{
"info": {
"nct_id": "NCT02788565",
"official_title": "SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)",
"inclusion_criteria": "* Signed informed consent\n* Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years\n* GEP-NET proliferation index Ki 67 <10%\n* Over 18 years of age\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* No specific exclusion criteria defined",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Signed informed consent",
"criterions": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"criterion": "informed consent",
"requirement": {
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"expected_value": true
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}
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}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)",
"criterion": "Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "treated with SSA for at least three months but not more than 3 years",
"criterion": "SSA treatment duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "months"
},
{
"operator": "<=",
"value": 3,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"criterion": "Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "treated with SSA for at least three months but not more than 3 years",
"criterion": "SSA treatment duration",
"requirement": {
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"expected_value": {
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"operator": ">=",
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"unit": "months"
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"value": 3,
"unit": "years"
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}
}
}
]
}
},
{
"identified_line": {
"line": "* GEP-NET proliferation index Ki 67 <10%",
"criterions": [
{
"exact_snippets": "GEP-NET proliferation index Ki 67 <10%",
"criterion": "GEP-NET proliferation index Ki 67",
"requirement": {
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"expected_value": {
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"value": 10,
"unit": "%"
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},
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"criterion": "GEP-NET proliferation index Ki 67",
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"expected_value": {
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"value": 10,
"unit": "%"
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{
"identified_line": {
"line": "* Over 18 years of age",
"criterions": [
{
"exact_snippets": "Over 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
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"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"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": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
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]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* No specific exclusion criteria defined",
"criterions": [
{
"exact_snippets": "No specific exclusion criteria defined",
"criterion": "exclusion criteria",
"requirement": {
"requirement_type": "definition",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No specific exclusion criteria defined",
"criterion": "exclusion criteria",
"requirement": {
"requirement_type": "definition",
"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}