ID

39625

Descrição

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01197157

Link

https://clinicaltrials.gov/show/NCT01197157

Palavras-chave

Versões (1)
  1. 05/02/2020 05/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de fevereiro de 2020

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.

Voltar para os comentários do modelo
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 Hepatitis C NCT01197157

Inglês

Eligibility Hepatitis C NCT01197157

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 and <60.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
liver biopsy showing chronic hepatitis with significant fibrosis using ishak scoring system.
Descrição

Chronic Hepatitis Biopsy of liver | Fibrosis Ishak Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0016059
UMLS CUI [2,2]
C2986945
compensated liver disease; serum bilirubin < 1.5 mg/dl, inr no more than 1.5, serum albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
Descrição

Compensated liver disease | Serum total bilirubin measurement | International Normalized Ratio | Serum albumin measurement | Platelet Count measurement | Hepatic decompensation Absent | Hepatic Encephalopathy Absent | Ascites Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0523465
UMLS CUI [5]
C0032181
UMLS CUI [6,1]
C1394798
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0019151
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0003962
UMLS CUI [8,2]
C0332197
acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.
Descrição

Index Hematological Acceptable | Index Biochemical Acceptable | Hemoglobin measurement | Gender | Neutrophil count | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0918012
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C1879533
UMLS CUI [2,1]
C0918012
UMLS CUI [2,2]
C0205474
UMLS CUI [2,3]
C1879533
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0201976
willing to be treated and to adhere to treatment requirements
Descrição

Treatment Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4319828
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
major uncontrolled depressive illness.
Descrição

Major Depressive Disorder Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205318
solid organ transplantation.
Descrição

Solid organ transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730400
autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
Descrição

Autoimmune Diseases | Exacerbation Due to PEGINTERFERON | Exacerbation Due to Ribavirin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0982327
UMLS CUI [3,1]
C4086268
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0035525
untreated thyroid disease.
Descrição

Thyroid Disease Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0332155
pregnant or unwilling to comply with adequate contraception.
Descrição

Pregnancy | Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
Descrição

Comorbidity Severe | Hypertension, severe | Heart failure | Coronary heart disease | Poorly controlled diabetes mellitus | Chronic Obstructive Airway Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C4013784
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0010068
UMLS CUI [5]
C0554876
UMLS CUI [6]
C0024117
known hypersensitivity to drugs used to treat hcv.
Descrição

Hypersensitivity Anti-hepatitis C (HCV) Agents,

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4324240
Voltar ao início da página

Similar models

Eligibility Hepatitis C NCT01197157

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 and <60.
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis Biopsy of liver | Fibrosis Ishak Score
Item
liver biopsy showing chronic hepatitis with significant fibrosis using ishak scoring system.
boolean
C0019189 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0016059 (UMLS CUI [2,1])
C2986945 (UMLS CUI [2,2])
Compensated liver disease | Serum total bilirubin measurement | International Normalized Ratio | Serum albumin measurement | Platelet Count measurement | Hepatic decompensation Absent | Hepatic Encephalopathy Absent | Ascites Absent
Item
compensated liver disease; serum bilirubin < 1.5 mg/dl, inr no more than 1.5, serum albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
boolean
C3839044 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1394798 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0019151 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0003962 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Index Hematological Acceptable | Index Biochemical Acceptable | Hemoglobin measurement | Gender | Neutrophil count | Creatinine measurement, serum
Item
acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.
boolean
C0918012 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Treatment Compliance
Item
willing to be treated and to adhere to treatment requirements
boolean
C4319828 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Major Depressive Disorder Uncontrolled
Item
major uncontrolled depressive illness.
boolean
C1269683 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Solid organ transplant
Item
solid organ transplantation.
boolean
C0730400 (UMLS CUI [1])
Autoimmune Diseases | Exacerbation Due to PEGINTERFERON | Exacerbation Due to Ribavirin
Item
autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
boolean
C0004364 (UMLS CUI [1])
C4086268 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0982327 (UMLS CUI [2,3])
C4086268 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Thyroid Disease Untreated
Item
untreated thyroid disease.
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Pregnancy | Contraceptive methods Unwilling
Item
pregnant or unwilling to comply with adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Severe | Hypertension, severe | Heart failure | Coronary heart disease | Poorly controlled diabetes mellitus | Chronic Obstructive Airway Disease
Item
severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4013784 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0010068 (UMLS CUI [4])
C0554876 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
Hypersensitivity Anti-hepatitis C (HCV) Agents,
Item
known hypersensitivity to drugs used to treat hcv.
boolean
C0020517 (UMLS CUI [1,1])
C4324240 (UMLS CUI [1,2])
Voltar ao início da página 

Contacto

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

Campos marcados com * são obrigatórios.

Ajuda

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