{
    "info": {
        "nct_id": "NCT05554666",
        "official_title": "A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.",
        "inclusion_criteria": "1. Male or female ≥ 18 years of age.\n2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.\n3. Measurable disease, per RECIST v1.1.\n4. ECOG Performance Status of ≤ 2.\n5. Life expectancy of ≥3 months, in the opinion of the Investigator.\n6. Adequate organ function defined.\n7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.\n8. Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.\n2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.\n3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.\n4. Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.\n5. Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1.\n6. Received a live attenuated vaccine within 4 weeks prior to C1D1.\n7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.\n8. History of hematologic stem cell transplant or solid organ transplant.\n9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.\n10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.\n11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection.\n12. Current clinically significant interstitial lung disease.\n13. History of serious cardiovascular or cerebrovascular diseases.\n14. Active or recurrent autoimmune diseases.\n15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.\n16. Other malignancies within 5 years.\n17. Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.\n18. Symptomatic with uncontrolled ascites or pleural effusion.\n19. Hyperglycemia that cannot be stably controlled.\n20. History of a grade ≥ 3 allergic reaction to protein drugs.\n21. Known to have alcohol or drug dependence.\n22. Severe mental disorder or poor compliance.\n23. Pregnant or nursing women\n24. Subjects should be excluded in the opinion of investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced malignant solid tumor",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "advanced malignant solid tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to or intolerant of all standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "refractory",
                                "intolerant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no standard therapy is available",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Measurable disease, per RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, per RECIST v1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG Performance Status of ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status of ≤ 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy of ≥3 months, in the opinion of the Investigator.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate organ function defined.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and at least 90 days after the last dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of the study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "documentation of lack of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "lack of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily enrolled",
                    "criterion": "voluntary enrollment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "followed the experimental treatment plan",
                    "criterion": "experimental treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "visit arrangement",
                    "criterion": "visit arrangement",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "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 have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Received chemotherapy within 3 weeks prior to Cycle 1 Day 1",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1",
                    "criterion": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "availability",
                            "expected_value": "not commercially available"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to Cycle 1 Day 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Had major organ surgery ... within 4 weeks prior to C1D1",
                    "criterion": "major organ surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant trauma within 4 weeks prior to C1D1",
                    "criterion": "significant trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since trauma",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planning elective surgery during the study period",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
                    "criterion": "systemic glucocorticoid treatment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks prior to C1D1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.",
                    "criterion": "immunosuppressant treatment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks prior to C1D1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Received immunomodulatory drugs, including but not limited to thymosin and interferon",
                    "criterion": "immunomodulatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 2 weeks prior to C1D1",
                    "criterion": "time since last immunomodulatory drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Received a live attenuated vaccine within 4 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Received a live attenuated vaccine within 4 weeks prior to C1D1.",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.",
                    "criterion": "IL-2 or IL-15 therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of hematologic stem cell transplant or solid organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "History of hematologic stem cell transplant",
                    "criterion": "hematologic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... solid organ transplant",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.",
            "criterions": [
                {
                    "exact_snippets": "Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.",
                    "criterion": "adverse reactions to previous antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE 5.0 grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.",
            "criterions": [
                {
                    "exact_snippets": "Cerebral parenchymal metastasis",
                    "criterion": "cerebral parenchymal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms",
                    "criterion": "clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection.",
            "criterions": [
                {
                    "exact_snippets": "Serious infection requiring intravenous infusion or hospitalization",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous infusion"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "active viral infection",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Current clinically significant interstitial lung disease.",
            "criterions": [
                {
                    "exact_snippets": "Current clinically significant interstitial lung disease.",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of serious cardiovascular or cerebrovascular diseases.",
            "criterions": [
                {
                    "exact_snippets": "History of serious cardiovascular ... diseases.",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of serious ... cerebrovascular diseases.",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active or recurrent autoimmune diseases.",
            "criterions": [
                {
                    "exact_snippets": "Active or recurrent autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.",
            "criterions": [
                {
                    "exact_snippets": "History of Grade ≥ 3 Immune-Related Adverse Events (irAE)",
                    "criterion": "immune-related adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... Grade ≥ 2 immunotherapy-associated myocarditis",
                    "criterion": "immunotherapy-associated myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Other malignancies within 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies within 5 years.",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
            "criterions": [
                {
                    "exact_snippets": "Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.",
                    "criterion": "bleeding symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE 5.0 grade"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to C1D1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Symptomatic with uncontrolled ascites or pleural effusion.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic with uncontrolled ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic with uncontrolled ... pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Hyperglycemia that cannot be stably controlled.",
            "criterions": [
                {
                    "exact_snippets": "Hyperglycemia that cannot be stably controlled.",
                    "criterion": "hyperglycemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. History of a grade ≥ 3 allergic reaction to protein drugs.",
            "criterions": [
                {
                    "exact_snippets": "History of a grade ≥ 3 allergic reaction to protein drugs.",
                    "criterion": "allergic reaction to protein drugs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Known to have alcohol or drug dependence.",
            "criterions": [
                {
                    "exact_snippets": "alcohol ... dependence",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug dependence",
                    "criterion": "drug dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Severe mental disorder or poor compliance.",
            "criterions": [
                {
                    "exact_snippets": "Severe mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "poor compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Pregnant or nursing women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Subjects should be excluded in the opinion of investigators.",
            "criterions": [
                {
                    "exact_snippets": "Subjects should be excluded in the opinion of investigators",
                    "criterion": "investigator's opinion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}