{
"info": {
"nct_id": "NCT03732482",
"official_title": "A Phase II/III Study of Non Small Cell Lung Cancer Patient With/Without Synchronous Oral Temozolomide Capsules Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost With Hippocampus Protection",
"inclusion_criteria": "1. Patients must have an estimated survival of at least 4 weeks\n2. Karnofsky Performance Status Scale (KPS) of 60-100.\n3. Patients' laboratory values had to meet these restrictions: hemoglobin>8 g/dL, platelets>70*109/L, white blood cells>4*109/L.\n4. Patients must sign a study specific informed consent form prior to study entry\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy\n2. had received previous brain irradiation\n3. could not be regularly followed\n4. with leptomeningeal involvement",
"miscellaneous_criteria": ""
},
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{
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"criterion": "estimated survival",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
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"value": 4,
"unit": "weeks"
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{
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"exact_snippets": "Karnofsky Performance Status Scale (KPS) of 60-100",
"criterion": "Karnofsky Performance Status Scale (KPS)",
"requirement": {
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"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 60,
"unit": "N/A"
},
{
"operator": "<=",
"value": 100,
"unit": "N/A"
}
]
}
}
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},
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"requirement": {
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"expected_value": {
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"unit": "N/A"
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"value": 100,
"unit": "N/A"
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{
"identified_line": {
"line": "3. Patients' laboratory values had to meet these restrictions: hemoglobin>8 g/dL, platelets>70*109/L, white blood cells>4*109/L.",
"criterions": [
{
"exact_snippets": "hemoglobin>8 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 8,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "platelets>70*109/L",
"criterion": "platelet count",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 70,
"unit": "*109/L"
}
}
},
{
"exact_snippets": "white blood cells>4*109/L",
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"requirement": {
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"expected_value": {
"operator": ">",
"value": 4,
"unit": "*109/L"
}
}
}
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"unit": "g/dL"
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"exact_snippets": "platelets>70*109/L",
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"value": 70,
"unit": "*109/L"
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}
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{
"exact_snippets": "white blood cells>4*109/L",
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"unit": "*109/L"
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{
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"criterions": [
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"requirement": {
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"expected_value": true
}
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{
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
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}
}
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}
},
{
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"line": "Must have minimum age of 18 Years",
"criterions": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"value": 18,
"unit": "Years"
}
}
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]
},
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"unit": "Years"
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},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
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"exact_snippets": "maximum age of 80 Years",
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"value": 80,
"unit": "Years"
}
}
}
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},
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"exact_snippets": "maximum age of 80 Years",
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"unit": "Years"
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}
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],
"exclusion_lines": [
{
"identified_line": {
"line": "2. had received previous brain irradiation",
"criterions": [
{
"exact_snippets": "had received previous brain irradiation",
"criterion": "previous brain irradiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "previous brain irradiation",
"requirement": {
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"expected_value": true
}
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}
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{
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"criterion": "follow-up capability",
"requirement": {
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"expected_value": true
}
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}
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{
"identified_line": {
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}
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"expected_value": true
}
}
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],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "1. Patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy",
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{
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
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{
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"requirement": {
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"expected_value": false
}
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"expected_value": true
}
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{
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"requirement": {
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"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}