ID

31885

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.10.18 07.10.18 -
Rechteinhaber

Shanghai Changzheng Hospital

Hochgeladen am

7. Oktober 2018

DOI

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Lizenz

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

Englisch

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT02115659

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

ADPKD and Age

Datentyp

boolean

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

GFR

Datentyp

boolean

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

Progressing kidney volume

Datentyp

boolean

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

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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
Beschreibung

Pregnant, lactating or unwilling to use contraception

Datentyp

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)
Beschreibung

Increased liver enzymes

Datentyp

boolean

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

Uncontrolled Hypercholesterolemia or hypertriglyceridaemia under therapy

Datentyp

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)
Beschreibung

Granulocytopenia or Thrombocytopenia

Datentyp

boolean

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

Hepatitis B, C or HIV infection

Datentyp

boolean

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

Malignancy

Datentyp

boolean

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

Mental illness affecting compliance

Datentyp

boolean

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

Drug or alcohol abuse

Datentyp

boolean

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

Hypersensitivity to triptolide-containing drugs

Datentyp

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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Ähnliche Modelle

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT02115659

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