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Packagehl7.fhir.uv.ebm
Resource TypeGroup
IdGroup-438155.json
FHIR VersionR6

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Source1

{
  "resourceType": "Group",
  "id": "438155",
  "meta": {
    "versionId": "30",
    "lastUpdated": "2026-08-15T16:22:59.044Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria"
    ]
  },
  "text": {
    "status": "empty",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
      "valueMarkdown": "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 2026-08-15. Available at: https://fevir.net/resources/Group/438155. Computable resource at: https://fevir.net/resources/Group/438155#json."
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail": {
        "name": "Brian S. Alper, MD, MSPH"
      }
    },
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code": "active",
            "display": "Active"
          }
        ]
      }
    }
  ],
  "url": "https://fevir.net/resources/Group/438155",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "438155",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "ARMYDA_Eligibility_Criteria",
  "title": "CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS",
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "description": "This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "type": "person",
  "membership": "definitional",
  "combinationMethod": "all-of",
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            "code": "64572001",
            "display": "Disease (disorder)"
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            "code": "44054006",
            "display": "Diabetes mellitus type 2 (disorder)"
          }
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      "description": "Diagnosis of T2DM"
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          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
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            "system": "http://snomed.info/sct",
            "code": "401314000",
            "display": "Acute non-ST segment elevation myocardial infarction (disorder)"
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        ]
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      "exclude": false,
      "description": "Non-ST-segment elevation ACS"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
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      "valueCodeableConcept": {
        "text": "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)"
      },
      "exclude": false,
      "description": "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "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"
      },
      "exclude": false,
      "description": "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"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "397669002",
            "display": "Age"
          }
        ]
      },
      "valueQuantity": {
        "value": 40,
        "comparator": ">=",
        "unit": "years",
        "system": "http://unitsofmeasure.org",
        "code": "a"
      },
      "exclude": false,
      "description": "Age ≥40 years"
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    {
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        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Signed informed consent."
      },
      "exclude": false,
      "description": "Signed informed consent."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
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      "code": {
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            "display": "Disease (disorder)"
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      "valueCodeableConcept": {
        "coding": [
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            "code": "10633002",
            "display": "Acute congestive heart failure (disorder)"
          }
        ]
      },
      "exclude": true,
      "description": "Acute heart failure"
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    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
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            "system": "http://loinc.org",
            "code": "45066-8",
            "display": "Creatinine and Glomerular filtration rate.predicted panel - Serum, Plasma or Blood"
          }
        ],
        "text": "Creatinine & Glomerular filtration rate.predicted panel:-:Pt:Ser/Plas/Bld:Qn"
      },
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        "value": 30,
        "comparator": "<",
        "unit": "mL/min/1.73 m²"
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      "exclude": true,
      "description": "Renal dysfunction (estimated GFR <30 mL/min/1.73 m²)"
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    {
      "extension": [
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          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
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      "code": {
        "coding": [
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            "system": "http://snomed.info/sct",
            "code": "71388002",
            "display": "Procedure (procedure)"
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        ]
      },
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "108241001",
            "display": "Dialysis procedure (Procedure)"
          }
        ]
      },
      "exclude": true,
      "description": "Renal dysfunction (on dialysis)"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "64572001",
            "display": "Disease (disorder)"
          }
        ]
      },
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "75694006",
            "display": "Pancreatitis (disorder)"
          }
        ]
      },
      "exclude": true,
      "description": "History of pancreatitis.",
      "relativeTime": [
        {
          "contextCode": {
            "coding": [
              {
                "system": "http://snomed.info/sct",
                "code": "709491003",
                "display": "Enrollment in clinical trial (procedure)"
              }
            ]
          },
          "offsetDuration": {
            "value": 0,
            "comparator": "<=",
            "unit": "seconds",
            "system": "http://unitsofmeasure.org",
            "code": "s"
          }
        }
      ]
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "High risk of pancreatitis."
      },
      "exclude": true,
      "description": "High risk of pancreatitis."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Severe gastroparesis requiring therapy <6 months prior to randomization."
      },
      "exclude": true,
      "description": "Severe gastroparesis requiring therapy <6 months prior to randomization."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Active malignancy or history of neuroendocrine tumors."
      },
      "exclude": true,
      "description": "Active malignancy or history of neuroendocrine tumors."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Hypersensitivity or contraindications to semaglutide or its excipients."
      },
      "exclude": true,
      "description": "Hypersensitivity or contraindications to semaglutide or its excipients."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "76625-3",
            "display": "Alanine aminotransferase [Enzymatic activity/volume] in Blood"
          }
        ]
      },
      "valueQuantity": {
        "value": 2,
        "comparator": ">",
        "unit": "upper limit of normal",
        "system": "http://hl7.org/fhir/characteristic-offset",
        "code": "UNL"
      },
      "exclude": true,
      "description": "Severe hepatic dysfunction (ALT >2× upper limit of normal)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "1920-8",
            "display": "Aspartate aminotransferase [Enzymatic activity/volume] in Serum or Plasma"
          }
        ],
        "text": "Aspartate aminotransferase [Enzymatic activity/volume] in Blood"
      },
      "valueQuantity": {
        "value": 2,
        "comparator": ">",
        "unit": "upper limit of normal",
        "system": "http://hl7.org/fhir/characteristic-offset",
        "code": "UNL"
      },
      "exclude": true,
      "description": "Severe hepatic dysfunction (AST >2× upper limit of normal)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "1975-2",
            "display": "Bilirubin.total [Mass/volume] in Serum or Plasma"
          }
        ],
        "text": "Total Bilirubin in Serum or Plasma (measured by mass/volume, e.g., mg/dL)"
      },
      "valueQuantity": {
        "value": 1.5,
        "comparator": ">",
        "unit": "upper limit of normal",
        "system": "http://hl7.org/fhir/characteristic-offset",
        "code": "UNL"
      },
      "exclude": true,
      "description": "Severe hepatic dysfunction (total bilirubin >1.5× upper limit of normal)."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study."
      },
      "exclude": true,
      "description": "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "64572001",
            "display": "Disease (disorder)"
          }
        ]
      },
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "420422005",
            "display": "Ketoacidosis due to diabetes mellitus (disorder)"
          }
        ]
      },
      "exclude": true,
      "description": "Patients with diabetic ketoacidosis"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": true
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/fhir-types",
            "code": "MedicationRequest",
            "display": "MedicationRequest"
          }
        ]
      },
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://www.nlm.nih.gov/research/umls/rxnorm",
            "code": "1991302",
            "display": "semaglutide"
          }
        ]
      },
      "exclude": true,
      "description": "Use of semaglutide at screening within 30 days prior to randomization.",
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        {
          "contextCode": {
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                "system": "http://snomed.info/sct",
                "code": "709491003",
                "display": "Enrollment in clinical trial (procedure)"
              }
            ]
          },
          "offsetRange": {
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              "value": -30,
              "unit": "days",
              "system": "http://unitsofmeasure.org",
              "code": "d"
            },
            "high": {
              "value": 0
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          }
        }
      ]
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
          "valueBoolean": false
        }
      ],
      "code": {
        "text": "Defined by CodeableConcept"
      },
      "valueCodeableConcept": {
        "text": "Inability to provide informed consent."
      },
      "exclude": true,
      "description": "Inability to provide informed consent."
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  ]
}