{
    "info": {
        "nct_id": "NCT04542291",
        "official_title": "Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition",
        "inclusion_criteria": "* Histologically or cytologically confirmed metastatic or locally advanced pancreatic ductal adenocarcinoma, pancreatic adenosquamous carcinoma or squamous cell carcinoma\n* Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible.\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.\n* No prior systemic therapy for pancreatic ductal adenocarcinoma in the metastatic or locally advanced setting.\n* Planning to receive treatment with nab-paclitaxel and gemcitabine.\n* At least 18 years of age.\n* ECOG performance status ≤ 1\n* Normal bone marrow and organ function as defined below:\n\n  * Leukocytes ≥ 3,000/mcL\n  * Absolute neutrophil count ≥ 1,500/mcL\n  * Platelets ≥ 100,000/mcL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN\n  * Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2\n* Because chemotherapeutic agents such as nab-paclitaxel and gemcitabine are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and at least one month after completion of the study\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of total pancreatectomy\n* Current or previous treatment with SGLT2i or thiazolidinedione.\n* Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone. Note that dexamethasone that can be prescribed for nausea on the day of chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic for patients in this trial. Topical steroid ointments or creams for occasional skin rash is allowed.\n* A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.\n* History of stroke or transient ischemic attack (in the last 5 years).\n* HbA1c > 10% unless approved by endocrinologist\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.\n* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed metastatic or locally advanced pancreatic ductal adenocarcinoma, pancreatic adenosquamous carcinoma or squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or locally advanced pancreatic ductal adenocarcinoma",
                    "criterion": "pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic adenosquamous carcinoma",
                    "criterion": "pancreatic adenosquamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible.",
            "criterions": [
                {
                    "exact_snippets": "treated/stable brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated/stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have received prior therapy for their brain metastases",
                    "criterion": "prior therapy for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS disease is radiographically stable at study entry",
                    "criterion": "CNS disease stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "radiographically stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan",
                    "criterion": "lesion size with CT scan",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) ... as ≥ 20 mm by chest x-ray",
                    "criterion": "lesion size by chest x-ray",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) ... ≥ 10 mm with calipers by clinical exam",
                    "criterion": "lesion size with calipers by clinical exam",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic therapy for pancreatic ductal adenocarcinoma in the metastatic or locally advanced setting.",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic therapy for pancreatic ductal adenocarcinoma",
                    "criterion": "prior systemic therapy for pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or locally advanced setting",
                    "criterion": "disease setting",
                    "requirements": [
                        {
                            "requirement_type": "specificity",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planning to receive treatment with nab-paclitaxel and gemcitabine.",
            "criterions": [
                {
                    "exact_snippets": "Planning to receive treatment with nab-paclitaxel",
                    "criterion": "treatment with nab-paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Planning to receive treatment with ... gemcitabine",
                    "criterion": "treatment with gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal bone marrow and organ function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Normal bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes ≥ 3,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥ 3,000/mcL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mcL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mcL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 x IULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x IULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN",
            "criterions": [
                {
                    "exact_snippets": "AST(SGOT) ... ≤ 3.0 x IULN",
                    "criterion": "AST(SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT(SGPT) ≤ 3.0 x IULN",
                    "criterion": "ALT(SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2",
            "criterions": [
                {
                    "exact_snippets": "Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2",
                    "criterion": "estimated glomerular filtration rate (eGFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min/1.73m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Because chemotherapeutic agents such as nab-paclitaxel and gemcitabine are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and at least one month after completion of the study",
            "criterions": [
                {
                    "exact_snippets": "women of childbearing potential ... must agree to use adequate contraception",
                    "criterion": "contraception use for women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "contraception use for men",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Should a woman become pregnant ... she must inform her treating physician immediately",
                    "criterion": "pregnancy reporting",
                    "requirements": [
                        {
                            "requirement_type": "obligation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agreement to adhere to Lifestyle Considerations throughout study duration",
            "criterions": [
                {
                    "exact_snippets": "Agreement to adhere to Lifestyle Considerations",
                    "criterion": "lifestyle considerations",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign an IRB approved written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of total pancreatectomy",
            "criterions": [
                {
                    "exact_snippets": "History of total pancreatectomy",
                    "criterion": "total pancreatectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or previous treatment with SGLT2i or thiazolidinedione.",
            "criterions": [
                {
                    "exact_snippets": "Current or previous treatment with SGLT2i",
                    "criterion": "treatment with SGLT2i",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or previous treatment with ... thiazolidinedione",
                    "criterion": "treatment with thiazolidinedione",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone. Note that dexamethasone that can be prescribed for nausea on the day of chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic for patients in this trial. Topical steroid ointments or creams for occasional skin rash is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone.",
                    "criterion": "systemic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dexamethasone that can be prescribed for nausea on the day of chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic",
                    "criterion": "dexamethasone use for nausea",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": "allowed only on the day of chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Topical steroid ointments or creams for occasional skin rash is allowed.",
                    "criterion": "topical steroid use",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": "allowed for occasional skin rash"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "A history of other malignancy",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancies for which all treatment was completed at least 2 years before registration",
                    "criterion": "treatment completion for other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally treated skin squamous or basal cell carcinoma",
                    "criterion": "locally treated skin squamous or basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of stroke or transient ischemic attack (in the last 5 years).",
            "criterions": [
                {
                    "exact_snippets": "History of stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack (in the last 5 years)",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HbA1c > 10% unless approved by endocrinologist",
            "criterions": [
                {
                    "exact_snippets": "HbA1c > 10%",
                    "criterion": "HbA1c",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving any other investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving any other investigational agents.",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents used in the study.",
            "criterions": [
                {
                    "exact_snippets": "A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents used in the study.",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": [
                                "compounds of similar chemical or biologic composition to dapagliflozin",
                                "nab-paclitaxel",
                                "gemcitabine",
                                "other agents used in the study"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... peripheral arterial disease",
                    "criterion": "peripheral arterial disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ketoacidosis",
                    "criterion": "ketoacidosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2)",
                    "criterion": "severe kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "estimated glomerular filtration rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic hypotension",
                    "criterion": "symptomatic hypotension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... chronic/frequent urinary tract infections or yeast infections",
                    "criterion": "chronic/frequent urinary tract infections or yeast infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential ... negative pregnancy test within 14 days of study entry",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.",
            "criterions": [
                {
                    "exact_snippets": "Patients with HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CD4+ T-cell counts are < 350 cells/mcL",
                    "criterion": "CD4+ T-cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 350,
                                "unit": "cells/mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of AIDS-defining opportunistic infection within the 12 months prior to registration",
                    "criterion": "AIDS-defining opportunistic infection history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 12 months prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended",
                    "criterion": "ART treatment",
                    "requirements": [
                        {
                            "requirement_type": "recommendation",
                            "expected_value": "according to DHHS treatment guidelines"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}