ID

36785

Descrição

Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02249559

Link

https://clinicaltrials.gov/show/NCT02249559

Palavras-chave

Versões (1)
  1. 08/06/2019 08/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de junho de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Parkinsons Disease NCT02249559

Inglês

Eligibility Parkinsons Disease NCT02249559

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. otherwise appropriate dbs candidates but deemed suboptimal for dbs on account of one or more of the following:
Descrição

Patient Appropriate Deep Brain Stimulation | Patient Suboptimal Deep Brain Stimulation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0394162
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2984009
UMLS CUI [2,3]
C0394162
advanced age greater than 74 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
medical comorbidities
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
need for continual anticoagulation
Descrição

Patient need for Anticoagulation Therapy Continuous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0549178
poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
Descrição

General Anesthesia At risk Due to Cardiac Status | General Anesthesia At risk Due to Hepatic status | General Anesthesia At risk Due to Kidney problem | General Anesthesia At risk Due to Lung status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1999091
UMLS CUI [2,1]
C0002915
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0449925
UMLS CUI [3,1]
C0002915
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0812426
UMLS CUI [4,1]
C0002915
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0449930
high infection risk if internal dbs device hardware is placed (ie. poor diabetes mellitus control)
Descrição

High risk of Communicable Disease | Etiology Deep Brain Stimulation Device placement | Diabetes mellitus poor control

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0394162
UMLS CUI [2,3]
C0021107
UMLS CUI [3]
C0860161
patient aversion to dbs
Descrição

Aversion Deep Brain Stimulation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0233496
UMLS CUI [1,2]
C0394162
2. patients with asymmetric disease symptoms including:
Descrição

Disease Symptoms Asymmetric

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332514
rigidity
Descrição

Rigidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026837
tremor
Descrição

Tremor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040822
bradykinesia
Descrição

Bradykinesia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0233565
dyskinesia
Descrição

Dyskinesia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013384
3. more than 30% improvement in updrs score in on versus off medication state, except:
Descrição

Improvement Percentage UPDRS

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C3639721
in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
Descrição

Exception Dyskinesia Contralateral | Exception Dystonia Contralateral | Dose Tolerance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0013384
UMLS CUI [1,3]
C0441988
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013421
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0231197
UMLS CUI [3,3]
C0439801
tremors that are medically refractory
Descrição

Tremors Unresponsive to Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040822
UMLS CUI [1,2]
C0205269
4. patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of gks, as determined by review of medical record
Descrição

Pharmacotherapy Stable | Symptoms Stable Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0449238
5. mmse score greater than or equal to 26
Descrição

Mini-mental state examination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on questions 28, 29 & 30 on the updrs
Descrição

Axial symptoms UPDRS | Postural instability UPDRS | Gait abnormality UPDRS

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4314351
UMLS CUI [1,2]
C3639721
UMLS CUI [2,1]
C1843921
UMLS CUI [2,2]
C3639721
UMLS CUI [3,1]
C0575081
UMLS CUI [3,2]
C3639721
patients whose symptoms do not improve by more than 30% in updrs score with medication, unless patient experiences dose-limiting side effects
Descrição

Pharmacotherapy | Improvement Percentage UPDRS | Exception Side effects Limiting Dose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C2986411
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C3639721
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0178602
the presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
Descrição

Dementia Mini-mental state examination | Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients who have had prior brain radiation
Descrição

Radiotherapy to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948319
patients with improvement and satisfactory symptom management will not be offered this procedure. we will only include patients without satisfactory symptom management.
Descrição

Improvement | Symptom Management satisfactory

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2986411
UMLS CUI [2,1]
C1536570
UMLS CUI [2,2]
C0205410
Voltar ao início da página

Similar models

Eligibility Parkinsons Disease NCT02249559

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Patient Appropriate Deep Brain Stimulation | Patient Suboptimal Deep Brain Stimulation
Item
1. otherwise appropriate dbs candidates but deemed suboptimal for dbs on account of one or more of the following:
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0394162 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
C0394162 (UMLS CUI [2,3])
Age
Item
advanced age greater than 74 years of age
boolean
C0001779 (UMLS CUI [1])
Comorbidity
Item
medical comorbidities
boolean
C0009488 (UMLS CUI [1])
Patient need for Anticoagulation Therapy Continuous
Item
need for continual anticoagulation
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
General Anesthesia At risk Due to Cardiac Status | General Anesthesia At risk Due to Hepatic status | General Anesthesia At risk Due to Kidney problem | General Anesthesia At risk Due to Lung status
Item
poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
boolean
C0002915 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1999091 (UMLS CUI [1,4])
C0002915 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0449925 (UMLS CUI [2,4])
C0002915 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0812426 (UMLS CUI [3,4])
C0002915 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0449930 (UMLS CUI [4,4])
High risk of Communicable Disease | Etiology Deep Brain Stimulation Device placement | Diabetes mellitus poor control
Item
high infection risk if internal dbs device hardware is placed (ie. poor diabetes mellitus control)
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0394162 (UMLS CUI [2,2])
C0021107 (UMLS CUI [2,3])
C0860161 (UMLS CUI [3])
Aversion Deep Brain Stimulation
Item
patient aversion to dbs
boolean
C0233496 (UMLS CUI [1,1])
C0394162 (UMLS CUI [1,2])
Disease Symptoms Asymmetric
Item
2. patients with asymmetric disease symptoms including:
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332514 (UMLS CUI [1,3])
Rigidity
Item
rigidity
boolean
C0026837 (UMLS CUI [1])
Tremor
Item
tremor
boolean
C0040822 (UMLS CUI [1])
Bradykinesia
Item
bradykinesia
boolean
C0233565 (UMLS CUI [1])
Dyskinesia
Item
dyskinesia
boolean
C0013384 (UMLS CUI [1])
Improvement Percentage UPDRS
Item
3. more than 30% improvement in updrs score in on versus off medication state, except:
boolean
C2986411 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
Exception Dyskinesia Contralateral | Exception Dystonia Contralateral | Dose Tolerance Limited
Item
in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
boolean
C1705847 (UMLS CUI [1,1])
C0013384 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0013421 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0231197 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Tremors Unresponsive to Treatment
Item
tremors that are medically refractory
boolean
C0040822 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Pharmacotherapy Stable | Symptoms Stable Duration
Item
4. patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of gks, as determined by review of medical record
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Mini-mental state examination
Item
5. mmse score greater than or equal to 26
boolean
C0451306 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axial symptoms UPDRS | Postural instability UPDRS | Gait abnormality UPDRS
Item
patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on questions 28, 29 & 30 on the updrs
boolean
C4314351 (UMLS CUI [1,1])
C3639721 (UMLS CUI [1,2])
C1843921 (UMLS CUI [2,1])
C3639721 (UMLS CUI [2,2])
C0575081 (UMLS CUI [3,1])
C3639721 (UMLS CUI [3,2])
Pharmacotherapy | Improvement Percentage UPDRS | Exception Side effects Limiting Dose
Item
patients whose symptoms do not improve by more than 30% in updrs score with medication, unless patient experiences dose-limiting side effects
boolean
C0013216 (UMLS CUI [1])
C2986411 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3639721 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
Dementia Mini-mental state examination | Informed Consent Unable
Item
the presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Radiotherapy to brain
Item
patients who have had prior brain radiation
boolean
C0948319 (UMLS CUI [1])
Improvement | Symptom Management satisfactory
Item
patients with improvement and satisfactory symptom management will not be offered this procedure. we will only include patients without satisfactory symptom management.
boolean
C2986411 (UMLS CUI [1])
C1536570 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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