ID

22087

Descrição

Iron Depletion Therapy for Type 2 DM and NAFLD; ODM derived from: https://clinicaltrials.gov/show/NCT00230087

Link

https://clinicaltrials.gov/show/NCT00230087

Palavras-chave

  1. 18/05/2017 18/05/2017 -
  2. 19/05/2017 19/05/2017 -
Transferido a

19 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological evidence of nafld and enrollment in nash crn database study
Descrição

Non-alcoholic Fatty Liver Disease | Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0400966
UMLS CUI [2]
C2348568
type 2 dm treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for > 3 mo.
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0359086
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
hemoglobin hba1c level ≤ 8 %
Descrição

Glucohemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202054
serum alt levels ≥1.3 x uln
Descrição

Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
between 18-65 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
hereditary hemochromatosis or hepatic iron overload defined as any of the following:
Descrição

Hereditary hemochromatosis | Iron Overload Hepatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392514
UMLS CUI [2,1]
C0282193
UMLS CUI [2,2]
C0205054
2+ iron on hepatic iron staining
Descrição

Iron Positive | Iron Hepatic Staining

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0302583
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0302583
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0487602
hepatic iron index ≥ 1.9
Descrição

Hepatic iron index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1954806
c282y homozygous or c282y/h63d compound heterozygous hfe genotype
Descrição

hfe gene c282y variant | hfe gene h63d variant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3468755
UMLS CUI [2]
C3468756
use of insulin or thiazolidinediones for the treatment of diabetes
Descrição

Insulin | Thiazolidinediones | Diabetes Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C3274787
use of anti-nash drugs (thiazolidinediones, vitamin e, udca, sam-e, betaine, milk thistle, gemfibrozil, anti-tnf therapies, probiotics)
Descrição

Pharmaceutical Preparations Against Nonalcoholic Steatohepatitis | Thiazolidinediones | Vitamin E | Ursodiol | S-Adenosylmethionine | Betaine | Milk thistle extract | Gemfibrozil | anti-tumor necrosis factor therapy | Probiotics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C3241937
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0042874
UMLS CUI [4]
C0042105
UMLS CUI [5]
C0036002
UMLS CUI [6]
C0005304
UMLS CUI [7]
C0937640
UMLS CUI [8]
C0017245
UMLS CUI [9]
C0281481
UMLS CUI [10]
C0525033
serum ferritin <50μg/l
Descrição

Serum ferritin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0696113
serum transferrin-iron saturation <10 %
Descrição

Transferrin saturation measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1277709
hemoglobin <10 mg/l
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
hematocrit <38 %
Descrição

Hematocrit level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518014
voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
Descrição

Blood Donation Voluntary | Venesection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439656
UMLS CUI [2]
C0684257
pregnant or lactating women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
Descrição

Coronary Artery Disease | Myocardial Infarction | Dyspnea on exertion | Chest pain at rest chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0231807
UMLS CUI [4,1]
C0392685
UMLS CUI [4,2]
C0205191
evidence of myocardial infarction as determined by an ecg
Descrição

Electrocardiogram: myocardial infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428953

Similar models

Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-alcoholic Fatty Liver Disease | Study Subject Participation Status
Item
histological evidence of nafld and enrollment in nash crn database study
boolean
C0400966 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable
Item
type 2 dm treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for > 3 mo.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0359086 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Glucohemoglobin measurement
Item
hemoglobin hba1c level ≤ 8 %
boolean
C0202054 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum alt levels ≥1.3 x uln
boolean
C0201836 (UMLS CUI [1])
Age
Item
between 18-65 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hereditary hemochromatosis | Iron Overload Hepatic
Item
hereditary hemochromatosis or hepatic iron overload defined as any of the following:
boolean
C0392514 (UMLS CUI [1])
C0282193 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
Iron Positive | Iron Hepatic Staining
Item
2+ iron on hepatic iron staining
boolean
C0302583 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0302583 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0487602 (UMLS CUI [2,3])
Hepatic iron index
Item
hepatic iron index ≥ 1.9
boolean
C1954806 (UMLS CUI [1])
hfe gene c282y variant | hfe gene h63d variant
Item
c282y homozygous or c282y/h63d compound heterozygous hfe genotype
boolean
C3468755 (UMLS CUI [1])
C3468756 (UMLS CUI [2])
Insulin | Thiazolidinediones | Diabetes Therapy
Item
use of insulin or thiazolidinediones for the treatment of diabetes
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C3274787 (UMLS CUI [3])
Pharmaceutical Preparations Against Nonalcoholic Steatohepatitis | Thiazolidinediones | Vitamin E | Ursodiol | S-Adenosylmethionine | Betaine | Milk thistle extract | Gemfibrozil | anti-tumor necrosis factor therapy | Probiotics
Item
use of anti-nash drugs (thiazolidinediones, vitamin e, udca, sam-e, betaine, milk thistle, gemfibrozil, anti-tnf therapies, probiotics)
boolean
C0013227 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C3241937 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2])
C0042874 (UMLS CUI [3])
C0042105 (UMLS CUI [4])
C0036002 (UMLS CUI [5])
C0005304 (UMLS CUI [6])
C0937640 (UMLS CUI [7])
C0017245 (UMLS CUI [8])
C0281481 (UMLS CUI [9])
C0525033 (UMLS CUI [10])
Serum ferritin measurement
Item
serum ferritin <50μg/l
boolean
C0696113 (UMLS CUI [1])
Transferrin saturation measurement
Item
serum transferrin-iron saturation <10 %
boolean
C1277709 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <10 mg/l
boolean
C0518015 (UMLS CUI [1])
Hematocrit level
Item
hematocrit <38 %
boolean
C0518014 (UMLS CUI [1])
Blood Donation Voluntary | Venesection
Item
voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
boolean
C0005794 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
C0684257 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Coronary Artery Disease | Myocardial Infarction | Dyspnea on exertion | Chest pain at rest chronic
Item
prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0231807 (UMLS CUI [3])
C0392685 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Electrocardiogram: myocardial infarction
Item
evidence of myocardial infarction as determined by an ecg
boolean
C0428953 (UMLS CUI [1])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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