ID

12026

Beschreibung

A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT01950468 Principal Investigator: Stephen Flitman, M.D and Ira Goodman, M.D

Link

https://clinicaltrials.gov/show/NCT01950468

Stichworte

Versionen (1)
  1. 01.09.15 01.09.15 -
Hochgeladen am

1. September 2015

DOI

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Creative Commons BY 4.0
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Eligibility Parkinson's Syndrome NCT01950468

Englisch

Eligibility Parkinson's Syndrome NCT01950468

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
Beschreibung

Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Age ≥ 40 years
Beschreibung

Age ≥ 40 years

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology
Beschreibung

Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology

Datentyp

boolean

Alias
UMLS CUI [1]
C0239412
Have a UPDRS part III score upon entry of ≤ 16
Beschreibung

UPDRS score

Datentyp

boolean

Alias
UMLS CUI [1]
C3827698
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
Beschreibung

Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator

Datentyp

boolean

Alias
UMLS CUI [1]
C0205485
UMLS CUI [2]
C1658764
Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
Beschreibung

Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)

Datentyp

boolean

Alias
UMLS CUI [1]
C0006111
Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
Beschreibung

Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0205161
Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
Beschreibung

Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator

Datentyp

boolean

Alias
UMLS CUI [1]
C2826714
UMLS CUI [2]
C0205161
Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])
Beschreibung

Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
Positive urine drug screen for opiates, cocaine, or amphetamines at screening
Beschreibung

Positive urine drug screen for opiates, cocaine, or amphetamines at screening

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
Positive pregnancy test before imaging
Beschreibung

Positive pregnancy test before imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
Beschreibung

Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0679823
UMLS CUI [2]
C0008976
Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN)
Beschreibung

Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN)

Datentyp

boolean

Alias
UMLS CUI [1]
C1512628
Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
Beschreibung

Any exposure to radiopharmaceuticals within 30 days before the date of informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0182638
Breast-feeding
Beschreibung

Breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
Inability to lie supine for 1 hour
Beschreibung

Inability to lie supine for 1 hour

Datentyp

boolean

Alias
UMLS CUI [1]
C0038846
Any thyroid disease other than adequately treated hypothyroidism
Beschreibung

Any thyroid disease other than adequately treated hypothyroidism

Datentyp

boolean

Alias
UMLS CUI [1]
C0040128
Known sensitivity or allergy to iodine or iodine containing products
Beschreibung

Known sensitivity or allergy to iodine or iodine containing products

Datentyp

boolean

Alias
UMLS CUI [1]
C0571818
UMLS CUI [2]
C0571817
Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.
Beschreibung

Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.

Datentyp

boolean

Alias
UMLS CUI [1]
C1323365
UMLS CUI [2]
C1254351
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Ähnliche Modelle

Eligibility Parkinson's Syndrome NCT01950468

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
informed consent
Item
Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
boolean
C0021430 (UMLS CUI [1])
age
Item
Age ≥ 40 years
boolean
C0001779 (UMLS CUI [1])
EXTREMITY TREMOR, UPPER
Item
Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology
boolean
C0239412 (UMLS CUI [1])
UPDRS score
Item
Have a UPDRS part III score upon entry of ≤ 16
boolean
C3827698 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
physical;psychological disease
Item
Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
boolean
C0205485 (UMLS CUI [1])
C1658764 (UMLS CUI [2])
Brain Diseases
Item
Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
boolean
C0006111 (UMLS CUI [1])
laboratory results;Abnormal
Item
Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
boolean
C1254595 (UMLS CUI [1])
C0205161 (UMLS CUI [2])
electrocardiogram results; abnormal
Item
Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
boolean
C2826714 (UMLS CUI [1])
C0205161 (UMLS CUI [2])
drug abuse
Item
Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])
boolean
C0013146 (UMLS CUI [1])
Urine drug screen positive
Item
Positive urine drug screen for opiates, cocaine, or amphetamines at screening
boolean
C0743300 (UMLS CUI [1])
positive pregnancy test
Item
Positive pregnancy test before imaging
boolean
C0240802 (UMLS CUI [1])
Participation; Clinical Trials
Item
Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
boolean
C0679823 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Imaging Agent
Item
Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN)
boolean
C1512628 (UMLS CUI [1])
radiopharmaceuticals
Item
Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
boolean
C0182638 (UMLS CUI [1])
Breast-feeding
Item
Breast-feeding
boolean
C0006147 (UMLS CUI [1])
Supine Position
Item
Inability to lie supine for 1 hour
boolean
C0038846 (UMLS CUI [1])
thyroid disease;
Item
Any thyroid disease other than adequately treated hypothyroidism
boolean
C0040128 (UMLS CUI [1])
Iodine allergy; Iodine compounds allergy
Item
Known sensitivity or allergy to iodine or iodine containing products
boolean
C0571818 (UMLS CUI [1])
C0571817 (UMLS CUI [2])
dopamine receptor binding;Pharmacologic Substance
Item
Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.
boolean
C1323365 (UMLS CUI [1])
C1254351 (UMLS CUI [2])
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