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ID
22378
Beschreibung
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00368108
Link
https://clinicaltrials.gov/show/NCT00368108
Stichworte
Versionen (3)
- 01.06.17 01.06.17 -
- 01.06.17 01.06.17 -
- 01.06.17 01.06.17 -
Hochgeladen am
1. Juni 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Parkinson's Disease NCT00368108
Eligibility Parkinson's Disease NCT00368108
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Parkinson's Disease NCT00368108
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Gender | Parkinson Disease | Levodopa | Good therapeutic response
Item
1. male or female patients with idiopathic parkinson's disease fulfilling the united kingdom (uk) parkinson's disease society brain bank diagnostic criteria 7, with a good response to levodopa.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
C0184785 (UMLS CUI [4])
C0030567 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
C0184785 (UMLS CUI [4])
Parkinson Disease | Age
Item
2. patients must have been diagnosed with idiopathic pd at > 30 years of age.
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Motor fluctuations | Wearing off effect
Item
3. patients must have predictable motor fluctuations of the wearing "off" type.
boolean
C1868976 (UMLS CUI [1])
C1504539 (UMLS CUI [2])
C1504539 (UMLS CUI [2])
Hoehn and Yahr Stage | Wearing off effect
Item
4. patients must rate between ii-iv on the hoehn & yahr scale when in an "off" state.
boolean
C3639483 (UMLS CUI [1])
C1504539 (UMLS CUI [2])
C1504539 (UMLS CUI [2])
Levodopa | Optimization of medication
Item
5. patients must be taking optimized levodopa therapy.
boolean
C0023570 (UMLS CUI [1])
C4075704 (UMLS CUI [2])
C4075704 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Infertility | Female Sterilization | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception | Serum pregnancy test (B-HCG) Negative | Urine pregnancy test negative | Postmenopausal state | Amenorrhea
Item
2. women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). these patients must have a negative serum beta-human chorionic gonadotrophin (b-hcg) test at the screening visit, and a negative urine pregnancy test at the baseline visit (day 0). these patients must also be willing to remain on their current form of contraception for the duration of the study. postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the investigator.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021359 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0430060 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0430057 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
C0002453 (UMLS CUI [11])
C0700589 (UMLS CUI [1,2])
C0021359 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0430060 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0430057 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
C0002453 (UMLS CUI [11])
Substance Use Disorders
Item
3. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria.
boolean
C0038586 (UMLS CUI [1])
Feeling suicidal | Suicide attempt
Item
4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0038663 (UMLS CUI [2])
Abnormality Unstable Complicating Investigational New Drugs Assessment | Liver diseases | Kidney Diseases | Cardiovascular Diseases | Respiration Disorders | Gastrointestinal Diseases | Hematological Disease | Endocrine System Diseases | Metabolic Diseases
Item
5. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
boolean
C1704258 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0231242 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0443343 (UMLS CUI [1,2])
C0231242 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])