ID

39153

Description

Pomegranate and Hemodialysis Pilot Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01562340

Link

https://clinicaltrials.gov/show/NCT01562340

Keywords

Versions (2)
  1. 12/5/19 12/5/19 -
  2. 12/5/19 12/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01562340

English

Eligibility End Stage Renal Disease NCT01562340

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with end-stage renal disease receiving thrice weekly hemodialysis
Description

Kidney Failure, Chronic | Hemodialysis times per week

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0456698
age > 18 or < 85 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy greater than one year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ability to understand and provide informed consent for participation in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of poor adherence to hemodialysis or medical regimen
Description

Adherence Poor Hemodialysis | Adherence Poor Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0542537
UMLS CUI [2,3]
C0040808
prisoners, patients with significant mental illness, and other vulnerable populations
Description

Prisoners | Mental disorders | Vulnerable Populations

Data type

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0949366
aids (hiv seropositivity is not an exclusion criteria)
Description

AIDS | HIV Seropositivity allowed

Data type

boolean

Alias
UMLS CUI [1]
C0001175
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0683607
active malignancy excluding basal cell carcinoma of the skin
Description

Malignant Neoplasms | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
gastrointestinal dysfunction requiring parenteral nutrition
Description

Gastrointestinal dysfunction Requirement Parenteral Nutrition

Data type

boolean

Alias
UMLS CUI [1,1]
C0679407
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0030547
history of functional kidney transplant < 6 months prior to study entry
Description

Kidney Transplantation Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205245
anticipated live donor kidney transplant
Description

Live donor renal transplant Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0401177
UMLS CUI [1,2]
C3840775
patients taking vitamin e supplements > 60 iu/day, vitamin c > 150 mg/day or other antioxidant or nutritional supplements
Description

Vitamin E supplement IU/day | Vitamin C mg/day | Antioxidant Supplements | Nutritional Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C3661607
UMLS CUI [1,2]
C0439465
UMLS CUI [2,1]
C0003968
UMLS CUI [2,2]
C0439422
UMLS CUI [3,1]
C0003402
UMLS CUI [3,2]
C0242295
UMLS CUI [4]
C0242295
incident hemodialysis patients (defined as within 30 days of dialysis initiation)
Description

Hemodialysis Initiation Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C1704686
UMLS CUI [1,3]
C0872291
patients hospitalized for more than 5 days within the past 30 days.
Description

Hospitalization Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
Description

Event atherosclerotic major | Incidence Combined | Myocardial Infarction | Target vessel Revascularization Urgent | Coronary Artery Bypass Surgery | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0333482
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0021149
UMLS CUI [2,2]
C0205195
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0449618
UMLS CUI [4,2]
C0581603
UMLS CUI [4,3]
C0439609
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0038454
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility End Stage Renal Disease NCT01562340

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Failure, Chronic | Hemodialysis times per week
Item
patients with end-stage renal disease receiving thrice weekly hemodialysis
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2,1])
C0456698 (UMLS CUI [2,2])
Age
Item
age > 18 or < 85 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than one year
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to understand and provide informed consent for participation in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adherence Poor Hemodialysis | Adherence Poor Regimen
Item
history of poor adherence to hemodialysis or medical regimen
boolean
C1510802 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C1510802 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0040808 (UMLS CUI [2,3])
Prisoners | Mental disorders | Vulnerable Populations
Item
prisoners, patients with significant mental illness, and other vulnerable populations
boolean
C0033167 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0949366 (UMLS CUI [3])
AIDS | HIV Seropositivity allowed
Item
aids (hiv seropositivity is not an exclusion criteria)
boolean
C0001175 (UMLS CUI [1])
C0019699 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Basal cell carcinoma
Item
active malignancy excluding basal cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Gastrointestinal dysfunction Requirement Parenteral Nutrition
Item
gastrointestinal dysfunction requiring parenteral nutrition
boolean
C0679407 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0030547 (UMLS CUI [1,3])
Kidney Transplantation Functional
Item
history of functional kidney transplant < 6 months prior to study entry
boolean
C0022671 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
Live donor renal transplant Anticipated
Item
anticipated live donor kidney transplant
boolean
C0401177 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Vitamin E supplement IU/day | Vitamin C mg/day | Antioxidant Supplements | Nutritional Supplements
Item
patients taking vitamin e supplements > 60 iu/day, vitamin c > 150 mg/day or other antioxidant or nutritional supplements
boolean
C3661607 (UMLS CUI [1,1])
C0439465 (UMLS CUI [1,2])
C0003968 (UMLS CUI [2,1])
C0439422 (UMLS CUI [2,2])
C0003402 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
C0242295 (UMLS CUI [4])
Hemodialysis Initiation Timespan
Item
incident hemodialysis patients (defined as within 30 days of dialysis initiation)
boolean
C0019004 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Hospitalization Duration
Item
patients hospitalized for more than 5 days within the past 30 days.
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Event atherosclerotic major | Incidence Combined | Myocardial Infarction | Target vessel Revascularization Urgent | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
boolean
C0441471 (UMLS CUI [1,1])
C0333482 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0021149 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0449618 (UMLS CUI [4,1])
C0581603 (UMLS CUI [4,2])
C0439609 (UMLS CUI [4,3])
C0010055 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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