ID

34062

Descripción

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02230904

Link

https://clinicaltrials.gov/show/NCT02230904

Palabras clave

Versiones (1)
  1. 13/1/19 13/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Parkinson's Disease NCT02230904

Inglés

Eligibility Parkinson's Disease NCT02230904

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has a diagnosis of idiopathic parkinson's disease
Descripción

Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030567
subject has been on continuous treatment with commercially available rotigotine transdermal patches (neupro®) for at least 3 months prior to enrollment
Descripción

Rotigotine Transdermal patch | Neupro

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1700683
UMLS CUI [1,2]
C0991556
UMLS CUI [2]
C1949346
subject has been taking a stable rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
Descripción

Rotigotine Dose Stable | Rotigotine Transdermal patch

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1700683
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1700683
UMLS CUI [2,2]
C0991556
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
Descripción

Medical condition compromises Study Subject Well Being | Mental condition compromises Study Subject Well Being | Medical condition compromises Study Subject Participation Status | Mental condition compromises Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C3813622
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0681850
UMLS CUI [2,4]
C3813622
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2348568
subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
Descripción

Cutaneous hypersensitivity Adhesives | Cutaneous hypersensitivity Transdermal Product | Contact Dermatitis Resolution Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0585186
UMLS CUI [1,2]
C0001516
UMLS CUI [2,1]
C0585186
UMLS CUI [2,2]
C3465388
UMLS CUI [3,1]
C0011616
UMLS CUI [3,2]
C1514893
UMLS CUI [3,3]
C0332268
subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, or an active skin disease
Descripción

Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0013595
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0037274
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) or baseline (visit 2)
Descripción

Suicide attempt Lifetime | Suicide attempt | Suicide attempt Interrupted | Suicide attempt aborted | Feeling suicidal C-SSRS Screening Questionnaire | Feeling suicidal C-SSRS Baseline Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038663
UMLS CUI [1,2]
C4071830
UMLS CUI [2]
C0038663
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C1512900
UMLS CUI [4,1]
C0038663
UMLS CUI [4,2]
C1609614
UMLS CUI [5,1]
C0424000
UMLS CUI [5,2]
C3827015
UMLS CUI [6,1]
C0424000
UMLS CUI [6,2]
C3639710
Volver a la parte superior de la página

Similar models

Eligibility Parkinson's Disease NCT02230904

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
subject has a diagnosis of idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1])
Rotigotine Transdermal patch | Neupro
Item
subject has been on continuous treatment with commercially available rotigotine transdermal patches (neupro®) for at least 3 months prior to enrollment
boolean
C1700683 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C1949346 (UMLS CUI [2])
Rotigotine Dose Stable | Rotigotine Transdermal patch
Item
subject has been taking a stable rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
boolean
C1700683 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1700683 (UMLS CUI [2,1])
C0991556 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition compromises Study Subject Well Being | Mental condition compromises Study Subject Well Being | Medical condition compromises Study Subject Participation Status | Mental condition compromises Study Subject Participation Status
Item
subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C3813622 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
C3813622 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Cutaneous hypersensitivity Adhesives | Cutaneous hypersensitivity Transdermal Product | Contact Dermatitis Resolution Lacking
Item
subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
boolean
C0585186 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0585186 (UMLS CUI [2,1])
C3465388 (UMLS CUI [2,2])
C0011616 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders
Item
subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, or an active skin disease
boolean
C0011615 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
C0037274 (UMLS CUI [4])
Suicide attempt Lifetime | Suicide attempt | Suicide attempt Interrupted | Suicide attempt aborted | Feeling suicidal C-SSRS Screening Questionnaire | Feeling suicidal C-SSRS Baseline Questionnaire
Item
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) or baseline (visit 2)
boolean
C0038663 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2])
C0038663 (UMLS CUI [3,1])
C1512900 (UMLS CUI [3,2])
C0038663 (UMLS CUI [4,1])
C1609614 (UMLS CUI [4,2])
C0424000 (UMLS CUI [5,1])
C3827015 (UMLS CUI [5,2])
C0424000 (UMLS CUI [6,1])
C3639710 (UMLS CUI [6,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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