustained-release nifedipine and temperature biofeedback for treatment of primary Raynaud phenomenon. Results from a randomized clinical trial with 1-year follow-up. Arch Intern Med. 2000 Apr 24;160(8):1101-8. doi: 10.1001/archinte.160.8.1101."}, {"ReferencePMID"=>"11392916", "ReferenceType"=>"background", "ReferenceCitation"=>"Brown KM, Middaugh SJ, Haythornthwaite JA, Bielory L. The effects of stress, anxiety, and outdoor temperature on the frequency and severity of Raynaud's attacks: the Raynaud's Treatment Study. J Behav Med. 2001 Apr;24(2):137-53. doi: 10.1023/a:1010758530555."}, {"ReferencePMID"=>"11104295", "ReferenceType"=>"background", "ReferenceCitation"=>"Maricq HR, Jennings JR, Valter I, Frederick M, Thompson B, Smith EA, Hill R; Raynaud's Treatment Study Investigators. Evaluation of treatment efficacy of Raynaud phenomenon by digital blood pressure response to cooling. Raynaud's Treatment Study Investigators. Vasc Med. 2000;5(3):135-40. doi: 10.1177/1358836X0000500302."}, {"ReferencePMID"=>"11802676", "ReferenceType"=>"background", "ReferenceCitation"=>"Middaugh SJ, Haythornthwaite JA, Thompson B, Hill R, Brown KM, Freedman RR, Attanasio V, Jacob RG, Scheier M, Smith EA. The Raynaud's Treatment Study: biofeedback protocols and acquisition of temperature biofeedback skills. Appl Psychophysiol Biofeedback. 2001 Dec;26(4):251-78. doi: 10.1023/a:1013182519331."}, {"ReferencePMID"=>"10027500", "ReferenceType"=>"background", "ReferenceCitation"=>"Thompson B, Geller NL, Hunsberger S, Frederick M, Hill R, Jacob RG, Smith EA, Kaufmann P, Freedman RR, Wigley FM, Bielory L. Behavioral and pharmacologic interventions: the Raynaud's Treatment Study. Control Clin Trials. 1999 Feb;20(1):52-63. doi: 10.1016/s0197-2456(98)00046-4."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.", "DetailedDescription"=>"BACKGROUND:\n\nPrimary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers, but may occur in other extremities as well.\n\nDESIGN NARRATIVE:\n\nRandomized. Patients were assigned to one of four treatment groups: slow release Nifedipine, a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph biofeedback from the frontalis muscle. The primary endpoint was reduction in number of vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including frequency, severity, duration, response to laboratory-based cold challenge, and quality of life."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"75 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men and women with documented primary or secondary Raynaud's syndrome."}, "IdentificationModule"=>{"NCTId"=>"NCT00000530", "BriefTitle"=>"Raynaud's Treatment Study (RTS)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"73"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"nifedipine", "InterventionType"=>"Drug"}, {"InterventionName"=>"biofeedback (psychology)", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"electromyography", "InterventionType"=>"Procedure"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Bruce Thompson", "OverallOfficialAffiliation"=>"Clinical Trials & Surveys Corp (C-TASC)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
