{
    "info": {
        "nct_id": "NCT01655927",
        "official_title": "PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS",
        "inclusion_criteria": "* Patients who agree to participate by giving informed consent\n* Eligible previously untreated patients with resectable brain tumor.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Patients with previous thromboembolic events.\n* Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)\n* Patients with impaired renal function (Creatinine >1.1mg/dl)\n* Patients with known contraindications to fibrinolytic treatment.\n* Patients receiving rejection therapy.\n* Patients with abnormal liver function.\n* Known allergies to Tranexamic Acid.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients who agree to participate by giving informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients who agree to participate by giving informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible previously untreated patients with resectable brain tumor.",
            "criterions": [
                {
                    "exact_snippets": "Eligible previously untreated patients",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable brain tumor",
                    "criterion": "brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 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": "* Patients with previous thromboembolic events.",
            "criterions": [
                {
                    "exact_snippets": "previous thromboembolic events",
                    "criterion": "thromboembolic events",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)",
            "criterions": [
                {
                    "exact_snippets": "Patients with coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anticoagulation therapy",
                    "criterion": "anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal PT",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal ... PTT",
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with impaired renal function (Creatinine >1.1mg/dl)",
            "criterions": [
                {
                    "exact_snippets": "impaired renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine >1.1mg/dl",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.1,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known contraindications to fibrinolytic treatment.",
            "criterions": [
                {
                    "exact_snippets": "known contraindications to fibrinolytic treatment",
                    "criterion": "contraindications to fibrinolytic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving rejection therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving rejection therapy",
                    "criterion": "rejection therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with abnormal liver function.",
            "criterions": [
                {
                    "exact_snippets": "abnormal liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergies to Tranexamic Acid.",
            "criterions": [
                {
                    "exact_snippets": "Known allergies to Tranexamic Acid.",
                    "criterion": "allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "Tranexamic Acid"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}