{
    "info": {
        "nct_id": "NCT00612066",
        "official_title": "An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Clinically demonstrable ACTH-secreting pituitary tumor\n\n  * Pituitary tumor demonstrated on MRI with and without contrast AND/OR evidence of a central ACTH source following inferior petrosal sinus sampling\n  * Newly diagnosed disease\n* Biochemically active disease that is not adequately controlled, as demonstrated by the following standard criteria:\n\n  * Elevated 24-hour urinary-free cortisol levels on at least 2 separate 24-hour urine collections 1 week apart\n  * Lack of suppression of serum cortisol to < 1.8 μg/dL (at 8 am) following administration of 1 mg of dexamethasone at 11 pm the night before\n  * Measurable plasma ACTH levels\n* Patient is hypercortisolemic and does not wish to receive alternate steroid-lowering therapy, such as ketoconazole and/or metyrapone\n* Patients with evidence of optic nerve or chiasm compression on post-operative MRI must have a normal visual field evaluation by Goldman perimetry\n\n  * No visual field abnormalities\n* Hypopituitarism* allowed, as evidenced by any or all of the following:\n\n  * Subnormal growth hormone (GH) response to arginine/growth hormone-releasing hormone (GHRH) testing (normal response is an increase of > 4 ng/mL)\n  * Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels\n  * Low thyroid-stimulating hormone (TSH) levels\n  * Low free triiodothyronine (T3) and free thyroxine (T4) levels\n  * Low estradiol levels\n  * Low luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in postmenopausal female patients\n  * Low testosterone, LH, and FSH levels in male patients NOTE: *Patients who are diagnosed with hypopituitarism will initiate thyroid hormone replacement therapy prior to pituitary surgery as part of routine care. Other hormone replacement, such as sex steroids or growth hormone, will not be initiated during the study.\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception (if oral contraception is used, it must be used for ≥ 2 months prior to, during, and for 1 month after completion of study therapy)\n* No clinically significant renal, hematologic, or hepatic abnormalities\n* No prior or concurrent medical condition that may interfere with the conduct of the study or the evaluation of its results, in the opinion of the investigator or the DSMB compliance officer\n* No history of immunocompromise, including HIV positivity by ELISA and western blot\n* No alcohol or drug abuse within the past 6 months\n* No blood donation (≥ 400 mL) within the past 2 months\n* No other active malignant disease within the past 5 years except for basal cell carcinoma or carcinoma in situ of the cervix\n* No active or suspected acute or chronic uncontrolled infection\n* No severe osteoporosis, defined as bone mineral density T scores < 2.5 standard deviations below age-matched controls\n* No history of noncompliance to medical regimens\n* Considered reliable\n* Able to complete the entire study\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 3 months since prior rosiglitazone or other thiazolidinedione\n* No prior or concurrent radiotherapy for pituitary tumor\n* More than 1 month since prior participation in any clinical investigation involving an investigational drug\n* More than 30 days since prior unlicensed drugs\n* No concurrent pituitary surgery"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically demonstrable ACTH-secreting pituitary tumor",
            "criterions": [
                {
                    "exact_snippets": "Clinically demonstrable ACTH-secreting pituitary tumor",
                    "criterion": "ACTH-secreting pituitary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pituitary tumor demonstrated on MRI with and without contrast AND/OR evidence of a central ACTH source following inferior petrosal sinus sampling",
            "criterions": [
                {
                    "exact_snippets": "Pituitary tumor demonstrated on MRI with and without contrast",
                    "criterion": "pituitary tumor",
                    "requirements": [
                        {
                            "requirement_type": "demonstration",
                            "expected_value": "on MRI with and without contrast"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of a central ACTH source following inferior petrosal sinus sampling",
                    "criterion": "central ACTH source",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "following inferior petrosal sinus sampling"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed disease",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed disease",
                    "criterion": "disease diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biochemically active disease that is not adequately controlled, as demonstrated by the following standard criteria:",
            "criterions": [
                {
                    "exact_snippets": "Biochemically active disease",
                    "criterion": "biochemically active disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not adequately controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elevated 24-hour urinary-free cortisol levels on at least 2 separate 24-hour urine collections 1 week apart",
            "criterions": [
                {
                    "exact_snippets": "Elevated 24-hour urinary-free cortisol levels",
                    "criterion": "24-hour urinary-free cortisol levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                },
                {
                    "exact_snippets": "on at least 2 separate 24-hour urine collections 1 week apart",
                    "criterion": "24-hour urine collections",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "collections"
                            }
                        },
                        {
                            "requirement_type": "time_interval",
                            "expected_value": "1 week apart"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of suppression of serum cortisol to < 1.8 μg/dL (at 8 am) following administration of 1 mg of dexamethasone at 11 pm the night before",
            "criterions": [
                {
                    "exact_snippets": "Lack of suppression of serum cortisol to < 1.8 μg/dL (at 8 am) following administration of 1 mg of dexamethasone at 11 pm the night before",
                    "criterion": "serum cortisol suppression",
                    "requirements": [
                        {
                            "requirement_type": "suppression",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.8,
                                "unit": "μg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable plasma ACTH levels",
            "criterions": [
                {
                    "exact_snippets": "Measurable plasma ACTH levels",
                    "criterion": "plasma ACTH levels",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is hypercortisolemic and does not wish to receive alternate steroid-lowering therapy, such as ketoconazole and/or metyrapone",
            "criterions": [
                {
                    "exact_snippets": "Patient is hypercortisolemic",
                    "criterion": "hypercortisolemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "does not wish to receive alternate steroid-lowering therapy, such as ketoconazole and/or metyrapone",
                    "criterion": "willingness to receive alternate steroid-lowering therapy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with evidence of optic nerve or chiasm compression on post-operative MRI must have a normal visual field evaluation by Goldman perimetry",
            "criterions": [
                {
                    "exact_snippets": "evidence of optic nerve or chiasm compression on post-operative MRI",
                    "criterion": "optic nerve or chiasm compression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "normal visual field evaluation by Goldman perimetry",
                    "criterion": "visual field evaluation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No visual field abnormalities",
            "criterions": [
                {
                    "exact_snippets": "No visual field abnormalities",
                    "criterion": "visual field",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypopituitarism* allowed, as evidenced by any or all of the following:",
            "criterions": [
                {
                    "exact_snippets": "Hypopituitarism",
                    "criterion": "hypopituitarism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subnormal growth hormone (GH) response to arginine/growth hormone-releasing hormone (GHRH) testing (normal response is an increase of > 4 ng/mL)",
            "criterions": [
                {
                    "exact_snippets": "Subnormal growth hormone (GH) response to arginine/growth hormone-releasing hormone (GHRH) testing",
                    "criterion": "growth hormone (GH) response",
                    "requirements": [
                        {
                            "requirement_type": "response level",
                            "expected_value": "subnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal response is an increase of > 4 ng/mL",
                    "criterion": "growth hormone (GH) response",
                    "requirements": [
                        {
                            "requirement_type": "normal response threshold",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels",
            "criterions": [
                {
                    "exact_snippets": "Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels",
                    "criterion": "insulin-like growth factor-1 (IGF-1) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        },
                        {
                            "requirement_type": "matching",
                            "expected_value": [
                                "age",
                                "sex"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low thyroid-stimulating hormone (TSH) levels",
            "criterions": [
                {
                    "exact_snippets": "Low thyroid-stimulating hormone (TSH) levels",
                    "criterion": "thyroid-stimulating hormone (TSH) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.4,
                                "unit": "mIU/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low free triiodothyronine (T3) and free thyroxine (T4) levels",
            "criterions": [
                {
                    "exact_snippets": "Low free triiodothyronine (T3)",
                    "criterion": "free triiodothyronine (T3) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "Low ... free thyroxine (T4) levels",
                    "criterion": "free thyroxine (T4) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low estradiol levels",
            "criterions": [
                {
                    "exact_snippets": "Low estradiol levels",
                    "criterion": "estradiol levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in postmenopausal female patients",
            "criterions": [
                {
                    "exact_snippets": "Low luteinizing hormone (LH)",
                    "criterion": "luteinizing hormone (LH) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Low ... follicle-stimulating hormone (FSH) levels",
                    "criterion": "follicle-stimulating hormone (FSH) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal female patients",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low testosterone, LH, and FSH levels in male patients NOTE: *Patients who are diagnosed with hypopituitarism will initiate thyroid hormone replacement therapy prior to pituitary surgery as part of routine care. Other hormone replacement, such as sex steroids or growth hormone, will not be initiated during the study.",
            "criterions": [
                {
                    "exact_snippets": "Low testosterone, LH, and FSH levels in male patients",
                    "criterion": "testosterone levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "Low testosterone, LH, and FSH levels in male patients",
                    "criterion": "LH levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "Low testosterone, LH, and FSH levels in male patients",
                    "criterion": "FSH levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception (if oral contraception is used, it must be used for ≥ 2 months prior to, during, and for 1 month after completion of study therapy)",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception usage",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if oral contraception is used, it must be used for ≥ 2 months prior to, during, and for 1 month after completion of study therapy",
                    "criterion": "oral contraception usage duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "months"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during study therapy"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant renal, hematologic, or hepatic abnormalities",
            "criterions": [
                {
                    "exact_snippets": "clinically significant renal ... abnormalities",
                    "criterion": "renal abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... hematologic ... abnormalities",
                    "criterion": "hematologic abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... hepatic abnormalities",
                    "criterion": "hepatic abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent medical condition that may interfere with the conduct of the study or the evaluation of its results, in the opinion of the investigator or the DSMB compliance officer",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent medical condition that may interfere with the conduct of the study or the evaluation of its results",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of immunocompromise, including HIV positivity by ELISA and western blot",
            "criterions": [
                {
                    "exact_snippets": "No history of immunocompromise",
                    "criterion": "immunocompromise",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV positivity by ELISA and western blot",
                    "criterion": "HIV positivity",
                    "requirements": [
                        {
                            "requirement_type": "test",
                            "expected_value": [
                                "ELISA",
                                "western blot"
                            ]
                        },
                        {
                            "requirement_type": "result",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No alcohol or drug abuse within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No alcohol ... within the past 6 months",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... drug abuse within the past 6 months",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No blood donation (≥ 400 mL) within the past 2 months",
            "criterions": [
                {
                    "exact_snippets": "No blood donation (≥ 400 mL) within the past 2 months",
                    "criterion": "blood donation",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">=",
                                "value": 400,
                                "unit": "mL"
                            }
                        },
                        {
                            "requirement_type": "time since last donation",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other active malignant disease within the past 5 years except for basal cell carcinoma or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other active malignant disease within the past 5 years",
                    "criterion": "active malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 5 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for basal cell carcinoma or carcinoma in situ of the cervix",
                    "criterion": "exceptions to malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "basal cell carcinoma",
                                "carcinoma in situ of the cervix"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active or suspected acute or chronic uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "No active or suspected acute or chronic uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "no active or suspected"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe osteoporosis, defined as bone mineral density T scores < 2.5 standard deviations below age-matched controls",
            "criterions": [
                {
                    "exact_snippets": "No severe osteoporosis, defined as bone mineral density T scores < 2.5 standard deviations below age-matched controls",
                    "criterion": "bone mineral density T scores",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": -2.5,
                                "unit": "standard deviations"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of noncompliance to medical regimens",
            "criterions": [
                {
                    "exact_snippets": "No history of noncompliance to medical regimens",
                    "criterion": "noncompliance to medical regimens",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Considered reliable",
            "criterions": [
                {
                    "exact_snippets": "Considered reliable",
                    "criterion": "reliability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "considered reliable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to complete the entire study",
            "criterions": [
                {
                    "exact_snippets": "Able to complete the entire study",
                    "criterion": "study completion ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 months since prior rosiglitazone or other thiazolidinedione",
            "criterions": [
                {
                    "exact_snippets": "More than 3 months since prior rosiglitazone",
                    "criterion": "time since prior rosiglitazone",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "More than 3 months since prior ... other thiazolidinedione",
                    "criterion": "time since prior thiazolidinedione",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent radiotherapy for pituitary tumor",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent radiotherapy for pituitary tumor",
                    "criterion": "radiotherapy for pituitary tumor",
                    "requirements": [
                        {
                            "requirement_type": "prior or concurrent treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 1 month since prior participation in any clinical investigation involving an investigational drug",
            "criterions": [
                {
                    "exact_snippets": "More than 1 month since prior participation in any clinical investigation involving an investigational drug",
                    "criterion": "time since prior participation in clinical investigation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 30 days since prior unlicensed drugs",
            "criterions": [
                {
                    "exact_snippets": "More than 30 days since prior unlicensed drugs",
                    "criterion": "prior unlicensed drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent pituitary surgery",
            "criterions": [
                {
                    "exact_snippets": "No concurrent pituitary surgery",
                    "criterion": "pituitary surgery",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}