{
    "info": {
        "nct_id": "NCT03392220",
        "official_title": "A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Selective Neck Dissection for Clinically Negative Neck of Supraglottic Laryngeal Carcinoma",
        "inclusion_criteria": "1. The patients obtain informed consent prior to any trial.\n2. Diagnosis: Histopathology was confirmed to be squamous cell carcinoma. Classified by laryngoscopy as supraglottic, no tongue and deep pharyngeal invasion, and subglottic invasion. Also, no distant signs of metastasis.\n3. Primary lesion is limited to one side, violation or more than midline, but preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions.\n4. Evaluation of cN0: Patients need to undergo neck palpation, ultrasound and enhanced CT, if the patient is allergic to CT enhancer, replace it with MRI.Not touch more than 2cm hard lymph nodes in the neck, moreover, ultrasound and enhanced CT are not found lymph node that diameter ≥ 1cm.Or, the size does not meet the above criteria, but find rim enhancement, central irregular or hypodensity, and with the surrounding tissue boundary is obscure, and other suspicious transfer signs.\n5. After multidisciplinary discussion, the preferred treatment for patients is surgical treatment.\n6. Patients with no other previous head and neck cancer, and neck did not receive radiation therapy, no deep neck surgery, skin resection excepted.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components.\n2. Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious.\n3. No surgical indications, or initial treatment evaluation recommends non-surgical treatment.\n4. The patient had other head and neck cancer.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. The patients obtain informed consent prior to any trial.",
                "criterions": [
                    {
                        "exact_snippets": "patients obtain informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "patients obtain informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Diagnosis: Histopathology was confirmed to be squamous cell carcinoma. Classified by laryngoscopy as supraglottic, no tongue and deep pharyngeal invasion, and subglottic invasion. Also, no distant signs of metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "Histopathology was confirmed to be squamous cell carcinoma",
                        "criterion": "histopathology",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "squamous cell carcinoma"
                        }
                    },
                    {
                        "exact_snippets": "Classified by laryngoscopy as supraglottic",
                        "criterion": "laryngoscopy classification",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "supraglottic"
                        }
                    },
                    {
                        "exact_snippets": "no tongue and deep pharyngeal invasion",
                        "criterion": "tongue and deep pharyngeal invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "subglottic invasion",
                        "criterion": "subglottic invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no distant signs of metastasis",
                        "criterion": "distant metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histopathology was confirmed to be squamous cell carcinoma",
                                "criterion": "histopathology",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "squamous cell carcinoma"
                                }
                            },
                            {
                                "exact_snippets": "Classified by laryngoscopy as supraglottic",
                                "criterion": "laryngoscopy classification",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "supraglottic"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "no tongue and deep pharyngeal invasion",
                                    "criterion": "tongue and deep pharyngeal invasion",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            },
                            {
                                "exact_snippets": "subglottic invasion",
                                "criterion": "subglottic invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "no distant signs of metastasis",
                                    "criterion": "distant metastasis",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Primary lesion is limited to one side, violation or more than midline, but preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions.",
                "criterions": [
                    {
                        "exact_snippets": "Primary lesion is limited to one side",
                        "criterion": "primary lesion location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "one side"
                        }
                    },
                    {
                        "exact_snippets": "violation or more than midline",
                        "criterion": "primary lesion location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "more than midline"
                        }
                    },
                    {
                        "exact_snippets": "preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions",
                        "criterion": "bilateral lesion severity",
                        "requirement": {
                            "requirement_type": "distinguishability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Primary lesion is limited to one side",
                                "criterion": "primary lesion location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "one side"
                                }
                            },
                            {
                                "exact_snippets": "violation or more than midline",
                                "criterion": "primary lesion location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "more than midline"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions",
                        "criterion": "bilateral lesion severity",
                        "requirement": {
                            "requirement_type": "distinguishability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. After multidisciplinary discussion, the preferred treatment for patients is surgical treatment.",
                "criterions": [
                    {
                        "exact_snippets": "multidisciplinary discussion",
                        "criterion": "multidisciplinary discussion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "preferred treatment ... surgical treatment",
                        "criterion": "preferred treatment",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "surgical treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "multidisciplinary discussion",
                        "criterion": "multidisciplinary discussion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "preferred treatment ... surgical treatment",
                        "criterion": "preferred treatment",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "surgical treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients with no other previous head and neck cancer, and neck did not receive radiation therapy, no deep neck surgery, skin resection excepted.",
                "criterions": [
                    {
                        "exact_snippets": "no other previous head and neck cancer",
                        "criterion": "previous head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "neck did not receive radiation therapy",
                        "criterion": "neck radiation therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no deep neck surgery",
                        "criterion": "deep neck surgery",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "skin resection excepted",
                        "criterion": "skin resection",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "no other previous head and neck cancer",
                                        "criterion": "previous head and neck cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "neck did not receive radiation therapy",
                                        "criterion": "neck radiation therapy",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "no deep neck surgery",
                                "criterion": "deep neck surgery",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "skin resection excepted",
                        "criterion": "skin resection",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components.",
                "criterions": [
                    {
                        "exact_snippets": "Laryngeal carcinoma",
                        "criterion": "laryngeal carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not squamous cell carcinoma",
                        "criterion": "squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "primary pathology includes non-squamous cell components",
                        "criterion": "non-squamous cell components",
                        "requirement": {
                            "requirement_type": "inclusion in primary pathology",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Laryngeal carcinoma",
                                "criterion": "laryngeal carcinoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "not squamous cell carcinoma",
                                "criterion": "squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "primary pathology includes non-squamous cell components",
                        "criterion": "non-squamous cell components",
                        "requirement": {
                            "requirement_type": "inclusion in primary pathology",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious.",
                "criterions": [
                    {
                        "exact_snippets": "Preoperative laryngoscopy assessment of primary lesions",
                        "criterion": "preoperative laryngoscopy assessment",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "middle or both sides of symmetry"
                        }
                    },
                    {
                        "exact_snippets": "Preoperative laryngoscopy assessment of primary lesions",
                        "criterion": "preoperative laryngoscopy assessment",
                        "requirement": {
                            "requirement_type": "severity distinction",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Preoperative laryngoscopy assessment of primary lesions",
                        "criterion": "preoperative laryngoscopy assessment",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "middle or both sides of symmetry"
                        }
                    },
                    {
                        "exact_snippets": "Preoperative laryngoscopy assessment of primary lesions",
                        "criterion": "preoperative laryngoscopy assessment",
                        "requirement": {
                            "requirement_type": "severity distinction",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. No surgical indications, or initial treatment evaluation recommends non-surgical treatment.",
                "criterions": [
                    {
                        "exact_snippets": "No surgical indications",
                        "criterion": "surgical indications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "initial treatment evaluation recommends non-surgical treatment",
                        "criterion": "initial treatment evaluation",
                        "requirement": {
                            "requirement_type": "recommendation",
                            "expected_value": "non-surgical treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "No surgical indications",
                        "criterion": "surgical indications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "initial treatment evaluation recommends non-surgical treatment",
                        "criterion": "initial treatment evaluation",
                        "requirement": {
                            "requirement_type": "recommendation",
                            "expected_value": "non-surgical treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. The patient had other head and neck cancer.",
                "criterions": [
                    {
                        "exact_snippets": "other head and neck cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other head and neck cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "other"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other head and neck cancer",
                                "criterion": "head and neck cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "other head and neck cancer",
                                "criterion": "head and neck cancer",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "other"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. Evaluation of cN0: Patients need to undergo neck palpation, ultrasound and enhanced CT, if the patient is allergic to CT enhancer, replace it with MRI.Not touch more than 2cm hard lymph nodes in the neck, moreover, ultrasound and enhanced CT are not found lymph node that diameter ≥ 1cm.Or, the size does not meet the above criteria, but find rim enhancement, central irregular or hypodensity, and with the surrounding tissue boundary is obscure, and other suspicious transfer signs.",
                "criterions": [
                    {
                        "exact_snippets": "neck palpation",
                        "criterion": "neck palpation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ultrasound",
                        "criterion": "ultrasound",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "enhanced CT",
                        "criterion": "enhanced CT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "allergic to CT enhancer",
                        "criterion": "allergy to CT enhancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "replace it with MRI",
                        "criterion": "MRI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Not touch more than 2cm hard lymph nodes in the neck",
                        "criterion": "hard lymph nodes in the neck",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ultrasound and enhanced CT are not found lymph node that diameter ≥ 1cm",
                        "criterion": "lymph node diameter on ultrasound and enhanced CT",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "rim enhancement, central irregular or hypodensity",
                        "criterion": "rim enhancement, central irregularity, or hypodensity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "surrounding tissue boundary is obscure",
                        "criterion": "obscure surrounding tissue boundary",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other suspicious transfer signs",
                        "criterion": "suspicious transfer signs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}