{
"info": {
"nct_id": "NCT00462657",
"official_title": "Early Diagnosis of Invasive Aspergillosis in a High Risk Group of Patients Using Serum and Bronchoalveolar Lavage Fluid Real Time PCR and Galactomannan ELISA",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* At high risk for developing invasive aspergillosis (IA) due to any of the following risk factors:\n\n * Diagnosis of acute myeloid leukemia, myelodysplastic syndromes, or acute lymphoblastic leukemia AND meets ≥ 1 of the following criteria:\n\n * Receiving intensive chemotherapy with expected duration of neutropenia (ANC < 500/mm³) of > 10 days\n * Receiving high-dose steroids\n * Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT)\n * Requirement for high-dose steroids for graft-versus-host disease after HSCT\n * History of probable or proven IA and receiving chemotherapy\n* No preexisting chest disease\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"
},
"inclusion_lines": [
{
"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"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* At high risk for developing invasive aspergillosis (IA) due to any of the following risk factors:",
"criterions": [
{
"exact_snippets": "high risk for developing invasive aspergillosis (IA)",
"criterion": "risk for developing invasive aspergillosis (IA)",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "high risk for developing invasive aspergillosis (IA)",
"criterion": "risk for developing invasive aspergillosis (IA)",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
}
]
}
},
{
"identified_line": {
"line": "* Receiving intensive chemotherapy with expected duration of neutropenia (ANC < 500/mm³) of > 10 days",
"criterions": [
{
"exact_snippets": "Receiving intensive chemotherapy",
"criterion": "intensive chemotherapy",
"requirement": {
"requirement_type": "receiving",
"expected_value": true
}
},
{
"exact_snippets": "expected duration of neutropenia (ANC < 500/mm³) of > 10 days",
"criterion": "neutropenia duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 10,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "expected duration of neutropenia (ANC < 500/mm³) of > 10 days",
"criterion": "neutropenia duration",
"requirement": {
"requirement_type": "ANC",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 500,
"unit": "mm³"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receiving intensive chemotherapy",
"criterion": "intensive chemotherapy",
"requirement": {
"requirement_type": "receiving",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "expected duration of neutropenia (ANC < 500/mm³) of > 10 days",
"criterion": "neutropenia duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 10,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "expected duration of neutropenia (ANC < 500/mm³) of > 10 days",
"criterion": "neutropenia duration",
"requirement": {
"requirement_type": "ANC",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 500,
"unit": "mm³"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Receiving high-dose steroids",
"criterions": [
{
"exact_snippets": "Receiving high-dose steroids",
"criterion": "steroid dosage",
"requirement": {
"requirement_type": "dosage",
"expected_value": "high-dose"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receiving high-dose steroids",
"criterion": "steroid dosage",
"requirement": {
"requirement_type": "dosage",
"expected_value": "high-dose"
}
}
]
}
},
{
"identified_line": {
"line": "* Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT)",
"criterions": [
{
"exact_snippets": "Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT)",
"criterion": "allogeneic hematopoietic stem cell transplantation (HSCT)",
"requirement": {
"requirement_type": "concurrent treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT)",
"criterion": "allogeneic hematopoietic stem cell transplantation (HSCT)",
"requirement": {
"requirement_type": "concurrent treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Requirement for high-dose steroids for graft-versus-host disease after HSCT",
"criterions": [
{
"exact_snippets": "Requirement for high-dose steroids for graft-versus-host disease after HSCT",
"criterion": "high-dose steroids",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "graft-versus-host disease after HSCT",
"criterion": "graft-versus-host disease",
"requirement": {
"requirement_type": "post-HSCT",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Requirement for high-dose steroids for graft-versus-host disease after HSCT",
"criterion": "high-dose steroids",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "graft-versus-host disease after HSCT",
"criterion": "graft-versus-host disease",
"requirement": {
"requirement_type": "post-HSCT",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of probable or proven IA and receiving chemotherapy",
"criterions": [
{
"exact_snippets": "History of probable or proven IA",
"criterion": "IA (Invasive Aspergillosis)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "receiving chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "History of probable or proven IA",
"criterion": "IA (Invasive Aspergillosis)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "receiving chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "see details"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "see details"
}
}
]
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Diagnosis of acute myeloid leukemia, myelodysplastic syndromes, or acute lymphoblastic leukemia AND meets ≥ 1 of the following criteria:",
"criterions": [
{
"exact_snippets": "Diagnosis of acute myeloid leukemia",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosis of ... myelodysplastic syndromes",
"criterion": "myelodysplastic syndromes",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosis of ... acute lymphoblastic leukemia",
"criterion": "acute lymphoblastic leukemia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* No preexisting chest disease",
"criterions": [
{
"exact_snippets": "No preexisting chest disease",
"criterion": "chest disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No preexisting chest disease",
"criterion": "chest disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}