{
    "info": {
        "nct_id": "NCT01261962",
        "official_title": "Modulation of Immune Response by Oral Zinc Supplementation in Adjuvant Chemotherapy for Colon Cancer: a Study of Global Gene Expression and Function of Humoral Immunity and Neutrophils",
        "inclusion_criteria": "* Age greater than 18 years\n* Diagnostic histopathology of colon cancer stage III (Dukes' stage C)\n* Performance Scale Karnofsky greater or equal to 70%\n* Have been subjected to resection of the primary neoplastic lesion in more than 8 weeks before start of chemotherapy\n* Patient in the first cycle of chemotherapy in adjuvant XELOX regimen.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease, renal failure or diabetes mellitus\n* Patients with metastatic disease\n* Have previously received radiotherapy or chemotherapy\n* Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte)\n* Use of immunosuppressive drugs, diuretics and supplements of zinc or copper.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age greater than 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age greater than 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnostic histopathology of colon cancer stage III (Dukes' stage C)",
            "criterions": [
                {
                    "exact_snippets": "Diagnostic histopathology of colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III (Dukes' stage C)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Scale Karnofsky greater or equal to 70%",
            "criterions": [
                {
                    "exact_snippets": "Performance Scale Karnofsky greater or equal to 70%",
                    "criterion": "Karnofsky Performance Scale",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been subjected to resection of the primary neoplastic lesion in more than 8 weeks before start of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "resection of the primary neoplastic lesion",
                    "criterion": "resection of primary neoplastic lesion",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient in the first cycle of chemotherapy in adjuvant XELOX regimen.",
            "criterions": [
                {
                    "exact_snippets": "first cycle of chemotherapy",
                    "criterion": "chemotherapy cycle",
                    "requirements": [
                        {
                            "requirement_type": "cycle number",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant XELOX regimen",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "regimen type",
                            "expected_value": "adjuvant XELOX"
                        }
                    ]
                }
            ]
        },
        {
            "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 with a history of autoimmune or inflammatory disease, active infectious disease, liver disease, renal failure or diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "history of autoimmune or inflammatory disease",
                    "criterion": "autoimmune or inflammatory disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infectious disease",
                    "criterion": "infectious disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have previously received radiotherapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "previously received radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously received ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte)",
            "criterions": [
                {
                    "exact_snippets": "Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte)",
                    "criterion": "GCSF-Granulokine ® (growth-stimulating factor granulocyte)",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Use of immunosuppressive drugs, diuretics and supplements of zinc or copper.",
            "criterions": [
                {
                    "exact_snippets": "Use of immunosuppressive drugs",
                    "criterion": "immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use ... diuretics",
                    "criterion": "diuretics",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use ... supplements of zinc",
                    "criterion": "zinc supplements",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use ... supplements of ... copper",
                    "criterion": "copper supplements",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}