ID

24465

Description

Evaluation of Renal Drug Transport in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00690014

Link

https://clinicaltrials.gov/show/NCT00690014

Keywords

Versions (1)
  1. 8/2/17 8/2/17 -
Uploaded on

August 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00690014

English

Eligibility Kidney Disease NCT00690014

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult, aged 18 to 40 years
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
healthy based on review of past medical history and physical examination (normal biochemical screen and urinalysis)
Description

Healthy Medical History | Healthy Physical Examination | Biochemical finding Normal | Normal urinalysis

Data type

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C0428132
UMLS CUI [3,2]
C0205307
UMLS CUI [4]
C0749920
signed inform consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any medications taken within 48 hours prior to study
Description

Pharmaceutical Preparations Intake Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0332185
history of gout or gouty arthritis
Description

Gout | Arthritis, Gouty

Data type

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0003868
history of uric acid
Description

Uric Acid

Data type

boolean

Alias
UMLS CUI [1]
C0041980
kidney stones
Description

Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0022650
history of known allergic or adverse reactions to diagnostic iodine containing compounds including iothalamate, pah or probenecid, will be excluded.
Description

Allergic Reaction Compound Containing Iodine | Adverse reactions Compound Containing Iodine | Allergic Reaction Iothalamate | Adverse reactions Iothalamate | Allergic Reaction PAH | Adverse reactions PAH | Allergic Reaction Probenecid | Adverse reactions Probenecid

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0021968
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0021968
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0022032
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C0022032
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0030123
UMLS CUI [6,1]
C0559546
UMLS CUI [6,2]
C0030123
UMLS CUI [7,1]
C1527304
UMLS CUI [7,2]
C0033209
UMLS CUI [8,1]
C0559546
UMLS CUI [8,2]
C0033209
subjects with current or preexisting liver disease (including hepatitis) as evidenced by elevated inr, liver transaminases (ast/alt), bilirubin, or serum albumin < 3.0 g/dl.
Description

Liver disease | Hepatitis | INR raised | Elevated hepatic transaminases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0853225
UMLS CUI [4]
C1848701
UMLS CUI [5]
C0151904
UMLS CUI [6]
C0151905
UMLS CUI [7]
C0741494
UMLS CUI [8]
C0523465
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Similar models

Eligibility Kidney Disease NCT00690014

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult, aged 18 to 40 years
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Healthy Medical History | Healthy Physical Examination | Biochemical finding Normal | Normal urinalysis
Item
healthy based on review of past medical history and physical examination (normal biochemical screen and urinalysis)
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0428132 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0749920 (UMLS CUI [4])
Informed Consent
Item
signed inform consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Intake Recent
Item
any medications taken within 48 hours prior to study
boolean
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Gout | Arthritis, Gouty
Item
history of gout or gouty arthritis
boolean
C0018099 (UMLS CUI [1])
C0003868 (UMLS CUI [2])
Uric Acid
Item
history of uric acid
boolean
C0041980 (UMLS CUI [1])
Kidney Calculi
Item
kidney stones
boolean
C0022650 (UMLS CUI [1])
Allergic Reaction Compound Containing Iodine | Adverse reactions Compound Containing Iodine | Allergic Reaction Iothalamate | Adverse reactions Iothalamate | Allergic Reaction PAH | Adverse reactions PAH | Allergic Reaction Probenecid | Adverse reactions Probenecid
Item
history of known allergic or adverse reactions to diagnostic iodine containing compounds including iothalamate, pah or probenecid, will be excluded.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0021968 (UMLS CUI [1,4])
C0559546 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0021968 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0022032 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C0022032 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0030123 (UMLS CUI [5,2])
C0559546 (UMLS CUI [6,1])
C0030123 (UMLS CUI [6,2])
C1527304 (UMLS CUI [7,1])
C0033209 (UMLS CUI [7,2])
C0559546 (UMLS CUI [8,1])
C0033209 (UMLS CUI [8,2])
Liver disease | Hepatitis | INR raised | Elevated hepatic transaminases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Serum albumin measurement
Item
subjects with current or preexisting liver disease (including hepatitis) as evidenced by elevated inr, liver transaminases (ast/alt), bilirubin, or serum albumin < 3.0 g/dl.
boolean
C0023895 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0853225 (UMLS CUI [3])
C1848701 (UMLS CUI [4])
C0151904 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
C0741494 (UMLS CUI [7])
C0523465 (UMLS CUI [8])
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