{
  "FullStudy":{
    "Rank":218279,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510379",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011H0236"
          },
          "Organization":{
            "OrgFullName":"Ohio State University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery",
          "OfficialTitle":"Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial",
          "Acronym":"Reletex"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 5, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "ResultsFirstSubmitDate":"November 15, 2013",
          "ResultsFirstSubmitQCDate":"February 24, 2014",
          "ResultsFirstPostDateStruct":{
            "ResultsFirstPostDate":"March 5, 2014",
            "ResultsFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 24, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 5, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Kyle A Perry",
            "ResponsiblePartyInvestigatorTitle":"Assistant Professor General Surgery 614-293-5815",
            "ResponsiblePartyInvestigatorAffiliation":"Ohio State University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Kyle A Perry",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use.\n\nThe hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Nausea and Vomiting Post-foregut Surgery"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "nausea",
              "vomiting",
              "post-operative",
              "foregut surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Reletex",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Reletex",
                    "Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses",
                    "Drug: IV promethazine 25 mg q 6 hours prn",
                    "Drug: Elixir promethazine 25 mg q 6 hours prn after discharge"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Reletex",
                    "Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses",
                    "Drug: IV promethazine 25 mg q 6 hours prn",
                    "Drug: Elixir promethazine 25 mg q 6 hours prn after discharge"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Reletex",
                "InterventionDescription":"Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control",
                    "Reletex"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"IV ondansetron 4 mg q 6 hours for a total of 4 doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control",
                    "Reletex"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"IV promethazine 25 mg q 6 hours prn",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control",
                    "Reletex"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Elixir promethazine 25 mg q 6 hours prn after discharge",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control",
                    "Reletex"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.",
                "PrimaryOutcomeDescription":"Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).",
                "PrimaryOutcomeTimeFrame":"24 hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Quantify the Amounts of Phenergan Used Between the Two Groups.",
                "SecondaryOutcomeTimeFrame":"one week"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18-85\nPlanned fundoplication\nWillingness to comply with randomization and follow-up protocol\nEnglish speaking\n\nExclusion Criteria:\n\n< 18 years of age or > 85\nChronic nausea requiring medical treatment\nPlanned concomitant procedures\nPacemaker or automatic internal cardiac defibrillator",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Kyle Perry, MD",
                "OverallOfficialAffiliation":"Ohio State University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The Ohio State University Medical Center",
                "LocationCity":"Columbus",
                "LocationState":"Ohio",
                "LocationZip":"43210",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "ResultsSection":{
        "ParticipantFlowModule":{
          "FlowPreAssignmentDetails":"Enrolled participants were not excluded from the trial before assignment to groups.",
          "FlowRecruitmentDetails":"Recruitment occurred at The Ohio State University Wexner Medical Center over a 1 year period.",
          "FlowGroupList":{
            "FlowGroup":[
              {
                "FlowGroupId":"FG000",
                "FlowGroupTitle":"Reletex",
                "FlowGroupDescription":"Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
              },{
                "FlowGroupId":"FG001",
                "FlowGroupTitle":"Control",
                "FlowGroupDescription":"Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
              }
            ]
          },
          "FlowPeriodList":{
            "FlowPeriod":[
              {
                "FlowPeriodTitle":"Overall Study",
                "FlowMilestoneList":{
                  "FlowMilestone":[
                    {
                      "FlowMilestoneType":"STARTED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"49"
                          },{
                            "FlowAchievementGroupId":"FG001",
                            "FlowAchievementNumSubjects":"51"
                          }
                        ]
                      }
                    },{
                      "FlowMilestoneType":"COMPLETED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"49"
                          },{
                            "FlowAchievementGroupId":"FG001",
                            "FlowAchievementNumSubjects":"51"
                          }
                        ]
                      }
                    },{
                      "FlowMilestoneType":"NOT COMPLETED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"0"
                          },{
                            "FlowAchievementGroupId":"FG001",
                            "FlowAchievementNumSubjects":"0"
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "BaselineCharacteristicsModule":{
          "BaselineGroupList":{
            "BaselineGroup":[
              {
                "BaselineGroupId":"BG000",
                "BaselineGroupTitle":"Reletex",
                "BaselineGroupDescription":"Reletex plus scheduled ondansetron and phenergan prn"
              },{
                "BaselineGroupId":"BG001",
                "BaselineGroupTitle":"Control",
                "BaselineGroupDescription":"Scheduled ondansetron plus phenergan prn"
              },{
                "BaselineGroupId":"BG002",
                "BaselineGroupTitle":"Total",
                "BaselineGroupDescription":"Total of all reporting groups"
              }
            ]
          },
          "BaselineDenomList":{
            "BaselineDenom":[
              {
                "BaselineDenomUnits":"Participants",
                "BaselineDenomCountList":{
                  "BaselineDenomCount":[
                    {
                      "BaselineDenomCountGroupId":"BG000",
                      "BaselineDenomCountValue":"49"
                    },{
                      "BaselineDenomCountGroupId":"BG001",
                      "BaselineDenomCountValue":"51"
                    },{
                      "BaselineDenomCountGroupId":"BG002",
                      "BaselineDenomCountValue":"100"
                    }
                  ]
                }
              }
            ]
          },
          "BaselineMeasureList":{
            "BaselineMeasure":[
              {
                "BaselineMeasureTitle":"Age, Categorical",
                "BaselineMeasureParamType":"Count of Participants",
                "BaselineMeasureUnitOfMeasure":"Participants",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineCategoryTitle":"<=18 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"0"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"0"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"0"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":"Between 18 and 65 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"38"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"36"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"74"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":">=65 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"11"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"15"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"26"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "BaselineMeasureTitle":"Age, Continuous",
                "BaselineMeasureParamType":"Mean",
                "BaselineMeasureDispersionType":"Standard Deviation",
                "BaselineMeasureUnitOfMeasure":"years",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"57",
                                  "BaselineMeasurementSpread":"14.22"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"58",
                                  "BaselineMeasurementSpread":"16.16"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"57",
                                  "BaselineMeasurementSpread":"15.17"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "BaselineMeasureTitle":"Sex: Female, Male",
                "BaselineMeasureParamType":"Count of Participants",
                "BaselineMeasureUnitOfMeasure":"Participants",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineCategoryTitle":"Female",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"35"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"34"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"69"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":"Male",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"14"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"17"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"31"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "BaselineMeasureTitle":"Region of Enrollment",
                "BaselineMeasureParamType":"Number",
                "BaselineMeasureUnitOfMeasure":"participants",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineClassTitle":"United States",
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"49"
                                },{
                                  "BaselineMeasurementGroupId":"BG001",
                                  "BaselineMeasurementValue":"51"
                                },{
                                  "BaselineMeasurementGroupId":"BG002",
                                  "BaselineMeasurementValue":"100"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "OutcomeMeasuresModule":{
          "OutcomeMeasureList":{
            "OutcomeMeasure":[
              {
                "OutcomeMeasureType":"Primary",
                "OutcomeMeasureTitle":"Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.",
                "OutcomeMeasureDescription":"Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"units on a scale",
                "OutcomeMeasureTimeFrame":"24 hours",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"Reletex",
                      "OutcomeGroupDescription":"Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
                    },{
                      "OutcomeGroupId":"OG001",
                      "OutcomeGroupTitle":"Control",
                      "OutcomeGroupDescription":"Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"49"
                          },{
                            "OutcomeDenomCountGroupId":"OG001",
                            "OutcomeDenomCountValue":"51"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"1.81",
                                  "OutcomeMeasurementSpread":"2.17",
                                  "OutcomeMeasurementLowerLimit":"0",
                                  "OutcomeMeasurementUpperLimit":"10"
                                },{
                                  "OutcomeMeasurementGroupId":"OG001",
                                  "OutcomeMeasurementValue":"2.03",
                                  "OutcomeMeasurementSpread":"2.83",
                                  "OutcomeMeasurementLowerLimit":"0",
                                  "OutcomeMeasurementUpperLimit":"10"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "OutcomeMeasureType":"Secondary",
                "OutcomeMeasureTitle":"Quantify the Amounts of Phenergan Used Between the Two Groups.",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"mg",
                "OutcomeMeasureTimeFrame":"one week",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"Reletex",
                      "OutcomeGroupDescription":"Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
                    },{
                      "OutcomeGroupId":"OG001",
                      "OutcomeGroupTitle":"Control",
                      "OutcomeGroupDescription":"Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"49"
                          },{
                            "OutcomeDenomCountGroupId":"OG001",
                            "OutcomeDenomCountValue":"51"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"42",
                                  "OutcomeMeasurementSpread":"75.6"
                                },{
                                  "OutcomeMeasurementGroupId":"OG001",
                                  "OutcomeMeasurementValue":"57.6",
                                  "OutcomeMeasurementSpread":"128.2"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "AdverseEventsModule":{
          "EventsFrequencyThreshold":"5",
          "EventGroupList":{
            "EventGroup":[
              {
                "EventGroupId":"EG000",
                "EventGroupTitle":"Reletex",
                "EventGroupDescription":"Reletex plus scheduled ondansetron and phenergan prn",
                "EventGroupSeriousNumAffected":"0",
                "EventGroupSeriousNumAtRisk":"49",
                "EventGroupOtherNumAffected":"0",
                "EventGroupOtherNumAtRisk":"49"
              },{
                "EventGroupId":"EG001",
                "EventGroupTitle":"Control",
                "EventGroupDescription":"Scheduled ondansetron plus phenergan prn",
                "EventGroupSeriousNumAffected":"0",
                "EventGroupSeriousNumAtRisk":"51",
                "EventGroupOtherNumAffected":"0",
                "EventGroupOtherNumAtRisk":"51"
              }
            ]
          }
        },
        "MoreInfoModule":{
          "CertainAgreement":{
            "AgreementPISponsorEmployee":"Yes"
          },
          "PointOfContact":{
            "PointOfContactTitle":"Kyle A. Perry, MD",
            "PointOfContactOrganization":"The Ohio State University",
            "PointOfContactEMail":"kyle.perry@osumc.edu",
            "PointOfContactPhone":"614-293-5815"
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000011398",
                "InterventionMeshTerm":"Promethazine"
              },{
                "InterventionMeshId":"D000004155",
                "InterventionMeshTerm":"Diphenhydramine"
              },{
                "InterventionMeshId":"D000017294",
                "InterventionMeshTerm":"Ondansetron"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000932",
                "InterventionAncestorTerm":"Antiemetics"
              },{
                "InterventionAncestorId":"D000001337",
                "InterventionAncestorTerm":"Autonomic Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              },{
                "InterventionAncestorId":"D000000982",
                "InterventionAncestorTerm":"Antipruritics"
              },{
                "InterventionAncestorId":"D000003879",
                "InterventionAncestorTerm":"Dermatologic Agents"
              },{
                "InterventionAncestorId":"D000012702",
                "InterventionAncestorTerm":"Serotonin Antagonists"
              },{
                "InterventionAncestorId":"D000018490",
                "InterventionAncestorTerm":"Serotonin Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000014150",
                "InterventionAncestorTerm":"Antipsychotic Agents"
              },{
                "InterventionAncestorId":"D000014149",
                "InterventionAncestorTerm":"Tranquilizing Agents"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000011619",
                "InterventionAncestorTerm":"Psychotropic Drugs"
              },{
                "InterventionAncestorId":"D000014151",
                "InterventionAncestorTerm":"Anti-Anxiety Agents"
              },{
                "InterventionAncestorId":"D000006634",
                "InterventionAncestorTerm":"Histamine H1 Antagonists"
              },{
                "InterventionAncestorId":"D000006633",
                "InterventionAncestorTerm":"Histamine Antagonists"
              },{
                "InterventionAncestorId":"D000018494",
                "InterventionAncestorTerm":"Histamine Agents"
              },{
                "InterventionAncestorId":"D000018926",
                "InterventionAncestorTerm":"Anti-Allergic Agents"
              },{
                "InterventionAncestorId":"D000068776",
                "InterventionAncestorTerm":"Sleep Aids, Pharmaceutical"
              },{
                "InterventionAncestorId":"D000006993",
                "InterventionAncestorTerm":"Hypnotics and Sedatives"
              },{
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