ID

44446

Beschrijving

Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01792206

Link

https://clinicaltrials.gov/show/NCT01792206

Trefwoorden

Versies (1)
  1. 22-09-21 22-09-21 -
Houder van rechten

Scott and White Hospital & Clinic Abbott

Geüploaded op

22 september 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Type 2 Diabetes NCT01792206

Engels

Eligibility Type 2 Diabetes NCT01792206

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with type 2 diabetes and ckd
Beschrijving

Type 2 diabetes and Chronic Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1561643
2. age 18 - 70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. stable anti-hypertensive and lipid lowering therapy for at least 2 months. all patients should be on an acei or arb unless contraindicated because of side effects (standard of care). no changes in lipid lowering therapy during the 3 months of this study. blood pressure doses may be changed but new therapy with ace inhibitors will not be allowed.
Beschrijving

Stable anti-hypertensive therapy | Stable lipid lowering therapy | ACEi | ARB

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0585943
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe co morbid conditions - e.g. cancer, etc.
Beschrijving

Severe comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
2. congestive heart failure.
Beschrijving

Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
3. inability to give informed consent or attend study related visits.
Beschrijving

Unable to give an informed consent | Unable to attend study related visits

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C1299582
4. have a history of abnormally high vitamin d or calcium levels in the bloodstream.
Beschrijving

Medical history of an abnormally high vitamin d or calcium levels

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0919758
UMLS CUI [1,3]
C0438215
UMLS CUI [1,4]
C0442805
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0201925
UMLS CUI [2,3]
C0438215
UMLS CUI [2,4]
C0442805
5. unwilling or unable to complete screening or data collection procedures.
Beschrijving

Protocol compliance unable | Protocol compliance unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
6. have a known allergy to the study drug.
Beschrijving

A known allergy to the study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
7. pregnant or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. plasma calcium >9 mg/dl
Beschrijving

Calcium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201925
9. patients should discontinue any calcium supplementation prior to entry into the study.
Beschrijving

Calcium supplementation

Datatype

boolean

Alias
UMLS CUI [1]
C1096745
10. other vitamin d analogs (eg sensipar) and vitamin d preparations are contraindicated
Beschrijving

Vitamin D supplement therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0420176
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Type 2 Diabetes NCT01792206

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes and Chronic Kidney Diseases
Item
1. patients with type 2 diabetes and ckd
boolean
C0011860 (UMLS CUI [1,1])
C1561643 (UMLS CUI [1,2])
Age
Item
2. age 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Stable anti-hypertensive therapy | Stable lipid lowering therapy | ACEi | ARB
Item
3. stable anti-hypertensive and lipid lowering therapy for at least 2 months. all patients should be on an acei or arb unless contraindicated because of side effects (standard of care). no changes in lipid lowering therapy during the 3 months of this study. blood pressure doses may be changed but new therapy with ace inhibitors will not be allowed.
boolean
C0585941 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0585943 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Severe comorbidity
Item
1. severe co morbid conditions - e.g. cancer, etc.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Congestive heart failure
Item
2. congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Unable to give an informed consent | Unable to attend study related visits
Item
3. inability to give informed consent or attend study related visits.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0008952 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical history of an abnormally high vitamin d or calcium levels
Item
4. have a history of abnormally high vitamin d or calcium levels in the bloodstream.
boolean
C0262926 (UMLS CUI [1,1])
C0919758 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C0442805 (UMLS CUI [1,4])
C0262926 (UMLS CUI [2,1])
C0201925 (UMLS CUI [2,2])
C0438215 (UMLS CUI [2,3])
C0442805 (UMLS CUI [2,4])
Protocol compliance unable | Protocol compliance unwilling
Item
5. unwilling or unable to complete screening or data collection procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
A known allergy to the study drug
Item
6. have a known allergy to the study drug.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
7. pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Calcium measurement
Item
8. plasma calcium >9 mg/dl
boolean
C0201925 (UMLS CUI [1])
Calcium supplementation
Item
9. patients should discontinue any calcium supplementation prior to entry into the study.
boolean
C1096745 (UMLS CUI [1])
Vitamin D supplement therapy
Item
10. other vitamin d analogs (eg sensipar) and vitamin d preparations are contraindicated
boolean
C0420176 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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