{
    "info": {
        "nct_id": "NCT06811857",
        "official_title": "An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery",
        "inclusion_criteria": "1. understand the study procedure, participate in the study voluntarily and sign the informed consent form\n2. aged ≥ 18 years and ≤ 60 years, female\n3. ECOG 0-2\n4. patients with The SKIN Score Degree of B-D and The SKIN area of 1-3 in the Clavien-Dindo classification after breast cancer surgery；\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 60 Years",
        "exclusion_criteria": "1. Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo), eye disease (retinal detachment).\n2. Pregnancy or lactation.\n3. any other condition that the investigators think the patient is unsuitable for participation in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. understand the study procedure, participate in the study voluntarily and sign the informed consent form",
            "criterions": [
                {
                    "exact_snippets": "understand the study procedure",
                    "criterion": "understanding of study procedure",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participate in the study voluntarily",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. aged ≥ 18 years and ≤ 60 years, female",
            "criterions": [
                {
                    "exact_snippets": "aged ≥ 18 years and ≤ 60 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 60,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "specificity",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. patients with The SKIN Score Degree of B-D and The SKIN area of 1-3 in the Clavien-Dindo classification after breast cancer surgery；",
            "criterions": [
                {
                    "exact_snippets": "The SKIN Score Degree of B-D",
                    "criterion": "SKIN Score Degree",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The SKIN area of 1-3",
                    "criterion": "SKIN area",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clavien-Dindo classification after breast cancer surgery",
                    "criterion": "Clavien-Dindo classification after breast cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 60 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 60 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo), eye disease (retinal detachment).",
            "criterions": [
                {
                    "exact_snippets": "lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax)",
                    "criterion": "lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "severe chronic obstructive airway disease",
                                "herpetic lung disease",
                                "acute or chronic lung infection",
                                "uncontrolled asthma",
                                "untreated pneumothorax"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of previous middle ear surgery",
                    "criterion": "history of previous middle ear surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo)",
                    "criterion": "middle ear disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Eustachian tube dysfunction",
                                "recurrent episodes of vertigo"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "eye disease (retinal detachment)",
                    "criterion": "eye disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "retinal detachment"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnancy or lactation.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. any other condition that the investigators think the patient is unsuitable for participation in the study",
            "criterions": [
                {
                    "exact_snippets": "any other condition that the investigators think the patient is unsuitable for participation in the study",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "investigator assessment",
                            "expected_value": "suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}