{
"info": {
"nct_id": "NCT00825448",
"official_title": "Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer",
"inclusion_criteria": "* Age 18-80 years, male or female\n* Clinically and histologically verified ORL cancer required surgery\n* Patient with alcohol addiction\n* Men must consume 21 glasses of wine a week\n* Women must consume 14 glasses of wine a week\n* CPAM affiliation\n* Able to give written informed consent to participate in the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Inability to give informed consent\n* Patient with regulatory authority or private patient freedom",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age 18-80 years, male or female",
"criterions": [
{
"exact_snippets": "Age 18-80 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "allowed_values",
"expected_value": [
"male",
"female"
]
}
]
}
]
},
{
"line": "* Clinically and histologically verified ORL cancer required surgery",
"criterions": [
{
"exact_snippets": "Clinically and histologically verified ORL cancer",
"criterion": "ORL cancer",
"requirements": [
{
"requirement_type": "verification",
"expected_value": [
"clinical",
"histological"
]
}
]
},
{
"exact_snippets": "required surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient with alcohol addiction",
"criterions": [
{
"exact_snippets": "alcohol addiction",
"criterion": "alcohol addiction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Men must consume 21 glasses of wine a week",
"criterions": [
{
"exact_snippets": "Men must consume 21 glasses of wine a week",
"criterion": "wine consumption",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 21,
"unit": "glasses per week"
}
}
]
}
]
},
{
"line": "* Women must consume 14 glasses of wine a week",
"criterions": [
{
"exact_snippets": "Women must consume 14 glasses of wine a week",
"criterion": "wine consumption",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 14,
"unit": "glasses per week"
}
}
]
}
]
},
{
"line": "* CPAM affiliation",
"criterions": [
{
"exact_snippets": "CPAM affiliation",
"criterion": "CPAM affiliation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Able to give written informed consent to participate in the study",
"criterions": [
{
"exact_snippets": "Able to give written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Inability to give informed consent",
"criterions": [
{
"exact_snippets": "Inability to give informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient with regulatory authority or private patient freedom",
"criterions": [
{
"exact_snippets": "regulatory authority",
"criterion": "regulatory authority",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "private patient freedom",
"criterion": "private patient freedom",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}