ID

28995

Descripción

Assessment of the Effects of a DPP-4 Inhibitor (Sitagliptin) Januvia on Immune Function in Healthy Individuals; ODM derived from: https://clinicaltrials.gov/show/NCT00813228

Link

https://clinicaltrials.gov/show/NCT00813228

Palabras clave

Versiones (1)
  1. 20/2/18 20/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 1 NCT00813228

Inglés

Eligibility Diabetes Mellitus Type 1 NCT00813228

1 formularios  
Criteria
Descripción

Criteria

age greater than 18
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
fasting blood glucose less than 100 mg/dl, and a normal hgb a1c (less than 5.7%),
Descripción

Fasting blood glucose measurement | Glucohemoglobin measurement Normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0202054
UMLS CUI [2,2]
C0205307
available for follow up through 9 weeks.
Descripción

Patient Available Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
in good general health without clinically significant medical history as deemed by study investigators.
Descripción

General health good | Absence Medical History Significant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0262926
UMLS CUI [2,3]
C0750502
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetes or other autoimmune diseases including (but not limited to) rheumatoid arthritis, lupus, multiple sclerosis.
Descripción

Diabetes Mellitus | Autoimmune Diseases | Rheumatoid Arthritis | Lupus Erythematosus | Multiple Sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0409974
UMLS CUI [5]
C0026769
active hepatitis b, c and/ or hiv infection.
Descripción

Hepatitis B | Hepatitis C | HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
recent diagnosis or active treatment for malignancy.
Descripción

Malignant Neoplasms | Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
recent (within 3 weeks) severe allergy symptoms such as allergy-induced asthma, skin eruptions or urticaria.
Descripción

Hypersensitivity Symptoms Severe | Asthma Hypersensitivity Induced | Exanthema | Urticaria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0205263
UMLS CUI [3]
C0015230
UMLS CUI [4]
C0042109
recent (within 3 weeks) viral or bacterial infections.
Descripción

Virus Diseases | Bacterial Infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0004623
history of other immune abnormalities, or the presence of disease processes or medications that, in the opinion of the investigator, may alter immune function.
Descripción

Abnormality of the immune system | Disease Changing Immune function | Pharmaceutical Preparations Changing Immune function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4021753
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1817756
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1817756
pregnant and nursing females.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women who have child-bearing potential but not using adequate birth control.
Descripción

Childbearing Potential Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
history of hypersensitivity reaction to sitagliptin.
Descripción

Allergic Reaction Sitagliptin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1565750
history of anemia (based on the nih laboratory department hemoglobin reference range for normal individuals).
Descripción

Anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
history of pancreatitis
Descripción

Pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
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Similar models

Eligibility Diabetes Mellitus Type 1 NCT00813228

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
age greater than 18
boolean
C0001779 (UMLS CUI [1])
Fasting blood glucose measurement | Glucohemoglobin measurement Normal
Item
fasting blood glucose less than 100 mg/dl, and a normal hgb a1c (less than 5.7%),
boolean
C0428568 (UMLS CUI [1])
C0202054 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Patient Available Follow-up
Item
available for follow up through 9 weeks.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
General health good | Absence Medical History Significant
Item
in good general health without clinically significant medical history as deemed by study investigators.
boolean
C1277245 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Autoimmune Diseases | Rheumatoid Arthritis | Lupus Erythematosus | Multiple Sclerosis
Item
history of diabetes or other autoimmune diseases including (but not limited to) rheumatoid arthritis, lupus, multiple sclerosis.
boolean
C0011849 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0409974 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
Hepatitis B | Hepatitis C | HIV Infection
Item
active hepatitis b, c and/ or hiv infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Malignant Neoplasms | Cancer treatment
Item
recent diagnosis or active treatment for malignancy.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Hypersensitivity Symptoms Severe | Asthma Hypersensitivity Induced | Exanthema | Urticaria
Item
recent (within 3 weeks) severe allergy symptoms such as allergy-induced asthma, skin eruptions or urticaria.
boolean
C0020517 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
C0015230 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
Virus Diseases | Bacterial Infections
Item
recent (within 3 weeks) viral or bacterial infections.
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
Abnormality of the immune system | Disease Changing Immune function | Pharmaceutical Preparations Changing Immune function
Item
history of other immune abnormalities, or the presence of disease processes or medications that, in the opinion of the investigator, may alter immune function.
boolean
C4021753 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1817756 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1817756 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant and nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
women who have child-bearing potential but not using adequate birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Allergic Reaction Sitagliptin
Item
history of hypersensitivity reaction to sitagliptin.
boolean
C1527304 (UMLS CUI [1,1])
C1565750 (UMLS CUI [1,2])
Anemia
Item
history of anemia (based on the nih laboratory department hemoglobin reference range for normal individuals).
boolean
C0002871 (UMLS CUI [1])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
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