ID

15141

Description

Palm Tocotrienols in Chronic Hemodialysis (USA); ODM derived from: https://clinicaltrials.gov/show/NCT02358967

Link

https://clinicaltrials.gov/show/NCT02358967

Keywords

Versions (1)
  1. 5/18/16 5/18/16 -
Uploaded on

May 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT02358967

English

Eligibility End Stage Renal Disease NCT02358967

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is willing and able to give informed consent for participation in the trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 18 years to 70 yrs. undergoing chronic hemodialysis treatment for more than 3 months (life expectancy > 1 year).
Description

Age | Chronic haemodialysis Therapeutic procedure | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1740835
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0023671
able and willing to comply with all trial requirements.
Description

Compliance behavior Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
willing to allow his or her /physician/nephrologist/general practitioner and consultant, if appropriate, to be notified of participation in the trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
history of functional kidney transplant 6 months before study entry; anticipated live donor kidney transplant over the study duration;
Description

Kidney Transplantation Functional | Live donor renal transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205245
UMLS CUI [2]
C0401177
participants who are taking vitamin e- containing supplements >60 iu/d during the past 30 days
Description

Vitamin E Containing Supplement

Data type

boolean

Alias
UMLS CUI [1,1]
C0042874
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C2348609
history of poor adherence to hemodialysis or medical regimen
Description

Compliance behavior Hemodialysis | Compliance behavior to medical regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0019004
UMLS CUI [2]
C4039237
participants who are currently on active treatment for cancer, excluding basal cell carcinoma of the skin
Description

cancer treatment | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0007117
participants who have been diagnosed as hiv/aids and/or on the anti-hiv therapy. (hiv seropositivity is not an exclusion criterion)
Description

HIV | Acquired Immunodeficiency Syndrome | Anti-HIV Therapy | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0001175
UMLS CUI [3]
C1510425
UMLS CUI [4]
C0019699
patients taking anti-inflammatory medication, except aspirin<325 mg/d, over the past 30 days
Description

Anti-Inflammatory Agents | Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2]
C0004057
female participant who is pregnant, lactating or planning pregnancy during the course of the trial
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
participants who are receiving nutritional support (i.e. enteral and intra-venous route)
Description

Enteral nutritional support | Nutritional Support Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0846670
UMLS CUI [2,1]
C0242739
UMLS CUI [2,2]
C0348016
patients using a temporary catheter for dialysis access at baseline or patients receiving a graft/fistula within the 6-month study period
Description

catheter Dialysis | Graft

Data type

boolean

Alias
UMLS CUI [1,1]
C0085590
UMLS CUI [1,2]
C0011946
UMLS CUI [2]
C0181074
more than two hospitalizations within the last 90 days or one hospitalization within the 30 days preceding enrollment
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
any other significant disease or disorder which, in the opinion of their nephrologist, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Description

Comorbidity Risk Study Subject | Comorbidity Affecting research results | Comorbidity Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0681850
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0439801
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Similar models

Eligibility End Stage Renal Disease NCT02358967

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patient is willing and able to give informed consent for participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Age | Chronic haemodialysis Therapeutic procedure | Life Expectancy
Item
male or female, aged 18 years to 70 yrs. undergoing chronic hemodialysis treatment for more than 3 months (life expectancy > 1 year).
boolean
C0001779 (UMLS CUI [1])
C1740835 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Compliance behavior Study Protocol
Item
able and willing to comply with all trial requirements.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Study Subject Participation Status
Item
willing to allow his or her /physician/nephrologist/general practitioner and consultant, if appropriate, to be notified of participation in the trial.
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participants who have participated in another research trial involving an investigational product in the past 12 weeks.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Kidney Transplantation Functional | Live donor renal transplant
Item
history of functional kidney transplant 6 months before study entry; anticipated live donor kidney transplant over the study duration;
boolean
C0022671 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0401177 (UMLS CUI [2])
Vitamin E Containing Supplement
Item
participants who are taking vitamin e- containing supplements >60 iu/d during the past 30 days
boolean
C0042874 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C2348609 (UMLS CUI [1,3])
Compliance behavior Hemodialysis | Compliance behavior to medical regimen
Item
history of poor adherence to hemodialysis or medical regimen
boolean
C1321605 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
C4039237 (UMLS CUI [2])
cancer treatment | Basal cell carcinoma
Item
participants who are currently on active treatment for cancer, excluding basal cell carcinoma of the skin
boolean
C0920425 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
HIV | Acquired Immunodeficiency Syndrome | Anti-HIV Therapy | HIV Seropositivity
Item
participants who have been diagnosed as hiv/aids and/or on the anti-hiv therapy. (hiv seropositivity is not an exclusion criterion)
boolean
C0019682 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C1510425 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Anti-Inflammatory Agents | Aspirin
Item
patients taking anti-inflammatory medication, except aspirin<325 mg/d, over the past 30 days
boolean
C0003209 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female participant who is pregnant, lactating or planning pregnancy during the course of the trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Enteral nutritional support | Nutritional Support Intravenous
Item
participants who are receiving nutritional support (i.e. enteral and intra-venous route)
boolean
C0846670 (UMLS CUI [1])
C0242739 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
catheter Dialysis | Graft
Item
patients using a temporary catheter for dialysis access at baseline or patients receiving a graft/fistula within the 6-month study period
boolean
C0085590 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0181074 (UMLS CUI [2])
Hospitalization
Item
more than two hospitalizations within the last 90 days or one hospitalization within the 30 days preceding enrollment
boolean
C0019993 (UMLS CUI [1])
Comorbidity Risk Study Subject | Comorbidity Affecting research results | Comorbidity Study Subject Participation Status Limited
Item
any other significant disease or disorder which, in the opinion of their nephrologist, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
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