ID

44239

Description

Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00852787

Link

https://clinicaltrials.gov/show/NCT00852787

Keywords

  1. 5/2/18 5/2/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypertension NCT00852787

Eligibility Hypertension NCT00852787

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18-75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
on hemodialysis with predialysis bp > 150/90 but ≤ 180/110
Description

Hemodialysis | Blood pressure Pre Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2,1]
C0005824
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0011946
on at least one anti-hypertensive medication for 6 consecutive readings
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
able to have blood pressure measured in an arm
Description

Blood pressure measurement Arm

Data type

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C1269078
women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
Description

Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
receiving adequate dialysis (kt/v > 1.2)
Description

Dialysis kt/V

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0429662
compliant with the dialysis schedule and duration
Description

Compliance Dialysis Schedule | Compliance Dialysis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0011946
UMLS CUI [1,3]
C0086960
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
arm blood pressure is not possible to obtain
Description

Blood pressure measurement Arm Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C1269078
UMLS CUI [1,3]
C1272705
currently on digitalis
Description

Digitalis

Data type

boolean

Alias
UMLS CUI [1]
C0304520
on any digibind-type product in the past
Description

Digibind Type Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0687706
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1514468
history of allergies to antibiotics
Description

Allergy to antibiotic agents

Data type

boolean

Alias
UMLS CUI [1]
C0455591
history of asthma
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
Description

Disease Unstable | Mental disorders Unstable | Disease Interferes with Research results | Mental disorders Interfere with Research results | Disease Interferes with Study Subject Participation Status | Mental disorders Interfere with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
history of use of, or evidence of need for, digitalis-like products
Description

Digitalis Similar Product | Patient need for Digitalis Similar Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0304520
UMLS CUI [1,2]
C2348205
UMLS CUI [1,3]
C1514468
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0304520
UMLS CUI [2,3]
C2348205
UMLS CUI [2,4]
C1514468
inability to understand or provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Hypertension NCT00852787

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18-75 years of age
boolean
C0001779 (UMLS CUI [1])
Hemodialysis | Blood pressure Pre Dialysis
Item
on hemodialysis with predialysis bp > 150/90 but ≤ 180/110
boolean
C0019004 (UMLS CUI [1])
C0005824 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Antihypertensive Agents Quantity
Item
on at least one anti-hypertensive medication for 6 consecutive readings
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Blood pressure measurement Arm
Item
able to have blood pressure measured in an arm
boolean
C0005824 (UMLS CUI [1,1])
C1269078 (UMLS CUI [1,2])
Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Dialysis kt/V
Item
receiving adequate dialysis (kt/v > 1.2)
boolean
C0011946 (UMLS CUI [1,1])
C0429662 (UMLS CUI [1,2])
Compliance Dialysis Schedule | Compliance Dialysis Duration
Item
compliant with the dialysis schedule and duration
boolean
C1321605 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Blood pressure measurement Arm Unsuccessful
Item
arm blood pressure is not possible to obtain
boolean
C0005824 (UMLS CUI [1,1])
C1269078 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Digitalis
Item
currently on digitalis
boolean
C0304520 (UMLS CUI [1])
Digibind Type Product
Item
on any digibind-type product in the past
boolean
C0687706 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
Allergy to antibiotic agents
Item
history of allergies to antibiotics
boolean
C0455591 (UMLS CUI [1])
Asthma
Item
history of asthma
boolean
C0004096 (UMLS CUI [1])
Disease Unstable | Mental disorders Unstable | Disease Interferes with Research results | Mental disorders Interfere with Research results | Disease Interferes with Study Subject Participation Status | Mental disorders Interfere with Study Subject Participation Status
Item
medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
Digitalis Similar Product | Patient need for Digitalis Similar Product
Item
history of use of, or evidence of need for, digitalis-like products
boolean
C0304520 (UMLS CUI [1,1])
C2348205 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0304520 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C1514468 (UMLS CUI [2,4])
Informed Consent Unable
Item
inability to understand or provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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