{
    "info": {
        "nct_id": "NCT06818994",
        "official_title": "Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed with Advanced Stage Cancer: a Pilot Study",
        "inclusion_criteria": "* Patients diagnosed with advanced stage cancer (stages 3 and 4)\n* Aged between 18 and 70 years.\n* Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30\n* English proficiency\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Condition impairing oral intake or digestive absorption.\n* Primary brain tumor.\n* Presence of delirium.\n* Significant suicide risk as defined by suicidal ideation with intent and a plan.\n* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.\n* Patients with first-degree relatives with schizophrenia or bipolar disorder\n* Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.\n* Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin.\n* Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:\n\n  * MAO inhibitors\n  * Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)\n  * Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)\n  * Aldehyde dehydrogenase inhibitors (e.g. disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10\n* Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.\n* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.\n* Women who are pregnant, nursing, or planning a pregnancy.\n* Use of a classic psychedelic or MDMA in the last 12 months",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients diagnosed with advanced stage cancer (stages 3 and 4)",
                "criterions": [
                    {
                        "exact_snippets": "advanced stage cancer (stages 3 and 4)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "advanced stage cancer (stages 3 and 4)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aged between 18 and 70 years.",
                "criterions": [
                    {
                        "exact_snippets": "Aged between 18 and 70 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aged between 18 and 70 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30",
                "criterions": [
                    {
                        "exact_snippets": "Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30",
                        "criterion": "demoralization",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30",
                        "criterion": "demoralization",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "Demoralization Scale"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30",
                        "criterion": "demoralization",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30",
                        "criterion": "demoralization",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "Demoralization Scale"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* English proficiency",
                "criterions": [
                    {
                        "exact_snippets": "English proficiency",
                        "criterion": "English proficiency",
                        "requirement": {
                            "requirement_type": "proficiency",
                            "expected_value": "English"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "English proficiency",
                        "criterion": "English proficiency",
                        "requirement": {
                            "requirement_type": "proficiency",
                            "expected_value": "English"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to understand and the willingness to sign a written informed consent document.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.",
                "criterions": [
                    {
                        "exact_snippets": "Individuals of child-bearing potential",
                        "criterion": "child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sexually active",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence)",
                        "criterion": "contraceptive method",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence)",
                        "criterion": "contraceptive method",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal",
                                "barrier",
                                "abstinence"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Men treated or enrolled in this protocol must also agree to use adequate contraception",
                        "criterion": "contraception for men",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "4 months after completion of psilocybin administration",
                        "criterion": "contraception duration for men",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Individuals of child-bearing potential",
                                                        "criterion": "child-bearing potential",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "sexually active",
                                                        "criterion": "sexual activity",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": true
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence)",
                                                        "criterion": "contraceptive method",
                                                        "requirement": {
                                                            "requirement_type": "agreement",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence)",
                                                        "criterion": "contraceptive method",
                                                        "requirement": {
                                                            "requirement_type": "type",
                                                            "expected_value": [
                                                                "hormonal",
                                                                "barrier",
                                                                "abstinence"
                                                            ]
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Men treated or enrolled in this protocol must also agree to use adequate contraception",
                                        "criterion": "contraception for men",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "4 months after completion of psilocybin administration",
                                        "criterion": "contraception duration for men",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 4,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Condition impairing oral intake or digestive absorption.",
                "criterions": [
                    {
                        "exact_snippets": "Condition impairing oral intake",
                        "criterion": "oral intake",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Condition impairing ... digestive absorption",
                        "criterion": "digestive absorption",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Condition impairing oral intake",
                        "criterion": "oral intake",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Condition impairing ... digestive absorption",
                        "criterion": "digestive absorption",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Primary brain tumor.",
                "criterions": [
                    {
                        "exact_snippets": "Primary brain tumor.",
                        "criterion": "primary brain tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Primary brain tumor.",
                    "criterion": "primary brain tumor",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Presence of delirium.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of delirium",
                        "criterion": "delirium",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Presence of delirium",
                    "criterion": "delirium",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Significant suicide risk as defined by suicidal ideation with intent and a plan.",
                "criterions": [
                    {
                        "exact_snippets": "Significant suicide risk as defined by suicidal ideation with intent and a plan.",
                        "criterion": "suicide risk",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "Significant suicide risk as defined by suicidal ideation with intent and a plan.",
                        "criterion": "suicide risk",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "suicidal ideation with intent and a plan"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Significant suicide risk as defined by suicidal ideation with intent and a plan.",
                        "criterion": "suicide risk",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "Significant suicide risk as defined by suicidal ideation with intent and a plan.",
                        "criterion": "suicide risk",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "suicidal ideation with intent and a plan"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.",
                "criterions": [
                    {
                        "exact_snippets": "Current or past history of schizophrenia",
                        "criterion": "schizophrenia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... psychotic disorder",
                        "criterion": "psychotic disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... bipolar disorder",
                        "criterion": "bipolar disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... delusional disorder",
                        "criterion": "delusional disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... paranoid personality disorder",
                        "criterion": "paranoid personality disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... schizoaffective disorder",
                        "criterion": "schizoaffective disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... borderline personality disorder",
                        "criterion": "borderline personality disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Current or past history of schizophrenia",
                        "criterion": "schizophrenia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... psychotic disorder",
                        "criterion": "psychotic disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... bipolar disorder",
                        "criterion": "bipolar disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... delusional disorder",
                        "criterion": "delusional disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... paranoid personality disorder",
                        "criterion": "paranoid personality disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... schizoaffective disorder",
                        "criterion": "schizoaffective disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Current or past history of ... borderline personality disorder",
                        "criterion": "borderline personality disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with first-degree relatives with schizophrenia or bipolar disorder",
                "criterions": [
                    {
                        "exact_snippets": "first-degree relatives with schizophrenia",
                        "criterion": "first-degree relatives with schizophrenia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "first-degree relatives with ... bipolar disorder",
                        "criterion": "first-degree relatives with bipolar disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "first-degree relatives with schizophrenia",
                        "criterion": "first-degree relatives with schizophrenia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "first-degree relatives with ... bipolar disorder",
                        "criterion": "first-degree relatives with bipolar disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.",
                "criterions": [
                    {
                        "exact_snippets": "Previous diagnosis of epilepsy",
                        "criterion": "epilepsy",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... stroke",
                        "criterion": "stroke",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... Transient Ischemic Attack (TIA)",
                        "criterion": "Transient Ischemic Attack (TIA)",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... Parkinson's disease",
                        "criterion": "Parkinson's disease",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Previous diagnosis of epilepsy",
                        "criterion": "epilepsy",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... stroke",
                        "criterion": "stroke",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... Transient Ischemic Attack (TIA)",
                        "criterion": "Transient Ischemic Attack (TIA)",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous diagnosis of ... Parkinson's disease",
                        "criterion": "Parkinson's disease",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.",
                        "criterion": "allergic reactions to compounds similar to psilocybin",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.",
                        "criterion": "allergic reactions to compounds similar to psilocybin",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin.",
                "criterions": [
                    {
                        "exact_snippets": "Other personal circumstances and behavior that would limit compliance with study requirements",
                        "criterion": "personal circumstances and behavior",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": false
                        }
                    },
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                        "exact_snippets": "judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport",
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                        "requirement": {
                            "requirement_type": "judgment",
                            "expected_value": "incompatible"
                        }
                    },
                    {
                        "exact_snippets": "judged by the study psychiatrist and/or principal investigator to be incompatible with ... safe exposure to psilocybin",
                        "criterion": "compatibility with safe exposure to psilocybin",
                        "requirement": {
                            "requirement_type": "judgment",
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                        }
                    }
                ]
            },
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Other personal circumstances and behavior that would limit compliance with study requirements",
                                "criterion": "personal circumstances and behavior",
                                "requirement": {
                                    "requirement_type": "compliance",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport",
                                        "criterion": "compatibility with establishing rapport",
                                        "requirement": {
                                            "requirement_type": "judgment",
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                                        }
                                    },
                                    {
                                        "exact_snippets": "judged by the study psychiatrist and/or principal investigator to be incompatible with ... safe exposure to psilocybin",
                                        "criterion": "compatibility with safe exposure to psilocybin",
                                        "requirement": {
                                            "requirement_type": "judgment",
                                            "expected_value": "incompatible"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:",
                "criterions": [
                    {
                        "exact_snippets": "Potential for adverse drug-drug interactions",
                        "criterion": "adverse drug-drug interactions",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concomitant medications with significant potential to interact with study medications",
                        "criterion": "concomitant medications",
                        "requirement": {
                            "requirement_type": "interaction potential",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "exact_snippets": "Potential for adverse drug-drug interactions",
                            "criterion": "adverse drug-drug interactions",
                            "requirement": {
                                "requirement_type": "potential",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "Concomitant medications with significant potential to interact with study medications",
                            "criterion": "concomitant medications",
                            "requirement": {
                                "requirement_type": "interaction potential",
                                "expected_value": "significant"
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "Concomitant medications with significant potential to interact with study medications",
                    "criterion": "concomitant medications",
                    "requirement": {
                        "requirement_type": "taperable",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* MAO inhibitors",
                "criterions": [
                    {
                        "exact_snippets": "MAO inhibitors",
                        "criterion": "MAO inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "MAO inhibitors",
                    "criterion": "MAO inhibitors",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)",
                "criterions": [
                    {
                        "exact_snippets": "Patients currently on antipsychotics (e.g. first and second generation)",
                        "criterion": "antipsychotic medication use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "when taken regularly (6 weeks or less prior to screening visit)",
                        "criterion": "duration of antipsychotic medication use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients currently on antipsychotics (e.g. first and second generation)",
                        "criterion": "antipsychotic medication use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "when taken regularly (6 weeks or less prior to screening visit)",
                        "criterion": "duration of antipsychotic medication use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)",
                "criterions": [
                    {
                        "exact_snippets": "Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)",
                        "criterion": "mood stabilizers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)",
                        "criterion": "mood stabilizers",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "lithium",
                                "valproic acid",
                                "lamotrigine"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)",
                        "criterion": "mood stabilizers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)",
                        "criterion": "mood stabilizers",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "lithium",
                                "valproic acid",
                                "lamotrigine"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aldehyde dehydrogenase inhibitors (e.g. disulfiram)",
                "criterions": [
                    {
                        "exact_snippets": "Aldehyde dehydrogenase inhibitors (e.g. disulfiram)",
                        "criterion": "aldehyde dehydrogenase inhibitors",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "disulfiram"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Aldehyde dehydrogenase inhibitors (e.g. disulfiram)",
                    "criterion": "aldehyde dehydrogenase inhibitors",
                    "requirement": {
                        "requirement_type": "examples",
                        "expected_value": [
                            "disulfiram"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Significant inhibitors of UGT 1A0 or UGT 1A10",
                "criterions": [
                    {
                        "exact_snippets": "Significant inhibitors of UGT 1A0",
                        "criterion": "UGT 1A0 inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Significant inhibitors of ... UGT 1A10",
                        "criterion": "UGT 1A10 inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Significant inhibitors of UGT 1A0",
                        "criterion": "UGT 1A0 inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Significant inhibitors of ... UGT 1A10",
                        "criterion": "UGT 1A10 inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.",
                "criterions": [
                    {
                        "exact_snippets": "elevated AST and ALT five times above the normal laboratory limit",
                        "criterion": "AST and ALT levels",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times above normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "symptoms suggestive of liver failure including confusion, asterixis or jaundice",
                        "criterion": "symptoms of liver failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "confusion",
                                "asterixis",
                                "jaundice"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "elevated AST and ALT five times above the normal laboratory limit",
                                "criterion": "AST and ALT levels",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "times above normal limit"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "symptoms suggestive of liver failure including confusion, asterixis or jaundice",
                                "criterion": "symptoms of liver failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "confusion",
                                        "asterixis",
                                        "jaundice"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women who are pregnant, nursing, or planning a pregnancy.",
                "criterions": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    },
                    {
                        "exact_snippets": "planning a pregnancy",
                        "criterion": "pregnancy intention",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": "planning a pregnancy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    },
                    {
                        "exact_snippets": "planning a pregnancy",
                        "criterion": "pregnancy intention",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": "planning a pregnancy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of a classic psychedelic or MDMA in the last 12 months",
                "criterions": [
                    {
                        "exact_snippets": "Use of a classic psychedelic",
                        "criterion": "classic psychedelic use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "in the last 12 months"
                        }
                    },
                    {
                        "exact_snippets": "Use of ... MDMA",
                        "criterion": "MDMA use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "in the last 12 months"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Use of a classic psychedelic",
                        "criterion": "classic psychedelic use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "in the last 12 months"
                        }
                    },
                    {
                        "exact_snippets": "Use of ... MDMA",
                        "criterion": "MDMA use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "in the last 12 months"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant cardiovascular ... condition",
                        "criterion": "clinically significant cardiovascular condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant pulmonary ... condition",
                        "criterion": "clinically significant pulmonary condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant gastrointestinal ... condition",
                        "criterion": "clinically significant gastrointestinal condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant hepatic ... condition",
                        "criterion": "clinically significant hepatic condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant renal condition",
                        "criterion": "clinically significant renal condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any other unstable condition",
                        "criterion": "unstable condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinical symptoms or recent history of significant tachyarrhythmias",
                        "criterion": "significant tachyarrhythmias",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe angina or myocardial ischemia",
                        "criterion": "severe angina or myocardial ischemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "poorly controlled congestive heart failure",
                        "criterion": "poorly controlled congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "poorly controlled hypertension",
                        "criterion": "poorly controlled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "poorly controlled hypo- or hyperthyroidism",
                        "criterion": "poorly controlled hypo- or hyperthyroidism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled diabetes",
                        "criterion": "uncontrolled diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe renal or liver dysfunction",
                        "criterion": "severe renal or liver dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "acute respiratory failure",
                        "criterion": "acute respiratory failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sepsis",
                        "criterion": "sepsis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of cerebral aneurysms",
                        "criterion": "history of cerebral aneurysms",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "glaucoma",
                        "criterion": "glaucoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "increased intracranial pressure",
                        "criterion": "increased intracranial pressure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any intracranial mass",
                        "criterion": "intracranial mass",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}