ID

23250

Descrição

Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715; ODM derived from: https://clinicaltrials.gov/show/NCT00365781

Link

https://clinicaltrials.gov/show/NCT00365781

Palavras-chave

Versões (1)
  1. 30/06/2017 30/06/2017 -
Transferido a

30 de junho 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.

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 Type 2 Diabetes Mellitus NCT00365781

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00365781

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female: females are post menopausal or surgically sterile; males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of isis 113715
Descrição

Postmenopausal state | Female Sterilization | Male sterilization | Gender Sexual Abstinence | Gender Barrier Contraception | ISIS-113715

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0024559
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0004764
UMLS CUI [6]
C1565486
aged 18 to 65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
weight > 50 kg
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
body mass index > 29 kg/m²
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant, breastfeeding, or intends to become pregnant
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
positive hepatitis b virus, hepatitis c virus, or hiv test
Descrição

Hepatitis B virus test positive | Hepatitis C virus test positive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2748184
UMLS CUI [2]
C2748185
UMLS CUI [3]
C0019699
history of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (nsaid)
Descrição

Blood coagulation Abnormality | Pharmaceutical Preparations Affecting Blood coagulation | Heparin | Warfarin | Aspirin Excluded | Non-Steroidal Anti-Inflammatory Agents Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005778
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0043031
UMLS CUI [5,1]
C0004057
UMLS CUI [5,2]
C2828389
UMLS CUI [6,1]
C0003211
UMLS CUI [6,2]
C2828389
current or history of significant skin disorders
Descrição

Dermatologic disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037274
history of alcohol or drug abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
history of liver or renal disease
Descrição

Liver diseases | Kidney Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year)
Descrição

Malignant Neoplasms | Basal cell carcinoma Treated Excluded | Squamous cell carcinoma of skin Treated Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C2828389
liver function tests greater than the upper limit of normal (uln)
Descrição

Increased liver function tests

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877359
clinically significant and currently active diseases or active infection requiring antiviral or antimicrobial therapy
Descrição

Disease Clinical Significance | Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Antimicrobial medicament

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0280274
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0443071
Voltar ao início da página

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00365781

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Female Sterilization | Male sterilization | Gender Sexual Abstinence | Gender Barrier Contraception | ISIS-113715
Item
male or female: females are post menopausal or surgically sterile; males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of isis 113715
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0024559 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0004764 (UMLS CUI [5,2])
C1565486 (UMLS CUI [6])
Age
Item
aged 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
weight > 50 kg
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index > 29 kg/m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breastfeeding, or intends to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hepatitis B virus test positive | Hepatitis C virus test positive | HIV Seropositivity
Item
positive hepatitis b virus, hepatitis c virus, or hiv test
boolean
C2748184 (UMLS CUI [1])
C2748185 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Blood coagulation Abnormality | Pharmaceutical Preparations Affecting Blood coagulation | Heparin | Warfarin | Aspirin Excluded | Non-Steroidal Anti-Inflammatory Agents Excluded
Item
history of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (nsaid)
boolean
C0005778 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005778 (UMLS CUI [2,3])
C0019134 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
C0004057 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
C0003211 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
Dermatologic disorders
Item
current or history of significant skin disorders
boolean
C0037274 (UMLS CUI [1])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Liver diseases | Kidney Diseases
Item
history of liver or renal disease
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated Excluded | Squamous cell carcinoma of skin Treated Excluded
Item
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year)
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Increased liver function tests
Item
liver function tests greater than the upper limit of normal (uln)
boolean
C0877359 (UMLS CUI [1])
Disease Clinical Significance | Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Antimicrobial medicament
Item
clinically significant and currently active diseases or active infection requiring antiviral or antimicrobial therapy
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0280274 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0443071 (UMLS CUI [3,3])
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