{
    "info": {
        "nct_id": "NCT01079520",
        "official_title": "A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer",
        "inclusion_criteria": "* Histology-proven non-small cell lung cancer\n* N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG uptake in N1 node(s)\n* The patient is otherwise considered a candidate for a surgical treatment with the intention to cure\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Distant metastasis\n* Inoperable T4 disease\n* Confirmed supraclavicular lymph node metastasis\n* Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer\n* Contraindications for bronchoscopy\n* Uncorrected coagulopathy\n* Concurrent other malignancies\n* Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histology-proven non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Histology-proven non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histology-proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG uptake in N1 node(s)",
            "criterions": [
                {
                    "exact_snippets": "N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans",
                    "criterion": "N2 or N3 lymph node invasion",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enlarged (1cm or more in short axis diameter) mediastinal lymph node(s)",
                    "criterion": "mediastinal lymph node size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FDG uptake in the mediastinal lymph node(s)",
                    "criterion": "FDG uptake in mediastinal lymph node(s)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "FDG uptake in N1 node(s)",
                    "criterion": "FDG uptake in N1 node(s)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is otherwise considered a candidate for a surgical treatment with the intention to cure",
            "criterions": [
                {
                    "exact_snippets": "considered a candidate for a surgical treatment",
                    "criterion": "surgical treatment candidacy",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "cure"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* Distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "Distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inoperable T4 disease",
            "criterions": [
                {
                    "exact_snippets": "Inoperable T4 disease",
                    "criterion": "T4 disease",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed supraclavicular lymph node metastasis",
            "criterions": [
                {
                    "exact_snippets": "Confirmed supraclavicular lymph node metastasis",
                    "criterion": "supraclavicular lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer",
                    "criterion": "former therapy for lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "chemotherapy",
                                "radiotherapy",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications for bronchoscopy",
            "criterions": [
                {
                    "exact_snippets": "Contraindications for bronchoscopy",
                    "criterion": "bronchoscopy",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncorrected coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "Uncorrected coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "correction status",
                            "expected_value": "uncorrected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent other malignancies",
            "criterions": [
                {
                    "exact_snippets": "Concurrent other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)",
            "criterions": [
                {
                    "exact_snippets": "Suspicious mediastinal lymph node metastasis",
                    "criterion": "mediastinal lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not accessible by EBUS-TBNA or mediastinoscopy",
                    "criterion": "accessibility by EBUS-TBNA or mediastinoscopy",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "paraaortic, aortopulmonary window, or paraesophageal lymph nodes",
                    "criterion": "lymph node location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "paraaortic",
                                "aortopulmonary window",
                                "paraesophageal"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}