{
"info": {
"nct_id": "NCT02682082",
"official_title": "A Randomize Double-Blind Control Trial Study Comparing Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis W/Wo Bupivacaine In Patient Being Treated Palliatively For Pancreatic Cancer",
"inclusion_criteria": "* Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail\n* Abdominal or back pain considered to be potentially related to the tumor\n\n * New onset pain (<3 months)\n * Constant\n * Centrally located\n * With or without irradiation to the back\n * No obvious other source of pain based on history and physical examination by the attending endosonographer\n* No possibility of surgical management\n* Signed, informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Allergy to bupivicaine\n* Age < 18 years\n* Inability or unwillingness to give informed consent",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail",
"criterions": [
{
"exact_snippets": "Confirmed malignant pancreatic lesion",
"criterion": "malignant pancreatic lesion",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "involving the pancreatic genu, body, or tail",
"criterion": "location of pancreatic lesion",
"requirement": {
"requirement_type": "location",
"expected_value": [
"pancreatic genu",
"pancreatic body",
"pancreatic tail"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Confirmed malignant pancreatic lesion",
"criterion": "malignant pancreatic lesion",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "involving the pancreatic genu, body, or tail",
"criterion": "location of pancreatic lesion",
"requirement": {
"requirement_type": "location",
"expected_value": [
"pancreatic genu",
"pancreatic body",
"pancreatic tail"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Abdominal or back pain considered to be potentially related to the tumor",
"criterions": [
{
"exact_snippets": "Abdominal ... pain",
"criterion": "abdominal pain",
"requirement": {
"requirement_type": "relation to tumor",
"expected_value": "potentially related"
}
},
{
"exact_snippets": "back pain",
"criterion": "back pain",
"requirement": {
"requirement_type": "relation to tumor",
"expected_value": "potentially related"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Abdominal ... pain",
"criterion": "abdominal pain",
"requirement": {
"requirement_type": "relation to tumor",
"expected_value": "potentially related"
}
},
{
"exact_snippets": "back pain",
"criterion": "back pain",
"requirement": {
"requirement_type": "relation to tumor",
"expected_value": "potentially related"
}
}
]
}
},
{
"identified_line": {
"line": "* New onset pain (<3 months)",
"criterions": [
{
"exact_snippets": "New onset pain (<3 months)",
"criterion": "pain onset",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 3,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "New onset pain (<3 months)",
"criterion": "pain onset",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 3,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Constant",
"criterions": [
{
"exact_snippets": "Constant",
"criterion": "constant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Constant",
"criterion": "constant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Centrally located",
"criterions": [
{
"exact_snippets": "Centrally located",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "centrally located"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Centrally located",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "centrally located"
}
}
]
}
},
{
"identified_line": {
"line": "* With or without irradiation to the back",
"criterions": [
{
"exact_snippets": "With or without irradiation to the back",
"criterion": "irradiation to the back",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"with",
"without"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "With or without irradiation to the back",
"criterion": "irradiation to the back",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"with",
"without"
]
}
}
]
}
},
{
"identified_line": {
"line": "* No obvious other source of pain based on history and physical examination by the attending endosonographer",
"criterions": [
{
"exact_snippets": "No obvious other source of pain based on history and physical examination",
"criterion": "other source of pain",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No obvious other source of pain based on history and physical examination",
"criterion": "other source of pain",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No possibility of surgical management",
"criterions": [
{
"exact_snippets": "No possibility of surgical management",
"criterion": "surgical management",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No possibility of surgical management",
"criterion": "surgical management",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Signed, informed consent",
"criterions": [
{
"exact_snippets": "Signed, informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Signed, informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Allergy to bupivicaine",
"criterions": [
{
"exact_snippets": "Allergy to bupivicaine",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": "bupivicaine"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Allergy to bupivicaine",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": "bupivicaine"
}
}
}
},
{
"identified_line": {
"line": "* Age < 18 years",
"criterions": [
{
"exact_snippets": "Age < 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age < 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Inability or unwillingness to give informed consent",
"criterions": [
{
"exact_snippets": "Inability ... to give informed consent",
"criterion": "ability to give informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "unwillingness to give informed consent",
"criterion": "willingness to give informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
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"exact_snippets": "Inability ... to give informed consent",
"criterion": "ability to give informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "unwillingness to give informed consent",
"criterion": "willingness to give informed consent",
"requirement": {
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"expected_value": true
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}