ID

44008

Descrição

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

Palavras-chave

Versões (2)
  1. 23/12/2016 23/12/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

Inglês

Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
perimenopausal or postmenopausal status
Descrição

Perimenopausal state | Postmenopausal state

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Mild depression Clinical | Moderate depression Clinical

Tipo de dados

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
Descrição

Hot flashes Moderate | Hot flashes Severe

Tipo de dados

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
Descrição

Sleeplessness caused by Hot flashes nocturnal

Tipo de dados

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
Descrição

Mammogram normal

Tipo de dados

boolean

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

Perimenopausal state Sexually active Contraceptive methods

Tipo de dados

boolean

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

Exclusion Criteria

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

Severe depression

Tipo de dados

boolean

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

Feeling suicidal | Homicidal thoughts

Tipo de dados

boolean

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

Psychotic symptom

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Substance Use Disorders

Tipo de dados

boolean

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

Hormone preparation Use of Regular

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Intolerance Oestrogen therapy | Medical contraindication Oestrogen therapy

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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