ID

23801

Description

Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00581269

Lien

https://clinicaltrials.gov/show/NCT00581269

Mots-clés

Versions (1)
  1. 14/07/2017 14/07/2017 -
Téléchargé le

14 juillet 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00581269

Anglais

Eligibility Chronic Kidney Disease NCT00581269

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with stage iii-iv (estimated gfr 20-59 min/ml) chronic kidney disease measured by mdrd formula.
Description

Chronic Kidney Disease Stage | MDRD formula eGFR

Type de données

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C3839656
UMLS CUI [2,2]
C3811844
2. bmi ≥ 30 kg/m2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
3. age > 18 or < 65 years.
Description

Age

Type de données

boolean

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

Life Expectancy

Type de données

boolean

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

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active inflammatory disease such as: aids (hiv seropositivity is not an exclusion criteria), active hepatitis c or b, active gout, other active inflammatory diseases.
Description

Inflammatory disorder | AIDS | HIV Seropositivity Excluded | Hepatitis C | Hepatitis B | Gout

Type de données

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0001175
UMLS CUI [3,1]
C0019699
UMLS CUI [3,2]
C2828389
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0018099
2. active malignancy excluding basal or squamous cell carcinoma of the skin.
Description

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
3. patients suffering from type i diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
4. patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
Description

Calorie intake per day Reduced | Malnutrition

Type de données

boolean

Alias
UMLS CUI [1,1]
C2095644
UMLS CUI [1,2]
C0392756
UMLS CUI [2]
C0162429
5. patients who are already on a consistent and rigorous exercise regimen.
Description

Exercise regime Consistent Strenuous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0454291
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1514989
6. gastrointestinal dysfunction requiring parental nutrition.
Description

Gastrointestinal dysfunction | Parenteral Nutrition Patient need for

Type de données

boolean

Alias
UMLS CUI [1]
C0679407
UMLS CUI [2,1]
C0030547
UMLS CUI [2,2]
C0686904
7. history of functional kidney transplant < 6 months prior to study entry.
Description

Kidney Transplantation Functional

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205245
8. anticipated live donor kidney transplant over study duration.
Description

Live donor renal transplant Expected

Type de données

boolean

Alias
UMLS CUI [1,1]
C0401177
UMLS CUI [1,2]
C1517001
9. patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
Description

Anti-Inflammatory Agents | Aspirin

Type de données

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2]
C0004057
10. patients taking vitamin e supplements > 60 iu/day, vitamin c > 500mg/day over the past 30days.
Description

Vitamin E supplement U/day | Ascorbic Acid U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C3661607
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0003968
UMLS CUI [2,2]
C0456683
11. patients taking any prednisone therapy.
Description

Prednisone

Type de données

boolean

Alias
UMLS CUI [1]
C0032952
12. hospital admission within the last 30 days.
Description

Hospital admission

Type de données

boolean

Alias
UMLS CUI [1]
C0184666
13. on experimental drug protocols.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
14. significant cardiac or vascular disease (symptomatic disease; cv event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
Description

Heart Disease | Vascular Disease | Disease Symptomatic | Cardiovascular event | Atherosclerotic occlusive disease | Ischemia | Diagnosis, Noninvasive | Diagnostic procedure Invasive

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0042373
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C1320716
UMLS CUI [5]
C0543822
UMLS CUI [6]
C0022116
UMLS CUI [7]
C0259832
UMLS CUI [8,1]
C0430022
UMLS CUI [8,2]
C0205281
15. significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
Description

Physical disability | Immobility | Arthropathy | Replacement; joint | Myopathy

Type de données

boolean

Alias
UMLS CUI [1]
C0520817
UMLS CUI [2]
C0231441
UMLS CUI [3]
C0022408
UMLS CUI [4]
C1442800
UMLS CUI [5]
C0026848
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Similar models

Eligibility Chronic Kidney Disease NCT00581269

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Disease Stage | MDRD formula eGFR
Item
1. patients with stage iii-iv (estimated gfr 20-59 min/ml) chronic kidney disease measured by mdrd formula.
boolean
C1561643 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C3839656 (UMLS CUI [2,1])
C3811844 (UMLS CUI [2,2])
Body mass index
Item
2. bmi ≥ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
3. age > 18 or < 65 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy greater than one year.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
5. ability to understand and provide informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory disorder | AIDS | HIV Seropositivity Excluded | Hepatitis C | Hepatitis B | Gout
Item
1. active inflammatory disease such as: aids (hiv seropositivity is not an exclusion criteria), active hepatitis c or b, active gout, other active inflammatory diseases.
boolean
C1290884 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0019699 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0018099 (UMLS CUI [6])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
2. active malignancy excluding basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
3. patients suffering from type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Calorie intake per day Reduced | Malnutrition
Item
4. patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
boolean
C2095644 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0162429 (UMLS CUI [2])
Exercise regime Consistent Strenuous
Item
5. patients who are already on a consistent and rigorous exercise regimen.
boolean
C0454291 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1514989 (UMLS CUI [1,3])
Gastrointestinal dysfunction | Parenteral Nutrition Patient need for
Item
6. gastrointestinal dysfunction requiring parental nutrition.
boolean
C0679407 (UMLS CUI [1])
C0030547 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Kidney Transplantation Functional
Item
7. 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 Expected
Item
8. anticipated live donor kidney transplant over study duration.
boolean
C0401177 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Anti-Inflammatory Agents | Aspirin
Item
9. patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
boolean
C0003209 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
Vitamin E supplement U/day | Ascorbic Acid U/day
Item
10. patients taking vitamin e supplements > 60 iu/day, vitamin c > 500mg/day over the past 30days.
boolean
C3661607 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0003968 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Prednisone
Item
11. patients taking any prednisone therapy.
boolean
C0032952 (UMLS CUI [1])
Hospital admission
Item
12. hospital admission within the last 30 days.
boolean
C0184666 (UMLS CUI [1])
Investigational New Drugs
Item
13. on experimental drug protocols.
boolean
C0013230 (UMLS CUI [1])
Heart Disease | Vascular Disease | Disease Symptomatic | Cardiovascular event | Atherosclerotic occlusive disease | Ischemia | Diagnosis, Noninvasive | Diagnostic procedure Invasive
Item
14. significant cardiac or vascular disease (symptomatic disease; cv event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
boolean
C0018799 (UMLS CUI [1])
C0042373 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1320716 (UMLS CUI [4])
C0543822 (UMLS CUI [5])
C0022116 (UMLS CUI [6])
C0259832 (UMLS CUI [7])
C0430022 (UMLS CUI [8,1])
C0205281 (UMLS CUI [8,2])
Physical disability | Immobility | Arthropathy | Replacement; joint | Myopathy
Item
15. significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
boolean
C0520817 (UMLS CUI [1])
C0231441 (UMLS CUI [2])
C0022408 (UMLS CUI [3])
C1442800 (UMLS CUI [4])
C0026848 (UMLS CUI [5])
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