{
"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": [
{
"identified_line": {
"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",
"requirement": {
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"expected_value": "scheduled or to be scheduled"
}
},
{
"exact_snippets": "neoplasms of the pelvis or lower limbs",
"criterion": "neoplasms location",
"requirement": {
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"pelvis",
"lower limbs"
]
}
},
{
"exact_snippets": "primary musculoskeletal lesions",
"criterion": "lesion type",
"requirement": {
"requirement_type": "type",
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}
},
{
"exact_snippets": "metastatic lesions",
"criterion": "lesion type",
"requirement": {
"requirement_type": "type",
"expected_value": "metastatic"
}
},
{
"exact_snippets": "major tumor resections",
"criterion": "procedure type",
"requirement": {
"requirement_type": "type",
"expected_value": "major tumor resections"
}
},
{
"exact_snippets": "metastatic and pathologic fractures of the hip and lower extremities (LE)",
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"requirement": {
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"expected_value": [
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"pathologic"
]
}
},
{
"exact_snippets": "open biopsies",
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"requirement": {
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"expected_value": "open biopsies"
}
},
{
"exact_snippets": "primary malignant tumors",
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}
},
{
"exact_snippets": "an active malignant neoplasm must be present at the time of surgery",
"criterion": "malignant neoplasm presence",
"requirement": {
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"expected_value": true
}
}
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"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
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"exact_snippets": "primary musculoskeletal lesions",
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}
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{
"exact_snippets": "metastatic and pathologic fractures of the hip and lower extremities (LE)",
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"requirement": {
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"requirement": {
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}
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}
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{
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]
}
},
{
"exact_snippets": "an active malignant neoplasm must be present at the time of surgery",
"criterion": "malignant neoplasm presence",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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}
}
]
},
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"value": 18,
"unit": "Years"
}
}
}
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}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior history of DVT or PE",
"criterions": [
{
"exact_snippets": "Prior history of DVT",
"criterion": "DVT (Deep Vein Thrombosis)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Prior history of ... PE",
"criterion": "PE (Pulmonary Embolism)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Prior history of DVT",
"criterion": "DVT (Deep Vein Thrombosis)",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Prior history of ... PE",
"criterion": "PE (Pulmonary Embolism)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Previously placed vena cava filter",
"criterions": [
{
"exact_snippets": "Previously placed vena cava filter",
"criterion": "vena cava filter",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previously placed vena cava filter",
"criterion": "vena cava filter",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No detectable malignant disease at the time of operation",
"criterions": [
{
"exact_snippets": "No detectable malignant disease",
"criterion": "malignant disease",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "No detectable malignant disease",
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"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "myocardial infarction [MI]",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "cerebral vascular accident [CVA]",
"criterion": "cerebral vascular accident",
"requirement": {
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"expected_value": true
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident [CVA])",
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"requirement": {
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"expected_value": true
}
},
{
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}
}
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{
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"criterion": "arterial thrombosis",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "cerebral vascular accident [CVA]",
"criterion": "cerebral vascular accident",
"requirement": {
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}
}
]
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
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"expected_value": "severe"
}
},
{
"exact_snippets": "Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis)",
"criterion": "platelet dysfunction",
"requirement": {
"requirement_type": "causes",
"expected_value": [
"uremia",
"medications",
"dysplastic hematopoiesis"
]
}
},
{
"exact_snippets": "excluded if platelets < 50,000",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50000,
"unit": ""
}
}
}
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{
"and_criteria": [
{
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}
},
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"unit": ""
}
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"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"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",
"requirement": {
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"expected_value": "aspirin"
}
},
{
"exact_snippets": "Hypersensitivity or allergy to ... heparin",
"criterion": "hypersensitivity or allergy",
"requirement": {
"requirement_type": "substance",
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}
},
{
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"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Hypersensitivity or allergy to aspirin",
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"expected_value": "aspirin"
}
},
{
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}
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}
}
]
}
}
],
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"failed_inclusion": [],
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"line": "* Conditions associated with bleeding (active ulcer disease, recent neurosurgery, bleeding disorders)",
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{
"exact_snippets": "Conditions associated with bleeding (active ulcer disease",
"criterion": "active ulcer disease",
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"expected_value": true
}
},
{
"exact_snippets": "Conditions associated with bleeding ... recent neurosurgery",
"criterion": "recent neurosurgery",
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"expected_value": true
}
},
{
"exact_snippets": "Conditions associated with bleeding ... bleeding disorders",
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}
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"identified_line": {
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"expected_value": true
}
},
{
"exact_snippets": "creatinine [Cr] > 1.5",
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"unit": "N/A"
}
}
}
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}
}
},
{
"identified_line": {
"line": "* Pregnant patients",
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{
"exact_snippets": "Pregnant patients",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"criterion": "failed",
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"identified_line": {
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{
"exact_snippets": "Epidural anesthesia",
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"expected_value": true
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},
{
"identified_line": {
"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",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "active/serious bleeding in past 2 weeks",
"criterion": "active/serious bleeding",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past 2 weeks"
}
},
{
"exact_snippets": "prothrombin time [PT] ... > 1.6",
"criterion": "prothrombin time (PT)",
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"expected_value": {
"operator": ">",
"value": 1.6,
"unit": "N/A"
}
}
},
{
"exact_snippets": "partial thromboplastin time [PTT] > 35",
"criterion": "partial thromboplastin time (PTT)",
"requirement": {
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"value": 35,
"unit": "N/A"
}
}
}
]
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}
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],
"failed_miscellaneous": []
}