ID

38945

Beschrijving

Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations; ODM derived from: https://clinicaltrials.gov/show/NCT01680328

Link

https://clinicaltrials.gov/show/NCT01680328

Trefwoorden

Versies (1)
  1. 14-11-19 14-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 november 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 Diabetes NCT01680328

Engels

Eligibility Diabetes NCT01680328

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680328
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
type 1 or type 2 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
daily injection(s) with anti-diabetic drug (insulin or glucagon like peptide-1 (glp-1) analogues) via pen-injector or vial/syringe for more than 6 months
Beschrijving

Antidiabetics Injection Daily | Insulin | GLP-1 Analogue | Injection via Pen Injector | Injection via Vial | Injection via Syringe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0021641
UMLS CUI [3]
C3273809
UMLS CUI [4,1]
C1533685
UMLS CUI [4,2]
C1550513
UMLS CUI [4,3]
C4025916
UMLS CUI [5,1]
C1533685
UMLS CUI [5,2]
C1550513
UMLS CUI [5,3]
C0184301
UMLS CUI [6,1]
C1533685
UMLS CUI [6,2]
C1550513
UMLS CUI [6,3]
C0039142
body mass index (bmi) between 18.5 and 30.0 kg/m^2 (both included)
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
caucasians
Beschrijving

Caucasians

Datatype

boolean

Alias
UMLS CUI [1]
C0043157
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
Beschrijving

Hypersensitivity Needle | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0027551
UMLS CUI [2]
C3846158
previous participation in this trial. participation is defined as: screened
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
Beschrijving

Investigational New Drugs Influence Pain Perception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C3714605
injection of more than 40 units of insulin per injection
Beschrijving

Injection Insulin Unit Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0869039
UMLS CUI [1,4]
C1265611
continuous subcutaneous insulin infusion use within the last 6 months
Beschrijving

Continuous subcutaneous infusion of insulin

Datatype

boolean

Alias
UMLS CUI [1]
C0393124
continuous glucose monitoring use within the last 6 months
Beschrijving

Continuous glucose monitoring

Datatype

boolean

Alias
UMLS CUI [1]
C4523945
intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
Beschrijving

Administration of analgesic | Exception Aspirin Low Dose

Datatype

boolean

Alias
UMLS CUI [1]
C0262176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
known active or in-active skin disease in the injection area or that may affect pain perception
Beschrijving

Dermatologic disorder Injection Area | Dermatologic disorder Affecting Pain Perception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0205146
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3714605
anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. however, not on the day of the injections)
Beschrijving

Anticoagulant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0150457
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes NCT01680328

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680328
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
type 1 or type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Antidiabetics Injection Daily | Insulin | GLP-1 Analogue | Injection via Pen Injector | Injection via Vial | Injection via Syringe
Item
daily injection(s) with anti-diabetic drug (insulin or glucagon like peptide-1 (glp-1) analogues) via pen-injector or vial/syringe for more than 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2])
C3273809 (UMLS CUI [3])
C1533685 (UMLS CUI [4,1])
C1550513 (UMLS CUI [4,2])
C4025916 (UMLS CUI [4,3])
C1533685 (UMLS CUI [5,1])
C1550513 (UMLS CUI [5,2])
C0184301 (UMLS CUI [5,3])
C1533685 (UMLS CUI [6,1])
C1550513 (UMLS CUI [6,2])
C0039142 (UMLS CUI [6,3])
Body mass index
Item
body mass index (bmi) between 18.5 and 30.0 kg/m^2 (both included)
boolean
C1305855 (UMLS CUI [1])
Caucasians
Item
caucasians
boolean
C0043157 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Needle | Other Coding
Item
known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
boolean
C0020517 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as: screened
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs Influence Pain Perception
Item
receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
boolean
C0013230 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C3714605 (UMLS CUI [1,3])
Injection Insulin Unit Quantity
Item
injection of more than 40 units of insulin per injection
boolean
C1533685 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Continuous subcutaneous infusion of insulin
Item
continuous subcutaneous insulin infusion use within the last 6 months
boolean
C0393124 (UMLS CUI [1])
Continuous glucose monitoring
Item
continuous glucose monitoring use within the last 6 months
boolean
C4523945 (UMLS CUI [1])
Administration of analgesic | Exception Aspirin Low Dose
Item
intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
boolean
C0262176 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608320 (UMLS CUI [2,2])
Dermatologic disorder Injection Area | Dermatologic disorder Affecting Pain Perception
Item
known active or in-active skin disease in the injection area or that may affect pain perception
boolean
C0037274 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3714605 (UMLS CUI [2,3])
Anticoagulant therapy
Item
anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. however, not on the day of the injections)
boolean
C0150457 (UMLS CUI [1])
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