ID

20087

Description

Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT01502137

Link

https://clinicaltrials.gov/show/NCT01502137

Keywords

Versions (1)
  1. 2/6/17 2/6/17 -
Uploaded on

February 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT01502137

English

Eligibility Chronic Kidney Disease NCT01502137

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients:
Description

Patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
male or female, age equal to or above 18 years undergoing chronic haemodialysis
Description

Age | Chronic haemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1740835
stable and adequate haemodialysis treatment three months prior to enrolment
Description

Hemodialysis Stable Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0205411
healthy subjects:
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
matching an individual of the patient group by: gender and age (± 5 years)
Description

Matching Individual Group as study subject | Gender | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C1708943
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0681860
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
matching an individual of the patient group by weight (after dialysis, ±10%)
Description

Matching Individual Group as study subject | Body Weight Post Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1708943
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0681860
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0011946
creatinine clearance above 80 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
subjects must be in good health in accordance with their age as determined by a medical
Description

Overall Well Being Age Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0205411
history, physical examination, vital signs, ecg (electrocardiogram), routine haematology and clinical chemistry
Description

Medical History | Physical Examination | Vital signs | Electrocardiography | Hematology procedure | Clinical Chemistry Test

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0518766
UMLS CUI [4]
C1623258
UMLS CUI [5]
C0200627
UMLS CUI [6]
C0525044
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of cuprophane membranes
Description

cuprophane membranes

Data type

boolean

Alias
UMLS CUI [1,1]
C0056591
UMLS CUI [1,2]
C0025255
active malignant disease
Description

Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
critical illness as defined by the need of respiratory or circulatory support
Description

Critical Illness | Support respiratory Patient need for | Support circulatory Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2,1]
C1521721
UMLS CUI [2,2]
C0521346
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C1521721
UMLS CUI [3,2]
C0005775
UMLS CUI [3,3]
C0686904
known or suspected allergy to the trial product
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Fertile Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0015895
UMLS CUI [4,3]
C0032961
using inadequate contraceptive measures
Description

Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205412
blood pressure (pre-dialysis) above 180/110
Description

Blood Pressure Pre-dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1264634
chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
Description

Steroids chronic | Prednisolone Dose U/day | Prednisolone Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0032950
UMLS CUI [3,2]
C0205163
treated with immunosuppressive agents
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
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Similar models

Eligibility Chronic Kidney Disease NCT01502137

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients
Item
patients:
boolean
C0030705 (UMLS CUI [1])
Age | Chronic haemodialysis
Item
male or female, age equal to or above 18 years undergoing chronic haemodialysis
boolean
C0001779 (UMLS CUI [1])
C1740835 (UMLS CUI [2])
Hemodialysis Stable Adequate
Item
stable and adequate haemodialysis treatment three months prior to enrolment
boolean
C0019004 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Healthy Volunteers
Item
healthy subjects:
boolean
C1708335 (UMLS CUI [1])
Matching Individual Group as study subject | Gender | Age
Item
matching an individual of the patient group by: gender and age (± 5 years)
boolean
C1708943 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0681860 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Matching Individual Group as study subject | Body Weight Post Dialysis
Item
matching an individual of the patient group by weight (after dialysis, ±10%)
boolean
C1708943 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0681860 (UMLS CUI [1,3])
C0005910 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Creatinine clearance measurement
Item
creatinine clearance above 80 ml/min
boolean
C0373595 (UMLS CUI [1])
Overall Well Being Age Adequate
Item
subjects must be in good health in accordance with their age as determined by a medical
boolean
C3813622 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Medical History | Physical Examination | Vital signs | Electrocardiography | Hematology procedure | Clinical Chemistry Test
Item
history, physical examination, vital signs, ecg (electrocardiogram), routine haematology and clinical chemistry
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0518766 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0200627 (UMLS CUI [5])
C0525044 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
cuprophane membranes
Item
use of cuprophane membranes
boolean
C0056591 (UMLS CUI [1,1])
C0025255 (UMLS CUI [1,2])
Malignant Neoplasm
Item
active malignant disease
boolean
C0006826 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Critical Illness | Support respiratory Patient need for | Support circulatory Patient need for
Item
critical illness as defined by the need of respiratory or circulatory support
boolean
C0010340 (UMLS CUI [1])
C1521721 (UMLS CUI [2,1])
C0521346 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C1521721 (UMLS CUI [3,1])
C0005775 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
known or suspected allergy to the trial product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Fertile Pregnancy
Item
pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0015895 (UMLS CUI [4,2])
C0032961 (UMLS CUI [4,3])
Contraceptive methods Inadequate
Item
using inadequate contraceptive measures
boolean
C0700589 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Blood Pressure Pre-dialysis
Item
blood pressure (pre-dialysis) above 180/110
boolean
C0005823 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
Steroids chronic | Prednisolone Dose U/day | Prednisolone Equivalent
Item
chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0032950 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Immunosuppressive Agents
Item
treated with immunosuppressive agents
boolean
C0021081 (UMLS CUI [1])
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