ID

33224

Beschrijving

Vitamin D Deficiency in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00974922

Link

https://clinicaltrials.gov/show/NCT00974922

Trefwoorden

Versies (1)
  1. 02-12-18 02-12-18 -
Houder van rechten

See clinicaltrials.gov

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2 december 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Vitamin D Deficiency NCT00974922

Engels

Eligibility Vitamin D Deficiency NCT00974922

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women over 21 years of age with a history of stage 1 or 2 hypertension (defined as a seated diastolic bp ≥ 90 mmhg and < 110 mmhg in the untreated state).
Beschrijving

Age | Hypertensive disease Stage | Sitting diastolic blood pressure | Sitting diastolic blood pressure Untreated

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0205390
UMLS CUI [3]
C1319894
UMLS CUI [4,1]
C1319894
UMLS CUI [4,2]
C0745134
patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
Beschrijving

On treatment for hypertension | Antihypertensive Agents Discontinue Willing | Antihypertensive Agents Discontinue Able

Datatype

boolean

Alias
UMLS CUI [1]
C0578998
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0085732
25-hydroxyvitamin d levels < 30 ng/ml and > 12 ng/ml.
Beschrijving

25-Hydroxyvitamin D Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2984945
women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.
Beschrijving

Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | aliskiren

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
UMLS CUI [4]
C1120110
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
vitamin d levels < 12 ng/ml
Beschrijving

Vitamin D measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0919758
known hypersensitivity or allergy to aliskiren
Beschrijving

Hypersensitivity Aliskiren

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1120110
clinic blood pressure > 180/110 mmhg
Beschrijving

Blood pressure determination

Datatype

boolean

Alias
UMLS CUI [1]
C0005824
known forms of secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
chronic atrial fibrillation
Beschrijving

Chronic atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0694539
uncontrolled or unstable cardiovascular diseases
Beschrijving

Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0443343
shift or night workers
Beschrijving

Shift worker | Night shift worker

Datatype

boolean

Alias
UMLS CUI [1]
C0425104
UMLS CUI [2]
C0555008
mid-arm circumference > 42 cm in diameter
Beschrijving

Mid arm muscle circumference Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0562347
UMLS CUI [1,2]
C1301886
current or recent (<1 year) alcohol or drug abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Vitamin D Deficiency NCT00974922

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease Stage | Sitting diastolic blood pressure | Sitting diastolic blood pressure Untreated
Item
men or women over 21 years of age with a history of stage 1 or 2 hypertension (defined as a seated diastolic bp ≥ 90 mmhg and < 110 mmhg in the untreated state).
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3])
C1319894 (UMLS CUI [4,1])
C0745134 (UMLS CUI [4,2])
On treatment for hypertension | Antihypertensive Agents Discontinue Willing | Antihypertensive Agents Discontinue Able
Item
patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
boolean
C0578998 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
25-Hydroxyvitamin D Measurement
Item
25-hydroxyvitamin d levels < 30 ng/ml and > 12 ng/ml.
boolean
C2984945 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | aliskiren
Item
women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C1120110 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Vitamin D measurement
Item
vitamin d levels < 12 ng/ml
boolean
C0919758 (UMLS CUI [1])
Hypersensitivity Aliskiren
Item
known hypersensitivity or allergy to aliskiren
boolean
C0020517 (UMLS CUI [1,1])
C1120110 (UMLS CUI [1,2])
Blood pressure determination
Item
clinic blood pressure > 180/110 mmhg
boolean
C0005824 (UMLS CUI [1])
Secondary hypertension
Item
known forms of secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Chronic atrial fibrillation
Item
chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Unstable
Item
uncontrolled or unstable cardiovascular diseases
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Shift worker | Night shift worker
Item
shift or night workers
boolean
C0425104 (UMLS CUI [1])
C0555008 (UMLS CUI [2])
Mid arm muscle circumference Diameter
Item
mid-arm circumference > 42 cm in diameter
boolean
C0562347 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Substance Use Disorders
Item
current or recent (<1 year) alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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