ID

23250

Description

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

Link

https://clinicaltrials.gov/show/NCT00365781

Keywords

Versions (1)
  1. 6/30/17 6/30/17 -
Uploaded on

June 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00365781

English

Eligibility Type 2 Diabetes Mellitus NCT00365781

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

Age

Data type

boolean

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

Body Weight

Data type

boolean

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

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

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

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

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

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

Data type

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)
Description

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

Data type

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
Description

Dermatologic disorders

Data type

boolean

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

Substance Use Disorders

Data type

boolean

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

Liver diseases | Kidney Diseases

Data type

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)
Description

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

Data type

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)
Description

Increased liver function tests

Data type

boolean

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

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

Data type

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
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00365781

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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