{
    "info": {
        "nct_id": "NCT06082648",
        "official_title": "Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors",
        "inclusion_criteria": "* Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.\n* Patient who is willing to participate in the study, and voluntarily sign informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Anastomotic leakage or other serious complications occur after surgery.\n* Advanced tumor, tumor recurrence or metastasis.\n* Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.\n* Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.\n* Combined with organic brain disease and drug abuse history.\n* Combined with other mental diseases.\n* Pregnant or lactating women.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.",
            "criterions": [
                {
                    "exact_snippets": "Primary ultra-low rectal tumor patient",
                    "criterion": "primary ultra-low rectal tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received intersphincteric resection",
                    "criterion": "intersphincteric resection",
                    "requirements": [
                        {
                            "requirement_type": "procedure received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preventive ileostomy was performed",
                    "criterion": "preventive ileostomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure performed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is willing to participate in the study, and voluntarily sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "willing to participate in the study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily sign 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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Anastomotic leakage or other serious complications occur after surgery.",
            "criterions": [
                {
                    "exact_snippets": "Anastomotic leakage",
                    "criterion": "anastomotic leakage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious complications occur after surgery",
                    "criterion": "serious complications after surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Advanced tumor, tumor recurrence or metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Advanced tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor recurrence",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.",
            "criterions": [
                {
                    "exact_snippets": "contraindications of fMRI scanning",
                    "criterion": "fMRI scanning contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of metal implants in the body",
                    "criterion": "metal implants in the body",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.",
            "criterions": [
                {
                    "exact_snippets": "contraindications for TMS treatment",
                    "criterion": "TMS treatment contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intracranial metal implants",
                    "criterion": "intracranial metal implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "epilepsy history",
                    "criterion": "epilepsy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart disease with unstable heart function",
                    "criterion": "heart disease with unstable heart function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "retinal detachment",
                    "criterion": "retinal detachment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Combined with organic brain disease and drug abuse history.",
            "criterions": [
                {
                    "exact_snippets": "organic brain disease",
                    "criterion": "organic brain disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug abuse history",
                    "criterion": "drug abuse history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Combined with other mental diseases.",
            "criterions": [
                {
                    "exact_snippets": "Combined with other mental diseases.",
                    "criterion": "mental diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}