Code Block | ||||||||
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<Protocol>
<InclusionExclusionCriteria>
<!-- List of criteria for inclusion of subjects in the study -->
<InclusionCriteria>
<Criterion OID="CRIT.001" Name="Age criterion 1" ConditionOID="COND.AGE_1">
<Description><TranslatedText xml:lang="en" type="text/plain">Subjects must be of age 18 years or older</TranslatedText></Description>
</Criterion>
<Criterion OID="CRIT.002" Name="Age criterion 2" ConditionOID="COND.AGE_2">
<Description><TranslatedText xml:lang="en" type="text/plain">Subjects must be of age 64 years or younger</TranslatedText></Description> <Coding>
</Criterion>
<Criterion OID="CRIT.003" Name="Diabetes Type 2 criterion" ConditionOID="COND.DIAB2">
<Description><TranslatedText type="text/plain">Subject has a diagnosis of Diabetes Type 2</TranslatedText></Description>
<Coding Code="44054006" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
</Criterion>
</InclusionCriteria>
<!-- List of criteria for exclusion of subjects in the study -->
<ExclusionCriteria>
<Criterion OID="CRIT.004" Name="Pregnancy criterion" ConditionOID="COND.PREGNANCY">
<Description><TranslatedText xml:lang="en" Type="text/plain">Pregnant women may not be included in the study</TranslatedText></Description>
<Coding Code="77386006" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
</Criterion>
</ExclusionCriteria>
</InclusionExclusionCriteria>
</Protocol>
<!-- The conditions -->
<ConditionDef OID="COND.AGE_1" Name="Age condition: minimum age is 16 years">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Subjects must be of age 18 years or older</TranslatedText>
</Description>
<!-- SNOMED-CT code for "age" is 397669002, for "unit of time" it is 258695005, for "year" it is 258707000 -->
<FormalExpression Context="SNOMED CT Expression Constraint Language">
<Code><![CDATA[
397669002 |Age| >= 18, 258695005 |Unit of time| = 258707000 |year|
]]></Code>
</FormalExpression>
</ConditionDef>
<ConditionDef OID="COND.AGE_2" Name="Age condition: maximum age is 64 years">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Subjects must be of age 64 years or younger</TranslatedText>
</Description>
<!-- SNOMED-CT code for "age" is 397669002, for "unit of time" it is 258695005, for "year" it is 258707000 -->
<!-- The code is SNOMED C -->
<FormalExpression Context="SNOMED CT Expression Constraint Language">
<Code><![CDATA[
397669002 |Age| <= 64, 258695005 |Unit of time| = 258707000 |year|
]]></Code>
</FormalExpression>
</ConditionDef>
<ConditionDef OID="COND.DIAB2" Name="Condition of a diagnosis of diabetes type 2">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Subject has a diagnosis of Diabetes Type 2</TranslatedText>
</Description>
<!-- SNOMED-CT code for Diabetes Type 2 is 44054006 (Diabetes mellitus type 2 (disorder)) -->
<FormalExpression Context="SNOMED CT Expression Constraint Language">
<Code><![CDATA[
43940101 | Diagnosis| = 44054006 |Diabetes mellitus type 2|
]]></Code>
</FormalExpression>
</ConditionDef>
<ConditionDef OID="COND.PREGNANCY" Name="Condition of pregnancy">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Pregnancy</TranslatedText>
</Description>
<!-- SNOMED-CT code for Pregnancy is 77386006 -->
<FormalExpression Context="SNOMED CT Expression Constraint Language">
<Code>77386006 |Pregnancy|</Code>
</FormalExpression>
</ConditionDef> |
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