{
    "info": {
        "nct_id": "NCT04836520",
        "official_title": "Single-arm, Single-center, PhaseⅡ Clinical Study of SHR6390 Combined With Anastrozole for Preoperative Treatment of Hormone Receptor Positive and HER2 Negative Early or Locally Advanced Breast Cancer.",
        "inclusion_criteria": "1.Female subjects aged 18 to 75 years old, meet any of the following:\n\n1. Both ovaries have been removed, or the age is ≥60 years old;\n2. Age <60 years, natural post-menopausal state (defined as spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons), E2 and FSH are at postmenopausal levels;\n3. Premenopausal or perimenopausal female subjects must be willing to receive LHRH agonist treatment during the study; 2.T2-T4cN0M0 invasive breast cancer (according to the AJCC 8th edition breast cancer clinical staging guidelines), the tumor must be surgically resectable, the measurable lesion conforms to the RECIST 1.1 standard, and the maximum diameter of the primary tumor has been evaluated by clinical or imaging evaluation ≥ 2cm; 3.Willing to accept biopsy; 4.Luminal A confirmed by immunohistochemistry, ER≥50% and PR≥50%; 5.HER2 negative, defined as immunohistochemical test 0/1+; or FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 6.Patients are suitable for neoadjuvant therapy and willing to accept (judged by the investigator); 7.ECOG performance status score 0 or 1; 8.The expected survival period is not less than 12 weeks; 9.Adequate function of major organs； 10.Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Metastases confirmed by imaging or pathology, not including lymph node metastases in the ipsilateral and/or contralateral thoracic region or mediastinum;\n2. Inflammatory breast cancer, bilateral breast cancer or DCIS, invasive breast cancer with multiple focal lesions;\n3. Previous pathological diagnosis of HER2-positive breast cancer;\n4. Suffering from gastrointestinal diseases such as intestinal obstruction, peptic ulcer or active bleeding, which affects the taking and absorption of drugs;\n5. Previously treated with radiotherapy, chemotherapy, surgery (not including percutaneous puncture) or molecular targeted treatment;\n6. Previously received any CDK4/6 inhibitor drug treatment;\n7. Participation in any other clinical trials within 4 weeks of enrollment；\n8. Concurrent use of any other Anti-cancer drugs；\n9. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;\n10. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study;\n11. History of allergy or hypersensitivity to any of the study drugs or study drug components; history of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation；\n12. A clear history of neurological or mental disorders, including epilepsy or dementia；\n13. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation；\n14. According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)；\n15. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1.Female subjects aged 18 to 75 years old, meet any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 to 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Both ovaries have been removed, or the age is ≥60 years old;",
            "criterions": [
                {
                    "exact_snippets": "Both ovaries have been removed",
                    "criterion": "ovaries",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "age is ≥60 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age <60 years, natural post-menopausal state (defined as spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons), E2 and FSH are at postmenopausal levels;",
            "criterions": [
                {
                    "exact_snippets": "Age <60 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "natural post-menopausal state (defined as spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons)",
                    "criterion": "menopausal state",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": "natural post-menopausal"
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons"
                        }
                    ]
                },
                {
                    "exact_snippets": "E2 and FSH are at postmenopausal levels",
                    "criterion": "E2 and FSH levels",
                    "requirements": [
                        {
                            "requirement_type": "levels",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Premenopausal or perimenopausal female subjects must be willing to receive LHRH agonist treatment during the study; 2.T2-T4cN0M0 invasive breast cancer (according to the AJCC 8th edition breast cancer clinical staging guidelines), the tumor must be surgically resectable, the measurable lesion conforms to the RECIST 1.1 standard, and the maximum diameter of the primary tumor has been evaluated by clinical or imaging evaluation ≥ 2cm; 3.Willing to accept biopsy; 4.Luminal A confirmed by immunohistochemistry, ER≥50% and PR≥50%; 5.HER2 negative, defined as immunohistochemical test 0/1+; or FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 6.Patients are suitable for neoadjuvant therapy and willing to accept (judged by the investigator); 7.ECOG performance status score 0 or 1; 8.The expected survival period is not less than 12 weeks; 9.Adequate function of major organs； 10.Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal or perimenopausal female subjects",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "premenopausal",
                                "perimenopausal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to receive LHRH agonist treatment during the study",
                    "criterion": "LHRH agonist treatment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "T2-T4cN0M0 invasive breast cancer (according to the AJCC 8th edition breast cancer clinical staging guidelines)",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T2-T4cN0M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor must be surgically resectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "surgically resectable",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable lesion conforms to the RECIST 1.1 standard",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "RECIST 1.1 standard",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum diameter of the primary tumor has been evaluated by clinical or imaging evaluation ≥ 2cm",
                    "criterion": "primary tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to accept biopsy",
                    "criterion": "biopsy acceptance",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Luminal A confirmed by immunohistochemistry",
                    "criterion": "luminal A subtype",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ER≥50%",
                    "criterion": "estrogen receptor (ER) status",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PR≥50%",
                    "criterion": "progesterone receptor (PR) status",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative, defined as immunohistochemical test 0/1+",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "immunohistochemical test",
                            "expected_value": "0/1+"
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH test HER2/CEP17 ratio is less than 2.0",
                    "criterion": "HER2/CEP17 ratio",
                    "requirements": [
                        {
                            "requirement_type": "ratio",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 gene copy number is less than 4",
                    "criterion": "HER2 gene copy number",
                    "requirements": [
                        {
                            "requirement_type": "copy number",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients are suitable for neoadjuvant therapy and willing to accept (judged by the investigator)",
                    "criterion": "neoadjuvant therapy suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status score 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "expected survival period is not less than 12 weeks",
                    "criterion": "expected survival period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate function of major organs",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up",
                    "criterion": "study participation",
                    "requirements": [
                        {
                            "requirement_type": "voluntary participation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signed informed consent",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "compliance",
                            "expected_value": "good"
                        },
                        {
                            "requirement_type": "willingness to cooperate",
                            "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 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. Metastases confirmed by imaging or pathology, not including lymph node metastases in the ipsilateral and/or contralateral thoracic region or mediastinum;",
            "criterions": [
                {
                    "exact_snippets": "Metastases confirmed by imaging or pathology",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "imaging",
                                "pathology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not including lymph node metastases in the ipsilateral and/or contralateral thoracic region or mediastinum",
                    "criterion": "lymph node metastases",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "ipsilateral thoracic region",
                                "contralateral thoracic region",
                                "mediastinum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Inflammatory breast cancer, bilateral breast cancer or DCIS, invasive breast cancer with multiple focal lesions;",
            "criterions": [
                {
                    "exact_snippets": "Inflammatory breast cancer",
                    "criterion": "inflammatory breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral breast cancer",
                    "criterion": "bilateral breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "DCIS",
                    "criterion": "DCIS (ductal carcinoma in situ)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple focal lesions",
                    "criterion": "multiple focal lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous pathological diagnosis of HER2-positive breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "Previous pathological diagnosis of HER2-positive breast cancer",
                    "criterion": "HER2-positive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Suffering from gastrointestinal diseases such as intestinal obstruction, peptic ulcer or active bleeding, which affects the taking and absorption of drugs;",
            "criterions": [
                {
                    "exact_snippets": "Suffering from gastrointestinal diseases such as intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suffering from gastrointestinal diseases such as ... peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suffering from gastrointestinal diseases such as ... active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Previously treated with radiotherapy, chemotherapy, surgery (not including percutaneous puncture) or molecular targeted treatment;",
            "criterions": [
                {
                    "exact_snippets": "Previously treated with radiotherapy",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously treated with ... chemotherapy",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously treated with ... surgery (not including percutaneous puncture)",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously treated with ... molecular targeted treatment",
                    "criterion": "molecular targeted treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Previously received any CDK4/6 inhibitor drug treatment;",
            "criterions": [
                {
                    "exact_snippets": "Previously received any CDK4/6 inhibitor drug treatment",
                    "criterion": "CDK4/6 inhibitor drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participation in any other clinical trials within 4 weeks of enrollment；",
            "criterions": [
                {
                    "exact_snippets": "Participation in any other clinical trials within 4 weeks of enrollment",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Concurrent use of any other Anti-cancer drugs；",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of any other Anti-cancer drugs",
                    "criterion": "use of other anti-cancer drugs",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies within 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except cured in-situ of uterine cervix carcinoma",
                    "criterion": "cured in-situ uterine cervix carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... skin basal cell carcinoma",
                    "criterion": "skin basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... squamous-cell carcinoma",
                    "criterion": "squamous-cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of allergy or hypersensitivity to any of the study drugs or study drug components; history of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation；",
            "criterions": [
                {
                    "exact_snippets": "History of allergy or hypersensitivity to any of the study drugs or study drug components",
                    "criterion": "allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. A clear history of neurological or mental disorders, including epilepsy or dementia；",
            "criterions": [
                {
                    "exact_snippets": "history of neurological or mental disorders",
                    "criterion": "neurological or mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation；",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or breastfeeding women",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "not pregnant",
                                "not breastfeeding"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential who have a positive pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential ... unwilling to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)；",
            "criterions": [
                {
                    "exact_snippets": "concomitant disease that seriously endangers the safety of subjects or affects the completion of the study",
                    "criterion": "concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "seriously endangers safety or affects study completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid disease that cannot be controlled by drugs",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "cannot be controlled by drugs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.",
            "criterions": [
                {
                    "exact_snippets": "Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.",
                    "criterion": "suitability for study participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator's opinion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "10. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study;",
            "criterions": [
                {
                    "exact_snippets": "History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of heart disease: ... (2) Myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of heart disease: ... (3) Heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of heart disease: ... (4) Any heart diseases that investigator believes not suitable for this study",
                    "criterion": "heart diseases",
                    "requirements": [
                        {
                            "requirement_type": "investigator discretion",
                            "expected_value": "not suitable for this study"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}