ID

17136

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-08-16 26-08-16 -
Geüploaded op

26 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00064714

Engels

Eligibility Diabetes Mellitus NCT00064714

1 Formulieren  
Criteria
Beschrijving

Criteria

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

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

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

Insulin Dependence | Insulin Quantity Requirement

Datatype

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).
Beschrijving

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

Datatype

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).
Beschrijving

Body mass index

Datatype

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.
Beschrijving

C-Peptide | C-peptide stimulation test Arginine

Datatype

boolean

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic gastroparesis.
Beschrijving

Gastroparesis Symptomatic

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Insulin Quantity Requirement

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Chronic infectious disease Evidence of

Datatype

boolean

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

Malignant Neoplasms

Datatype

boolean

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

Medical condition chronic High risk Patient

Datatype

boolean

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

Abnormality of blood and blood-forming tissues

Datatype

boolean

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

Anemia | Hematocrit level | Gender

Datatype

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)).
Beschrijving

Leukopenia | White Blood Cell Count

Datatype

boolean

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

Thrombocytopenia | Platelet Count measurement

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

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.
Beschrijving

Compliance behavior Limited

Datatype

boolean

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

Eligibility Diabetes Mellitus NCT00064714

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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