ID

32665

Descrição

Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00788827

Link

https://clinicaltrials.gov/show/NCT00788827

Palavras-chave

  1. 11/11/2018 11/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Type 1 Diabetes NCT00788827

Eligibility Type 1 Diabetes NCT00788827

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged from 16 to 65 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient with type i or type 2 diabetes mellitus plus:
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
successful previous kidney transplant.
Descrição

Kidney Transplantation Successful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1272703
good kidney allograft function /no episodes of rejection for at least one year post-transplant
Descrição

Allograft kidney function Good | Graft rejection episode Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564454
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205170
UMLS CUI [2,1]
C0877542
UMLS CUI [2,2]
C0332197
not taking steroids as part of standard immuno-suppression
Descrição

Steroids Immunosuppression Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0021079
UMLS CUI [1,3]
C0332197
has a who performance score of less than 2
Descrição

WHO performance status scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
has a life expectancy of at least 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
ability to give written consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients below the age of 16 or above the age of 65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with chronic pancreatitis and poor exocrine pancreatic function
Descrição

Pancreatitis, Chronic | Exocrine pancreatic function test abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C1262139
pregnant or lactating women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with recent recurrent gi bleeding or spontaneous bacterial peritonitis
Descrição

Recurrent gastrointestinal bleeding | Spontaneous bacterial peritonitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0585174
UMLS CUI [2]
C0275551
patients with evidence of hiv or other life threatening infection
Descrição

HIV Infection | Life-threatening infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C1859430
patients unable to give written consent
Descrição

Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients with a history of hypersensitivity to g-csf
Descrição

Hypersensitivity G-CSF

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079459
patients who have been included in any other clinical trial within the previous month
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Type 1 Diabetes NCT00788827

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged from 16 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
patient with type i or type 2 diabetes mellitus plus:
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Kidney Transplantation Successful
Item
successful previous kidney transplant.
boolean
C0022671 (UMLS CUI [1,1])
C1272703 (UMLS CUI [1,2])
Allograft kidney function Good | Graft rejection episode Absent
Item
good kidney allograft function /no episodes of rejection for at least one year post-transplant
boolean
C0564454 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205170 (UMLS CUI [1,3])
C0877542 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Steroids Immunosuppression Absent
Item
not taking steroids as part of standard immuno-suppression
boolean
C0038317 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
WHO performance status scale
Item
has a who performance score of less than 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
has a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to give written consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients below the age of 16 or above the age of 65 years
boolean
C0001779 (UMLS CUI [1])
Pancreatitis, Chronic | Exocrine pancreatic function test abnormal
Item
patients with chronic pancreatitis and poor exocrine pancreatic function
boolean
C0149521 (UMLS CUI [1])
C1262139 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Recurrent gastrointestinal bleeding | Spontaneous bacterial peritonitis
Item
patients with recent recurrent gi bleeding or spontaneous bacterial peritonitis
boolean
C0585174 (UMLS CUI [1])
C0275551 (UMLS CUI [2])
HIV Infection | Life-threatening infection
Item
patients with evidence of hiv or other life threatening infection
boolean
C0019693 (UMLS CUI [1])
C1859430 (UMLS CUI [2])
Informed Consent Unable
Item
patients unable to give written consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity G-CSF
Item
patients with a history of hypersensitivity to g-csf
boolean
C0020517 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients who have been included in any other clinical trial within the previous month
boolean
C2348568 (UMLS CUI [1])

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