ID

3845

Description

ODM derived from http://clinicaltrials.gov/show/NCT01386944

Link

http://clinicaltrials.gov/show/NCT01386944

Keywords

Versions (1)
  1. 4/17/13 4/17/13 - Martin Dugas
Uploaded on

April 17, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01386944 Restless Legs Syndrome

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
The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
Description

The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0332240
SNOMED CT 2011_0131
54690008
UMLS CUI 2011AA
C0035258
SNOMED CT 2011_0131
32914008
MedDRA 14.1
10058920
ICD-10-CM Version 2010
G25.81
ICD-9-CM Version 2011
333.94
The patient must be experiencing augmentation due to a prior dopaminergic treatment
Description

The patient must be experiencing augmentation due to a prior dopaminergic treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0442805
SNOMED CT 2011_0131
260366006
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL434269
MedDRA 14.1
10072385
The decision to prescribe Neupro has been made by the physician independently of his/her decision to enroll the patient in the study
Description

The decision to prescribe Neupro has been made by the physician independently of his/her decision to enroll the patient in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679006
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C1949346
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent
Description

Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent

Data type

boolean

Alias
UMLS CUI 2011AA
C1522154
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Exclusion Criteria
Description

Exclusion Criteria

Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study
Description

Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1536279
MedDRA 14.1
10064476
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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)
The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
Item
The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0332240 (UMLS CUI 2011AA)
54690008 (SNOMED CT 2011_0131)
C0035258 (UMLS CUI 2011AA)
32914008 (SNOMED CT 2011_0131)
10058920 (MedDRA 14.1)
G25.81 (ICD-10-CM Version 2010)
333.94 (ICD-9-CM Version 2011)
The patient must be experiencing augmentation due to a prior dopaminergic treatment
Item
The patient must be experiencing augmentation due to a prior dopaminergic treatment
boolean
C1514756 (UMLS CUI 2011AA)
C0442805 (UMLS CUI 2011AA)
260366006 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL434269 (UMLS CUI 2011AA)
10072385 (MedDRA 14.1)
The decision to prescribe Neupro has been made by the physician independently of his/her decision to enroll the patient in the study
Item
The decision to prescribe Neupro has been made by the physician independently of his/her decision to enroll the patient in the study
boolean
C0679006 (UMLS CUI 2011AA)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C1949346 (UMLS CUI 2011AA)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent
Item
Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent
boolean
C1522154 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study
Item
Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1536279 (UMLS CUI 2011AA)
10064476 (MedDRA 14.1)
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