{
"info": {
"nct_id": "NCT00841282",
"official_title": "Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 50 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion criteria:\n\n* Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,\n* Accept randomization to the study or the conventional method, and agree to complete study questionnaires\n* The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2\n\nExclusion criteria:\n\n* Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded\n* Excluded patients will be managed by usual procedures"
},
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"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 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,",
"criterions": [
{
"exact_snippets": "Adult (> 50 years old)",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 50,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
},
{
"exact_snippets": "scheduled and consented for screening or surveillance colonoscopy",
"criterion": "colonoscopy status",
"requirement": {
"requirement_type": "status",
"expected_value": "scheduled and consented"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adult (> 50 years old)",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 50,
"unit": "years"
}
]
}
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},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
}
]
},
{
"exact_snippets": "scheduled and consented for screening or surveillance colonoscopy",
"criterion": "colonoscopy status",
"requirement": {
"requirement_type": "status",
"expected_value": "scheduled and consented"
}
}
]
}
},
{
"identified_line": {
"line": "* Accept randomization to the study or the conventional method, and agree to complete study questionnaires",
"criterions": [
{
"exact_snippets": "Accept randomization to the study or the conventional method",
"criterion": "randomization acceptance",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
},
{
"exact_snippets": "agree to complete study questionnaires",
"criterion": "study questionnaire completion",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Accept randomization to the study or the conventional method",
"criterion": "randomization acceptance",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
}
]
},
{
"exact_snippets": "agree to complete study questionnaires",
"criterion": "study questionnaire completion",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2",
"criterions": [
{
"exact_snippets": "adults",
"criterion": "age",
"requirement": {
"requirement_type": "category",
"expected_value": "adults"
}
},
{
"exact_snippets": "normal healthy patients",
"criterion": "health status",
"requirement": {
"requirement_type": "condition",
"expected_value": "normal healthy"
}
},
{
"exact_snippets": "patients with mild systemic disease",
"criterion": "health status",
"requirement": {
"requirement_type": "condition",
"expected_value": "mild systemic disease"
}
},
{
"exact_snippets": "ASA 1",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": "ASA 1"
}
},
{
"exact_snippets": "ASA 2",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": "ASA 2"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "adults",
"criterion": "age",
"requirement": {
"requirement_type": "category",
"expected_value": "adults"
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},
{
"or_criteria": [
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"exact_snippets": "normal healthy patients",
"criterion": "health status",
"requirement": {
"requirement_type": "condition",
"expected_value": "normal healthy"
}
},
{
"exact_snippets": "patients with mild systemic disease",
"criterion": "health status",
"requirement": {
"requirement_type": "condition",
"expected_value": "mild systemic disease"
}
},
{
"or_criteria": [
{
"exact_snippets": "ASA 1",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": "ASA 1"
}
},
{
"exact_snippets": "ASA 2",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": "ASA 2"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded",
"criterions": [
{
"exact_snippets": "contraindications for sedation",
"criterion": "contraindications for sedation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "decline to participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
},
{
"exact_snippets": "unable to give informed consent",
"criterion": "ability to give informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "unable to ... complete the questionnaires due to language or other difficulties",
"criterion": "ability to complete questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "contraindications for sedation",
"criterion": "contraindications for sedation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "decline to participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
},
{
"exact_snippets": "unable to give informed consent",
"criterion": "ability to give informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
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{
"exact_snippets": "unable to ... complete the questionnaires due to language or other difficulties",
"criterion": "ability to complete questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Exclusion criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Excluded patients will be managed by usual procedures",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}