{
"info": {
"nct_id": "NCT00665782",
"official_title": "Stress Measures in Women With Newly Diagnosed Breast Cancer",
"inclusion_criteria": "* Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks\n* Surgery for breast cancer planned\n* Hormone receptor status not specified\n* Female\n* Menopausal status not specified\n* Able to refrain from:\n\n * Smoking cigarettes for the 24-hour period of saliva-sample collection\n * Brushing teeth or eating for up to one hour prior to saliva collection\n* More than 1 year since prior therapy for another malignancy\n* At least 1 month since prior withdrawal from hormone-replacement product\n* Able to refrain from steroid inhalers for greater than 24 hours\n* No chronic oral steroids\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks",
"criterions": [
{
"exact_snippets": "Diagnosed with stage I-III invasive breast cancer",
"criterion": "invasive breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "ductal carcinoma in situ of the breast",
"criterion": "ductal carcinoma in situ",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "within the past 2 weeks",
"criterion": "diagnosis timing",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Diagnosed with stage I-III invasive breast cancer",
"criterion": "invasive breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "within the past 2 weeks",
"criterion": "diagnosis timing",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "ductal carcinoma in situ of the breast",
"criterion": "ductal carcinoma in situ",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "within the past 2 weeks",
"criterion": "diagnosis timing",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Surgery for breast cancer planned",
"criterions": [
{
"exact_snippets": "Surgery for breast cancer planned",
"criterion": "surgery for breast cancer",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgery for breast cancer planned",
"criterion": "surgery for breast cancer",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Hormone receptor status not specified",
"criterions": [
{
"exact_snippets": "Hormone receptor status",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "specification",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hormone receptor status",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "specification",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Female",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "* Menopausal status not specified",
"criterions": [
{
"exact_snippets": "Menopausal status",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "specification",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Menopausal status",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "specification",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Able to refrain from:",
"criterions": [
{
"exact_snippets": "Able to refrain from",
"criterion": "refrain from certain activities",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to refrain from",
"criterion": "refrain from certain activities",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Smoking cigarettes for the 24-hour period of saliva-sample collection",
"criterions": [
{
"exact_snippets": "Smoking cigarettes for the 24-hour period of saliva-sample collection",
"criterion": "smoking",
"requirement": {
"requirement_type": "time period",
"expected_value": "24-hour period of saliva-sample collection"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Smoking cigarettes for the 24-hour period of saliva-sample collection",
"criterion": "smoking",
"requirement": {
"requirement_type": "time period",
"expected_value": "24-hour period of saliva-sample collection"
}
}
]
}
},
{
"identified_line": {
"line": "* Brushing teeth or eating for up to one hour prior to saliva collection",
"criterions": [
{
"exact_snippets": "Brushing teeth ... for up to one hour prior to saliva collection",
"criterion": "brushing teeth",
"requirement": {
"requirement_type": "time before saliva collection",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "hour"
}
}
},
{
"exact_snippets": "eating for up to one hour prior to saliva collection",
"criterion": "eating",
"requirement": {
"requirement_type": "time before saliva collection",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "hour"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Brushing teeth ... for up to one hour prior to saliva collection",
"criterion": "brushing teeth",
"requirement": {
"requirement_type": "time before saliva collection",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "hour"
}
}
},
{
"exact_snippets": "eating for up to one hour prior to saliva collection",
"criterion": "eating",
"requirement": {
"requirement_type": "time before saliva collection",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "hour"
}
}
}
]
}
},
{
"identified_line": {
"line": "* More than 1 year since prior therapy for another malignancy",
"criterions": [
{
"exact_snippets": "More than 1 year since prior therapy for another malignancy",
"criterion": "time since prior therapy for another malignancy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 1 year since prior therapy for another malignancy",
"criterion": "time since prior therapy for another malignancy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
}
},
{
"identified_line": {
"line": "* At least 1 month since prior withdrawal from hormone-replacement product",
"criterions": [
{
"exact_snippets": "At least 1 month since prior withdrawal from hormone-replacement product",
"criterion": "withdrawal from hormone-replacement product",
"requirement": {
"requirement_type": "time since withdrawal",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 1 month since prior withdrawal from hormone-replacement product",
"criterion": "withdrawal from hormone-replacement product",
"requirement": {
"requirement_type": "time since withdrawal",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Able to refrain from steroid inhalers for greater than 24 hours",
"criterions": [
{
"exact_snippets": "Able to refrain from steroid inhalers for greater than 24 hours",
"criterion": "use of steroid inhalers",
"requirement": {
"requirement_type": "abstinence duration",
"expected_value": {
"operator": ">",
"value": 24,
"unit": "hours"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to refrain from steroid inhalers for greater than 24 hours",
"criterion": "use of steroid inhalers",
"requirement": {
"requirement_type": "abstinence duration",
"expected_value": {
"operator": ">",
"value": 24,
"unit": "hours"
}
}
}
]
}
},
{
"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": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 120 Years",
"criterions": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* No chronic oral steroids",
"criterions": [
{
"exact_snippets": "No chronic oral steroids",
"criterion": "chronic oral steroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No chronic oral steroids",
"criterion": "chronic oral steroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}