{
"info": {
"nct_id": "NCT03315975",
"official_title": "Influenza Vaccine Responses in the Setting of Melanoma Treatment",
"inclusion_criteria": "* adults capable of providing consent\n* have a diagnosis of locally advanced or metastatic melanoma\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* are allergic to influenza vaccination\n* have received influenza vaccination within the past 6 months\n* require prednisone, methotrexate, or other immunosuppressing medications\n* have HIV infection\n* have a history of solid organ or bone marrow transplant\n* require combination immunotherapy\n* are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* adults capable of providing consent",
"criterions": [
{
"exact_snippets": [
"adults"
],
"criterion": "age",
"requirement_type": "category",
"expected_value": "adult"
},
{
"exact_snippets": [
"capable of providing consent"
],
"criterion": "consent capability",
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"line": "* have a diagnosis of locally advanced or metastatic melanoma",
"criterions": [
{
"exact_snippets": [
"diagnosis of locally advanced or metastatic melanoma"
],
"criterion": "melanoma",
"requirement_type": "diagnosis",
"expected_value": true
},
{
"exact_snippets": [
"locally advanced or metastatic melanoma"
],
"criterion": "melanoma",
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
],
"exclusion_lines": [
{
"line": "* are allergic to influenza vaccination",
"criterions": [
{
"exact_snippets": [
"allergic to influenza vaccination"
],
"criterion": "influenza vaccination allergy",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* have received influenza vaccination within the past 6 months",
"criterions": [
{
"exact_snippets": [
"received influenza vaccination"
],
"criterion": "influenza vaccination",
"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
"within the past 6 months"
],
"criterion": "influenza vaccination",
"requirement_type": "timeframe",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6
}
]
}
}
]
},
{
"line": "* have HIV infection",
"criterions": [
{
"exact_snippets": [
"have HIV infection"
],
"criterion": "HIV infection",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* have a history of solid organ or bone marrow transplant",
"criterions": [
{
"exact_snippets": [
"history of solid organ or bone marrow transplant"
],
"criterion": "solid organ transplant",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"history of solid organ or bone marrow transplant"
],
"criterion": "bone marrow transplant",
"requirement_type": "history",
"expected_value": true
}
]
},
{
"line": "* require combination immunotherapy",
"criterions": [
{
"exact_snippets": [
"require combination immunotherapy"
],
"criterion": "combination immunotherapy",
"requirement_type": "requirement",
"expected_value": true
}
]
},
{
"line": "* are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study",
"criterions": [
{
"exact_snippets": [
"are on other studies requiring blood draws"
],
"criterion": "participation in other studies",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"blood draws that might exceed 450 mL total"
],
"criterion": "blood draw volume",
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 450
}
]
}
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* require prednisone, methotrexate, or other immunosuppressing medications",
"criterions": [
{
"exact_snippets": [
"require prednisone"
],
"criterion": "prednisone",
"requirement_type": "requirement",
"expected_value": true
},
{
"exact_snippets": [
"require methotrexate"
],
"criterion": "methotrexate",
"requirement_type": "requirement",
"expected_value": true
},
{
"exact_snippets": [
"require",
"other immunosuppressing medications"
],
"criterion": "immunosuppressing medications",
"requirement_type": "requirement",
"expected_value": true
}
]
}
],
"failed_miscellaneous": []
}