{
"info": {
"nct_id": "NCT06250972",
"official_title": "Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy",
"inclusion_criteria": "* Ability to understand and the willingness to sign a written informed consent document.\n* Age ≥ 18 years and ≤ 80 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.\n* Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.\n* Locally advanced pancreatic cancer.\n* Baseline serum CA19-9 > 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .\n* Presence of at least of one measurable lesion in agreement to RECIST criteria.\n* The expected survival ≥ 3 months.\n* Adequate organ performance based on laboratory blood tests.\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Pregnant or nursing women.\n* Primary pancreatic cancer.\n* Baseline serum CA19-9 ≤ 37 U/mL.\n* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.\n* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.\n* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.\n* Renal insufficiency or dialysis\n* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.\n* Patients who are allergic to oxaplatin or other chemotherapy drugs.\n* Patients who are unwilling or unable to comply with study procedures.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Ability to understand and the willingness to sign a written informed consent document.",
"criterions": [
{
"exact_snippets": "Ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Age ≥ 18 years and ≤ 80 years.",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years and ≤ 80 years.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years and ≤ 80 years.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed advanced pancreas adenocarcinoma.",
"criterion": "advanced pancreas adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically or cytologically confirmed advanced pancreas adenocarcinoma.",
"criterion": "advanced pancreas adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.",
"criterions": [
{
"exact_snippets": "not refractory to previous chemotherapy",
"criterion": "refractory to previous chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "not received radiotherapy",
"criterion": "received radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "not refractory to previous chemotherapy",
"criterion": "refractory to previous chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "not received radiotherapy",
"criterion": "received radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Locally advanced pancreatic cancer.",
"criterions": [
{
"exact_snippets": "Locally advanced pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Locally advanced pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
}
},
{
"identified_line": {
"line": "* Baseline serum CA19-9 > 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .",
"criterions": [
{
"exact_snippets": "Baseline serum CA19-9 > 37 U/mL",
"criterion": "baseline serum CA19-9",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 37,
"unit": "U/mL"
}
}
},
{
"exact_snippets": "CA19-9 level within normal range (≤37 U/mL) after chemotherapy",
"criterion": "CA19-9 level after chemotherapy",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 37,
"unit": "U/mL"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Baseline serum CA19-9 > 37 U/mL",
"criterion": "baseline serum CA19-9",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 37,
"unit": "U/mL"
}
}
},
{
"exact_snippets": "CA19-9 level within normal range (≤37 U/mL) after chemotherapy",
"criterion": "CA19-9 level after chemotherapy",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 37,
"unit": "U/mL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Presence of at least of one measurable lesion in agreement to RECIST criteria.",
"criterions": [
{
"exact_snippets": "Presence of at least of one measurable lesion",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of at least of one measurable lesion",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "in agreement to RECIST criteria",
"criterion": "RECIST criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
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"exact_snippets": "Presence of at least of one measurable lesion",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of at least of one measurable lesion",
"criterion": "measurable lesion",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
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"exact_snippets": "in agreement to RECIST criteria",
"criterion": "RECIST criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The expected survival ≥ 3 months.",
"criterions": [
{
"exact_snippets": "expected survival ≥ 3 months",
"criterion": "expected survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
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"exact_snippets": "expected survival ≥ 3 months",
"criterion": "expected survival",
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"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate organ performance based on laboratory blood tests.",
"criterions": [
{
"exact_snippets": "Adequate organ performance based on laboratory blood tests.",
"criterion": "organ performance",
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"expected_value": "based on laboratory blood tests"
}
}
]
},
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"exact_snippets": "Adequate organ performance based on laboratory blood tests.",
"criterion": "organ performance",
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}
}
]
}
},
{
"identified_line": {
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"criterions": [
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"expected_value": true
}
},
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"exact_snippets": "men",
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}
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"exact_snippets": "must agree to use adequate contraception",
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"expected_value": true
}
},
{
"exact_snippets": "prior to study entry and for the duration of study participation",
"criterion": "timing of contraception use",
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}
}
]
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"or_criteria": [
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"and_criteria": [
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"identified_line": {
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
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}
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}
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}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
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"value": 18,
"unit": "Years"
}
}
}
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"operator": ">=",
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"unit": "Years"
}
}
}
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}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
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{
"exact_snippets": "maximum age of 80 Years",
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"value": 80,
"unit": "Years"
}
}
}
]
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"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Pregnant or nursing women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "nursing women",
"criterion": "nursing",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "nursing women",
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Primary pancreatic cancer.",
"criterions": [
{
"exact_snippets": "Primary pancreatic cancer.",
"criterion": "pancreatic cancer",
"requirement": {
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"expected_value": "primary"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Primary pancreatic cancer.",
"criterion": "pancreatic cancer",
"requirement": {
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"expected_value": "primary"
}
}
]
}
},
{
"identified_line": {
"line": "* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.",
"criterions": [
{
"exact_snippets": "diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas",
"criterion": "pancreatic cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "non-adenocarcinoma"
}
}
]
},
"logical_structure": {
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"exact_snippets": "diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas",
"criterion": "pancreatic cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "non-adenocarcinoma"
}
}
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "inflammation of the digestive tract",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "pancreatitis",
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}
},
{
"exact_snippets": "cholecystitis",
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"expected_value": true
}
},
{
"exact_snippets": "cholangitis",
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"expected_value": true
}
}
]
},
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"and_criteria": [
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"expected_value": true
}
}
]
},
{
"and_criteria": [
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"exact_snippets": "pancreatitis",
"criterion": "pancreatitis",
"requirement": {
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"expected_value": true
}
}
]
},
{
"and_criteria": [
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"exact_snippets": "cholecystitis",
"criterion": "cholecystitis",
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"expected_value": true
}
}
]
},
{
"and_criteria": [
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"criterion": "cholangitis",
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}
}
]
}
]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "accompanying diseases",
"requirement": {
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"expected_value": "severe"
}
},
{
"exact_snippets": "Severe and uncontrollable accompanying diseases",
"criterion": "accompanying diseases",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
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"criterion": "accompanying diseases",
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"expected_value": "severe"
}
},
{
"exact_snippets": "Severe and uncontrollable accompanying diseases",
"criterion": "accompanying diseases",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Renal insufficiency or dialysis",
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{
"exact_snippets": "Renal insufficiency",
"criterion": "renal insufficiency",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "dialysis",
"criterion": "dialysis",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Renal insufficiency",
"criterion": "renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dialysis",
"criterion": "dialysis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Other serious accompanying illnesses",
"criterion": "serious accompanying illnesses",
"requirement": {
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"expected_value": "serious"
}
},
{
"exact_snippets": "Other serious accompanying illnesses",
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}
}
]
},
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"expected_value": "serious"
}
},
{
"exact_snippets": "Other serious accompanying illnesses",
"criterion": "serious accompanying illnesses",
"requirement": {
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"expected_value": "could seriously adversely affect"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are allergic to oxaplatin or other chemotherapy drugs.",
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{
"exact_snippets": "allergic to oxaplatin",
"criterion": "oxaplatin allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "allergic to ... other chemotherapy drugs",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"exact_snippets": "allergic to oxaplatin",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "allergic to ... other chemotherapy drugs",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Baseline serum CA19-9 ≤ 37 U/mL.",
"criterions": [
{
"exact_snippets": "Baseline serum CA19-9 ≤ 37 U/mL.",
"criterion": "serum CA19-9",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 37,
"unit": "U/mL"
}
}
}
]
},
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"exact_snippets": "Baseline serum CA19-9 \u001f 37 U/mL.",
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"requirement_type": "level",
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"operator": "<=",
"value": 37,
"unit": "U/mL"
}
}
}
}
},
{
"identified_line": {
"line": "* Patients who are unwilling or unable to comply with study procedures.",
"criterions": [
{
"exact_snippets": "Patients who are unwilling ... comply with study procedures.",
"criterion": "willingness to comply with study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Patients who are ... unable to comply with study procedures.",
"criterion": "ability to comply with study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patients who are unwilling ... comply with study procedures.",
"criterion": "willingness to comply with study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
},
{
"exact_snippets": "Patients who are ... unable to comply with study procedures.",
"criterion": "ability to comply with study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
}
],
"failed_miscellaneous": []
}