ID

12099

Beschreibung

Randomized Safety Study of CVT-301 Compared to an Observational Control Group; ODM derived from: https://clinicaltrials.gov/show/NCT02352363

Link

https://clinicaltrials.gov/show/NCT02352363

Stichworte

Versionen (2)
  1. 22.09.15 22.09.15 - Julian Varghese
  2. 22.09.15 22.09.15 - Julian Varghese
Hochgeladen am

22. September 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT02352363

Englisch

Eligibility Idiopathic Parkinson's Disease NCT02352363

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
Beschreibung

Contraceptive methods | Female of child bearing age | serum human chorionic gonadotropin (hCG) measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1960468
UMLS CUI [3]
C2208823
patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
Beschreibung

PARKINSON IDIOPATHIC

Datentyp

boolean

Alias
UMLS CUI [1]
C0747270
patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
Beschreibung

severity; staging; stage; state

Datentyp

boolean

Alias
UMLS CUI [1]
C3639483
patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
Beschreibung

Motor fluctuations

Datentyp

boolean

Alias
UMLS CUI [1]
C1868976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
Beschreibung

Dyskinetic syndrome; Severities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0439793
pregnant or lactating females or females wishing to become pregnant.
Beschreibung

pregnant or lactating females

Datentyp

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
Beschreibung

Levodopa; Contraindication | melanoma | Angle Closure Glaucoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0522473
UMLS CUI [2]
C0025202
UMLS CUI [3]
C0017605
patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
Beschreibung

Surgery specialty; Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038894
UMLS CUI [1,2]
C0030567
patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
Beschreibung

Psychotic symptom | Suicide ideation

Datentyp

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C1821181
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Ähnliche Modelle

Eligibility Idiopathic Parkinson's Disease NCT02352363

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Female of child bearing age | serum human chorionic gonadotropin (hCG) measurement
Item
women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
boolean
C0700589 (UMLS CUI [1])
C1960468 (UMLS CUI [2])
C2208823 (UMLS CUI [3])
PARKINSON IDIOPATHIC
Item
patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
boolean
C0747270 (UMLS CUI [1])
severity; staging; stage; state
Item
patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
boolean
C3639483 (UMLS CUI [1])
Motor fluctuations
Item
patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
boolean
C1868976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Dyskinetic syndrome; Severities
Item
patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
boolean
C0013384 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
pregnant or lactating females
Item
pregnant or lactating females or females wishing to become pregnant.
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
Levodopa; Contraindication | melanoma | Angle Closure Glaucoma
Item
patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
boolean
C0023570 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0025202 (UMLS CUI [2])
C0017605 (UMLS CUI [3])
Surgery specialty; Parkinson Disease
Item
patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
boolean
C0038894 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Psychotic symptom | Suicide ideation
Item
patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
boolean
C0871189 (UMLS CUI [1])
C1821181 (UMLS CUI [2])
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