ID

5143

Description

ODM derived from http://clinicaltrials.gov/show/NCT01377090

Link

http://clinicaltrials.gov/show/NCT01377090

Keywords

Versions (2)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01377090 Systemic Sclerosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed informed consent prior to enrollment
Description

Signed informed consent prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
Description

Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0036421
SNOMED CT 2011_0131
89155008
MedDRA 14.1
10042953
ICD-10-CM Version 2010
M34.9
ICD-9-CM Version 2011
710.1
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL430579
UMLS CUI 2011AA
C0748540
SNOMED CT 2011_0131
298285004
UMLS CUI 2011AA
C1258104
SNOMED CT 2011_0131
444133002, 128460000
MedDRA 14.1
10012977
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL414621
For patients with no history of digital ulcers (DU) and no DU at enrollment only:
Description

For patients with no history of digital ulcers (DU) and no DU at enrollment only:

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
CL434168
MedDRA 14.1
10072119
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
Description

Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature

Data type

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2348519
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0034735
SNOMED CT 2011_0131
266261006
MedDRA 14.1
10037912
Exclusion Criteria
Description

Exclusion Criteria

Systemic sclerosis without skin thickening
Description

SSc sine scleroderma (without any skin involvement)

Data type

boolean

Alias
UMLS CUI 2011AA
C1290138
SNOMED CT 2011_0131
128461001
Patients who underwent stem cell transplantation
Description

Patients who underwent stem cell transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
Description

Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
CL432484
Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
Description

Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0231448
SNOMED CT 2011_0131
255536004
LOINC Version 232
MTHU010348
UMLS CUI 2011AA
C0016129
SNOMED CT 2011_0131
125685002
LOINC Version 232
MTHU011987
UMLS CUI 2011AA
C0205410
SNOMED CT 2011_0131
51117008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed informed consent prior to enrollment
Item
Signed informed consent prior to enrollment
boolean
C0021430 (UMLS CUI 2011AA)
Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
Item
Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0036421 (UMLS CUI 2011AA)
89155008 (SNOMED CT 2011_0131)
10042953 (MedDRA 14.1)
M34.9 (ICD-10-CM Version 2010)
710.1 (ICD-9-CM Version 2011)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL430579 (UMLS CUI 2011AA)
C0748540 (UMLS CUI 2011AA)
298285004 (SNOMED CT 2011_0131)
C1258104 (UMLS CUI 2011AA)
444133002, 128460000 (SNOMED CT 2011_0131)
10012977 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
For patients with no history of digital ulcers (DU) and no DU at enrollment only:
Item
For patients with no history of digital ulcers (DU) and no DU at enrollment only:
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
CL434168 (UMLS CUI 2011AA)
10072119 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
Item
Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2348519 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0034735 (UMLS CUI 2011AA)
266261006 (SNOMED CT 2011_0131)
10037912 (MedDRA 14.1)
Item Group
Exclusion Criteria
SSc sine scleroderma (without any skin involvement)
Item
Systemic sclerosis without skin thickening
boolean
C1290138 (UMLS CUI 2011AA)
128461001 (SNOMED CT 2011_0131)
Patients who underwent stem cell transplantation
Item
Patients who underwent stem cell transplantation
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
Item
Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
CL432484 (UMLS CUI 2011AA)
Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
Item
Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0231448 (UMLS CUI 2011AA)
255536004 (SNOMED CT 2011_0131)
MTHU010348 (LOINC Version 232)
C0016129 (UMLS CUI 2011AA)
125685002 (SNOMED CT 2011_0131)
MTHU011987 (LOINC Version 232)
C0205410 (UMLS CUI 2011AA)
51117008 (SNOMED CT 2011_0131)
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