{
    "info": {
        "nct_id": "NCT01148160",
        "official_title": "The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis",
        "inclusion_criteria": "all items below\n\n* male or female ≥ 15 years of age\n* immunocompromised patients with hematologic disorders\n* patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis\nHealthy volunteers allowed\nMust have minimum age of 15 Years",
        "exclusion_criteria": "* severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)\n* who experienced hypersensitivity to azoles\n* pregnant women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "all items below",
            "criterions": [
                {
                    "exact_snippets": "all items below",
                    "criterion": "all items",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* male or female ≥ 15 years of age",
            "criterions": [
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 15 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* immunocompromised patients with hematologic disorders",
            "criterions": [
                {
                    "exact_snippets": "immunocompromised patients",
                    "criterion": "immunocompromised status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hematologic disorders",
                    "criterion": "hematologic disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis",
            "criterions": [
                {
                    "exact_snippets": "patients received voriconazole",
                    "criterion": "voriconazole treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treat proven, probable invasive (pulmonary) aspergillosis",
                    "criterion": "invasive pulmonary aspergillosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "proven",
                                "probable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)",
            "criterions": [
                {
                    "exact_snippets": "severe hepatic dysfunction",
                    "criterion": "hepatic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "t.bil ... > 5 x upper normal limit",
                    "criterion": "total bilirubin (t.bil)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... > 5 x upper normal limit",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ... > 5 x upper normal limit",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALP > 5 x upper normal limit",
                    "criterion": "alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* who experienced hypersensitivity to azoles",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to azoles",
                    "criterion": "hypersensitivity to azoles",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pregnant women",
            "criterions": [
                {
                    "exact_snippets": "pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}