{
    "info": {
        "nct_id": "NCT05491694",
        "official_title": "To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induction",
        "inclusion_criteria": "1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;\n2. Histopathologically confirmed breast cancer patients who are negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 by immunohistochemistry; positive PD-L1 expression in tumor cells (≥ 1%);\n3. triple-negative breast cancer patients without distant metastasis;\n4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;\n5. ECOG PS score: 0 - 1;\n6. New York Heart Association (NYHA) functional class I;\n7. Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;\n8. Normal major organ function, Meet the following criteria:\n\nWBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;\n\n9) The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.\n\n-\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;\n2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;\n3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications;\n4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;\n5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;\n6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;\n7. Patients who are participating in other clinical trials within one month;\n8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;\n9. any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "require a negative pregnancy test for premenopausal and perimenopausal patients",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal and perimenopausal patients",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "premenopausal",
                                "perimenopausal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "promise to take reliable contraceptive measures during treatment",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "commitment",
                            "expected_value": "promise to take reliable measures"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histopathologically confirmed breast cancer patients who are negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 by immunohistochemistry; positive PD-L1 expression in tumor cells (≥ 1%);",
            "criterions": [
                {
                    "exact_snippets": "Histopathologically confirmed breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative for estrogen receptor (ER)",
                    "criterion": "estrogen receptor (ER)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative for ... progesterone receptor (PR)",
                    "criterion": "progesterone receptor (PR)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative for ... HER-2 by immunohistochemistry",
                    "criterion": "HER-2",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "immunohistochemistry"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive PD-L1 expression in tumor cells (≥ 1%)",
                    "criterion": "PD-L1 expression in tumor cells",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. triple-negative breast cancer patients without distant metastasis;",
            "criterions": [
                {
                    "exact_snippets": "triple-negative breast cancer patients",
                    "criterion": "triple-negative breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;",
            "criterions": [
                {
                    "exact_snippets": "at least one evaluable target lesion",
                    "criterion": "evaluable target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG PS score: 0 - 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS score: 0 - 1",
                    "criterion": "ECOG PS score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. New York Heart Association (NYHA) functional class I;",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) functional class I",
                    "criterion": "NYHA functional class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "I"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;",
            "criterions": [
                {
                    "exact_snippets": "Electrocardiogram without myocardial ischemia",
                    "criterion": "myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "echocardiography LVEF > 55%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac markers: cardiac troponin I (cTnI) ... test values within the normal range",
                    "criterion": "cardiac troponin I (cTnI)",
                    "requirements": [
                        {
                            "requirement_type": "test value",
                            "expected_value": "within the normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac markers: ... brain natriuretic peptide (BNP) test values within the normal range",
                    "criterion": "brain natriuretic peptide (BNP)",
                    "requirements": [
                        {
                            "requirement_type": "test value",
                            "expected_value": "within the normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Normal major organ function, Meet the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Normal major organ function",
                    "criterion": "major organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "WBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;",
            "criterions": [
                {
                    "exact_snippets": "WBC ≥ 4.0 × 10 9/L",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4.0,
                                "unit": "× 10 9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophil count (ANC) ≥ 1.5 × 10 9/L",
                    "criterion": "Neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10 9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet ≥ 100 × 10 9/L",
                    "criterion": "platelet",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10 9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 10 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ≤ 1.5 × upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 × ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ≤ 2.5 × ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 1.5 × ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9) The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.",
            "criterions": [
                {
                    "exact_snippets": "The subject is able to understand the study procedures",
                    "criterion": "understanding of study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily join the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "cooperate with the follow-up",
                    "criterion": "follow-up cooperation",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;",
            "criterions": [
                {
                    "exact_snippets": "Patients during pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age who refuse to take effective contraceptive measures during the study period",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with peripheral nervous system disorders caused by diseases",
                    "criterion": "peripheral nervous system disorders",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "diseases"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of significant mental disorders",
                    "criterion": "significant mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "central nervous system disorders",
                    "criterion": "central nervous system disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;",
            "criterions": [
                {
                    "exact_snippets": "Serious or uncontrolled infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis virus infection",
                    "criterion": "hepatitis virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV) antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lung infection",
                    "criterion": "lung infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications;",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to the active ingredients or other components of the study drug",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical contraindications",
                    "criterion": "surgical contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;",
            "criterions": [
                {
                    "exact_snippets": "cured basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancers are disease-free for less than 5 years",
                    "criterion": "other cancers",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;",
            "criterions": [
                {
                    "exact_snippets": "Severe liver disease (such as cirrhosis, etc.)",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "respiratory disease",
                    "criterion": "respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active gastrointestinal ulcers",
                    "criterion": "gastrointestinal ulcers",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;",
            "criterions": [
                {
                    "exact_snippets": "Need to receive other anti-tumor therapy (except ovarian function inhibitors)",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "ovarian function inhibitors"
                        }
                    ]
                },
                {
                    "exact_snippets": "during neoadjuvant therapy",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients who are participating in other clinical trials within one month;",
            "criterions": [
                {
                    "exact_snippets": "Patients who are participating in other clinical trials",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within one month",
                    "criterion": "time since participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;",
            "criterions": [
                {
                    "exact_snippets": "severe heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "discomfort",
                    "criterion": "discomfort",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Expected intolerance to chemotherapy",
                    "criterion": "intolerance to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fatal arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "fatal"
                        }
                    ]
                },
                {
                    "exact_snippets": "higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block)",
                    "criterion": "atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "second-degree type 2 [Mobitz 2]",
                                "third-degree"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant valvular heart disease",
                    "criterion": "valvular heart disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transmural myocardial infarction on electrocardiogram",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "transmural"
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "electrocardiogram"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.",
            "criterions": [
                {
                    "exact_snippets": "any other condition ... in the opinion of the investigator",
                    "criterion": "other condition",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}