{
    "info": {
        "nct_id": "NCT00042848",
        "official_title": "Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer\n* Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy\n\n  * Each course of chemotherapy must be at least 2 weeks in duration\n  * No concurrent radiotherapy or interferon therapy\n* Brief Fatigue Inventory question #3 \"fatigue worst\" score of 2 or greater 1 week after first chemotherapy course\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 6 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* No uncontrolled anemia\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No history of clinically significant cardiac disease, including any of the following:\n\n  * Unstable angina\n  * Left ventricular hypertrophy\n  * Ischemic echocardiogram changes\n  * Chest pain\n  * Arrhythmia\n  * Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)\n* No uncontrolled hypertension\n\nGastrointestinal\n\n* Able to swallow medication\n* No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract\n\nOther\n\n* No severe headaches\n* No glaucoma\n* No seizure disorder\n* No narcolepsy\n* No psychotic disorder\n* No Tourette's syndrome\n* No alcohol or drug abuse\n* Not pregnant or nursing\n* Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* No concurrent chronic corticosteroids\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior modafinil\n* At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)\n* No concurrent alcohol\n* Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed\n* Concurrent phenytoin allowed\n* Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed"
    },
    "inclusion_lines": [
        {
            "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": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 120 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
                "criterions": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of cancer",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Diagnosis of cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Concurrently receiving or has previously received chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "concurrently receiving",
                                "previously received"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "scheduled for at least 3 additional courses of chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "scheduled courses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "courses"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Concurrently receiving or has previously received chemotherapy",
                                "criterion": "chemotherapy",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "concurrently receiving",
                                        "previously received"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "scheduled for at least 3 additional courses of chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "scheduled courses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "courses"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Each course of chemotherapy must be at least 2 weeks in duration",
                "criterions": [
                    {
                        "exact_snippets": "Each course of chemotherapy must be at least 2 weeks in duration",
                        "criterion": "course of chemotherapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Each course of chemotherapy must be at least 2 weeks in duration",
                        "criterion": "course of chemotherapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No concurrent radiotherapy or interferon therapy",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent radiotherapy",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent ... interferon therapy",
                        "criterion": "interferon therapy",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No concurrent radiotherapy",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent ... interferon therapy",
                        "criterion": "interferon therapy",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Brief Fatigue Inventory question #3 \"fatigue worst\" score of 2 or greater 1 week after first chemotherapy course",
                "criterions": [
                    {
                        "exact_snippets": "Brief Fatigue Inventory question #3 \"fatigue worst\" score of 2 or greater",
                        "criterion": "fatigue worst score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "1 week after first chemotherapy course",
                        "criterion": "time since first chemotherapy course",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": "1 week"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Brief Fatigue Inventory question #3 \"fatigue worst\" score of 2 or greater",
                                "criterion": "fatigue worst score",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "1 week after first chemotherapy course",
                                "criterion": "time since first chemotherapy course",
                                "requirement": {
                                    "requirement_type": "time",
                                    "expected_value": "1 week"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Age",
                "criterions": [
                    {
                        "exact_snippets": "Age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 18 and over",
                "criterions": [
                    {
                        "exact_snippets": "18 and over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "18 and over",
                        "criterion": "age",
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                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Performance status",
                "criterions": [
                    {
                        "exact_snippets": "Performance status",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance status",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Life expectancy",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 6 months",
                "criterions": [
                    {
                        "exact_snippets": "At least 6 months",
                        "criterion": "time since a specific event",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 6 months",
                        "criterion": "time since a specific event",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hematopoietic",
                "criterions": [
                    {
                        "exact_snippets": "Hematopoietic",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematopoietic",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hepatic",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No uncontrolled anemia",
                "criterions": [
                    {
                        "exact_snippets": "No uncontrolled anemia",
                        "criterion": "anemia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No uncontrolled anemia",
                        "criterion": "anemia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Renal",
                "criterions": [
                    {
                        "exact_snippets": "Renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Cardiovascular",
                "criterions": [
                    {
                        "exact_snippets": "Cardiovascular",
                        "criterion": "cardiovascular",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cardiovascular",
                        "criterion": "cardiovascular",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of clinically significant cardiac disease, including any of the following:",
                "criterions": [
                    {
                        "exact_snippets": "No history of clinically significant cardiac disease",
                        "criterion": "clinically significant cardiac disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No history of clinically significant cardiac disease",
                        "criterion": "clinically significant cardiac disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unstable angina",
                "criterions": [
                    {
                        "exact_snippets": "Unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular hypertrophy",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular hypertrophy",
                        "criterion": "left ventricular hypertrophy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular hypertrophy",
                        "criterion": "left ventricular hypertrophy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ischemic echocardiogram changes",
                "criterions": [
                    {
                        "exact_snippets": "Ischemic echocardiogram changes",
                        "criterion": "ischemic echocardiogram changes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ischemic echocardiogram changes",
                        "criterion": "ischemic echocardiogram changes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Chest pain",
                "criterions": [
                    {
                        "exact_snippets": "Chest pain",
                        "criterion": "chest pain",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Chest pain",
                        "criterion": "chest pain",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Arrhythmia",
                "criterions": [
                    {
                        "exact_snippets": "Arrhythmia",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Arrhythmia",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant manifestations of mitral valve prolapse",
                        "criterion": "mitral valve prolapse",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)",
                        "criterion": "use of central nervous system stimulants",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": [
                                "caffeine",
                                "amphetamines",
                                "methylphenidate"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "clinically significant manifestations of mitral valve prolapse",
                        "criterion": "mitral valve prolapse",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)",
                        "criterion": "use of central nervous system stimulants",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": [
                                "caffeine",
                                "amphetamines",
                                "methylphenidate"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No uncontrolled hypertension",
                "criterions": [
                    {
                        "exact_snippets": "No uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Gastrointestinal",
                "criterions": [
                    {
                        "exact_snippets": "Gastrointestinal",
                        "criterion": "gastrointestinal condition",
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                "line": "PATIENT CHARACTERISTICS:",
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            "identified_line": {
                "line": "* Not specified",
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            "identified_line": {
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            "identified_line": {
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                    "criterion": "seizure disorder",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No psychotic disorder",
                "criterions": [
                    {
                        "exact_snippets": "No psychotic disorder",
                        "criterion": "psychotic disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No psychotic disorder",
                    "criterion": "psychotic disorder",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No prior modafinil",
                "criterions": [
                    {
                        "exact_snippets": "No prior modafinil",
                        "criterion": "prior modafinil use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No prior modafinil",
                    "criterion": "prior modafinil use",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ]
}