Informationen:
Fehler:
ID
38945
Beschreibung
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
Stichworte
Versionen (1)
- 14.11.19 14.11.19 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
14. November 2019
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Diabetes NCT01680328
Eligibility Diabetes NCT01680328
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Diabetes NCT01680328
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])