{
"info": {
"nct_id": "NCT04913376",
"official_title": "Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial",
"inclusion_criteria": "* 18 years or older\n* Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)\n* Starting oxaliplatin-based treatment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Already grade 2 or higher peripheral neuropathy\n\nFor a more detailed list, see protocol.",
"miscellaneous_criteria": "Most important Eligibility Criteria:"
},
"inclusion_lines": [
{
"line": "* 18 years or older",
"criterions": [
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)",
"criterions": [
{
"exact_snippets": "Gastro-intestinal tumor",
"criterion": "gastro-intestinal tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "treated in UZ Leuven (University Hospitals of Leuven)",
"criterion": "treatment location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "UZ Leuven (University Hospitals of Leuven)"
}
]
}
]
},
{
"line": "* Starting oxaliplatin-based treatment",
"criterions": [
{
"exact_snippets": "Starting oxaliplatin-based treatment",
"criterion": "oxaliplatin-based treatment",
"requirements": [
{
"requirement_type": "status",
"expected_value": "starting"
}
]
}
]
},
{
"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": "* Already grade 2 or higher peripheral neuropathy",
"criterions": [
{
"exact_snippets": "grade 2 or higher peripheral neuropathy",
"criterion": "peripheral neuropathy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "grade"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "For a more detailed list, see protocol.",
"criterions": []
}
],
"failed_miscellaneous": [
{
"line": "Most important Eligibility Criteria:",
"criterions": []
}
]
}