Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial

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    {
      "resourceType" : "Group",
      "id" : "DIBASY-Eligibility",
      "language" : "en",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: Group DIBASY-Eligibility</b></p><a name=\"DIBASY-Eligibility\"> </a><a name=\"hcDIBASY-Eligibility\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p></div><p><b>identifier</b>: Filler Identifier/172461</p><p><b>name</b>: DIBASY Eligibility Criteria</p><p><b>title</b>: StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Patients aged 30-60 years with a body-mass index of 35 kg/m(2) or more and a history of type 2 diabetes lasting at least 5 years</p>\n</div><p><b>type</b>: Person</p><p><b>membership</b>: Definitional</p><p><b>combinationMethod</b>: All of</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://snomed.info/sct 64572001}\">Disease (disorder)</span></p><p><b>value</b>: <span title=\"Codes:{http://snomed.info/sct 44054006}\">Diabetes mellitus type 2 (disorder)</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>history of type 2 diabetes lasting at least 5 years</p>\n</div><p><b>duration</b>: No display for Duration  (value: 5; comparator: &gt;=; unit: years; system: http://unitsofmeasure.org; code: a)</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://snomed.info/sct 397669002}\">Age</span></p><p><b>value</b>: 30-60 years</p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>aged 30-60 years</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://loinc.org 39156-5}\">Body mass index (BMI) [Ratio]</span></p><p><b>value</b>: &gt;=35 kilogram per square meter<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM  codekg/m2 = 'kg/m2')</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>body-mass index of 35 kg/m(2) or more</p>\n</div></blockquote></div>"
      },
      "identifier" : [
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                "code" : "FILL",
                "display" : "Filler Identifier"
              }
            ]
          },
          "system" : "https://example.org/ID-EligibilityCriteria",
          "value" : "172461"
        }
      ],
      "name" : "DIBASY Eligibility Criteria",
      "title" : "StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial",
      "status" : "active",
      "description" : "Patients aged 30-60 years with a body-mass index of 35 kg/m(2) or more and a history of type 2 diabetes lasting at least 5 years",
      "type" : "person",
      "membership" : "definitional",
      "combinationMethod" : "all-of",
      "characteristic" : [
        {
          "code" : {
            "coding" : [
              {
                "system" : "http://snomed.info/sct",
                "code" : "64572001",
                "display" : "Disease (disorder)"
              }
            ]
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://snomed.info/sct",
                "code" : "44054006",
                "display" : "Diabetes mellitus type 2 (disorder)"
              }
            ]
          },
          "exclude" : false,
          "description" : "history of type 2 diabetes lasting at least 5 years",
          "durationDuration" : {
            "value" : 5,
            "comparator" : ">=",
            "unit" : "years",
            "system" : "http://unitsofmeasure.org",
            "code" : "a"
          }
        },
        {
          "code" : {
            "coding" : [
              {
                "system" : "http://snomed.info/sct",
                "code" : "397669002",
                "display" : "Age"
              }
            ]
          },
          "valueRange" : {
            "low" : {
              "value" : 30,
              "unit" : "years",
              "system" : "http://unitsofmeasure.org",
              "code" : "a"
            },
            "high" : {
              "value" : 60,
              "unit" : "years",
              "system" : "http://unitsofmeasure.org",
              "code" : "a"
            }
          },
          "exclude" : false,
          "description" : "aged 30-60 years"
        },
        {
          "code" : {
            "coding" : [
              {
                "system" : "http://loinc.org",
                "code" : "39156-5",
                "display" : "Body mass index (BMI) [Ratio]"
              }
            ]
          },
          "valueQuantity" : {
            "value" : 35,
            "comparator" : ">=",
            "unit" : "kilogram per square meter",
            "system" : "http://unitsofmeasure.org",
            "code" : "kg/m2"
          },
          "exclude" : false,
          "description" : "body-mass index of 35 kg/m(2) or more"
        }
      ]
    }