ID

15878

Beskrivning

Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study; ODM derived from: https://clinicaltrials.gov/show/NCT02472717

Länk

https://clinicaltrials.gov/show/NCT02472717

Nyckelord

Versioner (1)
  1. 2016-06-17 2016-06-17 -
Uppladdad den

17 juni 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Psoriatic Arthritis NCT02472717

Engelsk

Eligibility Psoriatic Arthritis NCT02472717

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with active psoriatic arthritis (3 tender and swollen joints) meeting caspar study group criteria
Beskrivning

Arthritis, Psoriatic | Joint tenderness | Joint swelling

Datatyp

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2]
C0240094
UMLS CUI [3]
C0152031
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
bmi > 35 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
uncontrolled diabetes, hba1c > 10.5%
Beskrivning

DIABETES MELLITUS UNCONTROLLED | Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0743131
UMLS CUI [2]
C0019018
current biological treatment for any inflammatory disorder within the past three months
Beskrivning

Biological treatment Inflammatory disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C1290884
renal dysfunction (egfr < 50 ml/min/1.73m or macroalbuminuria >300mg)
Beskrivning

Renal dysfunction | Estimated Glomerular Filtration Rate | Macroalbuminuria

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C3811844
UMLS CUI [3]
C1654921
hepatic dysfunction (ast (aspartate aminotransferase), alt (alanine aminotransferase), total bilirubin > 3 times upper limit of normal)
Beskrivning

Liver Dysfunction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201913
history of pancreatitis or personal or family history of medullary thyroid cancer, c-cell hyperplasia, or men-2 syndrome
Beskrivning

Pancreatitis | Medullary carcinoma of thyroid | C-cell hyperplasia | Multiple Endocrine Neoplasia Type 2a

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0238462
UMLS CUI [3]
C0342190
UMLS CUI [4]
C0025268
current pregnancy or current breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of dpp-4 (dipeptidyl peptidase-4 inhibitor) or glp-1 receptor agonist within 2 months (washout is permitted)
Beskrivning

Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Receptor Agonist | Washout

Datatyp

boolean

Alias
UMLS CUI [1]
C3537225
UMLS CUI [2]
C2917359
UMLS CUI [3]
C1710661
drug or alcohol dependence
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
resting tachycardia > 100 bpm or conduction abnormalities associated with tachycardia
Beskrivning

TACHYCARDIA REST | Cardiac conduction abnormalities Associated with Tachycardia

Datatyp

boolean

Alias
UMLS CUI [1]
C0749248
UMLS CUI [2,1]
C1842820
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0039231
current enrollment in any other clinical trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
symptomatic gastroparesis
Beskrivning

Gastroparesis Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0231220
concomitant serious medical conditions
Beskrivning

concomitant conditions Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243086
UMLS CUI [1,2]
C0205404
all medication for the treatment of psoriatic arthritis such as mtx (methotrexate) < 25 mg, lfn (leflunomide) < 20 mg, and nsaids (non-steroidal anti-inflammatory drugs) will have been used at stable doses for at least 4 weeks, having been initiated at least 3 months prior to study start (8 weeks before screening, 4 weeks before baseline) for mtx and lfn and at least 4 weeks for nsaids
Beskrivning

Therapeutic procedure Arthritis, Psoriatic | Pharmaceutical Preparations Dosage Stable status | Methotrexate | leflunomide | Anti-Inflammatory Agents, Non-Steroidal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003872
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0063041
UMLS CUI [5]
C0003211
Tillbaka till toppen

Similar models

Eligibility Psoriatic Arthritis NCT02472717

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Arthritis, Psoriatic | Joint tenderness | Joint swelling
Item
patients with active psoriatic arthritis (3 tender and swollen joints) meeting caspar study group criteria
boolean
C0003872 (UMLS CUI [1])
C0240094 (UMLS CUI [2])
C0152031 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
bmi > 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
DIABETES MELLITUS UNCONTROLLED | Glycosylated hemoglobin A
Item
uncontrolled diabetes, hba1c > 10.5%
boolean
C0743131 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Biological treatment Inflammatory disorder
Item
current biological treatment for any inflammatory disorder within the past three months
boolean
C1531518 (UMLS CUI [1,1])
C1290884 (UMLS CUI [1,2])
Renal dysfunction | Estimated Glomerular Filtration Rate | Macroalbuminuria
Item
renal dysfunction (egfr < 50 ml/min/1.73m or macroalbuminuria >300mg)
boolean
C3279454 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1654921 (UMLS CUI [3])
Liver Dysfunction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement
Item
hepatic dysfunction (ast (aspartate aminotransferase), alt (alanine aminotransferase), total bilirubin > 3 times upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Pancreatitis | Medullary carcinoma of thyroid | C-cell hyperplasia | Multiple Endocrine Neoplasia Type 2a
Item
history of pancreatitis or personal or family history of medullary thyroid cancer, c-cell hyperplasia, or men-2 syndrome
boolean
C0030305 (UMLS CUI [1])
C0238462 (UMLS CUI [2])
C0342190 (UMLS CUI [3])
C0025268 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
current pregnancy or current breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Receptor Agonist | Washout
Item
use of dpp-4 (dipeptidyl peptidase-4 inhibitor) or glp-1 receptor agonist within 2 months (washout is permitted)
boolean
C3537225 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Substance Dependence
Item
drug or alcohol dependence
boolean
C0038580 (UMLS CUI [1])
TACHYCARDIA REST | Cardiac conduction abnormalities Associated with Tachycardia
Item
resting tachycardia > 100 bpm or conduction abnormalities associated with tachycardia
boolean
C0749248 (UMLS CUI [1])
C1842820 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0039231 (UMLS CUI [2,3])
Study Subject Participation Status
Item
current enrollment in any other clinical trial
boolean
C2348568 (UMLS CUI [1])
Gastroparesis Symptomatic
Item
symptomatic gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
concomitant conditions Serious
Item
concomitant serious medical conditions
boolean
C0243086 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Therapeutic procedure Arthritis, Psoriatic | Pharmaceutical Preparations Dosage Stable status | Methotrexate | leflunomide | Anti-Inflammatory Agents, Non-Steroidal
Item
all medication for the treatment of psoriatic arthritis such as mtx (methotrexate) < 25 mg, lfn (leflunomide) < 20 mg, and nsaids (non-steroidal anti-inflammatory drugs) will have been used at stable doses for at least 4 weeks, having been initiated at least 3 months prior to study start (8 weeks before screening, 4 weeks before baseline) for mtx and lfn and at least 4 weeks for nsaids
boolean
C0087111 (UMLS CUI [1,1])
C0003872 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3])
C0063041 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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