{
"info": {
"nct_id": "NCT04765462",
"official_title": "An Open-label, Phase 1/2 Study of Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors",
"inclusion_criteria": "1. Histological confirmation of malignant solid tumors, including patients received surgery, patients with initially diagnosed or pre-treated local advanced/metastatic malignancies, and patients with B-cell non-Hodgkin's lymphomas.\n2. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.\n3. Age from 18 to 75 years old, gender unlimited.\n4. Eastern Cooperative Oncology Group (ECOG) Performance score≤2.\n5. Patient with adequate bone marrow reserve (Haemoglobin≥80g/L, Absolute Neutrophil Count (ANC) ≥1×10^6/L, Platelet≥75×10^9/L or ≥50×10^9/L for liver tumors), hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases, Total bilirubin ≤ 1.5 x ULN), renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN)) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).\n6. Patient with life expectancy of at least 3 months.\n7. Patient without bleeding and coagulation disorders.\n8. Patient without obvious genetic diseases.\n9. Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).\n10. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.\n2. Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.\n3. Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia, HBV, HCV, HIV, TP, CMV or EBV infection).\n4. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency).\n5. Pregnancy or lactation before or during the trial.\n6. Patients with history of prior organ or bone marrow transplantation.\n7. Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.\n8. History of epilepsy or other active central nervous system disorders.\n9. Patients inoculated live vaccine within 6 weeks before screening.\n10. Allergic constitution, history of allergies to blood products, known to be allergic to any substances in the protocol(such as Zoledronate or similar).\n11. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.\n12. Any other situations that investigators believe the risk of the subjects is increased or results of the trial are disturbed\n\nDonor Inclusion Criteria:\n\n1. Sign informed consent form.\n2. Age 18 years up to the age of 50 (≤50), gender unlimited.\n3. Relative to patients (unrestricted to blood relationship).\n4. Apheresis available.\n5. PLT≥100×109/L with normal APTT or PT.\n6. preculture of γδ T cells meets the requirements of massive amplification and detection.\n\nDonor Exclusion Criteria:\n\n1. History of any severe clinical diseases or other severe organic diseases, including any history of clinically significant systematic diseases such as cardiovascular, urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrine diseases. History of high blood pressure or systolic pressure>140 mmHg, diastolic pressure>90 mmHg in screening stage. Any situation that investigators believe is clinically significant or with other severe diseases unsuitable of apheresis.\n2. Arterial thrombosis or venous thrombosis history 12 months prior to the trial or hemorrhagic tendency or history 2 months prior to the trial; oral administration of anticoagulation drugs (e. g. aspirin and warfarin).\n3. Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT. Apart from hypothyrosis which can be controlled by hormone replacement therapy, skin diseases without systemic therapy and celiac disease which is fully controlled.\n4. HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.\n5. Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection (e.g. fever, cough, urinary irritation, skin infectious wound).\n6. Female who are pregnant or cannot stop lactating.\n7. Those who cannot communicate with medical staff due to mental illness or language disabilities.\n8. Other unsuitable conditions that investigators believe unsuitable for the donation.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Histological confirmation of malignant solid tumors, including patients received surgery, patients with initially diagnosed or pre-treated local advanced/metastatic malignancies, and patients with B-cell non-Hodgkin's lymphomas.",
"criterions": [
{
"exact_snippets": "Histological confirmation of malignant solid tumors",
"criterion": "malignant solid tumors",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histological"
}
},
{
"exact_snippets": "patients received surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "initially diagnosed or pre-treated local advanced/metastatic malignancies",
"criterion": "local advanced/metastatic malignancies",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "initially diagnosed or pre-treated"
}
},
{
"exact_snippets": "patients with B-cell non-Hodgkin's lymphomas",
"criterion": "B-cell non-Hodgkin's lymphomas",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histological confirmation of malignant solid tumors",
"criterion": "malignant solid tumors",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histological"
}
},
{
"exact_snippets": "patients received surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "initially diagnosed or pre-treated local advanced/metastatic malignancies",
"criterion": "local advanced/metastatic malignancies",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "initially diagnosed or pre-treated"
}
},
{
"exact_snippets": "patients with B-cell non-Hodgkin's lymphomas",
"criterion": "B-cell non-Hodgkin's lymphomas",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.",
"criterions": [
{
"exact_snippets": "Patients should sign informed consent form voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "Patients should sign informed consent form voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "voluntarily",
"expected_value": true
}
},
{
"exact_snippets": "comply with the requirements of this study",
"criterion": "study compliance",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients should sign informed consent form voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "Patients should sign informed consent form voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "voluntarily",
"expected_value": true
}
},
{
"exact_snippets": "comply with the requirements of this study",
"criterion": "study compliance",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Age from 18 to 75 years old, gender unlimited.",
"criterions": [
{
"exact_snippets": "Age from 18 to 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "gender unlimited",
"criterion": "gender",
"requirement": {
"requirement_type": "restriction",
"expected_value": "unlimited"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age from 18 to 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "gender unlimited",
"criterion": "gender",
"requirement": {
"requirement_type": "restriction",
"expected_value": "unlimited"
}
}
]
}
},
{
"identified_line": {
"line": "4. Eastern Cooperative Oncology Group (ECOG) Performance score≤2.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance score≤2",
"criterion": "ECOG Performance score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance score≤2",
"criterion": "ECOG Performance score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "6. Patient with life expectancy of at least 3 months.",
"criterions": [
{
"exact_snippets": "life expectancy of at least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "life expectancy of at least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Patient without bleeding and coagulation disorders.",
"criterions": [
{
"exact_snippets": "bleeding and coagulation disorders",
"criterion": "bleeding disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "bleeding and coagulation disorders",
"criterion": "coagulation disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "bleeding and coagulation disorders",
"criterion": "bleeding disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "bleeding and coagulation disorders",
"criterion": "coagulation disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "8. Patient without obvious genetic diseases.",
"criterions": [
{
"exact_snippets": "without obvious genetic diseases",
"criterion": "genetic diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "without obvious genetic diseases",
"criterion": "genetic diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "10. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.",
"criterions": [
{
"exact_snippets": "Male and female patients of reproductive potential",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must agree to use birth control during the study and for at least 12 weeks post study",
"criterion": "birth control usage",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the study and for at least 12 weeks post study"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Male and female patients of reproductive potential",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must agree to use birth control during the study and for at least 12 weeks post study",
"criterion": "birth control usage",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the study and for at least 12 weeks post study"
}
}
]
}
},
{
"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": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "2. Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.",
"criterions": [
{
"exact_snippets": "Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.",
"criterion": "participation in other interventional clinical trial",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.",
"criterion": "participation in other interventional clinical trial",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia, HBV, HCV, HIV, TP, CMV or EBV infection).",
"criterions": [
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "sepsis",
"criterion": "sepsis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "bacteremia",
"criterion": "bacteremia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "fungemia",
"criterion": "fungemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBV",
"criterion": "HBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HIV",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "TP",
"criterion": "TP infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CMV",
"criterion": "CMV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "EBV",
"criterion": "EBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "Uncontrolled serious active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
{
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "bacteremia",
"criterion": "bacteremia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "fungemia",
"criterion": "fungemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBV",
"criterion": "HBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HIV",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "TP",
"criterion": "TP infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CMV",
"criterion": "CMV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "EBV",
"criterion": "EBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Patients with history of prior organ or bone marrow transplantation.",
"criterions": [
{
"exact_snippets": "history of prior organ or bone marrow transplantation",
"criterion": "organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of prior organ or bone marrow transplantation",
"criterion": "bone marrow transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "history of prior organ or bone marrow transplantation",
"criterion": "organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of prior organ or bone marrow transplantation",
"criterion": "bone marrow transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.",
"criterions": [
{
"exact_snippets": "systemic vasculitis",
"criterion": "systemic vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "active or uncontrolled autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "active or uncontrolled autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "primary or secondary immunodeficiency diseases",
"criterion": "immunodeficiency diseases",
"requirement": {
"requirement_type": "type",
"expected_value": [
"primary",
"secondary"
]
}
},
{
"exact_snippets": "primary or secondary immunodeficiency diseases",
"criterion": "immunodeficiency diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "systemic vasculitis",
"criterion": "systemic vasculitis",
"requirement": {
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"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "active or uncontrolled autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
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}
},
{
"exact_snippets": "active or uncontrolled autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
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"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "primary or secondary immunodeficiency diseases",
"criterion": "immunodeficiency diseases",
"requirement": {
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"expected_value": [
"primary",
"secondary"
]
}
},
{
"exact_snippets": "primary or secondary immunodeficiency diseases",
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"requirement": {
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"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "8. History of epilepsy or other active central nervous system disorders.",
"criterions": [
{
"exact_snippets": "History of epilepsy",
"criterion": "epilepsy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "other active central nervous system disorders",
"criterion": "central nervous system disorders",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of epilepsy",
"criterion": "epilepsy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "other active central nervous system disorders",
"criterion": "central nervous system disorders",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "9. Patients inoculated live vaccine within 6 weeks before screening.",
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"exact_snippets": "Patients inoculated live vaccine within 6 weeks before screening.",
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"requirement_type": "time since inoculation",
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"operator": "<=",
"value": 6,
"unit": "weeks"
}
}
}
]
},
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"exact_snippets": "Patients inoculated live vaccine within 6 weeks before screening.",
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"operator": "<=",
"value": 6,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "10. Allergic constitution, history of allergies to blood products, known to be allergic to any substances in the protocol(such as Zoledronate or similar).",
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"exact_snippets": "Allergic constitution",
"criterion": "allergic constitution",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "history of allergies to blood products",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "known to be allergic to any substances in the protocol",
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"expected_value": true
}
},
{
"exact_snippets": "such as Zoledronate or similar",
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}
}
]
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"expected_value": true
}
},
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"exact_snippets": "history of allergies to blood products",
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}
}
]
},
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}
},
{
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}
}
]
}
},
{
"identified_line": {
"line": "11. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.",
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{
"exact_snippets": "Uncontrolled intercurrent illness including, but not limited to ongoing or active infection",
"criterion": "intercurrent illness",
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"requirement_type": "control status",
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}
},
{
"exact_snippets": "symptomatic congestive heart failure",
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"requirement_type": "symptoms",
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}
},
{
"exact_snippets": "unstable angina pectoris",
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"requirement_type": "stability",
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}
},
{
"exact_snippets": "cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "any other medical condition that precludes surgery",
"criterion": "medical condition",
"requirement": {
"requirement_type": "surgical eligibility",
"expected_value": false
}
},
{
"exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
"criterion": "psychiatric illness/social situations",
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"requirement_type": "compliance impact",
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}
}
]
},
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"exact_snippets": "Uncontrolled intercurrent illness including, but not limited to ongoing or active infection",
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}
},
{
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"exact_snippets": "symptomatic congestive heart failure",
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},
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"exact_snippets": "any other medical condition that precludes surgery",
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]
}
},
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"line": "12. Any other situations that investigators believe the risk of the subjects is increased or results of the trial are disturbed",
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"exact_snippets": "Any other situations that investigators believe the risk of the subjects is increased",
"criterion": "risk of the subjects",
"requirement": {
"requirement_type": "investigator belief",
"expected_value": "increased"
}
},
{
"exact_snippets": "Any other situations that investigators believe ... results of the trial are disturbed",
"criterion": "results of the trial",
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}
}
]
},
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}
},
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"exact_snippets": "Any other situations that investigators believe ... results of the trial are disturbed",
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}
}
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}
},
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"line": "1. Sign informed consent form.",
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"requirement_type": "signed",
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}
}
]
},
"logical_structure": {
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}
}
}
},
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"operator": ">=",
"value": 18,
"unit": "years"
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{
"operator": "<=",
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"unit": "years"
}
]
}
}
},
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"exact_snippets": "gender unlimited",
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"requirement_type": "restriction",
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}
}
]
},
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"exact_snippets": "Age 18 years up to the age of 50 (≤50)",
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"operator": ">=",
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"unit": "years"
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{
"operator": "<=",
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"unit": "years"
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]
}
}
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"exact_snippets": "gender unlimited",
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}
}
]
}
},
{
"identified_line": {
"line": "3. Relative to patients (unrestricted to blood relationship).",
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"exact_snippets": "Relative to patients (unrestricted to blood relationship)",
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}
}
]
},
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"exact_snippets": "Relative to patients (unrestricted to blood relationship)",
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}
}
}
},
{
"identified_line": {
"line": "4. Apheresis available.",
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"requirement_type": "availability",
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}
}
]
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"exact_snippets": "Apheresis available",
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}
}
]
}
},
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"identified_line": {
"line": "5. PLT≥100×109/L with normal APTT or PT.",
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"exact_snippets": "PLT≥100×109/L",
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"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "normal APTT",
"criterion": "activated partial thromboplastin time (APTT)",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "normal ... PT",
"criterion": "prothrombin time (PT)",
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"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
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{
"exact_snippets": "PLT≥100×109/L",
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"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "normal APTT",
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}
}
]
},
{
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}
}
},
{
"exact_snippets": "normal ... PT",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "6. preculture of γδ T cells meets the requirements of massive amplification and detection.",
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"exact_snippets": "preculture of γδ T cells meets the requirements of massive amplification",
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"requirement_type": "amplification",
"expected_value": "massive"
}
},
{
"exact_snippets": "preculture of γδ T cells meets the requirements of ... detection",
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"expected_value": true
}
}
]
},
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"exact_snippets": "preculture of γδ T cells meets the requirements of massive amplification",
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}
},
{
"exact_snippets": "preculture of γδ T cells meets the requirements of ... detection",
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"expected_value": true
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}
]
}
},
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"identified_line": {
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"criterions": [
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"exact_snippets": "History of any severe clinical diseases or other severe organic diseases",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "history of clinically significant systematic diseases such as cardiovascular, urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrine diseases",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "History of high blood pressure",
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}
},
{
"exact_snippets": "systolic pressure>140 mmHg",
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"operator": ">",
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"unit": "mmHg"
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}
},
{
"exact_snippets": "diastolic pressure>90 mmHg",
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"operator": ">",
"value": 90,
"unit": "mmHg"
}
}
},
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"exact_snippets": "Any situation that investigators believe is clinically significant or with other severe diseases unsuitable of apheresis",
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}
}
]
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"or_criteria": [
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"and_criteria": [
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}
},
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{
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]
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"requirement": {
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"expected_value": "12 months prior to the trial"
}
},
{
"exact_snippets": "Arterial thrombosis or venous thrombosis history 12 months prior to the trial",
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}
},
{
"exact_snippets": "hemorrhagic tendency or history 2 months prior to the trial",
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}
},
{
"exact_snippets": "hemorrhagic tendency or history 2 months prior to the trial",
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}
},
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"exact_snippets": "oral administration of anticoagulation drugs (e. g. aspirin and warfarin)",
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}
}
]
},
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{
"or_criteria": [
{
"and_criteria": [
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"exact_snippets": "Arterial thrombosis or venous thrombosis history 12 months prior to the trial",
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]
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}
]
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]
},
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"exact_snippets": "oral administration of anticoagulation drugs (e. g. aspirin and warfarin)",
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}
}
]
}
},
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"exact_snippets": "Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT.",
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"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "hypothyrosis which can be controlled by hormone replacement therapy",
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}
},
{
"exact_snippets": "skin diseases without systemic therapy",
"criterion": "skin diseases",
"requirement": {
"requirement_type": "systemic therapy",
"expected_value": false
}
},
{
"exact_snippets": "celiac disease which is fully controlled",
"criterion": "celiac disease",
"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT.",
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}
},
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"not_criteria": {
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}
},
{
"not_criteria": {
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}
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]
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]
}
},
{
"identified_line": {
"line": "4. HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.",
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"criterion": "HIV antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "TP-Ab ... positive",
"criterion": "Treponema pallidum antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV-Ab ... positive",
"criterion": "Hepatitis C virus antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBsAg ... positive",
"criterion": "Hepatitis B surface antigen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBeAg ... positive",
"criterion": "Hepatitis B e antigen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBeAb ... positive",
"criterion": "Hepatitis B e antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBcAb ... positive",
"criterion": "Hepatitis B core antibody",
"requirement": {
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"expected_value": true
}
}
]
},
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"expected_value": true
}
},
{
"exact_snippets": "TP-Ab ... positive",
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}
},
{
"exact_snippets": "HCV-Ab ... positive",
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"expected_value": true
}
},
{
"exact_snippets": "HBsAg ... positive",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "HBeAg ... positive",
"criterion": "Hepatitis B e antigen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBeAb ... positive",
"criterion": "Hepatitis B e antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBcAb ... positive",
"criterion": "Hepatitis B core antibody",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection (e.g. fever, cough, urinary irritation, skin infectious wound).",
"criterions": [
{
"exact_snippets": "Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection",
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"requirement": {
"requirement_type": "suggestion",
"expected_value": true
}
},
{
"exact_snippets": "fever",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cough",
"criterion": "cough",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "urinary irritation",
"criterion": "urinary irritation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "skin infectious wound",
"criterion": "skin infectious wound",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection",
"criterion": "acute or subacute infection",
"requirement": {
"requirement_type": "suggestion",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "fever",
"criterion": "fever",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "cough",
"criterion": "cough",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "urinary irritation",
"criterion": "urinary irritation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "skin infectious wound",
"criterion": "skin infectious wound",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "7. Those who cannot communicate with medical staff due to mental illness or language disabilities.",
"criterions": [
{
"exact_snippets": "cannot communicate with medical staff due to mental illness",
"criterion": "communication ability",
"requirement": {
"requirement_type": "impairment",
"expected_value": "mental illness"
}
},
{
"exact_snippets": "cannot communicate with medical staff due to ... language disabilities",
"criterion": "communication ability",
"requirement": {
"requirement_type": "impairment",
"expected_value": "language disabilities"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "cannot communicate with medical staff due to mental illness",
"criterion": "communication ability",
"requirement": {
"requirement_type": "impairment",
"expected_value": "mental illness"
}
},
{
"exact_snippets": "cannot communicate with medical staff due to ... language disabilities",
"criterion": "communication ability",
"requirement": {
"requirement_type": "impairment",
"expected_value": "language disabilities"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "5. Patient with adequate bone marrow reserve (Haemoglobin≥80g/L, Absolute Neutrophil Count (ANC) ≥1×10^6/L, Platelet≥75×10^9/L or ≥50×10^9/L for liver tumors), hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases, Total bilirubin ≤ 1.5 x ULN), renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN)) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).",
"criterions": [
{
"exact_snippets": "adequate bone marrow reserve (Haemoglobin≥80g/L",
"criterion": "Haemoglobin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "g/L"
}
}
},
{
"exact_snippets": "adequate bone marrow reserve ... Absolute Neutrophil Count (ANC) ≥1×10^6/L",
"criterion": "Absolute Neutrophil Count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000000,
"unit": "L"
}
}
},
{
"exact_snippets": "adequate bone marrow reserve ... Platelet≥75×10^9/L or ≥50×10^9/L for liver tumors",
"criterion": "Platelet",
"requirement": {
"requirement_type": "quantity",
"expected_value": [
">=75×10^9/L",
">=50×10^9/L for liver tumors"
]
}
},
{
"exact_snippets": "hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases",
"criterion": "Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT)",
"requirement": {
"requirement_type": "quantity",
"expected_value": [
"≤ 3.0x upper limit of normal",
"≤ 5 x ULN for liver tumors or liver metastases"
]
}
},
{
"exact_snippets": "hepatic function ... Total bilirubin ≤ 1.5 x ULN",
"criterion": "Total bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN))",
"criterion": "Creatinine",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "cardiac function (Left ventricular ejection fraction of ≥50% by ECHO)",
"criterion": "Left ventricular ejection fraction",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "9. Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).",
"criterions": [
{
"exact_snippets": "Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0)",
"criterion": "toxicity from previous antitumor therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
},
{
"exact_snippets": "other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject",
"criterion": "other toxicities",
"requirement": {
"requirement_type": "safety risk",
"expected_value": "pose no safety risk to the subject"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Toxicity from previous antitumor therapy \u0010 grade 1 (according to CTCAE version 5.0)",
"criterion": "toxicity from previous antitumor therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
},
{
"exact_snippets": "other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject",
"criterion": "other toxicities",
"requirement": {
"requirement_type": "safety risk",
"expected_value": "pose no safety risk to the subject"
}
}
]
},
{
"exact_snippets": "other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject",
"criterion": "other toxicities",
"requirement": {
"requirement_type": "safety risk",
"expected_value": "pose no safety risk to the subject"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "1. Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.",
"criterions": [
{
"exact_snippets": "Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.",
"criterion": "other cell therapy",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
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{
"exact_snippets": "Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.",
"criterion": "other cell therapy",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency).",
"criterions": [
{
"exact_snippets": "Systemic steroid therapy",
"criterion": "systemic steroid therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "other immune-suppressants",
"criterion": "immune-suppressants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "treatment with replacement doses for adrenal insufficiency",
"criterion": "treatment with replacement doses for adrenal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "Systemic steroid therapy",
"criterion": "systemic steroid therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "treatment with replacement doses for adrenal insufficiency",
"criterion": "treatment with replacement doses for adrenal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
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}
]
},
{
"and_criteria": [
{
"exact_snippets": "other immune-suppressants",
"criterion": "immune-suppressants",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "treatment with replacement doses for adrenal insufficiency",
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"expected_value": true
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}
}
]
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "5. Pregnancy or lactation before or during the trial.",
"criterions": [
{
"exact_snippets": "Pregnancy ... before or during the trial.",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactation before or during the trial.",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnancy ... before or during the trial.",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lactation before or during the trial.",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Female who are pregnant or cannot stop lactating.",
"criterions": [
{
"exact_snippets": "Female who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "cannot stop lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "ability to stop",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Female who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cannot stop lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "ability to stop",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "8. Other unsuitable conditions that investigators believe unsuitable for the donation.",
"criterions": [
{
"exact_snippets": "Other unsuitable conditions that investigators believe unsuitable",
"criterion": "unsuitable conditions",
"requirement": {
"requirement_type": "investigator's belief",
"expected_value": "unsuitable for the donation"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Donor Inclusion Criteria:",
"criterions": []
},
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"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Donor Exclusion Criteria:",
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},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}