{
    "info": {
        "nct_id": "NCT00720031",
        "official_title": "Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones",
        "inclusion_criteria": "* HLA-A2 melanoma patients with :\n\n  * either loco-regional or lymph node metastasis\n  * transit nodules not surgically resectable\n  * measurable cutaneous or visceral metastasis\n* Patients' tumor express Melan-A/MART-1 antigen.\n* No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.\n* No other melanoma treatment during the protocol.\n* Life expectancy should be greater than 6 months.\n* General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.\n* Patient should be negative for HIV and B and C hepatitis.\n* Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.\n* Signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.\n* Infectious pathologies evoluting and requiring antibiotherapy.\n* Patients HIV+.\n* Transplanted patients or patients suffering from severe auto-immune disease.\n* Psychiatric troubles that do not allow the protocol follow-up.\n* Pregnant or breast-feeding women.\n* No contraception.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* HLA-A2 melanoma patients with :",
                "criterions": [
                    {
                        "exact_snippets": [
                            "HLA-A2 melanoma patients"
                        ],
                        "criterion": "HLA-A2",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "HLA-A2 melanoma patients"
                        ],
                        "criterion": "melanoma",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "HLA-A2 melanoma patients"
                        ],
                        "criterion": "HLA-A2",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "HLA-A2 melanoma patients"
                        ],
                        "criterion": "melanoma",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* either loco-regional or lymph node metastasis",
                "criterions": [
                    {
                        "exact_snippets": [
                            "loco-regional"
                        ],
                        "criterion": "loco-regional metastasis",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lymph node metastasis"
                        ],
                        "criterion": "lymph node metastasis",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "loco-regional"
                        ],
                        "criterion": "loco-regional metastasis",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lymph node metastasis"
                        ],
                        "criterion": "lymph node metastasis",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* transit nodules not surgically resectable",
                "criterions": [
                    {
                        "exact_snippets": [
                            "transit nodules not surgically resectable"
                        ],
                        "criterion": "transit nodules",
                        "requirement_type": "surgical resectability",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "transit nodules not surgically resectable"
                        ],
                        "criterion": "transit nodules",
                        "requirement_type": "surgical resectability",
                        "expected_value": false
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* measurable cutaneous or visceral metastasis",
                "criterions": [
                    {
                        "exact_snippets": [
                            "measurable cutaneous or visceral metastasis"
                        ],
                        "criterion": "cutaneous metastasis",
                        "requirement_type": "measurability",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "measurable cutaneous or visceral metastasis"
                        ],
                        "criterion": "visceral metastasis",
                        "requirement_type": "measurability",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "measurable cutaneous or visceral metastasis"
                        ],
                        "criterion": "cutaneous metastasis",
                        "requirement_type": "measurability",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "measurable cutaneous or visceral metastasis"
                        ],
                        "criterion": "visceral metastasis",
                        "requirement_type": "measurability",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients' tumor express Melan-A/MART-1 antigen.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "tumor express Melan-A/MART-1 antigen"
                        ],
                        "criterion": "tumor",
                        "requirement_type": "expression",
                        "expected_value": "Melan-A/MART-1 antigen"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "tumor express Melan-A/MART-1 antigen"
                        ],
                        "criterion": "tumor",
                        "requirement_type": "expression",
                        "expected_value": "Melan-A/MART-1 antigen"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No other melanoma treatment during the protocol.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "No other melanoma treatment"
                        ],
                        "criterion": "melanoma treatment",
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "No other melanoma treatment"
                        ],
                        "criterion": "melanoma treatment",
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy should be greater than 6 months.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Life expectancy should be greater than 6 months"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 6
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Life expectancy should be greater than 6 months"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 6
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Karnowsky greater than 80"
                        ],
                        "criterion": "Karnofsky performance status",
                        "requirement_type": "score",
                        "expected_value": {
                            "operator": ">",
                            "value": 80
                        }
                    },
                    {
                        "exact_snippets": [
                            "ECOG = 0, 1 or 2"
                        ],
                        "criterion": "ECOG performance status",
                        "requirement_type": "score",
                        "expected_value": [
                            "0",
                            "1",
                            "2"
                        ]
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Karnowsky greater than 80"
                        ],
                        "criterion": "Karnofsky performance status",
                        "requirement_type": "score",
                        "expected_value": {
                            "operator": ">",
                            "value": 80
                        }
                    },
                    {
                        "exact_snippets": [
                            "ECOG = 0, 1 or 2"
                        ],
                        "criterion": "ECOG performance status",
                        "requirement_type": "score",
                        "expected_value": [
                            "0",
                            "1",
                            "2"
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "leucocytes ³ 2000 elements per mm3"
                        ],
                        "criterion": "leucocytes",
                        "requirement_type": "count",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 2000
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "hemoglobin ³ 10.5g/dl"
                        ],
                        "criterion": "hemoglobin",
                        "requirement_type": "level",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 10.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "platelets ³ 100 000 per mm3"
                        ],
                        "criterion": "platelets",
                        "requirement_type": "count",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 100000
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal"
                        ],
                        "criterion": "phosphatases alcalines transaminases",
                        "requirement_type": "level",
                        "expected_value": "£ 1 time 1/2 compared to the normal"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "leucocytes ³ 2000 elements per mm3"
                        ],
                        "criterion": "leucocytes",
                        "requirement_type": "count",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 2000
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "hemoglobin ³ 10.5g/dl"
                        ],
                        "criterion": "hemoglobin",
                        "requirement_type": "level",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 10.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "platelets ³ 100 000 per mm3"
                        ],
                        "criterion": "platelets",
                        "requirement_type": "count",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 100000
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal"
                        ],
                        "criterion": "phosphatases alcalines transaminases",
                        "requirement_type": "level",
                        "expected_value": "£ 1 time 1/2 compared to the normal"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Signed informed consent",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Signed informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Signed informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 18
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 18
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "No chemotherapy treatment",
                            "in the last 4 weeks before infusion"
                        ],
                        "criterion": "chemotherapy treatment",
                        "requirement_type": "absence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "No radiotherapy",
                            "in the last 4 weeks before infusion"
                        ],
                        "criterion": "radiotherapy",
                        "requirement_type": "absence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "No immunotherapy",
                            "in the last 4 weeks before infusion"
                        ],
                        "criterion": "immunotherapy",
                        "requirement_type": "absence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": [
                                        "No chemotherapy treatment",
                                        "in the last 4 weeks before infusion"
                                    ],
                                    "criterion": "chemotherapy treatment",
                                    "requirement_type": "absence",
                                    "expected_value": true
                                },
                                {
                                    "exact_snippets": [
                                        "No radiotherapy",
                                        "in the last 4 weeks before infusion"
                                    ],
                                    "criterion": "radiotherapy",
                                    "requirement_type": "absence",
                                    "expected_value": true
                                },
                                {
                                    "exact_snippets": [
                                        "No immunotherapy",
                                        "in the last 4 weeks before infusion"
                                    ],
                                    "criterion": "immunotherapy",
                                    "requirement_type": "absence",
                                    "expected_value": true
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient should be negative for HIV and B and C hepatitis.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "negative for HIV"
                        ],
                        "criterion": "HIV",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    },
                    {
                        "exact_snippets": [
                            "negative for",
                            "B hepatitis"
                        ],
                        "criterion": "B hepatitis",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    },
                    {
                        "exact_snippets": [
                            "negative for",
                            "C hepatitis"
                        ],
                        "criterion": "C hepatitis",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "negative for HIV"
                        ],
                        "criterion": "HIV",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    },
                    {
                        "exact_snippets": [
                            "negative for",
                            "B hepatitis"
                        ],
                        "criterion": "B hepatitis",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    },
                    {
                        "exact_snippets": [
                            "negative for",
                            "C hepatitis"
                        ],
                        "criterion": "C hepatitis",
                        "requirement_type": "status",
                        "expected_value": "negative"
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Cardio-vascular pathologies"
                        ],
                        "criterion": "cardio-vascular pathologies",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "evoluting and uncontrolled"
                        ],
                        "criterion": "cardio-vascular pathologies",
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    },
                    {
                        "exact_snippets": [
                            "severe HTA"
                        ],
                        "criterion": "hypertension",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    },
                    {
                        "exact_snippets": [
                            "cardiac deficiency"
                        ],
                        "criterion": "cardiac deficiency",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "severe angor"
                        ],
                        "criterion": "angor",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    },
                    {
                        "exact_snippets": [
                            "severe arrhythmia"
                        ],
                        "criterion": "arrhythmia",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Cardio-vascular pathologies"
                                ],
                                "criterion": "cardio-vascular pathologies",
                                "requirement_type": "presence",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "evoluting and uncontrolled"
                                ],
                                "criterion": "cardio-vascular pathologies",
                                "requirement_type": "control status",
                                "expected_value": "uncontrolled"
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "severe HTA"
                        ],
                        "criterion": "hypertension",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    },
                    {
                        "exact_snippets": [
                            "cardiac deficiency"
                        ],
                        "criterion": "cardiac deficiency",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "severe angor"
                        ],
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                        "requirement_type": "severity",
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                    },
                    {
                        "exact_snippets": [
                            "severe arrhythmia"
                        ],
                        "criterion": "arrhythmia",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Infectious pathologies evoluting and requiring antibiotherapy.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Infectious pathologies"
                        ],
                        "criterion": "infectious pathologies",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "requiring antibiotherapy"
                        ],
                        "criterion": "antibiotherapy",
                        "requirement_type": "requirement",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Infectious pathologies"
                                ],
                                "criterion": "infectious pathologies",
                                "requirement_type": "presence",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "requiring antibiotherapy"
                                ],
                                "criterion": "antibiotherapy",
                                "requirement_type": "requirement",
                                "expected_value": true
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients HIV+.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Patients HIV+"
                        ],
                        "criterion": "HIV",
                        "requirement_type": "status",
                        "expected_value": "positive"
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Patients HIV+"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Transplanted patients or patients suffering from severe auto-immune disease.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Transplanted patients"
                        ],
                        "criterion": "transplant",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "patients suffering from severe auto-immune disease"
                        ],
                        "criterion": "auto-immune disease",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "Transplanted patients"
                        ],
                        "criterion": "transplant",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "patients suffering from severe auto-immune disease"
                        ],
                        "criterion": "auto-immune disease",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Psychiatric troubles that do not allow the protocol follow-up.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Psychiatric troubles"
                        ],
                        "criterion": "psychiatric troubles",
                        "requirement_type": "severity",
                        "expected_value": "do not allow the protocol follow-up"
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Psychiatric troubles"
                    ],
                    "criterion": "psychiatric troubles",
                    "requirement_type": "severity",
                    "expected_value": "do not allow the protocol follow-up"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breast-feeding women.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "breast-feeding"
                        ],
                        "criterion": "breastfeeding",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "breast-feeding"
                        ],
                        "criterion": "breastfeeding",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No contraception.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "No contraception"
                        ],
                        "criterion": "contraception",
                        "requirement_type": "usage",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "No contraception"
                        ],
                        "criterion": "contraception",
                        "requirement_type": "usage",
                        "expected_value": false
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}