{
"info": {
"nct_id": "NCT06687291",
"official_title": "Cognitive Impact Associated with Surgery for Gastric or Esophageal Cancer",
"inclusion_criteria": "* Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.\n* Age ≥18 at the time for inclusion.\n* Participate on a voluntary basis and can (for any reason) end its participation during the study.\n* Capable of giving informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients with preoperative cognitive dysfunction such as dementia.\n* Patients who are inoperable due to metastases.\n* Patients unable to communicate due to severely impaired hearing and/or - seeing.\n* Patients with ongoing drug and/or alcohol abuse.\n* Patients who cannot give informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.",
"criterions": [
{
"exact_snippets": "Patients diagnosed with esophageal or gastric cancer",
"criterion": "cancer diagnosis",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"esophageal",
"gastric"
]
}
]
},
{
"exact_snippets": "treated with (or without) chemotherapy",
"criterion": "chemotherapy treatment",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "optional"
}
]
},
{
"exact_snippets": "treated with (or without) ... surgery",
"criterion": "surgery treatment",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "optional"
}
]
}
]
},
{
"line": "* Age ≥18 at the time for inclusion.",
"criterions": [
{
"exact_snippets": "Age ≥18",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Participate on a voluntary basis and can (for any reason) end its participation during the study.",
"criterions": [
{
"exact_snippets": "Participate on a voluntary basis",
"criterion": "participation",
"requirements": [
{
"requirement_type": "voluntariness",
"expected_value": true
}
]
},
{
"exact_snippets": "can (for any reason) end its participation during the study",
"criterion": "participation",
"requirements": [
{
"requirement_type": "ability to withdraw",
"expected_value": true
}
]
}
]
},
{
"line": "* Capable of giving informed consent.",
"criterions": [
{
"exact_snippets": "Capable of giving informed consent.",
"criterion": "informed consent capability",
"requirements": [
{
"requirement_type": "capability",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patients with preoperative cognitive dysfunction such as dementia.",
"criterions": [
{
"exact_snippets": "preoperative cognitive dysfunction such as dementia",
"criterion": "preoperative cognitive dysfunction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients who are inoperable due to metastases.",
"criterions": [
{
"exact_snippets": "inoperable due to metastases",
"criterion": "operability",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "inoperable"
}
]
},
{
"exact_snippets": "metastases",
"criterion": "metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients unable to communicate due to severely impaired hearing and/or - seeing.",
"criterions": [
{
"exact_snippets": "severely impaired hearing",
"criterion": "hearing ability",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severely impaired"
}
]
},
{
"exact_snippets": "severely impaired ... seeing",
"criterion": "vision ability",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severely impaired"
}
]
}
]
},
{
"line": "* Patients with ongoing drug and/or alcohol abuse.",
"criterions": [
{
"exact_snippets": "ongoing drug ... abuse",
"criterion": "drug abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "ongoing ... alcohol abuse",
"criterion": "alcohol abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients who cannot give informed consent.",
"criterions": [
{
"exact_snippets": "Patients who cannot give informed consent.",
"criterion": "ability to give informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}