{
    "info": {
        "nct_id": "NCT04672876",
        "official_title": "Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors",
        "inclusion_criteria": "* Patients must have a grade 1 or grade 2 small bowel, neuroendocrine tumor (NET) that has been medically confirmed by a physician.\n* Patients who plan to have abdominal (stomach) surgery due to cancer that has spread to their liver. Patients must voluntarily choose to have surgery.\n* 18 years old or older.\n* Patients with small bowel neuroendocrine tumors who are asymptomatic (not showing symptoms) but have elevated serotonin or 5-HIAA (5-hydroxyindoleacetic acid) levels before surgery.\n* Patients who are symptomatic (showing carcinoid symptoms) and have elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients belonging to vulnerable populations such as children and prisoners.\n* Patients with grade 3 neuroendocrine tumors or neuroendocrine tumors that are hard to identify.\n* Patients with untreated carcinoid heart disease.\n* Patients who are receiving any other drugs or treatment as part of a research study.\n* Patients with a \"currently active\" second tumor other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" tumor if they have completed therapy and are free of disease for 3 or more years.\n* Patients with known brain cancers.\n* Patients who have a history of allergic reactions to medications that have similar chemical or biologic ingredients as those found in telotristat ethyl.\n* Uncontrolled illness that occurs while having cancer such as, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the patient's ability to follow study requirements.\n* Pregnant women are excluded from this study because telotristat ethyl can severely damage an embryo/fetus or cause an abortion. Because the drug also poses unknown, potential risks for nursing infants, breastfeeding should be discontinued if the mother is treated with telotristat ethyl.\n* Women of childbearing age who refuse to take a urinary pregnancy test and refuse to use an acceptable method of birth control during the time of the study and for at least 7 days after surgery. Acceptable contraception includes barrier method (male or female condom); hormonal (oral or implantable); documented sterilization procedure; cap, diaphragm, or sponge with spermicide; or abstinence as a lifestyle choice.\n* Patients on CYP3A4 substrates that cannot be stopped due to medical concerns for 15 days prior to surgery.\n* Patients with moderate or severe liver failure.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have a grade 1 or grade 2 small bowel, neuroendocrine tumor (NET) that has been medically confirmed by a physician.",
            "criterions": [
                {
                    "exact_snippets": "grade 1 or grade 2 small bowel, neuroendocrine tumor (NET)",
                    "criterion": "small bowel neuroendocrine tumor (NET)",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "grade 1",
                                "grade 2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "medically confirmed by a physician",
                    "criterion": "confirmation of diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "medically confirmed by a physician"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who plan to have abdominal (stomach) surgery due to cancer that has spread to their liver. Patients must voluntarily choose to have surgery.",
            "criterions": [
                {
                    "exact_snippets": "abdominal (stomach) surgery",
                    "criterion": "abdominal surgery",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "cancer that has spread to liver"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must voluntarily choose to have surgery",
                    "criterion": "voluntary surgery choice",
                    "requirements": [
                        {
                            "requirement_type": "choice",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years old or older.",
            "criterions": [
                {
                    "exact_snippets": "18 years old or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with small bowel neuroendocrine tumors who are asymptomatic (not showing symptoms) but have elevated serotonin or 5-HIAA (5-hydroxyindoleacetic acid) levels before surgery.",
            "criterions": [
                {
                    "exact_snippets": "small bowel neuroendocrine tumors",
                    "criterion": "small bowel neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic (not showing symptoms)",
                    "criterion": "asymptomatic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated serotonin",
                    "criterion": "serotonin levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated ... 5-HIAA (5-hydroxyindoleacetic acid) levels",
                    "criterion": "5-HIAA levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are symptomatic (showing carcinoid symptoms) and have elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are symptomatic (showing carcinoid symptoms)",
                    "criterion": "carcinoid symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery",
                    "criterion": "Serotonin levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery",
                    "criterion": "5-HIAA levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients belonging to vulnerable populations such as children and prisoners.",
            "criterions": [
                {
                    "exact_snippets": "vulnerable populations such as children",
                    "criterion": "vulnerable population",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "children"
                        }
                    ]
                },
                {
                    "exact_snippets": "vulnerable populations such as ... prisoners",
                    "criterion": "vulnerable population",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "prisoners"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with grade 3 neuroendocrine tumors or neuroendocrine tumors that are hard to identify.",
            "criterions": [
                {
                    "exact_snippets": "grade 3 neuroendocrine tumors",
                    "criterion": "neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "3"
                        }
                    ]
                },
                {
                    "exact_snippets": "neuroendocrine tumors that are hard to identify",
                    "criterion": "neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "identifiability",
                            "expected_value": "hard to identify"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with untreated carcinoid heart disease.",
            "criterions": [
                {
                    "exact_snippets": "untreated carcinoid heart disease",
                    "criterion": "carcinoid heart disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are receiving any other drugs or treatment as part of a research study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving any other drugs or treatment as part of a research study.",
                    "criterion": "participation in other research study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a \"currently active\" second tumor other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" tumor if they have completed therapy and are free of disease for 3 or more years.",
            "criterions": [
                {
                    "exact_snippets": "\"currently active\" second tumor other than non-melanoma skin cancers",
                    "criterion": "second tumor",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "currently active"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "other than non-melanoma skin cancers"
                        }
                    ]
                },
                {
                    "exact_snippets": "completed therapy and are free of disease for 3 or more years",
                    "criterion": "disease-free status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known brain cancers.",
            "criterions": [
                {
                    "exact_snippets": "known brain cancers",
                    "criterion": "brain cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a history of allergic reactions to medications that have similar chemical or biologic ingredients as those found in telotristat ethyl.",
            "criterions": [
                {
                    "exact_snippets": "history of allergic reactions to medications that have similar chemical or biologic ingredients as those found in telotristat ethyl",
                    "criterion": "allergic reactions to medications",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "similarity to telotristat ethyl",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled illness that occurs while having cancer such as, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the patient's ability to follow study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled illness ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled illness ... psychiatric illness/social situations that would limit the patient's ability to follow study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women are excluded from this study because telotristat ethyl can severely damage an embryo/fetus or cause an abortion. Because the drug also poses unknown, potential risks for nursing infants, breastfeeding should be discontinued if the mother is treated with telotristat ethyl.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding should be discontinued",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing age who refuse to take a urinary pregnancy test and refuse to use an acceptable method of birth control during the time of the study and for at least 7 days after surgery. Acceptable contraception includes barrier method (male or female condom); hormonal (oral or implantable); documented sterilization procedure; cap, diaphragm, or sponge with spermicide; or abstinence as a lifestyle choice.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse to take a urinary pregnancy test",
                    "criterion": "urinary pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse to use an acceptable method of birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acceptable method of birth control ... during the time of the study and for at least 7 days after surgery",
                    "criterion": "duration of birth control use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the time of the study and for at least 7 days after surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acceptable contraception includes barrier method (male or female condom); hormonal (oral or implantable); documented sterilization procedure; cap, diaphragm, or sponge with spermicide; or abstinence as a lifestyle choice",
                    "criterion": "acceptable contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "barrier method (male or female condom)",
                                "hormonal (oral or implantable)",
                                "documented sterilization procedure",
                                "cap, diaphragm, or sponge with spermicide",
                                "abstinence as a lifestyle choice"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on CYP3A4 substrates that cannot be stopped due to medical concerns for 15 days prior to surgery.",
            "criterions": [
                {
                    "exact_snippets": "Patients on CYP3A4 substrates",
                    "criterion": "CYP3A4 substrate usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be stopped due to medical concerns",
                    "criterion": "CYP3A4 substrate stoppage",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "15 days prior to surgery",
                    "criterion": "time before surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 15,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with moderate or severe liver failure.",
            "criterions": [
                {
                    "exact_snippets": "moderate or severe liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}