{
"info": {
"nct_id": "NCT05769491",
"official_title": "Investigation of Patterns in Clinical Trial Experiences by Patients Participating in Triple Negative Breast Cancer Clinical Trials",
"inclusion_criteria": "* Age ≥ 18 years\n* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\n* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Pregnant or lactating woman\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial\n* Inability to perform regular electronic reporting",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age ≥ 18 years",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.",
"criterions": [
{
"exact_snippets": "Willing and able to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Willing and able to comply with ... treatment schedule",
"criterion": "compliance with treatment schedule",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Willing and able to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Willing and able to comply with ... other requirements of the study",
"criterion": "compliance with other study requirements",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol",
"criterions": [
{
"exact_snippets": "Capable of giving signed informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "capability",
"expected_value": true
}
]
},
{
"exact_snippets": "compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol",
"criterion": "compliance with ICF and protocol",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Pregnant or lactating woman",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial",
"criterions": [
{
"exact_snippets": "Any mental or medical condition that prevents the patient from giving informed consent",
"criterion": "mental or medical condition",
"requirements": [
{
"requirement_type": "ability to give informed consent",
"expected_value": false
}
]
},
{
"exact_snippets": "Any mental or medical condition that prevents the patient from ... participating in the trial",
"criterion": "mental or medical condition",
"requirements": [
{
"requirement_type": "ability to participate in the trial",
"expected_value": false
}
]
}
]
},
{
"line": "* Inability to perform regular electronic reporting",
"criterions": [
{
"exact_snippets": "Inability to perform regular electronic reporting",
"criterion": "ability to perform regular electronic reporting",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}