{
"info": {
"nct_id": "NCT04301765",
"official_title": "Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency",
"inclusion_criteria": "* Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are <60 months from their last treatment (chemotherapy and/or radiation therapy) will be included.\n* Age: 55 years and older\n* Life expectancy of at least 6 months.\n* Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl and/or free testosterone <70 pg/ml. The lower limits of the normal range for total testosterone in healthy men is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone <70 pg/mL will be included.\n* Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of <40, which best divides cancer patients from the general population with accuracy.\n* Ability and willingness to provide informed consent\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 55 Years",
"exclusion_criteria": "* Men with current or prior history of prostate, breast, testicular, or adrenal cancers.\n* Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months\n* Hematocrit >48%, serum creatinine >2.5 mg/dL\n* PSA >4 ng/ml; nodule or induration on digital rectal exam\n* Severe untreated sleep apnea\n* Uncontrolled congestive heart failure\n* Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months\n* Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)\n* Previous stroke with residual cognitive or functional deficits\n* Inability to provide informed consent; MMSE score <24\n* Poorly controlled diabetes as defined by hemoglobin A1c >10.0%\n* Body mass index (BMI) >40 kg/m2\n* Bipolar disorder or schizophrenia",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age: 55 years and older",
"criterions": [
{
"exact_snippets": "Age: 55 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 55,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: 55 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 55,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy of at least 6 months.",
"criterions": [
{
"exact_snippets": "Life expectancy of at least 6 months.",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy of at least 6 months.",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl and/or free testosterone <70 pg/ml. The lower limits of the normal range for total testosterone in healthy men is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone <70 pg/mL will be included.",
"criterions": [
{
"exact_snippets": "Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl",
"criterion": "serum testosterone",
"requirement": {
"requirement_type": "measurement method",
"expected_value": "mass spectrometry"
}
},
{
"exact_snippets": "Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl",
"criterion": "serum testosterone",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 348,
"unit": "ng/dl"
}
}
},
{
"exact_snippets": "free testosterone <70 pg/ml",
"criterion": "free testosterone",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "pg/ml"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl",
"criterion": "serum testosterone",
"requirement": {
"requirement_type": "measurement method",
"expected_value": "mass spectrometry"
}
},
{
"exact_snippets": "Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl",
"criterion": "serum testosterone",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 348,
"unit": "ng/dl"
}
}
}
]
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{
"exact_snippets": "free testosterone <70 pg/ml",
"criterion": "free testosterone",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 70,
"unit": "pg/ml"
}
}
}
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},
{
"identified_line": {
"line": "* Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of <40, which best divides cancer patients from the general population with accuracy.",
"criterions": [
{
"exact_snippets": "Fatigue ... score on FACIT-Fatigue subscale of <40",
"criterion": "fatigue",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "FACIT-Fatigue subscale score"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Fatigue ... score on FACIT-Fatigue subscale of <40",
"criterion": "fatigue",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "FACIT-Fatigue subscale score"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Ability and willingness to provide informed consent",
"criterions": [
{
"exact_snippets": "Ability ... to provide informed consent",
"criterion": "ability to provide informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willingness to provide informed consent",
"criterion": "willingness to provide informed consent",
"requirement": {
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"expected_value": true
}
}
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"exact_snippets": "Ability ... to provide informed consent",
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"expected_value": true
}
},
{
"exact_snippets": "willingness to provide informed consent",
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"expected_value": true
}
}
]
}
},
{
"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": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "MALE",
"criterion": "gender",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 55 Years",
"criterions": [
{
"exact_snippets": "minimum age of 55 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 55,
"unit": "Years"
}
}
}
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},
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"exact_snippets": "minimum age of 55 Years",
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"operator": ">=",
"value": 55,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Men with current or prior history of prostate, breast, testicular, or adrenal cancers.",
"criterions": [
{
"exact_snippets": "Men with current or prior history of prostate ... cancers.",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Men with current or prior history of ... breast ... cancers.",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Men with current or prior history of ... testicular ... cancers.",
"criterion": "testicular cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Men with current or prior history of ... adrenal cancers.",
"criterion": "adrenal cancer",
"requirement": {
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"expected_value": true
}
}
]
},
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}
},
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}
}
]
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{
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"expected_value": true
}
},
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"exact_snippets": "Men with current or prior history of ... breast ... cancers.",
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}
}
]
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{
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"exact_snippets": "Men with current or prior history of ... testicular ... cancers.",
"criterion": "testicular cancer",
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}
},
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"exact_snippets": "Men with current or prior history of ... testicular ... cancers.",
"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
}
]
},
{
"and_criteria": [
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"exact_snippets": "Men with current or prior history of ... adrenal cancers.",
"criterion": "adrenal cancer",
"requirement": {
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"expected_value": true
}
},
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}
}
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}
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},
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"identified_line": {
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"criterions": [
{
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"criterion": "use of anabolic agents",
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}
}
]
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"and_criteria": [
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"criterion": "testosterone",
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"expected_value": true
}
}
]
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{
"exact_snippets": "Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months",
"criterion": "DHEA",
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"expected_value": true
}
}
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"exact_snippets": "Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months",
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}
}
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},
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"identified_line": {
"line": "* Hematocrit >48%, serum creatinine >2.5 mg/dL",
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{
"exact_snippets": "Hematocrit >48%",
"criterion": "hematocrit",
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"operator": ">",
"value": 48,
"unit": "%"
}
}
},
{
"exact_snippets": "serum creatinine >2.5 mg/dL",
"criterion": "serum creatinine",
"requirement": {
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"operator": ">",
"value": 2.5,
"unit": "mg/dL"
}
}
}
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"exact_snippets": "Hematocrit >48%",
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"value": 48,
"unit": "%"
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}
},
{
"exact_snippets": "serum creatinine >2.5 mg/dL",
"criterion": "serum creatinine",
"requirement": {
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"operator": ">",
"value": 2.5,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* PSA >4 ng/ml; nodule or induration on digital rectal exam",
"criterions": [
{
"exact_snippets": "PSA >4 ng/ml",
"criterion": "PSA level",
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"operator": ">",
"value": 4,
"unit": "ng/ml"
}
}
},
{
"exact_snippets": "nodule or induration on digital rectal exam",
"criterion": "digital rectal exam",
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"induration"
]
}
}
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"and_criteria": [
{
"exact_snippets": "PSA >4 ng/ml",
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"operator": ">",
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"unit": "ng/ml"
}
}
},
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"exact_snippets": "nodule or induration on digital rectal exam",
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},
{
"identified_line": {
"line": "* Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months",
"criterions": [
{
"exact_snippets": "Myocardial infarction ... within 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "acute coronary syndrome ... within 6 months",
"criterion": "acute coronary syndrome",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "revascularization surgery ... within 6 months",
"criterion": "revascularization surgery",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "stroke ... within 6 months",
"criterion": "stroke",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "thromboembolism (of any etiology) within 6 months",
"criterion": "thromboembolism",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
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{
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"unit": "months"
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},
{
"exact_snippets": "acute coronary syndrome ... within 6 months",
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"unit": "months"
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"exact_snippets": "stroke ... within 6 months",
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"unit": "months"
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"operator": "<=",
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"unit": "months"
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}
}
]
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},
{
"identified_line": {
"line": "* Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)",
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{
"exact_snippets": "Known history of thrombophilia",
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"expected_value": true
}
},
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"exact_snippets": "genetic mutation (e.g. Factor V Leiden)",
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}
]
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}
},
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}
]
}
]
}
},
{
"identified_line": {
"line": "* Previous stroke with residual cognitive or functional deficits",
"criterions": [
{
"exact_snippets": "Previous stroke",
"criterion": "previous stroke",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "residual cognitive ... deficits",
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}
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{
"exact_snippets": "Previous stroke",
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}
},
{
"or_criteria": [
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"exact_snippets": "residual cognitive ... deficits",
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}
},
{
"exact_snippets": "residual ... functional deficits",
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}
}
]
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]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Inability to provide informed consent; MMSE score <24",
"criterions": [
{
"exact_snippets": "Inability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "MMSE score <24",
"criterion": "MMSE score",
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"expected_value": {
"operator": "<",
"value": 24,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Inability to provide informed consent",
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"expected_value": false
}
},
{
"exact_snippets": "MMSE score <24",
"criterion": "MMSE score",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 24,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Poorly controlled diabetes as defined by hemoglobin A1c >10.0%",
"criterions": [
{
"exact_snippets": "Poorly controlled diabetes as defined by hemoglobin A1c >10.0%",
"criterion": "diabetes control",
"requirement": {
"requirement_type": "hemoglobin A1c level",
"expected_value": {
"operator": ">",
"value": 10.0,
"unit": "%"
}
}
}
]
},
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"exact_snippets": "Poorly controlled diabetes as defined by hemoglobin A1c >10.0%",
"criterion": "diabetes control",
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"expected_value": {
"operator": ">",
"value": 10.0,
"unit": "%"
}
}
}
}
},
{
"identified_line": {
"line": "* Body mass index (BMI) >40 kg/m2",
"criterions": [
{
"exact_snippets": "Body mass index (BMI) >40 kg/m2",
"criterion": "body mass index (BMI)",
"requirement": {
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"operator": ">",
"value": 40,
"unit": "kg/m2"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Body mass index (BMI) >40 kg/m2",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 40,
"unit": "kg/m2"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Bipolar disorder or schizophrenia",
"criterions": [
{
"exact_snippets": "Bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "schizophrenia",
"criterion": "schizophrenia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "schizophrenia",
"criterion": "schizophrenia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are <60 months from their last treatment (chemotherapy and/or radiation therapy) will be included.",
"criterions": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "expected value",
"expected_value": "male"
}
},
{
"exact_snippets": "active solid or hematologic (blood) cancers",
"criterion": "cancer type",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "active solid or hematologic (blood) cancers",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"solid",
"hematologic"
]
}
},
{
"exact_snippets": "have received or are receiving chemo- and/or radiation therapy",
"criterion": "treatment type",
"requirement": {
"requirement_type": "received",
"expected_value": [
"chemotherapy",
"radiation therapy"
]
}
},
{
"exact_snippets": "Patients who have no evidence of disease (NED) for 60 months or less",
"criterion": "disease status",
"requirement": {
"requirement_type": "NED duration",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Men",
"criterion": "gender",
"requirement": {
"requirement_type": "expected value",
"expected_value": "male"
}
},
{
"or_criteria": [
{
"exact_snippets": "active solid or hematologic (blood) cancers",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "solid"
}
},
{
"exact_snippets": "active solid or hematologic (blood) cancers",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "hematologic"
}
}
]
},
{
"exact_snippets": "active solid or hematologic (blood) cancers",
"criterion": "cancer type",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "have received or are receiving chemo- and/or radiation therapy",
"criterion": "treatment type",
"requirement": {
"requirement_type": "received",
"expected_value": [
"chemotherapy",
"radiation therapy"
]
}
}
]
},
{
"exact_snippets": "Patients who have no evidence of disease (NED) for 60 months or less",
"criterion": "disease status",
"requirement": {
"requirement_type": "NED duration",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "months"
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Severe untreated sleep apnea",
"criterions": [
{
"exact_snippets": "Severe untreated sleep apnea",
"criterion": "sleep apnea",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe untreated sleep apnea",
"criterion": "sleep apnea",
"requirement": {
"requirement_type": "treatment status",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Uncontrolled congestive heart failure",
"criterions": [
{
"exact_snippets": "Uncontrolled congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}