ID

15297

Beskrivning

Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT02242487

Länk

https://clinicaltrials.gov/show/NCT02242487

Nyckelord

Versioner (1)
  1. 2016-05-25 2016-05-25 -
Uppladdad den

25 maj 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 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 Idiopathic Parkinson's Disease NCT02242487

Engelsk

Eligibility Idiopathic Parkinson's Disease NCT02242487

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
Beskrivning

Parkinson Disease | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
hoehn and yahr stage 1-3 in an "on" state;
Beskrivning

Hoehn and Yahr grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0451215
require levodopa-containing medication regimen at least 4 times during the waking day;
Beskrivning

Levodopa Medication regimen Waking Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0442696
UMLS CUI [1,4]
C1514873
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Beskrivning

Motor fluctuations Waking | Levodopa Responsiveness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0442696
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0552602
are on stable pd medication regimen;
Beskrivning

Parkinson Disease Medication regimen Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0205360
total daily levodopa (ld) dose <1600 mg/day;
Beskrivning

Levodopa Daily Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C2348070
able to perform a spirometry maneuver in the on and off states
Beskrivning

Spirometry Ability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037981
UMLS CUI [1,2]
C0085732
normal cognition confirmed by mini mental state examination (mmse) score ≥25 ;
Beskrivning

Actual Effective Cognition mini-mental status exam score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712133
UMLS CUI [1,2]
C2225229
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous surgery for pd or plan to have stereotactic surgery during the study period;
Beskrivning

Parkinson Disease H/O: surgery | Stereotactic surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0455610
UMLS CUI [2,1]
C1735594
UMLS CUI [2,2]
C1301732
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Beskrivning

Psychotic symptom Requirement Therapeutic procedure | Suicide ideation | Suicide attempt

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C1821181
UMLS CUI [3]
C0038663
known contraindication to the use of levodopa;
Beskrivning

Medical contraindication Levodopa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0023570
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Beskrivning

Comorbidity Study Subject Participation Status Limited | Comorbidity At risk patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
any any contraindication to performing routine spirometry.
Beskrivning

Medical contraindication Spirometry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0037981
Tillbaka till toppen

Similar models

Eligibility Idiopathic Parkinson's Disease NCT02242487

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Age
Item
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hoehn and Yahr grades
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C0451215 (UMLS CUI [1])
Levodopa Medication regimen Waking Required
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C0023570 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0442696 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
Motor fluctuations Waking | Levodopa Responsiveness
Item
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
boolean
C1868976 (UMLS CUI [1,1])
C0442696 (UMLS CUI [1,2])
C0023570 (UMLS CUI [2,1])
C0552602 (UMLS CUI [2,2])
Parkinson Disease Medication regimen Stable
Item
are on stable pd medication regimen;
boolean
C0030567 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Levodopa Daily Dose
Item
total daily levodopa (ld) dose <1600 mg/day;
boolean
C0023570 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Spirometry Ability
Item
able to perform a spirometry maneuver in the on and off states
boolean
C0037981 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Actual Effective Cognition mini-mental status exam score
Item
normal cognition confirmed by mini mental state examination (mmse) score ≥25 ;
boolean
C2712133 (UMLS CUI [1,1])
C2225229 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Parkinson Disease H/O: surgery | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0030567 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Psychotic symptom Requirement Therapeutic procedure | Suicide ideation | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0871189 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1821181 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Medical contraindication Levodopa
Item
known contraindication to the use of levodopa;
boolean
C1301624 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Comorbidity Study Subject Participation Status Limited | Comorbidity At risk patient safety
Item
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Medical contraindication Spirometry
Item
any any contraindication to performing routine spirometry.
boolean
C1301624 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
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