ID

31582

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.09.18 07.09.18 -
Rechteinhaber

Mario Negri Institute for Pharmacological Research

Hochgeladen am

7. September 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

Englisch

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years
Beschreibung

Age

Datentyp

boolean

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

Clinical and ultrasound diagnosis of adpkd

Datentyp

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)
Beschreibung

gfr estimation by MDRD

Datentyp

boolean

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

Urinary protein excretion rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3897352
written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes
Beschreibung

Diabetes

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Urinary tract lithiasis, infection or obstruction

Datentyp

boolean

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

Cancer

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

Pregnancy, lactation or child bearing potential and ineffective contraception

Datentyp

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
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Ähnliche Modelle

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01223755

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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