{
  "FullStudy":{
    "Rank":217822,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516385",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SHEBA-12-8822-ORK-CTIL"
          },
          "Organization":{
            "OrgFullName":"Sheba Medical Center",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Detection of Peripheral Blood Biomarkers in Intermediate Phase Spinal Cord Injury: Correlation With Neurological and Functional Outcomes, and Comparison to Other Central and Peripheral Neurological Conditions."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Not yet recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 26, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 31, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Sheba Medical Center",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. Investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and Guillain-Barre syndrome.\n\nPatients participating in this trial will be those accepted to neuro-rehabilitation in Sheba medical center, Israel. They will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months.\n\nPatients will be examined by the research staff three times:\n\nAt arrival, the patients will be neurologically examined and their functional abilities will be assessed. Blood will be drawn and sent to the lab.\nAt 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab.\nThe final examination will take place 1 year after the beginning of the neurological condition. This time only the neurological and functional abilities will be assessed without blood tests.\n\nThe blood samples will be tested in the research lab. Then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Spinal Cord Injury"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "spinal cord injury",
              "biomarkers",
              "rehabilitation",
              "functional independence",
              "prognosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"150",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"spinal cord injury"
              },{
                "ArmGroupLabel":"other neurological conditions"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of traumatic or non-traumatic Spinal cord injury, Guillain-barre syndrome or Stroke\nNo more than 3 months after injury or disease onset\nCondition severe enough to necessitate hospital/day care unit\nSigned the informed consent form\n\nExclusion Criteria:\n\nPsychiatric or cognitive situations that may interfere with the trial",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"All patients attmited for neuro-rehabilitation with spinal cord injury, stroke or Guillain-Barre syndrome",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"orna rahmim-katz, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"972-3-5303715",
                "CentralContactEMail":"ornatova@gmail.com"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Sheba Medical Center",
                "LocationCity":"Ramat Gan",
                "LocationZip":"52620",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"orna rahamim-katz, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"972-3-5305715",
                      "LocationContactEMail":"ornatova@gmail.com"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013119",
                "ConditionMeshTerm":"Spinal Cord Injuries"
              },{
                "ConditionMeshId":"D000014947",
                "ConditionMeshTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000013118",
                "ConditionAncestorTerm":"Spinal Cord Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000020196",
                "ConditionAncestorTerm":"Trauma, Nervous System"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14499",
                "ConditionBrowseLeafName":"Spinal Cord Injuries",
                "ConditionBrowseLeafAsFound":"Spinal Cord Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafAsFound":"Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14498",
                "ConditionBrowseLeafName":"Spinal Cord Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20607",
                "ConditionBrowseLeafName":"Trauma, Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}