{
    "info": {
        "nct_id": "NCT05880927",
        "official_title": "Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial",
        "inclusion_criteria": "1. Women aged 18-75 years old\n2. HER2 positive breast cancer\n3. ECOG PS 0-1\n4. Known hormone receptor status\n5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months\n6. Patients at high risk\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Serious heart disease or discomfort\n2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption\n3. Known allergic history of drug components of this regimen\n4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation\n5. Pregnant and lactating female patients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Women aged 18-75 years old",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18-75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. HER2 positive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HER2 positive breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 positive breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG PS 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Known hormone receptor status",
            "criterions": [
                {
                    "exact_snippets": "Known hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months",
            "criterions": [
                {
                    "exact_snippets": "Completed 1 year of trastuzumab-based adjuvant therapy",
                    "criterion": "trastuzumab-based adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "year"
                            }
                        },
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months",
                    "criterion": "time since completion of trastuzumab-based adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients at high risk",
            "criterions": [
                {
                    "exact_snippets": "Patients at high risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "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 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": "1. Serious heart disease or discomfort",
            "criterions": [
                {
                    "exact_snippets": "Serious heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "discomfort",
                    "criterion": "discomfort",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of other factors that interfere with drug administration and absorption",
                    "criterion": "factors interfering with drug administration and absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Known allergic history of drug components of this regimen",
            "criterions": [
                {
                    "exact_snippets": "Known allergic history of drug components of this regimen",
                    "criterion": "allergic history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "A history of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired, congenital immunodeficiency diseases",
                    "criterion": "immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnant and lactating female patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female patients",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}