Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Alter 18 Jahre und älter
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed informed consent.
Item
Signed informed consent.
boolean
C1561610 (UMLS CUI 2011AA)
S (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
Item
Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
boolean
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0564405 (UMLS CUI 2011AA)
224978009 (SNOMED CT 2011_0131)
C0203057 (UMLS CUI 2011AA)
241157000 (SNOMED CT 2011_0131)
10046285 (MedDRA 14.1)
87.62 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0376660 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C0549184 (UMLS CUI 2011AA)
260413007 (SNOMED CT 2011_0131)
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0871208 (UMLS CUI 2011AA)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1948053 (UMLS CUI 2011AA)
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose NSAIDs.
Item
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose NSAIDs.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0029408 (UMLS CUI 2011AA)
396275006, 225655006 (SNOMED CT 2011_0131)
10031161 (MedDRA 14.1)
M19.9 (ICD-10-CM Version 2010)
715.9 (ICD-9-CM Version 2011)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and. Are expected to remain stable for the duration of the study. and. Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
Item
Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and. Are expected to remain stable for the duration of the study. and. Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
boolean
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0814259 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1273553 (UMLS CUI 2011AA)
394899003 (SNOMED CT 2011_0131)
Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.
Item
Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.
boolean
C0079488 (UMLS CUI 2011AA)
80774000 (SNOMED CT 2011_0131)
MTHU019876 (LOINC Version 232)
CL415098 (UMLS CUI 2011AA)
C0344441 (UMLS CUI 2011AA)
10062005 (MedDRA 14.1)
MTHU010496 (LOINC Version 232)
C1882330 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Discontinuation from study SH-NEN-0001
Item
Discontinuation from study SH-NEN-0001
boolean
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
Item
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
CL355048 (UMLS CUI 2011AA)
247347003 (SNOMED CT 2011_0131)
C0085624 (UMLS CUI 2011AA)
90673000 (SNOMED CT 2011_0131)
10006784 (MedDRA 14.1)
C2937240 (UMLS CUI 2011AA)
80581009 (SNOMED CT 2011_0131)
C1444748 (UMLS CUI 2011AA)
410658008 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0332303 (UMLS CUI 2011AA)
1241001 (SNOMED CT 2011_0131)
C0011135 (UMLS CUI 2011AA)
39211005 (SNOMED CT 2011_0131)
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs.
Item
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
CL355048 (UMLS CUI 2011AA)
247347003 (SNOMED CT 2011_0131)
C0085624 (UMLS CUI 2011AA)
90673000 (SNOMED CT 2011_0131)
10006784 (MedDRA 14.1)
C2937240 (UMLS CUI 2011AA)
80581009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
Item
Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0024501 (UMLS CUI 2011AA)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1948053 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Need for continuous concomitant therapy with: (Anticoagulants, Corticosteroids at doses higher than explained under inclusion criterion)
Item
Need for continuous concomitant therapy with: (Anticoagulants, Corticosteroids at doses higher than explained under inclusion criterion)
boolean
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0750536 (UMLS CUI 2011AA)
C1707479 (UMLS CUI 2011AA)
C0003280 (UMLS CUI 2011AA)
372862008 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
CL425202 (UMLS CUI 2011AA)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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