{
    "info": {
        "nct_id": "NCT03762694",
        "official_title": "The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study",
        "inclusion_criteria": "1. Female patients between 18 and 75 years of age;\n2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;\n3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;\n4. Insomnia onset after the diagnosis of breast cancer;\n5. Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;\n6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;\n7. Expected survival time of more than 6 months;\n8. Ability to understand the nature of the study and willingness to give informed consent;\n9. Ability to provide responses during outcome measurement.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Insomnia before the diagnosis of breast cancer;\n2. Other sleep disorder (e.g., obstructive sleep apnoea);\n3. Shift work or irregular sleep pattern;\n4. Severe visual, hearing or language defects;\n5. Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);\n6. With pacemakers or other electronic implants that could interfere with electroacupuncture;\n7. History of acupuncture use in the previous 3 months;\n8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female patients between 18 and 75 years of age;",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "between 18 and 75 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": "receiving"
                        }
                    ]
                },
                {
                    "exact_snippets": "completed chemotherapy no more than 6 months",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Insomnia onset after the diagnosis of breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "Insomnia onset after the diagnosis of breast cancer",
                    "criterion": "insomnia",
                    "requirements": [
                        {
                            "requirement_type": "onset",
                            "expected_value": "after the diagnosis of breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;",
            "criterions": [
                {
                    "exact_snippets": "Insomnia occurs at least 3 nights per week",
                    "criterion": "insomnia frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "nights per week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "presents for at least 1 month",
                    "criterion": "insomnia duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder",
                    "criterion": "DSM-5 diagnostic criteria for brief insomnia disorder",
                    "requirements": [
                        {
                            "requirement_type": "fulfilment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Insomnia severity as defined by an ISI score of no less than 10",
                    "criterion": "Insomnia severity",
                    "requirements": [
                        {
                            "requirement_type": "ISI score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Expected survival time of more than 6 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time of more than 6 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Ability to understand the nature of the study and willingness to give informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand the nature of the study",
                    "criterion": "understanding of the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Ability to provide responses during outcome measurement.",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide responses during outcome measurement",
                    "criterion": "ability to provide responses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Insomnia before the diagnosis of breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "Insomnia before the diagnosis of breast cancer",
                    "criterion": "insomnia",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "before the diagnosis of breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Other sleep disorder (e.g., obstructive sleep apnoea);",
            "criterions": [
                {
                    "exact_snippets": "Other sleep disorder",
                    "criterion": "sleep disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "obstructive sleep apnoea",
                    "criterion": "obstructive sleep apnoea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Shift work or irregular sleep pattern;",
            "criterions": [
                {
                    "exact_snippets": "Shift work",
                    "criterion": "shift work",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "irregular sleep pattern",
                    "criterion": "irregular sleep pattern",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severe visual, hearing or language defects;",
            "criterions": [
                {
                    "exact_snippets": "Severe visual ... defects",
                    "criterion": "visual defects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... hearing ... defects",
                    "criterion": "hearing defects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... language defects",
                    "criterion": "language defects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);",
            "criterions": [
                {
                    "exact_snippets": "Severe hematological dysfunction (platelet count <60,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 60000,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe hematological dysfunction ... haemoglobin <8 g/dL",
                    "criterion": "haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe hematological dysfunction ... absolute neutrophil count <1000/μL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. With pacemakers or other electronic implants that could interfere with electroacupuncture;",
            "criterions": [
                {
                    "exact_snippets": "With pacemakers or other electronic implants",
                    "criterion": "electronic implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that could interfere with electroacupuncture",
                    "criterion": "interference with electroacupuncture",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of acupuncture use in the previous 3 months;",
            "criterions": [
                {
                    "exact_snippets": "History of acupuncture use in the previous 3 months",
                    "criterion": "acupuncture use",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "previous 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.",
            "criterions": [
                {
                    "exact_snippets": "Participation in other clinical trials with intervention",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}