{
"info": {
"nct_id": "NCT02894645",
"official_title": "Ma-Spore ALL 2010 Study",
"inclusion_criteria": "1. Confirmed diagnosis of non-Burkitt B-lineage ALL\n2. 1 to 17 years of age (before 18th birthday)\n3. Renal function within normal range for age\n4. Liver function within normal range for age\n5. Able to participate in the full 2 years of treatment\nHealthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 17 Years",
"exclusion_criteria": "1. Age less than one year or age greater than/equals to 18 years\n2. Previous treatment with cytotoxic agents or high-dose steroids\n3. Mixed phenotype acute leukemia (MPAL)\n4. ALL as secondary malignancy\n5. Abnormal renal or liver function\n6. Doubtful compliance or unable to afford full course of therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Confirmed diagnosis of non-Burkitt B-lineage ALL",
"criterions": [
{
"exact_snippets": "Confirmed diagnosis of non-Burkitt B-lineage ALL",
"criterion": "non-Burkitt B-lineage ALL",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Confirmed diagnosis of non-Burkitt B-lineage ALL",
"criterion": "non-Burkitt B-lineage ALL",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "1 to 17 years of age (before 18th birthday)",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"criterion": "age",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Renal function within normal range for age",
"criterions": [
{
"exact_snippets": "Renal function within normal range for age",
"criterion": "renal function",
"requirement": {
"requirement_type": "range",
"expected_value": "within normal range for age"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal function within normal range for age",
"criterion": "renal function",
"requirement": {
"requirement_type": "range",
"expected_value": "within normal range for age"
}
}
]
}
},
{
"identified_line": {
"line": "4. Liver function within normal range for age",
"criterions": [
{
"exact_snippets": "Liver function within normal range for age",
"criterion": "liver function",
"requirement": {
"requirement_type": "range",
"expected_value": "normal range for age"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Liver function within normal range for age",
"criterion": "liver function",
"requirement": {
"requirement_type": "range",
"expected_value": "normal range for age"
}
}
]
}
},
{
"identified_line": {
"line": "5. Able to participate in the full 2 years of treatment",
"criterions": [
{
"exact_snippets": "Able to participate in the full 2 years of treatment",
"criterion": "participation duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to participate in the full 2 years of treatment",
"criterion": "participation duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "years"
}
}
}
]
}
},
{
"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 1 Year",
"criterions": [
{
"exact_snippets": "minimum age of 1 Year",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "Year"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 1 Year",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "Year"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 17 Years",
"criterions": [
{
"exact_snippets": "maximum age of 17 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 17,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 17 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 17,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "2. Previous treatment with cytotoxic agents or high-dose steroids",
"criterions": [
{
"exact_snippets": "Previous treatment with cytotoxic agents",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "cytotoxic agents"
}
},
{
"exact_snippets": "Previous treatment with ... high-dose steroids",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "high-dose steroids"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Previous treatment with cytotoxic agents",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "cytotoxic agents"
}
},
{
"exact_snippets": "Previous treatment with ... high-dose steroids",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "high-dose steroids"
}
}
]
}
},
{
"identified_line": {
"line": "3. Mixed phenotype acute leukemia (MPAL)",
"criterions": [
{
"exact_snippets": "Mixed phenotype acute leukemia (MPAL)",
"criterion": "mixed phenotype acute leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Mixed phenotype acute leukemia (MPAL)",
"criterion": "mixed phenotype acute leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. ALL as secondary malignancy",
"criterions": [
{
"exact_snippets": "ALL as secondary malignancy",
"criterion": "secondary malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "ALL"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ALL as secondary malignancy",
"criterion": "secondary malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "ALL"
}
}
]
}
},
{
"identified_line": {
"line": "5. Abnormal renal or liver function",
"criterions": [
{
"exact_snippets": "Abnormal renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "abnormal"
}
},
{
"exact_snippets": "Abnormal ... liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "abnormal"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Abnormal renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "abnormal"
}
},
{
"exact_snippets": "Abnormal ... liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "abnormal"
}
}
]
}
},
{
"identified_line": {
"line": "6. Doubtful compliance or unable to afford full course of therapy",
"criterions": [
{
"exact_snippets": "Doubtful compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "certainty",
"expected_value": "doubtful"
}
},
{
"exact_snippets": "unable to afford full course of therapy",
"criterion": "affordability of therapy",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
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"criterion": "compliance",
"requirement": {
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"expected_value": "doubtful"
}
},
{
"exact_snippets": "unable to afford full course of therapy",
"criterion": "affordability of therapy",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "1. Age less than one year or age greater than/equals to 18 years",
"criterions": [
{
"exact_snippets": "Age less than one year",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
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"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "age greater than/equals to 18 years",
"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}