{
  "FullStudy":{
    "Rank":217566,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519726",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MEMO study"
          },
          "Organization":{
            "OrgFullName":"St. Antonius Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug",
          "OfficialTitle":"CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug",
          "Acronym":"MEMO"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 4, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 3, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 4, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Catherijne Knibbe",
            "ResponsiblePartyInvestigatorTitle":"Professor in Pharmacology, Hospital pharmacist",
            "ResponsiblePartyInvestigatorAffiliation":"St. Antonius Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"St. Antonius Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Morbid Obesity"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Morbidly obese patients",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Midazolam"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Midazolam",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Morbidly obese patients"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery",
                "PrimaryOutcomeTimeFrame":"0.5-2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBMI>40\nundergoing bariatric surgery\n\nExclusion Criteria:\n\nuse of drug inducing or inhibiting CYP3A4 activity\npregnancy, breastfeeding\nrenl insufficiency",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"St Antonius Hospital",
                "LocationCity":"Nieuwegein",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000008874",
                "InterventionMeshTerm":"Midazolam"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000759",
                "InterventionAncestorTerm":"Adjuvants, Anesthesia"
              },{
                "InterventionAncestorId":"D000006993",
                "InterventionAncestorTerm":"Hypnotics and Sedatives"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000014151",
                "InterventionAncestorTerm":"Anti-Anxiety Agents"
              },{
                "InterventionAncestorId":"D000014149",
                "InterventionAncestorTerm":"Tranquilizing Agents"
              },{
                "InterventionAncestorId":"D000011619",
                "InterventionAncestorTerm":"Psychotropic Drugs"
              },{
                "InterventionAncestorId":"D000018686",
                "InterventionAncestorTerm":"Anesthetics, Intravenous"
              },{
                "InterventionAncestorId":"D000018681",
                "InterventionAncestorTerm":"Anesthetics, General"
              },{
                "InterventionAncestorId":"D000000777",
                "InterventionAncestorTerm":"Anesthetics"
              },{
                "InterventionAncestorId":"D000018757",
                "InterventionAncestorTerm":"GABA Modulators"
              },{
                "InterventionAncestorId":"D000018682",
                "InterventionAncestorTerm":"GABA Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M10428",
                "InterventionBrowseLeafName":"Midazolam",
                "InterventionBrowseLeafAsFound":"Midazolam",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8626",
                "InterventionBrowseLeafName":"Hypnotics and Sedatives",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15488",
                "InterventionBrowseLeafName":"Anti-Anxiety Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M13057",
                "InterventionBrowseLeafName":"Psychotropic Drugs",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19350",
                "InterventionBrowseLeafName":"Anesthetics, Intravenous",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19345",
                "InterventionBrowseLeafName":"Anesthetics, General",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19411",
                "InterventionBrowseLeafName":"GABA Modulators",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AdjAn",
                "InterventionBrowseBranchName":"Adjuvants, Anesthesia"
              },{
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"PsychDr",
                "InterventionBrowseBranchName":"Psychotropic Drugs"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009767",
                "ConditionMeshTerm":"Obesity, Morbid"
              },{
                "ConditionMeshId":"D000015431",
                "ConditionMeshTerm":"Weight Loss"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001836",
                "ConditionAncestorTerm":"Body Weight Changes"
              },{
                "ConditionAncestorId":"D000001835",
                "ConditionAncestorTerm":"Body Weight"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000009765",
                "ConditionAncestorTerm":"Obesity"
              },{
                "ConditionAncestorId":"D000044343",
                "ConditionAncestorTerm":"Overnutrition"
              },{
                "ConditionAncestorId":"D000009748",
                "ConditionAncestorTerm":"Nutrition Disorders"
              },{
                "ConditionAncestorId":"D000050177",
                "ConditionAncestorTerm":"Overweight"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11285",
                "ConditionBrowseLeafName":"Obesity, Morbid",
                "ConditionBrowseLeafAsFound":"Morbid Obesity",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16685",
                "ConditionBrowseLeafName":"Weight Loss",
                "ConditionBrowseLeafAsFound":"Weight Loss",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3697",
                "ConditionBrowseLeafName":"Body Weight Changes",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}