ID

12932

Description

Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.; ODM derived from: https://clinicaltrials.gov/show/NCT00184769

Link

https://clinicaltrials.gov/show/NCT00184769

Keywords

Versions (1)
  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Chronic Kidney Disease NCT00184769

English

Eligibility Chronic Kidney Disease NCT00184769

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
Description

patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0151686
to be included in the trial, patients must meet all of the following inclusion criteria a.)-c.):
Description

inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
a.) male or female infants with a chronological age of 12 ± 3 months
Description

a.) male or female infants with a chronological age of 12 ± 3 months

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
b.) chronic renal insufficiency with glomerular filtration rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
Description

b.) chronic renal insufficiency with glomerular filtration rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center

Data type

boolean

Alias
UMLS CUI [1]
C0017654
c.) growth retardation documented at the start of the trial, according to the following criteria: length less than -2 sds by chronological age and sex and linear growth velocity <p50 according to the hernández standards and to lubchenko in the case of infants born prematurely (<37 weeks)
Description

c.) growth retardation documented at the start of the trial, according to the following criteria: length less than -2 sds by chronological age and sex and linear growth velocity <p50 according to the hernández standards and to lubchenko in the case of infants born prematurely (<37 weeks)

Data type

boolean

Alias
UMLS CUI [1]
C0151686
conservative treatment or chronic peritoneal dialysis
Description

conservative treatment or chronic peritoneal dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0031139
euthyroid
Description

euthyroid

Data type

boolean

Alias
UMLS CUI [1]
C0117002
the parent or guardian must give informed consent to the child's participation in the study before any trial related activities. trial related activities are any procedures that would not have been performed during the normal management of the subject
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
optimal nutritional management criteria met
Description

nutritional management

Data type

boolean

Alias
UMLS CUI [1]
C0392209
appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance
Description

appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance

Data type

boolean

Alias
UMLS CUI [1]
C0020502
UMLS CUI [2]
C0013832
UMLS CUI [3]
C0740747
UMLS CUI [4]
C2945688
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any primary endocrinological disorder and severe renal osteodystrophy.other causes, apart from cri, giving rise to growth retardation.hydrocephalus.
Description

any primary endocrinological disorder and severe renal osteodystrophy.other causes, apart from cri, giving rise to growth retardation.hydrocephalus.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
known or suspected allergy to the trial product or related products.
Description

known or suspected allergy to the trial product or related products.

Data type

boolean

Alias
UMLS CUI [1]
C0020517
treatment with corticosteroids within the last six months.
Description

corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0001617
renal disease due to the fanconi syndrome or to oxalosis (except if not under dialysis).
Description

fanconi syndrome or to oxalosis

Data type

boolean

Alias
UMLS CUI [1]
C0015624
UMLS CUI [2]
C1298681
known or suspected malignancy.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Chronic Kidney Disease NCT00184769

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
Item
patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
boolean
C0079399 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0151686 (UMLS CUI [3])
inclusion criteria
Item
to be included in the trial, patients must meet all of the following inclusion criteria a.)-c.):
boolean
C1512693 (UMLS CUI [1])
a.) male or female infants with a chronological age of 12 ± 3 months
Item
a.) male or female infants with a chronological age of 12 ± 3 months
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
b.) chronic renal insufficiency with glomerular filtration rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
Item
b.) chronic renal insufficiency with glomerular filtration rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
boolean
C0017654 (UMLS CUI [1])
c.) growth retardation documented at the start of the trial, according to the following criteria: length less than -2 sds by chronological age and sex and linear growth velocity <p50 according to the hernández standards and to lubchenko in the case of infants born prematurely (<37 weeks)
Item
c.) growth retardation documented at the start of the trial, according to the following criteria: length less than -2 sds by chronological age and sex and linear growth velocity <p50 according to the hernández standards and to lubchenko in the case of infants born prematurely (<37 weeks)
boolean
C0151686 (UMLS CUI [1])
conservative treatment or chronic peritoneal dialysis
Item
conservative treatment or chronic peritoneal dialysis
boolean
C0087111 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
euthyroid
Item
euthyroid
boolean
C0117002 (UMLS CUI [1])
informed consent
Item
the parent or guardian must give informed consent to the child's participation in the study before any trial related activities. trial related activities are any procedures that would not have been performed during the normal management of the subject
boolean
C0021430 (UMLS CUI [1])
nutritional management
Item
optimal nutritional management criteria met
boolean
C0392209 (UMLS CUI [1])
appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance
Item
appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance
boolean
C0020502 (UMLS CUI [1])
C0013832 (UMLS CUI [2])
C0740747 (UMLS CUI [3])
C2945688 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
any primary endocrinological disorder and severe renal osteodystrophy.other causes, apart from cri, giving rise to growth retardation.hydrocephalus.
Item
any primary endocrinological disorder and severe renal osteodystrophy.other causes, apart from cri, giving rise to growth retardation.hydrocephalus.
boolean
C0009488 (UMLS CUI [1])
known or suspected allergy to the trial product or related products.
Item
known or suspected allergy to the trial product or related products.
boolean
C0020517 (UMLS CUI [1])
corticosteroids
Item
treatment with corticosteroids within the last six months.
boolean
C0001617 (UMLS CUI [1])
fanconi syndrome or to oxalosis
Item
renal disease due to the fanconi syndrome or to oxalosis (except if not under dialysis).
boolean
C0015624 (UMLS CUI [1])
C1298681 (UMLS CUI [2])
malignancy
Item
known or suspected malignancy.
boolean
C0006826 (UMLS CUI [1])
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