{
    "info": {
        "nct_id": "NCT04737265",
        "official_title": "A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients with Lymphoma or Breast Cancer Treated with Anthracyclines",
        "inclusion_criteria": "* Provision of written informed consent and HIPAA authorization\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, ≥ 18 years of age\n* Diagnosed with breast cancer or lymphoma (any subtype), planned to receive an anthracycline based chemotherapy regimen. Patients may be enrolled up to their first dose of anthracycline even if they have already received other chemotherapeutic or targeted agents as part of neo-adjuvant or adjuvant systemic therapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Diagnosed with Stage IV breast cancer\n* Uncontrolled blood pressure defined by SBP > 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to enrollment.\n* Baseline systolic blood pressure < 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, the average SBP will be considered)\n* Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient with prior or concurrent malignancy whose natural history of treatment, in the opinion of the investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Patient must not have any of the following\n* Severe hepatic impairment, defined as serum bilirubin > ULN, or AST or ALT > 5.0 ULN on most recent labs prior to enrollment. Results of serum bilirubin, AST, and ALT must be checked for screening if no results available in the EMR within 28 days prior to enrollment.\n* end-stage renal failure on dialysis\n* hyperkalemia with a potassium > 5.5 mEq/l on most recent labs prior to enrollment. Serum potassium must be checked for screening if no results available in the EMR within 28 days prior to enrollment.\n* a history of kidney transplant\n* an eGFR < 30 ml/min/1.73m2 at most recent check prior to enrollment. Creatinine must be checked for screening if no results available in the EMR within 28 days prior to enrollment\n* cardiogenic shock\n* decompensated heart failure requiring the use of IV inotropic therapy\n* Non-English speaking",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Provision of written informed consent and HIPAA authorization",
            "criterions": [
                {
                    "exact_snippets": "Provision of written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA authorization",
                    "criterion": "HIPAA authorization",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stated willingness to comply with all study procedures and availability for the duration of the study",
            "criterions": [
                {
                    "exact_snippets": "Stated willingness to comply with all study procedures",
                    "criterion": "willingness to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "availability for the duration of the study",
                    "criterion": "availability for the duration of the study",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male or female, ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosed with breast cancer or lymphoma (any subtype), planned to receive an anthracycline based chemotherapy regimen. Patients may be enrolled up to their first dose of anthracycline even if they have already received other chemotherapeutic or targeted agents as part of neo-adjuvant or adjuvant systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with breast cancer or lymphoma (any subtype)",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "breast cancer",
                                "lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to receive an anthracycline based chemotherapy regimen",
                    "criterion": "planned chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "anthracycline based"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may be enrolled up to their first dose of anthracycline",
                    "criterion": "enrollment timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "up to first dose of anthracycline"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Diagnosed with Stage IV breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with Stage IV breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled blood pressure defined by SBP > 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled blood pressure defined by SBP > 180mmHg",
                    "criterion": "systolic blood pressure (SBP)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "taking three or more antihypertensives",
                    "criterion": "antihypertensive medication",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "medications"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 month prior to enrollment",
                    "criterion": "timeframe for medication use",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "1 month prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline systolic blood pressure < 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, the average SBP will be considered)",
            "criterions": [
                {
                    "exact_snippets": "Baseline systolic blood pressure < 90mmHg within 1 month prior to enrollment",
                    "criterion": "baseline systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).",
            "criterions": [
                {
                    "exact_snippets": "Women must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must not be ... breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 10 days prior to enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A female of childbearing potential is defined as any woman ... who meets the following criteria: 1) has achieved menarche at some point",
                    "criterion": "menarche",
                    "requirements": [
                        {
                            "requirement_type": "achievement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A female of childbearing potential is defined as any woman ... who meets the following criteria: ... 2) has not undergone a hysterectomy or bilateral oophorectomy",
                    "criterion": "hysterectomy or bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A female of childbearing potential is defined as any woman ... who meets the following criteria: ... 3) has not been naturally postmenopausal ... for at least 24 consecutive months",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with prior or concurrent malignancy whose natural history of treatment, in the opinion of the investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen",
            "criterions": [
                {
                    "exact_snippets": "prior or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "temporal",
                            "expected_value": [
                                "prior",
                                "concurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "natural history of treatment ... has the potential to interfere with the safety or efficacy assessment",
                    "criterion": "treatment history interference",
                    "requirements": [
                        {
                            "requirement_type": "potential to interfere",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have any of the following",
            "criterions": [
                {
                    "exact_snippets": "Patient must not have any of the following",
                    "criterion": "unspecified conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe hepatic impairment, defined as serum bilirubin > ULN, or AST or ALT > 5.0 ULN on most recent labs prior to enrollment. Results of serum bilirubin, AST, and ALT must be checked for screening if no results available in the EMR within 28 days prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Severe hepatic impairment, defined as serum bilirubin > ULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe hepatic impairment, defined as ... AST or ALT > 5.0 ULN",
                    "criterion": "AST or ALT",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 5.0,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Results of serum bilirubin, AST, and ALT must be checked for screening if no results available in the EMR within 28 days prior to enrollment",
                    "criterion": "availability of lab results",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* end-stage renal failure on dialysis",
            "criterions": [
                {
                    "exact_snippets": "end-stage renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "end-stage"
                        }
                    ]
                },
                {
                    "exact_snippets": "on dialysis",
                    "criterion": "dialysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hyperkalemia with a potassium > 5.5 mEq/l on most recent labs prior to enrollment. Serum potassium must be checked for screening if no results available in the EMR within 28 days prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "hyperkalemia with a potassium > 5.5 mEq/l",
                    "criterion": "potassium level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5.5,
                                "unit": "mEq/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum potassium must be checked for screening",
                    "criterion": "serum potassium check",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a history of kidney transplant",
            "criterions": [
                {
                    "exact_snippets": "a history of kidney transplant",
                    "criterion": "kidney transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* an eGFR < 30 ml/min/1.73m2 at most recent check prior to enrollment. Creatinine must be checked for screening if no results available in the EMR within 28 days prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "eGFR < 30 ml/min/1.73m2",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min/1.73m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine must be checked ... within 28 days prior to enrollment",
                    "criterion": "creatinine check",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* cardiogenic shock",
            "criterions": [
                {
                    "exact_snippets": "cardiogenic shock",
                    "criterion": "cardiogenic shock",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* decompensated heart failure requiring the use of IV inotropic therapy",
            "criterions": [
                {
                    "exact_snippets": "decompensated heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "compensation status",
                            "expected_value": "decompensated"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring the use of IV inotropic therapy",
                    "criterion": "IV inotropic therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-English speaking",
            "criterions": [
                {
                    "exact_snippets": "Non-English speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "non-English"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}