{
"info": {
"nct_id": "NCT02152020",
"official_title": "Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors",
"inclusion_criteria": "* Women or men age 18 years or older\n* Primary diagnosis of cancer with history of stage I, II, or III cancer\n* Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)\n* Have a Karnofsky score of 60 or greater\n* Can understand written English\n* Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week\n* Have been taking pain medications daily\n* Have had at least 15 days with pain in the preceding 30 days.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Women or men with metastatic (stage IV) cancer\n* Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks\n* Planned surgical procedures in the next 12 weeks\n* Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization\n* Women who are pregnant or breastfeeding\n* Unwillingness to adhere to study related procedures.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Women or men age 18 years or older",
"criterions": [
{
"exact_snippets": "age 18 years or older",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
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"unit": "years"
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}
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}
},
{
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"requirement": {
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"expected_value": true
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},
{
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"expected_value": true
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},
{
"identified_line": {
"line": "* Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)",
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"exact_snippets": "Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)",
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"requirement": {
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"expected_value": true
}
}
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"expected_value": true
}
}
]
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},
{
"identified_line": {
"line": "* Have a Karnofsky score of 60 or greater",
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{
"exact_snippets": "Karnofsky score of 60 or greater",
"criterion": "Karnofsky score",
"requirement": {
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"expected_value": {
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"value": 60,
"unit": "N/A"
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}
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"criterion": "Karnofsky score",
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"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Can understand written English",
"criterions": [
{
"exact_snippets": "Can understand written English",
"criterion": "ability to understand written English",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Can understand written English",
"criterion": "ability to understand written English",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week",
"criterions": [
{
"exact_snippets": "worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale",
"criterion": "worst pain",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "N/A"
}
}
}
]
},
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"requirement": {
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"expected_value": {
"operator": ">=",
"value": 4,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Have been taking pain medications daily",
"criterions": [
{
"exact_snippets": "taking pain medications daily",
"criterion": "pain medication usage",
"requirement": {
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"expected_value": "daily"
}
}
]
},
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}
}
]
}
},
{
"identified_line": {
"line": "* Have had at least 15 days with pain in the preceding 30 days.",
"criterions": [
{
"exact_snippets": "at least 15 days with pain in the preceding 30 days",
"criterion": "pain frequency",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 15,
"unit": "days"
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}
}
]
},
"logical_structure": {
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"criterion": "pain frequency",
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"unit": "days"
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},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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"criterion": "volunteer health status",
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}
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}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"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": "* Women or men with metastatic (stage IV) cancer",
"criterions": [
{
"exact_snippets": "Women or men",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"women",
"men"
]
}
},
{
"exact_snippets": "metastatic (stage IV) cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women or men",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"women",
"men"
]
}
},
{
"exact_snippets": "metastatic (stage IV) cancer",
"criterion": "cancer stage",
"requirement": {
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"expected_value": "IV"
}
}
]
}
},
{
"identified_line": {
"line": "* Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks",
"criterions": [
{
"exact_snippets": "Unstable and progressive medical conditions",
"criterion": "medical condition stability",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable and progressive"
}
},
{
"exact_snippets": "progressive cancer",
"criterion": "cancer progression",
"requirement": {
"requirement_type": "progression",
"expected_value": "progressive"
}
},
{
"exact_snippets": "uncontrolled heart failure",
"criterion": "heart failure control",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "require hospitalization in the next 12 weeks",
"criterion": "hospitalization requirement",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "next 12 weeks"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"and_criteria": [
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}
},
{
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},
{
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}
}
]
}
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{
"exact_snippets": "require hospitalization in the next 12 weeks",
"criterion": "hospitalization requirement",
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"expected_value": "next 12 weeks"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Planned surgical procedures in the next 12 weeks",
"criterions": [
{
"exact_snippets": "Planned surgical procedures in the next 12 weeks",
"criterion": "planned surgical procedures",
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}
}
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"requirement": {
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"expected_value": "next 12 weeks"
}
}
}
},
{
"identified_line": {
"line": "* Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization",
"criterions": [
{
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"criterion": "pain crisis",
"requirement": {
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"expected_value": true
}
},
{
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"requirement": {
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "or hospitalization",
"criterion": "hospitalization",
"requirement": {
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"expected_value": true
}
}
]
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"and_criteria": [
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"and_criteria": [
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{
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"exact_snippets": "Women who are pregnant",
"criterion": "pregnancy",
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"expected_value": false
}
},
{
"exact_snippets": "Women who are ... breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
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},
{
"exact_snippets": "Women who are ... breastfeeding",
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* Unwillingness to adhere to study related procedures.",
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{
"exact_snippets": "Unwillingness to adhere to study related procedures",
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}
]
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],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}