Clinical Study Protocol
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Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

: StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial

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<Group xmlns="http://hl7.org/fhir">
  <id value="DIBASY-Eligibility"/>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <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>
</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>
</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>
</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>
</div></blockquote></div>
  </text>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="FILL"/>
        <display value="Filler Identifier"/>
      </coding>
    </type>
    <system value="https://example.org/ID-EligibilityCriteria"/>
    <value value="172461"/>
  </identifier>
  <name value="DIBASY Eligibility Criteria"/>
  <title
         value="StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial"/>
  <status value="active"/>
  <description
               value="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 value="person"/>
  <membership value="definitional"/>
  <combinationMethod value="all-of"/>
  <characteristic>
    <code>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="64572001"/>
        <display value="Disease (disorder)"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="44054006"/>
        <display value="Diabetes mellitus type 2 (disorder)"/>
      </coding>
    </valueCodeableConcept>
    <exclude value="false"/>
    <description value="history of type 2 diabetes lasting at least 5 years"/>
    <durationDuration>
      <value value="5"/>
      <comparator value="&gt;="/>
      <unit value="years"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="a"/>
    </durationDuration>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="397669002"/>
        <display value="Age"/>
      </coding>
    </code>
    <valueRange>
      <low>
        <value value="30"/>
        <unit value="years"/>
        <system value="http://unitsofmeasure.org"/>
        <code value="a"/>
      </low>
      <high>
        <value value="60"/>
        <unit value="years"/>
        <system value="http://unitsofmeasure.org"/>
        <code value="a"/>
      </high>
    </valueRange>
    <exclude value="false"/>
    <description value="aged 30-60 years"/>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="39156-5"/>
        <display value="Body mass index (BMI) [Ratio]"/>
      </coding>
    </code>
    <valueQuantity>
      <value value="35"/>
      <comparator value="&gt;="/>
      <unit value="kilogram per square meter"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="kg/m2"/>
    </valueQuantity>
    <exclude value="false"/>
    <description value="body-mass index of 35 kg/m(2) or more"/>
  </characteristic>
</Group>