{
    "info": {
        "nct_id": "NCT01696760",
        "official_title": "Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology",
        "inclusion_criteria": "-Scheduled or to be scheduled for surgery performed on neoplasms of the pelvis or lower limbs, including both primary musculoskeletal lesions as well as metastatic lesions; these neoplasms may include major tumor resections, metastatic and pathologic fractures of the hip and lower extremities (LE), open biopsies, and primary malignant tumors; an active malignant neoplasm must be present at the time of surgery\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior history of DVT or PE\n* Previously placed vena cava filter\n* No detectable malignant disease at the time of operation\n* Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident [CVA])\n* Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis); excluded if platelets < 50,000\n* Preoperative anticoagulation or active/serious bleeding in past 2 weeks (prothrombin time [PT] & partial thromboplastin time [PTT] > 1.6 & > 35)\n* Hypersensitivity or allergy to aspirin or heparin (including those diagnosed with heparin-induced thrombocytopenia)\n* Conditions associated with bleeding (active ulcer disease, recent neurosurgery, bleeding disorders)\n* Patients with renal insufficiency (creatinine [Cr] > 1.5)\n* Pregnant patients\n* Epidural anesthesia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "-Scheduled or to be scheduled for surgery performed on neoplasms of the pelvis or lower limbs, including both primary musculoskeletal lesions as well as metastatic lesions; these neoplasms may include major tumor resections, metastatic and pathologic fractures of the hip and lower extremities (LE), open biopsies, and primary malignant tumors; an active malignant neoplasm must be present at the time of surgery",
            "criterions": [
                {
                    "exact_snippets": "Scheduled or to be scheduled for surgery",
                    "criterion": "surgery schedule",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "scheduled or to be scheduled"
                        }
                    ]
                },
                {
                    "exact_snippets": "neoplasms of the pelvis or lower limbs",
                    "criterion": "neoplasms location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pelvis",
                                "lower limbs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary musculoskeletal lesions",
                    "criterion": "lesion type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary musculoskeletal"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic lesions",
                    "criterion": "lesion type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "major tumor resections",
                    "criterion": "procedure type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "major tumor resections"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic and pathologic fractures of the hip and lower extremities (LE)",
                    "criterion": "fracture type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "metastatic",
                                "pathologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "open biopsies",
                    "criterion": "procedure type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "open biopsies"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary malignant tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary malignant"
                        }
                    ]
                },
                {
                    "exact_snippets": "an active malignant neoplasm must be present at the time of surgery",
                    "criterion": "malignant neoplasm presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior history of DVT or PE",
            "criterions": [
                {
                    "exact_snippets": "Prior history of DVT",
                    "criterion": "DVT (Deep Vein Thrombosis)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of ... PE",
                    "criterion": "PE (Pulmonary Embolism)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously placed vena cava filter",
            "criterions": [
                {
                    "exact_snippets": "Previously placed vena cava filter",
                    "criterion": "vena cava filter",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No detectable malignant disease at the time of operation",
            "criterions": [
                {
                    "exact_snippets": "No detectable malignant disease",
                    "criterion": "malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident [CVA])",
            "criterions": [
                {
                    "exact_snippets": "Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident [CVA])",
                    "criterion": "arterial thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction [MI]",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebral vascular accident [CVA]",
                    "criterion": "cerebral vascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis); excluded if platelets < 50,000",
            "criterions": [
                {
                    "exact_snippets": "Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis)",
                    "criterion": "platelet dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "causes",
                            "expected_value": [
                                "uremia",
                                "medications",
                                "dysplastic hematopoiesis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "excluded if platelets < 50,000",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": ""
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity or allergy to aspirin or heparin (including those diagnosed with heparin-induced thrombocytopenia)",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity or allergy to aspirin",
                    "criterion": "hypersensitivity or allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "aspirin"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity or allergy to ... heparin",
                    "criterion": "hypersensitivity or allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "heparin"
                        }
                    ]
                },
                {
                    "exact_snippets": "heparin-induced thrombocytopenia",
                    "criterion": "heparin-induced thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conditions associated with bleeding (active ulcer disease, recent neurosurgery, bleeding disorders)",
            "criterions": [
                {
                    "exact_snippets": "Conditions associated with bleeding (active ulcer disease",
                    "criterion": "active ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Conditions associated with bleeding ... recent neurosurgery",
                    "criterion": "recent neurosurgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Conditions associated with bleeding ... bleeding disorders",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with renal insufficiency (creatinine [Cr] > 1.5)",
            "criterions": [
                {
                    "exact_snippets": "renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine [Cr] > 1.5",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant patients",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Epidural anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Epidural anesthesia",
                    "criterion": "epidural anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Preoperative anticoagulation or active/serious bleeding in past 2 weeks (prothrombin time [PT] & partial thromboplastin time [PTT] > 1.6 & > 35)",
            "criterions": [
                {
                    "exact_snippets": "Preoperative anticoagulation",
                    "criterion": "preoperative anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active/serious bleeding in past 2 weeks",
                    "criterion": "active/serious bleeding",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 weeks"
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time [PT] ... > 1.6",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "partial thromboplastin time [PTT] > 35",
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 35,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}