{
    "info": {
        "nct_id": "NCT04027348",
        "official_title": "Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center",
        "inclusion_criteria": "* Age ≥ 18 years of age.\n* Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.\n* Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.\n* Patient must have an inoperable MBO\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Evidence of complete bowel obstruction by imaging.\n* Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.\n* Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.\n* Patients undergoing bowel surgery or stent placement for bowel obstruction.\n* Those patients with MBO in setting of incarcerated hernia.\n* Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470 msec in females on baseline EKG within 2 weeks of enrollment.\n* Lack of decision making capacity/delirium.\n* Pregnant or nursing female participants.\n* Actively suicidal patients.\n* Acute cholecystitis",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.",
            "criterions": [
                {
                    "exact_snippets": "Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction",
                    "criterion": "cross-sectional imaging",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 24 hours of clinical symptoms of bowel obstruction"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain)",
                    "criterion": "clinical symptoms of bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "nausea",
                                "vomiting",
                                "constipation",
                                "abdominal pain"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have an inoperable MBO",
            "criterions": [
                {
                    "exact_snippets": "inoperable MBO",
                    "criterion": "MBO (Malignant Bowel Obstruction)",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Evidence of complete bowel obstruction by imaging.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of complete bowel obstruction by imaging.",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "evidence",
                            "expected_value": "imaging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Bacteremia/septicemia with a documented positive blood culture",
                    "criterion": "bacteremia/septicemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If a blood culture comes back positive after study enrollment, patient will be excluded.",
                    "criterion": "positive blood culture after study enrollment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients already taking a steroid equivalent to 8 mg of dexamethasone per day",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 8,
                                "unit": "mg of dexamethasone per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients undergoing bowel surgery or stent placement for bowel obstruction.",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing bowel surgery",
                    "criterion": "bowel surgery",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stent placement for bowel obstruction",
                    "criterion": "stent placement for bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those patients with MBO in setting of incarcerated hernia.",
            "criterions": [
                {
                    "exact_snippets": "MBO in setting of incarcerated hernia",
                    "criterion": "MBO (Malignant Bowel Obstruction)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "incarcerated hernia",
                    "criterion": "incarcerated hernia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470 msec in females on baseline EKG within 2 weeks of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Known history of QT prolongation syndrome",
                    "criterion": "QT prolongation syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc is > 450 msec in males",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc is ... > 470 msec in females",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline EKG within 2 weeks of enrollment",
                    "criterion": "baseline EKG timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of decision making capacity/delirium.",
            "criterions": [
                {
                    "exact_snippets": "Lack of decision making capacity",
                    "criterion": "decision making capacity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "delirium",
                    "criterion": "delirium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing female participants.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing female participants",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Actively suicidal patients.",
            "criterions": [
                {
                    "exact_snippets": "Actively suicidal patients",
                    "criterion": "suicidal ideation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute cholecystitis",
            "criterions": [
                {
                    "exact_snippets": "Acute cholecystitis",
                    "criterion": "acute cholecystitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of partial bowel obstruction",
                    "criterion": "partial bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "secondary to active or prior malignancy",
                    "criterion": "malignancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "prior"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "(primary or metastatic GI, GYN, and carcinomatosis)",
                    "criterion": "malignancy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary GI",
                                "metastatic GI",
                                "primary GYN",
                                "metastatic GYN",
                                "carcinomatosis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "caused either by tumor itself or adhesions",
                    "criterion": "cause of bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "tumor",
                                "adhesions"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in the setting of active malignancy",
                    "criterion": "malignancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.",
            "criterions": [
                {
                    "exact_snippets": "Participant must understand the investigational nature of this study",
                    "criterion": "understanding of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}