{
"info": {
"nct_id": "NCT04406662",
"official_title": "Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms",
"inclusion_criteria": "* Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).\n* Aged 18-years and over\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator.\n* Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Aged 18-years and over",
"criterions": [
{
"exact_snippets": "Aged 18-years and over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Aged 18-years and over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"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": "* Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator.",
"criterions": [
{
"exact_snippets": "Any concomitant medical or psychiatric problems",
"criterion": "concomitant medical or psychiatric problems",
"requirement": {
"requirement_type": "risk of complication",
"expected_value": "increase"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any concomitant medical or psychiatric problems",
"criterion": "concomitant medical or psychiatric problems",
"requirement": {
"requirement_type": "risk of complication",
"expected_value": "increase"
}
},
{
"exact_snippets": "in the opinion of the investigator",
"criterion": "investigator opinion",
"requirement": {
"requirement_type": "risk assessment",
"expected_value": "increase"
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).",
"criterions": [
{
"exact_snippets": "incurable cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "curability",
"expected_value": false
}
},
{
"exact_snippets": "metastatic cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "Clinical, histological, cytological or radiological evidence",
"criterion": "cancer evidence",
"requirement": {
"requirement_type": "type",
"expected_value": [
"clinical",
"histological",
"cytological",
"radiological"
]
}
},
{
"exact_snippets": "receiving anti-cancer therapy with palliative intent",
"criterion": "anti-cancer therapy",
"requirement": {
"requirement_type": "intent",
"expected_value": "palliative"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "metastatic cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "Clinical, histological, cytological or radiological evidence",
"criterion": "cancer evidence",
"requirement": {
"requirement_type": "type",
"expected_value": [
"clinical",
"histological",
"cytological",
"radiological"
]
}
}
]
},
{
"exact_snippets": "receiving anti-cancer therapy with palliative intent",
"criterion": "anti-cancer therapy",
"requirement": {
"requirement_type": "intent",
"expected_value": "palliative"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.",
"criterions": [
{
"exact_snippets": "Participants will not be able to take part in bio-impedance analysis if they have a pacemaker",
"criterion": "pacemaker",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Participants will not be able to take part in bio-impedance analysis if they have ... implantable cardiac defibrillator",
"criterion": "implantable cardiac defibrillator",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Participants will not be able to take part in bio-impedance analysis if they have a pacemaker",
"criterion": "pacemaker",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participants will not be able to take part in bio-impedance analysis if they have ... implantable cardiac defibrillator",
"criterion": "implantable cardiac defibrillator",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}