{
"info": {
"nct_id": "NCT01567462",
"official_title": "PK Button Vaporization Electrode for Treatment of Bladder Tumors",
"inclusion_criteria": "* Patients with cystoscopically detected bladder tumors requiring TURBT\n* Patients with bladder tumors which are endoscopically resectable by surgeon's judgment with only one trip into the operating room.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 89 Years",
"exclusion_criteria": "* Patients with clinical evidence of locally advanced, nodal, or metastatic bladder cancer\n* Patients with hydronephrosis secondary to bladder cancer\n* Patients with diffuse tumor throughout bladder that is deemed unresectable by surgeon",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with cystoscopically detected bladder tumors requiring TURBT",
"criterions": [
{
"exact_snippets": "cystoscopically detected bladder tumors",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "detection method",
"expected_value": "cystoscopy"
}
},
{
"exact_snippets": "bladder tumors requiring TURBT",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "TURBT"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "cystoscopically detected bladder tumors",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "detection method",
"expected_value": "cystoscopy"
}
},
{
"exact_snippets": "bladder tumors requiring TURBT",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "TURBT"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with bladder tumors which are endoscopically resectable by surgeon's judgment with only one trip into the operating room.",
"criterions": [
{
"exact_snippets": "bladder tumors",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "endoscopically resectable",
"criterion": "tumor resectability",
"requirement": {
"requirement_type": "method",
"expected_value": "endoscopic"
}
},
{
"exact_snippets": "by surgeon's judgment",
"criterion": "surgeon's judgment",
"requirement": {
"requirement_type": "approval",
"expected_value": true
}
},
{
"exact_snippets": "only one trip into the operating room",
"criterion": "operating room visits",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "trip"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "bladder tumors",
"criterion": "bladder tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
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"criterion": "tumor resectability",
"requirement": {
"requirement_type": "method",
"expected_value": "endoscopic"
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}
]
},
{
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"criterion": "surgeon's judgment",
"requirement": {
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"expected_value": true
}
},
{
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"criterion": "operating room visits",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "trip"
}
}
}
]
}
},
{
"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 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": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 89 Years",
"criterions": [
{
"exact_snippets": "maximum age of 89 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 89,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "maximum age of 89 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 89,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients with clinical evidence of locally advanced, nodal, or metastatic bladder cancer",
"criterions": [
{
"exact_snippets": "clinical evidence of locally advanced ... bladder cancer",
"criterion": "locally advanced bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinical evidence of ... nodal ... bladder cancer",
"criterion": "nodal bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinical evidence of ... metastatic bladder cancer",
"criterion": "metastatic bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "locally advanced bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinical evidence of ... nodal ... bladder cancer",
"criterion": "nodal bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinical evidence of ... metastatic bladder cancer",
"criterion": "metastatic bladder cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with hydronephrosis secondary to bladder cancer",
"criterions": [
{
"exact_snippets": "hydronephrosis secondary to bladder cancer",
"criterion": "hydronephrosis",
"requirement": {
"requirement_type": "cause",
"expected_value": "bladder cancer"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "hydronephrosis secondary to bladder cancer",
"criterion": "hydronephrosis",
"requirement": {
"requirement_type": "cause",
"expected_value": "bladder cancer"
}
}
}
},
{
"identified_line": {
"line": "* Patients with diffuse tumor throughout bladder that is deemed unresectable by surgeon",
"criterions": [
{
"exact_snippets": "diffuse tumor throughout bladder",
"criterion": "diffuse tumor throughout bladder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "deemed unresectable by surgeon",
"criterion": "tumor resectability",
"requirement": {
"requirement_type": "resectability",
"expected_value": "unresectable"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diffuse tumor throughout bladder",
"criterion": "diffuse tumor throughout bladder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "deemed unresectable by surgeon",
"criterion": "tumor resectability",
"requirement": {
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"expected_value": "unresectable"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}