{
    "info": {
        "nct_id": "NCT00041782",
        "official_title": "Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\nCancer patients with documented DVT and meeting eligibility criteria will be entered on the study if they consent to participate.\n\nPatients eligible for the study will include:\n\n* Patients with solid tumors (including lymphoma and myeloma).\n* Patients with clinical and venographic or ultrasonographic evidence of thrombosis of the proximal or distal lower or upper extremity.\n* Patients with catheter-related thrombosis will be eligible for the study if they are not candidates for thrombolytic therapy.\n* Patients with Zubrod performance status of <2. (Appendix A)\n* Patients with adequate bone marrow function: platelets >100,000/mm3, and ANC >1,500 cells/mm3.\n* Patients with adequate renal function: creatinine < 2.5 mg/dL.\n* Patients with adequate liver function: SGPT < 1.5 x upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, bilirubin < 1.5 mg/dL.\n* Patients must have caregiver available and willing to assist with care and transportation for the first 72 hours of the study period.\n* Patients must have a telephone within the home.\n* Patients must live or stay within a 30-mile radius of the study site.\n* Patients must have a history of compliance with outpatient therapy and follow-up visits.\n* Patients must be able to read to complete study instruments.\n\nExclusion Criteria\n\nA patient must not be enrolled if any of these criteria apply:\n\n* Prior history of DVT or PE in the past year.\n* Evidence of active bleeding, active peptic ulcer disease, or a familial bleeding disorder proven with a diagnostic study.\n* A Hemoglobin of 7.5 or less.\n* Concurrent symptomatic PE in the past year.\n* Currently receiving treatment with UFH for DVT.\n* An inability to be treated with LMWH as an outpatient because of comorbidities or clinical condition requiring hospitalization: (cerebral vascular accident, uncontrolled diabetes mellitus, uncontrolled hypertension, new onset atrial fibrillation, chronic obstructive pulmonary disease with dyspnea, and / or trauma).\n* Hypotension (systolic blood pressure < 90 mm Hg).\n* Tachypnea (respiratory rate > 30/min.).\n* Altered sensorium.\n* Uncontrolled hypercalcemia (Corrected calcium > 12mg/dL).\n* Hyponatremia (serum sodium < 128 mg/dL).\n* Women who are pregnant or nursing.\n* Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.\n* Patients with the presence of known deficiency of antithrombin III, protein C, or protein S.\n* Patients with known history of activated protein C resistance.\n* Patients on oral anticoagulants (anisindione, dicumarol or warfarin) and/or platelet inhibitors (aspirin, abciximab, alprostadil, dipyridamole, sulfinpyrazone, ticlopidine or NSAIDS) that could affect hemostasis.\n* Patients with previous heparin-induced thrombocytopenia.\n* Patients with epidural catheters.\n* Patients with a hypersensitivity reaction of UFH, dalteparin or porcine products.\n* Patients with known non-compliance with previous treatment regimens.\n* Patients with primary central nervous system tumors, brain metastases or evidence of leptomeningeal disease.\n* Treatment Plan (Appendix B)"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Cancer patients with documented DVT and meeting eligibility criteria will be entered on the study if they consent to participate.",
                "criterions": [
                    {
                        "exact_snippets": "Cancer patients",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "documented DVT",
                        "criterion": "DVT (Deep Vein Thrombosis)",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "consent to participate",
                        "criterion": "consent",
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                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Cancer patients",
                                "criterion": "cancer",
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                                    "expected_value": true
                                }
                            },
                            {
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        },
        {
            "identified_line": {
                "line": "* Patients with solid tumors (including lymphoma and myeloma).",
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                    {
                        "exact_snippets": "solid tumors",
                        "criterion": "solid tumors",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lymphoma",
                        "criterion": "lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myeloma",
                        "criterion": "myeloma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "solid tumors",
                                "criterion": "solid tumors",
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                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "lymphoma",
                                    "criterion": "lymphoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "myeloma",
                                    "criterion": "myeloma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "lymphoma",
                        "criterion": "lymphoma",
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                    },
                    {
                        "exact_snippets": "myeloma",
                        "criterion": "myeloma",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with catheter-related thrombosis will be eligible for the study if they are not candidates for thrombolytic therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with catheter-related thrombosis",
                        "criterion": "catheter-related thrombosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "if they are not candidates for thrombolytic therapy",
                        "criterion": "candidacy for thrombolytic therapy",
                        "requirement": {
                            "requirement_type": "candidacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                    "criterion": "catheter-related thrombosis",
                    "requirement": {
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                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "if they are not candidates for thrombolytic therapy",
                    "criterion": "candidacy for thrombolytic therapy",
                    "requirement": {
                        "requirement_type": "candidacy",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients with Zubrod performance status of <2. (Appendix A)",
                "criterions": [
                    {
                        "exact_snippets": "Zubrod performance status of <2",
                        "criterion": "Zubrod performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Zubrod performance status of <2",
                        "criterion": "Zubrod performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with adequate bone marrow function: platelets >100,000/mm3, and ANC >1,500 cells/mm3.",
                "criterions": [
                    {
                        "exact_snippets": "adequate bone marrow function: platelets >100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "adequate bone marrow function: ... ANC >1,500 cells/mm3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate bone marrow function: platelets >100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "adequate bone marrow function: ... ANC >1,500 cells/mm3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with adequate renal function: creatinine < 2.5 mg/dL.",
                "criterions": [
                    {
                        "exact_snippets": "adequate renal function: creatinine < 2.5 mg/dL",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate renal function: creatinine < 2.5 mg/dL",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be able to read to complete study instruments.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be able to read",
                        "criterion": "reading ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must be able to read",
                        "criterion": "reading ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "A patient must not be enrolled if any of these criteria apply:",
                "criterions": [
                    {
                        "exact_snippets": "A patient must not be enrolled if any of these criteria apply",
                        "criterion": "enrollment exclusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "or_criteria": [
                        {
                            "exact_snippets": "A patient must not be enrolled if any of these criteria apply",
                            "criterion": "enrollment exclusion",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
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                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Prior history of DVT or PE in the past year.",
                "criterions": [
                    {
                        "exact_snippets": "Prior history of DVT",
                        "criterion": "DVT (Deep Vein Thrombosis)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior history of DVT",
                        "criterion": "DVT (Deep Vein Thrombosis)",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior history of ... PE",
                        "criterion": "PE (Pulmonary Embolism)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior history of ... PE",
                        "criterion": "PE (Pulmonary Embolism)",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior history of DVT",
                                "criterion": "DVT (Deep Vein Thrombosis)",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior history of DVT",
                                "criterion": "DVT (Deep Vein Thrombosis)",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
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                                                "unit": "year"
                                            }
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                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior history of ... PE",
                                "criterion": "PE (Pulmonary Embolism)",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior history of ... PE",
                                "criterion": "PE (Pulmonary Embolism)",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "year"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of active bleeding, active peptic ulcer disease, or a familial bleeding disorder proven with a diagnostic study.",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of active bleeding",
                        "criterion": "active bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active peptic ulcer disease",
                        "criterion": "active peptic ulcer disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "familial bleeding disorder proven with a diagnostic study",
                        "criterion": "familial bleeding disorder",
                        "requirement": {
                            "requirement_type": "diagnostic study",
                            "expected_value": "proven"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Evidence of active bleeding",
                        "criterion": "active bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active peptic ulcer disease",
                        "criterion": "active peptic ulcer disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "familial bleeding disorder proven with a diagnostic study",
                        "criterion": "familial bleeding disorder",
                        "requirement": {
                            "requirement_type": "diagnostic study",
                            "expected_value": "proven"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A Hemoglobin of 7.5 or less.",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin of 7.5 or less",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin of 7.5 or less",
                        "criterion": "hemoglobin level",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent symptomatic PE in the past year.",
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                    {
                        "exact_snippets": "Concurrent symptomatic PE",
                        "criterion": "symptomatic pulmonary embolism (PE)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the past year",
                        "criterion": "timeframe of PE occurrence",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "past year"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Concurrent symptomatic PE",
                        "criterion": "symptomatic pulmonary embolism (PE)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the past year",
                        "criterion": "timeframe of PE occurrence",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "past year"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently receiving treatment with UFH for DVT.",
                "criterions": [
                    {
                        "exact_snippets": "Currently receiving treatment with UFH",
                        "criterion": "treatment with UFH",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "DVT",
                        "criterion": "DVT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Currently receiving treatment with UFH",
                        "criterion": "treatment with UFH",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "DVT",
                        "criterion": "DVT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* An inability to be treated with LMWH as an outpatient because of comorbidities or clinical condition requiring hospitalization: (cerebral vascular accident, uncontrolled diabetes mellitus, uncontrolled hypertension, new onset atrial fibrillation, chronic obstructive pulmonary disease with dyspnea, and / or trauma).",
                "criterions": [
                    {
                        "exact_snippets": "cerebral vascular accident",
                        "criterion": "cerebral vascular accident",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled diabetes mellitus",
                        "criterion": "uncontrolled diabetes mellitus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "new onset atrial fibrillation",
                        "criterion": "new onset atrial fibrillation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic obstructive pulmonary disease with dyspnea",
                        "criterion": "chronic obstructive pulmonary disease with dyspnea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "trauma",
                        "criterion": "trauma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "cerebral vascular accident",
                                "criterion": "cerebral vascular accident",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled diabetes mellitus",
                                "criterion": "uncontrolled diabetes mellitus",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled hypertension",
                                "criterion": "uncontrolled hypertension",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "new onset atrial fibrillation",
                                "criterion": "new onset atrial fibrillation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "chronic obstructive pulmonary disease with dyspnea",
                                "criterion": "chronic obstructive pulmonary disease with dyspnea",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "trauma",
                                "criterion": "trauma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hypotension (systolic blood pressure < 90 mm Hg).",
                "criterions": [
                    {
                        "exact_snippets": "Hypotension (systolic blood pressure < 90 mm Hg)",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hypotension (systolic blood pressure < 90 mm Hg)",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Tachypnea (respiratory rate > 30/min.).",
                "criterions": [
                    {
                        "exact_snippets": "Tachypnea (respiratory rate > 30/min.)",
                        "criterion": "tachypnea",
                        "requirement": {
                            "requirement_type": "respiratory rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Tachypnea (respiratory rate > 30/min.)",
                        "criterion": "tachypnea",
                        "requirement": {
                            "requirement_type": "respiratory rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Altered sensorium.",
                "criterions": [
                    {
                        "exact_snippets": "Altered sensorium",
                        "criterion": "sensorium",
                        "requirement": {
                            "requirement_type": "state",
                            "expected_value": "altered"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Altered sensorium",
                        "criterion": "sensorium",
                        "requirement": {
                            "requirement_type": "state",
                            "expected_value": "altered"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled hypercalcemia (Corrected calcium > 12mg/dL).",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypercalcemia (Corrected calcium > 12mg/dL)",
                        "criterion": "corrected calcium",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled hypercalcemia (Corrected calcium > 12mg/dL)",
                    "criterion": "corrected calcium",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": ">",
                            "value": 12,
                            "unit": "mg/dL"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Hyponatremia (serum sodium < 128 mg/dL).",
                "criterions": [
                    {
                        "exact_snippets": "Hyponatremia (serum sodium < 128 mg/dL)",
                        "criterion": "serum sodium",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 128,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hyponatremia (serum sodium < 128 mg/dL)",
                        "criterion": "serum sodium",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 128,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women who are pregnant or nursing.",
                "criterions": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.",
                "criterions": [
                    {
                        "exact_snippets": "Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.",
                        "criterion": "platelet count decrease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.",
                        "criterion": "platelet count decrease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "10 days following entry"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.",
                        "criterion": "platelet count decrease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Expected decrease in the platelet count of less than 50,000 during the next 10 days following entry.",
                        "criterion": "platelet count decrease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "10 days following entry"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with the presence of known deficiency of antithrombin III, protein C, or protein S.",
                "criterions": [
                    {
                        "exact_snippets": "presence of known deficiency of antithrombin III",
                        "criterion": "antithrombin III deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presence of known deficiency of ... protein C",
                        "criterion": "protein C deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presence of known deficiency of ... protein S",
                        "criterion": "protein S deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "presence of known deficiency of antithrombin III",
                        "criterion": "antithrombin III deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presence of known deficiency of ... protein C",
                        "criterion": "protein C deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presence of known deficiency of ... protein S",
                        "criterion": "protein S deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known history of activated protein C resistance.",
                "criterions": [
                    {
                        "exact_snippets": "known history of activated protein C resistance",
                        "criterion": "activated protein C resistance",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "known history of activated protein C resistance",
                        "criterion": "activated protein C resistance",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients on oral anticoagulants (anisindione, dicumarol or warfarin) and/or platelet inhibitors (aspirin, abciximab, alprostadil, dipyridamole, sulfinpyrazone, ticlopidine or NSAIDS) that could affect hemostasis.",
                "criterions": [
                    {
                        "exact_snippets": "Patients on oral anticoagulants (anisindione, dicumarol or warfarin)",
                        "criterion": "oral anticoagulants",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients on ... platelet inhibitors (aspirin, abciximab, alprostadil, dipyridamole, sulfinpyrazone, ticlopidine or NSAIDS)",
                        "criterion": "platelet inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients on oral anticoagulants (anisindione, dicumarol or warfarin)",
                                "criterion": "oral anticoagulants",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients on ... platelet inhibitors (aspirin, abciximab, alprostadil, dipyridamole, sulfinpyrazone, ticlopidine or NSAIDS)",
                                "criterion": "platelet inhibitors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with previous heparin-induced thrombocytopenia.",
                "criterions": [
                    {
                        "exact_snippets": "previous heparin-induced thrombocytopenia",
                        "criterion": "heparin-induced thrombocytopenia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "previous heparin-induced thrombocytopenia",
                    "criterion": "heparin-induced thrombocytopenia",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with epidural catheters.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with epidural catheters",
                        "criterion": "epidural catheters",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with epidural catheters",
                        "criterion": "epidural catheters",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with a hypersensitivity reaction of UFH, dalteparin or porcine products.",
                "criterions": [
                    {
                        "exact_snippets": "hypersensitivity reaction of UFH",
                        "criterion": "hypersensitivity to UFH",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity reaction of ... dalteparin",
                        "criterion": "hypersensitivity to dalteparin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity reaction of ... porcine products",
                        "criterion": "hypersensitivity to porcine products",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "hypersensitivity reaction of UFH",
                        "criterion": "hypersensitivity to UFH",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity reaction of ... dalteparin",
                        "criterion": "hypersensitivity to dalteparin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity reaction of ... porcine products",
                        "criterion": "hypersensitivity to porcine products",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known non-compliance with previous treatment regimens.",
                "criterions": [
                    {
                        "exact_snippets": "known non-compliance with previous treatment regimens",
                        "criterion": "non-compliance with previous treatment regimens",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "known non-compliance with previous treatment regimens",
                    "criterion": "non-compliance with previous treatment regimens",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with primary central nervous system tumors, brain metastases or evidence of leptomeningeal disease.",
                "criterions": [
                    {
                        "exact_snippets": "primary central nervous system tumors",
                        "criterion": "primary central nervous system tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evidence of leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "primary central nervous system tumors",
                        "criterion": "primary central nervous system tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evidence of leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Treatment Plan (Appendix B)",
                "criterions": [
                    {
                        "exact_snippets": "Treatment Plan (Appendix B)",
                        "criterion": "treatment plan",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "Appendix B"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Treatment Plan (Appendix B)",
                        "criterion": "treatment plan",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "Appendix B"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Inclusion Criteria",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Patients eligible for the study will include:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Exclusion Criteria",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Patients with clinical and venographic or ultrasonographic evidence of thrombosis of the proximal or distal lower or upper extremity.",
                "criterions": [
                    {
                        "exact_snippets": "clinical and venographic or ultrasonographic evidence of thrombosis",
                        "criterion": "thrombosis",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "venographic",
                                "ultrasonographic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "thrombosis of the proximal or distal lower or upper extremity",
                        "criterion": "location of thrombosis",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "proximal lower extremity",
                                "distal lower extremity",
                                "proximal upper extremity",
                                "distal upper extremity"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinical and venographic or ultrasonographic evidence of thrombosis",
                                "criterion": "thrombosis",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": [
                                        "clinical",
                                        "venographic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "clinical and venographic or ultrasonographic evidence of thrombosis",
                                "criterion": "thrombosis",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": [
                                        "ultrasonographic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "thrombosis of the proximal or distal lower or upper extremity",
                                "criterion": "location of thrombosis",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "proximal lower extremity"
                                }
                            },
                            {
                                "exact_snippets": "thrombosis of the proximal or distal lower or upper extremity",
                                "criterion": "location of thrombosis",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "distal lower extremity"
                                }
                            },
                            {
                                "exact_snippets": "thrombosis of the proximal or distal lower or upper extremity",
                                "criterion": "location of thrombosis",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "proximal upper extremity"
                                }
                            },
                            {
                                "exact_snippets": "thrombosis of the proximal or distal lower or upper extremity",
                                "criterion": "location of thrombosis",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "distal upper extremity"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with adequate liver function: SGPT < 1.5 x upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, bilirubin < 1.5 mg/dL.",
                "criterions": [
                    {
                        "exact_snippets": "SGPT < 1.5 x upper limit of normal",
                        "criterion": "SGPT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase < 2.5 x upper limit of normal",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin < 1.5 mg/dL",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have caregiver available and willing to assist with care and transportation for the first 72 hours of the study period.",
                "criterions": [
                    {
                        "exact_snippets": "caregiver available",
                        "criterion": "caregiver",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to assist with care and transportation",
                        "criterion": "caregiver assistance",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "first 72 hours of the study period",
                        "criterion": "caregiver assistance duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have a telephone within the home.",
                "criterions": [
                    {
                        "exact_snippets": "telephone within the home",
                        "criterion": "telephone access",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must live or stay within a 30-mile radius of the study site.",
                "criterions": [
                    {
                        "exact_snippets": "live or stay within a 30-mile radius of the study site",
                        "criterion": "distance from study site",
                        "requirement": {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "mile"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have a history of compliance with outpatient therapy and follow-up visits.",
                "criterions": [
                    {
                        "exact_snippets": "history of compliance with outpatient therapy",
                        "criterion": "compliance with outpatient therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of compliance with ... follow-up visits",
                        "criterion": "compliance with follow-up visits",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}