ID

29288

Beskrivning

Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01048229

Länk

https://clinicaltrials.gov/show/NCT01048229

Nyckelord

Versioner (1)
  1. 2018-03-15 2018-03-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Early-stage Parkinson's Disease NCT01048229

Engelsk

Eligibility Early-stage Parkinson's Disease NCT01048229

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged between 18 and 70
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
capable of reading and understanding the information leaflet given to him/her
Beskrivning

Comprehension Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
signed an inform consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
presenting with idiopathic parkinson's disease with a hoehn and yahr score of ≤ 3
Beskrivning

Parkinson Disease Hoehn and Yahr Scale score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C4274823
has never been given anti-parkinson medication, or has been treated with l-dopa, on condition that the total duration of treatment was less than twelve weeks at a dosage of under 200 mg, or has been treated with a dopamine agonist other than pramipexole, on condition that:
Beskrivning

Antiparkinson Agents Absent | Levodopa Dosage | Dopamine Agonists | Exception Pramipexole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0178601
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0074710
either the patient is still in the dose-titration phase at the time of inclusion
Beskrivning

Dosage Titration Phase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0162621
UMLS CUI [1,3]
C0205390
or that the treatment was administered for less than six weeks and was completed two weeks before inclusion
Beskrivning

Duration of treatment | Treatment completed

Datatyp

boolean

Alias
UMLS CUI [1]
C0444921
UMLS CUI [2]
C0580352
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant, breastfeeding, or planning a pregnancy in the months after joining the study
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
women of reproductive age who have not undergone surgical sterilisation or who are not using a reliable method of contraception before joining the study and during the study
Beskrivning

Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0015787
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
patient presenting with hepatic insufficiency
Beskrivning

Hepatic Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1306571
patient presenting with a concommitant illness which is considered significant by the investigator, after examination of the history, the patient's clinical condition, or on the basis on any additional examinations performed
Beskrivning

Comorbidity Significant Medical History | Comorbidity Significant Medical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0582103
patient presenting with a skin lesion considered to be suspect by the investigator and which has not been evaluated by a dermatologist
Beskrivning

Skin lesion Suspect | Evaluation Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0332268
patient presenting with a contraindication to treatment with rasagiline or pramipexole (please see the spc for the respective products)
Beskrivning

Medical contraindication rasagiline | Medical contraindication Pramipexole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0525678
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0074710
patient treated with fuoxetine during the five weeks preceding inclusion
Beskrivning

Fluoxetine

Datatyp

boolean

Alias
UMLS CUI [1]
C0016365
patient treated with fluvoxamine, pethidine, selegiline or any other maoi during the two weeks preceding inclusion
Beskrivning

Fluvoxamine | Meperidine | Selegiline | Monoamine Oxidase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0085228
UMLS CUI [2]
C0025376
UMLS CUI [3]
C0036579
UMLS CUI [4]
C0026457
patient who has had deep brain stimulation treatment
Beskrivning

Deep Brain Stimulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0394162
patient who might receive dextromethorphan or a sympathomimetic during the study
Beskrivning

Dextromethorphan | Sympathomimetics

Datatyp

boolean

Alias
UMLS CUI [1]
C0011816
UMLS CUI [2]
C0039052
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Similar models

Eligibility Early-stage Parkinson's Disease NCT01048229

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female aged between 18 and 70
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol
Item
capable of reading and understanding the information leaflet given to him/her
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
signed an inform consent form
boolean
C0021430 (UMLS CUI [1])
Parkinson Disease Hoehn and Yahr Scale score
Item
presenting with idiopathic parkinson's disease with a hoehn and yahr score of ≤ 3
boolean
C0030567 (UMLS CUI [1,1])
C4274823 (UMLS CUI [1,2])
Antiparkinson Agents Absent | Levodopa Dosage | Dopamine Agonists | Exception Pramipexole
Item
has never been given anti-parkinson medication, or has been treated with l-dopa, on condition that the total duration of treatment was less than twelve weeks at a dosage of under 200 mg, or has been treated with a dopamine agonist other than pramipexole, on condition that:
boolean
C0003405 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023570 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0178601 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0074710 (UMLS CUI [4,2])
Dosage Titration Phase
Item
either the patient is still in the dose-titration phase at the time of inclusion
boolean
C0178602 (UMLS CUI [1,1])
C0162621 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
Duration of treatment | Treatment completed
Item
or that the treatment was administered for less than six weeks and was completed two weeks before inclusion
boolean
C0444921 (UMLS CUI [1])
C0580352 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, breastfeeding, or planning a pregnancy in the months after joining the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods Absent
Item
women of reproductive age who have not undergone surgical sterilisation or who are not using a reliable method of contraception before joining the study and during the study
boolean
C3831118 (UMLS CUI [1,1])
C0015787 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hepatic Insufficiency
Item
patient presenting with hepatic insufficiency
boolean
C1306571 (UMLS CUI [1])
Comorbidity Significant Medical History | Comorbidity Significant Medical Examination
Item
patient presenting with a concommitant illness which is considered significant by the investigator, after examination of the history, the patient's clinical condition, or on the basis on any additional examinations performed
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0582103 (UMLS CUI [2,3])
Skin lesion Suspect | Evaluation Lacking
Item
patient presenting with a skin lesion considered to be suspect by the investigator and which has not been evaluated by a dermatologist
boolean
C0037284 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Medical contraindication rasagiline | Medical contraindication Pramipexole
Item
patient presenting with a contraindication to treatment with rasagiline or pramipexole (please see the spc for the respective products)
boolean
C1301624 (UMLS CUI [1,1])
C0525678 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0074710 (UMLS CUI [2,2])
Fluoxetine
Item
patient treated with fuoxetine during the five weeks preceding inclusion
boolean
C0016365 (UMLS CUI [1])
Fluvoxamine | Meperidine | Selegiline | Monoamine Oxidase Inhibitors
Item
patient treated with fluvoxamine, pethidine, selegiline or any other maoi during the two weeks preceding inclusion
boolean
C0085228 (UMLS CUI [1])
C0025376 (UMLS CUI [2])
C0036579 (UMLS CUI [3])
C0026457 (UMLS CUI [4])
Deep Brain Stimulation
Item
patient who has had deep brain stimulation treatment
boolean
C0394162 (UMLS CUI [1])
Dextromethorphan | Sympathomimetics
Item
patient who might receive dextromethorphan or a sympathomimetic during the study
boolean
C0011816 (UMLS CUI [1])
C0039052 (UMLS CUI [2])
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