{
    "info": {
        "nct_id": "NCT04049331",
        "official_title": "Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer",
        "inclusion_criteria": "* Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year\n* Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias\n* Age: 18-54 years\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 young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone <348 ng/dl could be considered testosterone deficient. 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. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone <70 pg/mL.\n* Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).\n* Ability and willingness to provide informed consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 54 Years",
        "exclusion_criteria": "* Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)\n* Men with brain cancer (potential cognitive impairment)\n* Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months\n* Appetite stimulating agents e.g. megestrol acetate within the past 6 months\n* Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months\n* Baseline hematocrit >48%\n* PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans\n* Men with 1st order relatives with a history of prostate cancer\n* Uncontrolled congestive heart failure\n* Severe untreated sleep apnea\n* Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months\n\n  o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score <24\n* Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal\n* Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI) >45 kg/m2\n* Untreated unipolar depression (treated depression with medications or counseling will be allowed\n* Bipolar disorder or schizophrenia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year",
            "criterions": [
                {
                    "exact_snippets": "Cancer survivors",
                    "criterion": "cancer survivor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received ... radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "now in remission for at least one year",
                    "criterion": "remission duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias",
            "criterions": [
                {
                    "exact_snippets": "Non-hormone-dependent cancer",
                    "criterion": "cancer hormone dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": "non-hormone-dependent"
                        }
                    ]
                },
                {
                    "exact_snippets": "including most solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... lymphomas",
                    "criterion": "lymphomas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... leukemias",
                    "criterion": "leukemias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: 18-54 years",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-54 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 54,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone <348 ng/dl could be considered testosterone deficient. 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. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone <70 pg/mL.",
            "criterions": [
                {
                    "exact_snippets": "Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "mass spectrometry"
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 348,
                                "unit": "ng/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "free testosterone <70 pg/ml",
                    "criterion": "free testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "pg/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).",
            "criterions": [
                {
                    "exact_snippets": "Self-reported fatigue",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40",
                    "criterion": "FACIT-F score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability and willingness to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Ability ... to provide informed consent.",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to provide informed consent.",
                    "criterion": "willingness to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 54 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 54 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 54,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)",
            "criterions": [
                {
                    "exact_snippets": "Men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone-dependent cancers",
                    "criterion": "cancer hormone dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": "hormone-dependent"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "prostate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of unknown origin",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "adenocarcinoma of unknown origin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men with brain cancer (potential cognitive impairment)",
            "criterions": [
                {
                    "exact_snippets": "Men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "potential cognitive impairment",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months",
                    "criterion": "use of anabolic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Appetite stimulating agents e.g. megestrol acetate within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Appetite stimulating agents e.g. megestrol acetate within the past 6 months",
                    "criterion": "appetite stimulating agents",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids",
                    "criterion": "systemic glucocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mg"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline hematocrit >48%",
            "criterions": [
                {
                    "exact_snippets": "Baseline hematocrit >48%",
                    "criterion": "hematocrit",
                    "requirements": [
                        {
                            "requirement_type": "baseline level",
                            "expected_value": {
                                "operator": ">",
                                "value": 48,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans",
            "criterions": [
                {
                    "exact_snippets": "PSA >4 ng/ml in Caucasians",
                    "criterion": "PSA level in Caucasians",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA ... >3 ng/ml in African-Americans",
                    "criterion": "PSA level in African-Americans",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men with 1st order relatives with a history of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "1st order relatives with a history of prostate cancer",
                    "criterion": "family history of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "relationship degree",
                            "expected_value": "1st order"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe untreated sleep apnea",
            "criterions": [
                {
                    "exact_snippets": "Severe untreated sleep apnea",
                    "criterion": "sleep apnea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction ... within 3 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "acute coronary syndrome ... within 3 months",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "revascularization surgery ... within 3 months",
                    "criterion": "revascularization surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke within 3 months",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score <24",
            "criterions": [
                {
                    "exact_snippets": "Previous stroke with residual cognitive or functional deficits",
                    "criterion": "previous stroke",
                    "requirements": [
                        {
                            "requirement_type": "residual deficits",
                            "expected_value": [
                                "cognitive",
                                "functional"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Mini-Mental State Examination score <24",
                    "criterion": "Mini-Mental State Examination score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 24,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine >2.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT 3x upper limit of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "3x upper limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI) >45 kg/m2",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled diabetes as defined by hemoglobin A1c >8.5%",
                    "criterion": "hemoglobin A1c",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.5,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Body mass index (BMI) >45 kg/m2",
                    "criterion": "Body mass index (BMI)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 45,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated unipolar depression (treated depression with medications or counseling will be allowed",
            "criterions": [
                {
                    "exact_snippets": "Untreated unipolar depression",
                    "criterion": "unipolar depression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "treated depression with medications or counseling will be allowed",
                    "criterion": "depression treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "medications",
                                "counseling"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bipolar disorder or schizophrenia",
            "criterions": [
                {
                    "exact_snippets": "Bipolar disorder",
                    "criterion": "bipolar disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "schizophrenia",
                    "criterion": "schizophrenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}