{
"info": {
"nct_id": "NCT02901782",
"official_title": "Personalized Titanium Plate Improves Clinical Outcome in Microwave Ablation of Bone Tumors Around the Knee",
"inclusion_criteria": "1. Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy.\n2. Malignant soft tissue tumor invading distal femur or proximal tibia.\n3. The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation.\nHealthy volunteers allowed\nMust have minimum age of 5 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Distant metastasis.\n2. Benign tumor.\n3. Metastatic tumor around the knee.\n4. No indication of limb salvage.\n5. Malignant soft tissue tumor without bone invasion.\n6. Recrudescent tumors.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "2. Malignant soft tissue tumor invading distal femur or proximal tibia.",
"criterions": [
{
"exact_snippets": "Malignant soft tissue tumor",
"criterion": "soft tissue tumor",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "invading distal femur",
"criterion": "tumor invasion",
"requirement": {
"requirement_type": "location",
"expected_value": "distal femur"
}
},
{
"exact_snippets": "invading ... proximal tibia",
"criterion": "tumor invasion",
"requirement": {
"requirement_type": "location",
"expected_value": "proximal tibia"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Malignant soft tissue tumor",
"criterion": "soft tissue tumor",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "invading distal femur",
"criterion": "tumor invasion",
"requirement": {
"requirement_type": "location",
"expected_value": "distal femur"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Malignant soft tissue tumor",
"criterion": "soft tissue tumor",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "invading ... proximal tibia",
"criterion": "tumor invasion",
"requirement": {
"requirement_type": "location",
"expected_value": "proximal tibia"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "3. The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation.",
"criterions": [
{
"exact_snippets": "The patients have the opportunity of limb salvage",
"criterion": "limb salvage",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
},
{
"exact_snippets": "treatment of microwave-induced hyperthermia in situ",
"criterion": "microwave-induced hyperthermia treatment",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
},
{
"exact_snippets": "reconstruction with internal fixation",
"criterion": "reconstruction with internal fixation",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The patients have the opportunity of limb salvage",
"criterion": "limb salvage",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
},
{
"exact_snippets": "treatment of microwave-induced hyperthermia in situ",
"criterion": "microwave-induced hyperthermia treatment",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
},
{
"exact_snippets": "reconstruction with internal fixation",
"criterion": "reconstruction with internal fixation",
"requirement": {
"requirement_type": "opportunity",
"expected_value": true
}
}
]
}
},
{
"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",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 5 Years",
"criterions": [
{
"exact_snippets": "minimum age of 5 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 5 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Distant metastasis.",
"criterions": [
{
"exact_snippets": "Distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. Benign tumor.",
"criterions": [
{
"exact_snippets": "Benign tumor",
"criterion": "tumor",
"requirement": {
"requirement_type": "type",
"expected_value": "benign"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Benign tumor",
"criterion": "tumor",
"requirement": {
"requirement_type": "type",
"expected_value": "benign"
}
}
]
}
},
{
"identified_line": {
"line": "3. Metastatic tumor around the knee.",
"criterions": [
{
"exact_snippets": "Metastatic tumor around the knee",
"criterion": "metastatic tumor",
"requirement": {
"requirement_type": "location",
"expected_value": "around the knee"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Metastatic tumor around the knee",
"criterion": "metastatic tumor",
"requirement": {
"requirement_type": "location",
"expected_value": "around the knee"
}
}
]
}
},
{
"identified_line": {
"line": "4. No indication of limb salvage.",
"criterions": [
{
"exact_snippets": "No indication of limb salvage.",
"criterion": "limb salvage",
"requirement": {
"requirement_type": "indication",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No indication of limb salvage.",
"criterion": "limb salvage",
"requirement": {
"requirement_type": "indication",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "5. Malignant soft tissue tumor without bone invasion.",
"criterions": [
{
"exact_snippets": "Malignant soft tissue tumor",
"criterion": "soft tissue tumor",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "without bone invasion",
"criterion": "bone invasion",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Malignant soft tissue tumor",
"criterion": "soft tissue tumor",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "without bone invasion",
"criterion": "bone invasion",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "6. Recrudescent tumors.",
"criterions": [
{
"exact_snippets": "Recrudescent tumors",
"criterion": "tumors",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recrudescent tumors",
"criterion": "tumors",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "1. Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy.",
"criterions": [
{
"exact_snippets": "Clinical diagnosis of primary malignant bone tumors",
"criterion": "primary malignant bone tumors",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "distal femur or proximal tibia",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"distal femur",
"proximal tibia"
]
}
},
{
"exact_snippets": "according to the preoperative biopsy",
"criterion": "preoperative biopsy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Clinical diagnosis of primary malignant bone tumors",
"criterion": "primary malignant bone tumors",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "according to the preoperative biopsy",
"criterion": "preoperative biopsy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "distal femur or proximal tibia",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"distal femur"
]
}
},
{
"exact_snippets": "distal femur or proximal tibia",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"proximal tibia"
]
}
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}