{
"info": {
"nct_id": "NCT05553873",
"official_title": "Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.",
"inclusion_criteria": "* Age ≥ 18 years at the time of diagnosis of MPN Ph negative\n* Diagnosis of PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)\n* Obtaining informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
"exclusion_criteria": "* Life expectancy of less than 6 months\n* Accelerated phase myelofibrosis or MPN with signs of leukemic evolution",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age ≥ 18 years at the time of diagnosis of MPN Ph negative",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "diagnosis of MPN Ph negative",
"criterion": "MPN Ph negative diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "diagnosis of MPN Ph negative",
"criterion": "MPN Ph negative diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)",
"criterions": [
{
"exact_snippets": "Diagnosis of PV",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "PV"
}
},
{
"exact_snippets": "Diagnosis of ... ET",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "ET"
}
},
{
"exact_snippets": "Diagnosis of ... PMF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "PMF"
}
},
{
"exact_snippets": "Diagnosis of ... post PV ... MF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "post PV MF"
}
},
{
"exact_snippets": "Diagnosis of ... post ET MF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "post ET MF"
}
},
{
"exact_snippets": "according to current WHO or IWG-MRT criteria",
"criterion": "diagnostic criteria",
"requirement": {
"requirement_type": "standard",
"expected_value": [
"current WHO",
"IWG-MRT"
]
}
},
{
"exact_snippets": "diagnosis since 2000",
"criterion": "diagnosis date",
"requirement": {
"requirement_type": "year",
"expected_value": {
"operator": ">=",
"value": 2000,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Diagnosis of PV",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "PV"
}
},
{
"exact_snippets": "Diagnosis of ... ET",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "ET"
}
},
{
"exact_snippets": "Diagnosis of ... PMF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "PMF"
}
},
{
"exact_snippets": "Diagnosis of ... post PV ... MF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "post PV MF"
}
},
{
"exact_snippets": "Diagnosis of ... post ET MF",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "post ET MF"
}
}
]
},
{
"exact_snippets": "according to current WHO or IWG-MRT criteria",
"criterion": "diagnostic criteria",
"requirement": {
"requirement_type": "standard",
"expected_value": [
"current WHO",
"IWG-MRT"
]
}
},
{
"exact_snippets": "diagnosis since 2000",
"criterion": "diagnosis date",
"requirement": {
"requirement_type": "year",
"expected_value": {
"operator": ">=",
"value": 2000,
"unit": "year"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Obtaining informed consent",
"criterions": [
{
"exact_snippets": "Obtaining informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "obtaining",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Obtaining informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "obtaining",
"expected_value": true
}
}
]
}
},
{
"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 99 Years",
"criterions": [
{
"exact_snippets": "maximum age of 99 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 99,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 99 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 99,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Life expectancy of less than 6 months",
"criterions": [
{
"exact_snippets": "Life expectancy of less than 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy of less than 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Accelerated phase myelofibrosis or MPN with signs of leukemic evolution",
"criterions": [
{
"exact_snippets": "Accelerated phase myelofibrosis",
"criterion": "myelofibrosis",
"requirement": {
"requirement_type": "phase",
"expected_value": "accelerated"
}
},
{
"exact_snippets": "MPN with signs of leukemic evolution",
"criterion": "MPN",
"requirement": {
"requirement_type": "signs of leukemic evolution",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}