ID

42528

Description

Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01091324

Link

https://clinicaltrials.gov/show/NCT01091324

Keywords

Versions (1)
  1. 8/18/21 8/18/21 -
Copyright Holder

National Cheng-Kung University Hospital

Uploaded on

August 18, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Proteinuria NCT01091324

English

Eligibility Proteinuria NCT01091324

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with stage 3 or 4 chronic kidney disease as measured by a modification in diet in renal disease study (mdrd) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day<proteinuria<3g/day.
Description

Chronic kidney disease stage | MDRD estimate | Proteinuria

Data type

boolean

Alias
UMLS CUI [1,1]
C2074731
UMLS CUI [1,2]
C3839656
UMLS CUI [1,3]
C0033687
2. age between 18 and 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
Description

Recent hospitalization for cardiac morbidity absent | Recent hospitalization for infection related morbidity absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0018799
UMLS CUI [1,4]
C0332185
UMLS CUI [1,5]
C0332197
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0009450
UMLS CUI [2,4]
C0332185
UMLS CUI [2,5]
C0332197
4. patients who are able to provide consent to participate in the study.-
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients will significant mental illness, pregnant women, and other vulnerable populations.
Description

Significant mental illness | Pregnancy | Other vulnerable populations

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C0949366
UMLS CUI [3,2]
C0205394
2. patients with active hepatic disease and/or alt > 2.5 times upper limit of normal.
Description

Active hepatic disease | ALT mesurement increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0442805
3. patients with history of congestive heart failure and nyha class iii-iv symptoms at any time.
Description

History of congestive heart failure | NYHA classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018802
UMLS CUI [1,3]
C1275491
UMLS CUI [1,4]
C1457887
4. patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
Description

Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluate

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0348050
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0348050
UMLS CUI [2,3]
C0220825
5. patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, hiv infection with aids).
Description

Severe comorbidities

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
6. patient with active inflammatory process (eg., sle, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
Description

Receiving immune modulating medications due to active inflammation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678889
UMLS CUI [1,3]
C0021368
UMLS CUI [1,4]
C0205177
UMLS CUI [1,5]
C0678226
7. patients who are on corticosteroid therapy.
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
8. patients who do not consent to participate in the study.
Description

Informed consent absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Proteinuria NCT01091324

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic kidney disease stage | MDRD estimate | Proteinuria
Item
1. patients with stage 3 or 4 chronic kidney disease as measured by a modification in diet in renal disease study (mdrd) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day<proteinuria<3g/day.
boolean
C2074731 (UMLS CUI [1,1])
C3839656 (UMLS CUI [1,2])
C0033687 (UMLS CUI [1,3])
Age
Item
2. age between 18 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
Recent hospitalization for cardiac morbidity absent | Recent hospitalization for infection related morbidity absent
Item
3. patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0332197 (UMLS CUI [1,5])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
C0332185 (UMLS CUI [2,4])
C0332197 (UMLS CUI [2,5])
Informed consent
Item
4. patients who are able to provide consent to participate in the study.-
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Significant mental illness | Pregnancy | Other vulnerable populations
Item
1. patients will significant mental illness, pregnant women, and other vulnerable populations.
boolean
C0004936 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0949366 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Active hepatic disease | ALT mesurement increased
Item
2. patients with active hepatic disease and/or alt > 2.5 times upper limit of normal.
boolean
C0023895 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
History of congestive heart failure | NYHA classification
Item
3. patients with history of congestive heart failure and nyha class iii-iv symptoms at any time.
boolean
C0262926 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluate
Item
4. patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
boolean
C0022671 (UMLS CUI [1,1])
C0348050 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0022671 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Severe comorbidities
Item
5. patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, hiv infection with aids).
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Receiving immune modulating medications due to active inflammation
Item
6. patient with active inflammatory process (eg., sle, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
boolean
C0013227 (UMLS CUI [1,1])
C0678889 (UMLS CUI [1,2])
C0021368 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0678226 (UMLS CUI [1,5])
Adrenal Cortex Hormones
Item
7. patients who are on corticosteroid therapy.
boolean
C0001617 (UMLS CUI [1])
Informed consent absent
Item
8. patients who do not consent to participate in the study.
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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