{
"info": {
"nct_id": "NCT04943757",
"official_title": "Graft-versus-host Disease Prophylaxis With Combination of Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy)",
"inclusion_criteria": "* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with 5-10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms\n\n* Salvage hematopoietic stem cell transplantation defined as:\n* Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm\n* No severe concurrent illness\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%\n* Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted\n* Respiratory distress >grade I\n* Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits\n* Creatinine clearance < 60 mL/min\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Karnofsky index <30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with indication for allogeneic hematopoietic stem cell transplantation",
"criterions": [
{
"exact_snippets": "indication for allogeneic hematopoietic stem cell transplantation",
"criterion": "indication for allogeneic hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "indication for allogeneic hematopoietic stem cell transplantation",
"criterion": "indication for allogeneic hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with 5-10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.",
"criterions": [
{
"exact_snippets": "5-10/10 HLA-matched related or unrelated donor available",
"criterion": "HLA-matched donor",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "5-10/10 HLA-matched related or unrelated donor available",
"criterion": "HLA-matched donor",
"requirement": {
"requirement_type": "matching",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 5,
"unit": "HLA-matched"
},
{
"operator": "<=",
"value": 10,
"unit": "HLA-matched"
}
]
}
}
},
{
"exact_snippets": "The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1",
"criterion": "genetic loci matching",
"requirement": {
"requirement_type": "loci",
"expected_value": [
"HLA-A",
"HLA-B",
"HLA-Cw",
"HLA-DRB1",
"HLA-DQB1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "5-10/10 HLA-matched related or unrelated donor available",
"criterion": "HLA-matched donor",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "5-10/10 HLA-matched related or unrelated donor available",
"criterion": "HLA-matched donor",
"requirement": {
"requirement_type": "matching",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 5,
"unit": "HLA-matched"
},
{
"operator": "<=",
"value": 10,
"unit": "HLA-matched"
}
]
}
}
}
]
},
{
"exact_snippets": "The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1",
"criterion": "genetic loci matching",
"requirement": {
"requirement_type": "loci",
"expected_value": [
"HLA-A",
"HLA-B",
"HLA-Cw",
"HLA-DRB1",
"HLA-DQB1"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Peripheral blood stem cells or bone marrow as a graft source",
"criterions": [
{
"exact_snippets": "Peripheral blood stem cells ... as a graft source",
"criterion": "peripheral blood stem cells",
"requirement": {
"requirement_type": "graft source",
"expected_value": true
}
},
{
"exact_snippets": "bone marrow as a graft source",
"criterion": "bone marrow",
"requirement": {
"requirement_type": "graft source",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Peripheral blood stem cells ... as a graft source",
"criterion": "peripheral blood stem cells",
"requirement": {
"requirement_type": "graft source",
"expected_value": true
}
},
{
"exact_snippets": "bone marrow as a graft source",
"criterion": "bone marrow",
"requirement": {
"requirement_type": "graft source",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis:",
"criterions": [
{
"exact_snippets": "Diagnosis",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms",
"criterions": [
{
"exact_snippets": "Acute myeloid leukemia",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Chronic myeloid leukemia, Ph+",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Chronic myeloid leukemia, Ph+",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "Philadelphia chromosome",
"expected_value": true
}
},
{
"exact_snippets": "Myelodysplastic Syndromes",
"criterion": "myelodysplastic syndromes",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Chronic myeloid leukemia, Ph+",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Chronic myeloid leukemia, Ph+",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "Philadelphia chromosome",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Acute myeloid leukemia",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Myelodysplastic Syndromes",
"criterion": "myelodysplastic syndromes",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Salvage hematopoietic stem cell transplantation defined as:",
"criterions": [
{
"exact_snippets": "Salvage hematopoietic stem cell transplantation",
"criterion": "salvage hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "definition",
"expected_value": "defined as"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Salvage hematopoietic stem cell transplantation",
"criterion": "salvage hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "definition",
"expected_value": "defined as"
}
}
]
}
},
{
"identified_line": {
"line": "* No severe concurrent illness",
"criterions": [
{
"exact_snippets": "No severe concurrent illness",
"criterion": "concurrent illness",
"requirement": {
"requirement_type": "severity",
"expected_value": "not severe"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No severe concurrent illness",
"criterion": "concurrent illness",
"requirement": {
"requirement_type": "severity",
"expected_value": "not severe"
}
}
]
}
},
{
"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": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterions": [
{
"exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "clonal blasts percentage",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "%"
}
}
},
{
"exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": [
"adequate previous induction therapy",
"allogeneic stem cell transplantation"
]
}
},
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "blasts percentage",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "%"
}
}
},
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": [
"-7 karyotype",
"complex karyotype",
"p53 mutation"
]
}
},
{
"exact_snippets": "Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "disease phase",
"expected_value": [
"blast crisis",
"acceleration phase"
]
}
},
{
"exact_snippets": "Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "at least 3 previous lines of TKIs"
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "tumor burden",
"expected_value": "high"
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": true
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "WBC count",
"expected_value": {
"operator": ">",
"value": 20000,
"unit": "WBC/ul"
}
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "splenomegaly size",
"expected_value": {
"operator": ">",
"value": 15,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "clonal blasts percentage",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "%"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "adequate previous induction therapy"
}
},
{
"exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "allogeneic stem cell transplantation"
}
}
]
}
]
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "blasts percentage",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "%"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "-7 karyotype"
}
},
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "complex karyotype"
}
},
{
"exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
"criterion": "myelodysplastic syndrome",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "p53 mutation"
}
}
]
}
]
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "disease phase",
"expected_value": [
"blast crisis",
"acceleration phase"
]
}
},
{
"exact_snippets": "Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs",
"criterion": "chronic myeloid leukemia",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": "at least 3 previous lines of TKIs"
}
}
]
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "tumor burden",
"expected_value": "high"
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "previous therapy",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "WBC count",
"expected_value": {
"operator": ">",
"value": 20000,
"unit": "WBC/ul"
}
}
},
{
"exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
"criterion": "myeloproliferative neoplasms",
"requirement": {
"requirement_type": "splenomegaly size",
"expected_value": {
"operator": ">",
"value": 15,
"unit": "cm"
}
}
}
]
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%",
"criterions": [
{
"exact_snippets": "Moderate or severe cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
}
},
{
"exact_snippets": "left ventricular ejection fraction <50%",
"criterion": "left ventricular ejection fraction",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted",
"criterions": [
{
"exact_snippets": "Moderate or severe decrease in pulmonary function",
"criterion": "pulmonary function",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
}
},
{
"exact_snippets": "FEV1 <70%",
"criterion": "FEV1",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "%"
}
}
},
{
"exact_snippets": "DLCO<70% of predicted",
"criterion": "DLCO",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Respiratory distress >grade I",
"criterions": [
{
"exact_snippets": "Respiratory distress >grade I",
"criterion": "respiratory distress",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "grade"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits",
"criterions": [
{
"exact_snippets": "AST or ALT >5 upper normal limits",
"criterion": "AST or ALT levels",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "upper normal limits"
}
}
},
{
"exact_snippets": "bilirubin >1.5 upper normal limits",
"criterion": "bilirubin levels",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "upper normal limits"
}
}
},
{
"exact_snippets": "creatinine >2 upper normal limits",
"criterion": "creatinine levels",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "upper normal limits"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Creatinine clearance < 60 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine clearance < 60 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "mL/min"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Uncontrolled bacterial or fungal infection at the time of enrollment",
"criterions": [
{
"exact_snippets": "Uncontrolled bacterial or fungal infection",
"criterion": "bacterial or fungal infection",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Requirement for vasopressor support at the time of enrollment",
"criterions": [
{
"exact_snippets": "Requirement for vasopressor support",
"criterion": "vasopressor support",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Karnofsky index <30%",
"criterions": [
{
"exact_snippets": "Karnofsky index <30%",
"criterion": "Karnofsky index",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 30,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Somatic or psychiatric disorder making the patient unable to sign informed consent",
"criterions": [
{
"exact_snippets": "Somatic or psychiatric disorder",
"criterion": "somatic or psychiatric disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to sign informed consent",
"criterion": "ability to sign informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}