ID

42531

Beskrivning

Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study); ODM derived from: https://clinicaltrials.gov/show/NCT00821743

Länk

https://clinicaltrials.gov/show/NCT00821743

Nyckelord

Versioner (1)
  1. 2021-08-18 2021-08-18 -
Rättsinnehavare

Centre Hospitalier Universitaire de Nice

Uppladdad den

18 augusti 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Parkinson Disease NCT00821743

Engelsk

Eligibility Parkinson Disease NCT00821743

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
severe idiopathic parkinson's disease (stage of hoehn and yahr ≥ 3).
Beskrivning

Severe idiopathic parkinson's disease (Hoehn and Yahr Stage)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0865475
UMLS CUI [1,2]
C3639483
UMLS CUI [1,3]
C0205082
disease duration ≥ 5 years.
Beskrivning

Disease duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
predominant axial motor signs (gait and balance disturbance as freezing of gait, postural instability, falls) with disability in daily life, defined by a score updrs ii 2 of item 13 or 3 of item 14 or 15.
Beskrivning

Predominant axial motor signs | Gait disturbance | Balance ability absent | UPRDS score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C1542147
UMLS CUI [2,1]
C0560184
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1856566
UMLS CUI [4]
C3639721
axial motor signs resistant to optimal drug and non-drug treatment, including physical therapy and eventually stn-dbs (if stn-dbs is ongoing for at least 1 year and has shown no efficacy on axial motor signs).
Beskrivning

Axial motor signs resistant to treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C0205269
no significant abnormality on brain mri.
Beskrivning

Significant abnormality on brain MRI absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
patient with non-axial, dopa-responsive motor signs and indication of first line stn-dbs. in case of absence of efficacy of stn-dbs on axial motor signs after one year of stimulation, ppn-dbs may be proposed to these patients.
Beskrivning

Non-axial, dopa-responsive motor signs | Indication of first line stn-dbs | When absence of efficacy of stn-dbs after one year, pps-dbs allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0205131
UMLS CUI [1,4]
C0023570
UMLS CUI [1,5]
C0205342
UMLS CUI [2,1]
C0152355
UMLS CUI [2,2]
C0394162
UMLS CUI [2,3]
C1708063
UMLS CUI [2,4]
C3146298
UMLS CUI [3,1]
C0152355
UMLS CUI [3,2]
C0394162
UMLS CUI [3,3]
C0235828
UMLS CUI [3,4]
C0449238
UMLS CUI [3,5]
C0683607
UMLS CUI [3,6]
C0262306
UMLS CUI [3,7]
C0394162
patient with major cognitive disturbances defined by a score mattis drs 130 (of 144).
Beskrivning

Impaired cognition defined by Clinical dementia rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0451074
pregnant or breast-feeding woman.
Beskrivning

Pregnancy | Breast-feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with contraindication for general anaesthesia, a contraindication for surgery (including disorders of haemostasis, or necessity of anticoagulant and antiaggregant drug), or a contraindication for mri.
Beskrivning

Contraindication for general anaesthesia | Contraindication for surgery | Contraindication for mri.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1301624
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301624
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C1301624
patient presenting major depression, psychosis or addiction in six months preceding inclusion.
Beskrivning

Major depression recent | Psychosis recent | Addiction recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C0332185
Tillbaka till toppen

Similar models

Eligibility Parkinson Disease NCT00821743

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Severe idiopathic parkinson's disease (Hoehn and Yahr Stage)
Item
severe idiopathic parkinson's disease (stage of hoehn and yahr ≥ 3).
boolean
C0865475 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Disease duration
Item
disease duration ≥ 5 years.
boolean
C0872146 (UMLS CUI [1])
Predominant axial motor signs | Gait disturbance | Balance ability absent | UPRDS score
Item
predominant axial motor signs (gait and balance disturbance as freezing of gait, postural instability, falls) with disability in daily life, defined by a score updrs ii 2 of item 13 or 3 of item 14 or 15.
boolean
C0426980 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C0560184 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1856566 (UMLS CUI [3])
C3639721 (UMLS CUI [4])
Axial motor signs resistant to treatment
Item
axial motor signs resistant to optimal drug and non-drug treatment, including physical therapy and eventually stn-dbs (if stn-dbs is ongoing for at least 1 year and has shown no efficacy on axial motor signs).
boolean
C0426980 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Significant abnormality on brain MRI absent
Item
no significant abnormality on brain mri.
boolean
C0412675 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Non-axial, dopa-responsive motor signs | Indication of first line stn-dbs | When absence of efficacy of stn-dbs after one year, pps-dbs allowed
Item
patient with non-axial, dopa-responsive motor signs and indication of first line stn-dbs. in case of absence of efficacy of stn-dbs on axial motor signs after one year of stimulation, ppn-dbs may be proposed to these patients.
boolean
C0426980 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0205131 (UMLS CUI [1,3])
C0023570 (UMLS CUI [1,4])
C0205342 (UMLS CUI [1,5])
C0152355 (UMLS CUI [2,1])
C0394162 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C3146298 (UMLS CUI [2,4])
C0152355 (UMLS CUI [3,1])
C0394162 (UMLS CUI [3,2])
C0235828 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0683607 (UMLS CUI [3,5])
C0262306 (UMLS CUI [3,6])
C0394162 (UMLS CUI [3,7])
Impaired cognition defined by Clinical dementia rating scale
Item
patient with major cognitive disturbances defined by a score mattis drs 130 (of 144).
boolean
C0338656 (UMLS CUI [1,1])
C0451074 (UMLS CUI [1,2])
Pregnancy | Breast-feeding
Item
pregnant or breast-feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraindication for general anaesthesia | Contraindication for surgery | Contraindication for mri.
Item
patient with contraindication for general anaesthesia, a contraindication for surgery (including disorders of haemostasis, or necessity of anticoagulant and antiaggregant drug), or a contraindication for mri.
boolean
C0002915 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
Major depression recent | Psychosis recent | Addiction recent
Item
patient presenting major depression, psychosis or addiction in six months preceding inclusion.
boolean
C1269683 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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