{
    "info": {
        "nct_id": "NCT04665882",
        "official_title": "Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial",
        "inclusion_criteria": "* Patients aged 18 years or older with T1-3 invasive breast cancer;\n* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;\n* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);\n* Patients who underwent breast-conserving surgery containing more than two positive SLNs.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Neoadjuvant chemotherapy;\n* Previous history of breast cancer.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients aged 18 years or older with T1-3 invasive breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "Patients aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T1-3 invasive breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2",
                                "T3"
                            ]
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "invasive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;",
            "criterions": [
                {
                    "exact_snippets": "Clinically node-positive breast cancer",
                    "criterion": "node-positive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive on preoperative axillary palpation",
                    "criterion": "preoperative axillary palpation",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive on ... ultrasound examination",
                    "criterion": "ultrasound examination",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive on ... computed tomography scan with contrast",
                    "criterion": "computed tomography scan with contrast",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);",
            "criterions": [
                {
                    "exact_snippets": "underwent mastectomy",
                    "criterion": "mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive sentinel lymph node (SLN)",
                    "criterion": "sentinel lymph node (SLN)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who underwent breast-conserving surgery containing more than two positive SLNs.",
            "criterions": [
                {
                    "exact_snippets": "breast-conserving surgery",
                    "criterion": "breast-conserving surgery",
                    "requirements": [
                        {
                            "requirement_type": "underwent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "more than two positive SLNs",
                    "criterion": "positive SLNs",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "SLNs"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Neoadjuvant chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous history of breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Previous history of breast cancer.",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}