{
    "info": {
        "nct_id": "NCT00477880",
        "official_title": "Treatment of Ménétrier's Disease With EGF Receptor Blockade",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed Ménétrier disease\n\n  * Symptomatic disease, including gastrointestinal symptoms which interfere with daily life\n\n    * Patient is considering surgery\n* Must have failed medical therapy that was given for 6 months\n* No Helicobacter pylori infection\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No NYHA class III-IV cardiovascular disease\n* No clinically unstable pulmonary disease\n* No chronic disease requiring ongoing therapy for stabilization, including any of the following:\n\n  * Uncontrolled diabetes mellitus\n  * Malignancy\n  * Thyroid disease\n  * Hypertension\n  * Active infections requiring systemic antibiotics, antivirals, or antifungals\n  * Uncontrolled seizure disorder\n  * Active neurological disease\n* No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "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",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
                "criterions": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically confirmed Ménétrier disease",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed Ménétrier disease",
                        "criterion": "Ménétrier disease",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed Ménétrier disease",
                        "criterion": "Ménétrier disease",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic disease, including gastrointestinal symptoms which interfere with daily life",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic disease",
                        "criterion": "symptomatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal symptoms which interfere with daily life",
                        "criterion": "gastrointestinal symptoms",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "interfere with daily life"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Symptomatic disease",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal symptoms which interfere with daily life",
                        "criterion": "gastrointestinal symptoms",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "interfere with daily life"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient is considering surgery",
                "criterions": [
                    {
                        "exact_snippets": "Patient is considering surgery",
                        "criterion": "surgery consideration",
                        "requirement": {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is considering surgery",
                        "criterion": "surgery consideration",
                        "requirement": {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have failed medical therapy that was given for 6 months",
                "criterions": [
                    {
                        "exact_snippets": "failed medical therapy",
                        "criterion": "medical therapy",
                        "requirement": {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    },
                    {
                        "exact_snippets": "given for 6 months",
                        "criterion": "medical therapy duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "failed medical therapy",
                        "criterion": "medical therapy",
                        "requirement": {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    },
                    {
                        "exact_snippets": "given for 6 months",
                        "criterion": "medical therapy duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative pregnancy test",
                "criterions": [
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fertile patients must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Fertile patients",
                        "criterion": "fertility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    },
                    {
                        "exact_snippets": "must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "fertile"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No NYHA class III-IV cardiovascular disease",
                "criterions": [
                    {
                        "exact_snippets": "No NYHA class III-IV cardiovascular disease",
                        "criterion": "NYHA class cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "NYHA class"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No NYHA class III-IV cardiovascular disease",
                    "criterion": "NYHA class cardiovascular disease",
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                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": "<",
                            "value": 3,
                            "unit": "NYHA class"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No clinically unstable pulmonary disease",
                "criterions": [
                    {
                        "exact_snippets": "clinically unstable pulmonary disease",
                        "criterion": "pulmonary disease",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "clinically stable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "clinically unstable pulmonary disease",
                    "criterion": "pulmonary disease",
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                        "requirement_type": "stability",
                        "expected_value": "clinically stable"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No chronic disease requiring ongoing therapy for stabilization, including any of the following:",
                "criterions": [
                    {
                        "exact_snippets": "chronic disease requiring ongoing therapy for stabilization",
                        "criterion": "chronic disease",
                        "requirement": {
                            "requirement_type": "ongoing therapy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": "chronic disease requiring ongoing therapy for stabilization",
                    "criterion": "chronic disease",
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                        "requirement_type": "ongoing therapy",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "Uncontrolled diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
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                "line": "* Malignancy",
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                    {
                        "exact_snippets": "Malignancy",
                        "criterion": "malignancy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Malignancy",
                        "criterion": "malignancy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Thyroid disease",
                "criterions": [
                    {
                        "exact_snippets": "Thyroid disease",
                        "criterion": "thyroid disease",
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                            "expected_value": true
                        }
                    }
                ]
            },
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                        "exact_snippets": "Thyroid disease",
                        "criterion": "thyroid disease",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "Hypertension",
                        "criterion": "hypertension",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Hypertension",
                        "criterion": "hypertension",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active infections requiring systemic antibiotics, antivirals, or antifungals",
                "criterions": [
                    {
                        "exact_snippets": "Active infections requiring systemic antibiotics",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic antibiotics",
                                "antivirals",
                                "antifungals"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Active infections requiring systemic antibiotics",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic antibiotics",
                                "antivirals",
                                "antifungals"
                            ]
                        }
                    }
                ]
            }
        },
        {
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                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled seizure disorder",
                        "criterion": "seizure disorder",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Uncontrolled seizure disorder",
                        "criterion": "seizure disorder",
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                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active neurological disease",
                "criterions": [
                    {
                        "exact_snippets": "Active neurological disease",
                        "criterion": "neurological disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active neurological disease",
                        "criterion": "neurological disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management",
                "criterions": [
                    {
                        "exact_snippets": "No unstable coagulation disorders",
                        "criterion": "unstable coagulation disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hemorrhagic diatheses",
                        "criterion": "hemorrhagic diatheses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active bleeding disorders",
                        "criterion": "active bleeding disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "require medical management",
                        "criterion": "requirement for medical management",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "No unstable coagulation disorders",
                                        "criterion": "unstable coagulation disorders",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "hemorrhagic diatheses",
                                        "criterion": "hemorrhagic diatheses",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "active bleeding disorders",
                                "criterion": "active bleeding disorders",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "require medical management",
                        "criterion": "requirement for medical management",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
                "criterions": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant or nursing",
                "criterions": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Not specified",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* No Helicobacter pylori infection",
                "criterions": [
                    {
                        "exact_snippets": "No Helicobacter pylori infection",
                        "criterion": "Helicobacter pylori infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No Helicobacter pylori infection",
                    "criterion": "Helicobacter pylori infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ]
}