ID

40367

Beskrivning

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT01777555

Länk

https://clinicaltrials.gov/show/NCT01777555

Nyckelord

Versioner (1)
  1. 2020-04-14 2020-04-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 april 2020

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 NCT01777555

Engelsk

Eligibility Idiopathic Parkinson's Disease NCT01777555

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 Stage

Datatyp

boolean

Alias
UMLS CUI [1]
C3639483
require levodopa-containing medication regimen at least 4 times during the waking day;
Beskrivning

Requirement Pharmacotherapy Levodopa | Levodopa times/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0023570
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0439511
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 | Levodopa Responsive

Datatyp

boolean

Alias
UMLS CUI [1]
C1868976
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0205342
are on stable pd medication regimen.
Beskrivning

Pharmacotherapy Stable Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0030567
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

Prior surgery Parkinson Disease | Stereotactic surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0030567
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

Treatment required for Psychotic symptoms | Feeling suicidal | Suicide attempt

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0871189
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0038663
adequate lung function as measured by spirometry;
Beskrivning

Lung function Spirometry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0037981
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
Beskrivning

Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition At risk Patient safety | Comorbidity Severe At risk Patient safety | Abnormality At risk Patient safety | Finding At risk Patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C0243095
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C1444641
UMLS CUI [6,4]
C1113679
UMLS CUI [7,1]
C1704258
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0243095
UMLS CUI [8,2]
C1444641
UMLS CUI [8,3]
C1113679
Tillbaka till toppen

Similar models

Eligibility Idiopathic Parkinson's Disease NCT01777555

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 Stage
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C3639483 (UMLS CUI [1])
Requirement Pharmacotherapy Levodopa | Levodopa times/day
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C1514873 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
Motor fluctuations | Levodopa Responsive
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])
C0023570 (UMLS CUI [2,1])
C0205342 (UMLS CUI [2,2])
Pharmacotherapy Stable Parkinson Disease
Item
are on stable pd medication regimen.
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior surgery Parkinson Disease | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0455610 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Treatment required for Psychotic symptoms | Feeling suicidal | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0332121 (UMLS CUI [1,1])
C0871189 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Lung function Spirometry
Item
adequate lung function as measured by spirometry;
boolean
C0024119 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition At risk Patient safety | Comorbidity Severe At risk Patient safety | Abnormality At risk Patient safety | Finding 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
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C1704258 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0243095 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C1113679 (UMLS CUI [6,4])
C1704258 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0243095 (UMLS CUI [8,1])
C1444641 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
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