{
    "info": {
        "nct_id": "NCT05544227",
        "official_title": "Immunotherapy Regimen Given After Targeted Local Cryolysis (TLC) for Patients With Advanced/Metastatic Castration-resistant Prostate Cancer (mCRPC) OR Those With Metastatic Prostate Cancer Who Refused Hormone Therapy and Chemotherapy.",
        "inclusion_criteria": "1. Male >18 years old at the time of signed informed consent\n2. Provide written informed consent\n3. Subjects with advanced and/or metastatic histologically or cytologically confirmed castrate-resistant prostate cancer\n4. After failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors and with or without a prior course of taxanes therapy or those with metastatic prostate cancer who have refused hormone therapy and chemotherapy, or have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available\n5. Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I&T\n6. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.\n7. Measurable disease by RECIST.\n8. Meet all eligibility criteria\n9. Able to undergo general anesthesia or conscious sedation\n10. Has undergone a cardiac work-up and received cardiac clearance two months before first treatment\n11. Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.\n12. Eastern Cooperative Oncology Group (ECOG) performance status of < 3 (0, 1, or 2)\n13. All subjects with female partners of childbearing potential must use effective contraception throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention\n14. Has at least one lesion within the prostate accessible transperineally using transrectal ultrasound (TRUS) that is demonstrable on PET/CT, CT, Ultrasound, or MRI and is accessible for infusion on TRUS or, if a radical prostatectomy has been performed, has a metastatic lesion or lymph node lesion that is demonstrable on PET/CT, CT, or MRI and accessible by a percutaneous needle to permit treatment.\n15. Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable doses for at least 42 days prior to the cryolysis\n16. Adequate bone marrow, renal, and hepatic function, defined as follows:\n\n    a. Bone marrow function without transfusion 30 days before first dosing: i. Absolute neutrophil count ≥ 1.5 x 109/L; Lymphocyte count of ≥ 1.0 x 109/L; Platelet count ≥ 100 x 109/L; ii. Hemoglobin ≥ 9.0 g/dL b. Renal function\" i. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation ≥30 mL/ c. Hepatic function i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome iv. Patients with liver metastases ≤5x ULN\n17. All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline (except alopecia or ototoxicity\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast\n2. Has an obstructed urinary system before or after stenting\n3. Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study drug and has not recovered adequately from the toxicities and/or complications\n4. Has an active infection (including tuberculosis) requiring systemic therapy\n5. Has a history of non-infectious pneumonitis that required steroids\n6. Has received a live vaccine within 30 days prior to the enrollment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first treatment\n7. Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g. New York Heart Association Class 4), or history of previous heart failure\n8. Malignant pleural effusions or ascites that require immediate intervention\n9. Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes, cardiac arrhythmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate.\n10. Any primary or acquired immunodeficiency\n11. Active COVID infection or tests positive for COVID day before or day of planned treatment\n12. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion)\n13. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load\n14. Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Male >18 years old at the time of signed informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Male",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": ">18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": ">18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Provide written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. After failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors and with or without a prior course of taxanes therapy or those with metastatic prostate cancer who have refused hormone therapy and chemotherapy, or have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available",
                "criterions": [
                    {
                        "exact_snippets": "failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors",
                        "criterion": "treatment failure",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "second-generation androgen-receptor-pathway inhibitors"
                        }
                    },
                    {
                        "exact_snippets": "with or without a prior course of taxanes therapy",
                        "criterion": "prior taxanes therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "metastatic prostate cancer who have refused hormone therapy and chemotherapy",
                        "criterion": "refusal of hormone therapy and chemotherapy",
                        "requirement": {
                            "requirement_type": "refusal",
                            "expected_value": [
                                "hormone therapy",
                                "chemotherapy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "metastatic prostate cancer ... have not responded or progressed after standard therapies",
                        "criterion": "response to standard therapies",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "not responded or progressed"
                        }
                    },
                    {
                        "exact_snippets": "metastatic prostate cancer ... for whom no further standard therapy exists or standard therapy is not available",
                        "criterion": "availability of standard therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors",
                                        "criterion": "treatment failure",
                                        "requirement": {
                                            "requirement_type": "treatment type",
                                            "expected_value": "second-generation androgen-receptor-pathway inhibitors"
                                        }
                                    },
                                    {
                                        "exact_snippets": "with or without a prior course of taxanes therapy",
                                        "criterion": "prior taxanes therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "metastatic prostate cancer ... have not responded or progressed after standard therapies",
                                        "criterion": "response to standard therapies",
                                        "requirement": {
                                            "requirement_type": "response",
                                            "expected_value": "not responded or progressed"
                                        }
                                    },
                                    {
                                        "exact_snippets": "metastatic prostate cancer ... for whom no further standard therapy exists or standard therapy is not available",
                                        "criterion": "availability of standard therapy",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "metastatic prostate cancer who have refused hormone therapy and chemotherapy",
                        "criterion": "refusal of hormone therapy and chemotherapy",
                        "requirement": {
                            "requirement_type": "refusal",
                            "expected_value": [
                                "hormone therapy",
                                "chemotherapy"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Able to undergo general anesthesia or conscious sedation",
                "criterions": [
                    {
                        "exact_snippets": "Able to undergo general anesthesia",
                        "criterion": "ability to undergo general anesthesia",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to undergo ... conscious sedation",
                        "criterion": "ability to undergo conscious sedation",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Able to undergo general anesthesia",
                        "criterion": "ability to undergo general anesthesia",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to undergo ... conscious sedation",
                        "criterion": "ability to undergo conscious sedation",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Has undergone a cardiac work-up and received cardiac clearance two months before first treatment",
                "criterions": [
                    {
                        "exact_snippets": "Has undergone a cardiac work-up",
                        "criterion": "cardiac work-up",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "received cardiac clearance",
                        "criterion": "cardiac clearance",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "two months before first treatment",
                        "criterion": "timing of cardiac clearance",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "two months before first treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has undergone a cardiac work-up",
                        "criterion": "cardiac work-up",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "received cardiac clearance",
                        "criterion": "cardiac clearance",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "two months before first treatment",
                        "criterion": "timing of cardiac clearance",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "two months before first treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.",
                        "criterion": "use of anticoagulants or other blood thinners",
                        "requirement": {
                            "requirement_type": "cessation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.",
                        "criterion": "use of anticoagulants or other blood thinners",
                        "requirement": {
                            "requirement_type": "cessation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Eastern Cooperative Oncology Group (ECOG) performance status of < 3 (0, 1, or 2)",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of < 3 (0, 1, or 2)",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of < 3 (0, 1, or 2)",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. All subjects with female partners of childbearing potential must use effective contraception throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention",
                "criterions": [
                    {
                        "exact_snippets": "female partners of childbearing potential",
                        "criterion": "female partner's childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention",
                        "criterion": "duration of contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "female partners of childbearing potential",
                                "criterion": "female partner's childbearing potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "must use effective contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention",
                        "criterion": "duration of contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "3. Subjects with advanced and/or metastatic histologically or cytologically confirmed castrate-resistant prostate cancer",
                "criterions": [
                    {
                        "exact_snippets": "advanced and/or metastatic",
                        "criterion": "prostate cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "histologically or cytologically confirmed",
                        "criterion": "confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "castrate-resistant prostate cancer",
                        "criterion": "prostate cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "castrate-resistant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "advanced and/or metastatic",
                                "criterion": "prostate cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "advanced"
                                }
                            },
                            {
                                "exact_snippets": "advanced and/or metastatic",
                                "criterion": "prostate cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "metastatic"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "histologically or cytologically confirmed",
                                "criterion": "confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "histologically"
                                }
                            },
                            {
                                "exact_snippets": "histologically or cytologically confirmed",
                                "criterion": "confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "cytologically"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "castrate-resistant prostate cancer",
                        "criterion": "prostate cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "castrate-resistant"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I&T",
                "criterions": [
                    {
                        "exact_snippets": "Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I&T",
                        "criterion": "prior therapy with Lutetium Lu-177-PSMA-I&T",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "may",
                                "may not"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.",
                "criterions": [
                    {
                        "exact_snippets": "Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.",
                        "criterion": "acute toxic effects of prior anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE v5 grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Measurable disease by RECIST.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease by RECIST",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Meet all eligibility criteria",
                "criterions": [
                    {
                        "exact_snippets": "Meet all eligibility criteria",
                        "criterion": "eligibility criteria",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "14. Has at least one lesion within the prostate accessible transperineally using transrectal ultrasound (TRUS) that is demonstrable on PET/CT, CT, Ultrasound, or MRI and is accessible for infusion on TRUS or, if a radical prostatectomy has been performed, has a metastatic lesion or lymph node lesion that is demonstrable on PET/CT, CT, or MRI and accessible by a percutaneous needle to permit treatment.",
                "criterions": [
                    {
                        "exact_snippets": "at least one lesion within the prostate",
                        "criterion": "lesion within the prostate",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "accessible transperineally using transrectal ultrasound (TRUS)",
                        "criterion": "lesion accessibility",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "transperineally using transrectal ultrasound (TRUS)"
                        }
                    },
                    {
                        "exact_snippets": "demonstrable on PET/CT, CT, Ultrasound, or MRI",
                        "criterion": "lesion demonstrability",
                        "requirement": {
                            "requirement_type": "imaging methods",
                            "expected_value": [
                                "PET/CT",
                                "CT",
                                "Ultrasound",
                                "MRI"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "accessible for infusion on TRUS",
                        "criterion": "lesion accessibility for infusion",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "TRUS"
                        }
                    },
                    {
                        "exact_snippets": "if a radical prostatectomy has been performed",
                        "criterion": "radical prostatectomy",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "metastatic lesion or lymph node lesion",
                        "criterion": "metastatic or lymph node lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "demonstrable on PET/CT, CT, or MRI",
                        "criterion": "lesion demonstrability",
                        "requirement": {
                            "requirement_type": "imaging methods",
                            "expected_value": [
                                "PET/CT",
                                "CT",
                                "MRI"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "accessible by a percutaneous needle",
                        "criterion": "lesion accessibility",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "percutaneous needle"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "15. Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable doses for at least 42 days prior to the cryolysis",
                "criterions": [
                    {
                        "exact_snippets": "Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab)",
                        "criterion": "bone resorptive therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must be on stable doses for at least 42 days prior to the cryolysis",
                        "criterion": "stable doses of bone resorptive therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 42,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "16. Adequate bone marrow, renal, and hepatic function, defined as follows:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "a. Bone marrow function without transfusion 30 days before first dosing: i. Absolute neutrophil count ≥ 1.5 x 109/L; Lymphocyte count of ≥ 1.0 x 109/L; Platelet count ≥ 100 x 109/L; ii. Hemoglobin ≥ 9.0 g/dL b. Renal function\" i. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation ≥30 mL/ c. Hepatic function i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome iv. Patients with liver metastases ≤5x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Bone marrow function without transfusion 30 days before first dosing",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1.5 x 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Lymphocyte count of ≥ 1.0 x 109/L",
                        "criterion": "lymphocyte count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "estimated glomerular filtration rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "alanine aminotransferase",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "aspartate aminotransferase",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "total bilirubin",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "total bilirubin with direct bilirubin",
                            "expected_value": "≤ 1.5x ULN with direct bilirubin ≤ ULN in subjects with documented Gilbert's Syndrome"
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "liver metastases",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "17. All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline (except alopecia or ototoxicity",
                "criterions": [
                    {
                        "exact_snippets": "All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline",
                        "criterion": "clinically relevant toxicities related to prior anticancer therapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "except alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except ... ototoxicity",
                        "criterion": "ototoxicity",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast",
                "criterions": [
                    {
                        "exact_snippets": "Has a known other primary malignancy other than prostate cancer",
                        "criterion": "other primary malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "that is progressing",
                        "criterion": "progression of other primary malignancy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "or has required active treatment in the last 3 years",
                        "criterion": "active treatment for other primary malignancy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast",
                        "criterion": "exclusion of specific cancers",
                        "requirement": {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "basal cell carcinoma",
                                "squamous cell carcinoma",
                                "papillary thyroid cancer",
                                "ductal carcinoma in situ of the breast"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Has an obstructed urinary system before or after stenting",
                "criterions": [
                    {
                        "exact_snippets": "obstructed urinary system",
                        "criterion": "urinary system obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study drug and has not recovered adequately from the toxicities and/or complications",
                "criterions": [
                    {
                        "exact_snippets": "Has undergone major surgery",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "local prostate intervention (excluding prostate biopsy)",
                        "criterion": "local prostate intervention",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not recovered adequately from the toxicities and/or complications",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not adequately recovered"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Has an active infection (including tuberculosis) requiring systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Has an active infection (including tuberculosis) requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has an active infection (including tuberculosis) requiring systemic therapy",
                        "criterion": "systemic therapy for infection",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Has a history of non-infectious pneumonitis that required steroids",
                "criterions": [
                    {
                        "exact_snippets": "history of non-infectious pneumonitis",
                        "criterion": "non-infectious pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "required steroids",
                        "criterion": "steroid requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Has received a live vaccine within 30 days prior to the enrollment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first treatment",
                "criterions": [
                    {
                        "exact_snippets": "Has received a live vaccine within 30 days prior to the enrollment",
                        "criterion": "live vaccine",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Is currently participating in or has participated in a study of an investigational agent",
                        "criterion": "participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "participation status",
                            "expected_value": [
                                "currently participating",
                                "has participated"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "has used an investigational device within 28 days prior to the first treatment",
                        "criterion": "use of an investigational device",
                        "requirement": {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g. New York Heart Association Class 4), or history of previous heart failure",
                "criterions": [
                    {
                        "exact_snippets": "Significant cardiac or other medical illness such as severe congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac or other medical illness such as ... unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac or other medical illness such as ... serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association Class 4",
                        "criterion": "New York Heart Association class",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": "Class 4"
                        }
                    },
                    {
                        "exact_snippets": "history of previous heart failure",
                        "criterion": "history of heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Malignant pleural effusions or ascites that require immediate intervention",
                "criterions": [
                    {
                        "exact_snippets": "Malignant pleural effusions",
                        "criterion": "malignant pleural effusions",
                        "requirement": {
                            "requirement_type": "intervention necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ascites that require immediate intervention",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "intervention necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes, cardiac arrhythmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate.",
                "criterions": [
                    {
                        "exact_snippets": "Prior history of autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except hypothyroidism",
                        "criterion": "hypothyroidism",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled or unmanaged diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cardiac arrhythmia (unstable or untreated)",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cardiac arrhythmia (unstable or untreated)",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate",
                        "criterion": "other illness or disease",
                        "requirement": {
                            "requirement_type": "opinion of Principal Investigator and Chief Medical Officer",
                            "expected_value": "makes the subject a poor candidate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Any primary or acquired immunodeficiency",
                "criterions": [
                    {
                        "exact_snippets": "Any primary or acquired immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "acquired"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Active COVID infection or tests positive for COVID day before or day of planned treatment",
                "criterions": [
                    {
                        "exact_snippets": "Active COVID infection",
                        "criterion": "COVID infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tests positive for COVID",
                        "criterion": "COVID test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion)",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected hepatitis B if active infection",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "chronic hepatitis B infection ... undetectable Hepatitis B virus (HBV) viral load on suppressive therapy",
                        "criterion": "chronic hepatitis B infection",
                        "requirement": {
                            "requirement_type": "HBV viral load",
                            "expected_value": "undetectable"
                        }
                    },
                    {
                        "exact_snippets": "positive surface antibody alone is not an exclusion",
                        "criterion": "hepatitis B surface antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "13. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected hepatitis C infection",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "which has not been treated and cured",
                        "criterion": "hepatitis C infection treatment status",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "not treated and cured"
                        }
                    },
                    {
                        "exact_snippets": "unless currently on treatment with an undetectable viral load",
                        "criterion": "hepatitis C infection treatment status",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "currently on treatment with an undetectable viral load"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "14. Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.",
                "criterions": [
                    {
                        "exact_snippets": "Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug",
                        "criterion": "condition increasing risk for toxicities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any condition(s) that, in the opinion of the Investigator, would ... interfere with subject compliance",
                        "criterion": "condition interfering with subject compliance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any condition(s) that, in the opinion of the Investigator, would ... interfere with ... conduct of this study",
                        "criterion": "condition interfering with conduct of study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}