{
    "info": {
        "nct_id": "NCT01479348",
        "official_title": "Phase 0 Trial of [F-18]-5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n* Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan.\n* Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines\n* For females: Negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy\n\nEXCLUSION CRITERIA:\n\n* Participants with severe claustrophobia unresponsive to oral anxiolytics\n* Subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry\n* Known allergy to FdCyd\n* The subject is unable to lie still for 75 minutes\n* 5 Pregnant or lactating women. Pregnant women are excluded from this study because the effects of 18F-FdCyd in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18F-FdCyd in the mother, breastfeeding should be discontinued if the mother receives 18F-FdCyd\n* Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results"
    },
    "inclusion_lines": [
        {
            "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 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan.",
            "criterions": [
                {
                    "exact_snippets": "Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214)",
                    "criterion": "enrollment in NIH Phase II Clinical protocol",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan",
                    "criterion": "target lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines",
            "criterions": [
                {
                    "exact_snippets": "Written, voluntary, informed consent of the patient must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For females: Negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "females: Negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "females: ... post-menopausal for at least 2 years",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "females: ... patient has had a hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with severe claustrophobia unresponsive to oral anxiolytics",
            "criterions": [
                {
                    "exact_snippets": "severe claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresponsive to oral anxiolytics",
                    "criterion": "response to oral anxiolytics",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "unresponsive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry",
            "criterions": [
                {
                    "exact_snippets": "Subjects weighing > 400 lbs",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 400,
                                "unit": "lbs"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to fit within the imaging gantry",
                    "criterion": "fit within imaging gantry",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergy to FdCyd",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to FdCyd",
                    "criterion": "allergy to FdCyd",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is unable to lie still for 75 minutes",
            "criterions": [
                {
                    "exact_snippets": "unable to lie still for 75 minutes",
                    "criterion": "ability to lie still",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 75,
                                "unit": "minutes"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5 Pregnant or lactating women. Pregnant women are excluded from this study because the effects of 18F-FdCyd in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18F-FdCyd in the mother, breastfeeding should be discontinued if the mother receives 18F-FdCyd",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women. Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women ... breastfeeding should be discontinued",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results",
            "criterions": [
                {
                    "exact_snippets": "any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results",
                    "criterion": "co-existing medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}