ID

38931

Beskrivning

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is to be filled in if Liver Imaging was performed as a result of an Adverse Liver Event. There are seperate forms for general information on the Adverse Liver Event and the Liver Biopsy (if performed).

Länk

https://clinicaltrials.gov/ct2/show/NCT00992160

Nyckelord

  1. 2019-11-14 2019-11-14 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

14 november 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Liver Imaging

  1. StudyEvent: ODM
    1. Liver Imaging
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Study site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beskrivning

Subject No.

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Liver imaging - General
Beskrivning

Liver imaging - General

Alias
UMLS CUI-1
C2711860
Date of hepatic or liver imaging test
Beskrivning

Date of liver imaging

Datatyp

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
What method was used for this imaging test?
Beskrivning

if other, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Specify other method used for this imaging test
Beskrivning

Specify other liver imaging method

Datatyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Are images technically adequate?
Beskrivning

if other, specify

Datatyp

text

Alias
UMLS CUI [1]
C0806487
Other, specify
Beskrivning

Specify other image quality

Datatyp

text

Alias
UMLS CUI [1,1]
C0806487
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver size
Beskrivning

If other, specify

Datatyp

text

Alias
UMLS CUI [1]
C0426688
Other liver size, specify
Beskrivning

Specify other liver size

Datatyp

text

Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver texture
Beskrivning

If other, specify

Datatyp

text

Alias
UMLS CUI [1]
C1285481
Other liver texture, specify
Beskrivning

Specify other liver texture

Datatyp

text

Alias
UMLS CUI [1,1]
C1285481
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Grade the diffuse and/or geographic fatty infiltrate of the liver
Beskrivning

if other, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
Other diffuse and/or geographic fatty infiltrate of the liver, specify
Beskrivning

Specify other diffuse and/or geographic fatty infiltrate of the liver

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235
Ascites present
Beskrivning

if other, specify

Datatyp

text

Alias
UMLS CUI [1]
C0003962
Other ascites, specify
Beskrivning

Specify other ascites

Datatyp

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Are Focal Hepatic Lesions characterisable?
Beskrivning

Are Focal Hepatic Lesions characterisable?

Alias
UMLS CUI-1
C0577053
UMLS CUI-2
C0205234
Are Focal Hepatic Lesions characterisable?
Beskrivning

If characterisable, check all that apply in next questions

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
Solid
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205208
Cystic
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205207
Hemangioma
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0018916
Focal Nodular Hyperplasia
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0020510
Other Focal Hepatic Lesions, specify
Beskrivning

if applicable please specify

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
Other Focal Hepatic Lesions, specify
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Gallstones or gallbladder lesions?
Beskrivning

Gallstones or gallbladder lesions?

Alias
UMLS CUI-1
C0008350
UMLS CUI-3
C0016976
UMLS CUI-4
C0221198
Gallstones or gallbladder lesions?
Beskrivning

If present, check all that apply in next questions

Datatyp

text

Alias
UMLS CUI [1]
C0008350
UMLS CUI [2,1]
C0016976
UMLS CUI [2,2]
C0221198
Gallstones
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0008350
Gallbladder polyp(s)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0262493
Sludge
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0860209
Gallbladder wall thickening/oedema
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0744257
UMLS CUI [2,1]
C0734014
UMLS CUI [2,2]
C0013604
Gallbladder wall gas
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0734014
UMLS CUI [1,2]
C0333139
Cholecystitis
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0008325
Gallbladder wall calcification
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0734014
UMLS CUI [1,2]
C1533591
Gallbladder mass
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C3874422
Other gallstones or gallbladder lesions, specify
Beskrivning

if applicable please specify

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0008350
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0016976
UMLS CUI [2,3]
C0221198
Other gallstones or gallbladder lesions, specify
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0008350
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
UMLS CUI [2,3]
C0016976
UMLS CUI [2,4]
C0221198
Biliary ductal lesions?
Beskrivning

Biliary ductal lesions?

Alias
UMLS CUI-1
C0005423
UMLS CUI-2
C0221198
Biliary ductal lesions?
Beskrivning

If present, check all that apply in next questions

Datatyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
Intrahepatic ductal dilation (focal involving the right hepatic lobe)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0700124
UMLS CUI [1,3]
C0227481
Intrahepatic ductal dilation (focal involving the left hepatic lobe)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0700124
UMLS CUI [1,3]
C0227486
Intrahepatic ductal dilation (involving both right and left hepatic lobes)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0700124
UMLS CUI [1,3]
C0227486
UMLS CUI [2,1]
C0005401
UMLS CUI [2,2]
C0700124
UMLS CUI [2,3]
C0227481
Extrahepatic ductal dilation
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700124
UMLS CUI [1,2]
C0206187
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0700124
UMLS CUI [2,1]
C0700124
UMLS CUI [2,2]
C0206187
Acute Cholangitis
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0267917
Primary sclerosing cholangitis
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0566602
Choledocholithiasis (gallstone in duct)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0701818
Ductal filling defect(s), other than gallstone
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512083
UMLS CUI [1,2]
C0332555
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0242216
Ductal wall thickening or oedema
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0442069
UMLS CUI [1,3]
C0205400
UMLS CUI [2,1]
C0005423
UMLS CUI [2,2]
C0442069
UMLS CUI [2,3]
C0013604
Choledochal cyst
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0008340
Ductal mass
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0577559
Extrinsic mass compressing bile duct(s)
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205101
UMLS CUI [1,2]
C0577559
UMLS CUI [1,3]
C0332260
UMLS CUI [1,4]
C0005400
Other Biliary ductal lesions, specify
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
Other biliary ductal lesions, specify
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Portal/Hepatic vein abnormalities?
Beskrivning

Portal/Hepatic vein abnormalities?

Alias
UMLS CUI-1
C0019155
UMLS CUI-2
C1704258
UMLS CUI-3
C0032718
Portal/Hepatic vein abnormalities?
Beskrivning

If present, check all that apply in next questions

Datatyp

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
Portal vein enlargement
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0700124
Hepatic vein enlargement
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C0700124
Nonocclusive portal vein thrombosis
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0333204
Occlusive portal vein thrombosis - bland
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C1265798
Hepatic vein thrombosis - bland
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019154
UMLS CUI [1,2]
C1265798
Occlusive portal vein thrombosis - malignant
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0205282
Hepatic vein thrombosis - malignant
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019154
UMLS CUI [1,2]
C0205282
Involvement of the main portal vein
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392760
UMLS CUI [1,2]
C1183135
Involvement of the right portal vein
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392760
UMLS CUI [1,2]
C0205090
UMLS CUI [1,3]
C0032718
Involvement of the left portal vein
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392760
UMLS CUI [1,2]
C0205091
UMLS CUI [1,3]
C0032718
Budd-Chiari syndrome
Beskrivning

if applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C0856761
Other portal/hepatic vein abnormalities, specify
Beskrivning

if applicable please specify

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0019155
UMLS CUI [1,3]
C1704258
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0032718
UMLS CUI [2,3]
C1704258
Other portal/hepatic vein abnormalities, specify
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235

Similar models

Liver Imaging

  1. StudyEvent: ODM
    1. Liver Imaging
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Liver imaging - General
C2711860 (UMLS CUI-1)
Date of liver imaging
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Code List
What method was used for this imaging test?
CL Item
Ultrasound - transabdominal (Ultrasound - transabdominal)
CL Item
Ultrasound - endoscopic (Ultrasound - endoscopic)
CL Item
Magnetic Resonance Imaging (MRI) (Magnetic Resonance Imaging (MRI))
CL Item
Computerised Tomography (CT) (Computerised Tomography (CT))
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (Endoscopic Retrograde Cholangiopancreatography (ERCP))
CL Item
Positron Emission Tomography (PET) (Positron Emission Tomography (PET))
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (Positron Emission Tomography/Computerised Tomography (PET/CT))
CL Item
Other (Other)
Specify other liver imaging method
Item
Specify other method used for this imaging test
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Are images technically adequate?
text
C0806487 (UMLS CUI [1])
Code List
Are images technically adequate?
CL Item
Optimal (Optimal)
CL Item
Readable, but not optimal (Readable, but not optimal)
CL Item
Not readable (Not readable)
CL Item
Other (Other)
Specify other image quality
Item
Other, specify
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver size
text
C0426688 (UMLS CUI [1])
Code List
Indicate the liver size
CL Item
Normal size (Normal size)
CL Item
Hypertrophy (or enlarged) (Hypertrophy (or enlarged))
CL Item
Atrophy (or smaller than normal) (Atrophy (or smaller than normal))
CL Item
Segmental hypertrophy (Segmental hypertrophy)
CL Item
Other (Other)
Specify other liver size
Item
Other liver size, specify
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture
text
C1285481 (UMLS CUI [1])
Code List
Indicate the liver texture
CL Item
Normal (Normal)
CL Item
Heterogenous (Heterogenous)
CL Item
Suggestive of fibrosis (Suggestive of fibrosis)
CL Item
Nodular or suggestive of cirrhosis (Nodular or suggestive of cirrhosis)
CL Item
Other (Other)
Specify other liver texture
Item
Other liver texture, specify
text
C1285481 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (Not applicable - no fatty infiltration)
CL Item
25%) (Mild (<)
CL Item
Moderate (>25% to <75%) (Moderate (>25% to <75%))
CL Item
75%) (Severe (>)
CL Item
Other, specify (Other, specify)
Specify other diffuse and/or geographic fatty infiltrate of the liver
Item
Other diffuse and/or geographic fatty infiltrate of the liver, specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item
Ascites present
text
C0003962 (UMLS CUI [1])
Code List
Ascites present
CL Item
None present (None present)
CL Item
Yes - small amount (Yes - small amount)
CL Item
Yes - moderate or severe amount (Yes - moderate or severe amount)
CL Item
Other, specify (Other, specify)
Specify other ascites
Item
Other ascites, specify
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Are Focal Hepatic Lesions characterisable?
C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
Item
Are Focal Hepatic Lesions characterisable?
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (Not applicable - no hepatic lesions)
CL Item
Check all that apply (Check all that apply)
Solid Focal Hepatic Lesion
Item
Solid
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
Cystic Focal Hepatic Lesion
Item
Cystic
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
Focal Hepatic Lesion: Hemangioma
Item
Hemangioma
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])
Focal Hepatic Lesion: Focal Nodular Hyperplasia
Item
Focal Nodular Hyperplasia
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])
Other Focal Hepatic Lesions
Item
Other Focal Hepatic Lesions, specify
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other Focal Hepatic Lesions
Item
Other Focal Hepatic Lesions, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Gallstones or gallbladder lesions?
C0008350 (UMLS CUI-1)
C0016976 (UMLS CUI-3)
C0221198 (UMLS CUI-4)
Item
Gallstones or gallbladder lesions?
text
C0008350 (UMLS CUI [1])
C0016976 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
Code List
Gallstones or gallbladder lesions?
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Gallstones
Item
Gallstones
boolean
C0008350 (UMLS CUI [1])
Gallbladder polyps
Item
Gallbladder polyp(s)
boolean
C0262493 (UMLS CUI [1])
Sludge
Item
Sludge
boolean
C0860209 (UMLS CUI [1])
Gallbladder wall thickening/oedema
Item
Gallbladder wall thickening/oedema
boolean
C0744257 (UMLS CUI [1])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
Gallbladder wall gas
Item
Gallbladder wall gas
boolean
C0734014 (UMLS CUI [1,1])
C0333139 (UMLS CUI [1,2])
Cholecystitis
Item
Cholecystitis
boolean
C0008325 (UMLS CUI [1])
Gallbladder wall calcification
Item
Gallbladder wall calcification
boolean
C0734014 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])
Gallbladder mass
Item
Gallbladder mass
boolean
C3874422 (UMLS CUI [1])
Other gallstones or gallbladder lesion
Item
Other gallstones or gallbladder lesions, specify
boolean
C0205394 (UMLS CUI [1,1])
C0008350 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0016976 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Specify other gallstones or gallbladder lesions
Item
Other gallstones or gallbladder lesions, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0008350 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0016976 (UMLS CUI [2,3])
C0221198 (UMLS CUI [2,4])
Item Group
Biliary ductal lesions?
C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Code List
Biliary ductal lesions?
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Intrahepatic ductal dilation (right hepatic lobe)
Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe)
boolean
C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
Intrahepatic ductal dilation (left hepatic lobe)
Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe)
boolean
C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
Intrahepatic ductal dilation (right and left hepatic lobes)
Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes)
boolean
C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0005401 (UMLS CUI [2,1])
C0700124 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])
Extrahepatic ductal dilation
Item
Extrahepatic ductal dilation
boolean
C0700124 (UMLS CUI [1,1])
C0206187 (UMLS CUI [1,2])
Diffuse ductal dilation (intrahepatic and extrahepatic ducts)
Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
boolean
C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [2,1])
C0206187 (UMLS CUI [2,2])
Acute Cholangitis
Item
Acute Cholangitis
boolean
C0267917 (UMLS CUI [1])
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
C0566602 (UMLS CUI [1])
Choledocholithiasis
Item
Choledocholithiasis (gallstone in duct)
boolean
C0701818 (UMLS CUI [1])
Ductal filling defect other than gallstone
Item
Ductal filling defect(s), other than gallstone
boolean
C1512083 (UMLS CUI [1,1])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])
Ductal wall thickening or oedema
Item
Ductal wall thickening or oedema
boolean
C0005423 (UMLS CUI [1,1])
C0442069 (UMLS CUI [1,2])
C0205400 (UMLS CUI [1,3])
C0005423 (UMLS CUI [2,1])
C0442069 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])
Choledochal cyst
Item
Choledochal cyst
boolean
C0008340 (UMLS CUI [1])
Ductal mass
Item
Ductal mass
boolean
C0005423 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
Extrinsic mass compressing bile duct
Item
Extrinsic mass compressing bile duct(s)
boolean
C0205101 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
Other Biliary ductal lesions
Item
Other Biliary ductal lesions, specify
boolean
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other biliary ductal lesions
Item
Other biliary ductal lesions, specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Portal/Hepatic vein abnormalities?
C0019155 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)
Item
Portal/Hepatic vein abnormalities?
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (None)
CL Item
Check all that apply (Check all that apply)
Portal vein enlargement
Item
Portal vein enlargement
boolean
C0032718 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
Hepatic vein enlargement
Item
Hepatic vein enlargement
boolean
C0019155 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
Nonocclusive portal vein thrombosis
Item
Nonocclusive portal vein thrombosis
boolean
C0155773 (UMLS CUI [1,1])
C0333204 (UMLS CUI [1,2])
Occlusive portal vein thrombosis - bland
Item
Occlusive portal vein thrombosis - bland
boolean
C0155773 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])
Hepatic vein thrombosis - bland
Item
Hepatic vein thrombosis - bland
boolean
C0019154 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])
Occlusive portal vein thrombosis - malignant
Item
Occlusive portal vein thrombosis - malignant
boolean
C0155773 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
Hepatic vein thrombosis - malignant
Item
Hepatic vein thrombosis - malignant
boolean
C0019154 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
Involvement of the main portal vein
Item
Involvement of the main portal vein
boolean
C0392760 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])
Involvement of the right portal vein
Item
Involvement of the right portal vein
boolean
C0392760 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
Involvement of the left portal vein
Item
Involvement of the left portal vein
boolean
C0392760 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
C0856761 (UMLS CUI [1])
Other portal/hepatic vein abnormalities
Item
Other portal/hepatic vein abnormalities, specify
boolean
C0205394 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
Specify other portal/hepatic vein abnormalities
Item
Other portal/hepatic vein abnormalities, specify
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])

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