{
    "info": {
        "nct_id": "NCT05591560",
        "official_title": "The Possible Effect of Itraconazole as add-on Therapy to Paclitaxel and Carboplatin on the Treatment Outcome in Patients With Advanced Ovarian Cancer",
        "inclusion_criteria": "* Female patients Age >18 years old < 65 years old.\n* Patients with histopathological and radiological based diagnosis of III, IV epithelial ovarian carcinoma according to 8th edition AJCC, primary tumor, regional nodes, metastasis (TNM) staging system.11\n* Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1. 13\n* Patients able to swallow and retain oral medications (without crushing, dissolving, or chewing tablets).\n* Patients with adequate hematologic and organ function within 14 days before the first Cycle which can be defined by the following:\n\n  * Neutrophils (absolute neutrophil count (ANC) >1.5 X 10^9/L).\n  * Hemoglobin >9 g/dl.\n  * Platelet count >100,000/L.\n  * Serum albumin >3 g/dl.\n  * Total bilirubin 1.5 ≤ of the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine transaminase ( ALT) ≤ 2 of the upper limit of normal (ULN).\n  * Serum creatinine ≤ 1.5 of the upper limit of normal (ULN) or estimated creatinine clearance >50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Presence of 2nd primary malignancy\n* History of allergic reactions attributed to paclitaxel, carboplatin, and itraconazole or to compounds of similar chemical or biologic composition to itraconazole.\n* Concurrent use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants).\n* Patients with hyperthyroidism (which would increase metabolism of itraconazole).\n* Patients with grade ≥ 2 neuropathy.\n* Patients with Uncontrolled, concurrent medical illness.\n* Patients with active hepatitis or symptomatic liver disease.\n* History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or patients with class III and class IV heart failure according to New York Heart Association (NYHA).\n* Pregnant or lactating female .",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female patients Age >18 years old < 65 years old.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "Age >18 years old < 65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histopathological and radiological based diagnosis of III, IV epithelial ovarian carcinoma according to 8th edition AJCC, primary tumor, regional nodes, metastasis (TNM) staging system.11",
            "criterions": [
                {
                    "exact_snippets": "histopathological and radiological based diagnosis",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "histopathological",
                                "radiological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "III, IV epithelial ovarian carcinoma",
                    "criterion": "epithelial ovarian carcinoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "8th edition AJCC, primary tumor, regional nodes, metastasis (TNM) staging system",
                    "criterion": "staging system",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "8th"
                        },
                        {
                            "requirement_type": "system",
                            "expected_value": "AJCC TNM"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1. 13",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status of 0 or 1",
                    "criterion": "Eastern Cooperative Oncology Group Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients able to swallow and retain oral medications (without crushing, dissolving, or chewing tablets).",
            "criterions": [
                {
                    "exact_snippets": "Patients able to swallow and retain oral medications",
                    "criterion": "ability to swallow and retain oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without crushing, dissolving, or chewing tablets",
                    "criterion": "method of tablet consumption",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "not crushing",
                                "not dissolving",
                                "not chewing"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with adequate hematologic and organ function within 14 days before the first Cycle which can be defined by the following:",
            "criterions": [
                {
                    "exact_snippets": "adequate hematologic ... within 14 days before the first Cycle",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first Cycle"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... organ function within 14 days before the first Cycle",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first Cycle"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophils (absolute neutrophil count (ANC) >1.5 X 10^9/L).",
            "criterions": [
                {
                    "exact_snippets": "Neutrophils (absolute neutrophil count (ANC) >1.5 X 10^9/L)",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "X 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >9 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >9 g/dl.",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >100,000/L.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >100,000/L.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum albumin >3 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Serum albumin >3 g/dl",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin 1.5 ≤ of the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine transaminase ( ALT) ≤ 2 of the upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin 1.5 ≤ of the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine transaminase ( ALT) ≤ 2 of the upper limit of normal (ULN)",
                    "criterion": "aspartate aminotransferase (AST) and alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 of the upper limit of normal (ULN) or estimated creatinine clearance >50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 of the upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated creatinine clearance >50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Presence of 2nd primary malignancy",
            "criterions": [
                {
                    "exact_snippets": "Presence of 2nd primary malignancy",
                    "criterion": "2nd primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to paclitaxel, carboplatin, and itraconazole or to compounds of similar chemical or biologic composition to itraconazole.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to paclitaxel",
                    "criterion": "allergic reactions to paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to ... carboplatin",
                    "criterion": "allergic reactions to carboplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to ... itraconazole",
                    "criterion": "allergic reactions to itraconazole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to ... compounds of similar chemical or biologic composition to itraconazole",
                    "criterion": "allergic reactions to compounds similar to itraconazole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants).",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of medications significantly affecting metabolism of itraconazole",
                    "criterion": "medication use",
                    "requirements": [
                        {
                            "requirement_type": "effect on metabolism",
                            "expected_value": "significantly affecting metabolism of itraconazole"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hyperthyroidism (which would increase metabolism of itraconazole).",
            "criterions": [
                {
                    "exact_snippets": "Patients with hyperthyroidism",
                    "criterion": "hyperthyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with grade ≥ 2 neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "grade ≥ 2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Uncontrolled, concurrent medical illness.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, concurrent medical illness",
                    "criterion": "concurrent medical illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active hepatitis or symptomatic liver disease.",
            "criterions": [
                {
                    "exact_snippets": "active hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or patients with class III and class IV heart failure according to New York Heart Association (NYHA).",
            "criterions": [
                {
                    "exact_snippets": "History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure)",
                    "criterion": "uncontrolled cardiac ventricular dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with class III and class IV heart failure according to New York Heart Association (NYHA)",
                    "criterion": "NYHA heart failure class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "class III",
                                "class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating female .",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}