{
"info": {
"nct_id": "NCT02543762",
"official_title": "Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease",
"inclusion_criteria": "* Diagnosis of UC or colitis EC corroborated by clinical and histology\n* involvement of at least one third of the colon in patients with CD\n* involvement proximal to the rectum in patients with UC\n* Duration of disease > 10 years\n* No clinical activity:\n* May Score <6\n* CDEIS <3.5\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Personal history of CRC\n* colectomy\n* coagulopathy\n* refusal to participate in the study\n* known allergy to indigo carmine\n* colonoscopy in the last 6 months",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosis of UC or colitis EC corroborated by clinical and histology",
"criterions": [
{
"exact_snippets": "Diagnosis of UC",
"criterion": "ulcerative colitis (UC)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "colitis EC corroborated by clinical and histology",
"criterion": "colitis EC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "colitis EC corroborated by clinical and histology",
"criterion": "colitis EC",
"requirement": {
"requirement_type": "corroboration",
"expected_value": [
"clinical",
"histology"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Diagnosis of UC",
"criterion": "ulcerative colitis (UC)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "colitis EC corroborated by clinical and histology",
"criterion": "colitis EC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "colitis EC corroborated by clinical and histology",
"criterion": "colitis EC",
"requirement": {
"requirement_type": "corroboration",
"expected_value": [
"clinical",
"histology"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* involvement of at least one third of the colon in patients with CD",
"criterions": [
{
"exact_snippets": "involvement of at least one third of the colon",
"criterion": "colon involvement",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "third"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "involvement of at least one third of the colon",
"criterion": "colon involvement",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "third"
}
}
},
{
"exact_snippets": "patients with CD",
"criterion": "CD diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* involvement proximal to the rectum in patients with UC",
"criterions": [
{
"exact_snippets": "involvement proximal to the rectum",
"criterion": "involvement proximal to the rectum",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "involvement proximal to the rectum",
"criterion": "involvement proximal to the rectum",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients with UC",
"criterion": "ulcerative colitis (UC)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Duration of disease > 10 years",
"criterions": [
{
"exact_snippets": "Duration of disease > 10 years",
"criterion": "duration of disease",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Duration of disease > 10 years",
"criterion": "duration of disease",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No clinical activity:",
"criterions": [
{
"exact_snippets": "No clinical activity",
"criterion": "clinical activity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No clinical activity",
"criterion": "clinical activity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* May Score <6",
"criterions": [
{
"exact_snippets": "May Score <6",
"criterion": "May Score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "May Score <6",
"criterion": "May Score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* CDEIS <3.5",
"criterions": [
{
"exact_snippets": "CDEIS <3.5",
"criterion": "CDEIS",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 3.5,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "CDEIS <3.5",
"criterion": "CDEIS",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 3.5,
"unit": "N/A"
}
}
}
]
}
},
{
"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": "* Personal history of CRC",
"criterions": [
{
"exact_snippets": "Personal history of CRC",
"criterion": "personal history of CRC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Personal history of CRC",
"criterion": "personal history of CRC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* colectomy",
"criterions": [
{
"exact_snippets": "colectomy",
"criterion": "colectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "colectomy",
"criterion": "colectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* coagulopathy",
"criterions": [
{
"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* refusal to participate in the study",
"criterions": [
{
"exact_snippets": "refusal to participate in the study",
"criterion": "participation in the study",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "refusal to participate in the study",
"criterion": "participation in the study",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* known allergy to indigo carmine",
"criterions": [
{
"exact_snippets": "known allergy to indigo carmine",
"criterion": "allergy",
"requirement": {
"requirement_type": "substance",
"expected_value": "indigo carmine"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "known allergy to indigo carmine",
"criterion": "allergy",
"requirement": {
"requirement_type": "substance",
"expected_value": "indigo carmine"
}
}
}
},
{
"identified_line": {
"line": "* colonoscopy in the last 6 months",
"criterions": [
{
"exact_snippets": "colonoscopy in the last 6 months",
"criterion": "colonoscopy",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "colonoscopy in the last 6 months",
"criterion": "colonoscopy",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}