{
    "info": {
        "nct_id": "NCT00231582",
        "official_title": "Sequential High-Dose Chemotherapy Combining Two Mobilization and Cyto-Reductive Treatments Followed by Three High-Dose Chemotherapy Regimens Supported by Autologous Stem Cell Transplantation",
        "inclusion_criteria": "Eligibility requirements includes the following criteria:\n\n* Age >18 years and < 65\n* Performance status < 3\n* Histologically or biologically documented GCTs\n* Testicular, abdominal, or mediastinal tumors\n* Measurable or evaluable disease\n* Life expectancy > 3 months\n* Normal cardiac, liver, and renal function tests\n* Absence of infection\n* HIV negative test\n* Signed informed consent\n* All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)\n* Relapses after complete answer obtained by surgery ( sCR )\n* Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn\n* Antecedents of congestive even compensated cardiac insufficiency\n* Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens\n* Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age >18 years and < 65",
            "criterions": [
                {
                    "exact_snippets": "Age >18 years and < 65",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status < 3",
            "criterions": [
                {
                    "exact_snippets": "Performance status < 3",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or biologically documented GCTs",
            "criterions": [
                {
                    "exact_snippets": "Histologically or biologically documented GCTs",
                    "criterion": "GCTs documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "biologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Testicular, abdominal, or mediastinal tumors",
            "criterions": [
                {
                    "exact_snippets": "Testicular",
                    "criterion": "testicular tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal",
                    "criterion": "abdominal tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mediastinal tumors",
                    "criterion": "mediastinal tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal cardiac, liver, and renal function tests",
            "criterions": [
                {
                    "exact_snippets": "Normal cardiac ... function tests",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... liver ... function tests",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... renal function tests",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of infection",
            "criterions": [
                {
                    "exact_snippets": "Absence of infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV negative test",
            "criterions": [
                {
                    "exact_snippets": "HIV negative test",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT",
            "criterions": [
                {
                    "exact_snippets": "previously treated with at least one line of a cisplatin-containing regimen",
                    "criterion": "previous treatment with cisplatin-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory after one or two line(s) of cisplatin-based CT",
                    "criterion": "refractory status after cisplatin-based CT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "line"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "lines"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed after two lines of a cisplatin-based CT",
                    "criterion": "relapsed status after cisplatin-based CT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)",
            "criterions": [
                {
                    "exact_snippets": "Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)",
                    "criterion": "fireproof diseases",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relapses after complete answer obtained by surgery ( sCR )",
            "criterions": [
                {
                    "exact_snippets": "Relapses after complete answer obtained by surgery ( sCR )",
                    "criterion": "relapse after surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn",
            "criterions": [
                {
                    "exact_snippets": "Neuropathy of superior rank or = II",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "rank"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "renal Function (Office) superior creatinine or = 125 mmol/l",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 125,
                                "unit": "mmol/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clearance of the creatinine subordinate or = II 60ml / mn",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/mn"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antecedents of congestive even compensated cardiac insufficiency",
            "criterions": [
                {
                    "exact_snippets": "Antecedents of congestive even compensated cardiac insufficiency",
                    "criterion": "congestive cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "antecedents",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Antecedents of ... compensated cardiac insufficiency",
                    "criterion": "compensated cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "antecedents",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens",
            "criterions": [
                {
                    "exact_snippets": "Hurts of growing teratoma that is measurable",
                    "criterion": "growing teratoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hurts increasing by size (cutting)",
                    "criterion": "hurts",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "increasing"
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of rise of marker pens",
                    "criterion": "marker pens",
                    "requirements": [
                        {
                            "requirement_type": "rise",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized",
            "criterions": [
                {
                    "exact_snippets": "Extensive chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "support of haematopoietic stem cells",
                    "criterion": "haematopoietic stem cells",
                    "requirements": [
                        {
                            "requirement_type": "support",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "estimation clarifies capacities of the haematopoietic marrow",
                    "criterion": "haematopoietic marrow capacity",
                    "requirements": [
                        {
                            "requirement_type": "estimation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "observation of the evolution of the NFP in the course of chemotherapy",
                    "criterion": "NFP evolution",
                    "requirements": [
                        {
                            "requirement_type": "observation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "quantification of cells CD 34 + in the peripheral blood",
                    "criterion": "CD 34+ cells in peripheral blood",
                    "requirements": [
                        {
                            "requirement_type": "quantification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Eligibility requirements includes the following criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}