{
"info": {
"nct_id": "NCT06325891",
"official_title": "Microbiota Diversity and Composition in Gastric Cancer by Gastric Mucosal Brushing: a Cross-sectional Case-control Study",
"inclusion_criteria": "* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy (EGD)\n* Gastric cancer group: patients with pathological diagnosis of high-grade dysplasia or gastric cancer\n* Control group: patients with no or minimal upper GI symptoms and current EGD appear normal or minimal gastritis\n* Informed consent obtained\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Had a history of GI or hepatobiliary surgery\n* Had a history of recent (within 4 weeks) antibiotic or probiotic use\n* Had a history of PPI use within 2 weeks",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy (EGD)",
"criterions": [
{
"exact_snippets": "Adult patients (≥18 years of age)",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "undergoing esophagogastroduodenoscopy (EGD)",
"criterion": "procedure",
"requirement": {
"requirement_type": "undergoing",
"expected_value": "esophagogastroduodenoscopy (EGD)"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adult patients (≥18 years of age)",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "undergoing esophagogastroduodenoscopy (EGD)",
"criterion": "procedure",
"requirement": {
"requirement_type": "undergoing",
"expected_value": "esophagogastroduodenoscopy (EGD)"
}
}
]
}
},
{
"identified_line": {
"line": "* Gastric cancer group: patients with pathological diagnosis of high-grade dysplasia or gastric cancer",
"criterions": [
{
"exact_snippets": "pathological diagnosis of high-grade dysplasia",
"criterion": "high-grade dysplasia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "pathological diagnosis of ... gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "pathological diagnosis of high-grade dysplasia",
"criterion": "high-grade dysplasia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "pathological diagnosis of ... gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Informed consent obtained",
"criterions": [
{
"exact_snippets": "Informed consent obtained",
"criterion": "informed consent",
"requirement": {
"requirement_type": "obtained",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Informed consent obtained",
"criterion": "informed consent",
"requirement": {
"requirement_type": "obtained",
"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": "* Had a history of GI or hepatobiliary surgery",
"criterions": [
{
"exact_snippets": "history of GI or hepatobiliary surgery",
"criterion": "GI or hepatobiliary surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "history of GI or hepatobiliary surgery",
"criterion": "GI or hepatobiliary surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Had a history of recent (within 4 weeks) antibiotic or probiotic use",
"criterions": [
{
"exact_snippets": "Had a history of recent (within 4 weeks) antibiotic ... use",
"criterion": "antibiotic use",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Had a history of recent (within 4 weeks) ... probiotic use",
"criterion": "probiotic use",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Had a history of recent (within 4 weeks) antibiotic ... use",
"criterion": "antibiotic use",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Had a history of recent (within 4 weeks) ... probiotic use",
"criterion": "probiotic use",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Had a history of PPI use within 2 weeks",
"criterions": [
{
"exact_snippets": "Had a history of PPI use within 2 weeks",
"criterion": "PPI use",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Had a history of PPI use within 2 weeks",
"criterion": "PPI use",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Control group: patients with no or minimal upper GI symptoms and current EGD appear normal or minimal gastritis",
"criterions": [
{
"exact_snippets": "no or minimal upper GI symptoms",
"criterion": "upper GI symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": "no or minimal"
}
},
{
"exact_snippets": "current EGD appear normal or minimal gastritis",
"criterion": "EGD results",
"requirement": {
"requirement_type": "appearance",
"expected_value": "normal or minimal gastritis"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "no or minimal upper GI symptoms",
"criterion": "upper GI symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": "no or minimal"
}
},
{
"exact_snippets": "current EGD appear normal or minimal gastritis",
"criterion": "EGD results",
"requirement": {
"requirement_type": "appearance",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "current EGD appear normal or minimal gastritis",
"criterion": "EGD results",
"requirement": {
"requirement_type": "appearance",
"expected_value": "minimal gastritis"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}