{
    "info": {
        "nct_id": "NCT03982082",
        "official_title": "Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer",
        "inclusion_criteria": "* Participants are willing and able to give written informed consent and to comply with study procedures.\n* Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:\n\n  * Group 1: Patients with cachexia, defined by loss of > 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss > 2% with BMI < 20.\n  * Group 2: Patients without cachexia, as defined above.\n* Patients who have a record of weight or BMI over preceding 6-months.\n* Patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Non-English speaking patients.\n* Patient with neurological compromise of both lower extremities causing muscle atrophy.\n* Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity.\n* Patients who are unable to understand or follow through with study instructions.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants are willing and able to give written informed consent and to comply with study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Participants are willing and able to give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants are ... able ... to comply with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:",
            "criterions": [
                {
                    "exact_snippets": "biopsy-confirmed solid malignant neoplasm",
                    "criterion": "solid malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "biopsy-confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one neurologically-intact lower extremity",
                    "criterion": "neurologically-intact lower extremity",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "extremity"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Group 1: Patients with cachexia, defined by loss of > 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss > 2% with BMI < 20.",
            "criterions": [
                {
                    "exact_snippets": "cachexia, defined by loss of > 5% of body weight over the preceding 6-months",
                    "criterion": "cachexia",
                    "requirements": [
                        {
                            "requirement_type": "weight loss",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time period",
                            "expected_value": "preceding 6-months"
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of simple starvation defined as intentional weight loss",
                    "criterion": "simple starvation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "weight loss > 2% with BMI < 20",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "weight loss",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "BMI",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 20,
                                        "unit": ""
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Group 2: Patients without cachexia, as defined above.",
            "criterions": [
                {
                    "exact_snippets": "Patients without cachexia",
                    "criterion": "cachexia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a record of weight or BMI over preceding 6-months.",
            "criterions": [
                {
                    "exact_snippets": "record of weight",
                    "criterion": "weight record",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "record of ... BMI",
                    "criterion": "BMI record",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be receiving rehabilitation",
                    "criterion": "rehabilitation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rehabilitation that includes exercise",
                    "criterion": "exercise",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "under the direction of a physical therapist",
                    "criterion": "direction by a physical therapist",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Non-English speaking patients.",
            "criterions": [
                {
                    "exact_snippets": "Non-English speaking patients",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "non-English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with neurological compromise of both lower extremities causing muscle atrophy.",
            "criterions": [
                {
                    "exact_snippets": "neurological compromise of both lower extremities",
                    "criterion": "neurological compromise",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "both lower extremities"
                        }
                    ]
                },
                {
                    "exact_snippets": "muscle atrophy",
                    "criterion": "muscle atrophy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity.",
            "criterions": [
                {
                    "exact_snippets": "Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological)",
                    "criterion": "underlying unstable medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity",
                    "criterion": "musculoskeletal injury",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "limits participation in exercise of the measured lower extremity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are unable to understand or follow through with study instructions.",
            "criterions": [
                {
                    "exact_snippets": "unable to understand",
                    "criterion": "understanding of study instructions",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to ... follow through with study instructions",
                    "criterion": "ability to follow study instructions",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}