{
    "info": {
        "nct_id": "NCT03286062",
        "official_title": "VM110 in Detection of Microscopic Tumors: A Phase I Study",
        "inclusion_criteria": "1. Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will not undergo laparoscopy solely for the purpose of participation in this trial.\n2. Patients must have evidence of disease either through elevation of tumor markers or radiologic evidence of disease\n3. Patient may be male or female and of any race / ethnicity.\n4. Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care\n5. ECOG PS of 0-1\n6. Patients should be free of active infection requiring antibiotics\n7. Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration\n8. Patients must have adequate:\n\n   * Renal function: serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)\n   * Hepatic function: Total bilirubin less than or equal to 1.5 x ULN , SGOT and alkaline phosphatase less than or equal to 2.5 x ULN\n   * PTT (partial thromboplastin time) ≤ 1x ULN and INR ≤ 1.5 x ULN.\n9. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:\n\n   1. Use of oral, injected or implanted hormonal methods of contraception, or;\n   2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n   3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;\n   4. Total abstinence or;\n   5. Male/female sterilization\n10. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.\n\n    a. Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment\n11. Age ≥ 18\n12. Capable of complying with study procedures and communicating with study personnel.\n13. Patients must have signed an approved informed consent and authorization permitting release of personal health information. Ability to understand and willingness to sign a written informed consent and HIPAA consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n2. Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis).\n3. Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy. Caution should be taken if prior ICG allergy is noted.\n4. Pregnant or nursing (lactating) women\n5. History of congestive cardiac failure or an EKG suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study.\n6. Subject has previously received VM110, or any other investigational product in the past thirty days.\n7. Inadequate tumor sites or volume to allow for biopsy per standard of care.\n8. Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will not undergo laparoscopy solely for the purpose of participation in this trial.",
            "criterions": [
                {
                    "exact_snippets": "known or suspected pancreatic or ovarian carcinoma",
                    "criterion": "pancreatic or ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing clinically appropriate laparoscopic evaluation or treatment",
                    "criterion": "laparoscopic evaluation or treatment",
                    "requirements": [
                        {
                            "requirement_type": "planned procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must have evidence of disease either through elevation of tumor markers or radiologic evidence of disease",
            "criterions": [
                {
                    "exact_snippets": "evidence of disease ... elevation of tumor markers",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "elevation of tumor markers"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of disease ... radiologic evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "radiologic evidence of disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient may be male or female and of any race / ethnicity.",
            "criterions": [
                {
                    "exact_snippets": "Patient may be male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any race / ethnicity",
                    "criterion": "race/ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care",
            "criterions": [
                {
                    "exact_snippets": "Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care",
                    "criterion": "alteration of care",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG PS of 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients should be free of active infection requiring antibiotics",
            "criterions": [
                {
                    "exact_snippets": "free of active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring antibiotics",
                    "criterion": "antibiotic requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration",
                    "criterion": "therapy directed at the malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients must have adequate:",
            "criterions": [
                {
                    "exact_snippets": "adequate",
                    "criterion": "adequacy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal function: serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Renal function: serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic function: Total bilirubin less than or equal to 1.5 x ULN , SGOT and alkaline phosphatase less than or equal to 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin less than or equal to 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT ... less than or equal to 2.5 x ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase less than or equal to 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PTT (partial thromboplastin time) ≤ 1x ULN and INR ≤ 1.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "PTT (partial thromboplastin time) ≤ 1x ULN",
                    "criterion": "PTT (partial thromboplastin time)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "INR ≤ 1.5 x ULN",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "physiological capability",
                            "expected_value": "capable of becoming pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use highly effective methods of contraception during the study and 8 weeks after",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and 8 weeks after"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Use of oral, injected or implanted hormonal methods of contraception, or;",
            "criterions": [
                {
                    "exact_snippets": "Use of oral, injected or implanted hormonal methods of contraception",
                    "criterion": "hormonal contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);",
            "criterions": [
                {
                    "exact_snippets": "Placement of an intrauterine device (IUD) or intrauterine system (IUS)",
                    "criterion": "intrauterine device (IUD) or intrauterine system (IUS) placement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;",
            "criterions": [
                {
                    "exact_snippets": "Barrier methods of contraception: condom",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "condom"
                        }
                    ]
                },
                {
                    "exact_snippets": "Barrier methods of contraception: ... occlusive cap (diaphragm or cervical/vault caps)",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "diaphragm",
                                "cervical cap",
                                "vault cap"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Barrier methods of contraception: ... spermicidal foam/gel/film/cream/ vaginal suppository",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "spermicidal foam",
                                "spermicidal gel",
                                "spermicidal film",
                                "spermicidal cream",
                                "vaginal suppository"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Total abstinence or;",
            "criterions": [
                {
                    "exact_snippets": "Total abstinence",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Male/female sterilization",
            "criterions": [
                {
                    "exact_snippets": "Male/female sterilization",
                    "criterion": "sterilization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.",
            "criterions": [
                {
                    "exact_snippets": "12 months of natural (spontaneous) amenorrhea",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "age appropriate",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "age appropriate"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of vasomotor symptoms",
                    "criterion": "vasomotor symptoms",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical bilateral oophorectomy",
                    "criterion": "surgical bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tubal ligation at least six weeks prior to randomization",
                    "criterion": "tubal ligation",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "oophorectomy alone ... reproductive status ... confirmed by follow up hormone level assessment",
                    "criterion": "reproductive status confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment",
            "criterions": [
                {
                    "exact_snippets": "Male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "sexual partner(s) are WOCBP",
                    "criterion": "partner's reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "WOCBP"
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 8 weeks after the end of treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "during the study and for 8 weeks after the end of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Age ≥ 18",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Capable of complying with study procedures and communicating with study personnel.",
            "criterions": [
                {
                    "exact_snippets": "Capable of complying with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Capable of ... communicating with study personnel",
                    "criterion": "communication with study personnel",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients must have signed an approved informed consent and authorization permitting release of personal health information. Ability to understand and willingness to sign a written informed consent and HIPAA consent document",
            "criterions": [
                {
                    "exact_snippets": "Patients must have signed an approved informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "authorization permitting release of personal health information",
                    "criterion": "authorization for release of personal health information",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ability to understand and willingness to sign a written informed consent",
                    "criterion": "ability to understand informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a ... HIPAA consent document",
                    "criterion": "willingness to sign HIPAA consent document",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.",
                    "criterion": "prior radiotherapy to abdominal cavity or pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration",
                    "criterion": "prior radiation for localized cancer of the breast, head and neck, or skin",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient remains free of recurrent or metastatic disease",
                    "criterion": "recurrent or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis).",
            "criterions": [
                {
                    "exact_snippets": "Patients with an active bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "on oral anti-vitamin K medication",
                    "criterion": "oral anti-vitamin K medication",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except low-dose warfarin used for catheter-related thrombosis prophylaxis",
                    "criterion": "low-dose warfarin for catheter-related thrombosis prophylaxis",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy. Caution should be taken if prior ICG allergy is noted.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of hypersensitivity to Pegylated liposomal doxorubicin",
                    "criterion": "hypersensitivity to Pegylated liposomal doxorubicin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ICG allergy",
                    "criterion": "ICG allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pregnant or nursing (lactating) women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing (lactating) women",
                    "criterion": "nursing (lactating)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of congestive cardiac failure or an EKG suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study.",
            "criterions": [
                {
                    "exact_snippets": "History of congestive cardiac failure",
                    "criterion": "congestive cardiac failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EKG suggesting significant conduction defect",
                    "criterion": "conduction defect",
                    "requirements": [
                        {
                            "requirement_type": "suggested by EKG",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EKG suggesting ... myocardial ischemia",
                    "criterion": "myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "suggested by EKG",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active psychiatric disease requiring treatment",
                    "criterion": "psychiatric disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject has previously received VM110, or any other investigational product in the past thirty days.",
            "criterions": [
                {
                    "exact_snippets": "Subject has previously received VM110",
                    "criterion": "previous receipt of VM110",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other investigational product in the past thirty days",
                    "criterion": "receipt of investigational product",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Inadequate tumor sites or volume to allow for biopsy per standard of care.",
            "criterions": [
                {
                    "exact_snippets": "Inadequate tumor sites or volume to allow for biopsy",
                    "criterion": "tumor sites or volume",
                    "requirements": [
                        {
                            "requirement_type": "adequacy for biopsy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.",
            "criterions": [
                {
                    "exact_snippets": "psychiatric or other conditions rendering them incapable of participating in informed consent",
                    "criterion": "psychiatric or other conditions",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "incapable of participating in informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data",
                    "criterion": "condition or personal circumstance",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": "might interfere with the collection of complete good quality data"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}