{
"info": {
"nct_id": "NCT00308165",
"official_title": "A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors",
"inclusion_criteria": "* Single primary malignant brain tumor\n* Previous treatment with external beam radiation\n* Tumor is stereotactically accessible\n* Karnofsky Performance Score of at least 60\nHealthy volunteers allowed\nMust have minimum age of 1 Year",
"exclusion_criteria": "* Diffuse subependymal or Cerebrospinal fluid (CSF) disease\n* Tumor involves brainstem, cerebellum or both hemispheres\n* Active infection\n* Systemic disease associated with unacceptable anesthetic/operative risk\n* Previous treatment with topotecan\n* Unable to receive MRI scans",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Single primary malignant brain tumor",
"criterions": [
{
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"criterion": "primary brain tumor",
"requirement": {
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"expected_value": "single"
}
},
{
"exact_snippets": "Single primary malignant brain tumor",
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"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"requirement": {
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"expected_value": "single"
}
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{
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"expected_value": true
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}
]
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},
{
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"criterions": [
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"exact_snippets": "Previous treatment with external beam radiation",
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"expected_value": true
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}
]
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"logical_structure": {
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"requirement": {
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{
"identified_line": {
"line": "* Tumor is stereotactically accessible",
"criterions": [
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"requirement": {
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"expected_value": true
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}
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},
"logical_structure": {
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"requirement": {
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]
}
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{
"identified_line": {
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"criterion": "Karnofsky Performance Score",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
}
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"unit": "N/A"
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}
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{
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"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
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},
{
"identified_line": {
"line": "Must have minimum age of 1 Year",
"criterions": [
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"exact_snippets": "minimum age of 1 Year",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "Year"
}
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"logical_structure": {
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"criterion": "age",
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"value": 1,
"unit": "Year"
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"exclusion_lines": [
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"line": "* Diffuse subependymal or Cerebrospinal fluid (CSF) disease",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Cerebrospinal fluid (CSF) disease",
"criterion": "Cerebrospinal fluid (CSF) disease",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
},
{
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"criterion": "Cerebrospinal fluid (CSF) disease",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Tumor involves brainstem, cerebellum or both hemispheres",
"criterions": [
{
"exact_snippets": "Tumor involves brainstem",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "brainstem"
}
},
{
"exact_snippets": "Tumor involves ... cerebellum",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "cerebellum"
}
},
{
"exact_snippets": "Tumor involves ... both hemispheres",
"criterion": "tumor location",
"requirement": {
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"expected_value": "both hemispheres"
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}
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},
"logical_structure": {
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"criterion": "tumor location",
"requirement": {
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"expected_value": "brainstem"
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},
{
"exact_snippets": "Tumor involves ... cerebellum",
"criterion": "tumor location",
"requirement": {
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"expected_value": "cerebellum"
}
},
{
"exact_snippets": "Tumor involves ... both hemispheres",
"criterion": "tumor location",
"requirement": {
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"expected_value": "both hemispheres"
}
}
]
}
},
{
"identified_line": {
"line": "* Active infection",
"criterions": [
{
"exact_snippets": "Active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"not_criteria": {
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"criterion": "infection",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
}
},
{
"identified_line": {
"line": "* Systemic disease associated with unacceptable anesthetic/operative risk",
"criterions": [
{
"exact_snippets": "Systemic disease associated with unacceptable anesthetic/operative risk",
"criterion": "systemic disease",
"requirement": {
"requirement_type": "risk level",
"expected_value": "unacceptable anesthetic/operative risk"
}
}
]
},
"logical_structure": {
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"requirement": {
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}
}
}
},
{
"identified_line": {
"line": "* Previous treatment with topotecan",
"criterions": [
{
"exact_snippets": "Previous treatment with topotecan",
"criterion": "treatment with topotecan",
"requirement": {
"requirement_type": "previous treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Unable to receive MRI scans",
"criterions": [
{
"exact_snippets": "Unable to receive MRI scans",
"criterion": "MRI scan",
"requirement": {
"requirement_type": "ability to receive",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"criterion": "MRI scan",
"requirement": {
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"expected_value": false
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}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}