{
    "info": {
        "nct_id": "NCT00091676",
        "official_title": "Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.\n* Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm\n* No prior chemotherapy other than local radiation (not greater than 2 sites)\n* ECOG < 2\n* Survival > 1 yr\n* Serum creatinine < 1.5 mg/dl\n* Bilirubin <1.5 mg/dl\n* SGOT/SGPT < 3.5 ULN\n* No HIV antibodies or HBV antigen\n* Negative pregnancy screen (females)\n* No unrelated neoplasm in the previous 10 years\n* No evidence of primary or secondary CNS lymphoma",
        "miscellaneous_criteria": "Inclusion/"
    },
    "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",
                        "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": "* Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm",
                "criterions": [
                    {
                        "exact_snippets": "Stage III-IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "lymph node > 2cm",
                        "criterion": "lymph node size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "lymph node > 5 cm",
                        "criterion": "lymph node size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Stage III-IV",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "III",
                                        "IV"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "lymph node > 2cm",
                                "criterion": "lymph node size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Stage II",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "II"
                                }
                            },
                            {
                                "exact_snippets": "lymph node > 5 cm",
                                "criterion": "lymph node size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior chemotherapy other than local radiation (not greater than 2 sites)",
                "criterions": [
                    {
                        "exact_snippets": "No prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "local radiation (not greater than 2 sites)",
                        "criterion": "local radiation",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "sites"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "local radiation (not greater than 2 sites)",
                    "criterion": "local radiation",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": "<=",
                            "value": 2,
                            "unit": "sites"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* ECOG < 2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG < 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "ECOG < 2",
                    "criterion": "ECOG performance status",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": "<",
                            "value": 2,
                            "unit": "N/A"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Survival > 1 yr",
                "criterions": [
                    {
                        "exact_snippets": "Survival > 1 yr",
                        "criterion": "survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "yr"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Survival > 1 yr",
                        "criterion": "survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "yr"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum creatinine < 1.5 mg/dl",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine < 1.5 mg/dl",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Serum creatinine < 1.5 mg/dl",
                    "criterion": "serum creatinine",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 1.5,
                            "unit": "mg/dl"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin <1.5 mg/dl",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin <1.5 mg/dl",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Bilirubin <1.5 mg/dl",
                    "criterion": "bilirubin level",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 1.5,
                            "unit": "mg/dl"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* SGOT/SGPT < 3.5 ULN",
                "criterions": [
                    {
                        "exact_snippets": "SGOT/SGPT < 3.5 ULN",
                        "criterion": "SGOT/SGPT levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "SGOT/SGPT < 3.5 ULN",
                    "criterion": "SGOT/SGPT levels",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 3.5,
                            "unit": "ULN"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No HIV antibodies or HBV antigen",
                "criterions": [
                    {
                        "exact_snippets": "No HIV antibodies",
                        "criterion": "HIV antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... HBV antigen",
                        "criterion": "HBV antigen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No HIV antibodies",
                        "criterion": "HIV antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... HBV antigen",
                        "criterion": "HBV antigen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative pregnancy screen (females)",
                "criterions": [
                    {
                        "exact_snippets": "Negative pregnancy screen (females)",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "screen result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Negative pregnancy screen (females)",
                    "criterion": "pregnancy",
                    "requirement": {
                        "requirement_type": "screen result",
                        "expected_value": "negative"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No unrelated neoplasm in the previous 10 years",
                "criterions": [
                    {
                        "exact_snippets": "No unrelated neoplasm in the previous 10 years",
                        "criterion": "unrelated neoplasm",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No unrelated neoplasm in the previous 10 years",
                        "criterion": "unrelated neoplasm",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No unrelated neoplasm in the previous 10 years",
                        "criterion": "unrelated neoplasm",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No unrelated neoplasm in the previous 10 years",
                        "criterion": "unrelated neoplasm",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No evidence of primary or secondary CNS lymphoma",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of primary ... CNS lymphoma",
                        "criterion": "primary CNS lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No evidence of ... secondary CNS lymphoma",
                        "criterion": "secondary CNS lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of primary ... CNS lymphoma",
                        "criterion": "primary CNS lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No evidence of ... secondary CNS lymphoma",
                        "criterion": "secondary CNS lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Inclusion/",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of indolent follicular lymphoma",
                        "criterion": "indolent follicular lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes",
                        "criterion": "follicular lymphoma subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "follicular small-cleaved cell",
                                "follicular mixed",
                                "follicular large cell with centrocytes"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "surface IgM or IgG phenotype",
                        "criterion": "surface immunoglobulin phenotype",
                        "requirement": {
                            "requirement_type": "phenotype",
                            "expected_value": [
                                "IgM",
                                "IgG"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Diagnosis of indolent follicular lymphoma",
                                "criterion": "indolent follicular lymphoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes",
                                "criterion": "follicular lymphoma subtype",
                                "requirement": {
                                    "requirement_type": "subtype",
                                    "expected_value": [
                                        "follicular small-cleaved cell",
                                        "follicular mixed",
                                        "follicular large cell with centrocytes"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "surface IgM or IgG phenotype",
                                "criterion": "surface immunoglobulin phenotype",
                                "requirement": {
                                    "requirement_type": "phenotype",
                                    "expected_value": "IgM"
                                }
                            },
                            {
                                "exact_snippets": "surface IgM or IgG phenotype",
                                "criterion": "surface immunoglobulin phenotype",
                                "requirement": {
                                    "requirement_type": "phenotype",
                                    "expected_value": "IgG"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}