{
    "info": {
        "nct_id": "NCT01841060",
        "official_title": "Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria :\n\n1. Patients over 18 years\n2. Histological diagnosis of non-small cell lung tumor established.\n3. Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT\n4. Surgical treatment of the lesion contrindiqué or refused by the patient,\n5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)\n6. Expectancy greater than 6 months life\n7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated,\n8. Signed informed consent,\n9. Patient affiliated to a social security scheme.\n\nExclusion criteria :\n\n1. Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)\n2. Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control).\n3. Abnormal blood count platelets <90000/mm3\n4. Cons-indication to general anesthesia\n5. Patient with a cardiac pacemaker if a review indicates treatment against ARF\n6. pregnancy\n7. Patient included in another clinical study\n8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,\n9. Private patient freedom and major subject of a measure of legal protection or unable to consent."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Patients over 18 years",
            "criterions": [
                {
                    "exact_snippets": "Patients over 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histological diagnosis of non-small cell lung tumor established.",
            "criterions": [
                {
                    "exact_snippets": "Histological diagnosis of non-small cell lung tumor",
                    "criterion": "non-small cell lung tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT",
            "criterions": [
                {
                    "exact_snippets": "Stage 1A tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "1A"
                        }
                    ]
                },
                {
                    "exact_snippets": "lesions <= 3 cm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "report prepared by PET and CT",
                    "criterion": "imaging report",
                    "requirements": [
                        {
                            "requirement_type": "imaging modalities",
                            "expected_value": [
                                "PET",
                                "CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Surgical treatment of the lesion contrindiqué or refused by the patient,",
            "criterions": [
                {
                    "exact_snippets": "Surgical treatment of the lesion contrindiqué",
                    "criterion": "surgical treatment of the lesion",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgical treatment of the lesion ... refused by the patient",
                    "criterion": "surgical treatment of the lesion",
                    "requirements": [
                        {
                            "requirement_type": "refusal",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)",
            "criterions": [
                {
                    "exact_snippets": "ARF considered technically feasible",
                    "criterion": "ARF technical feasibility",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discussing the case in a multidisciplinary meeting (RCP)",
                    "criterion": "multidisciplinary meeting discussion",
                    "requirements": [
                        {
                            "requirement_type": "discussion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Expectancy greater than 6 months life",
            "criterions": [
                {
                    "exact_snippets": "Expectancy greater than 6 months life",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated,",
            "criterions": [
                {
                    "exact_snippets": "PET before inclusion (8 weeks maximum before radiofrequency)",
                    "criterion": "PET scan timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "showing uptake (SUV> = 2.5) at the lesion to be treated",
                    "criterion": "lesion uptake",
                    "requirements": [
                        {
                            "requirement_type": "SUV",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "SUV"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Signed informed consent,",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient affiliated to a social security scheme.",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a social security scheme.",
                    "criterion": "social security scheme affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)",
            "criterions": [
                {
                    "exact_snippets": "Location of the lesion does not allow achieving ablathermy under satisfactory conditions",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "suitability for ablathermy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion contiguous to the major anatomical structures of the mediastinum",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "proximity to major anatomical structures of the mediastinum",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hilar location (less than 1 cm from the hilum)",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "proximity to hilum",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control).",
            "criterions": [
                {
                    "exact_snippets": "Disorder of uncontrolled bleeding",
                    "criterion": "uncontrolled bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "TP <50%",
                    "criterion": "TP (Thromboplastin)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TCA> 1.5 x control",
                    "criterion": "TCA (Thrombin Clotting Activity)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x control"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Abnormal blood count platelets <90000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Abnormal blood count platelets <90000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 90000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Cons-indication to general anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Cons-indication to general anesthesia",
                    "criterion": "general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient with a cardiac pacemaker if a review indicates treatment against ARF",
            "criterions": [
                {
                    "exact_snippets": "Patient with a cardiac pacemaker",
                    "criterion": "cardiac pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment against ARF",
                    "criterion": "treatment against ARF",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. pregnancy",
            "criterions": [
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient included in another clinical study",
            "criterions": [
                {
                    "exact_snippets": "Patient included in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,",
            "criterions": [
                {
                    "exact_snippets": "Unable to undergo medical monitoring test for geographical, social or psychological reasons",
                    "criterion": "ability to undergo medical monitoring test",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Private patient freedom and major subject of a measure of legal protection or unable to consent.",
            "criterions": [
                {
                    "exact_snippets": "Private patient freedom",
                    "criterion": "private patient freedom",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "major subject of a measure of legal protection",
                    "criterion": "measure of legal protection",
                    "requirements": [
                        {
                            "requirement_type": "subject status",
                            "expected_value": "major"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to consent",
                    "criterion": "ability to consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria :",
            "criterions": []
        },
        {
            "line": "Exclusion criteria :",
            "criterions": []
        }
    ]
}