{
    "info": {
        "nct_id": "NCT05045066",
        "official_title": "Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients with Localized Versus Metastatic Disease",
        "inclusion_criteria": "* African American males, age >= 18 years\n* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Patients with Vitamin D levels below 30 ng/mL\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known hypersensitivity to vitamin D\n* End stage renal failure on dialysis\n* Liver cirrhosis\n* Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month\n* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature\n* Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection\n* History of hypercalcemia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* African American males, age >= 18 years",
            "criterions": [
                {
                    "exact_snippets": "African American males",
                    "criterion": "race and gender",
                    "requirements": [
                        {
                            "requirement_type": "specificity",
                            "expected_value": [
                                "African American",
                                "male"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age >= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "previous history of localized ... prostate cancer",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous history of ... metastatic ... prostate cancer",
                    "criterion": "metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous history of ... locally recurrent prostate cancer",
                    "criterion": "locally recurrent prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Vitamin D levels below 30 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Vitamin D levels below 30 ng/mL",
                    "criterion": "Vitamin D levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Known hypersensitivity to vitamin D",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to vitamin D",
                    "criterion": "hypersensitivity to vitamin D",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* End stage renal failure on dialysis",
            "criterions": [
                {
                    "exact_snippets": "End stage renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "end stage"
                        }
                    ]
                },
                {
                    "exact_snippets": "on dialysis",
                    "criterion": "dialysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver cirrhosis",
            "criterions": [
                {
                    "exact_snippets": "Liver cirrhosis",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month",
            "criterions": [
                {
                    "exact_snippets": "Currently taking a vitamin D or multivitamin supplement",
                    "criterion": "vitamin D or multivitamin supplement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 400 IU/10mcg of vitamin D daily",
                    "criterion": "vitamin D dosage",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 400,
                                "unit": "IU"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for the past month",
                    "criterion": "duration of supplement intake",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "past month"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature",
            "criterions": [
                {
                    "exact_snippets": "Legal inability or restricted legal ability",
                    "criterion": "legal ability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "unrestricted"
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical or psychological conditions not allowing proper study completion",
                    "criterion": "medical or psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study completion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical or psychological conditions not allowing ... informed consent signature",
                    "criterion": "medical or psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on informed consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... within the last 3 weeks prior to blood collection",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "surgery ... within the last 3 weeks prior to blood collection",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation within the last 3 weeks prior to blood collection",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypercalcemia",
            "criterions": [
                {
                    "exact_snippets": "History of hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}