ID

22433

Description

Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT); ODM derived from: https://clinicaltrials.gov/show/NCT00668603

Link

https://clinicaltrials.gov/show/NCT00668603

Keywords

Versions (1)
  1. 6/3/17 6/3/17 -
Uploaded on

June 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Postmenopausal Vasomotor Symptoms NCT00668603

English

Eligibility Postmenopausal Vasomotor Symptoms NCT00668603

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women between ages 48-55
Description

Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
minimum of 6 months and maximum of 36 months from last menstrual period
Description

Menstrual cycle Last | Past Month Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0025329
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C1444637
UMLS CUI [2,2]
C0439231
UMLS CUI [2,3]
C1265611
postmenopausal status of these women will be confirmed by level of fsh that should exceed 30 u/l
Description

Postmenopausal state Follicle stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0202022
eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless
Description

Gender Quantity Vasomotor symptom Severe | Hot flushes Severe Quantity per day | Hot flushes Moderate Quantity per day | Comparator Quantity Asymptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0750152
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0600142
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0439505
UMLS CUI [3,1]
C0600142
UMLS CUI [3,2]
C0205081
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0439505
UMLS CUI [4,1]
C1707504
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0231221
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoking
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
hysterectomy
Description

Hysterectomy

Data type

boolean

Alias
UMLS CUI [1]
C0020699
dyslipidemia
Description

Dyslipidemia

Data type

boolean

Alias
UMLS CUI [1]
C0242339
overt hypertension (blood pressure > 140/90)
Description

Hypertensive disease | Blood Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
any regular medication
Description

Pharmaceutical Preparations Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205272
ht in the previous 3 months
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
body mass index over 27
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Postmenopausal Vasomotor Symptoms NCT00668603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Age
Item
postmenopausal women between ages 48-55
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Menstrual cycle Last | Past Month Quantity
Item
minimum of 6 months and maximum of 36 months from last menstrual period
boolean
C0025329 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1444637 (UMLS CUI [2,1])
C0439231 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Postmenopausal state Follicle stimulating hormone measurement
Item
postmenopausal status of these women will be confirmed by level of fsh that should exceed 30 u/l
boolean
C0232970 (UMLS CUI [1,1])
C0202022 (UMLS CUI [1,2])
Gender Quantity Vasomotor symptom Severe | Hot flushes Severe Quantity per day | Hot flushes Moderate Quantity per day | Comparator Quantity Asymptomatic
Item
eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless
boolean
C0079399 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0750152 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0600142 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
C0600142 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0439505 (UMLS CUI [3,4])
C1707504 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Tobacco use
Item
smoking
boolean
C0543414 (UMLS CUI [1])
Hysterectomy
Item
hysterectomy
boolean
C0020699 (UMLS CUI [1])
Dyslipidemia
Item
dyslipidemia
boolean
C0242339 (UMLS CUI [1])
Hypertensive disease | Blood Pressure
Item
overt hypertension (blood pressure > 140/90)
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Pharmaceutical Preparations Regular
Item
any regular medication
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Hormone Therapy
Item
ht in the previous 3 months
boolean
C0279025 (UMLS CUI [1])
Body mass index
Item
body mass index over 27
boolean
C1305855 (UMLS CUI [1])
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