{
    "info": {
        "nct_id": "NCT05821582",
        "official_title": "Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens",
        "inclusion_criteria": "Must have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Cohort 1: Colorectal Cancer\n\nInclusion:\n\n1. The participant is willing and able to provide written informed consent\n2. The participant is willing and able to provide appropriate photo identification\n3. Participants aged 18 to 85, Inclusive\n4. Participants have been diagnosed with Active Colorectal Cancer (CRC)\n5. Subjects currently taking irinotecan\n\nExclusion:\n\n1. Participants who are pregnant or are nursing\n2. Participants with a known history of HIV, hepatitis, or other infectious diseases\n3. Participants who have taken an investigational product in the last 30 days\n4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months\n5. Subjects who are currently in remission for CRC.\n\n   * Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*"
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Cohort 1: Colorectal Cancer",
            "criterions": [
                {
                    "exact_snippets": "Colorectal Cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "colorectal cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. The participant is willing and able to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "The participant is willing and able to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The participant is willing and able to provide appropriate photo identification",
            "criterions": [
                {
                    "exact_snippets": "participant is willing and able to provide appropriate photo identification",
                    "criterion": "willingness and ability to provide photo identification",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participants aged 18 to 85, Inclusive",
            "criterions": [
                {
                    "exact_snippets": "aged 18 to 85, Inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participants have been diagnosed with Active Colorectal Cancer (CRC)",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with Active Colorectal Cancer (CRC)",
                    "criterion": "Active Colorectal Cancer (CRC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects currently taking irinotecan",
            "criterions": [
                {
                    "exact_snippets": "currently taking irinotecan",
                    "criterion": "irinotecan usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Participants who are pregnant or are nursing",
            "criterions": [
                {
                    "exact_snippets": "Participants who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "are nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participants with a known history of HIV, hepatitis, or other infectious diseases",
            "criterions": [
                {
                    "exact_snippets": "known history of HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... other infectious diseases",
                    "criterion": "other infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participants who have taken an investigational product in the last 30 days",
            "criterions": [
                {
                    "exact_snippets": "Participants who have taken an investigational product in the last 30 days",
                    "criterion": "investigational product usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last usage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months",
            "criterions": [
                {
                    "exact_snippets": "Participants who have experienced excess blood loss, including blood donation",
                    "criterion": "excess blood loss",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "defined as 250 mL in the last month",
                    "criterion": "blood loss amount",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 250,
                                "unit": "mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "500 mL in the previous two months",
                    "criterion": "blood loss amount",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 500,
                                "unit": "mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects who are currently in remission for CRC.",
            "criterions": [
                {
                    "exact_snippets": "currently in remission for CRC",
                    "criterion": "remission status for CRC",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "in remission"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*",
            "criterions": [
                {
                    "exact_snippets": "Exclude subjects currently taking antibiotics",
                    "criterion": "antibiotic use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion:",
            "criterions": []
        },
        {
            "line": "Exclusion:",
            "criterions": []
        }
    ]
}