{
    "info": {
        "nct_id": "NCT01105182",
        "official_title": "A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors",
        "inclusion_criteria": "* adult (> 18 years) male or female patient\n* patient has biopsy-proven NSCLC or lung metastasis\n* patient has been rejected for surgery and has been considered unfit for radiation therapy\n* each 6 cm or smaller in greatest diameter of tumor, by CT scan\n* tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart\n* tumors are accessible by percutaneous route\n* patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5\n* patient has signed written informed consent prior to any study specific procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* patient is considered at high-risk for RF ablation due to major co-morbid medical conditions\n* patient has more than 3 tumors / lung\n* patient has at least one tumor > 6 cm in greatest diameter\n* tumor is associated with atelectasis or obstructive pneumonitis\n* patient has renal failure requiring hemodialysis or peritoneal dialysis\n* patient has active clinically serious infection\n* patient has history of organ allograft\n* patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results\n* patient is pregnant or breast-feeding\n* patient has ECOG performance status > 2\n* patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* adult (> 18 years) male or female patient",
            "criterions": [
                {
                    "exact_snippets": "adult (> 18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has biopsy-proven NSCLC or lung metastasis",
            "criterions": [
                {
                    "exact_snippets": "biopsy-proven NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy-proven ... lung metastasis",
                    "criterion": "lung metastasis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has been rejected for surgery and has been considered unfit for radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "patient has been rejected for surgery",
                    "criterion": "surgery eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "considered unfit for radiation therapy",
                    "criterion": "radiation therapy fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* each 6 cm or smaller in greatest diameter of tumor, by CT scan",
            "criterions": [
                {
                    "exact_snippets": "6 cm or smaller in greatest diameter of tumor, by CT scan",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart",
            "criterions": [
                {
                    "exact_snippets": "tumors are located at least 1 cm from trachea",
                    "criterion": "tumor location relative to trachea",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... main bronchi",
                    "criterion": "tumor location relative to main bronchi",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... esophagus",
                    "criterion": "tumor location relative to esophagus",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... aorta",
                    "criterion": "tumor location relative to aorta",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... aortic arch branches",
                    "criterion": "tumor location relative to aortic arch branches",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... pulmonary artery",
                    "criterion": "tumor location relative to pulmonary artery",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors are located at least 1 cm from ... heart",
                    "criterion": "tumor location relative to heart",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tumors are accessible by percutaneous route",
            "criterions": [
                {
                    "exact_snippets": "tumors are accessible by percutaneous route",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "percutaneous route"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5",
            "criterions": [
                {
                    "exact_snippets": "platelet count > 100 x 109 /L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "x 109 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "international normalized ratio ≤ 1.5",
                    "criterion": "international normalized ratio",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has signed written informed consent prior to any study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "patient has signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* patient is considered at high-risk for RF ablation due to major co-morbid medical conditions",
            "criterions": [
                {
                    "exact_snippets": "high-risk for RF ablation",
                    "criterion": "risk for RF ablation",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high-risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "major co-morbid medical conditions",
                    "criterion": "co-morbid medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "major"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has more than 3 tumors / lung",
            "criterions": [
                {
                    "exact_snippets": "more than 3 tumors",
                    "criterion": "number of tumors",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lung",
                    "criterion": "location of tumors",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "lung"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has at least one tumor > 6 cm in greatest diameter",
            "criterions": [
                {
                    "exact_snippets": "patient has at least one tumor > 6 cm in greatest diameter",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "tumor"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tumor is associated with atelectasis or obstructive pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "tumor is associated with atelectasis",
                    "criterion": "atelectasis",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor is associated with ... obstructive pneumonitis",
                    "criterion": "obstructive pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "tumor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has renal failure requiring hemodialysis or peritoneal dialysis",
            "criterions": [
                {
                    "exact_snippets": "renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring hemodialysis",
                    "criterion": "hemodialysis",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring ... peritoneal dialysis",
                    "criterion": "peritoneal dialysis",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has active clinically serious infection",
            "criterions": [
                {
                    "exact_snippets": "active clinically serious infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically serious"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has history of organ allograft",
            "criterions": [
                {
                    "exact_snippets": "history of organ allograft",
                    "criterion": "organ allograft",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results",
            "criterions": [
                {
                    "exact_snippets": "patient has history of substance abuse",
                    "criterion": "substance abuse history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results",
                    "criterion": "medical, psychological or social conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient is pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "patient is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has ECOG performance status > 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status > 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.",
            "criterions": [
                {
                    "exact_snippets": "platelet count ≤ 100 x 109 /L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "x 10^9 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "international normalized ratio > 1.5",
                    "criterion": "international normalized ratio",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}