ID

44008

Description

Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia; ODM derived from: https://clinicaltrials.gov/show/NCT00227942

Link

https://clinicaltrials.gov/show/NCT00227942

Keywords

Versions (2)
  1. 12/23/16 12/23/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

    English

    Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    perimenopausal or postmenopausal status
    Description

    Perimenopausal state | Postmenopausal state

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3839366
    UMLS CUI [2]
    C0232970
    surgical menopause or hysterectomy with one or both ovaries preserved if serum follicle stimulating hormone is greater than 20 iu/l
    Description

    Postsurgical menopause | Hysterectomy | Ovary Preserved | Both ovaries Preserved | Serum follicle stimulating hormone measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0740421
    UMLS CUI [2]
    C0020699
    UMLS CUI [3,1]
    C0029939
    UMLS CUI [3,2]
    C0033085
    UMLS CUI [4,1]
    C0227898
    UMLS CUI [4,2]
    C0033085
    UMLS CUI [5]
    C0455276
    diagnosed with mild to moderate clinical depression
    Description

    Mild depression Clinical | Moderate depression Clinical

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0588006
    UMLS CUI [1,2]
    C0205210
    UMLS CUI [2,1]
    C0588007
    UMLS CUI [2,2]
    C0205210
    currently experiencing moderate to severe hot flashes
    Description

    Hot flashes Moderate | Hot flashes Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0600142
    UMLS CUI [1,2]
    C0205081
    UMLS CUI [2,1]
    C0600142
    UMLS CUI [2,2]
    C0205082
    currently experiencing insomnia caused by nocturnal hot flashes
    Description

    Sleeplessness caused by Hot flashes nocturnal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0917801
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C0600142
    UMLS CUI [1,4]
    C0240526
    normal mammogram within the 2 years prior to study entry
    Description

    Mammogram normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0740311
    willing to use an effective form of contraception throughout the study if perimenopausal and sexually active
    Description

    Perimenopausal state Sexually active Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3839366
    UMLS CUI [1,2]
    C0241028
    UMLS CUI [1,3]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    current severe depression or history of severe depression within the 5 years prior to study entry
    Description

    Severe depression

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0588008
    suicidal or homicidal ideation
    Description

    Feeling suicidal | Homicidal thoughts

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0424000
    UMLS CUI [2]
    C0455204
    psychotic symptoms
    Description

    Psychotic symptom

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0871189
    history of any psychiatric disorder (e.g., psychosis, bipolar disorder, panic disorder, obsessive-compulsive disorder, or anorexia nervosa)
    Description

    Mental disorders | Psychotic Disorders | Bipolar Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Anorexia Nervosa

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0033975
    UMLS CUI [3]
    C0005586
    UMLS CUI [4]
    C0030319
    UMLS CUI [5]
    C0028768
    UMLS CUI [6]
    C0003125
    history of any substance abuse (including alcohol abuse) within the 5 years prior to study entry
    Description

    Substance Use Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    regular use of hormonal medications within the month prior to study entry
    Description

    Hormone preparation Use of Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019932
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0205272
    regular use of hypnotic drugs, antidepressants, or over-the-counter drugs known to influence hot flashes, sleep, or mood within the 2 weeks prior to study entry
    Description

    Hypnotics Use of Regular | Antidepressive Agents | Non-Prescription Drugs Affecting Hot flashes | Non-Prescription Drugs Affecting Sleep | Non-Prescription Drugs Affecting Mood

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020591
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0205272
    UMLS CUI [2]
    C0003289
    UMLS CUI [3,1]
    C0013231
    UMLS CUI [3,2]
    C0392760
    UMLS CUI [3,3]
    C0600142
    UMLS CUI [4,1]
    C0013231
    UMLS CUI [4,2]
    C0392760
    UMLS CUI [4,3]
    C0037313
    UMLS CUI [5,1]
    C0013231
    UMLS CUI [5,2]
    C0392760
    UMLS CUI [5,3]
    C0026516
    intolerance to estrogen therapy or informed that estrogen therapy is medically inadvisable
    Description

    Intolerance Oestrogen therapy | Medical contraindication Oestrogen therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231199
    UMLS CUI [1,2]
    C0279494
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0279494
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    Similar models

    Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Perimenopausal state | Postmenopausal state
    Item
    perimenopausal or postmenopausal status
    boolean
    C3839366 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    Postsurgical menopause | Hysterectomy | Ovary Preserved | Both ovaries Preserved | Serum follicle stimulating hormone measurement
    Item
    surgical menopause or hysterectomy with one or both ovaries preserved if serum follicle stimulating hormone is greater than 20 iu/l
    boolean
    C0740421 (UMLS CUI [1])
    C0020699 (UMLS CUI [2])
    C0029939 (UMLS CUI [3,1])
    C0033085 (UMLS CUI [3,2])
    C0227898 (UMLS CUI [4,1])
    C0033085 (UMLS CUI [4,2])
    C0455276 (UMLS CUI [5])
    Mild depression Clinical | Moderate depression Clinical
    Item
    diagnosed with mild to moderate clinical depression
    boolean
    C0588006 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    C0588007 (UMLS CUI [2,1])
    C0205210 (UMLS CUI [2,2])
    Hot flashes Moderate | Hot flashes Severe
    Item
    currently experiencing moderate to severe hot flashes
    boolean
    C0600142 (UMLS CUI [1,1])
    C0205081 (UMLS CUI [1,2])
    C0600142 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    Sleeplessness caused by Hot flashes nocturnal
    Item
    currently experiencing insomnia caused by nocturnal hot flashes
    boolean
    C0917801 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0600142 (UMLS CUI [1,3])
    C0240526 (UMLS CUI [1,4])
    Mammogram normal
    Item
    normal mammogram within the 2 years prior to study entry
    boolean
    C0740311 (UMLS CUI [1])
    Perimenopausal state Sexually active Contraceptive methods
    Item
    willing to use an effective form of contraception throughout the study if perimenopausal and sexually active
    boolean
    C3839366 (UMLS CUI [1,1])
    C0241028 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Severe depression
    Item
    current severe depression or history of severe depression within the 5 years prior to study entry
    boolean
    C0588008 (UMLS CUI [1])
    Feeling suicidal | Homicidal thoughts
    Item
    suicidal or homicidal ideation
    boolean
    C0424000 (UMLS CUI [1])
    C0455204 (UMLS CUI [2])
    Psychotic symptom
    Item
    psychotic symptoms
    boolean
    C0871189 (UMLS CUI [1])
    Mental disorders | Psychotic Disorders | Bipolar Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Anorexia Nervosa
    Item
    history of any psychiatric disorder (e.g., psychosis, bipolar disorder, panic disorder, obsessive-compulsive disorder, or anorexia nervosa)
    boolean
    C0004936 (UMLS CUI [1])
    C0033975 (UMLS CUI [2])
    C0005586 (UMLS CUI [3])
    C0030319 (UMLS CUI [4])
    C0028768 (UMLS CUI [5])
    C0003125 (UMLS CUI [6])
    Substance Use Disorders
    Item
    history of any substance abuse (including alcohol abuse) within the 5 years prior to study entry
    boolean
    C0038586 (UMLS CUI [1])
    Hormone preparation Use of Regular
    Item
    regular use of hormonal medications within the month prior to study entry
    boolean
    C0019932 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0205272 (UMLS CUI [1,3])
    Hypnotics Use of Regular | Antidepressive Agents | Non-Prescription Drugs Affecting Hot flashes | Non-Prescription Drugs Affecting Sleep | Non-Prescription Drugs Affecting Mood
    Item
    regular use of hypnotic drugs, antidepressants, or over-the-counter drugs known to influence hot flashes, sleep, or mood within the 2 weeks prior to study entry
    boolean
    C0020591 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0205272 (UMLS CUI [1,3])
    C0003289 (UMLS CUI [2])
    C0013231 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0600142 (UMLS CUI [3,3])
    C0013231 (UMLS CUI [4,1])
    C0392760 (UMLS CUI [4,2])
    C0037313 (UMLS CUI [4,3])
    C0013231 (UMLS CUI [5,1])
    C0392760 (UMLS CUI [5,2])
    C0026516 (UMLS CUI [5,3])
    Intolerance Oestrogen therapy | Medical contraindication Oestrogen therapy
    Item
    intolerance to estrogen therapy or informed that estrogen therapy is medically inadvisable
    boolean
    C0231199 (UMLS CUI [1,1])
    C0279494 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C0279494 (UMLS CUI [2,2])
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