{
    "info": {
        "nct_id": "NCT05890872",
        "official_title": "A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer",
        "inclusion_criteria": "* Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.\n* Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.\n* Patient is deemed eligible to receive 1L SOC therapy for their malignancy.\n* In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.\n* Life expectancy ≥ 6 months.\nHealthy volunteers allowed\nMust have minimum age of 22 Years",
        "exclusion_criteria": "* Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.\n* Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.\n* Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.\n* Patient with active, known, or suspected autoimmune disease.\n* Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.\n* Patient has any history of primary immunodeficiency.\n* Patient has clinical signs or symptoms of active tuberculosis infection.\n* Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.\n* Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,\n\nOther protocol defined inclusion/exclusion criteria apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.",
            "criterions": [
                {
                    "exact_snippets": "suspected or confirmed metastatic cancer within the lungs",
                    "criterion": "metastatic cancer within the lungs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "suspected",
                                "confirmed"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IV non-small cell lung cancer (NSCLC)",
                    "criterion": "stage IV non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring biopsy",
                    "criterion": "biopsy requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.",
            "criterions": [
                {
                    "exact_snippets": "radiologically documented suspected, or confirmed tumor(s)",
                    "criterion": "tumor presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor(s) that are ≤ 5 cm in longest diameter",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF",
                    "criterion": "suitability for PEF treatment",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is deemed eligible to receive 1L SOC therapy for their malignancy.",
            "criterions": [
                {
                    "exact_snippets": "deemed eligible to receive 1L SOC therapy",
                    "criterion": "eligibility for 1L SOC therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for their malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.",
            "criterions": [
                {
                    "exact_snippets": "the patient is not a surgical candidate for curative intent",
                    "criterion": "surgical candidacy for curative intent",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient has refused surgery",
                    "criterion": "surgery refusal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 22 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 22 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 22,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received any prior cancer therapy for current tumor(s)",
                    "criterion": "prior cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.",
            "criterions": [
                {
                    "exact_snippets": "Patient is scheduled to receive investigational therapies (including device-based therapy)",
                    "criterion": "investigational therapies",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "investigational therapies (including device-based therapy) that may interfere with the study endpoints",
                    "criterion": "interference with study endpoints",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.",
            "criterions": [
                {
                    "exact_snippets": "clinical evidence of leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases that require SOC treatment",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "SOC treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with active, known, or suspected autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "active, known, or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.",
            "criterions": [
                {
                    "exact_snippets": "type I diabetes mellitus",
                    "criterion": "type I diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism only requiring hormone replacement",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement"
                        }
                    ]
                },
                {
                    "exact_snippets": "skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment",
                    "criterion": "skin disorders",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "not requiring systemic treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions not expected to recur in the absence of an external trigger",
                    "criterion": "conditions not expected to recur",
                    "requirements": [
                        {
                            "requirement_type": "trigger",
                            "expected_value": "absence of an external trigger"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) ... within 30 days prior to study enrollment.",
                    "criterion": "systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone or equivalent"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days prior to study enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received ... other immunosuppressive medications within 30 days prior to study enrollment.",
                    "criterion": "immunosuppressive medication treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days prior to study enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.",
                    "criterion": "inhaled or topical steroids",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.",
                    "criterion": "adrenal replacement doses",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone or equivalent"
                            }
                        },
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the absence of active autoimmune disease.",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has any history of primary immunodeficiency.",
            "criterions": [
                {
                    "exact_snippets": "any history of primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has clinical signs or symptoms of active tuberculosis infection.",
            "criterions": [
                {
                    "exact_snippets": "clinical signs or symptoms of active tuberculosis infection",
                    "criterion": "active tuberculosis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "documented evidence of acute hepatitis",
                    "criterion": "acute hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,",
            "criterions": [
                {
                    "exact_snippets": "Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has planned major surgeries while enrolled in the study",
                    "criterion": "planned major surgeries",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol defined inclusion/exclusion criteria apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined inclusion/exclusion criteria apply",
                    "criterion": "protocol defined inclusion/exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "application",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}