{
    "info": {
        "nct_id": "NCT05081882",
        "official_title": "Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava",
        "inclusion_criteria": "* adults aged 21 years or above\n* self-reported smoking at least 5 cigarettes/day for the past year with no intention to quit\n* expired carbon monoxide level of more than 8 ppm at recruitment\n* willingness to participate in the proposed study\n* access to a functional telephone\n* expected presence in the study's geographical area for the next 4 months\n* not currently enrolled in any smoking cessation programs\n* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, Intrauterine Device [IUD], Diaphragm, and cervical cap)\nHealthy volunteers allowed\nMust have minimum age of 21 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* diagnosed with cancer (other than non-melanoma skin cancer)\n* diagnosed with liver dysfunction or with previous liver diseases\n* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen\n* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances\n* use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes\n* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study\n* participant answered \"Yes\" to any of the ASQ questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place >12 months from screening visit then subject is still eligible.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* adults aged 21 years or above",
            "criterions": [
                {
                    "exact_snippets": "adults aged 21 years or above",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* self-reported smoking at least 5 cigarettes/day for the past year with no intention to quit",
            "criterions": [
                {
                    "exact_snippets": "self-reported smoking",
                    "criterion": "smoking",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "cigarettes/day"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "past year"
                        },
                        {
                            "requirement_type": "intention to quit",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* expired carbon monoxide level of more than 8 ppm at recruitment",
            "criterions": [
                {
                    "exact_snippets": "expired carbon monoxide level of more than 8 ppm",
                    "criterion": "expired carbon monoxide level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "ppm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* willingness to participate in the proposed study",
            "criterions": [
                {
                    "exact_snippets": "willingness to participate",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* access to a functional telephone",
            "criterions": [
                {
                    "exact_snippets": "access to a functional telephone",
                    "criterion": "telephone access",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "functionality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* expected presence in the study's geographical area for the next 4 months",
            "criterions": [
                {
                    "exact_snippets": "expected presence in the study's geographical area for the next 4 months",
                    "criterion": "presence in the study's geographical area",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "4 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* not currently enrolled in any smoking cessation programs",
            "criterions": [
                {
                    "exact_snippets": "not currently enrolled in any smoking cessation programs",
                    "criterion": "enrollment in smoking cessation programs",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, Intrauterine Device [IUD], Diaphragm, and cervical cap)",
            "criterions": [
                {
                    "exact_snippets": "female subjects of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "required to practice acceptable methods of birth control",
                    "criterion": "birth control practice",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, Intrauterine Device [IUD], Diaphragm, and cervical cap",
                    "criterion": "acceptable methods of birth control",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "birth control pills",
                                "Birth Control Shot",
                                "Birth Control Implant",
                                "Intrauterine Device [IUD]",
                                "Diaphragm",
                                "cervical cap"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "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": [
        {
            "line": "* diagnosed with cancer (other than non-melanoma skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with cancer (other than non-melanoma skin cancer)",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "non-melanoma skin cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* diagnosed with liver dysfunction or with previous liver diseases",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with liver dysfunction",
                    "criterion": "liver dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous liver diseases",
                    "criterion": "liver diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen",
            "criterions": [
                {
                    "exact_snippets": "levels of alanine transaminase ... over limit of normal range",
                    "criterion": "alanine transaminase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "over limit of normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "levels of ... aspartate transaminase ... over limit of normal range",
                    "criterion": "aspartate transaminase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "over limit of normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "levels of ... alkaline phosphatase ... over limit of normal range",
                    "criterion": "alkaline phosphatase levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "over limit of normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "levels of ... total bilirubin over limit of normal range",
                    "criterion": "total bilirubin levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "over limit of normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances",
            "criterions": [
                {
                    "exact_snippets": "inability to refrain from acetaminophen",
                    "criterion": "use of acetaminophen",
                    "requirements": [
                        {
                            "requirement_type": "ability to refrain",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to refrain from ... alcohol (no more than one drink daily via self-report)",
                    "criterion": "alcohol consumption",
                    "requirements": [
                        {
                            "requirement_type": "ability to refrain",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "maximum daily consumption",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "drink"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to refrain from ... other potentially hepatotoxic substances",
                    "criterion": "use of potentially hepatotoxic substances",
                    "requirements": [
                        {
                            "requirement_type": "ability to refrain",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes",
            "criterions": [
                {
                    "exact_snippets": "use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes",
                    "criterion": "use of non-cigarette nicotine products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study",
            "criterions": [
                {
                    "exact_snippets": "are pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing (lactating)",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "of childbearing age planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to use adequate contraception during the study",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* participant answered \"Yes\" to any of the ASQ questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place &gt;12 months from screening visit then subject is still eligible.",
            "criterions": [
                {
                    "exact_snippets": "participant answered \"Yes\" to any of the ASQ questions 1 through 4",
                    "criterion": "ASQ questions 1 through 4",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "Yes"
                        }
                    ]
                },
                {
                    "exact_snippets": "refuses to answer",
                    "criterion": "ASQ questions 1 through 4",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "refusal"
                        }
                    ]
                },
                {
                    "exact_snippets": "answers 'Yes' to question 4 ... most recent suicide attempt took place >12 months from screening visit",
                    "criterion": "time since most recent suicide attempt",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}