ID

42966

Descripción

Pharmacokinectics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity; ODM derived from: https://clinicaltrials.gov/show/NCT01709136

Link

https://clinicaltrials.gov/show/NCT01709136

Palabras clave

Versiones (2)
  1. 10/4/17 10/4/17 -
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT01709136

Inglés

Eligibility Hypertension NCT01709136

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
Descripción

Recipient Transplanted liver Primary | Transplant from cadaver Whole | Transplant from cadaver Segmental | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1280833
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C1456051
UMLS CUI [2,2]
C0439751
UMLS CUI [3,1]
C1456051
UMLS CUI [3,2]
C0205122
UMLS CUI [4]
C0001779
rejection-free post-transplant course for at least 3 months
Descripción

Liver transplant rejection Free of Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0400968
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0449238
renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
Descripción

Renal dysfunction | Creatinine clearance estimation decreased Age adjusted

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C1262229
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0456081
hypertension requiring anti-hypertensive mediations.
Descripción

Hypertensive disease Requirement Antihypertensive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003364
informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
weight ≥15 kg.
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
rejection or infections within 3 months of enrollment.
Descripción

Rejection | Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018129
UMLS CUI [2]
C3714514
intent to continue tac
Descripción

Tacrolimus Continue Intent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085149
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1283828
active participation in ongoing studies of immunosuppressive agents.
Descripción

Study Subject Participation Status | Immunosuppressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0021081
lack of informed consent.
Descripción

Informed Consent Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
pregnant or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hiv positive
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Hypertension NCT01709136

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Recipient Transplanted liver Primary | Transplant from cadaver Whole | Transplant from cadaver Segmental | Age
Item
recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
boolean
C1709854 (UMLS CUI [1,1])
C1280833 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1456051 (UMLS CUI [2,1])
C0439751 (UMLS CUI [2,2])
C1456051 (UMLS CUI [3,1])
C0205122 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Liver transplant rejection Free of Duration
Item
rejection-free post-transplant course for at least 3 months
boolean
C0400968 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Renal dysfunction | Creatinine clearance estimation decreased Age adjusted
Item
renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
boolean
C3279454 (UMLS CUI [1])
C1262229 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
Hypertensive disease Requirement Antihypertensive Agents
Item
hypertension requiring anti-hypertensive mediations.
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
Informed Consent
Item
informed consent.
boolean
C0021430 (UMLS CUI [1])
Body Weight
Item
weight ≥15 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rejection | Infection
Item
rejection or infections within 3 months of enrollment.
boolean
C0018129 (UMLS CUI [1])
C3714514 (UMLS CUI [2])
Tacrolimus Continue Intent
Item
intent to continue tac
boolean
C0085149 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Study Subject Participation Status | Immunosuppressive Agents
Item
active participation in ongoing studies of immunosuppressive agents.
boolean
C2348568 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Informed Consent Lacking
Item
lack of informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
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