{
"info": {
"nct_id": "NCT02662348",
"official_title": "T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System",
"inclusion_criteria": "1. Patient with Her2-positive neoplasms of digestive system: IHC 3+\n2. Clinical staging: Phase III or above\n3. Ages: < 65\n4. Expected survival time: > 1 year\n5. Quality of Life: > 60\n6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal\n7. The volunteers with informed consent\n\nExclusion criteria:\n\n1. Patient with Her2-negative neoplasms of digestive system\n2. Hepatic renal dysfunction\n3. Cardiopulmonary insufficiency\n4. Mental disorder\n5. Allergic condition\n6. With other malignant tumor\n7. Lactating women\n8. Patients with infection or received chemotherapy in the past two weeks\n9. Patient with autoimmune disease using immunosuppressive drug\n10. Patient with organ transplantation with long term use of immunosupresive drug\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patient with Her2-positive neoplasms of digestive system: IHC 3+",
"criterions": [
{
"exact_snippets": "Her2-positive neoplasms of digestive system",
"criterion": "Her2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "neoplasms of digestive system",
"criterion": "neoplasms location",
"requirement": {
"requirement_type": "location",
"expected_value": "digestive system"
}
},
{
"exact_snippets": "IHC 3+",
"criterion": "IHC score",
"requirement": {
"requirement_type": "score",
"expected_value": "3+"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Her2-positive neoplasms of digestive system",
"criterion": "Her2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "neoplasms of digestive system",
"criterion": "neoplasms location",
"requirement": {
"requirement_type": "location",
"expected_value": "digestive system"
}
},
{
"exact_snippets": "IHC 3+",
"criterion": "IHC score",
"requirement": {
"requirement_type": "score",
"expected_value": "3+"
}
}
]
}
},
{
"identified_line": {
"line": "2. Clinical staging: Phase III or above",
"criterions": [
{
"exact_snippets": "Clinical staging: Phase III or above",
"criterion": "clinical staging",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "Phase"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clinical staging: Phase III or above",
"criterion": "clinical staging",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "Phase"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Ages: < 65",
"criterions": [
{
"exact_snippets": "Ages: < 65",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 65,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ages: < 65",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 65,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Expected survival time: > 1 year",
"criterions": [
{
"exact_snippets": "Expected survival time: > 1 year",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Expected survival time: > 1 year",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Quality of Life: > 60",
"criterions": [
{
"exact_snippets": "Quality of Life: > 60",
"criterion": "Quality of Life",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Quality of Life: > 60",
"criterion": "Quality of Life",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterions": [
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "heart function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "liver function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "lung function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "kidney function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "heart function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "liver function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "lung function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of important organs( heart, liver, lung, kidney and etc.)are normal",
"criterion": "kidney function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
}
]
}
},
{
"identified_line": {
"line": "7. The volunteers with informed consent",
"criterions": [
{
"exact_snippets": "informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "informed consent",
"criterion": "informed consent",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Patient with Her2-negative neoplasms of digestive system",
"criterions": [
{
"exact_snippets": "Her2-negative neoplasms",
"criterion": "Her2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "neoplasms of digestive system",
"criterion": "neoplasms location",
"requirement": {
"requirement_type": "location",
"expected_value": "digestive system"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Her2-negative neoplasms",
"criterion": "Her2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "neoplasms of digestive system",
"criterion": "neoplasms location",
"requirement": {
"requirement_type": "location",
"expected_value": "digestive system"
}
}
]
}
},
{
"identified_line": {
"line": "2. Hepatic renal dysfunction",
"criterions": [
{
"exact_snippets": "Hepatic renal dysfunction",
"criterion": "hepatic renal dysfunction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hepatic renal dysfunction",
"criterion": "hepatic renal dysfunction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Cardiopulmonary insufficiency",
"criterions": [
{
"exact_snippets": "Cardiopulmonary insufficiency",
"criterion": "cardiopulmonary insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Cardiopulmonary insufficiency",
"criterion": "cardiopulmonary insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "4. Mental disorder",
"criterions": [
{
"exact_snippets": "Mental disorder",
"criterion": "mental disorder",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Mental disorder",
"criterion": "mental disorder",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Allergic condition",
"criterions": [
{
"exact_snippets": "Allergic condition",
"criterion": "allergic condition",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Allergic condition",
"criterion": "allergic condition",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. With other malignant tumor",
"criterions": [
{
"exact_snippets": "With other malignant tumor",
"criterion": "malignant tumor",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "With other malignant tumor",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Lactating women",
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"exact_snippets": "Lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": "lactating"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": "lactating"
}
}
]
}
},
{
"identified_line": {
"line": "9. Patient with autoimmune disease using immunosuppressive drug",
"criterions": [
{
"exact_snippets": "Patient with autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "using immunosuppressive drug",
"criterion": "immunosuppressive drug",
"requirement": {
"requirement_type": "usage",
"expected_value": true
}
}
]
},
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"exact_snippets": "Patient with autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "using immunosuppressive drug",
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}
}
]
}
},
{
"identified_line": {
"line": "10. Patient with organ transplantation with long term use of immunosupresive drug",
"criterions": [
{
"exact_snippets": "Patient with organ transplantation",
"criterion": "organ transplantation",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "long term use of immunosupresive drug",
"criterion": "immunosuppressive drug use",
"requirement": {
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"expected_value": "long term"
}
}
]
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"exact_snippets": "Patient with organ transplantation",
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"expected_value": true
}
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{
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
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"unit": "Years"
}
}
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},
{
"identified_line": {
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{
"exact_snippets": "maximum age of 65 Years",
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"value": 65,
"unit": "Years"
}
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{
"identified_line": {
"line": "Exclusion criteria:",
"criterions": []
},
"logical_structure": {
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}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "8. Patients with infection or received chemotherapy in the past two weeks",
"criterions": [
{
"exact_snippets": "Patients with infection",
"criterion": "infection",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "received chemotherapy in the past two weeks",
"criterion": "chemotherapy",
"requirement": {
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"expected_value": {
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"value": 2,
"unit": "weeks"
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}
}
]
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}
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{
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"value": 2,
"unit": "weeks"
}
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}