{
    "info": {
        "nct_id": "NCT06837831",
        "official_title": "Efficacy of Mepilex Lite Dressings Combined with Indomethacin Suppositories in the Treatment of Anal Pain in Patients Undergoing Radiotherapy for Rectal Cancer: Protocol for a Randomized Controlled Trial",
        "inclusion_criteria": "* (1) Patients with low and intermediate rectal cancer confirmed by pathological histologic diagnosis; (2) Patients who received radiotherapy; (3) Anal pain numerical rating scale (Numerical Rating Scale,NRS) ≥7 points; (4) Age ≥18 years; (5) Those who volunteered to participate in this study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Allergy, allergy to the drugs used in this study;\n2. Mental illness, emotional instability or inability to express their feelings;\n3. Combined serious cardiovascular and cerebrovascular diseases, digestive system diseases, blood system diseases and infectious diseases;\n4. Previous history of pelvic radiotherapy;\n5. Physical strength score (PS score) > 3 points -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* (1) Patients with low and intermediate rectal cancer confirmed by pathological histologic diagnosis; (2) Patients who received radiotherapy; (3) Anal pain numerical rating scale (Numerical Rating Scale,NRS) ≥7 points; (4) Age ≥18 years; (5) Those who volunteered to participate in this study.",
                "criterions": [
                    {
                        "exact_snippets": "low and intermediate rectal cancer confirmed by pathological histologic diagnosis",
                        "criterion": "rectal cancer",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "low",
                                "intermediate"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "low and intermediate rectal cancer confirmed by pathological histologic diagnosis",
                        "criterion": "rectal cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathological histologic diagnosis"
                        }
                    },
                    {
                        "exact_snippets": "received radiotherapy",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Anal pain numerical rating scale (Numerical Rating Scale,NRS) ≥7 points",
                        "criterion": "anal pain",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "points"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "volunteered to participate in this study",
                        "criterion": "voluntary participation",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "low and intermediate rectal cancer confirmed by pathological histologic diagnosis",
                                "criterion": "rectal cancer",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "low",
                                        "intermediate"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "low and intermediate rectal cancer confirmed by pathological histologic diagnosis",
                                "criterion": "rectal cancer",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": "pathological histologic diagnosis"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "received radiotherapy",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Anal pain numerical rating scale (Numerical Rating Scale,NRS) ≥7 points",
                        "criterion": "anal pain",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "points"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "volunteered to participate in this study",
                        "criterion": "voluntary participation",
                        "requirement": {
                            "requirement_type": "willingness",
                            "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 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Allergy, allergy to the drugs used in this study;",
                "criterions": [
                    {
                        "exact_snippets": "Allergy, allergy to the drugs used in this study",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "specificity",
                            "expected_value": "drugs used in this study"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Allergy, allergy to the drugs used in this study",
                    "criterion": "allergy",
                    "requirement": {
                        "requirement_type": "specificity",
                        "expected_value": "drugs used in this study"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Mental illness, emotional instability or inability to express their feelings;",
                "criterions": [
                    {
                        "exact_snippets": "Mental illness",
                        "criterion": "mental illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "emotional instability",
                        "criterion": "emotional instability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "inability to express their feelings",
                        "criterion": "ability to express feelings",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Mental illness",
                                "criterion": "mental illness",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "emotional instability",
                                "criterion": "emotional instability",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "inability to express their feelings",
                        "criterion": "ability to express feelings",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Combined serious cardiovascular and cerebrovascular diseases, digestive system diseases, blood system diseases and infectious diseases;",
                "criterions": [
                    {
                        "exact_snippets": "Combined serious cardiovascular and cerebrovascular diseases",
                        "criterion": "cardiovascular and cerebrovascular diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "digestive system diseases",
                        "criterion": "digestive system diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "blood system diseases",
                        "criterion": "blood system diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infectious diseases",
                        "criterion": "infectious diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Combined serious cardiovascular and cerebrovascular diseases",
                                "criterion": "cardiovascular and cerebrovascular diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            },
                            {
                                "exact_snippets": "digestive system diseases",
                                "criterion": "digestive system diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "blood system diseases",
                                "criterion": "blood system diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "infectious diseases",
                                "criterion": "infectious diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Previous history of pelvic radiotherapy;",
                "criterions": [
                    {
                        "exact_snippets": "Previous history of pelvic radiotherapy",
                        "criterion": "pelvic radiotherapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous history of pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Physical strength score (PS score) > 3 points -",
                "criterions": [
                    {
                        "exact_snippets": "Physical strength score (PS score) > 3 points",
                        "criterion": "physical strength score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "points"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Physical strength score (PS score) > 3 points",
                        "criterion": "physical strength score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "points"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}