{
"info": {
"nct_id": "NCT05502276",
"official_title": "Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), \"no Lift\" Lesions and Residual / Relapses of Previous Resections. Endoscopic.",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion criteria:\n\n* patients of age >18 years\n* Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter\n* \"no-lift\" colic injuries ≤ 3cm in diameter\n* residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter\n\nExclusion criteria:\n\n* pregnant women\n* failure to accept or understand the consent to participate in the study\n* patients with severe coagulopathies\n* patients with short life expectancy (Charlson comorbidity index ≥8)\n* patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)"
},
"inclusion_lines": [
{
"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": [
{
"identified_line": {
"line": "* patients of age >18 years",
"criterions": [
{
"exact_snippets": "age >18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "age >18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter",
"criterions": [
{
"exact_snippets": "residual / recurrence on the scar of previous endoscopic resections of the colon",
"criterion": "residual/recurrence on scar of previous endoscopic resections",
"requirement": {
"requirement_type": "location",
"expected_value": "colon"
}
},
{
"exact_snippets": "≤ 3cm in diameter",
"criterion": "diameter of residual/recurrence",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "residual / recurrence on the scar of previous endoscopic resections of the colon",
"criterion": "residual/recurrence on scar of previous endoscopic resections",
"requirement": {
"requirement_type": "location",
"expected_value": "colon"
}
},
{
"exact_snippets": "≤ 3cm in diameter",
"criterion": "diameter of residual/recurrence",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* pregnant women",
"criterions": [
{
"exact_snippets": "pregnant women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "pregnant women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* failure to accept or understand the consent to participate in the study",
"criterions": [
{
"exact_snippets": "failure to accept ... consent to participate in the study",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
},
{
"exact_snippets": "failure to ... understand the consent to participate in the study",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "understanding",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "failure to accept ... consent to participate in the study",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
},
{
"exact_snippets": "failure to ... understand the consent to participate in the study",
"criterion": "consent to participate",
"requirement": {
"requirement_type": "understanding",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* patients with severe coagulopathies",
"criterions": [
{
"exact_snippets": "patients with severe coagulopathies",
"criterion": "coagulopathies",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "patients with severe coagulopathies",
"criterion": "coagulopathies",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
}
},
{
"identified_line": {
"line": "* patients with short life expectancy (Charlson comorbidity index ≥8)",
"criterions": [
{
"exact_snippets": "short life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "severity",
"expected_value": "short"
}
},
{
"exact_snippets": "Charlson comorbidity index ≥8",
"criterion": "Charlson comorbidity index",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "short life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "severity",
"expected_value": "short"
}
},
{
"exact_snippets": "Charlson comorbidity index ≥8",
"criterion": "Charlson comorbidity index",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)",
"criterions": [
{
"exact_snippets": "American Society of Anesthesiologists score ≥3",
"criterion": "American Society of Anesthesiologists score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "American Society of Anesthesiologists score ≥3",
"criterion": "American Society of Anesthesiologists score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "Inclusion criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Exclusion criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter",
"criterions": [
{
"exact_snippets": "Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter",
"criterion": "Laterally Spreading Tumor Non Granular Type (LST-NG)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Laterally Spreading Tumor Non Granular Type (LST-NG) \u001f 3cm in diameter",
"criterion": "Laterally Spreading Tumor Non Granular Type (LST-NG)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* \"no-lift\" colic injuries ≤ 3cm in diameter",
"criterions": [
{
"exact_snippets": "\"no-lift\" colic injuries ≤ 3cm in diameter",
"criterion": "colic injuries",
"requirement": {
"requirement_type": "type",
"expected_value": "no-lift"
}
},
{
"exact_snippets": "\"no-lift\" colic injuries ≤ 3cm in diameter",
"criterion": "colic injuries",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "\"no-lift\" colic injuries \u0010 3cm in diameter",
"criterion": "colic injuries",
"requirement": {
"requirement_type": "type",
"expected_value": "no-lift"
}
},
{
"exact_snippets": "\"no-lift\" colic injuries \u0010 3cm in diameter",
"criterion": "colic injuries",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "cm"
}
}
}
]
}
}
]
}