{
    "info": {
        "nct_id": "NCT00178373",
        "official_title": "Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer",
        "inclusion_criteria": "* Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer\n* Patient is 18 years of age or older\n* Patient is able to swallow medication\n* Patient has a Brief Fatigue Inventory (BFI) question #3 \"fatigue worst\" score of 2 or greater\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has ever taken modafinil (PROVIGIL)\n* Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)\n* Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome\n* Patient presently taking on a regular basis:\n\n  * an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable\n  * alpha-interferon or interleukin-2,\n  * a corticosteroid (dexamethasone, prednisone, prednisolone)\n* Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract\n* Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study\n* Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer",
            "criterions": [
                {
                    "exact_snippets": "longer than one-month post chemotherapy",
                    "criterion": "post chemotherapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "longer than one-month post ... radiation treatment",
                    "criterion": "post radiation treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "initial diagnosis of cancer",
                    "criterion": "initial diagnosis of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is able to swallow medication",
            "criterions": [
                {
                    "exact_snippets": "able to swallow medication",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a Brief Fatigue Inventory (BFI) question #3 \"fatigue worst\" score of 2 or greater",
            "criterions": [
                {
                    "exact_snippets": "Brief Fatigue Inventory (BFI) question #3 \"fatigue worst\" score of 2 or greater",
                    "criterion": "fatigue worst score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient has ever taken modafinil (PROVIGIL)",
            "criterions": [
                {
                    "exact_snippets": "Patient has ever taken modafinil (PROVIGIL)",
                    "criterion": "modafinil (PROVIGIL) usage",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)",
            "criterions": [
                {
                    "exact_snippets": "Patient has taken an anticonvulsant for a seizure disorder",
                    "criterion": "anticonvulsant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert])",
                    "criterion": "psychostimulant use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 30 days"
                        }
                    ]
                },
                {
                    "exact_snippets": "has taken any of the following on a regular basis within the past 30 days, ... a monoamine oxidase inhibitor (MAOIs)",
                    "criterion": "monoamine oxidase inhibitor use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 30 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome",
            "criterions": [
                {
                    "exact_snippets": "history of clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "alcohol or drug abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe headaches",
                    "criterion": "headaches",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "glaucoma",
                    "criterion": "glaucoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "narcolepsy",
                    "criterion": "narcolepsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychotic disorder",
                    "criterion": "psychotic disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tourette's syndrome",
                    "criterion": "Tourette's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient presently taking on a regular basis:",
            "criterions": [
                {
                    "exact_snippets": "Patient presently taking on a regular basis",
                    "criterion": "medication usage",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "regular"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable",
            "criterions": [
                {
                    "exact_snippets": "an anticoagulant (Coumadin [warfarin], heparin)",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable",
                    "criterion": "low dose Coumadin for venous access devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* alpha-interferon or interleukin-2,",
            "criterions": [
                {
                    "exact_snippets": "alpha-interferon",
                    "criterion": "alpha-interferon",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interleukin-2",
                    "criterion": "interleukin-2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a corticosteroid (dexamethasone, prednisone, prednisolone)",
            "criterions": [
                {
                    "exact_snippets": "a corticosteroid (dexamethasone, prednisone, prednisolone)",
                    "criterion": "corticosteroid",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "dexamethasone",
                                "prednisone",
                                "prednisolone"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract",
            "criterions": [
                {
                    "exact_snippets": "narrowing (pathological or iatrogenic) ... of the gastrointestinal tract",
                    "criterion": "narrowing of the gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "obstruction of the gastrointestinal tract",
                    "criterion": "obstruction of the gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable",
            "criterions": [
                {
                    "exact_snippets": "Patient has uncontrolled anemia",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving treatment for anemia and currently stable is acceptable",
                    "criterion": "anemia treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study",
            "criterions": [
                {
                    "exact_snippets": "Patient is currently pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "currently nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "currently using a steroidal contraceptive for fertility control",
                    "criterion": "steroidal contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study",
                    "criterion": "barrier method of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}