ID

19548

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00346918

Palabras clave

Versiones (1)
  1. 9/1/17 9/1/17 -
Subido en

9 de enero de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

Inglés

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Polycystic Kidney, Autosomal Dominant | Age

Tipo de datos

boolean

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

Glomerular Filtration Rate

Tipo de datos

boolean

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

Kidney Volume Progressive

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 of childbearing potential who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
Descripción

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

Tipo de datos

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)
Descripción

Elevated liver enzymes

Tipo de datos

boolean

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

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

Tipo de datos

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),
Descripción

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

Tipo de datos

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
Descripción

Hepatitis B | Hepatitis C | HIV Infection

Tipo de datos

boolean

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

Malignant Neoplasms

Tipo de datos

boolean

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

Mental disorder Interferes with Protocol Compliance

Tipo de datos

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
Descripción

Substance Use Disorders

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Macrolide allergy | Hypersensitivity Rapamune

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571383
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0813828
Volver a la parte superior de la página

Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT00346918

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial