Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot3 International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS

Page standards status: Informative

Raw ttl | Download


@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

<http://hl7.org/fhir/Group/438155> a fhir:Group ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "438155"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "25" ] ;
     fhir:lastUpdated [ fhir:v "2026-07-23T13:49:34.467Z"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria>
     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "empty" ] ;
     fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>[No data.]</p></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as>
     ] ;
     fhir:value [
       a fhir:Markdown ;
       fhir:v "CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS [Database Entry: FHIR Group Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 438155. Revised 2026-07-23. Available at: https://fevir.net/resources/Group/438155. Computable resource at: https://fevir.net/resources/Group/438155#json."
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-author>
     ] ;
     fhir:value [
       a fhir:ContactDetail ;
       fhir:name [ fhir:v "Brian S. Alper, MD, MSPH" ]
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact>
     ] ;
     fhir:value [
       a fhir:RelatedArtifact ;
       fhir:type [ fhir:v "derived-from" ] ;
       fhir:resourceReference [
         fhir:l <http://hl7.org/fhir/Group/438152> ;
         fhir:reference [ fhir:v "Group/438152" ] ;
         fhir:type [
           fhir:v "Group"^^xsd:anyURI ;
           fhir:l fhir:Group
         ] ;
         fhir:display [ fhir:v "CTIS2025-523977-40-00 Eligibility Criteria" ]
       ]
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact>
     ] ;
     fhir:value [
       a fhir:RelatedArtifact ;
       fhir:type [ fhir:v "supports" ] ;
       fhir:resourceReference [
         fhir:l <http://hl7.org/fhir/ResearchStudy/438151> ;
         fhir:reference [ fhir:v "ResearchStudy/438151" ] ;
         fhir:type [
           fhir:v "ResearchStudy"^^xsd:anyURI ;
           fhir:l fhir:ResearchStudy
         ] ;
         fhir:display [ fhir:v "Changes in Coronary Plaque Composition By Semaglutide Use in Diabetic Patients With Acute Coronary Syndrome: A Randomized Optical Coherence Tomography Trial - ARMYDA - 10 study" ]
       ]
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type>
         ] ;
         fhir:code [ fhir:v "active" ] ;
         fhir:display [ fhir:v "Active" ]
       ] )
     ]
  ] ) ; # 
  fhir:url [
     fhir:v "https://fevir.net/resources/Group/438155"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Group/438155>
  ] ; # 
  fhir:identifier ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>
         ] ;
         fhir:code [ fhir:v "ACSN" ] ;
         fhir:display [ fhir:v "Accession ID" ]
       ] ) ;
       fhir:text [ fhir:v "FEvIR Object Identifier" ]
     ] ;
     fhir:system [
       fhir:v "https://fevir.net/FOI"^^xsd:anyURI ;
       fhir:l <https://fevir.net/FOI>
     ] ;
     fhir:value [ fhir:v "438155" ] ;
     fhir:assigner [
       fhir:display [ fhir:v "Computable Publishing LLC" ]
     ]
  ] ) ; # 
  fhir:name [ fhir:v "ARMYDA_Eligibility_Criteria"] ; # 
  fhir:title [ fhir:v "CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS"] ; # 
  fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # 
  fhir:contact ( [
     fhir:telecom ( [
       fhir:system [ fhir:v "email" ] ;
       fhir:value [ fhir:v "support@computablepublishing.com" ]
     ] )
  ] ) ; # 
  fhir:description [ fhir:v "This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide."] ; # 
  fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # 
  fhir:type [ fhir:v "person"] ; # 
  fhir:membership [ fhir:v "definitional"] ; # 
  fhir:combinationMethod [ fhir:v "all-of"] ; # 
  fhir:characteristic ( [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:64572001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "64572001" ] ;
         fhir:display [ fhir:v "Disease (disorder)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:44054006 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "44054006" ] ;
         fhir:display [ fhir:v "Diabetes mellitus type 2 (disorder)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Diagnosis of T2DM" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:64572001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "64572001" ] ;
         fhir:display [ fhir:v "Disease (disorder)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:401314000 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "401314000" ] ;
         fhir:display [ fhir:v "Acute non-ST segment elevation myocardial infarction (disorder)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Non-ST-segment elevation ACS" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)" ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel" ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:397669002 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "397669002" ] ;
         fhir:display [ fhir:v "Age" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Quantity ;
       fhir:value [ fhir:v "40"^^xsd:decimal ] ;
       fhir:comparator [ fhir:v ">=" ] ;
       fhir:unit [ fhir:v "years" ] ;
       fhir:system [
         fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
         fhir:l <http://unitsofmeasure.org>
       ] ;
       fhir:code [ fhir:v "a" ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Age ≥40 years" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Signed informed consent." ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Signed informed consent." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:64572001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "64572001" ] ;
         fhir:display [ fhir:v "Disease (disorder)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:10633002 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "10633002" ] ;
         fhir:display [ fhir:v "Acute congestive heart failure (disorder)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Acute heart failure" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://loinc.org"^^xsd:anyURI ;
           fhir:l <http://loinc.org>
         ]
       ] ) ;
       fhir:text [ fhir:v "Estimated glomerular filtration rate" ]
     ] ;
     fhir:value [
       a fhir:Quantity ;
       fhir:value [ fhir:v "30"^^xsd:decimal ] ;
       fhir:comparator [ fhir:v "<" ] ;
       fhir:unit [ fhir:v "mL/min/1.73 m²" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Renal dysfunction (estimated GFR <30 mL/min/1.73 m²)" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:71388002 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "71388002" ] ;
         fhir:display [ fhir:v "Procedure (procedure)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:108241001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "108241001" ] ;
         fhir:display [ fhir:v "Dialysis procedure (Procedure)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Renal dysfunction (on dialysis)" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:64572001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "64572001" ] ;
         fhir:display [ fhir:v "Disease (disorder)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:75694006 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "75694006" ] ;
         fhir:display [ fhir:v "Pancreatitis (disorder)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "History of pancreatitis." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "High risk of pancreatitis." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "High risk of pancreatitis." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Severe gastroparesis requiring therapy <6 months prior to randomization." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Severe gastroparesis requiring therapy <6 months prior to randomization." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Active malignancy or history of neuroendocrine tumors." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Active malignancy or history of neuroendocrine tumors." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Hypersensitivity or contraindications to semaglutide or its excipients." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Hypersensitivity or contraindications to semaglutide or its excipients." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a loinc:76625-3 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://loinc.org"^^xsd:anyURI ;
           fhir:l <http://loinc.org>
         ] ;
         fhir:code [ fhir:v "76625-3" ] ;
         fhir:display [ fhir:v "Alanine aminotransferase [Enzymatic activity/volume] in Blood" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Quantity ;
       fhir:value [ fhir:v "2"^^xsd:decimal ] ;
       fhir:comparator [ fhir:v ">" ] ;
       fhir:unit [ fhir:v "upper limit of normal" ] ;
       fhir:system [
         fhir:v "http://hl7.org/fhir/characteristic-offset"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/characteristic-offset>
       ] ;
       fhir:code [ fhir:v "UNL" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Severe hepatic dysfunction (ALT >2× upper limit of normal)." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a loinc:1920-8 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://loinc.org"^^xsd:anyURI ;
           fhir:l <http://loinc.org>
         ] ;
         fhir:code [ fhir:v "1920-8" ] ;
         fhir:display [ fhir:v "Aspartate aminotransferase [Enzymatic activity/volume] in Blood" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Quantity ;
       fhir:value [ fhir:v "2"^^xsd:decimal ] ;
       fhir:comparator [ fhir:v ">" ] ;
       fhir:unit [ fhir:v "upper limit of normal" ] ;
       fhir:system [
         fhir:v "http://hl7.org/fhir/characteristic-offset"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/characteristic-offset>
       ] ;
       fhir:code [ fhir:v "UNL" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Severe hepatic dysfunction (AST >2× upper limit of normal)." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a loinc:1975-2 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://loinc.org"^^xsd:anyURI ;
           fhir:l <http://loinc.org>
         ] ;
         fhir:code [ fhir:v "1975-2" ] ;
         fhir:display [ fhir:v "Total Bilirubin in Serum or Plasma (measured by mass/volume, e.g., mg/dL)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Quantity ;
       fhir:value [ fhir:v 1.5 ] ;
       fhir:comparator [ fhir:v ">" ] ;
       fhir:unit [ fhir:v "upper limit of normal" ] ;
       fhir:system [
         fhir:v "http://hl7.org/fhir/characteristic-offset"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/characteristic-offset>
       ] ;
       fhir:code [ fhir:v "UNL" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Severe hepatic dysfunction (total bilirubin >1.5× upper limit of normal)." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       a sct:64572001 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "64572001" ] ;
         fhir:display [ fhir:v "Disease (disorder)" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept, sct:420422005 ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
           fhir:l <http://snomed.info/sct>
         ] ;
         fhir:code [ fhir:v "420422005" ] ;
         fhir:display [ fhir:v "Ketoacidosis due to diabetes mellitus (disorder)" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Patients with diabetic ketoacidosis" ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v true
       ]
     ] ) ;
     fhir:code [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://hl7.org/fhir/fhir-types"^^xsd:anyURI ;
           fhir:l <http://hl7.org/fhir/fhir-types>
         ] ;
         fhir:code [ fhir:v "MedicationRequest" ] ;
         fhir:display [ fhir:v "MedicationRequest" ]
       ] )
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://www.nlm.nih.gov/research/umls/rxnorm"^^xsd:anyURI ;
           fhir:l <http://www.nlm.nih.gov/research/umls/rxnorm>
         ] ;
         fhir:code [ fhir:v "1991302" ] ;
         fhir:display [ fhir:v "semaglutide" ]
       ] )
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Use of semaglutide at screening within 30 days prior to randomization." ]
  ] [
     fhir:extension ( [
       fhir:url [
         fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching"^^xsd:anyURI ;
         fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching>
       ] ;
       fhir:value [
         a fhir:Boolean ;
         fhir:v false
       ]
     ] ) ;
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Inability to provide informed consent." ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Inability to provide informed consent." ]
  ] ) . # 

<http://hl7.org/fhir/Group/438152> a fhir:Group .

<http://hl7.org/fhir/ResearchStudy/438151> a fhir:ResearchStudy .