ID

36576

Beskrivning

Phase II-III Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02005848

Länk

https://clinicaltrials.gov/show/NCT02005848

Nyckelord

Versioner (1)
  1. 2019-05-22 2019-05-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility New Onset Type-1 Diabetes NCT02005848

Engelsk

Eligibility New Onset Type-1 Diabetes NCT02005848

1 Formulär  
Criteria
Beskrivning

Criteria

subject (or parent/guardian) willing and able to sign an informed consent
Beskrivning

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
age 8-25 (inclusive) years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
recently diagnosed with t1dm
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
basal c-peptide ≥ 0.2 pmol/ml
Beskrivning

Basal insulin C-peptide measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0202100
positive for at least one diabetes-related autoantibody
Beskrivning

Autoantibody Relationship Diabetes Mellitus | Autoantibody positive Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004358
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0853878
UMLS CUI [2,2]
C1265611
ability and consent to comply with completion of patient diary
Beskrivning

Subject Diary Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
no significant abnormalities in serum hematology, serum chemistry
Beskrivning

Serum Hematologic Test Normal | Serum chemistry test Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0205307
UMLS CUI [2,1]
C0236613
UMLS CUI [2,2]
C0205307
no significant abnormalities in urinalysis
Beskrivning

Normal urinalysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0749920
no significant abnormalities in ecg
Beskrivning

ECG normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0522054
for women of child bearing potential, non-pregnant, non-lactating female patients
Beskrivning

Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
main exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
iga deficient subjects
Beskrivning

Immunoglobulin A deficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0162538
subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
Beskrivning

Vaccines | Vaccines, Attenuated

Datatyp

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C0042211
subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
Beskrivning

Steroid therapy | Immunosuppressive Agents | Cytostatic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0010858
individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
Beskrivning

Immediate hypersensitivity Severe Plasma Product | Anaphylaxis Plasma Product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020523
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4521445
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C4521445
clinically significant intercurrent illnesses
Beskrivning

Comorbidity Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current use of any medication known to influence glucose tolerance
Beskrivning

Pharmaceutical Preparations Influence Glucose tolerance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0178665
current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors or amylin.
Beskrivning

Metformin | Sulfonylureas | Glinides | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin

Datatyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3]
C3537178
UMLS CUI [4]
C1257987
UMLS CUI [5]
C0167117
UMLS CUI [6]
C1456408
UMLS CUI [7]
C1827106
UMLS CUI [8]
C0063684
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Similar models

Eligibility New Onset Type-1 Diabetes NCT02005848

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
subject (or parent/guardian) willing and able to sign an informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Age
Item
age 8-25 (inclusive) years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
recently diagnosed with t1dm
boolean
C0011854 (UMLS CUI [1])
Basal insulin C-peptide measurement
Item
basal c-peptide ≥ 0.2 pmol/ml
boolean
C0650607 (UMLS CUI [1,1])
C0202100 (UMLS CUI [1,2])
Autoantibody Relationship Diabetes Mellitus | Autoantibody positive Quantity
Item
positive for at least one diabetes-related autoantibody
boolean
C0004358 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0853878 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Subject Diary Completion
Item
ability and consent to comply with completion of patient diary
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Serum Hematologic Test Normal | Serum chemistry test Normal
Item
no significant abnormalities in serum hematology, serum chemistry
boolean
C0229671 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0236613 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Normal urinalysis
Item
no significant abnormalities in urinalysis
boolean
C0749920 (UMLS CUI [1])
ECG normal
Item
no significant abnormalities in ecg
boolean
C0522054 (UMLS CUI [1])
Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent
Item
for women of child bearing potential, non-pregnant, non-lactating female patients
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Immunoglobulin A deficiency
Item
iga deficient subjects
boolean
C0162538 (UMLS CUI [1])
Vaccines | Vaccines, Attenuated
Item
subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
boolean
C0042210 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
Steroid therapy | Immunosuppressive Agents | Cytostatic Agents
Item
subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
boolean
C0149783 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0010858 (UMLS CUI [3])
Immediate hypersensitivity Severe Plasma Product | Anaphylaxis Plasma Product
Item
individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
boolean
C0020523 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4521445 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C4521445 (UMLS CUI [2,2])
Comorbidity Clinical Significance
Item
clinically significant intercurrent illnesses
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Influence Glucose tolerance
Item
current use of any medication known to influence glucose tolerance
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
Metformin | Sulfonylureas | Glinides | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin
Item
current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors or amylin.
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C3537178 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1456408 (UMLS CUI [6])
C1827106 (UMLS CUI [7])
C0063684 (UMLS CUI [8])
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