{
    "info": {
        "nct_id": "NCT02518373",
        "official_title": "An Open-label Volunteer Study of the Effect of G17DT on the Elevation of Plasma Gastrin Levels After Therapy With a Proton Pump Inhibitor (Omeperazole) in Patients With Treated Stage II/III Colorectal Cancer",
        "inclusion_criteria": "* Male or female subjects aged 18 to 70 years, inclusive\n* Written informed consent was provided\n* Histologically confirmed Stage II/III colorectal cancer after radical surgery\n* A minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy\n* Subject had recovered from any toxic effects of chemotherapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions\n* Was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active\n* Was unable to comply with the protocol\n* Was unable to abstain from H2 receptor antagonists, PPIs or anticholinergics medications for 2 weeks\n* Required H. pylori eradication therapy during the study\n* Had prior vaccination with G17DT or any other product with a similar mechanism of action\n* Had a history of gastric or vagus nerve surgery\n* Had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study\n* Had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants [except for aspirin])\n* Had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results\n* Had a known hypersensitivity to diphtheria toxoid, G17DT, any of its components or any similar compound\n* Had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, Zollinger-Ellison syndrome)\n* Had used of an investigational drug within the previous month\n* Had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (Inhaled corticosteroids were permitted.)\n* Had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome)\n* Had a history of drug or alcohol abuse within the past year\n* Was unable to accept a standard breakfast for dietary reasons",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female subjects aged 18 to 70 years, inclusive",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 to 70 years, inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent was provided",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent was provided",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed Stage II/III colorectal cancer after radical surgery",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed Stage II/III colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage II",
                                "Stage III"
                            ]
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "after radical surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radical"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "A minimum of 3 months elapsed since completion of the chemotherapy",
                    "criterion": "elapsed time since completion of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject had recovered from any toxic effects of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Subject had recovered from any toxic effects of chemotherapy",
                    "criterion": "recovery from chemotherapy toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions",
            "criterions": [
                {
                    "exact_snippets": "known local recurrence of colorectal cancer",
                    "criterion": "local recurrence of colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of metastatic colorectal cancer lesions",
                    "criterion": "metastatic colorectal cancer lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active",
            "criterions": [
                {
                    "exact_snippets": "inadequate method of contraception ... only for women of childbearing potential who were sexually active",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "inadequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "only for women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Was unable to comply with the protocol",
            "criterions": [
                {
                    "exact_snippets": "unable to comply with the protocol",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Was unable to abstain from H2 receptor antagonists, PPIs or anticholinergics medications for 2 weeks",
            "criterions": [
                {
                    "exact_snippets": "unable to abstain from H2 receptor antagonists",
                    "criterion": "H2 receptor antagonists",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to abstain from ... PPIs",
                    "criterion": "PPIs",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to abstain from ... anticholinergics medications",
                    "criterion": "anticholinergics medications",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Required H. pylori eradication therapy during the study",
            "criterions": [
                {
                    "exact_snippets": "Required H. pylori eradication therapy",
                    "criterion": "H. pylori eradication therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had prior vaccination with G17DT or any other product with a similar mechanism of action",
            "criterions": [
                {
                    "exact_snippets": "prior vaccination with G17DT",
                    "criterion": "prior vaccination",
                    "requirements": [
                        {
                            "requirement_type": "product",
                            "expected_value": "G17DT"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior vaccination with ... any other product with a similar mechanism of action",
                    "criterion": "prior vaccination",
                    "requirements": [
                        {
                            "requirement_type": "mechanism of action",
                            "expected_value": "similar"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had a history of gastric or vagus nerve surgery",
            "criterions": [
                {
                    "exact_snippets": "history of gastric or vagus nerve surgery",
                    "criterion": "gastric surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of gastric or vagus nerve surgery",
                    "criterion": "vagus nerve surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study",
            "criterions": [
                {
                    "exact_snippets": "clinically significant laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical conditions which were unexplained",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "explanation",
                            "expected_value": "unexplained"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator, did not allow for safe entry of the subject into the study",
                    "criterion": "safe entry into the study",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "did not allow"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants [except for aspirin])",
            "criterions": [
                {
                    "exact_snippets": "contraindications to intramuscular injections",
                    "criterion": "contraindications to intramuscular injections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding disorders",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with anticoagulants [except for aspirin]",
                    "criterion": "treatment with anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results",
            "criterions": [
                {
                    "exact_snippets": "serious and unstable cardiovascular or respiratory disease",
                    "criterion": "cardiovascular or respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious and unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other condition that would have jeopardized subject safety or confounded the results",
                    "criterion": "condition jeopardizing safety or confounding results",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": [
                                "jeopardized subject safety",
                                "confounded the results"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had a known hypersensitivity to diphtheria toxoid, G17DT, any of its components or any similar compound",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to diphtheria toxoid",
                    "criterion": "hypersensitivity to diphtheria toxoid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to ... G17DT",
                    "criterion": "hypersensitivity to G17DT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to ... any of its components",
                    "criterion": "hypersensitivity to any components of G17DT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to ... any similar compound",
                    "criterion": "hypersensitivity to any similar compound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, Zollinger-Ellison syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Had any other condition that might have influenced the plasma gastrin level",
                    "criterion": "condition influencing plasma gastrin level",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "achlorhydria",
                    "criterion": "achlorhydria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Zollinger-Ellison syndrome",
                    "criterion": "Zollinger-Ellison syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had used of an investigational drug within the previous month",
            "criterions": [
                {
                    "exact_snippets": "Had used of an investigational drug within the previous month",
                    "criterion": "use of investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (Inhaled corticosteroids were permitted.)",
            "criterions": [
                {
                    "exact_snippets": "Had taken treatments that alter the immune response such as radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history of treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Had taken treatments that alter the immune response such as ... corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "history of treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Had taken treatments that alter the immune response such as ... antineoplastic drugs",
                    "criterion": "antineoplastic drugs",
                    "requirements": [
                        {
                            "requirement_type": "history of treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inhaled corticosteroids were permitted",
                    "criterion": "inhaled corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome)",
            "criterions": [
                {
                    "exact_snippets": "conditions that impaired the immune response",
                    "criterion": "immune response impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired immune deficiency syndrome",
                    "criterion": "acquired immune deficiency syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had a history of drug or alcohol abuse within the past year",
            "criterions": [
                {
                    "exact_snippets": "history of drug or alcohol abuse within the past year",
                    "criterion": "drug or alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Was unable to accept a standard breakfast for dietary reasons",
            "criterions": [
                {
                    "exact_snippets": "unable to accept a standard breakfast for dietary reasons",
                    "criterion": "ability to accept a standard breakfast",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}