ID

31460

Descripción

A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01007630

Link

https://clinicaltrials.gov/show/NCT01007630

Palabras clave

Versiones (2)
  1. 24/8/18 24/8/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01007630

Inglés

Eligibility Parkinson's Disease NCT01007630

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women with parkinson's disease (pd), defined as the presence of at least two of the cardinal signs of pd (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
Descripción

Parkinson Disease | Signs Main Quantity | Bradykinesia | Resting Tremor | Muscle Rigidity | Absence Cause Other Parkinsonian Disorders | Absence Signs Atypical Parkinsonism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0233565
UMLS CUI [4]
C0234379
UMLS CUI [5]
C0026837
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0015127
UMLS CUI [6,3]
C0205394
UMLS CUI [6,4]
C0242422
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0311392
UMLS CUI [7,3]
C4302185
functional hyposmia or anosmia, as defined by upsit scores less than the 25th percentile for age- and gender-matched norms
Descripción

Hyposmia Functional | Anosmia Functional | Smell Identification Test Score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364082
UMLS CUI [1,2]
C0205245
UMLS CUI [2,1]
C0003126
UMLS CUI [2,2]
C0205245
UMLS CUI [3,1]
C0037361
UMLS CUI [3,2]
C0205396
UMLS CUI [3,3]
C0039593
UMLS CUI [3,4]
C0449820
have been on stable dose of pd medications for at least 30 days
Descripción

Antiparkinson Agents Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
age < or = 90 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
Descripción

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of an mao inhibitor, including selegiline or rasagiline within the last 12 months
Descripción

Monoamine Oxidase Inhibitors | Selegiline | rasagiline

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0036579
UMLS CUI [3]
C0525678
presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (zicam) use, history of smoking within the past year
Descripción

Condition Causing Olfactory impairment | Craniocerebral Trauma | Operation on nose | Nasal inflammation Causing Congestion | Nasal inflammation Causing Polyps | Nasal infection | Sinusitis | Zinc salts Intranasal | Zicam | Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1510410
UMLS CUI [2]
C0018674
UMLS CUI [3]
C0188970
UMLS CUI [4,1]
C2718128
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0700148
UMLS CUI [5,1]
C2718128
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0032584
UMLS CUI [6]
C0555970
UMLS CUI [7]
C0037199
UMLS CUI [8,1]
C0351669
UMLS CUI [8,2]
C0001560
UMLS CUI [9]
C3855401
UMLS CUI [10]
C0543414
presence of dementia or significant cognitive impairment with mini-mental state examination (mmse) < 24
Descripción

Dementia Mini-mental state examination | Impaired cognition Mini-mental state examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0451306
present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
Descripción

Medical condition Study Subject Participation Status Excluded | Operative Surgical Procedures Study Subject Participation Status Excluded | Medical condition Excludes Completion of clinical trial | Operative Surgical Procedures Exclude Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C2732579
use of any experimental medication within 60 days of baseline
Descripción

Experimental drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304229
use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
Descripción

Decongestants | Antihistamines | Inhaled steroids use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282374
UMLS CUI [2]
C0003360
UMLS CUI [3]
C0586793
use of any medication contraindicated with use of rasagiline (investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
Descripción

Pharmaceutical Preparations Contraindicated Rasagiline

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0525678
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Similar models

Eligibility Parkinson's Disease NCT01007630

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Signs Main Quantity | Bradykinesia | Resting Tremor | Muscle Rigidity | Absence Cause Other Parkinsonian Disorders | Absence Signs Atypical Parkinsonism
Item
men and women with parkinson's disease (pd), defined as the presence of at least two of the cardinal signs of pd (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
boolean
C0030567 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0233565 (UMLS CUI [3])
C0234379 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
C0332197 (UMLS CUI [6,1])
C0015127 (UMLS CUI [6,2])
C0205394 (UMLS CUI [6,3])
C0242422 (UMLS CUI [6,4])
C0332197 (UMLS CUI [7,1])
C0311392 (UMLS CUI [7,2])
C4302185 (UMLS CUI [7,3])
Hyposmia Functional | Anosmia Functional | Smell Identification Test Score
Item
functional hyposmia or anosmia, as defined by upsit scores less than the 25th percentile for age- and gender-matched norms
boolean
C2364082 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0003126 (UMLS CUI [2,1])
C0205245 (UMLS CUI [2,2])
C0037361 (UMLS CUI [3,1])
C0205396 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
C0449820 (UMLS CUI [3,4])
Antiparkinson Agents Dose Stable
Item
have been on stable dose of pd medications for at least 30 days
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Age
Item
age < or = 90 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent
Item
women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Monoamine Oxidase Inhibitors | Selegiline | rasagiline
Item
prior use of an mao inhibitor, including selegiline or rasagiline within the last 12 months
boolean
C0026457 (UMLS CUI [1])
C0036579 (UMLS CUI [2])
C0525678 (UMLS CUI [3])
Condition Causing Olfactory impairment | Craniocerebral Trauma | Operation on nose | Nasal inflammation Causing Congestion | Nasal inflammation Causing Polyps | Nasal infection | Sinusitis | Zinc salts Intranasal | Zicam | Tobacco use
Item
presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (zicam) use, history of smoking within the past year
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1510410 (UMLS CUI [1,3])
C0018674 (UMLS CUI [2])
C0188970 (UMLS CUI [3])
C2718128 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0700148 (UMLS CUI [4,3])
C2718128 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0032584 (UMLS CUI [5,3])
C0555970 (UMLS CUI [6])
C0037199 (UMLS CUI [7])
C0351669 (UMLS CUI [8,1])
C0001560 (UMLS CUI [8,2])
C3855401 (UMLS CUI [9])
C0543414 (UMLS CUI [10])
Dementia Mini-mental state examination | Impaired cognition Mini-mental state examination
Item
presence of dementia or significant cognitive impairment with mini-mental state examination (mmse) < 24
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2,1])
C0451306 (UMLS CUI [2,2])
Medical condition Study Subject Participation Status Excluded | Operative Surgical Procedures Study Subject Participation Status Excluded | Medical condition Excludes Completion of clinical trial | Operative Surgical Procedures Exclude Completion of clinical trial
Item
present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Experimental drug
Item
use of any experimental medication within 60 days of baseline
boolean
C0304229 (UMLS CUI [1])
Decongestants | Antihistamines | Inhaled steroids use
Item
use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
boolean
C0282374 (UMLS CUI [1])
C0003360 (UMLS CUI [2])
C0586793 (UMLS CUI [3])
Pharmaceutical Preparations Contraindicated Rasagiline
Item
use of any medication contraindicated with use of rasagiline (investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0525678 (UMLS CUI [1,3])
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