{
    "info": {
        "nct_id": "NCT06387368",
        "official_title": "Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer",
        "inclusion_criteria": "* Age ≥ 18 years old, regardless of gender.\n* The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).\n* Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.\n* The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.\n* ECOG score 0-3 points.\n* The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).\n* Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.\n* After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.\n* History of merging with other malignant tumors.\n* Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment.\n* Concomitant severe infection.\n* Child-Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate<90ml/min).\n* Pregnant or lactating women or those planning to conceive.\n* The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).\n* Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Age ≥ 18 years old, regardless of gender.",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "regardless of gender",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "all genders"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "regardless of gender",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "all genders"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).",
                "criterions": [
                    {
                        "exact_snippets": "clear evaluable lesion (RECIST 1.1)",
                        "criterion": "evaluable lesion",
                        "requirement": {
                            "requirement_type": "clarity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clear evaluable lesion (RECIST 1.1)",
                        "criterion": "evaluable lesion",
                        "requirement": {
                            "requirement_type": "evaluation standard",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "diagnosed with pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tissue or cellular pathology",
                        "criterion": "diagnosis method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "tissue pathology",
                                "cellular pathology"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "radical surgical resection cannot be performed",
                        "criterion": "surgical resection feasibility",
                        "requirement": {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "jaundice",
                        "criterion": "jaundice",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal obstruction caused by tumor compression",
                        "criterion": "gastrointestinal obstruction",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "tumor compression"
                        }
                    },
                    {
                        "exact_snippets": "stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed",
                        "criterion": "stent treatment or biliary and gastrointestinal anastomosis",
                        "requirement": {
                            "requirement_type": "feasibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clear evaluable lesion (RECIST 1.1)",
                                "criterion": "evaluable lesion",
                                "requirement": {
                                    "requirement_type": "clarity",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "clear evaluable lesion (RECIST 1.1)",
                                "criterion": "evaluable lesion",
                                "requirement": {
                                    "requirement_type": "evaluation standard",
                                    "expected_value": "RECIST 1.1"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "diagnosed with pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tissue or cellular pathology",
                        "criterion": "diagnosis method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "tissue pathology",
                                "cellular pathology"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "radical surgical resection cannot be performed",
                        "criterion": "surgical resection feasibility",
                        "requirement": {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "jaundice",
                                "criterion": "jaundice",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "gastrointestinal obstruction caused by tumor compression",
                                "criterion": "gastrointestinal obstruction",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "tumor compression"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed",
                        "criterion": "stent treatment or biliary and gastrointestinal anastomosis",
                        "requirement": {
                            "requirement_type": "feasibility",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.",
                "criterions": [
                    {
                        "exact_snippets": "Patients voluntarily give up conversion therapy",
                        "criterion": "conversion therapy",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients voluntarily give up ... local radiation therapy",
                        "criterion": "local radiation therapy",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients voluntarily give up ... targeted immunity",
                        "criterion": "targeted immunity",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients voluntarily give up ... other programs",
                        "criterion": "other programs",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patients voluntarily give up conversion therapy",
                                                "criterion": "conversion therapy",
                                                "requirement": {
                                                    "requirement_type": "participation",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "Patients voluntarily give up ... local radiation therapy",
                                                "criterion": "local radiation therapy",
                                                "requirement": {
                                                    "requirement_type": "participation",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Patients voluntarily give up ... targeted immunity",
                                        "criterion": "targeted immunity",
                                        "requirement": {
                                            "requirement_type": "participation",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Patients voluntarily give up ... other programs",
                                "criterion": "other programs",
                                "requirement": {
                                    "requirement_type": "participation",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.",
                "criterions": [
                    {
                        "exact_snippets": "The patient voluntarily choose chemotherapy",
                        "criterion": "chemotherapy choice",
                        "requirement": {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the plan is to take capecitabine monotherapy orally",
                        "criterion": "capecitabine monotherapy",
                        "requirement": {
                            "requirement_type": "administration route",
                            "expected_value": "oral"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "The patient voluntarily choose chemotherapy",
                        "criterion": "chemotherapy choice",
                        "requirement": {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the plan is to take capecitabine monotherapy orally",
                        "criterion": "capecitabine monotherapy",
                        "requirement": {
                            "requirement_type": "administration route",
                            "expected_value": "oral"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG score 0-3 points.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG score 0-3 points",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "points"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "points"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG score 0-3 points",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "points"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "points"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.",
                "criterions": [
                    {
                        "exact_snippets": "patients voluntarily participate",
                        "criterion": "voluntary participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cooperates with all aspects of the research",
                        "criterion": "cooperation with research",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cooperating with treatment",
                        "criterion": "cooperation with treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cooperating with the researcher in data collection",
                        "criterion": "cooperation with data collection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not actively taking other treatments",
                        "criterion": "absence of other treatments",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "signing a written informed consent form",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "patients voluntarily participate",
                                                        "criterion": "voluntary participation",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "cooperates with all aspects of the research",
                                                        "criterion": "cooperation with research",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": true
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "cooperating with treatment",
                                                "criterion": "cooperation with treatment",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "cooperating with the researcher in data collection",
                                        "criterion": "cooperation with data collection",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "not actively taking other treatments",
                                "criterion": "absence of other treatments",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "signing a written informed consent form",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).",
                "criterions": [
                    {
                        "exact_snippets": "Known to be allergic to the components of Huaier granules",
                        "criterion": "allergy to Huaier granules components",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "to avoid or use Huaier granules with caution",
                        "criterion": "use of Huaier granules",
                        "requirement": {
                            "requirement_type": "caution",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known to be allergic to the components of Huaier granules",
                                "criterion": "allergy to Huaier granules components",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "to avoid or use Huaier granules with caution",
                                "criterion": "use of Huaier granules",
                                "requirement": {
                                    "requirement_type": "caution",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Child-Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate<90ml/min).",
                "criterions": [
                    {
                        "exact_snippets": "Child-Pugh C-grade liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "Child-Pugh C"
                        }
                    },
                    {
                        "exact_snippets": "renal function 2-5 grades",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "glomerular filtration rate<90ml/min",
                        "criterion": "glomerular filtration rate",
                        "requirement": {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Child-Pugh C-grade liver function",
                                "criterion": "liver function",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": "Child-Pugh C"
                                }
                            },
                            {
                                "exact_snippets": "renal function 2-5 grades",
                                "criterion": "renal function",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "grade"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "grade"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "glomerular filtration rate<90ml/min",
                        "criterion": "glomerular filtration rate",
                        "requirement": {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating women or those planning to conceive.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "planning to conceive",
                        "criterion": "plans to conceive",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "planning to conceive",
                        "criterion": "plans to conceive",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).",
                "criterions": [
                    {
                        "exact_snippets": "The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect",
                        "criterion": "traditional Chinese patent medicines and simple preparations with anti-tumor effect",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has received ... chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient has received ... physical therapy",
                        "criterion": "physical therapy",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect",
                                        "criterion": "traditional Chinese patent medicines and simple preparations with anti-tumor effect",
                                        "requirement": {
                                            "requirement_type": "received",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "The patient has received ... chemotherapy",
                                        "criterion": "chemotherapy",
                                        "requirement": {
                                            "requirement_type": "received",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "The patient has received ... physical therapy",
                                "criterion": "physical therapy",
                                "requirement": {
                                    "requirement_type": "received",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.",
                "criterions": [
                    {
                        "exact_snippets": "Suffering from serious mental illness",
                        "criterion": "serious mental illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other reasons that the researcher deems unsuitable",
                        "criterion": "suitability for study participation",
                        "requirement": {
                            "requirement_type": "researcher assessment",
                            "expected_value": "unsuitable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Suffering from serious mental illness",
                        "criterion": "serious mental illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other reasons that the researcher deems unsuitable",
                        "criterion": "suitability for study participation",
                        "requirement": {
                            "requirement_type": "researcher assessment",
                            "expected_value": "unsuitable"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.",
                "criterions": [
                    {
                        "exact_snippets": "difficulty swallowing",
                        "criterion": "difficulty swallowing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "complete or incomplete gastrointestinal obstruction",
                        "criterion": "gastrointestinal obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active gastrointestinal bleeding",
                        "criterion": "gastrointestinal bleeding",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "perforation",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other oral medication difficulties",
                        "criterion": "oral medication difficulties",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.",
                "criterions": [
                    {
                        "exact_snippets": "levels of aspartate aminotransferase ... are still 2.5 times higher than the upper limit of normal values",
                        "criterion": "aspartate aminotransferase levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "levels of ... alanine aminotransferase ... are still 2.5 times higher than the upper limit of normal values",
                        "criterion": "alanine aminotransferase levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "levels of ... total bilirubin are still 2.5 times higher than the upper limit of normal values",
                        "criterion": "total bilirubin levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of merging with other malignant tumors.",
                "criterions": [
                    {
                        "exact_snippets": "History of merging with other malignant tumors.",
                        "criterion": "merging with other malignant tumors",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment.",
                "criterions": [
                    {
                        "exact_snippets": "concomitant myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cerebral infarction",
                        "criterion": "cerebral infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other thromboembolic diseases requiring surgical treatment",
                        "criterion": "thromboembolic diseases",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "surgical"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Concomitant severe infection.",
                "criterions": [
                    {
                        "exact_snippets": "Concomitant severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Concomitant severe infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "concomitance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}