ID

31885

Descripción

Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD); ODM derived from: https://clinicaltrials.gov/show/NCT02115659

Link

https://clinicaltrials.gov/show/NCT02115659

Palabras clave

Versiones (1)
  1. 7/10/18 7/10/18 -
Titular de derechos de autor

Shanghai Changzheng Hospital

Subido en

7 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT02115659

Inglés

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT02115659

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adpkd patient older then 40 years of age without gender limitation
Descripción

ADPKD and Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085413
UMLS CUI [2]
C0001779
estimated glomerular filtration rate (egfr) higher than 60 ml/min 1.73m2
Descripción

GFR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017654
documented kidney volume progression with yearly increasing rate more than 6%
Descripción

Progressing kidney volume

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2827452
UMLS CUI [1,2]
C0205329
informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
Descripción

Pregnant, lactating or unwilling to use contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
impaired liver function as increased liver enzymes (2-fold above normal values)
Descripción

Increased liver enzymes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235996
uncontrolled hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) under lipid lowering therapy
Descripción

Uncontrolled Hypercholesterolemia or hypertriglyceridaemia under therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0020443
UMLS CUI [1,3]
C0585943
UMLS CUI [2,1]
C0205318
UMLS CUI [2,2]
C0020557
UMLS CUI [2,3]
C0585943
UMLS CUI [3]
C1445957
UMLS CUI [4]
C0542495
granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
Descripción

Granulocytopenia or Thrombocytopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001824
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0005821
hepatitis b or c, hiv infection
Descripción

Hepatitis B, C or HIV infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
malignancy
Descripción

Malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
mental illness that interfere with the patient ability to comply with the protocol
Descripción

Mental illness affecting compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
drug or alcohol abuse
Descripción

Drug or alcohol abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0013146
known hypersensitivity to similar drugs as triptolide-containing formulation
Descripción

Hypersensitivity to triptolide-containing drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0077274
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3827767
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT02115659

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ADPKD and Age
Item
adpkd patient older then 40 years of age without gender limitation
boolean
C0085413 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
GFR
Item
estimated glomerular filtration rate (egfr) higher than 60 ml/min 1.73m2
boolean
C0017654 (UMLS CUI [1])
Progressing kidney volume
Item
documented kidney volume progression with yearly increasing rate more than 6%
boolean
C2827452 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnant, lactating or unwilling to use contraception
Item
female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Increased liver enzymes
Item
impaired liver function as increased liver enzymes (2-fold above normal values)
boolean
C0235996 (UMLS CUI [1])
Uncontrolled Hypercholesterolemia or hypertriglyceridaemia under therapy
Item
uncontrolled hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) under lipid lowering therapy
boolean
C0205318 (UMLS CUI [1,1])
C0020443 (UMLS CUI [1,2])
C0585943 (UMLS CUI [1,3])
C0205318 (UMLS CUI [2,1])
C0020557 (UMLS CUI [2,2])
C0585943 (UMLS CUI [2,3])
C1445957 (UMLS CUI [3])
C0542495 (UMLS CUI [4])
Granulocytopenia or Thrombocytopenia
Item
granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
boolean
C0001824 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
Hepatitis B, C or HIV infection
Item
hepatitis b or c, hiv infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Malignancy
Item
malignancy
boolean
C0006826 (UMLS CUI [1])
Mental illness affecting compliance
Item
mental illness that interfere with the patient ability to comply with the protocol
boolean
C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Drug or alcohol abuse
Item
drug or alcohol abuse
boolean
C0085762 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Hypersensitivity to triptolide-containing drugs
Item
known hypersensitivity to similar drugs as triptolide-containing formulation
boolean
C0020517 (UMLS CUI [1,1])
C0077274 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3827767 (UMLS CUI [2,2])
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