ID

19548

Beschrijving

Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD); ODM derived from: https://clinicaltrials.gov/show/NCT00346918

Link

https://clinicaltrials.gov/show/NCT00346918

Trefwoorden

Versies (1)
  1. 09-01-17 09-01-17 -
Geüploaded op

9 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

Engels

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female adpkd patient between 18 and 40 years of age
Beschrijving

Polycystic Kidney, Autosomal Dominant | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0085413
UMLS CUI [2]
C0001779
measured gfr higher than 70 ml/min 1.73m2
Beschrijving

Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0017654
documented kidney volume progression
Beschrijving

Kidney Volume Progressive

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Childbearing Potential Planned Pregnancy | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032992
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
increased liver enzymes (2-fold above normal values)
Beschrijving

Elevated liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C0235996
hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy
Beschrijving

Hypercholesterolemia Uncontrolled | Fasting cholesterol level | Hypertriglyceridemia Uncontrolled | Lipid-lowering therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020443
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1282513
UMLS CUI [3,1]
C0020557
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0585943
granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3),
Beschrijving

Agranulocytosis | White Blood Cell Count procedure | Thrombocytopenia | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0001824
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0032181
infection with hepatitis b or c, hiv
Beschrijving

Hepatitis B | Hepatitis C | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
any past or present malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

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

Mental disorder Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
drug or alcohol abuse within one year of baseline
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
co-medication with strong inhibitor of cyp3a4 and or p-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin
Beschrijving

Cytochrome P450 3A4 Inhibitor Strong | P-Glycoprotein Similarity | Voriconazole | Ketoconazole | Diltiazem | Verapamil | Erythromycin

Datatype

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C0242643
UMLS CUI [2,2]
C2348205
UMLS CUI [3]
C0393080
UMLS CUI [4]
C0022625
UMLS CUI [5]
C0012373
UMLS CUI [6]
C0042523
UMLS CUI [7]
C0014806
co-medication with strong cyp3a4 and or p-gp inductor like rifampicin
Beschrijving

Cytochrome P-450 CYP3A4 Strong | P-Glycoprotein Inducer Similarity | Rifampin

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714798
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C0242643
UMLS CUI [2,2]
C3898767
UMLS CUI [2,3]
C2348205
UMLS CUI [3]
C0035608
known hypersensitivity to macrolides or rapamune
Beschrijving

Macrolide allergy | Hypersensitivity Rapamune

Datatype

boolean

Alias
UMLS CUI [1]
C0571383
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0813828
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Polycystic Kidney, Autosomal Dominant | Age
Item
male or female adpkd patient between 18 and 40 years of age
boolean
C0085413 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Glomerular Filtration Rate
Item
measured gfr higher than 70 ml/min 1.73m2
boolean
C0017654 (UMLS CUI [1])
Kidney Volume Progressive
Item
documented kidney volume progression
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)
Childbearing Potential Planned Pregnancy | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
female of childbearing potential who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Elevated liver enzymes
Item
increased liver enzymes (2-fold above normal values)
boolean
C0235996 (UMLS CUI [1])
Hypercholesterolemia Uncontrolled | Fasting cholesterol level | Hypertriglyceridemia Uncontrolled | Lipid-lowering therapy
Item
hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy
boolean
C0020443 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1282513 (UMLS CUI [2])
C0020557 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0585943 (UMLS CUI [4])
Agranulocytosis | White Blood Cell Count procedure | Thrombocytopenia | Platelet Count measurement
Item
granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3),
boolean
C0001824 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Hepatitis B | Hepatitis C | HIV Infection
Item
infection with hepatitis b or c, hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Malignant Neoplasms
Item
any past or present malignancy
boolean
C0006826 (UMLS CUI [1])
Mental disorder Interferes with Protocol Compliance
Item
mental illness that interfere with the patient ability to comply with the protocol
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Substance Use Disorders
Item
drug or alcohol abuse within one year of baseline
boolean
C0038586 (UMLS CUI [1])
Cytochrome P450 3A4 Inhibitor Strong | P-Glycoprotein Similarity | Voriconazole | Ketoconazole | Diltiazem | Verapamil | Erythromycin
Item
co-medication with strong inhibitor of cyp3a4 and or p-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0242643 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
C0393080 (UMLS CUI [3])
C0022625 (UMLS CUI [4])
C0012373 (UMLS CUI [5])
C0042523 (UMLS CUI [6])
C0014806 (UMLS CUI [7])
Cytochrome P-450 CYP3A4 Strong | P-Glycoprotein Inducer Similarity | Rifampin
Item
co-medication with strong cyp3a4 and or p-gp inductor like rifampicin
boolean
C3714798 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0242643 (UMLS CUI [2,1])
C3898767 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0035608 (UMLS CUI [3])
Macrolide allergy | Hypersensitivity Rapamune
Item
known hypersensitivity to macrolides or rapamune
boolean
C0571383 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0813828 (UMLS CUI [2,2])
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