{
    "info": {
        "nct_id": "NCT04934982",
        "official_title": "A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)",
        "inclusion_criteria": "1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2).\n2. Age ≥ 21 years and ≤ 70 years.\n3. Surgery type B and C (refer to Q-M surgical staging)\n4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.\n5. No history of other malignancies.\n6. Non-pregnancy.\n7. Physical strength classification: Karnofsky score ≥ 60;\n8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.\n9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 21 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Those who are contraindicated for various surgeries and cannot undergo surgery.\n2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.\n3. Patients with recurrent cervical cancer\n4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2).",
            "criterions": [
                {
                    "exact_snippets": "Clinical diagnosis of squamous carcinoma of the cervix",
                    "criterion": "squamous carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical diagnosis of ... adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical diagnosis of ... squamous adenocarcinoma",
                    "criterion": "squamous adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "IA1 with lymphovascular interstitial invasion",
                    "criterion": "stage IA1 with lymphovascular interstitial invasion",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IA1"
                        },
                        {
                            "requirement_type": "lymphovascular interstitial invasion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IA2",
                    "criterion": "stage IA2",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IA2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥ 21 years and ≤ 70 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 21 years and ≤ 70 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Surgery type B and C (refer to Q-M surgical staging)",
            "criterions": [
                {
                    "exact_snippets": "Surgery type B and C",
                    "criterion": "surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Q-M surgical staging",
                    "criterion": "surgical staging",
                    "requirements": [
                        {
                            "requirement_type": "system",
                            "expected_value": "Q-M"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.",
            "criterions": [
                {
                    "exact_snippets": "Normal range of liver and kidney function",
                    "criterion": "liver and kidney function",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal range of ... blood count",
                    "criterion": "blood count",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin > 60g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets > 70*109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "*109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Leukocytes > 3*109/L",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "*109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine < 50mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Transaminase abnormal indicators ≤ 3",
                    "criterion": "transaminase abnormal indicators",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Maximum value of transaminases not exceeding 3 times the corresponding normal value",
                    "criterion": "transaminases",
                    "requirements": [
                        {
                            "requirement_type": "maximum value",
                            "expected_value": "not exceeding 3 times the corresponding normal value"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. No history of other malignancies.",
            "criterions": [
                {
                    "exact_snippets": "No history of other malignancies",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Non-pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Non-pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Physical strength classification: Karnofsky score ≥ 60;",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky score ≥ 60",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.",
            "criterions": [
                {
                    "exact_snippets": "voluntarily joined the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "were compliant",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cooperated with the follow-up",
                    "criterion": "follow-up cooperation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... serious immune system disorders",
                    "criterion": "serious immune system disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Those who are contraindicated for various surgeries and cannot undergo surgery.",
            "criterions": [
                {
                    "exact_snippets": "contraindicated for various surgeries",
                    "criterion": "surgery contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot undergo surgery",
                    "criterion": "ability to undergo surgery",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received pelvic/abdominal radiotherapy irradiation",
                    "criterion": "pelvic/abdominal radiotherapy irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have received ... neoadjuvant chemotherapy for cervical cancer",
                    "criterion": "neoadjuvant chemotherapy for cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with recurrent cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "recurrent cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.",
            "criterions": [
                {
                    "exact_snippets": "CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes",
                    "criterion": "suspicious metastasis of pelvic lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "PET-CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum diameter >2cm",
                    "criterion": "pelvic lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}