{
"info": {
"nct_id": "NCT06332976",
"official_title": "Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer",
"inclusion_criteria": "* Patients with early or locally advanced breast cancer\n* Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy\n* Sufficient literacy in Italian to complete the questionnaires\n* Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* None",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Patients candidate to adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"exact_snippets": "patients who are receiving adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
},
{
"exact_snippets": "patients who received adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "past treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patients candidate to adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"exact_snippets": "patients who are receiving adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
},
{
"exact_snippets": "patients who received adjuvant/neoadjuvant chemotherapy",
"criterion": "adjuvant/neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "past treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Sufficient literacy in Italian to complete the questionnaires",
"criterions": [
{
"exact_snippets": "Sufficient literacy in Italian",
"criterion": "literacy in Italian",
"requirement": {
"requirement_type": "sufficiency",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Sufficient literacy in Italian",
"criterion": "literacy in Italian",
"requirement": {
"requirement_type": "sufficiency",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterions": [
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
},
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "signature type",
"requirement": {
"requirement_type": "type",
"expected_value": "signed"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
},
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "signature type",
"requirement": {
"requirement_type": "type",
"expected_value": "written"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "signature type",
"requirement": {
"requirement_type": "type",
"expected_value": "AES"
}
},
{
"exact_snippets": "Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent",
"criterion": "signature type",
"requirement": {
"requirement_type": "type",
"expected_value": "AdES"
}
}
]
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* None",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients with early or locally advanced breast cancer",
"criterions": [
{
"exact_snippets": "early or locally advanced breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"early",
"locally advanced"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "early or locally advanced breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "early"
}
},
{
"exact_snippets": "early or locally advanced breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}