{
    "info": {
        "nct_id": "NCT00599131",
        "official_title": "A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab",
        "inclusion_criteria": "* Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx.\n* Disease must be Stage III or IV.\n* Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy.\n* Patients must undergo pre-treatment endoscopic tumor staging and CT scanning.\n* ECOG Performance status 0-2\n* Pre-treatment laboratory criteria:\n* WBC > or = to 3500/ul, granulocyte > or = to 1500/ul.\n* Platelet count > or equal to 100,000/ul.\n* Calculated or measured creatinine clearance > or = to 60 cc/min.\n* Total Bilirubin < or = to 1.5 X ULN.\n* AST and ALT < or = to 2.5 X ULN.\n* Patients must give documented informed consent to participate in this study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.\n* Prior head and neck radiation or prior chemotherapy.\n* Documented evidence of distant metastases.\n* Active infection.\n* Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment.\n* Patients residing in prison.\n* Age < 18 years.\n* Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.\n* Patients with prior radiation to the head and neck.\n* Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy with a tyrosine-kinase inhibitor.\n* Patients with Grade > 2 peripheral neuropathy.\n* Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx.",
                "criterions": [
                    {
                        "exact_snippets": "pathologically confirmed",
                        "criterion": "pathological confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previously untreated",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "resectable",
                        "criterion": "resectability",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma of the larynx",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "specific type",
                            "expected_value": "squamous cell carcinoma of the larynx"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "pathologically confirmed",
                        "criterion": "pathological confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previously untreated",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "resectable",
                        "criterion": "resectability",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma of the larynx",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "specific type",
                            "expected_value": "squamous cell carcinoma of the larynx"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* WBC > or = to 3500/ul, granulocyte > or = to 1500/ul.",
                "criterions": [
                    {
                        "exact_snippets": "WBC > or = to 3500/ul",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "ul"
                            }
                        }
                    },
                    {
                        "exact_snippets": "granulocyte > or = to 1500/ul",
                        "criterion": "granulocyte",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "ul"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WBC > or = to 3500/ul",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "ul"
                            }
                        }
                    },
                    {
                        "exact_snippets": "granulocyte > or = to 1500/ul",
                        "criterion": "granulocyte",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "ul"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count > or equal to 100,000/ul.",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count > or equal to 100,000/ul.",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "ul"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count > or equal to 100,000/ul.",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "ul"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Calculated or measured creatinine clearance > or = to 60 cc/min.",
                "criterions": [
                    {
                        "exact_snippets": "creatinine clearance > or = to 60 cc/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "cc/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "creatinine clearance > or = to 60 cc/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "cc/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total Bilirubin < or = to 1.5 X ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Total Bilirubin < or = to 1.5 X ULN.",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total Bilirubin < or = to 1.5 X ULN.",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* AST and ALT < or = to 2.5 X ULN.",
                "criterions": [
                    {
                        "exact_snippets": "AST ... < or = to 2.5 X ULN",
                        "criterion": "AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT < or = to 2.5 X ULN",
                        "criterion": "ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "AST ... < or = to 2.5 X ULN",
                        "criterion": "AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT < or = to 2.5 X ULN",
                        "criterion": "ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must give documented informed consent to participate in this study.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must give documented informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must give documented informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "documentation",
                            "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 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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.",
                "criterions": [
                    {
                        "exact_snippets": "Prior head and neck malignancy",
                        "criterion": "head and neck malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of other prior non-head and neck malignancy within the past 3 years",
                        "criterion": "non-head and neck malignancy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of other prior non-head and neck malignancy within the past 3 years",
                        "criterion": "non-head and neck malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior head and neck malignancy",
                        "criterion": "head and neck malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of other prior non-head and neck malignancy within the past 3 years",
                                "criterion": "non-head and neck malignancy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of other prior non-head and neck malignancy within the past 3 years",
                                "criterion": "non-head and neck malignancy",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
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                                            {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior head and neck radiation or prior chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "Prior head and neck radiation",
                        "criterion": "head and neck radiation",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior head and neck radiation",
                        "criterion": "head and neck radiation",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented evidence of distant metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Documented evidence of distant metastases.",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Documented evidence of distant metastases.",
                    "criterion": "distant metastases",
                    "requirement": {
                        "requirement_type": "documentation",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active infection.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection.",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Active infection.",
                    "criterion": "infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must agree to use adequate contraception (hormonal or barrier method of birth control)",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior to study entry",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "prior to study entry"
                        }
                    },
                    {
                        "exact_snippets": "for the duration of study participation",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "for the duration of study participation"
                        }
                    },
                    {
                        "exact_snippets": "for 3 months after discontinuing therapy",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "for 3 months after discontinuing therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Pregnancy",
                                        "criterion": "pregnancy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "lactation",
                                        "criterion": "lactation",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients must agree to use adequate contraception (hormonal or barrier method of birth control)",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "prior to study entry",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "timing",
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                                        }
                                    },
                                    {
                                        "exact_snippets": "for the duration of study participation",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "for the duration of study participation"
                                        }
                                    },
                                    {
                                        "exact_snippets": "for 3 months after discontinuing therapy",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "for 3 months after discontinuing therapy"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients residing in prison.",
                "criterions": [
                    {
                        "exact_snippets": "Patients residing in prison",
                        "criterion": "residence",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "prison"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients residing in prison",
                    "criterion": "residence",
                    "requirement": {
                        "requirement_type": "location",
                        "expected_value": "prison"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Age < 18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age < 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age < 18 years",
                        "criterion": "age",
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                            "requirement_type": "N/A",
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                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.",
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                    {
                        "exact_snippets": "psychiatric/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "criterion": "psychiatric/social situations",
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                        "expected_value": "limit compliance with study requirements"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with prior radiation to the head and neck.",
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                    {
                        "exact_snippets": "prior radiation to the head and neck",
                        "criterion": "radiation to the head and neck",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                    "criterion": "radiation to the head and neck",
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                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy with a tyrosine-kinase inhibitor.",
                "criterions": [
                    {
                        "exact_snippets": "prior anti-epidermal growth-factor receptor antibody therapy",
                        "criterion": "prior anti-epidermal growth-factor receptor antibody therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "therapy with a tyrosine-kinase inhibitor",
                        "criterion": "therapy with a tyrosine-kinase inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "prior anti-epidermal growth-factor receptor antibody therapy",
                        "criterion": "prior anti-epidermal growth-factor receptor antibody therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "therapy with a tyrosine-kinase inhibitor",
                        "criterion": "therapy with a tyrosine-kinase inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with Grade > 2 peripheral neuropathy.",
                "criterions": [
                    {
                        "exact_snippets": "Grade > 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Grade > 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.",
                "criterions": [
                    {
                        "exact_snippets": "Any history of severe hypersensitivity reaction to docetaxel",
                        "criterion": "hypersensitivity reaction to docetaxel",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any history of severe hypersensitivity reaction to docetaxel",
                        "criterion": "hypersensitivity reaction to docetaxel",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Any history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                        "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                        "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any history of severe hypersensitivity reaction to docetaxel",
                                "criterion": "hypersensitivity reaction to docetaxel",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Any history of severe hypersensitivity reaction to docetaxel",
                                "criterion": "hypersensitivity reaction to docetaxel",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                                "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Any history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                                "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Disease must be Stage III or IV.",
                "criterions": [
                    {
                        "exact_snippets": "Disease must be Stage III or IV.",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage III",
                                "Stage IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Tumor must be potentially surgically resectable",
                        "criterion": "tumor resectability",
                        "requirement": {
                            "requirement_type": "potential resectability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Tumor must be ... curable with conventional surgery and radiation therapy",
                        "criterion": "tumor curability",
                        "requirement": {
                            "requirement_type": "curability",
                            "expected_value": [
                                "conventional surgery",
                                "radiation therapy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must undergo pre-treatment endoscopic tumor staging and CT scanning.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must undergo pre-treatment endoscopic tumor staging",
                        "criterion": "endoscopic tumor staging",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "pre-treatment"
                        }
                    },
                    {
                        "exact_snippets": "Patients must undergo ... CT scanning",
                        "criterion": "CT scanning",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "pre-treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
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                }
            }
        },
        {
            "identified_line": {
                "line": "* ECOG Performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG Performance status 0-2",
                        "criterion": "ECOG Performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pre-treatment laboratory criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Pre-treatment laboratory criteria",
                        "criterion": "pre-treatment laboratory criteria",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
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            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Any medical or psychiatric illness",
                        "criterion": "medical or psychiatric illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any medical or psychiatric illness",
                        "criterion": "medical or psychiatric illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment",
                        "criterion": "compromise ability to tolerate treatment",
                        "requirement": {
                            "requirement_type": "opinion",
                            "expected_value": "principal investigator"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}