{
"info": {
"nct_id": "NCT05223582",
"official_title": "Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial",
"inclusion_criteria": "1. Age ≥ 18 years old.\n2. Patients must have histologically or cytologically confirmed prostate adenocarcinoma, clinically assessed as localized or with only pelvic lymph node metastasis according to radiological evaluation, and categorized as high- or very-high risk per the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Patients need to maintain effective luteinizing hormone-releasing hormone analogue (LHRHa) therapy throughout the study treatment.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n5. Males choosing radical prostatectomy as the primary treatment for prostate cancer.\n6. Normal bone marrow function: Absolute neutrophil count ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 90g/L; white blood cell count ≥ 3.6×10^9/L.\n7. Normal liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 ULN (upper limit of normal), total bilirubin ≤ 1.5 times ULN, Child-Pugh Class A, serum albumin ≥ 3g/dL.\n8. Normal coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 ULN, prothrombin time (PT) < ULN + 4 seconds.\n9. Normal cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc < 450ms for males, < 470ms for females, blood potassium ≥ 3.5mmol/L.\n10. Normal blood pressure: Systolic blood pressure < 160mmHg, diastolic blood pressure < 95mmHg, patients with normal blood pressure after appropriate clinical treatment can be included.\n11. Normal kidney function: Serum creatinine ≤ 1.5 ULN, creatinine clearance ≥ 50 mL/min.\n12. Patients deemed to have the ability to ejaculate and an active sexual life must agree to use effective contraception and not to donate sperm from the first administration of the study drug until 3 months after the last administration.\n13. Patients are able to understand and willing to sign the informed consent form. Patients are able to comply with the study visit schedule and other protocol requirements.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients with a history of other malignant tumors, myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or who have had other malignant tumors within 5 years before the first dosa (excluding completely resolved in situ cancers and malignancies deemed by the investigator to progress slowly).\n2. Patients who have undergone local treatment for prostate cancer (such as radical prostatectomy, radiotherapy, or brachytherapy).\n3. Patients who have received radiotherapy or major surgery within 3 weeks before the first dose or participated in another drug clinical trial within 4 weeks before the first dose.\n4. Patients planning to receive any other antitumor therapy during the study treatment.\n5. Patients who have received treatment with PARP inhibitors (e.g., fluzoparib, olaparib, talazoparib, veliparib, niraparib, lucaparib, or others), chemotherapy (e.g., docetaxel, cisplatin, carboplatin, oxaliplatin, or others), mitoxantrone, cyclophosphamide, CYP17 inhibitors such as ketoconazole, conventional anti-androgen therapy (luteinizing hormone-releasing hormone [LHRH] agonists/antagonists, bicalutamide, nilutamide), novel hormonal therapy (e.g., abiraterone, enzalutamide, apalutamide), or immunotherapy (e.g., sipuleucel-T vaccine, ipilimumab). Patients who have received conventional anti-androgen therapy or abiraterone for no more than 1 month are allowed to enroll.\n6. Patients who have previous treated with strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The washout period before the first dose should be at least 2 weeks.\n7. Patients who have previous treated with strong CYP3A inducers (e.g., phenobarbital, phenytoin, rifampin, rifabutin, rifapentine, carbamazepine, nevirapine) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide and 3 weeks for other drugs.\n8. Habitual drinking grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages, which cannot be discontinued during the study.\n9. Inability to discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study, including but not limited to amiodarone, carvedilol, clarithromycin, delavirdine, erythromycin, lapatinib, lopinavir, nelfinavir, propranolol, quinidine, ranolazine, tipranavir, and verapamil.\n10. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases, active or symptomatic viral hepatitis, or chronic liver disease (HBV viral load ≥ 10^4 copies/mL, HCV viral load ≥ 10^3 copies/mL).\n11. Clinically significant heart disease, such as New York Heart Association (NYHA) Class III-IV heart failure, myocardial infarction within the past 6 months, severe or unstable angina, or recent ventricular arrhythmias.\n12. Preexisting duodenal stents or any gastrointestinal disorder or defect that the investigator believes would interfere with drug absorption.\n13. Habitual constipation or diarrhea, irritable bowel syndrome, or inflammatory bowel disease; intra-abdominal fistula, gastrointestinal perforation, or abdominal abscess within the past 6 months, requiring blood transfusion for gastrointestinal bleeding.\n14. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting medication intake and absorption.\n15. History of asthma induced by nonsteroidal anti-inflammatory drugs (NSAIDs) or classified as \"mild persistent\" or more severe asthma history (symptoms ≥ 2 days per week).\n16. History of uncontrolled pituitary or adrenal dysfunction, existing gonadal dysfunction, or severe hypogonadism.\n17. Contraindications to the use of prednisone (corticosteroids) such as active infections or other lesions.\n18. Any chronic disease requiring corticosteroid therapy at doses exceeding \"prednisone 5mg, twice daily.\"\n19. Allergy or intolerance to the active ingredients of fluzoparib, abiraterone, or prednisone.\n20. History of neurological and psychiatric disorders such as dementia, epilepsy, or seizure susceptibility.\n21. According to the investigator's judgment, there are severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.) or unstable medical, psychological, or other conditions (including laboratory abnormalities) that may pose a serious risk to the subject's safety, affect the subject's completion of the study, or affect the study protocol and follow-up schedule.\n22. Unsuitable for participation in this clinical trial for any reason according to the investigator's judgment.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Age ≥ 18 years old.",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
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"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
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{
"identified_line": {
"line": "2. Patients must have histologically or cytologically confirmed prostate adenocarcinoma, clinically assessed as localized or with only pelvic lymph node metastasis according to radiological evaluation, and categorized as high- or very-high risk per the National Comprehensive Cancer Network (NCCN) guidelines.",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed prostate adenocarcinoma",
"criterion": "prostate adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "clinically assessed as localized or with only pelvic lymph node metastasis",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"localized",
"pelvic lymph node metastasis"
]
}
},
{
"exact_snippets": "categorized as high- or very-high risk per the National Comprehensive Cancer Network (NCCN) guidelines",
"criterion": "risk category",
"requirement": {
"requirement_type": "risk level",
"expected_value": [
"high",
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]
}
},
{
"exact_snippets": "categorized as high- or very-high risk per the National Comprehensive Cancer Network (NCCN) guidelines",
"criterion": "risk category",
"requirement": {
"requirement_type": "guideline",
"expected_value": "National Comprehensive Cancer Network (NCCN)"
}
}
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{
"and_criteria": [
{
"and_criteria": [
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"requirement": {
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}
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{
"identified_line": {
"line": "3. Patients need to maintain effective luteinizing hormone-releasing hormone analogue (LHRHa) therapy throughout the study treatment.",
"criterions": [
{
"exact_snippets": "maintain effective luteinizing hormone-releasing hormone analogue (LHRHa) therapy throughout the study treatment",
"criterion": "LHRHa therapy",
"requirement": {
"requirement_type": "maintenance",
"expected_value": true
}
}
]
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"exact_snippets": "maintain effective luteinizing hormone-releasing hormone analogue (LHRHa) therapy throughout the study treatment",
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"expected_value": true
}
}
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"identified_line": {
"line": "5. Males choosing radical prostatectomy as the primary treatment for prostate cancer.",
"criterions": [
{
"exact_snippets": "Males",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
},
{
"exact_snippets": "choosing radical prostatectomy as the primary treatment",
"criterion": "treatment choice",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "radical prostatectomy"
}
},
{
"exact_snippets": "prostate cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "prostate cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Males",
"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
},
{
"exact_snippets": "choosing radical prostatectomy as the primary treatment",
"criterion": "treatment choice",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "radical prostatectomy"
}
},
{
"exact_snippets": "prostate cancer",
"criterion": "cancer type",
"requirement": {
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"expected_value": "prostate cancer"
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]
}
},
{
"identified_line": {
"line": "6. Normal bone marrow function: Absolute neutrophil count ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 90g/L; white blood cell count ≥ 3.6×10^9/L.",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1.5×10^9/L",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "platelets ≥ 100×10^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "hemoglobin ≥ 90g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "g/L"
}
}
},
{
"exact_snippets": "white blood cell count ≥ 3.6×10^9/L",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3.6,
"unit": "10^9/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Absolute neutrophil count ≥ 1.5×10^9/L",
"criterion": "absolute neutrophil count",
"requirement": {
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"operator": ">=",
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"unit": "10^9/L"
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"criterion": "platelet count",
"requirement": {
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"operator": ">=",
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"unit": "10^9/L"
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"exact_snippets": "hemoglobin ≥ 90g/L",
"criterion": "hemoglobin level",
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"unit": "g/L"
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{
"exact_snippets": "white blood cell count ≥ 3.6×10^9/L",
"criterion": "white blood cell count",
"requirement": {
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"operator": ">=",
"value": 3.6,
"unit": "10^9/L"
}
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}
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}
},
{
"identified_line": {
"line": "8. Normal coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 ULN, prothrombin time (PT) < ULN + 4 seconds.",
"criterions": [
{
"exact_snippets": "International normalized ratio (INR) ≤ 1.5",
"criterion": "International normalized ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "activated partial thromboplastin time (APTT) ≤ 1.5 ULN",
"criterion": "activated partial thromboplastin time (APTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "prothrombin time (PT) < ULN + 4 seconds",
"criterion": "prothrombin time (PT)",
"requirement": {
"requirement_type": "value",
"expected_value": "< ULN + 4 seconds"
}
}
]
},
"logical_structure": {
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"criterion": "International normalized ratio (INR)",
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"unit": "ULN"
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"exact_snippets": "prothrombin time (PT) < ULN + 4 seconds",
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}
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},
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"identified_line": {
"line": "10. Normal blood pressure: Systolic blood pressure < 160mmHg, diastolic blood pressure < 95mmHg, patients with normal blood pressure after appropriate clinical treatment can be included.",
"criterions": [
{
"exact_snippets": "Systolic blood pressure < 160mmHg",
"criterion": "systolic blood pressure",
"requirement": {
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"expected_value": {
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"unit": "mmHg"
}
}
},
{
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"unit": "mmHg"
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}
},
{
"exact_snippets": "patients with normal blood pressure after appropriate clinical treatment can be included",
"criterion": "blood pressure normalization after treatment",
"requirement": {
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}
}
]
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"and_criteria": [
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"exact_snippets": "Systolic blood pressure < 160mmHg",
"criterion": "systolic blood pressure",
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"unit": "mmHg"
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},
{
"exact_snippets": "diastolic blood pressure < 95mmHg",
"criterion": "diastolic blood pressure",
"requirement": {
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"operator": "<",
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"unit": "mmHg"
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"exact_snippets": "patients with normal blood pressure after appropriate clinical treatment can be included",
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"requirement": {
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}
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},
{
"identified_line": {
"line": "12. Patients deemed to have the ability to ejaculate and an active sexual life must agree to use effective contraception and not to donate sperm from the first administration of the study drug until 3 months after the last administration.",
"criterions": [
{
"exact_snippets": "ability to ejaculate",
"criterion": "ability to ejaculate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active sexual life",
"criterion": "active sexual life",
"requirement": {
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"expected_value": true
}
}
]
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"condition": {
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{
"exact_snippets": "ability to ejaculate",
"criterion": "ability to ejaculate",
"requirement": {
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"expected_value": true
}
},
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"requirement": {
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]
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"then_criteria": {
"and_criteria": [
{
"exact_snippets": "must agree to use effective contraception",
"criterion": "use effective contraception",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "not to donate sperm from the first administration of the study drug until 3 months after the last administration",
"criterion": "sperm donation",
"requirement": {
"requirement_type": "prohibition",
"expected_value": true
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "13. Patients are able to understand and willing to sign the informed consent form. Patients are able to comply with the study visit schedule and other protocol requirements.",
"criterions": [
{
"exact_snippets": "Patients are able to understand",
"criterion": "understanding",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willing to sign the informed consent form",
"criterion": "willingness to sign informed consent",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Patients are able to comply with the study visit schedule",
"criterion": "compliance with study visit schedule",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "comply with ... other protocol requirements",
"criterion": "compliance with protocol requirements",
"requirement": {
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"expected_value": true
}
}
]
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"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "Patients are able to understand",
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"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willing to sign the informed consent form",
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"requirement": {
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}
}
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},
{
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"criterion": "compliance with study visit schedule",
"requirement": {
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"expected_value": true
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{
"exact_snippets": "comply with ... other protocol requirements",
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}
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"exact_snippets": "Healthy volunteers allowed",
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}
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
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"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Must be MALE",
"criterion": "gender",
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"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"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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},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"unit": "Years"
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}
}
]
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},
{
"identified_line": {
"line": "9. Normal cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc < 450ms for males, < 470ms for females, blood potassium ≥ 3.5mmol/L.",
"criterions": [
{
"exact_snippets": "Normal cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "QTc < 450ms for males",
"criterion": "QTc interval for males",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 450,
"unit": "ms"
}
}
},
{
"exact_snippets": "QTc < 470ms for females",
"criterion": "QTc interval for females",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 470,
"unit": "ms"
}
}
},
{
"exact_snippets": "blood potassium ≥ 3.5mmol/L",
"criterion": "blood potassium",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 3.5,
"unit": "mmol/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Normal cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "blood potassium ≥ 3.5mmol/L",
"criterion": "blood potassium",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 3.5,
"unit": "mmol/L"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "QTc < 450ms for males",
"criterion": "QTc interval for males",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 450,
"unit": "ms"
}
}
},
{
"exact_snippets": "QTc < 470ms for females",
"criterion": "QTc interval for females",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 470,
"unit": "ms"
}
}
}
]
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Patients with a history of other malignant tumors, myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or who have had other malignant tumors within 5 years before the first dosa (excluding completely resolved in situ cancers and malignancies deemed by the investigator to progress slowly).",
"criterions": [
{
"exact_snippets": "history of other malignant tumors",
"criterion": "history of other malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myelodysplastic syndrome (MDS)",
"criterion": "myelodysplastic syndrome (MDS)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "acute myeloid leukemia (AML)",
"criterion": "acute myeloid leukemia (AML)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other malignant tumors within 5 years before the first dosa",
"criterion": "other malignant tumors within 5 years",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "history of other malignant tumors",
"criterion": "history of other malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "completely resolved in situ cancers",
"criterion": "completely resolved in situ cancers",
"requirement": {
"requirement_type": "resolution",
"expected_value": true
}
},
{
"exact_snippets": "malignancies deemed by the investigator to progress slowly",
"criterion": "malignancies deemed to progress slowly",
"requirement": {
"requirement_type": "progression",
"expected_value": "slow"
}
}
]
}
}
]
},
{
"exact_snippets": "myelodysplastic syndrome (MDS)",
"criterion": "myelodysplastic syndrome (MDS)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "acute myeloid leukemia (AML)",
"criterion": "acute myeloid leukemia (AML)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "other malignant tumors within 5 years before the first dosa",
"criterion": "other malignant tumors within 5 years",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "completely resolved in situ cancers",
"criterion": "completely resolved in situ cancers",
"requirement": {
"requirement_type": "resolution",
"expected_value": true
}
},
{
"exact_snippets": "malignancies deemed by the investigator to progress slowly",
"criterion": "malignancies deemed to progress slowly",
"requirement": {
"requirement_type": "progression",
"expected_value": "slow"
}
}
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Patients who have undergone local treatment for prostate cancer (such as radical prostatectomy, radiotherapy, or brachytherapy).",
"criterions": [
{
"exact_snippets": "undergone local treatment for prostate cancer",
"criterion": "local treatment for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "radical prostatectomy",
"criterion": "radical prostatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "brachytherapy",
"criterion": "brachytherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "undergone local treatment for prostate cancer",
"criterion": "local treatment for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "radical prostatectomy",
"criterion": "radical prostatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "undergone local treatment for prostate cancer",
"criterion": "local treatment for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "undergone local treatment for prostate cancer",
"criterion": "local treatment for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "brachytherapy",
"criterion": "brachytherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Patients who have received radiotherapy or major surgery within 3 weeks before the first dose or participated in another drug clinical trial within 4 weeks before the first dose.",
"criterions": [
{
"exact_snippets": "Patients who have received radiotherapy ... within 3 weeks before the first dose",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Patients who have received ... major surgery within 3 weeks before the first dose",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Patients who have ... participated in another drug clinical trial within 4 weeks before the first dose",
"criterion": "participation in another drug clinical trial",
"requirement": {
"requirement_type": "time since last participation",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who have received radiotherapy ... within 3 weeks before the first dose",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Patients who have received ... major surgery within 3 weeks before the first dose",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
]
},
{
"exact_snippets": "Patients who have ... participated in another drug clinical trial within 4 weeks before the first dose",
"criterion": "participation in another drug clinical trial",
"requirement": {
"requirement_type": "time since last participation",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Patients planning to receive any other antitumor therapy during the study treatment.",
"criterions": [
{
"exact_snippets": "Patients planning to receive any other antitumor therapy during the study treatment.",
"criterion": "antitumor therapy",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients planning to receive any other antitumor therapy during the study treatment.",
"criterion": "antitumor therapy",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "5. Patients who have received treatment with PARP inhibitors (e.g., fluzoparib, olaparib, talazoparib, veliparib, niraparib, lucaparib, or others), chemotherapy (e.g., docetaxel, cisplatin, carboplatin, oxaliplatin, or others), mitoxantrone, cyclophosphamide, CYP17 inhibitors such as ketoconazole, conventional anti-androgen therapy (luteinizing hormone-releasing hormone [LHRH] agonists/antagonists, bicalutamide, nilutamide), novel hormonal therapy (e.g., abiraterone, enzalutamide, apalutamide), or immunotherapy (e.g., sipuleucel-T vaccine, ipilimumab). Patients who have received conventional anti-androgen therapy or abiraterone for no more than 1 month are allowed to enroll.",
"criterions": [
{
"exact_snippets": "Patients who have received treatment with PARP inhibitors (e.g., fluzoparib, olaparib, talazoparib, veliparib, niraparib, lucaparib, or others)",
"criterion": "treatment with PARP inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... chemotherapy (e.g., docetaxel, cisplatin, carboplatin, oxaliplatin, or others)",
"criterion": "treatment with chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... mitoxantrone",
"criterion": "treatment with mitoxantrone",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... cyclophosphamide",
"criterion": "treatment with cyclophosphamide",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... CYP17 inhibitors such as ketoconazole",
"criterion": "treatment with CYP17 inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... conventional anti-androgen therapy (luteinizing hormone-releasing hormone [LHRH] agonists/antagonists, bicalutamide, nilutamide)",
"criterion": "treatment with conventional anti-androgen therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... novel hormonal therapy (e.g., abiraterone, enzalutamide, apalutamide)",
"criterion": "treatment with novel hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... immunotherapy (e.g., sipuleucel-T vaccine, ipilimumab)",
"criterion": "treatment with immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received conventional anti-androgen therapy or abiraterone for no more than 1 month are allowed to enroll",
"criterion": "duration of conventional anti-androgen therapy or abiraterone",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who have received treatment with PARP inhibitors (e.g., fluzoparib, olaparib, talazoparib, veliparib, niraparib, lucaparib, or others)",
"criterion": "treatment with PARP inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... chemotherapy (e.g., docetaxel, cisplatin, carboplatin, oxaliplatin, or others)",
"criterion": "treatment with chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... mitoxantrone",
"criterion": "treatment with mitoxantrone",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... cyclophosphamide",
"criterion": "treatment with cyclophosphamide",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... CYP17 inhibitors such as ketoconazole",
"criterion": "treatment with CYP17 inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... immunotherapy (e.g., sipuleucel-T vaccine, ipilimumab)",
"criterion": "treatment with immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received treatment with ... novel hormonal therapy (e.g., abiraterone, enzalutamide, apalutamide)",
"criterion": "treatment with novel hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients who have received treatment with ... conventional anti-androgen therapy (luteinizing hormone-releasing hormone [LHRH] agonists/antagonists, bicalutamide, nilutamide)",
"criterion": "treatment with conventional anti-androgen therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have received conventional anti-androgen therapy or abiraterone for no more than 1 month are allowed to enroll",
"criterion": "duration of conventional anti-androgen therapy or abiraterone",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "6. Patients who have previous treated with strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The washout period before the first dose should be at least 2 weeks.",
"criterions": [
{
"exact_snippets": "previous treated with strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir)",
"criterion": "treatment with strong CYP3A inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "previous treated with ... moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)",
"criterion": "treatment with moderate CYP3A inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "washout period before the first dose should be at least 2 weeks",
"criterion": "washout period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "previous treated with strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir)",
"criterion": "treatment with strong CYP3A inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "washout period before the first dose should be at least 2 weeks",
"criterion": "washout period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "previous treated with ... moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)",
"criterion": "treatment with moderate CYP3A inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "washout period before the first dose should be at least 2 weeks",
"criterion": "washout period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "7. Patients who have previous treated with strong CYP3A inducers (e.g., phenobarbital, phenytoin, rifampin, rifabutin, rifapentine, carbamazepine, nevirapine) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide and 3 weeks for other drugs.",
"criterions": [
{
"exact_snippets": "previous treated with strong CYP3A inducers",
"criterion": "previous treatment with strong CYP3A inducers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "previous treated with ... moderate CYP3A inducers",
"criterion": "previous treatment with moderate CYP3A inducers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide",
"criterion": "washout period for phenobarbital or enzalutamide",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "weeks"
}
}
},
{
"exact_snippets": "washout period before the first dose should be ... 3 weeks for other drugs",
"criterion": "washout period for other drugs",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "previous treated with strong CYP3A inducers",
"criterion": "previous treatment with strong CYP3A inducers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"or_criteria": [
{
"exact_snippets": "washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide",
"criterion": "washout period for phenobarbital or enzalutamide",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "weeks"
}
}
},
{
"exact_snippets": "washout period before the first dose should be ... 3 weeks for other drugs",
"criterion": "washout period for other drugs",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
]
},
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "previous treated with ... moderate CYP3A inducers",
"criterion": "previous treatment with moderate CYP3A inducers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"or_criteria": [
{
"exact_snippets": "washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide",
"criterion": "washout period for phenobarbital or enzalutamide",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "weeks"
}
}
},
{
"exact_snippets": "washout period before the first dose should be ... 3 weeks for other drugs",
"criterion": "washout period for other drugs",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "8. Habitual drinking grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages, which cannot be discontinued during the study.",
"criterions": [
{
"exact_snippets": "Habitual drinking grapefruit juice",
"criterion": "grapefruit juice consumption",
"requirement": {
"requirement_type": "habitual consumption",
"expected_value": true
}
},
{
"exact_snippets": "excessive tea, coffee, and/or caffeine-containing beverages",
"criterion": "caffeine consumption",
"requirement": {
"requirement_type": "excessive consumption",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Habitual drinking grapefruit juice",
"criterion": "grapefruit juice consumption",
"requirement": {
"requirement_type": "habitual consumption",
"expected_value": true
}
},
{
"exact_snippets": "which cannot be discontinued during the study",
"criterion": "discontinuation of grapefruit juice consumption",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "excessive tea, coffee, and/or caffeine-containing beverages",
"criterion": "caffeine consumption",
"requirement": {
"requirement_type": "excessive consumption",
"expected_value": true
}
},
{
"exact_snippets": "which cannot be discontinued during the study",
"criterion": "discontinuation of caffeine consumption",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "9. Inability to discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study, including but not limited to amiodarone, carvedilol, clarithromycin, delavirdine, erythromycin, lapatinib, lopinavir, nelfinavir, propranolol, quinidine, ranolazine, tipranavir, and verapamil.",
"criterions": [
{
"exact_snippets": "Inability to discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study",
"criterion": "use of medications affecting P-glycoprotein (P-gp)",
"requirement": {
"requirement_type": "discontinuation ability",
"expected_value": false
}
},
{
"exact_snippets": "including but not limited to amiodarone, carvedilol, clarithromycin, delavirdine, erythromycin, lapatinib, lopinavir, nelfinavir, propranolol, quinidine, ranolazine, tipranavir, and verapamil",
"criterion": "specific medications",
"requirement": {
"requirement_type": "list",
"expected_value": [
"amiodarone",
"carvedilol",
"clarithromycin",
"delavirdine",
"erythromycin",
"lapatinib",
"lopinavir",
"nelfinavir",
"propranolol",
"quinidine",
"ranolazine",
"tipranavir",
"verapamil"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Inability to discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study",
"criterion": "use of medications affecting P-glycoprotein (P-gp)",
"requirement": {
"requirement_type": "discontinuation ability",
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}
},
{
"exact_snippets": "including but not limited to amiodarone, carvedilol, clarithromycin, delavirdine, erythromycin, lapatinib, lopinavir, nelfinavir, propranolol, quinidine, ranolazine, tipranavir, and verapamil",
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"requirement_type": "list",
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"amiodarone",
"carvedilol",
"clarithromycin",
"delavirdine",
"erythromycin",
"lapatinib",
"lopinavir",
"nelfinavir",
"propranolol",
"quinidine",
"ranolazine",
"tipranavir",
"verapamil"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "10. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases, active or symptomatic viral hepatitis, or chronic liver disease (HBV viral load ≥ 10^4 copies/mL, HCV viral load ≥ 10^3 copies/mL).",
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{
"exact_snippets": "Known human immunodeficiency virus (HIV) infection",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "acquired immunodeficiency syndrome (AIDS)-related diseases",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active or symptomatic viral hepatitis",
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"requirement_type": "status",
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"active",
"symptomatic"
]
}
},
{
"exact_snippets": "chronic liver disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBV viral load ≥ 10^4 copies/mL",
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"requirement_type": "quantity",
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"operator": ">=",
"value": 10000,
"unit": "copies/mL"
}
}
},
{
"exact_snippets": "HCV viral load ≥ 10^3 copies/mL",
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"requirement_type": "quantity",
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"operator": ">=",
"value": 1000,
"unit": "copies/mL"
}
}
}
]
},
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},
{
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},
{
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"active",
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}
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"operator": ">=",
"value": 10000,
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}
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}
},
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"exact_snippets": "Clinically significant heart disease",
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"requirement_type": "presence",
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"exact_snippets": "New York Heart Association (NYHA) Class III-IV heart failure",
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},
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"requirement_type": "time since event",
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"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "severe or unstable angina",
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"requirement_type": "presence",
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},
{
"exact_snippets": "recent ventricular arrhythmias",
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},
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{
"exact_snippets": "inflammatory bowel disease",
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"requirement_type": "presence",
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},
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},
{
"exact_snippets": "requiring blood transfusion for gastrointestinal bleeding",
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{
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{
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}
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{
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]
}
},
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},
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}
}
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"exact_snippets": "seizure susceptibility",
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"and_criteria": [
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},
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"identified_line": {
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"value": 2.5,
"unit": "ULN"
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"value": 1.5,
"unit": "times ULN"
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}
},
{
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},
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"exact_snippets": "serum albumin ≥ 3g/dL",
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"or_criteria": [
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}
}
},
{
"exact_snippets": "Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \u00102.5 ULN (upper limit of normal)",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
}
]
},
{
"exact_snippets": "total bilirubin \u0010 1.5 times ULN",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Child-Pugh Class A",
"criterion": "Child-Pugh Class",
"requirement": {
"requirement_type": "classification",
"expected_value": "A"
}
},
{
"exact_snippets": "serum albumin \u0010 3g/dL",
"criterion": "serum albumin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "11. Normal kidney function: Serum creatinine ≤ 1.5 ULN, creatinine clearance ≥ 50 mL/min.",
"criterions": [
{
"exact_snippets": "Normal kidney function: Serum creatinine ≤ 1.5 ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "Normal kidney function: ... creatinine clearance ≥ 50 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Normal kidney function: Serum creatinine \u0010.5 ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "Normal kidney function: ... creatinine clearance \u00050 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/min"
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "12. Preexisting duodenal stents or any gastrointestinal disorder or defect that the investigator believes would interfere with drug absorption.",
"criterions": [
{
"exact_snippets": "Preexisting duodenal stents",
"criterion": "duodenal stents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "any gastrointestinal disorder or defect",
"criterion": "gastrointestinal disorder or defect",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "the investigator believes would interfere with drug absorption",
"criterion": "interference with drug absorption",
"requirement": {
"requirement_type": "investigator belief",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Preexisting duodenal stents",
"criterion": "duodenal stents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "any gastrointestinal disorder or defect",
"criterion": "gastrointestinal disorder or defect",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"and_criteria": [
{
"exact_snippets": "any gastrointestinal disorder or defect",
"criterion": "gastrointestinal disorder or defect",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "the investigator believes would interfere with drug absorption",
"criterion": "interference with drug absorption",
"requirement": {
"requirement_type": "investigator belief",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "21. According to the investigator's judgment, there are severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.) or unstable medical, psychological, or other conditions (including laboratory abnormalities) that may pose a serious risk to the subject's safety, affect the subject's completion of the study, or affect the study protocol and follow-up schedule.",
"criterions": [
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "risk to subject's safety",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "affect study completion",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.)",
"criterion": "severe concurrent diseases",
"requirement": {
"requirement_type": "affect study protocol",
"expected_value": true
}
}
]
}
]
},
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "risk to subject's safety",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
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"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unstable medical, psychological, or other conditions (including laboratory abnormalities)",
"criterion": "unstable conditions",
"requirement": {
"requirement_type": "affect study protocol",
"expected_value": true
}
}
]
}
]
}
]
}
}
],
"failed_miscellaneous": []
}