{
    "info": {
        "nct_id": "NCT03525873",
        "official_title": "A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy",
        "inclusion_criteria": "* Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment\n* Part 1: be willing to engage in follow-up telephone calls with a research staff\n* Part 1: have telephone access so they can be contacted by the research staff\n* Part 1: hemoglobin level of >= 8 g/dL within 2 weeks of enrollment\n\n  * Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin < 8 g/dl\n* Part 1: be able to understand the description of the study and give written informed consent\n* Part 1: able to read, write and speak English\n* Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment\n* Part 2: be willing to engage in follow-up telephone calls with a research staff\n* Part 2: have telephone access so they can be contacted by the research staff\n* Part 2: have a hemoglobin level of >=8 g/dL within 2 weeks of enrollment\n\n  * PRBC transfusions will be allowed to patients with hemoglobin < 8 g/dl\n* Part 2: be able to understand the description of the study and give written or verbal informed consent\n* Part 2: able to read, write and speak English\n* Part 2: presence of fatigue as defined FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)\n* Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days\n* Part 2: able to complete the baseline assessment forms\n* Part 2: able to understand the recommendations for participation in the study\n* Part 2: can be enrolled directly to part 2 independent of part 1 if on immunotherapy and having a FACIT-F fatigue =< 34, and able to complete baseline assessment and bloodwork as detailed in Part 1 at baseline and day 14 +/-3 days. Treating Oncologist should agree for participation in the intervention trial\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Part 1: patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference\n* Part 2: Patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference\n* Part 2: have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician\n* Part 2: on monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine\n* Part 2: history of glaucoma\n* Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)\n* Part 2: tachycardia and/or uncontrolled hypertension\n* Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)\n* Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) >= 2",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "diagnosis of metastatic or recurrent cancer",
                        "criterion": "cancer diagnosis",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "previously received anti PD1 immunotherapy",
                        "criterion": "anti PD1 immunotherapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "received therapy up to 1 month prior to enrollment",
                        "criterion": "therapy timing",
                        "requirement": {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "diagnosis of metastatic or recurrent cancer",
                                "criterion": "cancer diagnosis",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "metastatic",
                                        "recurrent"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "previously received anti PD1 immunotherapy",
                                "criterion": "anti PD1 immunotherapy",
                                "requirement": {
                                    "requirement_type": "previous treatment",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
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                        "criterion": "therapy timing",
                        "requirement": {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 1: be willing to engage in follow-up telephone calls with a research staff",
                "criterions": [
                    {
                        "exact_snippets": "be willing to engage in follow-up telephone calls with a research staff",
                        "criterion": "willingness to engage in follow-up telephone calls",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
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                ]
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                        "exact_snippets": "be willing to engage in follow-up telephone calls with a research staff",
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                            "expected_value": true
                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "* Part 1: have telephone access so they can be contacted by the research staff",
                "criterions": [
                    {
                        "exact_snippets": "have telephone access",
                        "criterion": "telephone access",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "have telephone access",
                        "criterion": "telephone access",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 1: hemoglobin level of >= 8 g/dL within 2 weeks of enrollment",
                "criterions": [
                    {
                        "exact_snippets": "hemoglobin level of >= 8 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 2 weeks of enrollment",
                        "criterion": "timeframe for hemoglobin level measurement",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks of enrollment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "hemoglobin level of >= 8 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 2 weeks of enrollment",
                        "criterion": "timeframe for hemoglobin level measurement",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks of enrollment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin < 8 g/dl",
                "criterions": [
                    {
                        "exact_snippets": "hemoglobin < 8 g/dl",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 8,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "hemoglobin < 8 g/dl",
                    "criterion": "hemoglobin level",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": "<",
                            "value": 8,
                            "unit": "g/dl"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Packed red blood cell (PRBC) transfusions will be allowed",
                    "criterion": "PRBC transfusions",
                    "requirement": {
                        "requirement_type": "allowance",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Part 1: be able to understand the description of the study and give written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "be able to understand the description of the study",
                        "criterion": "understanding of study description",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "give written informed consent",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "be able to understand the description of the study",
                        "criterion": "understanding of study description",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "give written informed consent",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 1: able to read, write and speak English",
                "criterions": [
                    {
                        "exact_snippets": "able to read, write and speak English",
                        "criterion": "English language proficiency",
                        "requirement": {
                            "requirement_type": "skills",
                            "expected_value": [
                                "read",
                                "write",
                                "speak"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "able to read, write and speak English",
                        "criterion": "English language proficiency",
                        "requirement": {
                            "requirement_type": "skills",
                            "expected_value": [
                                "read",
                                "write",
                                "speak"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "diagnosis of metastatic or recurrent cancer",
                        "criterion": "cancer diagnosis",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "previously received anti PD1 immunotherapy",
                        "criterion": "anti PD1 immunotherapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "received therapy up to 1 month prior to enrollment",
                        "criterion": "therapy timing",
                        "requirement": {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "diagnosis of metastatic or recurrent cancer",
                                "criterion": "cancer diagnosis",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
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                                        "recurrent"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "previously received anti PD1 immunotherapy",
                                "criterion": "anti PD1 immunotherapy",
                                "requirement": {
                                    "requirement_type": "previous treatment",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "previously received anti PD1 immunotherapy",
                            "criterion": "anti PD1 immunotherapy",
                            "requirement": {
                                "requirement_type": "previous treatment",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "received therapy up to 1 month prior to enrollment",
                            "criterion": "therapy timing",
                            "requirement": {
                                "requirement_type": "time since last therapy",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 1,
                                    "unit": "month"
                                }
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: be willing to engage in follow-up telephone calls with a research staff",
                "criterions": [
                    {
                        "exact_snippets": "be willing to engage in follow-up telephone calls with a research staff",
                        "criterion": "willingness to engage in follow-up telephone calls",
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                            "requirement_type": "willingness",
                            "expected_value": true
                        }
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                ]
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            "logical_structure": {
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                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: have telephone access so they can be contacted by the research staff",
                "criterions": [
                    {
                        "exact_snippets": "have telephone access",
                        "criterion": "telephone access",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "have telephone access",
                        "criterion": "telephone access",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: have a hemoglobin level of >=8 g/dL within 2 weeks of enrollment",
                "criterions": [
                    {
                        "exact_snippets": "hemoglobin level of >=8 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "hemoglobin level of >=8 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PRBC transfusions will be allowed to patients with hemoglobin < 8 g/dl",
                "criterions": [
                    {
                        "exact_snippets": "hemoglobin < 8 g/dl",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 8,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "hemoglobin < 8 g/dl",
                    "criterion": "hemoglobin level",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": "<",
                            "value": 8,
                            "unit": "g/dl"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "PRBC transfusions will be allowed",
                    "criterion": "PRBC transfusions",
                    "requirement": {
                        "requirement_type": "allowance",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: be able to understand the description of the study and give written or verbal informed consent",
                "criterions": [
                    {
                        "exact_snippets": "be able to understand the description of the study",
                        "criterion": "understanding of study description",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "give written or verbal informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "be able to understand the description of the study",
                        "criterion": "understanding of study description",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "give written or verbal informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: able to read, write and speak English",
                "criterions": [
                    {
                        "exact_snippets": "able to read, write and speak English",
                        "criterion": "English language proficiency",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": [
                                "read",
                                "write",
                                "speak"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "able to read, write and speak English",
                        "criterion": "English language proficiency",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": [
                                "read",
                                "write",
                                "speak"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: presence of fatigue as defined FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)",
                "criterions": [
                    {
                        "exact_snippets": "presence of fatigue",
                        "criterion": "fatigue",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "FACIT-F subscale of =< 34 on a 0 to 52 scale",
                        "criterion": "FACIT-F subscale score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 34,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "presence of fatigue",
                        "criterion": "fatigue",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "FACIT-F subscale of =< 34 on a 0 to 52 scale",
                        "criterion": "FACIT-F subscale score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 34,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days",
                "criterions": [
                    {
                        "exact_snippets": "not currently taking methylphenidate",
                        "criterion": "methylphenidate usage",
                        "requirement": {
                            "requirement_type": "current usage",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "have taken it within the previous 10 days",
                        "criterion": "methylphenidate usage",
                        "requirement": {
                            "requirement_type": "recent usage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "not currently taking methylphenidate",
                                "criterion": "methylphenidate usage",
                                "requirement": {
                                    "requirement_type": "current usage",
                                    "expected_value": false
                                }
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                            {
                                "exact_snippets": "have taken it within the previous 10 days",
                                "criterion": "methylphenidate usage",
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                                    "requirement_type": "recent usage",
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                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "days"
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                    {
                        "exact_snippets": "not currently taking methylphenidate",
                        "criterion": "methylphenidate usage",
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                            "requirement_type": "current usage",
                            "expected_value": false
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                ]
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        },
        {
            "identified_line": {
                "line": "* Part 2: able to complete the baseline assessment forms",
                "criterions": [
                    {
                        "exact_snippets": "able to complete the baseline assessment forms",
                        "criterion": "ability to complete baseline assessment forms",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "able to complete the baseline assessment forms",
                        "criterion": "ability to complete baseline assessment forms",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: able to understand the recommendations for participation in the study",
                "criterions": [
                    {
                        "exact_snippets": "able to understand the recommendations for participation in the study",
                        "criterion": "understanding of study recommendations",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "able to understand the recommendations for participation in the study",
                        "criterion": "understanding of study recommendations",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: can be enrolled directly to part 2 independent of part 1 if on immunotherapy and having a FACIT-F fatigue =< 34, and able to complete baseline assessment and bloodwork as detailed in Part 1 at baseline and day 14 +/-3 days. Treating Oncologist should agree for participation in the intervention trial",
                "criterions": [
                    {
                        "exact_snippets": "on immunotherapy",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "FACIT-F fatigue =< 34",
                        "criterion": "FACIT-F fatigue",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 34,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "able to complete baseline assessment and bloodwork",
                        "criterion": "ability to complete baseline assessment and bloodwork",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Treating Oncologist should agree for participation",
                        "criterion": "Treating Oncologist agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "on immunotherapy",
                                                "criterion": "immunotherapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "FACIT-F fatigue =< 34",
                                                "criterion": "FACIT-F fatigue",
                                                "requirement": {
                                                    "requirement_type": "severity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 34,
                                                        "unit": "N/A"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "able to complete baseline assessment and bloodwork",
                                        "criterion": "ability to complete baseline assessment and bloodwork",
                                        "requirement": {
                                            "requirement_type": "ability",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Treating Oncologist should agree for participation",
                                "criterion": "Treating Oncologist agreement",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Part 2: have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician",
                "criterions": [
                    {
                        "exact_snippets": "major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents)",
                        "criterion": "major contraindication to MP",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "conditions making adherence difficult as determined by the attending physician",
                        "criterion": "conditions making adherence difficult",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "attending physician"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents)",
                                "criterion": "major contraindication to MP",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "conditions making adherence difficult as determined by the attending physician",
                                "criterion": "conditions making adherence difficult",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": "attending physician"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: on monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine",
                "criterions": [
                    {
                        "exact_snippets": "on monoamine oxidase inhibitors",
                        "criterion": "monoamine oxidase inhibitors",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on ... tricyclic antidepressants",
                        "criterion": "tricyclic antidepressants",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on ... clonidine",
                        "criterion": "clonidine",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "on monoamine oxidase inhibitors",
                        "criterion": "monoamine oxidase inhibitors",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on ... tricyclic antidepressants",
                        "criterion": "tricyclic antidepressants",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on ... clonidine",
                        "criterion": "clonidine",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: history of glaucoma",
                "criterions": [
                    {
                        "exact_snippets": "history of glaucoma",
                        "criterion": "glaucoma",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "history of glaucoma",
                    "criterion": "glaucoma",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)",
                "criterions": [
                    {
                        "exact_snippets": "severe cardiac disease (New York Heart Association functional class III or IV)",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe cardiac disease (New York Heart Association functional class III or IV)",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "New York Heart Association functional class III",
                                "New York Heart Association functional class IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "severe cardiac disease (New York Heart Association functional class III or IV)",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe cardiac disease (New York Heart Association functional class III or IV)",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "New York Heart Association functional class III",
                                "New York Heart Association functional class IV"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: tachycardia and/or uncontrolled hypertension",
                "criterions": [
                    {
                        "exact_snippets": "tachycardia",
                        "criterion": "tachycardia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tachycardia",
                                "criterion": "tachycardia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled hypertension",
                                "criterion": "uncontrolled hypertension",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "tachycardia",
                        "criterion": "tachycardia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)",
                "criterions": [
                    {
                        "exact_snippets": "currently receiving anticoagulants",
                        "criterion": "anticoagulant use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "currently receiving ... anticonvulsants (phenobarbital, diphenylhydantoin, primidone)",
                        "criterion": "anticonvulsant use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "currently receiving ... phenylbutazone",
                        "criterion": "phenylbutazone use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "currently receiving ... tricyclic drugs (imipramine, clomipramine, or desipramine)",
                        "criterion": "tricyclic drug use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "currently receiving anticoagulants",
                                "criterion": "anticoagulant use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "currently receiving ... anticonvulsants (phenobarbital, diphenylhydantoin, primidone)",
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                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "currently receiving ... phenylbutazone",
                                "criterion": "phenylbutazone use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "currently receiving ... tricyclic drugs (imipramine, clomipramine, or desipramine)",
                                "criterion": "tricyclic drug use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) >= 2",
                "criterions": [
                    {
                        "exact_snippets": "CAGE-AID >= 2",
                        "criterion": "CAGE-AID score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "CAGE-AID >= 2",
                        "criterion": "CAGE-AID score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Part 1: patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference",
                "criterions": [
                    {
                        "exact_snippets": "clinical evidence of cognitive failure",
                        "criterion": "cognitive failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Memorial Delirium Assessment Scale score of >= 13",
                        "criterion": "Memorial Delirium Assessment Scale score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "completed in person, by phone, or via video-conference",
                        "criterion": "assessment completion method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "in person",
                                "by phone",
                                "via video-conference"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Part 2: Patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference",
                "criterions": [
                    {
                        "exact_snippets": "clinical evidence of cognitive failure",
                        "criterion": "cognitive failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Memorial Delirium Assessment Scale score of >= 13",
                        "criterion": "Memorial Delirium Assessment Scale score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}