{
  "FullStudy":{
    "Rank":218187,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511601",
          "OrgStudyIdInfo":{
            "OrgStudyId":"999912048"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"12-I-N048"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"National Institutes of Health Clinical Center (CC)",
            "OrgClass":"NIH"
          },
          "BriefTitle":"Apheresis to Obtain Plasma and White Blood Cells in Malies",
          "OfficialTitle":"Apheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 28, 2016",
          "OverallStatus":"Withdrawn",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 20, 2011"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 28, 2016"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 13, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 16, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"National Institute of Allergy and Infectious Diseases (NIAID)",
            "LeadSponsorClass":"NIH"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Background:\n\n- Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Healthy volunteers who provide plasma and white blood cells for study may need to give multiple donations. Researchers want to use apheresis to collect plasma and white blood cells from healthy volunteers in Mali.\n\nObjectives:\n\n- To collect plasma and white blood cells from healthy volunteers in Mali.\n\nEligibility:\n\nHealthy volunteers between 18 and 55 years of age.\nVolunteers must be in National Institute of Allergy and Infectious Diseases clinical trials.\n\nDesign:\n\nParticipants will be screened with a physical exam and medical history. They will also provide basic blood and urine samples.\nParticipants will have apheresis to collect plasma and white blood cells for study. Before each collection, they will provide a small blood sample for testing. They will be monitored during and after donation to prevent side effects.\nUnder this protocol, participants may have apheresis up to six times per year.\nNo treatment will be provided as part of this protocol....",
          "DetailedDescription":"To carry out in vitro research procedures on plasma or leukocyte components of whole blood, it is often necessary to obtain larger quantities of plasma or leukocytes than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using a well-established standard apheresis procedure that is in common use at the National Institutes of Health Apheresis Unit. This protocol describes the implementation of the same apheresis procedure at the National Blood Transfusion Center in Bamako, Mali. This is not a research protocol per se, but rather an adjunct protocol which allows healthy donors 18-55 years of age to undergo apheresis. Subjects must already be enrolled in another protocol which has been approved by the National Institute of Allergy and Infectious Diseases Institutional Review Board and the Faculty of Medicine, Pharmacy, and Odonto-Stomatology Ethics Committee."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Malaria"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Apheresis",
              "Leukocytes",
              "Plasma",
              "Plamodium Falciparum Malaria",
              "Immunology"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"INCLUSION CRITERIA:\n\nIndividuals 18-55 years of age are eligible to enter the study if they:\n\nAre enrolled on another NIAID/FMPOS-approved protocol.\nWeigh greater than or equal to 50 kg.\nAgree to have blood specimens stored for future studies.\nAgree to undergo genetic testing.\nAgree to undergo HIV, hepatitis B, and hepatitis C virus testing.\n\nEXCLUSION CRITERIA:\n\nThe following criteria are exclusionary:\n\nPositive at screening for HIV, hepatitis B, and/or hepatitis C.\nCardiovascular instability (blood pressure <90/50 or >180/100; pulse <40 or >110.\nInadequate peripheral venous access.\nAnemia (hemoglobin <11 g/dL).\nCurrent use of corticosteroids or other immunosuppressants.\nUnderlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis.\nTemperature greater than or equal to 37.5 degree C or other clinical evidence of an acute infection.\nCurrently pregnant or breastfeeding.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Peter D Crompton, M.D.",
                "OverallOfficialAffiliation":"National Institute of Allergy and Infectious Diseases (NIAID)",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020",
          "RemovedCountryList":{
            "RemovedCountry":[
              "Mali"
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008288",
                "ConditionMeshTerm":"Malaria"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000011528",
                "ConditionAncestorTerm":"Protozoan Infections"
              },{
                "ConditionAncestorId":"D000010272",
                "ConditionAncestorTerm":"Parasitic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9863",
                "ConditionBrowseLeafName":"Malaria",
                "ConditionBrowseLeafAsFound":"Malaria",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M17716",
                "ConditionBrowseLeafName":"Malaria, Falciparum",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12971",
                "ConditionBrowseLeafName":"Protozoan Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11768",
                "ConditionBrowseLeafName":"Parasitic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3584",
                "ConditionBrowseLeafName":"Malaria",
                "ConditionBrowseLeafAsFound":"Malaria",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC03",
                "ConditionBrowseBranchName":"Parasitic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}