{
    "info": {
        "nct_id": "NCT02526823",
        "official_title": "Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma",
        "inclusion_criteria": "1. Primary B-NHL, PTCL (ALK+ anaplastic large cell lymphoma and NK(natural killer cell )/T cell lymphoma were excluded) or HL patients confirmed by histopathology;\n2. Ages ≥18 years old, < 80 years old;\n3. ECOG (Eastern Cooperative Oncology Group）score: 0-2\n4. At least one measurable lesion;\n5. Expected survival time≥3 months;\n6. Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤1.5×upper limit of normal value;\n7. Renal function: serum creatinine is 44-133 mmol/L;\n8. Routine blood test：WBC≥3.0×109/L，Neutrophils≥1.5×109/L，Hb≥100g/L，Platelet≥80×109/L； LVEF≥50%;\n9. New York Heart Association (NYHA) heart function classification is I-II grade\n10. signed informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Patients with severe complications or severe infection;\n2. Invasion of central nervous system;\n3. Patients with severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;\n4. patients with severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;\n5. patients received doxorubicin therapy, total cumulative dose of adriamycin was more than 300 mg/m2, total cumulative dose of epirubicin was more than 450 mg/m2;\n6. Patients participate in other clinical studies;\n7. Other patients who are not suitable for the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Primary B-NHL, PTCL (ALK+ anaplastic large cell lymphoma and NK(natural killer cell )/T cell lymphoma were excluded) or HL patients confirmed by histopathology;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Primary B-NHL"
                    ],
                    "criterion": "B-NHL",
                    "requirement_type": "type",
                    "expected_value": "primary"
                },
                {
                    "exact_snippets": [
                        "PTCL"
                    ],
                    "criterion": "PTCL",
                    "requirement_type": "type",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ALK+ anaplastic large cell lymphoma",
                        "excluded"
                    ],
                    "criterion": "ALK+ anaplastic large cell lymphoma",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "NK(natural killer cell )/T cell lymphoma",
                        "excluded"
                    ],
                    "criterion": "NK/T cell lymphoma",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "HL patients"
                    ],
                    "criterion": "HL",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "confirmed by histopathology"
                    ],
                    "criterion": "histopathology confirmation",
                    "requirement_type": "confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Ages ≥18 years old, < 80 years old;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ages ≥18 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "< 80 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 80
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "3. ECOG (Eastern Cooperative Oncology Group）score: 0-2",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG (Eastern Cooperative Oncology Group）score"
                    ],
                    "criterion": "ECOG score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. At least one measurable lesion;",
            "criterions": [
                {
                    "exact_snippets": [
                        "At least one measurable lesion"
                    ],
                    "criterion": "measurable lesion",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "5. Expected survival time≥3 months;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Expected survival time",
                        "≥3 months"
                    ],
                    "criterion": "survival time",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "6. Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤1.5×upper limit of normal value;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Liver function: transaminase≤2.5× upper limit of normal value"
                    ],
                    "criterion": "transaminase",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "bilirubin≤1.5×upper limit of normal value"
                    ],
                    "criterion": "bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "7. Renal function: serum creatinine is 44-133 mmol/L;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Renal function: serum creatinine is 44-133 mmol/L"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 44
                            },
                            {
                                "operator": "<=",
                                "value": 133
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "8. Routine blood test：WBC≥3.0×109/L，Neutrophils≥1.5×109/L，Hb≥100g/L，Platelet≥80×109/L； LVEF≥50%;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Routine blood test",
                        "WBC≥3.0×109/L"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Routine blood test",
                        "Neutrophils≥1.5×109/L"
                    ],
                    "criterion": "neutrophils",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Routine blood test",
                        "Hb≥100g/L"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Routine blood test",
                        "Platelet≥80×109/L"
                    ],
                    "criterion": "platelet",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 80
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "LVEF≥50%"
                    ],
                    "criterion": "left ventricular ejection fraction",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 50
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "9. New York Heart Association (NYHA) heart function classification is I-II grade",
            "criterions": [
                {
                    "exact_snippets": [
                        "New York Heart Association (NYHA) heart function classification"
                    ],
                    "criterion": "NYHA heart function classification",
                    "requirement_type": "grade",
                    "expected_value": [
                        "I",
                        "II"
                    ]
                }
            ]
        },
        {
            "line": "10. signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "signed informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "signed",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 80 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 80
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with severe complications or severe infection;",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe complications"
                    ],
                    "criterion": "complications",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "severe infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "line": "2. Invasion of central nervous system;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Invasion of central nervous system"
                    ],
                    "criterion": "central nervous system",
                    "requirement_type": "invasion",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Patients with severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe heart disease history"
                    ],
                    "criterion": "heart disease",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "ventricular tachycardia (VT)"
                    ],
                    "criterion": "ventricular tachycardia",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "atrial fibrillation (AF)"
                    ],
                    "criterion": "atrial fibrillation",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "heart block"
                    ],
                    "criterion": "heart block",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "myocardial infarction (MI)"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "congestive heart failure (CHF)"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "coronary heart disease",
                        "needed therapy"
                    ],
                    "criterion": "coronary heart disease",
                    "requirement_type": "therapy requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "4. patients with severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe allergic constitution"
                    ],
                    "criterion": "allergic constitution",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "allergic to",
                        "drug composition in chemotherapy regimens"
                    ],
                    "criterion": "allergy",
                    "requirement_type": "presence",
                    "expected_value": "drug composition in chemotherapy regimens"
                },
                {
                    "exact_snippets": [
                        "intolerant of",
                        "drug composition in chemotherapy regimens"
                    ],
                    "criterion": "intolerance",
                    "requirement_type": "presence",
                    "expected_value": "drug composition in chemotherapy regimens"
                },
                {
                    "exact_snippets": [
                        "other malignant tumors",
                        "in the past 5 years"
                    ],
                    "criterion": "malignant tumors",
                    "requirement_type": "history",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "5. patients received doxorubicin therapy, total cumulative dose of adriamycin was more than 300 mg/m2, total cumulative dose of epirubicin was more than 450 mg/m2;",
            "criterions": [
                {
                    "exact_snippets": [
                        "patients received doxorubicin therapy"
                    ],
                    "criterion": "doxorubicin therapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "total cumulative dose of adriamycin was more than 300 mg/m2"
                    ],
                    "criterion": "adriamycin",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 300
                    }
                },
                {
                    "exact_snippets": [
                        "total cumulative dose of epirubicin was more than 450 mg/m2"
                    ],
                    "criterion": "epirubicin",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 450
                    }
                }
            ]
        },
        {
            "line": "6. Patients participate in other clinical studies;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients participate in other clinical studies"
                    ],
                    "criterion": "participation in other clinical studies",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "7. Other patients who are not suitable for the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other patients who are not suitable for the study"
                    ],
                    "criterion": "suitability for the study",
                    "requirement_type": "suitability",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}