{
    "info": {
        "nct_id": "NCT06049901",
        "official_title": "Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Patients With Metastatic Colorectal Cancer",
        "inclusion_criteria": "1. Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC\n2. Male or female patients with age range from 18-65 years old\n3. Women of childbearing age will be required to be on acceptable forms of contraception\n4. No contraindication to chemotherapy (absence of myelosuppression)\n5. Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score\n6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)\n7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) < grade 2) according to NCI-CTCAE, v 5.0\n8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) < grade 2 according to NCI-CTCAE, v 5.0\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "1. Pregnant or lactating women\n2. Patients who have known allergy to nitazoxanide or its metabolites\n3. Patients with concurrent active cancer originating from a primary site other than the colon or rectum\n4. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of stage IV (metastatic) CRC",
                    "criterion": "stage IV CRC",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition",
                    "criterion": "staging",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "AJCC 8th edition"
                        }
                    ]
                },
                {
                    "exact_snippets": "documented by all investigating parameters of metastatic CRC",
                    "criterion": "metastatic CRC parameters",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "all investigating parameters"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female patients with age range from 18-65 years old",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age range from 18-65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Women of childbearing age will be required to be on acceptable forms of contraception",
            "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": "required to be on acceptable forms of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No contraindication to chemotherapy (absence of myelosuppression)",
            "criterions": [
                {
                    "exact_snippets": "No contraindication to chemotherapy",
                    "criterion": "contraindication to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of myelosuppression",
                    "criterion": "myelosuppression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score",
            "criterions": [
                {
                    "exact_snippets": "Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "ECOG"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function (alanine aminotransferase (ALT) ... < grade 2)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate liver function ... aspartate aminotransferase (AST) < grade 2)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) < grade 2) according to NCI-CTCAE, v 5.0",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated creatinine clearance (eCrCl)",
                    "criterion": "estimated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine (SCr) < grade 2",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) < grade 2 according to NCI-CTCAE, v 5.0",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin ... < grade 2 according to NCI-CTCAE, v 5.0",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade according to NCI-CTCAE, v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "erythrocytes ... < grade 2 according to NCI-CTCAE, v 5.0",
                    "criterion": "erythrocytes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade according to NCI-CTCAE, v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ... < grade 2 according to NCI-CTCAE, v 5.0",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade according to NCI-CTCAE, v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "leukocytes ... < grade 2 according to NCI-CTCAE, v 5.0",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade according to NCI-CTCAE, v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count (ANC) < grade 2 according to NCI-CTCAE, v 5.0",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade according to NCI-CTCAE, v 5.0"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who have known allergy to nitazoxanide or its metabolites",
            "criterions": [
                {
                    "exact_snippets": "known allergy to nitazoxanide or its metabolites",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": [
                                "nitazoxanide",
                                "its metabolites"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with concurrent active cancer originating from a primary site other than the colon or rectum",
            "criterions": [
                {
                    "exact_snippets": "concurrent active cancer originating from a primary site other than the colon or rectum",
                    "criterion": "concurrent active cancer",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": {
                                "operator": "!=",
                                "value": 0,
                                "unit": "colon or rectum"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving highly plasma protein-bound drugs",
                    "criterion": "receiving highly plasma protein-bound drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving ... drugs with extensive hepatic metabolism",
                    "criterion": "receiving drugs with extensive hepatic metabolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving ... coumarin anti-coagulants",
                    "criterion": "receiving coumarin anti-coagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving ... oral hypoglycemic drugs",
                    "criterion": "receiving oral hypoglycemic drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving ... anti-epileptic drugs",
                    "criterion": "receiving anti-epileptic drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}