ID

4295

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT01159691

Link

http://clinicaltrials.gov/show/NCT01159691

Palavras-chave

Versões (1)
  1. 06/12/2013 06/12/2013 - Martin Dugas
Transferido a

6 de dezembro de 2013

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT01159691 Idiopathic Parkinson's Disease

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Descrição

age at least 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
The decision to prescribe Neupro must have been made by the physician before and independently of his/her decision to include the patient in the study.
Descrição

The decision to prescribe Neupro must have been made by the physician before and independently of his/her decision to include the patient in the study.

Tipo de dados

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
C1949346
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C0679006
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1705313
UMLS CUI 2011AA
CL415814
UMLS CUI 2011AA
C1949346
The patients must have a diagnosis of Idiopathic Parkinson's disease.
Descrição

The patients must have a diagnosis of Idiopathic Parkinson's disease.

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0030567
SNOMED CT 2011_0131
49049000
MedDRA 14.1
10061536
LOINC Version 232
MTHU020807
ICD-10-CM Version 2010
G20
ICD-9-CM Version 2011
332.0
Only patients having signed the Consent form regarding study information, data transfer and use
Descrição

Only patients having signed the Consent form regarding study information, data transfer and use

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2348583
UMLS CUI 2011AA
C1511726
UMLS CUI 2011AA
C1705822
LOINC Version 232
MTHU034962
UMLS CUI 2011AA
CL414708
Patients suffering from gastrointestinal symptoms whilst on a label compliant dose of anti-Parkinson's medication
Descrição

Patients suffering from gastrointestinal symptoms whilst on a label compliant dose of anti-Parkinson's medication

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0426576
SNOMED CT 2011_0131
267045008
MedDRA 14.1
10018011
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
CL415824
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0003405
SNOMED CT 2011_0131
58050004
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients not fulfilling the inclusion criteria
Descrição

Patients not fulfilling the inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL425202
And according to SmPC:
Descrição

And according to SmPC:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709515
Hypersensitivity to the active substance or to any of the excipients
Descrição

Hypersensitivity to the active substance or to any of the excipients

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1372955
HL7 V3 2006_05
ACTI
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Magnetic resonance tomography (MRT) or cardioversion
Descrição

Magnetic resonance tomography (MRT) or cardioversion

Tipo de dados

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 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 decision to prescribe Neupro must have been made by the physician before and independently of his/her decision to include the patient in the study.
Item
The decision to prescribe Neupro must have been made by the physician before and 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)
C1949346 (UMLS CUI 2011AA)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C0679006 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro
Item
The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro
boolean
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1705313 (UMLS CUI 2011AA)
CL415814 (UMLS CUI 2011AA)
C1949346 (UMLS CUI 2011AA)
The patients must have a diagnosis of Idiopathic Parkinson's disease.
Item
The patients must have a diagnosis of Idiopathic Parkinson's disease.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0030567 (UMLS CUI 2011AA)
49049000 (SNOMED CT 2011_0131)
10061536 (MedDRA 14.1)
MTHU020807 (LOINC Version 232)
G20 (ICD-10-CM Version 2010)
332.0 (ICD-9-CM Version 2011)
Only patients having signed the Consent form regarding study information, data transfer and use
Item
Only patients having signed the Consent form regarding study information, data transfer and use
boolean
C2348583 (UMLS CUI 2011AA)
C1511726 (UMLS CUI 2011AA)
C1705822 (UMLS CUI 2011AA)
MTHU034962 (LOINC Version 232)
CL414708 (UMLS CUI 2011AA)
Patients suffering from gastrointestinal symptoms whilst on a label compliant dose of anti-Parkinson's medication
Item
Patients suffering from gastrointestinal symptoms whilst on a label compliant dose of anti-Parkinson's medication
boolean
C0426576 (UMLS CUI 2011AA)
267045008 (SNOMED CT 2011_0131)
10018011 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
CL415824 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003405 (UMLS CUI 2011AA)
58050004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients not fulfilling the inclusion criteria
Item
Patients not fulfilling the inclusion criteria
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL425202 (UMLS CUI 2011AA)
And according to SmPC:
Item
And according to SmPC:
boolean
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709515 (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)
C1372955 (UMLS CUI 2011AA)
ACTI (HL7 V3 2006_05)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Magnetic resonance tomography (MRT) or cardioversion
Item
Magnetic resonance tomography (MRT) or cardioversion
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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