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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