{
"info": {
"nct_id": "NCT01219673",
"official_title": "A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer",
"inclusion_criteria": "1. Patients with a pathologically proven diagnosis of epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.\n2. Patients >/= 18 years old and </= 65 years old.\n3. Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.\n4. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)\n5. Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.\n6. Patients must be willing and able to review, understand, and provide written consent.\n7. Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..\n8. Sexually active males and females must agree to use birth control or abstinence for the duration of the trial.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "1. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician\n2. Patients taking CHANTIX (smoking cessation medication)\n3. Patients who are enrolled in other symptom management trial or receiving active therapy as part of a treatment clinical trial.\n4. Bile duct obstruction or cholelithiasis\n5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction\n6. Pre-existing psychosis or bipolar disorder. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.\n7. Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.\n8. Pre-existing hepatic impairment: The screening for total bilirubin > 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for >2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available in the medical records.\n9. Pre-existing Tourette's syndrome\n10. Seizure disorder\n11. Anorexia/bulimia in past two months\n12. Use of monoamine oxidase (MAO inhibitors) within 14 days\n13. Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)\n14. Patients currently taking any of the study drugs\n15. Hypersensitivity to any tetracyclines\n16. Patients on anticoagulants (ie warfarin/heparin)\n17. Patients with INR > 1.5.\n18. Patients being treated with concurrent cetuximab chemotherapy with radiation therapy.\n19. Patients currently receiving any tetracycline family antibiotic or within the previous past 14 days before chemoradiation.\n20. Previous radiation therapy for a cancer in the head and neck region.\n21. Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.\n22. Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients with a pathologically proven diagnosis of epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.",
"criterions": [
{
"exact_snippets": "pathologically proven diagnosis of epithelial carcinoma",
"criterion": "epithelial carcinoma diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity",
"criterion": "cancer location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"oropharynx",
"nasopharynx",
"hypopharynx",
"larynx",
"oral cavity"
]
}
},
{
"exact_snippets": "being treated at MDACC",
"criterion": "treatment location",
"requirement": {
"requirement_type": "location",
"expected_value": "MDACC"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "pathologically proven diagnosis of epithelial carcinoma",
"criterion": "epithelial carcinoma diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity",
"criterion": "cancer location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"oropharynx",
"nasopharynx",
"hypopharynx",
"larynx",
"oral cavity"
]
}
},
{
"exact_snippets": "being treated at MDACC",
"criterion": "treatment location",
"requirement": {
"requirement_type": "location",
"expected_value": "MDACC"
}
}
]
}
},
{
"identified_line": {
"line": "2. Patients >/= 18 years old and </= 65 years old.",
"criterions": [
{
"exact_snippets": "Patients >/= 18 years old and </= 65 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 65,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients >/= 18 years old and </= 65 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 65,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.",
"criterions": [
{
"exact_snippets": "scheduled to receive definitive concurrent chemoradiation",
"criterion": "treatment plan",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "definitive concurrent chemoradiation"
}
},
{
"exact_snippets": "over 6 - 7 weeks",
"criterion": "treatment duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
},
{
"operator": "<=",
"value": 7,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "scheduled to receive definitive concurrent chemoradiation",
"criterion": "treatment plan",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "definitive concurrent chemoradiation"
}
},
{
"exact_snippets": "over 6 - 7 weeks",
"criterion": "treatment duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
},
{
"operator": "<=",
"value": 7,
"unit": "weeks"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)",
"criterions": [
{
"exact_snippets": "Patients who speak English ... we are only accruing English speaking patients",
"criterion": "language",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who speak English ... we are only accruing English speaking patients",
"criterion": "language",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "5. Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.",
"criterions": [
{
"exact_snippets": "discontinue any current herbal supplement use",
"criterion": "herbal supplement use",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": true
}
},
{
"exact_snippets": "refrain from taking any herbal supplement while on protocol",
"criterion": "herbal supplement use",
"requirement": {
"requirement_type": "refrain from use",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "discontinue any current herbal supplement use",
"criterion": "herbal supplement use",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": true
}
},
{
"exact_snippets": "refrain from taking any herbal supplement while on protocol",
"criterion": "herbal supplement use",
"requirement": {
"requirement_type": "refrain from use",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Patients must be willing and able to review, understand, and provide written consent.",
"criterions": [
{
"exact_snippets": "willing and able to review, understand, and provide written consent",
"criterion": "consent capability",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "willing and able to review, understand, and provide written consent",
"criterion": "consent capability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "willing and able to review, understand, and provide written consent",
"criterion": "consent capability",
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"expected_value": true
}
},
{
"exact_snippets": "willing and able to review, understand, and provide written consent",
"criterion": "consent capability",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..",
"criterions": [
{
"exact_snippets": "Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile)",
"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "definition",
"expected_value": "women who are not postmenopausal for at least one year and are not surgically sterile"
}
},
{
"exact_snippets": "must have negative urine pregnancy test",
"criterion": "urine pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"condition": {
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"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "definition",
"expected_value": "women who are not postmenopausal for at least one year and are not surgically sterile"
}
},
"then_criteria": {
"exact_snippets": "must have negative urine pregnancy test",
"criterion": "urine pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "8. Sexually active males and females must agree to use birth control or abstinence for the duration of the trial.",
"criterions": [
{
"exact_snippets": "Sexually active males and females",
"criterion": "sexual activity",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must agree to use birth control or abstinence",
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"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
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"expected_value": true
}
},
{
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"expected_value": true
}
}
]
}
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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"
}
}
]
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
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"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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}
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},
{
"identified_line": {
"line": "Must have maximum age of 65 Years",
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{
"exact_snippets": "maximum age of 65 Years",
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"operator": "<=",
"value": 65,
"unit": "Years"
}
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}
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{
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"operator": "<=",
"value": 65,
"unit": "Years"
}
}
}
]
}
}
],
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{
"identified_line": {
"line": "1. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician",
"criterions": [
{
"exact_snippets": "Patients who are taking medications",
"criterion": "medications",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Patients who ... have conditions",
"criterion": "conditions",
"requirement": {
"requirement_type": "potentially preclude use of study medications or interventions",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "medications",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Patients who ... have conditions",
"criterion": "conditions",
"requirement": {
"requirement_type": "potentially preclude use of study medications or interventions",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Patients taking CHANTIX (smoking cessation medication)",
"criterions": [
{
"exact_snippets": "Patients taking CHANTIX (smoking cessation medication)",
"criterion": "CHANTIX usage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients taking CHANTIX (smoking cessation medication)",
"criterion": "CHANTIX usage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "3. Patients who are enrolled in other symptom management trial or receiving active therapy as part of a treatment clinical trial.",
"criterions": [
{
"exact_snippets": "Patients who are enrolled in other symptom management trial",
"criterion": "enrollment in other symptom management trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "receiving active therapy as part of a treatment clinical trial",
"criterion": "receiving active therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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{
"exact_snippets": "Patients who are enrolled in other symptom management trial",
"criterion": "enrollment in other symptom management trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "receiving active therapy as part of a treatment clinical trial",
"criterion": "receiving active therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Bile duct obstruction or cholelithiasis",
"criterions": [
{
"exact_snippets": "Bile duct obstruction",
"criterion": "bile duct obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cholelithiasis",
"criterion": "cholelithiasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Bile duct obstruction",
"criterion": "bile duct obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cholelithiasis",
"criterion": "cholelithiasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction",
"criterions": [
{
"exact_snippets": "History of clinically significant cutaneous drug reaction",
"criterion": "cutaneous drug reaction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of clinically significant cutaneous drug reaction",
"criterion": "cutaneous drug reaction",
"requirement": {
"requirement_type": "significance",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "history of clinically significant hypersensitivity reaction",
"criterion": "hypersensitivity reaction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of clinically significant hypersensitivity reaction",
"criterion": "hypersensitivity reaction",
"requirement": {
"requirement_type": "significance",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "history of ... multiple allergies",
"criterion": "multiple allergies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... drug reaction",
"criterion": "drug reaction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of clinically significant cutaneous drug reaction",
"criterion": "cutaneous drug reaction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of clinically significant cutaneous drug reaction",
"criterion": "cutaneous drug reaction",
"requirement": {
"requirement_type": "significance",
"expected_value": "clinically significant"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "history of clinically significant hypersensitivity reaction",
"criterion": "hypersensitivity reaction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of clinically significant hypersensitivity reaction",
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}
}
]
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{
"exact_snippets": "history of ... multiple allergies",
"criterion": "multiple allergies",
"requirement": {
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"expected_value": true
}
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{
"exact_snippets": "history of ... drug reaction",
"criterion": "drug reaction",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Pre-existing psychosis or bipolar disorder. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.",
"criterions": [
{
"exact_snippets": "Pre-existing psychosis",
"criterion": "psychosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "major depressive disorder",
"criterion": "major depressive disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "severe depression ... a score of 13 or greater on the BDI Fast Screen (BDI-FS)",
"criterion": "severe depression",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 13,
"unit": "BDI-FS score"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "major depressive disorder",
"criterion": "major depressive disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "severe depression ... a score of 13 or greater on the BDI Fast Screen (BDI-FS)",
"criterion": "severe depression",
"requirement": {
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"operator": ">=",
"value": 13,
"unit": "BDI-FS score"
}
}
}
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}
]
},
{
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"criterion": "psychosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "7. Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.",
"criterions": [
{
"exact_snippets": "Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "upper limit of normal"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "upper limit of normal"
}
}
}
}
},
{
"identified_line": {
"line": "9. Pre-existing Tourette's syndrome",
"criterions": [
{
"exact_snippets": "Pre-existing Tourette's syndrome",
"criterion": "Tourette's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pre-existing Tourette's syndrome",
"criterion": "Tourette's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "10. Seizure disorder",
"criterions": [
{
"exact_snippets": "Seizure disorder",
"criterion": "seizure disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Seizure disorder",
"criterion": "seizure disorder",
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"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "11. Anorexia/bulimia in past two months",
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{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "anorexia",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "anorexia",
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"requirement_type": "time frame",
"expected_value": "past two months"
}
},
{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "bulimia",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "bulimia",
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"requirement_type": "time frame",
"expected_value": "past two months"
}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "anorexia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Anorexia/bulimia in past two months",
"criterion": "anorexia",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past two months"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Anorexia/bulimia in past two months",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Anorexia/bulimia in past two months",
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"requirement_type": "time frame",
"expected_value": "past two months"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "13. Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)",
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{
"exact_snippets": "abrupt discontinuation of ethanol",
"criterion": "ethanol discontinuation",
"requirement": {
"requirement_type": "method",
"expected_value": "abrupt"
}
},
{
"exact_snippets": "abrupt discontinuation of ... sedatives (including benzodiazepines)",
"criterion": "sedative discontinuation",
"requirement": {
"requirement_type": "method",
"expected_value": "abrupt"
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "abrupt discontinuation of ethanol",
"criterion": "ethanol discontinuation",
"requirement": {
"requirement_type": "method",
"expected_value": "abrupt"
}
},
{
"exact_snippets": "abrupt discontinuation of ... sedatives (including benzodiazepines)",
"criterion": "sedative discontinuation",
"requirement": {
"requirement_type": "method",
"expected_value": "abrupt"
}
}
]
}
},
{
"identified_line": {
"line": "14. Patients currently taking any of the study drugs",
"criterions": [
{
"exact_snippets": "Patients currently taking any of the study drugs",
"criterion": "study drug usage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"not_criteria": {
"exact_snippets": "Patients currently taking any of the study drugs",
"criterion": "study drug usage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "15. Hypersensitivity to any tetracyclines",
"criterions": [
{
"exact_snippets": "Hypersensitivity to any tetracyclines",
"criterion": "hypersensitivity to tetracyclines",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"not_criteria": {
"exact_snippets": "Hypersensitivity to any tetracyclines",
"criterion": "hypersensitivity to tetracyclines",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "16. Patients on anticoagulants (ie warfarin/heparin)",
"criterions": [
{
"exact_snippets": "Patients on anticoagulants (ie warfarin/heparin)",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients on anticoagulants (ie warfarin/heparin)",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "specific drugs",
"expected_value": [
"warfarin",
"heparin"
]
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients on anticoagulants (ie warfarin/heparin)",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients on anticoagulants (ie warfarin/heparin)",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "specific drugs",
"expected_value": [
"warfarin",
"heparin"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "17. Patients with INR > 1.5.",
"criterions": [
{
"exact_snippets": "INR > 1.5",
"criterion": "INR",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
}
]
},
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"exact_snippets": "INR > 1.5",
"criterion": "INR",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "18. Patients being treated with concurrent cetuximab chemotherapy with radiation therapy.",
"criterions": [
{
"exact_snippets": "Patients being treated with concurrent cetuximab chemotherapy",
"criterion": "cetuximab chemotherapy",
"requirement": {
"requirement_type": "concurrent treatment",
"expected_value": true
}
},
{
"exact_snippets": "Patients being treated with ... radiation therapy",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "concurrent treatment",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Patients being treated with concurrent cetuximab chemotherapy",
"criterion": "cetuximab chemotherapy",
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"requirement_type": "concurrent treatment",
"expected_value": true
}
},
{
"exact_snippets": "Patients being treated with ... radiation therapy",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "concurrent treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "20. Previous radiation therapy for a cancer in the head and neck region.",
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{
"exact_snippets": "Previous radiation therapy for a cancer in the head and neck region.",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Previous radiation therapy for a cancer in the head and neck region.",
"criterion": "cancer location",
"requirement": {
"requirement_type": "location",
"expected_value": "head and neck region"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Previous radiation therapy for a cancer in the head and neck region.",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Previous radiation therapy for a cancer in the head and neck region.",
"criterion": "cancer location",
"requirement": {
"requirement_type": "location",
"expected_value": "head and neck region"
}
}
]
}
},
{
"identified_line": {
"line": "21. Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.",
"criterions": [
{
"exact_snippets": "history of cardiac disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "angina",
"criterion": "angina",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "cardiac ischemia",
"criterion": "cardiac ischemia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "left ventricular hypertrophy",
"criterion": "left ventricular hypertrophy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "mitral valve prolapse",
"criterion": "mitral valve prolapse",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "history of cardiac disease",
"criterion": "cardiac disease",
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"requirement_type": "history",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "angina",
"criterion": "angina",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "cardiac ischemia",
"criterion": "cardiac ischemia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "left ventricular hypertrophy",
"criterion": "left ventricular hypertrophy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "mitral valve prolapse",
"criterion": "mitral valve prolapse",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
]
}
}
],
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{
"identified_line": {
"line": "8. Pre-existing hepatic impairment: The screening for total bilirubin > 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for >2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available in the medical records.",
"criterions": [
{
"exact_snippets": "Pre-existing hepatic impairment",
"criterion": "pre-existing hepatic impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "total bilirubin > 1.5 times the upper limit of normal",
"criterion": "total bilirubin",
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"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "hepatotoxicity: Alkaline phosphatase (ALP) ... >2 times the upper limit of normal",
"criterion": "Alkaline phosphatase (ALP)",
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"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "hepatotoxicity: ... Alanine aminotransferase (ALT) ... >2 times the upper limit of normal",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal",
"criterion": "Aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
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"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Pre-existing hepatic impairment",
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"expected_value": false
}
}
},
{
"or_criteria": [
{
"exact_snippets": "total bilirubin > 1.5 times the upper limit of normal",
"criterion": "total bilirubin",
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"operator": ">",
"value": 1.5,
"unit": "times the upper limit of normal"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "hepatotoxicity: Alkaline phosphatase (ALP) ... >2 times the upper limit of normal",
"criterion": "Alkaline phosphatase (ALP)",
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"requirement_type": "level",
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"operator": ">",
"value": 2,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "hepatotoxicity: ... Alanine aminotransferase (ALT) ... >2 times the upper limit of normal",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
}
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}
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}
},
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"line": "12. Use of monoamine oxidase (MAO inhibitors) within 14 days",
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{
"exact_snippets": "Use of monoamine oxidase (MAO inhibitors) within 14 days",
"criterion": "monoamine oxidase (MAO) inhibitors",
"requirement": {
"requirement_type": "use",
"expected_value": false
}
},
{
"exact_snippets": "Use of monoamine oxidase (MAO inhibitors) within 14 days",
"criterion": "monoamine oxidase (MAO) inhibitors",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
}
]
},
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"exact_snippets": "Use of monoamine oxidase (MAO inhibitors) within 14 days",
"criterion": "monoamine oxidase (MAO) inhibitors",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
},
{
"exact_snippets": "Use of monoamine oxidase (MAO inhibitors) within 14 days",
"criterion": "monoamine oxidase (MAO) inhibitors",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "19. Patients currently receiving any tetracycline family antibiotic or within the previous past 14 days before chemoradiation.",
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{
"exact_snippets": "Patients currently receiving any tetracycline family antibiotic",
"criterion": "tetracycline family antibiotic usage",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "within the previous past 14 days before chemoradiation",
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{
"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Patients currently receiving any tetracycline family antibiotic",
"criterion": "tetracycline family antibiotic usage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
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"exact_snippets": "within the previous past 14 days before chemoradiation",
"criterion": "tetracycline family antibiotic usage",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "22. Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.",
"criterions": [
{
"exact_snippets": "Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.",
"criterion": "medication use",
"requirement": {
"requirement_type": "medication type",
"expected_value": [
"antifungals",
"antiretrovirals",
"macrolides"
]
}
},
{
"exact_snippets": "Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.",
"criterion": "medication use",
"requirement": {
"requirement_type": "CYP3A4 inhibition",
"expected_value": "strong"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}