ID

31582

Description

Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT01223755 Sponsor: Mario Negri Institute for Pharmacological Research Information provided by (Responsible Party): Mario Negri Institute for Pharmacological Research

Link

https://clinicaltrials.gov/show/NCT01223755

Keywords

  1. 9/7/18 9/7/18 -
Copyright Holder

Mario Negri Institute for Pharmacological Research

Uploaded on

September 7, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
clinical and ultrasound diagnosis of adpkd
Description

Clinical and ultrasound diagnosis of adpkd

Data type

boolean

Alias
UMLS CUI [1,1]
C0085413
UMLS CUI [1,2]
C0332140
UMLS CUI [2,1]
C0085413
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0041618
gfr 40-15 ml/min/1.73 m2 (estimated by the 4 variable mdrd equation)
Description

gfr estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C1316377
urinary protein excretion rate < 0.5 g/ 24 hrs
Description

Urinary protein excretion rate

Data type

boolean

Alias
UMLS CUI [1]
C3897352
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes
Description

Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
urinary protein excretion rate >0.5 g/ 24 hrs or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease
Description

Urinary protein excretion rate, urinalysis suggestive of clinically significant glomerular disease

Data type

boolean

Alias
UMLS CUI [1]
C3897352
UMLS CUI [2,1]
C0042014
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0268731
urinary tract lithiasis, infection or obstruction
Description

Urinary tract lithiasis, infection or obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0451641
UMLS CUI [2]
C0042029
UMLS CUI [3]
C0178879
cancer
Description

Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
Description

Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study

Data type

boolean

Alias
UMLS CUI [1]
C0004936
pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)
Description

Pregnancy, lactation or child bearing potential and ineffective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C3242229

Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Clinical and ultrasound diagnosis of adpkd
Item
clinical and ultrasound diagnosis of adpkd
boolean
C0085413 (UMLS CUI [1,1])
C0332140 (UMLS CUI [1,2])
C0085413 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
gfr estimation by MDRD
Item
gfr 40-15 ml/min/1.73 m2 (estimated by the 4 variable mdrd equation)
boolean
C1316377 (UMLS CUI [1])
Urinary protein excretion rate
Item
urinary protein excretion rate < 0.5 g/ 24 hrs
boolean
C3897352 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Urinary protein excretion rate, urinalysis suggestive of clinically significant glomerular disease
Item
urinary protein excretion rate >0.5 g/ 24 hrs or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease
boolean
C3897352 (UMLS CUI [1])
C0042014 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0268731 (UMLS CUI [2,3])
Urinary tract lithiasis, infection or obstruction
Item
urinary tract lithiasis, infection or obstruction
boolean
C0451641 (UMLS CUI [1])
C0042029 (UMLS CUI [2])
C0178879 (UMLS CUI [3])
Cancer
Item
cancer
boolean
C0006826 (UMLS CUI [1])
Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
Item
psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
boolean
C0004936 (UMLS CUI [1])
Pregnancy, lactation or child bearing potential and ineffective contraception
Item
pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3242229 (UMLS CUI [3,3])

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