ID

17136

Description

Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00064714

Link

https://clinicaltrials.gov/show/NCT00064714

Keywords

Versions (1)
  1. 8/26/16 8/26/16 -
Uploaded on

August 26, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00064714

English

Eligibility Diabetes Mellitus NCT00064714

1 forms  
Criteria
Description

Criteria

t1dm for at least 5 years as defined by the following:
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
1. insulin dependence (with an insulin requirement less than 0.8 units/kg/day).
Description

Insulin Dependence | Insulin Quantity Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1514873
2. current or past anti-islet antibodies (anti-insulin before initiation of insulin therapy, anti-islet cell (ica), anti-tyrosine phosphatase ia-2, and/or anti-glutamic acid decarboxylase (gad65) antibodies).
Description

islet cell antibody | Insulin Antibodies | Insulin regime | islet cell antibody | IA-2 (Protein Tyrosine Phosphatase Antibody) | Anti-GAD antibody

Data type

boolean

Alias
UMLS CUI [1]
C0063900
UMLS CUI [2]
C0021644
UMLS CUI [3]
C0557978
UMLS CUI [4]
C0063900
UMLS CUI [5]
C1139665
UMLS CUI [6]
C1167897
3. bmi greater than or equal to 20 kg/m(2) and less than or equal to 30 kg/m(2).
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
c-peptide greater than or equal to 0.3 and less than or equal to 1.2 ng/ml at baseline or during an arginine-stimulated c-peptide test.
Description

C-Peptide | C-peptide stimulation test Arginine

Data type

boolean

Alias
UMLS CUI [1]
C0006558
UMLS CUI [2,1]
C0430183
UMLS CUI [2,2]
C0003765
age 18 to 60 years, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic gastroparesis.
Description

Gastroparesis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0231220
diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24-hour urine albumin greater than 300 mg.
Description

Diabetic Nephropathy | Creatinine clearance measurement | 24 hour urine albumin output measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011881
UMLS CUI [2]
C0373595
UMLS CUI [3]
C1278236
insulin requirements greater than 0.8 units/kg/day.
Description

Insulin Quantity Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1514873
hypoglycemia unawareness: unless easily corrected via simple modifications in the patient's diabetes regimen, the potential enrollee will be excluded if he/she has suffered greater than or equal to 2 episodes of severe hypoglycemia during the most recent 12 months, defined as requiring assistance from a third party, receiving assistance from medics, visiting an er or being hospitalized due to the hypoglycemia.
Description

Loss of hypoglycemic warning | Diabetes Therapy Modification | Episode Quantity Hypoglycemia Severe | Assistance Patient need for | Hospitalization Due to Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C3274787
UMLS CUI [2,2]
C0392747
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0020615
UMLS CUI [3,4]
C0205082
UMLS CUI [4,1]
C1269765
UMLS CUI [4,2]
C0686904
UMLS CUI [5,1]
C0019993
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0020615
evidence of chronic infection.
Description

Chronic infectious disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C0332120
history of any malignancy.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any chronic medical condition that unduly increase risk for the potential enrollee as judged by study investigators.
Description

Medical condition chronic High risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332167
UMLS CUI [1,4]
C0030705
hematologic abnormalities:
Description

Abnormality of blood and blood-forming tissues

Data type

boolean

Alias
UMLS CUI [1]
C0850715
1. anemia (hematocrit less than 31.8% in women and less than 36.7% in men).
Description

Anemia | Hematocrit level | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0079399
2. leukopenia (wbc count less than 3.4 k/mm(3)).
Description

Leukopenia | White Blood Cell Count

Data type

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0023508
3. thrombocytopenia (platelet count less than 162 k/mm(3)).
Description

Thrombocytopenia | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
hypertension, whether untreated or resistant to medical treatment, with blood pressure greater than 140/85 mm hg.
Description

hypertension untreated | HYPERTENSION, RESISTANT TO CONVENTIONAL THERAPY | Blood Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0745134
UMLS CUI [2]
C1834155
UMLS CUI [3]
C0005823
pregnancy, breastfeeding or planned pregnancy within two years.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
unable to identify primary care provider willing to partner with study investigators.
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Diabetes Mellitus NCT00064714

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Diabetes Mellitus, Insulin-Dependent
Item
t1dm for at least 5 years as defined by the following:
boolean
C0011854 (UMLS CUI [1])
Insulin Dependence | Insulin Quantity Requirement
Item
1. insulin dependence (with an insulin requirement less than 0.8 units/kg/day).
boolean
C0021641 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
islet cell antibody | Insulin Antibodies | Insulin regime | islet cell antibody | IA-2 (Protein Tyrosine Phosphatase Antibody) | Anti-GAD antibody
Item
2. current or past anti-islet antibodies (anti-insulin before initiation of insulin therapy, anti-islet cell (ica), anti-tyrosine phosphatase ia-2, and/or anti-glutamic acid decarboxylase (gad65) antibodies).
boolean
C0063900 (UMLS CUI [1])
C0021644 (UMLS CUI [2])
C0557978 (UMLS CUI [3])
C0063900 (UMLS CUI [4])
C1139665 (UMLS CUI [5])
C1167897 (UMLS CUI [6])
Body mass index
Item
3. bmi greater than or equal to 20 kg/m(2) and less than or equal to 30 kg/m(2).
boolean
C1305855 (UMLS CUI [1])
C-Peptide | C-peptide stimulation test Arginine
Item
c-peptide greater than or equal to 0.3 and less than or equal to 1.2 ng/ml at baseline or during an arginine-stimulated c-peptide test.
boolean
C0006558 (UMLS CUI [1])
C0430183 (UMLS CUI [2,1])
C0003765 (UMLS CUI [2,2])
Age
Item
age 18 to 60 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gastroparesis Symptomatic
Item
symptomatic gastroparesis.
boolean
C0152020 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Diabetic Nephropathy | Creatinine clearance measurement | 24 hour urine albumin output measurement
Item
diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24-hour urine albumin greater than 300 mg.
boolean
C0011881 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C1278236 (UMLS CUI [3])
Insulin Quantity Requirement
Item
insulin requirements greater than 0.8 units/kg/day.
boolean
C0021641 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Loss of hypoglycemic warning | Diabetes Therapy Modification | Episode Quantity Hypoglycemia Severe | Assistance Patient need for | Hospitalization Due to Hypoglycemia
Item
hypoglycemia unawareness: unless easily corrected via simple modifications in the patient's diabetes regimen, the potential enrollee will be excluded if he/she has suffered greater than or equal to 2 episodes of severe hypoglycemia during the most recent 12 months, defined as requiring assistance from a third party, receiving assistance from medics, visiting an er or being hospitalized due to the hypoglycemia.
boolean
C0342317 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0020615 (UMLS CUI [3,3])
C0205082 (UMLS CUI [3,4])
C1269765 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0019993 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0020615 (UMLS CUI [5,3])
Chronic infectious disease Evidence of
Item
evidence of chronic infection.
boolean
C0151317 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasms
Item
history of any malignancy.
boolean
C0006826 (UMLS CUI [1])
Medical condition chronic High risk Patient
Item
any chronic medical condition that unduly increase risk for the potential enrollee as judged by study investigators.
boolean
C3843040 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
Abnormality of blood and blood-forming tissues
Item
hematologic abnormalities:
boolean
C0850715 (UMLS CUI [1])
Anemia | Hematocrit level | Gender
Item
1. anemia (hematocrit less than 31.8% in women and less than 36.7% in men).
boolean
C0002871 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Leukopenia | White Blood Cell Count
Item
2. leukopenia (wbc count less than 3.4 k/mm(3)).
boolean
C0023530 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
3. thrombocytopenia (platelet count less than 162 k/mm(3)).
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
hypertension untreated | HYPERTENSION, RESISTANT TO CONVENTIONAL THERAPY | Blood Pressure
Item
hypertension, whether untreated or resistant to medical treatment, with blood pressure greater than 140/85 mm hg.
boolean
C0745134 (UMLS CUI [1])
C1834155 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy, breastfeeding or planned pregnancy within two years.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Compliance behavior Limited
Item
unable to identify primary care provider willing to partner with study investigators.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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