ID

4319

Description

ODM derived from http://clinicaltrials.gov/show/NCT01113710

Link

http://clinicaltrials.gov/show/NCT01113710

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01113710 Idiopathic Restless Legs Syndrome

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
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 patient's treatment must be in accordance with the local marketing authorization (MA) for Neupro
Description

The patient's treatment must be in accordance with the local marketing authorization (MA) for Neupro

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
CL415814
UMLS CUI 2011AA
C1949346
The patient must have a diagnosis of moderate to severe idiopathic RLS
Description

The patient must have a diagnosis of moderate to severe idiopathic RLS

Data type

boolean

Alias
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 is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
Description

The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C2347947
UMLS CUI 2011AA
C2698977
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0150270
SNOMED CT 2011_0131
182832007
LOINC Version 232
MTHU008871
The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AA
C0679006
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Subject 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

Subject 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
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Hypersensitivity to the active substance or to any of the excipients
Description

Hypersensitivity to the active substance or to any of the excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0439861
SNOMED CT 2011_0131
105590001
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Magnetic resonance imaging or cardioversion (see SmPC)
Description

Magnetic resonance imaging or cardioversion (see SmPC)

Data type

boolean

Alias
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0013778
SNOMED CT 2011_0131
250980009
MedDRA 14.1
10007661
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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
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
The patient's treatment must be in accordance with the local marketing authorization (MA) for Neupro
Item
The patient's treatment must be in accordance with the local marketing authorization (MA) for Neupro
boolean
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415116 (UMLS CUI 2011AA)
CL415814 (UMLS CUI 2011AA)
C1949346 (UMLS CUI 2011AA)
The patient must have a diagnosis of moderate to severe idiopathic RLS
Item
The patient must have a diagnosis of moderate to severe idiopathic RLS
boolean
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 is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
Item
The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
boolean
C2347947 (UMLS CUI 2011AA)
C2698977 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0150270 (UMLS CUI 2011AA)
182832007 (SNOMED CT 2011_0131)
MTHU008871 (LOINC Version 232)
The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
Item
The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
boolean
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0679006 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Subject 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
Subject 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)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Hypersensitivity to the active substance or to any of the excipients
Item
Hypersensitivity to the active substance or to any of the excipients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Magnetic resonance imaging or cardioversion (see SmPC)
Item
Magnetic resonance imaging or cardioversion (see SmPC)
boolean
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0013778 (UMLS CUI 2011AA)
250980009 (SNOMED CT 2011_0131)
10007661 (MedDRA 14.1)
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