{
    "info": {
        "nct_id": "NCT06725082",
        "official_title": "Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol",
        "inclusion_criteria": "1. Females aged 18 years or older but not exceeding 80 years;\n2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;\n3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;\n4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;\n5. ECOG Performance Status (PS) - 0 or 1;\n6. Subjects voluntarily join this study and sign the informed consent form.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "a.Tumor-related symptoms and treatments\n\n1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Females aged 18 years or older but not exceeding 80 years;",
            "criterions": [
                {
                    "exact_snippets": "Females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older but not exceeding 80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;",
            "criterions": [
                {
                    "exact_snippets": "Clinical and imaging diagnosis of breast tumor",
                    "criterion": "breast tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "clinical",
                                "imaging"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "planned for needle biopsy",
                    "criterion": "needle biopsy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Planned to undergo breast tumor surgery",
                    "criterion": "breast tumor surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may plan for whole-breast radiotherapy",
                    "criterion": "whole-breast radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;",
            "criterions": [
                {
                    "exact_snippets": "No systemic anti-tumor treatment ... has been received before screening",
                    "criterion": "systemic anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... local treatment (including chemotherapy and radiotherapy) has been received before screening",
                    "criterion": "local treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG Performance Status (PS) - 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status (PS) - 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects voluntarily join this study and sign the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Subjects voluntarily join this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form",
                    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "a.Tumor-related symptoms and treatments",
            "criterions": [
                {
                    "exact_snippets": "Tumor-related symptoms",
                    "criterion": "tumor-related symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor-related ... treatments",
                    "criterion": "tumor-related treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.",
            "criterions": [
                {
                    "exact_snippets": "Bilateral, multiple lesions",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bilateral"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                },
                {
                    "exact_snippets": "Skin damage and ulceration on the affected side of the breast",
                    "criterion": "skin condition",
                    "requirements": [
                        {
                            "requirement_type": "damage",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ulceration",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "affected side of the breast"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergy to collagen products or their excipients or severe allergic constitution",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": [
                                "collagen products",
                                "their excipients"
                            ]
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe allergic constitution"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of breast cancer or other malignant tumors",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "breast cancer",
                                "other malignant tumors"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serum pregnancy test or lactation",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "lactation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs",
                    "criterion": "anticoagulant drug use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "drug type",
                            "expected_value": [
                                "aspirin",
                                "non-steroidal anti-inflammatory drugs",
                                "antiplatelet drugs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders",
                    "criterion": "severe comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "cardiovascular diseases",
                                "hematological diseases",
                                "autoimmune diseases",
                                "neurological or psychiatric disorders"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}