{
"info": {
"nct_id": "NCT04214782",
"official_title": "Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm",
"inclusion_criteria": "* Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;\n* Women aged over 18 years old;\n* Women willing to participant in this study evidenced by signing the informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;\n* Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;\n* Women with mental abnormal;\n* Women did not cooperate or participate in other clinical trials;\n* Pregnant or lactating women.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "scheduled for Transvaginal Ultrasound examination",
"criterion": "procedure",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
},
{
"exact_snippets": "adnexal lesions",
"criterion": "condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Women aged over 18 years old;",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "aged over 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum_age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;",
"criterions": [
{
"exact_snippets": "Women without adnexa for any reasons",
"criterion": "adnexa presence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "at the time of Transvaginal Ultrasound examination",
"criterion": "timing of adnexa absence",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "at the time of Transvaginal Ultrasound examination"
}
]
}
]
},
{
"line": "* Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "pathologic diagnosis of ovarian cancer",
"criterion": "ovarian cancer diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Women with mental abnormal;",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "female"
}
]
},
{
"exact_snippets": "mental abnormal",
"criterion": "mental health",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "abnormal"
}
]
}
]
},
{
"line": "* Women did not cooperate or participate in other clinical trials;",
"criterions": [
{
"exact_snippets": "Women did not cooperate or participate in other clinical trials",
"criterion": "participation in other clinical trials",
"requirements": [
{
"requirement_type": "participation",
"expected_value": false
}
]
}
]
},
{
"line": "* Pregnant or lactating women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* Women willing to participant in this study evidenced by signing the informed consent.",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "willing to participate",
"criterion": "willingness to participate",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": true
}
]
},
{
"exact_snippets": "evidenced by signing the informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}