ID

24907

Descrição

Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00584025

Link

https://clinicaltrials.gov/show/NCT00584025

Palavras-chave

Versões (1)
  1. 22/08/2017 22/08/2017 -
Transferido a

22 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00584025

Inglês

Eligibility Parkinson's Disease NCT00584025

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. outpatients with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnosis criteria.
Descrição

Outpatients | Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0030567
2. age 30 years to 80 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. dyskinesias with a minimum severity equal to a rating of 10 or higher on the aims rating scale at baseline.
Descrição

Dyskinesia Severity Minimum Abnormal Involuntary Movement Scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0450978
4. dyskinesias at least moderately disabling (historical information from item 33 of updrs).
Descrição

Dyskinesia disability Moderate UPDRS

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4034322
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C3639721
5. stable dose of antiparkinsonian medication 4 weeks prior to study entry.
Descrição

Antiparkinson Agents Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
6. women of child-bearing potential must use a reliable method of contraception and must be willing to perform a pregnancy test paid for and provided by dr. zesiewicz and the usf medical clinic. there must be a negative result before entry into the study.
Descrição

Childbearing Potential Contraceptive methods Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0427780
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any illness that in the investigator's opinion preclude participation in this study. this includes patients with unstable disease and those pd patients who can not tolerate iv infusion.
Descrição

Illness Study Subject Participation Status Exclusion | Disease Unstable | Parkinson Disease Intravenous infusion intolerant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0030567
UMLS CUI [3,2]
C0021440
UMLS CUI [3,3]
C0231200
2. pregnant or lactating women. pregnancy will not be allowed whether as a pre-existing condition or a positive result on the pregnancy test in the screening process. lactation includes any woman wanting to participate who is currently breast-feeding.
Descrição

Pregnancy | Breast Feeding | Pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0240802
3. patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
Descrição

Study Subject Participation Status Requirement Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021430
4. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini mental status exam score of less than 20).
Descrição

Dementia Preventing Informed Consent | Mental disorder Preventing Informed Consent | Mini-mental state examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3]
C0451306
5. legal incapacity or limited legal capacity.
Descrição

Disability Legal | Legal capacity Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C1301860
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
6. presence of severe renal disease (bun 50% greater than normal). patients must have evidence from their pcp or urologists of normal psa and urodynamic tests within the last 12 months; patients with bun 50% greater than normal (5 to 20 mg/ d l) or creatinine 50% greater than normal (0 .7 and 1.4 mg/ d l) will be excluded. labs will be requested from pcp.
Descrição

Kidney Disease Severe | Blood urea increased | Prostate specific antigen normal | Urodynamic studies normal | Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151539
UMLS CUI [3]
C0580554
UMLS CUI [4]
C0580523
UMLS CUI [5]
C0700225
7. concomitant or prior therapy with the following treatments: neuroleptics, metoclopramide, domperidone (in doses >60mg/day), azole antifungals (e.g. ketoonazole), etomidate, ciprofloxacin, fluvoxamine, cimetidine, fludrocortizone, encainide, flecainide, mexiletine, propafenone, guanoxane, maprotiline, antidepressants on doses higher than the maximum approved daily dose for outpatients, intermittent therapy with oral corticoids.
Descrição

Antipsychotic Agents Dose U/day | Metoclopramide Dose U/day | Domperidone Dose U/day | Azole antifungal High dose | Ketoconazole High dose | Etomidate High dose | Ciprofloxacin High dose | Fluvoxamine High dose | Cimetidine High dose | Fludrocortisone High dose | Encainide High dose | Flecainide High dose | Mexiletine High dose | Propafenone High dose | Guanoxan High dose | Maprotiline High dose | Antidepressive Agents High dose | Adrenal Cortex Hormones Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0025853
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0013015
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C0360363
UMLS CUI [4,2]
C0444956
UMLS CUI [5,1]
C0022625
UMLS CUI [5,2]
C0444956
UMLS CUI [6,1]
C0015131
UMLS CUI [6,2]
C0444956
UMLS CUI [7,1]
C0008809
UMLS CUI [7,2]
C0444956
UMLS CUI [8,1]
C0085228
UMLS CUI [8,2]
C0444956
UMLS CUI [9,1]
C0008783
UMLS CUI [9,2]
C0444956
UMLS CUI [10,1]
C0016280
UMLS CUI [10,2]
C0444956
UMLS CUI [11,1]
C0085251
UMLS CUI [11,2]
C0444956
UMLS CUI [12,1]
C0016229
UMLS CUI [12,2]
C0444956
UMLS CUI [13,1]
C0025887
UMLS CUI [13,2]
C0444956
UMLS CUI [14,1]
C0033429
UMLS CUI [14,2]
C0444956
UMLS CUI [15,1]
C0650263
UMLS CUI [15,2]
C0444956
UMLS CUI [16,1]
C0024778
UMLS CUI [16,2]
C0444956
UMLS CUI [17,1]
C0003289
UMLS CUI [17,2]
C0444956
UMLS CUI [18,1]
C0001617
UMLS CUI [18,2]
C1527415
8. patients who are not fluent in english.
Descrição

Able to speak fluently English Language Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0332268
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Similar models

Eligibility Parkinson's Disease NCT00584025

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Parkinson Disease
Item
1. outpatients with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnosis criteria.
boolean
C0029921 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
Age
Item
2. age 30 years to 80 years.
boolean
C0001779 (UMLS CUI [1])
Dyskinesia Severity Minimum Abnormal Involuntary Movement Scale
Item
3. dyskinesias with a minimum severity equal to a rating of 10 or higher on the aims rating scale at baseline.
boolean
C0013384 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0450978 (UMLS CUI [1,4])
Dyskinesia disability Moderate UPDRS
Item
4. dyskinesias at least moderately disabling (historical information from item 33 of updrs).
boolean
C4034322 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
Antiparkinson Agents Dose Stable
Item
5. stable dose of antiparkinsonian medication 4 weeks prior to study entry.
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Pregnancy test negative
Item
6. women of child-bearing potential must use a reliable method of contraception and must be willing to perform a pregnancy test paid for and provided by dr. zesiewicz and the usf medical clinic. there must be a negative result before entry into the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Illness Study Subject Participation Status Exclusion | Disease Unstable | Parkinson Disease Intravenous infusion intolerant
Item
1. any illness that in the investigator's opinion preclude participation in this study. this includes patients with unstable disease and those pd patients who can not tolerate iv infusion.
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0030567 (UMLS CUI [3,1])
C0021440 (UMLS CUI [3,2])
C0231200 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Pregnancy test positive
Item
2. pregnant or lactating women. pregnancy will not be allowed whether as a pre-existing condition or a positive result on the pregnancy test in the screening process. lactation includes any woman wanting to participate who is currently breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0240802 (UMLS CUI [3])
Study Subject Participation Status Requirement Informed Consent
Item
3. patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
boolean
C2348568 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Dementia Preventing Informed Consent | Mental disorder Preventing Informed Consent | Mini-mental state examination
Item
4. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini mental status exam score of less than 20).
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0451306 (UMLS CUI [3])
Disability Legal | Legal capacity Limited
Item
5. legal incapacity or limited legal capacity.
boolean
C0231170 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Kidney Disease Severe | Blood urea increased | Prostate specific antigen normal | Urodynamic studies normal | Serum creatinine raised
Item
6. presence of severe renal disease (bun 50% greater than normal). patients must have evidence from their pcp or urologists of normal psa and urodynamic tests within the last 12 months; patients with bun 50% greater than normal (5 to 20 mg/ d l) or creatinine 50% greater than normal (0 .7 and 1.4 mg/ d l) will be excluded. labs will be requested from pcp.
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151539 (UMLS CUI [2])
C0580554 (UMLS CUI [3])
C0580523 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Antipsychotic Agents Dose U/day | Metoclopramide Dose U/day | Domperidone Dose U/day | Azole antifungal High dose | Ketoconazole High dose | Etomidate High dose | Ciprofloxacin High dose | Fluvoxamine High dose | Cimetidine High dose | Fludrocortisone High dose | Encainide High dose | Flecainide High dose | Mexiletine High dose | Propafenone High dose | Guanoxan High dose | Maprotiline High dose | Antidepressive Agents High dose | Adrenal Cortex Hormones Oral
Item
7. concomitant or prior therapy with the following treatments: neuroleptics, metoclopramide, domperidone (in doses >60mg/day), azole antifungals (e.g. ketoonazole), etomidate, ciprofloxacin, fluvoxamine, cimetidine, fludrocortizone, encainide, flecainide, mexiletine, propafenone, guanoxane, maprotiline, antidepressants on doses higher than the maximum approved daily dose for outpatients, intermittent therapy with oral corticoids.
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0025853 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0013015 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0360363 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C0022625 (UMLS CUI [5,1])
C0444956 (UMLS CUI [5,2])
C0015131 (UMLS CUI [6,1])
C0444956 (UMLS CUI [6,2])
C0008809 (UMLS CUI [7,1])
C0444956 (UMLS CUI [7,2])
C0085228 (UMLS CUI [8,1])
C0444956 (UMLS CUI [8,2])
C0008783 (UMLS CUI [9,1])
C0444956 (UMLS CUI [9,2])
C0016280 (UMLS CUI [10,1])
C0444956 (UMLS CUI [10,2])
C0085251 (UMLS CUI [11,1])
C0444956 (UMLS CUI [11,2])
C0016229 (UMLS CUI [12,1])
C0444956 (UMLS CUI [12,2])
C0025887 (UMLS CUI [13,1])
C0444956 (UMLS CUI [13,2])
C0033429 (UMLS CUI [14,1])
C0444956 (UMLS CUI [14,2])
C0650263 (UMLS CUI [15,1])
C0444956 (UMLS CUI [15,2])
C0024778 (UMLS CUI [16,1])
C0444956 (UMLS CUI [16,2])
C0003289 (UMLS CUI [17,1])
C0444956 (UMLS CUI [17,2])
C0001617 (UMLS CUI [18,1])
C1527415 (UMLS CUI [18,2])
Able to speak fluently English Language Lacking
Item
8. patients who are not fluent in english.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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