{
    "info": {
        "nct_id": "NCT00924001",
        "official_title": "Phase I/II Study Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Allogeneic Tumor-Reactive Lymphocyte Cell Line DMF5 in Metastatic Melanoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "-INCLUSION CRITERIA:\n\n1. Measurable metastatic melanoma that is refractory to standard treatment including high dose aldesleukin.\n2. Unsuitable autologous cells for Institutional Review Board (IRB) approved Surgery Branch adoptive cell therapy studies.\n3. Greater than or equal to 18 years of age.\n4. Life expectancy of greater than three months.\n5. Willing to sign a durable power of attorney.\n6. Able to understand and sign the Informed Consent Document.\n7. Human leukocyte antigen A (HLA-A) 0201 positive.\n8. Willing to practice birth control during treatment and for four months after receiving the preparative regimen.\n9. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n10. Hematology:\n\n    * Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim.\n    * WBC greater than 3000/mm^3.\n    * Hemoglobin greater than 8.0 g/dl.\n    * Platelet count greater than 100,000/mm^3.\n11. Serology:\n\n    * Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune - competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n    * Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative.\n12. Chemistry:\n\n    * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal.\n    * Serum creatinine less than or equal to 1.6 mg/dl.\n    * Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.\n13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n14. Six weeks must have elapsed since prior Ipilimumab (MDX-010) therapy to allow antibody levels to decline.\n15. Patients who have previously received MDX-010 must have a normal colonoscopy with normal colonic biopsies.\n\nEXCLUSION CRITERIA:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n2. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.\n3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n4. Opportunistic infections (The experimental treatment being evaluated in his protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n5. Symptomatic central nervous system (CNS) lesions (Patients maybe eligible after treatment of their symptomatic lesions.)\n6. Systemic steroid therapy.\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. History of coronary revascularization or ischemic symptoms.\n9. Patients with a prolonged (greater than 20 pk/yrs) history of cigarette smoking or symptoms of respiratory dysfunction with pulmonary function tests (PFT's) indicating an forced expiratory volume (FEV1) less than 60 percent predicted for age.\n10. Patients with a history of clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, heart block or greater than or equal to age 60 with an left ventricular ejection fraction (LVEF) of less than 45 percent on cardiac evaluation (echocardiogram, multi-gated acquisition scan (MUGA), etc.) will be excluded.\n11. Positive allo-specific reactivity of the DMF5 cells to the patient's peripheral blood mononuclear cells (PBMC).\n12. Documented penicillin allergy."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "1. Measurable metastatic melanoma that is refractory to standard treatment including high dose aldesleukin.",
            "criterions": [
                {
                    "exact_snippets": "Measurable metastatic melanoma",
                    "criterion": "metastatic melanoma",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard treatment including high dose aldesleukin",
                    "criterion": "refractory to standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "standard treatment",
                                "high dose aldesleukin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Unsuitable autologous cells for Institutional Review Board (IRB) approved Surgery Branch adoptive cell therapy studies.",
            "criterions": [
                {
                    "exact_snippets": "Unsuitable autologous cells",
                    "criterion": "autologous cells",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Greater than or equal to 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Greater than or equal to 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy of greater than three months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than three months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Willing to sign a durable power of attorney.",
            "criterions": [
                {
                    "exact_snippets": "Willing to sign a durable power of attorney.",
                    "criterion": "willingness to sign a durable power of attorney",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Able to understand and sign the Informed Consent Document.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "understand"
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the Informed Consent Document",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "sign"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Human leukocyte antigen A (HLA-A) 0201 positive.",
            "criterions": [
                {
                    "exact_snippets": "Human leukocyte antigen A (HLA-A) 0201 positive",
                    "criterion": "HLA-A 0201",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Willing to practice birth control during treatment and for four months after receiving the preparative regimen.",
            "criterions": [
                {
                    "exact_snippets": "Willing to practice birth control during treatment and for four months after receiving the preparative regimen.",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for four months after receiving the preparative regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Hematology:",
            "criterions": [
                {
                    "exact_snippets": "Hematology",
                    "criterion": "hematology",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count greater than 1000/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without support of filgrastim",
                    "criterion": "support of filgrastim",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC greater than 3000/mm^3.",
            "criterions": [
                {
                    "exact_snippets": "WBC greater than 3000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin greater than 8.0 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin greater than 8.0 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count greater than 100,000/mm^3.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm^3.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Serology:",
            "criterions": [
                {
                    "exact_snippets": "Serology",
                    "criterion": "serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune - competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)",
            "criterions": [
                {
                    "exact_snippets": "Seronegative for human immunodeficiency virus (HIV) antibody.",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "serostatus",
                            "expected_value": "seronegative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative.",
            "criterions": [
                {
                    "exact_snippets": "Seronegative for hepatitis B antigen",
                    "criterion": "hepatitis B antigen",
                    "requirements": [
                        {
                            "requirement_type": "serostatus",
                            "expected_value": "seronegative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Seronegative for ... hepatitis C antibody",
                    "criterion": "hepatitis C antibody",
                    "requirements": [
                        {
                            "requirement_type": "serostatus",
                            "expected_value": "seronegative"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless antigen negative",
                    "criterion": "hepatitis C antigen",
                    "requirements": [
                        {
                            "requirement_type": "serostatus",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine less than or equal to 1.6 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine less than or equal to 1.6 mg/dl.",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.6,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin less than or equal to 2.0 mg/dl",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's Syndrome ... total bilirubin less than 3.0 mg/dl",
                    "criterion": "total bilirubin in patients with Gilbert's Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).",
            "criterions": [
                {
                    "exact_snippets": "More than four weeks must have elapsed since any prior systemic therapy",
                    "criterion": "elapsed time since prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients' toxicities must have recovered to a grade 1 or less",
                    "criterion": "recovery of toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for toxicities such as alopecia or vitiligo",
                    "criterion": "exceptions for specific toxicities",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "alopecia",
                                "vitiligo"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Six weeks must have elapsed since prior Ipilimumab (MDX-010) therapy to allow antibody levels to decline.",
            "criterions": [
                {
                    "exact_snippets": "Six weeks must have elapsed since prior Ipilimumab (MDX-010) therapy",
                    "criterion": "time since prior Ipilimumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients who have previously received MDX-010 must have a normal colonoscopy with normal colonic biopsies.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received MDX-010",
                    "criterion": "previous MDX-010 treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a normal colonoscopy",
                    "criterion": "colonoscopy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal colonic biopsies",
                    "criterion": "colonic biopsies",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of child-bearing potential who are ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.",
            "criterions": [
                {
                    "exact_snippets": "Active systemic infections",
                    "criterion": "systemic infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "major medical illnesses of the cardiovascular, respiratory or immune system",
                    "criterion": "major medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "systems affected",
                            "expected_value": [
                                "cardiovascular",
                                "respiratory",
                                "immune"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "obstructive or restrictive pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "obstructive",
                                "restrictive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).",
            "criterions": [
                {
                    "exact_snippets": "Any form of primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Opportunistic infections (The experimental treatment being evaluated in his protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)",
            "criterions": [
                {
                    "exact_snippets": "Opportunistic infections",
                    "criterion": "opportunistic infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intact immune system",
                    "criterion": "immune system integrity",
                    "requirements": [
                        {
                            "requirement_type": "integrity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "decreased immune competence",
                    "criterion": "immune competence",
                    "requirements": [
                        {
                            "requirement_type": "competence",
                            "expected_value": "not decreased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Symptomatic central nervous system (CNS) lesions (Patients maybe eligible after treatment of their symptomatic lesions.)",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic central nervous system (CNS) lesions",
                    "criterion": "central nervous system (CNS) lesions",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Systemic steroid therapy.",
            "criterions": [
                {
                    "exact_snippets": "Systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.",
            "criterions": [
                {
                    "exact_snippets": "History of severe immediate hypersensitivity reaction",
                    "criterion": "hypersensitivity reaction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "immediate"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any of the agents used in this study",
                    "criterion": "agents used in this study",
                    "requirements": [
                        {
                            "requirement_type": "hypersensitivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of coronary revascularization or ischemic symptoms.",
            "criterions": [
                {
                    "exact_snippets": "History of coronary revascularization",
                    "criterion": "coronary revascularization",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... ischemic symptoms",
                    "criterion": "ischemic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with a prolonged (greater than 20 pk/yrs) history of cigarette smoking or symptoms of respiratory dysfunction with pulmonary function tests (PFT's) indicating an forced expiratory volume (FEV1) less than 60 percent predicted for age.",
            "criterions": [
                {
                    "exact_snippets": "prolonged (greater than 20 pk/yrs) history of cigarette smoking",
                    "criterion": "history of cigarette smoking",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "pk/yrs"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms of respiratory dysfunction",
                    "criterion": "symptoms of respiratory dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary function tests (PFT's) indicating an forced expiratory volume (FEV1) less than 60 percent predicted for age",
                    "criterion": "forced expiratory volume (FEV1)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "percent predicted for age"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with a history of clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, heart block or greater than or equal to age 60 with an left ventricular ejection fraction (LVEF) of less than 45 percent on cardiac evaluation (echocardiogram, multi-gated acquisition scan (MUGA), etc.) will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "history of clinically significant atrial and/or ventricular arrhythmias",
                    "criterion": "atrial and/or ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart block",
                    "criterion": "heart block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to age 60",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) of less than 45 percent",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "percent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac evaluation (echocardiogram, multi-gated acquisition scan (MUGA), etc.)",
                    "criterion": "cardiac evaluation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiogram",
                                "multi-gated acquisition scan (MUGA)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Positive allo-specific reactivity of the DMF5 cells to the patient's peripheral blood mononuclear cells (PBMC).",
            "criterions": [
                {
                    "exact_snippets": "Positive allo-specific reactivity of the DMF5 cells to the patient's peripheral blood mononuclear cells (PBMC)",
                    "criterion": "allo-specific reactivity of DMF5 cells to PBMC",
                    "requirements": [
                        {
                            "requirement_type": "reactivity",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Documented penicillin allergy.",
            "criterions": [
                {
                    "exact_snippets": "Documented penicillin allergy",
                    "criterion": "penicillin allergy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "-INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "12. Chemistry:",
            "criterions": []
        },
        {
            "line": "* Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "Serum alanine aminotransferase (ALT) less than three times the upper limit of normal.",
                    "criterion": "serum alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) less than three times the upper limit of normal.",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}