{
    "info": {
        "nct_id": "NCT00507260",
        "official_title": "A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue Among Post-Allogeneic Blood and Marrow Transplantation Recipients",
        "inclusion_criteria": "1. Subject has been diagnosed with cancer (leukemia or lymphoma).\n2. Age 18 years or older\n3. Subject has received their allogeneic BMT, fully ablative transplants, from either related or unrelated donors in the past 40 days\n4. Subject can read, write, speak, and understand English\n5. Subject has a caregiver (family member or friend) to keep the food diary record.\n6. Subject voluntarily agrees and signs informed consent prior to participate in this study.\n7. Subject is oriented to time, place, and person.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Subject has major organ failure such as kidney, heart, or liver failure.\n2. Subject has allergies to latex preventing use of the mouthpiece during indirect calorimetry testing.\n3. Subject has been scheduled to withhold oral intake or parenteral nutrition support for more than 4 days during the week of dietary record (week 2, 4, and 6)\n4. Subject has a diagnosis of gastro-intestinal graft versus host disease (GI-GVHD).\n5. Subject has pre-transplant pulmonary function tests (PFTs) with force vital capacity (FVC) or forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 65% of predicted value.\n6. Subject who is physically unable to complete the indirect calorimetry or who refuses calorimetry or who cannot understand the instructions.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subject has been diagnosed with cancer (leukemia or lymphoma).",
            "criterions": [
                {
                    "exact_snippets": "Subject has been diagnosed with cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(leukemia or lymphoma)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "leukemia",
                                "lymphoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject has received their allogeneic BMT, fully ablative transplants, from either related or unrelated donors in the past 40 days",
            "criterions": [
                {
                    "exact_snippets": "Subject has received their allogeneic BMT",
                    "criterion": "allogeneic BMT",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fully ablative transplants",
                    "criterion": "fully ablative transplants",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from either related or unrelated donors",
                    "criterion": "donor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "related",
                                "unrelated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in the past 40 days",
                    "criterion": "time since transplant",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 40,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject can read, write, speak, and understand English",
            "criterions": [
                {
                    "exact_snippets": "Subject can read ... English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "reading ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject can ... write ... English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "writing ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject can ... speak ... English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "speaking ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject can ... understand English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "understanding ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subject has a caregiver (family member or friend) to keep the food diary record.",
            "criterions": [
                {
                    "exact_snippets": "Subject has a caregiver (family member or friend)",
                    "criterion": "caregiver",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to keep the food diary record",
                    "criterion": "food diary record",
                    "requirements": [
                        {
                            "requirement_type": "responsibility",
                            "expected_value": "caregiver"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject voluntarily agrees and signs informed consent prior to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "Subject voluntarily agrees and signs informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subject is oriented to time, place, and person.",
            "criterions": [
                {
                    "exact_snippets": "Subject is oriented to time",
                    "criterion": "orientation to time",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject is oriented to ... place",
                    "criterion": "orientation to place",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject is oriented to ... person",
                    "criterion": "orientation to person",
                    "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": "1. Subject has major organ failure such as kidney, heart, or liver failure.",
            "criterions": [
                {
                    "exact_snippets": "major organ failure such as kidney",
                    "criterion": "kidney failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "major organ failure such as ... heart",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "major organ failure such as ... liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject has allergies to latex preventing use of the mouthpiece during indirect calorimetry testing.",
            "criterions": [
                {
                    "exact_snippets": "allergies to latex",
                    "criterion": "latex allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preventing use of the mouthpiece during indirect calorimetry testing",
                    "criterion": "ability to use mouthpiece during indirect calorimetry testing",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject has been scheduled to withhold oral intake or parenteral nutrition support for more than 4 days during the week of dietary record (week 2, 4, and 6)",
            "criterions": [
                {
                    "exact_snippets": "Subject has been scheduled to withhold oral intake",
                    "criterion": "oral intake",
                    "requirements": [
                        {
                            "requirement_type": "scheduled withholding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "parenteral nutrition support",
                    "criterion": "parenteral nutrition support",
                    "requirements": [
                        {
                            "requirement_type": "scheduled withholding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 4 days",
                    "criterion": "duration of withholding",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject has a diagnosis of gastro-intestinal graft versus host disease (GI-GVHD).",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of gastro-intestinal graft versus host disease (GI-GVHD)",
                    "criterion": "gastro-intestinal graft versus host disease (GI-GVHD)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subject has pre-transplant pulmonary function tests (PFTs) with force vital capacity (FVC) or forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 65% of predicted value.",
            "criterions": [
                {
                    "exact_snippets": "pre-transplant pulmonary function tests (PFTs) with force vital capacity (FVC) ... < 65% of predicted value",
                    "criterion": "force vital capacity (FVC)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 65,
                                "unit": "% of predicted value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-transplant pulmonary function tests (PFTs) with ... forced expiratory volume in one second (FEV1) ... < 65% of predicted value",
                    "criterion": "forced expiratory volume in one second (FEV1)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 65,
                                "unit": "% of predicted value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-transplant pulmonary function tests (PFTs) with ... diffusing capacity of the lung for carbon monoxide (DLCO) < 65% of predicted value",
                    "criterion": "diffusing capacity of the lung for carbon monoxide (DLCO)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 65,
                                "unit": "% of predicted value"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject who is physically unable to complete the indirect calorimetry or who refuses calorimetry or who cannot understand the instructions.",
            "criterions": [
                {
                    "exact_snippets": "physically unable to complete the indirect calorimetry",
                    "criterion": "ability to complete indirect calorimetry",
                    "requirements": [
                        {
                            "requirement_type": "physical ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refuses calorimetry",
                    "criterion": "willingness to undergo calorimetry",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot understand the instructions",
                    "criterion": "ability to understand instructions",
                    "requirements": [
                        {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}