{
    "info": {
        "nct_id": "NCT00217373",
        "official_title": "A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-Tricom (B7.1/ICAM/LFA3) and Vaccinia-CEA (6D)-Tricom, in Combination With GM-CSF and Interferon-Alfa-2B in Patients With CEA-Expressing Carcinomas",
        "inclusion_criteria": "* Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma\n\n  * Metastatic or locally advanced disease\n* Tumor accessible for biopsy\n* Must have received ≥ 1 prior systemic regimen for metastatic disease\n* No known brain metastases\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* More than 6 months\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Bilirubin ≤ 2.0 times upper limit of normal (ULN)\n* AST and ALT ≤ 4.0 times ULN\n* Hepatitis B negative\n* Hepatitis C negative\n* Creatinine ≤ 1.96 mg/dL\n* Creatinine clearance > 50 mL/min\n* No persistent proteinuria\n* Protein < 1,000 mg by 24-hour urine collection\n* No urinary sediment abnormalities\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No clinically significant cardiomyopathy requiring treatment\n* No impaired function (i.e., ejection fraction < 50%) for patients who have not had prior vaccine and are asymptomatic\n* HIV negative\n* No ongoing or active infection\n* No history of allergic reaction to eggs or egg products\n* No history of allergy or untoward reaction to prior vaccinia vaccination (e.g., smallpox immunization) or to any of its components\n* No history of or active eczema or other eczematoid skin disorders\n* No atopic dermatitis\n* No other acute, chronic, or exfoliative skin conditions, including any of the following:\n\n  * Burns\n  * Impetigo\n  * Varicella zoster\n  * Severe acne\n  * Other open wounds or rashes\n* No immunocompromised condition\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment\n\n  * No sexual contact for 3 weeks after each vaccination treatment\n* Must be willing to undergo tumor biopsy\n* No psychiatric illness or social situation that would preclude study compliance\n* No life-threatening illness\n* No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder or cervical lesions treated with surgical resection\n* No other uncontrolled illness\n* Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination:\n\n  * Pregnant or nursing women\n  * Children under 5 years of age\n  * Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV infection)\n  * Individuals with the following conditions:\n\n    * History of or active eczema or other eczematoid skin disorders\n    * Atopic dermatitis\n    * Other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)\n* No concurrent influenza vaccine\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n* No concurrent steroid therapy, except topical or inhaled steroids\n* No concurrent steroid eye drops\n* More than 4 weeks since prior radiotherapy and recovered\n* More than 4 weeks since prior surgery and recovered\n* No prior splenectomy\n* No other concurrent investigational agents\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma",
                    "criterion": "carcinoembryonic antigen (CEA)-expressing carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic or locally advanced disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced disease",
                    "criterion": "locally advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor accessible for biopsy",
            "criterions": [
                {
                    "exact_snippets": "Tumor accessible for biopsy",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "accessibility for biopsy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have received ≥ 1 prior systemic regimen for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Must have received ≥ 1 prior systemic regimen for metastatic disease",
                    "criterion": "prior systemic regimen for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "No known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status - ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - Karnofsky 60-100%",
            "criterions": [
                {
                    "exact_snippets": "Performance status - Karnofsky 60-100%",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Karnofsky"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 6 months",
            "criterions": [
                {
                    "exact_snippets": "More than 6 months",
                    "criterion": "time since a specific event",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 2.0 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 2.0 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT ≤ 4.0 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ... ≤ 4.0 times ULN",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ≤ 4.0 times ULN",
                    "criterion": "ALT level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis B negative",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B negative",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis C negative",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis C negative",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.96 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.96 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.96,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance > 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance > 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No persistent proteinuria",
            "criterions": [
                {
                    "exact_snippets": "No persistent proteinuria",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Protein < 1,000 mg by 24-hour urine collection",
            "criterions": [
                {
                    "exact_snippets": "Protein < 1,000 mg by 24-hour urine collection",
                    "criterion": "protein in urine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No urinary sediment abnormalities",
            "criterions": [
                {
                    "exact_snippets": "No urinary sediment abnormalities",
                    "criterion": "urinary sediment abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant cardiomyopathy requiring treatment",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiomyopathy requiring treatment",
                    "criterion": "cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No impaired function (i.e., ejection fraction < 50%) for patients who have not had prior vaccine and are asymptomatic",
            "criterions": [
                {
                    "exact_snippets": "impaired function (i.e., ejection fraction < 50%)",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have not had prior vaccine",
                    "criterion": "prior vaccine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic",
                    "criterion": "symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV negative",
            "criterions": [
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ongoing or active infection",
            "criterions": [
                {
                    "exact_snippets": "No ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergic reaction to eggs or egg products",
            "criterions": [
                {
                    "exact_snippets": "No history of allergic reaction to eggs or egg products",
                    "criterion": "allergic reaction to eggs or egg products",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergy or untoward reaction to prior vaccinia vaccination (e.g., smallpox immunization) or to any of its components",
            "criterions": [
                {
                    "exact_snippets": "No history of allergy or untoward reaction to prior vaccinia vaccination",
                    "criterion": "allergy or untoward reaction to vaccinia vaccination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergy or untoward reaction ... to any of its components",
                    "criterion": "allergy or untoward reaction to components of vaccinia vaccination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of or active eczema or other eczematoid skin disorders",
            "criterions": [
                {
                    "exact_snippets": "No history of or active eczema",
                    "criterion": "eczema",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "active",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of or active ... other eczematoid skin disorders",
                    "criterion": "eczematoid skin disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "active",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No atopic dermatitis",
            "criterions": [
                {
                    "exact_snippets": "No atopic dermatitis",
                    "criterion": "atopic dermatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other acute, chronic, or exfoliative skin conditions, including any of the following:",
            "criterions": [
                {
                    "exact_snippets": "No other acute, chronic, or exfoliative skin conditions",
                    "criterion": "skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acute",
                    "criterion": "acute skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic",
                    "criterion": "chronic skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exfoliative",
                    "criterion": "exfoliative skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Burns",
            "criterions": [
                {
                    "exact_snippets": "Burns",
                    "criterion": "burns",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impetigo",
            "criterions": [
                {
                    "exact_snippets": "Impetigo",
                    "criterion": "impetigo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Varicella zoster",
            "criterions": [
                {
                    "exact_snippets": "Varicella zoster",
                    "criterion": "Varicella zoster",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe acne",
            "criterions": [
                {
                    "exact_snippets": "Severe acne",
                    "criterion": "acne",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other open wounds or rashes",
            "criterions": [
                {
                    "exact_snippets": "open wounds",
                    "criterion": "open wounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rashes",
                    "criterion": "rashes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No immunocompromised condition",
            "criterions": [
                {
                    "exact_snippets": "No immunocompromised condition",
                    "criterion": "immunocompromised condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for ≥ 3 months after completion of study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No sexual contact for 3 weeks after each vaccination treatment",
            "criterions": [
                {
                    "exact_snippets": "No sexual contact for 3 weeks after each vaccination treatment",
                    "criterion": "sexual contact",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be willing to undergo tumor biopsy",
            "criterions": [
                {
                    "exact_snippets": "Must be willing to undergo tumor biopsy",
                    "criterion": "tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric illness or social situation that would preclude study compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social situation that would preclude study compliance",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No life-threatening illness",
            "criterions": [
                {
                    "exact_snippets": "No life-threatening illness",
                    "criterion": "life-threatening illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder or cervical lesions treated with surgical resection",
            "criterions": [
                {
                    "exact_snippets": "No other active malignancy within the past 2 years",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... superficial bladder or cervical lesions treated with surgical resection",
                    "criterion": "superficial bladder or cervical lesions",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "surgical resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other uncontrolled illness",
            "criterions": [
                {
                    "exact_snippets": "No other uncontrolled illness",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination:",
            "criterions": [
                {
                    "exact_snippets": "Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination",
                    "criterion": "ability to avoid close household contact",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Children under 5 years of age",
            "criterions": [
                {
                    "exact_snippets": "Children under 5 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV infection)",
            "criterions": [
                {
                    "exact_snippets": "immunodeficient",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunosuppressed by disease or therapy",
                    "criterion": "immunosuppression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with the following conditions:",
            "criterions": [
                {
                    "exact_snippets": "Individuals with the following conditions",
                    "criterion": "conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of or active eczema or other eczematoid skin disorders",
            "criterions": [
                {
                    "exact_snippets": "History of or active eczema",
                    "criterion": "eczema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other eczematoid skin disorders",
                    "criterion": "eczematoid skin disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Atopic dermatitis",
            "criterions": [
                {
                    "exact_snippets": "Atopic dermatitis",
                    "criterion": "atopic dermatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)",
            "criterions": [
                {
                    "exact_snippets": "acute, chronic, or exfoliative skin conditions",
                    "criterion": "skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "burns",
                    "criterion": "burns",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "impetigo",
                    "criterion": "impetigo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "varicella zoster",
                    "criterion": "varicella zoster",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe acne",
                    "criterion": "severe acne",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "open rashes or wounds",
                    "criterion": "open rashes or wounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent influenza vaccine",
            "criterions": [
                {
                    "exact_snippets": "No concurrent influenza vaccine",
                    "criterion": "influenza vaccine",
                    "requirements": [
                        {
                            "requirement_type": "concurrent administration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior chemotherapy",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks for nitrosoureas or mitomycin",
                    "criterion": "time since prior nitrosoureas or mitomycin",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent steroid therapy, except topical or inhaled steroids",
            "criterions": [
                {
                    "exact_snippets": "No concurrent steroid therapy",
                    "criterion": "steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except topical or inhaled steroids",
                    "criterion": "steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "topical",
                                "inhaled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent steroid eye drops",
            "criterions": [
                {
                    "exact_snippets": "No concurrent steroid eye drops",
                    "criterion": "steroid eye drops",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior surgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior surgery",
                    "criterion": "time since prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior splenectomy",
            "criterions": [
                {
                    "exact_snippets": "No prior splenectomy",
                    "criterion": "splenectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational agents",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational agents",
                    "criterion": "concurrent investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}