{
    "info": {
        "nct_id": "NCT00572572",
        "official_title": "Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen",
        "inclusion_criteria": "* Histologic, serologic or clinical evidence of germ cell tumor.\n* Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens\n* Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.\n* Male patients 15 years of age or older at time of registration.\n* Patient will provide written informed consent and authorization to release personal health information.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 15 Years",
        "exclusion_criteria": "* No known history of anticipatory nausea or vomiting.\n* No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.\n* No known central nervous system (CNS) metastasis.\n* No known hypersensitivity to any component of study regimen.\n* No concurrent participation in a clinical trial which involves another investigational agent.\n* No use of warfarin while on study.\n* No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.\n* No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologic, serologic or clinical evidence of germ cell tumor.",
                "criterions": [
                    {
                        "exact_snippets": "Histologic ... evidence of germ cell tumor.",
                        "criterion": "germ cell tumor",
                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "histologic"
                        }
                    },
                    {
                        "exact_snippets": "serologic ... evidence of germ cell tumor.",
                        "criterion": "germ cell tumor",
                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "serologic"
                        }
                    },
                    {
                        "exact_snippets": "clinical evidence of germ cell tumor.",
                        "criterion": "germ cell tumor",
                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "clinical"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Histologic ... evidence of germ cell tumor.",
                        "criterion": "germ cell tumor",
                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "histologic"
                        }
                    },
                    {
                        "exact_snippets": "serologic ... evidence of germ cell tumor.",
                        "criterion": "germ cell tumor",
                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "serologic"
                        }
                    },
                    {
                        "exact_snippets": "clinical evidence of germ cell tumor.",
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                        "requirement": {
                            "requirement_type": "evidence type",
                            "expected_value": "clinical"
                        }
                    }
                ]
            }
        },
        {
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                "line": "* Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens",
                "criterions": [
                    {
                        "exact_snippets": "scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "cisplatin-based combination"
                        }
                    },
                    {
                        "exact_snippets": "scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "schedule",
                            "expected_value": "5 day fractionated"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy",
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                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "cisplatin-based combination"
                        }
                    },
                    {
                        "exact_snippets": "scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "schedule",
                            "expected_value": "5 day fractionated"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Prior chemotherapy is allowed",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients will be stratified based on previous treatment",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "stratification",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior chemotherapy is allowed",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients will be stratified based on previous treatment",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "stratification",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male patients 15 years of age or older at time of registration.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "15 years of age or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "15 years of age or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient will provide written informed consent and authorization to release personal health information.",
                "criterions": [
                    {
                        "exact_snippets": "Patient will provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "authorization to release personal health information",
                        "criterion": "authorization to release personal health information",
                        "requirement": {
                            "requirement_type": "authorization",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient will provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "authorization to release personal health information",
                        "criterion": "authorization to release personal health information",
                        "requirement": {
                            "requirement_type": "authorization",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 15 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 15 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 15 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* No known history of anticipatory nausea or vomiting.",
                "criterions": [
                    {
                        "exact_snippets": "No known history of anticipatory nausea or vomiting.",
                        "criterion": "anticipatory nausea or vomiting",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No known history of anticipatory nausea or vomiting.",
                        "criterion": "anticipatory nausea or vomiting",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.",
                        "criterion": "use of another antiemetic agent",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.",
                    "criterion": "use of another antiemetic agent",
                    "requirement": {
                        "requirement_type": "time since last use",
                        "expected_value": {
                            "operator": ">=",
                            "value": 72,
                            "unit": "hours"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No known central nervous system (CNS) metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "No known central nervous system (CNS) metastasis.",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No known central nervous system (CNS) metastasis.",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No known hypersensitivity to any component of study regimen.",
                "criterions": [
                    {
                        "exact_snippets": "No known hypersensitivity to any component of study regimen.",
                        "criterion": "hypersensitivity to study regimen components",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No known hypersensitivity to any component of study regimen.",
                    "criterion": "hypersensitivity to study regimen components",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No concurrent participation in a clinical trial which involves another investigational agent.",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent participation in a clinical trial which involves another investigational agent.",
                        "criterion": "concurrent participation in a clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent participation in a clinical trial which involves another investigational agent.",
                        "criterion": "involvement of another investigational agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No concurrent participation in a clinical trial which involves another investigational agent.",
                        "criterion": "concurrent participation in a clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent participation in a clinical trial which involves another investigational agent.",
                        "criterion": "involvement of another investigational agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No use of warfarin while on study.",
                "criterions": [
                    {
                        "exact_snippets": "No use of warfarin while on study.",
                        "criterion": "warfarin use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No use of warfarin while on study.",
                        "criterion": "warfarin use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.",
                "criterions": [
                    {
                        "exact_snippets": "No use of agents which may impair metabolism of aprepitant",
                        "criterion": "use of agents impairing metabolism of aprepitant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Cisapride",
                        "criterion": "use of Cisapride",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin)",
                        "criterion": "use of macrolide antibiotics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole)",
                        "criterion": "use of azole antifungal agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Amifostine",
                        "criterion": "use of Amifostine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Nelfinavir",
                        "criterion": "use of Nelfinavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Ritonavir",
                        "criterion": "use of Ritonavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "No use of agents which may impair metabolism of aprepitant",
                                                                        "criterion": "use of agents impairing metabolism of aprepitant",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": false
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Cisapride",
                                                                        "criterion": "use of Cisapride",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": false
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin)",
                                                                "criterion": "use of macrolide antibiotics",
                                                                "requirement": {
                                                                    "requirement_type": "presence",
                                                                    "expected_value": false
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole)",
                                                        "criterion": "use of azole antifungal agents",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "Amifostine",
                                                "criterion": "use of Amifostine",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Nelfinavir",
                                        "criterion": "use of Nelfinavir",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Ritonavir",
                                "criterion": "use of Ritonavir",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                "criterions": [
                    {
                        "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                        "criterion": "use of agents that induce the metabolism of aprepitant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                                "criterion": "use of Rifampin",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                                "criterion": "use of Rifabutin",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                                "criterion": "use of Phenytoin",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                                "criterion": "use of Carbamazepine",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.",
                                "criterion": "use of barbiturates",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}