{
    "info": {
        "nct_id": "NCT03690401",
        "official_title": "Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device",
        "inclusion_criteria": "* Willingness and ability to provide consent\n* Mentally and physically able to comply with protocol\n* Age 18 and over\n* Body Mass Index (BMI) ≤ 40 or body weight of <300 pounds\n* Recent diagnosis of first cancer stage I-III\n* Completion of final primary cancer treatment within 6 months of Screening/Baseline visit\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active implanted medical device (cardiac pacemakers, defibrillators) or connected to electronic life support devices or patients with other metallic devices that would interfere with BIS measurements\n* Amputees\n* Any acute swelling condition diagnosed or actively being treated within 30 days of screening/baseline (including, but not limited to: acute heart failure, renal disease with dialysis, pulmonary edema, thrombophlebitis, deep vein thrombosis, pleural effusion, ascites, pregnancy)\n* Patients with basal cell carcinoma or squamous cell skin cancer\n* Patients with head or neck cancer\n* Currently suffering from uncontrolled intercurrent illness, including: ongoing/active infection, unstable angina pectoris, or cardiac arrhythmia\n* Enrollment of female breast cancer patients not to exceed 60% of total projected enrollment. Once this threshold has been reached, these subjects will be excluded\n* Planned orthopedic implant surgery\n* Planned breast implant surgery\n* Presence of or plan for breast expanders post-mastectomy\n* Dependent upon transfusions\n* Any history of organ transplant\n* Presence of colostomy/ostomy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Willingness and ability to provide consent",
            "criterions": [
                {
                    "exact_snippets": "Willingness ... to provide consent",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to provide consent",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mentally and physically able to comply with protocol",
            "criterions": [
                {
                    "exact_snippets": "Mentally ... able to comply with protocol",
                    "criterion": "mental ability",
                    "requirements": [
                        {
                            "requirement_type": "ability to comply",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physically able to comply with protocol",
                    "criterion": "physical ability",
                    "requirements": [
                        {
                            "requirement_type": "ability to comply",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 and over",
            "criterions": [
                {
                    "exact_snippets": "Age 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body Mass Index (BMI) ≤ 40 or body weight of <300 pounds",
            "criterions": [
                {
                    "exact_snippets": "Body Mass Index (BMI) ≤ 40",
                    "criterion": "Body Mass Index (BMI)",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<=",
                                "value": 40,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "body weight of <300 pounds",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<",
                                "value": 300,
                                "unit": "pounds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent diagnosis of first cancer stage I-III",
            "criterions": [
                {
                    "exact_snippets": "Recent diagnosis of first cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "first"
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I-III",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completion of final primary cancer treatment within 6 months of Screening/Baseline visit",
            "criterions": [
                {
                    "exact_snippets": "Completion of final primary cancer treatment within 6 months of Screening/Baseline visit",
                    "criterion": "completion of final primary cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "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 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": "* Active implanted medical device (cardiac pacemakers, defibrillators) or connected to electronic life support devices or patients with other metallic devices that would interfere with BIS measurements",
            "criterions": [
                {
                    "exact_snippets": "Active implanted medical device (cardiac pacemakers, defibrillators)",
                    "criterion": "active implanted medical device",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "connected to electronic life support devices",
                    "criterion": "connection to electronic life support devices",
                    "requirements": [
                        {
                            "requirement_type": "connection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with other metallic devices that would interfere with BIS measurements",
                    "criterion": "metallic devices interfering with BIS measurements",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amputees",
            "criterions": [
                {
                    "exact_snippets": "Amputees",
                    "criterion": "amputation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any acute swelling condition diagnosed or actively being treated within 30 days of screening/baseline (including, but not limited to: acute heart failure, renal disease with dialysis, pulmonary edema, thrombophlebitis, deep vein thrombosis, pleural effusion, ascites, pregnancy)",
            "criterions": [
                {
                    "exact_snippets": "acute swelling condition diagnosed or actively being treated within 30 days of screening/baseline",
                    "criterion": "acute swelling condition",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis or treatment status",
                            "expected_value": "diagnosed or actively being treated within 30 days of screening/baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute heart failure",
                    "criterion": "acute heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "renal disease with dialysis",
                    "criterion": "renal disease with dialysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary edema",
                    "criterion": "pulmonary edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombophlebitis",
                    "criterion": "thrombophlebitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with basal cell carcinoma or squamous cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell skin cancer",
                    "criterion": "squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with head or neck cancer",
            "criterions": [
                {
                    "exact_snippets": "head or neck cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "head",
                                "neck"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently suffering from uncontrolled intercurrent illness, including: ongoing/active infection, unstable angina pectoris, or cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Currently suffering from uncontrolled intercurrent illness, including: ongoing/active infection",
                    "criterion": "ongoing/active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently suffering from uncontrolled intercurrent illness, including: ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently suffering from uncontrolled intercurrent illness, including: ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Enrollment of female breast cancer patients not to exceed 60% of total projected enrollment. Once this threshold has been reached, these subjects will be excluded",
            "criterions": [
                {
                    "exact_snippets": "Enrollment of female breast cancer patients not to exceed 60% of total projected enrollment",
                    "criterion": "female breast cancer patient enrollment",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "% of total projected enrollment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned orthopedic implant surgery",
            "criterions": [
                {
                    "exact_snippets": "Planned orthopedic implant surgery",
                    "criterion": "orthopedic implant surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned breast implant surgery",
            "criterions": [
                {
                    "exact_snippets": "Planned breast implant surgery",
                    "criterion": "breast implant surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of or plan for breast expanders post-mastectomy",
            "criterions": [
                {
                    "exact_snippets": "Presence of ... breast expanders",
                    "criterion": "breast expanders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plan for breast expanders post-mastectomy",
                    "criterion": "breast expanders",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dependent upon transfusions",
            "criterions": [
                {
                    "exact_snippets": "Dependent upon transfusions",
                    "criterion": "transfusion dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any history of organ transplant",
            "criterions": [
                {
                    "exact_snippets": "Any history of organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of colostomy/ostomy",
            "criterions": [
                {
                    "exact_snippets": "Presence of colostomy/ostomy",
                    "criterion": "colostomy/ostomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}