ID

36805

Beschreibung

Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02443779

Link

https://clinicaltrials.gov/show/NCT02443779

Stichworte

Versionen (1)
  1. 11.06.19 11.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02443779

Englisch

Eligibility Parkinson's Disease NCT02443779

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. willing and able to give informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. between the ages of 50-80 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. male or female with idiopathic pd who fulfill uk pd society brain bank criteria for diagnosis of parkinson's disease.
Beschreibung

Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
4. early stage subjects will need to have unified parkinson's disease rating scale (updrs) motor scores of < 10, be within 3 years of diagnosis, and not requiring dopaminergic therapy
Beschreibung

Parkinson Disease Early stage Unified Parkinson's Disease Rating Scale | Disease length | Dopaminergic Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C2363430
UMLS CUI [1,3]
C3639721
UMLS CUI [2]
C0872146
UMLS CUI [3,1]
C0013036
UMLS CUI [3,2]
C0332197
5. later stage subjects will need to have unified parkinson's disease rating scale motor scores of > 20 and be > 5 years from diagnosis
Beschreibung

Parkinson Disease Late stage Unified Parkinson's Disease Rating Scale | Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0544467
UMLS CUI [1,3]
C3639721
UMLS CUI [2]
C0872146
6. if female, one of the following three scenarios must apply:
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
at least two years post-menopausal
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
surgically sterile
Beschreibung

Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
negative urine pregnancy test, and following a reliable method of birth control (oral contraceptive, intrauterine device, contraceptive implant, barrier, or abstinence) for at least two months prior to entry, and agreeing both to follow a reliable method of birth control, and (if relevant) to desist from breast feeding during, and for two weeks following tracer administration.
Beschreibung

Urine pregnancy test negative | Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant | Contraception, Barrier | Sexual Abstinence | Breast Feeding To be stopped

Datentyp

boolean

Alias
UMLS CUI [1]
C0430057
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0021900
UMLS CUI [5]
C1657106
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0006147
UMLS CUI [8,2]
C1272691
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. abrupt onset of parkinsonism
Beschreibung

Sudden onset Parkinsonian Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1276802
UMLS CUI [1,2]
C0242422
2. 'other parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system atrophy)
Beschreibung

Syndrome Similar Parkinson Disease | Progressive supranuclear palsy | Multiple System Atrophy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C2348205
UMLS CUI [1,3]
C0030567
UMLS CUI [2]
C0038868
UMLS CUI [3]
C0393571
3. any condition that would preclude successful completion of spect scanning
Beschreibung

Condition Excludes SPECT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0040399
4. use of anti-coagulant therapy
Beschreibung

Anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
5. any clinically significant eye disease that would complicate interpretation of oct data
Beschreibung

Disorder of eye | Interpretation OCT Data Complicated

Datentyp

boolean

Alias
UMLS CUI [1]
C0015397
UMLS CUI [2,1]
C0459471
UMLS CUI [2,2]
C0920367
UMLS CUI [2,3]
C1511726
UMLS CUI [2,4]
C0231242
6. use of any drugs that would alter or interfere with tracer binding for spect imaging studies (ex., cocaine, amphetamines, methylphenidate, ephedrine, phentermine, bupropion, fentanyl, selective serotonin reuptake inhibitors).
Beschreibung

Pharmaceutical Preparations Interfere with Tracer SPECT | Cocaine | Amphetamines | Methylphenidate | Ephedrine | Phentermine | Bupropion | Fentanyl | Selective Serotonin Reuptake Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0040399
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0002667
UMLS CUI [4]
C0025810
UMLS CUI [5]
C0014479
UMLS CUI [6]
C0031447
UMLS CUI [7]
C0085208
UMLS CUI [8]
C0015846
UMLS CUI [9]
C0360105
7. known sensitivity to the imaging agent or to lugol's solution or to potassium perchlorate.
Beschreibung

Hypersensitivity Imaging Agent | Hypersensitivity Lugol's solution | Hypersensitivity Potassium perchlorate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1512628
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0065234
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0071774
8. history or presence of severe renal disease.
Beschreibung

Kidney Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT02443779

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. willing and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. between the ages of 50-80 years old.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
3. male or female with idiopathic pd who fulfill uk pd society brain bank criteria for diagnosis of parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
Parkinson Disease Early stage Unified Parkinson's Disease Rating Scale | Disease length | Dopaminergic Agents Absent
Item
4. early stage subjects will need to have unified parkinson's disease rating scale (updrs) motor scores of < 10, be within 3 years of diagnosis, and not requiring dopaminergic therapy
boolean
C0030567 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
C0872146 (UMLS CUI [2])
C0013036 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Parkinson Disease Late stage Unified Parkinson's Disease Rating Scale | Disease length
Item
5. later stage subjects will need to have unified parkinson's disease rating scale motor scores of > 20 and be > 5 years from diagnosis
boolean
C0030567 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
C0872146 (UMLS CUI [2])
Gender
Item
6. if female, one of the following three scenarios must apply:
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state
Item
at least two years post-menopausal
boolean
C0232970 (UMLS CUI [1])
Female Sterilization
Item
surgically sterile
boolean
C0015787 (UMLS CUI [1])
Urine pregnancy test negative | Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant | Contraception, Barrier | Sexual Abstinence | Breast Feeding To be stopped
Item
negative urine pregnancy test, and following a reliable method of birth control (oral contraceptive, intrauterine device, contraceptive implant, barrier, or abstinence) for at least two months prior to entry, and agreeing both to follow a reliable method of birth control, and (if relevant) to desist from breast feeding during, and for two weeks following tracer administration.
boolean
C0430057 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0006147 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Sudden onset Parkinsonian Disorders
Item
1. abrupt onset of parkinsonism
boolean
C1276802 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
Syndrome Similar Parkinson Disease | Progressive supranuclear palsy | Multiple System Atrophy
Item
2. 'other parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system atrophy)
boolean
C0039082 (UMLS CUI [1,1])
C2348205 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0038868 (UMLS CUI [2])
C0393571 (UMLS CUI [3])
Condition Excludes SPECT
Item
3. any condition that would preclude successful completion of spect scanning
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0040399 (UMLS CUI [1,3])
Anticoagulant therapy
Item
4. use of anti-coagulant therapy
boolean
C0150457 (UMLS CUI [1])
Disorder of eye | Interpretation OCT Data Complicated
Item
5. any clinically significant eye disease that would complicate interpretation of oct data
boolean
C0015397 (UMLS CUI [1])
C0459471 (UMLS CUI [2,1])
C0920367 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0231242 (UMLS CUI [2,4])
Pharmaceutical Preparations Interfere with Tracer SPECT | Cocaine | Amphetamines | Methylphenidate | Ephedrine | Phentermine | Bupropion | Fentanyl | Selective Serotonin Reuptake Inhibitors
Item
6. use of any drugs that would alter or interfere with tracer binding for spect imaging studies (ex., cocaine, amphetamines, methylphenidate, ephedrine, phentermine, bupropion, fentanyl, selective serotonin reuptake inhibitors).
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0040399 (UMLS CUI [1,4])
C0009170 (UMLS CUI [2])
C0002667 (UMLS CUI [3])
C0025810 (UMLS CUI [4])
C0014479 (UMLS CUI [5])
C0031447 (UMLS CUI [6])
C0085208 (UMLS CUI [7])
C0015846 (UMLS CUI [8])
C0360105 (UMLS CUI [9])
Hypersensitivity Imaging Agent | Hypersensitivity Lugol's solution | Hypersensitivity Potassium perchlorate
Item
7. known sensitivity to the imaging agent or to lugol's solution or to potassium perchlorate.
boolean
C0020517 (UMLS CUI [1,1])
C1512628 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0065234 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0071774 (UMLS CUI [3,2])
Kidney Disease Severe
Item
8. history or presence of severe renal disease.
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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