ID

36576

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02005848

Trefwoorden

Versies (1)
  1. 22-05-19 22-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 mei 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility New Onset Type-1 Diabetes NCT02005848

Engels

Eligibility New Onset Type-1 Diabetes NCT02005848

1 Formulieren  
Criteria
Beschrijving

Criteria

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

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datatype

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
Beschrijving

Age

Datatype

boolean

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

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

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

Basal insulin C-peptide measurement

Datatype

boolean

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

Autoantibody Relationship Diabetes Mellitus | Autoantibody positive Quantity

Datatype

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
Beschrijving

Subject Diary Completion

Datatype

boolean

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

Serum Hematologic Test Normal | Serum chemistry test Normal

Datatype

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
Beschrijving

Normal urinalysis

Datatype

boolean

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

ECG normal

Datatype

boolean

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

Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent

Datatype

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:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

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

Immunoglobulin A deficiency

Datatype

boolean

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

Vaccines | Vaccines, Attenuated

Datatype

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
Beschrijving

Steroid therapy | Immunosuppressive Agents | Cytostatic Agents

Datatype

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
Beschrijving

Immediate hypersensitivity Severe Plasma Product | Anaphylaxis Plasma Product

Datatype

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
Beschrijving

Comorbidity Clinical Significance

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Pharmaceutical Preparations Influence Glucose tolerance

Datatype

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.
Beschrijving

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility New Onset Type-1 Diabetes NCT02005848

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial