ID

22367

Descrição

Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00292227

Link

https://clinicaltrials.gov/show/NCT00292227

Palavras-chave

Versões (2)
  1. 31/05/2017 31/05/2017 -
  2. 20/09/2021 20/09/2021 -
Transferido a

31 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00292227

Inglês

Eligibility Parkinson's Disease NCT00292227

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female at least 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
advanced-stage idiopathic parkinson's disease requiring treatment with levodopa.
Descrição

Parkinson Disease Advanced Hoehn and Yahr Stage | Levodopa Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3639483
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0686904
nonchildbearing potential
Descrição

Childbearing Potential Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
atypical parkinson's syndrome(s).
Descrição

Atypical Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868596
history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.
Descrição

Pallidotomy | Thalamotomy | Deep Brain Stimulation | Fetal Tissue Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0195893
UMLS CUI [2]
C0195894
UMLS CUI [3]
C0394162
UMLS CUI [4]
C0079345
significant tremor or dyskinesias.
Descrição

Tremor | Dyskinetic syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040822
UMLS CUI [2]
C0013384
severe dysfunction of the autonomic nervous system.
Descrição

Dysfunction of the autonomic nervous system Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3277919
UMLS CUI [1,2]
C0205082
history of transient ischemic attack or stroke within the last 12 months.
Descrição

Transient Ischemic Attack | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
conduction abnormality or relevant cardiac dysfunction and/or myocardial infarction within last 12 months.
Descrição

Abnormal cardiac conduction | Cardiac dysfunction | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232219
UMLS CUI [2]
C3277906
UMLS CUI [3]
C0027051
history or current condition of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia), or a family history of long qt syndrome and/or of torsade de pointes.
Descrição

Risk factors Torsades de Pointes | Heart failure | Hypokalemia | Long QT Syndrome Family history | Torsades de Pointes Family history

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0040479
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0020621
UMLS CUI [4,1]
C0023976
UMLS CUI [4,2]
C0241889
UMLS CUI [5,1]
C0040479
UMLS CUI [5,2]
C0241889
no stable sinus rhythm: more than 20 ectopics/h.
Descrição

Sinus rhythm Unstable Ectopic beats

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0428986
any other clinically relevant ecg abnormality.
Descrição

ECG abnormality

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1832603
history or current condition of epilepsy and/or seizures.
Descrição

Epilepsy | Seizures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
history or current condition of atopic or eczematous dermatitis, psoriasis, or another active skin disease.
Descrição

Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0013595
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0037274
history or current condition of symptomatic orthostatic hypotension.
Descrição

Hypotension orthostatic symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0740482
history or current condition of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis.
Descrição

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

Tipo de dados

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]
C0332197
history of glucose 6-phosphate dehydrogenase deficiency.
Descrição

Deficiency of glucose-6-phosphate dehydrogenase

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2939465
history of tendonitis or tendon rupture with quinolone antibiotics.
Descrição

Tendinitis | Rupture of tendon | Quinolone Antibiotic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0039503
UMLS CUI [2]
C0151937
UMLS CUI [3]
C1882518
renal or hepatic dysfunction.
Descrição

Renal dysfunction | Liver Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0086565
treatment with dopamine agonists, mao a inhibitors, reserpine, or alpha-methyldopa
Descrição

Dopamine Agonists | Monoamine Oxidase-A Inhibitors | Reserpine | Methyldopa

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C2917289
UMLS CUI [3]
C0035179
UMLS CUI [4]
C0025741
therapy known to produce a nontrivial prolongation of the qt interval.
Descrição

Therapeutic procedure Causing Prolonged QT interval

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
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Similar models

Eligibility Parkinson's Disease NCT00292227

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Advanced Hoehn and Yahr Stage | Levodopa Patient need for
Item
advanced-stage idiopathic parkinson's disease requiring treatment with levodopa.
boolean
C0030567 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3639483 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Childbearing Potential Absent
Item
nonchildbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinson Disease
Item
atypical parkinson's syndrome(s).
boolean
C1868596 (UMLS CUI [1])
Pallidotomy | Thalamotomy | Deep Brain Stimulation | Fetal Tissue Transplantation
Item
history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.
boolean
C0195893 (UMLS CUI [1])
C0195894 (UMLS CUI [2])
C0394162 (UMLS CUI [3])
C0079345 (UMLS CUI [4])
Tremor | Dyskinetic syndrome
Item
significant tremor or dyskinesias.
boolean
C0040822 (UMLS CUI [1])
C0013384 (UMLS CUI [2])
Dysfunction of the autonomic nervous system Severe
Item
severe dysfunction of the autonomic nervous system.
boolean
C3277919 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
history of transient ischemic attack or stroke within the last 12 months.
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Abnormal cardiac conduction | Cardiac dysfunction | Myocardial Infarction
Item
conduction abnormality or relevant cardiac dysfunction and/or myocardial infarction within last 12 months.
boolean
C0232219 (UMLS CUI [1])
C3277906 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Risk factors Torsades de Pointes | Heart failure | Hypokalemia | Long QT Syndrome Family history | Torsades de Pointes Family history
Item
history or current condition of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia), or a family history of long qt syndrome and/or of torsade de pointes.
boolean
C0035648 (UMLS CUI [1,1])
C0040479 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0020621 (UMLS CUI [3])
C0023976 (UMLS CUI [4,1])
C0241889 (UMLS CUI [4,2])
C0040479 (UMLS CUI [5,1])
C0241889 (UMLS CUI [5,2])
Sinus rhythm Unstable Ectopic beats
Item
no stable sinus rhythm: more than 20 ectopics/h.
boolean
C0232201 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0428986 (UMLS CUI [1,3])
ECG abnormality
Item
any other clinically relevant ecg abnormality.
boolean
C1832603 (UMLS CUI [1])
Epilepsy | Seizures
Item
history or current condition of epilepsy and/or seizures.
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders
Item
history or current condition of atopic or eczematous dermatitis, psoriasis, or another active skin disease.
boolean
C0011615 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
C0037274 (UMLS CUI [4])
Hypotension orthostatic symptomatic
Item
history or current condition of symptomatic orthostatic hypotension.
boolean
C0740482 (UMLS CUI [1])
Cutaneous hypersensitivity Adhesives | Cutaneous hypersensitivity Transdermal Product | Contact Dermatitis Resolution Absent
Item
history or current condition of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved 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])
C0332197 (UMLS CUI [3,3])
Deficiency of glucose-6-phosphate dehydrogenase
Item
history of glucose 6-phosphate dehydrogenase deficiency.
boolean
C2939465 (UMLS CUI [1])
Tendinitis | Rupture of tendon | Quinolone Antibiotic
Item
history of tendonitis or tendon rupture with quinolone antibiotics.
boolean
C0039503 (UMLS CUI [1])
C0151937 (UMLS CUI [2])
C1882518 (UMLS CUI [3])
Renal dysfunction | Liver Dysfunction
Item
renal or hepatic dysfunction.
boolean
C3279454 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Dopamine Agonists | Monoamine Oxidase-A Inhibitors | Reserpine | Methyldopa
Item
treatment with dopamine agonists, mao a inhibitors, reserpine, or alpha-methyldopa
boolean
C0178601 (UMLS CUI [1])
C2917289 (UMLS CUI [2])
C0035179 (UMLS CUI [3])
C0025741 (UMLS CUI [4])
Therapeutic procedure Causing Prolonged QT interval
Item
therapy known to produce a nontrivial prolongation of the qt interval.
boolean
C0087111 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
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