ID

31395

Descripción

Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00438607

Link

https://clinicaltrials.gov/show/NCT00438607

Palabras clave

Versiones (1)
  1. 19/8/18 19/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de agosto de 2018

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 NCT00438607

Inglés

Eligibility Parkinson's Disease NCT00438607

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
must carry a diagnosis of idiopathic pd according to uk parkinson's disease society brain bank clinical diagnostic criteria, and be hoehn & yahr stage ii to iv (inclusive) when off.
Descripción

Parkinson Disease Hoehn and Yahr Stage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639483
must be on a stable dose of l-3,4-dihydroxyphenylalanine (l-dopa)/carbidopa or l-dopa/benserazide for at least 4 weeks prior to enrollment.
Descripción

Carbidopa / Levodopa Dose Stable | Benserazide / Levodopa Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0353697
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0358787
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
except for l-dopa and certain allowed dopamine agonists, must not be receiving any other pd medications. (current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
Descripción

Other Antiparkinson Agents Absent | Exception Levodopa | Exception Dopamine Agonists allowed | Dopamine Agonists Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1579414
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023570
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0178601
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0178601
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
some subjects must demonstrate a definite end of l-dopa dose wearing off (at least 2 hours off time per waking day) and must be able to keep accurate patient diaries of pd activity.
Descripción

Levodopa Dose Wearing off effect Discontinued | Subject Diary Parkinson Disease Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1504539
UMLS CUI [1,4]
C1444662
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0030567
UMLS CUI [2,3]
C0205197
major exclusion criteria:
Descripción

Exclusion Criteria Major

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
a mini mental state examination (mmse) score <26.
Descripción

Mini-mental state examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451306
history or clinical features consistent with an atypical parkinsonian syndrome.
Descripción

Feature Clinical Consistent with Atypical Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C1868596
any significant non-parkinson's central nervous system disorder.
Descripción

CNS disorder | Exception Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
any significant axis i psychiatric disease from the diagnostic and statistical manual of mental disorders (dsm).
Descripción

Axis I diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0270287
any previous surgical intervention for parkinson's disease.
Descripción

Operative Surgical Procedures Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
history of certain malignancies.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
history of severe allergic anaphylactic reactions to any drug.
Descripción

Anaphylaxis Severe Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0013227
clinically significant baseline electrocardiogram (ecg).
Descripción

Electrocardiography Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2826293
orthostatic hypotension.
Descripción

Hypotension, Orthostatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020651
hba1c >7.0%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
Volver a la parte superior de la página

Similar models

Eligibility Parkinson's Disease NCT00438607

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Hoehn and Yahr Stage
Item
must carry a diagnosis of idiopathic pd according to uk parkinson's disease society brain bank clinical diagnostic criteria, and be hoehn & yahr stage ii to iv (inclusive) when off.
boolean
C0030567 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
Carbidopa / Levodopa Dose Stable | Benserazide / Levodopa Dose Stable
Item
must be on a stable dose of l-3,4-dihydroxyphenylalanine (l-dopa)/carbidopa or l-dopa/benserazide for at least 4 weeks prior to enrollment.
boolean
C0353697 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0358787 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Other Antiparkinson Agents Absent | Exception Levodopa | Exception Dopamine Agonists allowed | Dopamine Agonists Dose Stable
Item
except for l-dopa and certain allowed dopamine agonists, must not be receiving any other pd medications. (current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
boolean
C1579414 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0178601 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0178601 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Levodopa Dose Wearing off effect Discontinued | Subject Diary Parkinson Disease Completion
Item
some subjects must demonstrate a definite end of l-dopa dose wearing off (at least 2 hours off time per waking day) and must be able to keep accurate patient diaries of pd activity.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1504539 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,4])
C3890583 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Mini-mental state examination
Item
a mini mental state examination (mmse) score <26.
boolean
C0451306 (UMLS CUI [1])
Feature Clinical Consistent with Atypical Parkinson Disease
Item
history or clinical features consistent with an atypical parkinsonian syndrome.
boolean
C2348519 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1868596 (UMLS CUI [1,4])
CNS disorder | Exception Parkinson Disease
Item
any significant non-parkinson's central nervous system disorder.
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Axis I diagnosis
Item
any significant axis i psychiatric disease from the diagnostic and statistical manual of mental disorders (dsm).
boolean
C0270287 (UMLS CUI [1])
Operative Surgical Procedures Parkinson Disease
Item
any previous surgical intervention for parkinson's disease.
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Malignant Neoplasms
Item
history of certain malignancies.
boolean
C0006826 (UMLS CUI [1])
Anaphylaxis Severe Pharmaceutical Preparations
Item
history of severe allergic anaphylactic reactions to any drug.
boolean
C0002792 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Electrocardiography Clinical Significance
Item
clinically significant baseline electrocardiogram (ecg).
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hypotension, Orthostatic
Item
orthostatic hypotension.
boolean
C0020651 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c >7.0%
boolean
C0474680 (UMLS CUI [1])
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