ID

40034

Description

Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01472796

Link

https://clinicaltrials.gov/show/NCT01472796

Keywords

Versions (1)
  1. 3/10/20 3/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01472796

English

Eligibility Hypertension NCT01472796

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 30-74
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
systolic blood pressure 140-159 mm hg and diastolic blood pressure <100 or diastolic blood pressure 90-99mm hg and systolic blood pressure <160mm hg
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
vitamin d deficiency: serum 25-oh d >= 10 ng/ml (25 nmol/l) to < 20 ng/ml (50 nmol/l)
Description

Vitamin D Deficiency | 25-Oh D Vitamin Test

Data type

boolean

Alias
UMLS CUI [1]
C0042870
UMLS CUI [2]
C1255280
not using any antihypertensive medication(s) for the previous 3 months
Description

Antihypertensive Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cancer(other than skin) known hiv or other medical condition that might limit life expectancy.
Description

Malignant Neoplasms | Exception Skin carcinoma | HIV Infection | Other medical condition Limiting Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3]
C0019693
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0023671
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
know adverse reactions to dri's
Description

Adverse reactions Direct Renin Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C2917241
hepatitis or liver enzyme elevations > 1.5x normal
Description

Hepatitis | Elevated liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0235996
estimated glomerular filtration rate (egfr) <50 ml/min/1.7m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
serum calcium > 10.5 mg/dl or history of hypercalcemia
Description

Serum calcium measurement | Hypercalcemia

Data type

boolean

Alias
UMLS CUI [1]
C0728876
UMLS CUI [2]
C0020437
history of primary hyperparathyroidism
Description

Hyperparathyroidism, Primary

Data type

boolean

Alias
UMLS CUI [1]
C0221002
sarcoidosis or other granulomatous disease
Description

Sarcoidosis | Granulomatous disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036202
UMLS CUI [2]
C0740451
taking > 500 mg/d of supplemental elemental calcium
Description

Elemental Calcium Supplemental Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0006675
UMLS CUI [1,2]
C2348609
UMLS CUI [1,3]
C0178602
taking any drugs that decrease absorption of vitamin d, ex:xenical
Description

Pharmaceutical Preparations Decreasing Absorption Vitamin D | Xenical

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0442797
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0042866
UMLS CUI [2]
C0732649
taking the drug cyclosporine
Description

Cyclosporine

Data type

boolean

Alias
UMLS CUI [1]
C0010592
taking any antihypertensive medications in the previous 3 months
Description

Antihypertensive Agents Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332185
history of kidney stones
Description

Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0022650
planning to move > 50 miles in the next 9 months
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
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Similar models

Eligibility Hypertension NCT01472796

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 30-74
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure 140-159 mm hg and diastolic blood pressure <100 or diastolic blood pressure 90-99mm hg and systolic blood pressure <160mm hg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Vitamin D Deficiency | 25-Oh D Vitamin Test
Item
vitamin d deficiency: serum 25-oh d >= 10 ng/ml (25 nmol/l) to < 20 ng/ml (50 nmol/l)
boolean
C0042870 (UMLS CUI [1])
C1255280 (UMLS CUI [2])
Antihypertensive Agents Absent
Item
not using any antihypertensive medication(s) for the previous 3 months
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Skin carcinoma | HIV Infection | Other medical condition Limiting Life Expectancy
Item
cancer(other than skin) known hiv or other medical condition that might limit life expectancy.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0023671 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adverse reactions Direct Renin Inhibitors
Item
know adverse reactions to dri's
boolean
C0559546 (UMLS CUI [1,1])
C2917241 (UMLS CUI [1,2])
Hepatitis | Elevated liver enzymes
Item
hepatitis or liver enzyme elevations > 1.5x normal
boolean
C0019158 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) <50 ml/min/1.7m2
boolean
C3811844 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Serum calcium measurement | Hypercalcemia
Item
serum calcium > 10.5 mg/dl or history of hypercalcemia
boolean
C0728876 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
Hyperparathyroidism, Primary
Item
history of primary hyperparathyroidism
boolean
C0221002 (UMLS CUI [1])
Sarcoidosis | Granulomatous disorder
Item
sarcoidosis or other granulomatous disease
boolean
C0036202 (UMLS CUI [1])
C0740451 (UMLS CUI [2])
Elemental Calcium Supplemental Dose
Item
taking > 500 mg/d of supplemental elemental calcium
boolean
C0006675 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Pharmaceutical Preparations Decreasing Absorption Vitamin D | Xenical
Item
taking any drugs that decrease absorption of vitamin d, ex:xenical
boolean
C0013227 (UMLS CUI [1,1])
C0442797 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0042866 (UMLS CUI [1,4])
C0732649 (UMLS CUI [2])
Cyclosporine
Item
taking the drug cyclosporine
boolean
C0010592 (UMLS CUI [1])
Antihypertensive Agents Recent
Item
taking any antihypertensive medications in the previous 3 months
boolean
C0003364 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Kidney Calculi
Item
history of kidney stones
boolean
C0022650 (UMLS CUI [1])
Relocation of home Planned
Item
planning to move > 50 miles in the next 9 months
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
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