ID

31340

Description

Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00427674

Lien

https://clinicaltrials.gov/show/NCT00427674

Mots-clés

Versions (1)
  1. 16/08/2018 16/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00427674

Anglais

Eligibility Parkinson Disease NCT00427674

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
health control:
Description

Healthy Control Inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986479
UMLS CUI [1,2]
C1512693
the subject is aged 18-70.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent is obtained.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
the participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
Description

Laboratory Results Clinical Significance Absent | Illness Unstable Absent | Nervous system disorder Unstable Absent | Mental disorders Unstable Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0332197
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] mzint injection.
Description

Gender | Childbearing Potential Absent | Urine pregnancy test negative | Other Coding

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0430057
UMLS CUI [4]
C3846158
willingness to comply with the study protocol
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
parkinson disease:
Description

Parkinson Disease Inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1512693
the subject is aged 18-70.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic parkinson's disease.
Description

Parkinson Disease | Symptoms Main Quantity | Resting Tremor | Muscle Rigidity | Bradykinesia

Type de données

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0026837
UMLS CUI [5]
C0233565
hoehn and yahr stages < 3.
Description

Hoehn and Yahr Stage

Type de données

boolean

Alias
UMLS CUI [1]
C3639483
written informed consent is obtained.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
the participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
Description

Laboratory Results Clinical Significance Absent | Illness Unstable Absent | Nervous system disorder Unstable Absent | Mental disorders Unstable Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0332197
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] mzint injection.
Description

Gender | Childbearing Potential Absent | Urine pregnancy test negative | Other Coding

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0430057
UMLS CUI [4]
C3846158
willingness to comply with the study protocol
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all subjects will be excluded from participation for the following reasons:
Description

Study Subject Participation Status Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332196
the subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
Description

Laboratory test result abnormal | Illness | Mental disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0221423
UMLS CUI [3]
C0004936
the subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
Description

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1378698
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
UMLS CUI [5]
C0524722
the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
Description

Gastrointestinal Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Neoplastic disease | Endocrine System Diseases | Nervous system disorder | Immunodeficiency | Lung diseases | Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0018939
UMLS CUI [6]
C1882062
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0021051
UMLS CUI [10]
C0024115
UMLS CUI [11]
C0012634
use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.
Description

Pharmaceutical Preparations Effect Serotonin | Non-Prescription Drugs Effect Serotonin | Antidepressive Agents | Sertraline | Fluoxetine | Fluvoxamine | venlafaxine

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0036751
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0036751
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0074393
UMLS CUI [5]
C0016365
UMLS CUI [6]
C0085228
UMLS CUI [7]
C0078569
the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the diagnostic and statistical manual of the american psychiatric association, 4th edition (dsm iv) {american psychiatric association, 1994 #2} within the past 2 years.
Description

Substance Use Disorders | Narcotic Abuse

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0524661
pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
Retour au début de la page

Similar models

Eligibility Parkinson Disease NCT00427674

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Control Inclusion criteria
Item
health control:
boolean
C2986479 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Age
Item
the subject is aged 18-70.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Laboratory Results Clinical Significance Absent | Illness Unstable Absent | Nervous system disorder Unstable Absent | Mental disorders Unstable Absent
Item
the participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Gender | Childbearing Potential Absent | Urine pregnancy test negative | Other Coding
Item
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] mzint injection.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430057 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Protocol Compliance
Item
willingness to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Parkinson Disease Inclusion criteria
Item
parkinson disease:
boolean
C0030567 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Age
Item
the subject is aged 18-70.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | Symptoms Main Quantity | Resting Tremor | Muscle Rigidity | Bradykinesia
Item
participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0234379 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Hoehn and Yahr Stage
Item
hoehn and yahr stages < 3.
boolean
C3639483 (UMLS CUI [1])
Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Laboratory Results Clinical Significance Absent | Illness Unstable Absent | Nervous system disorder Unstable Absent | Mental disorders Unstable Absent
Item
the participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Gender | Childbearing Potential Absent | Urine pregnancy test negative | Other Coding
Item
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] mzint injection.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430057 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Protocol Compliance
Item
willingness to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Excluded
Item
all subjects will be excluded from participation for the following reasons:
boolean
C2348568 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Laboratory test result abnormal | Illness | Mental disorders
Item
the subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
boolean
C0438215 (UMLS CUI [1])
C0221423 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure
Item
the subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1378698 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0524722 (UMLS CUI [5])
Gastrointestinal Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Neoplastic disease | Endocrine System Diseases | Nervous system disorder | Immunodeficiency | Lung diseases | Disease
Item
the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
boolean
C0017178 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C1882062 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0021051 (UMLS CUI [9])
C0024115 (UMLS CUI [10])
C0012634 (UMLS CUI [11])
Pharmaceutical Preparations Effect Serotonin | Non-Prescription Drugs Effect Serotonin | Antidepressive Agents | Sertraline | Fluoxetine | Fluvoxamine | venlafaxine
Item
use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0036751 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0036751 (UMLS CUI [2,3])
C0003289 (UMLS CUI [3])
C0074393 (UMLS CUI [4])
C0016365 (UMLS CUI [5])
C0085228 (UMLS CUI [6])
C0078569 (UMLS CUI [7])
Substance Use Disorders | Narcotic Abuse
Item
the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the diagnostic and statistical manual of the american psychiatric association, 4th edition (dsm iv) {american psychiatric association, 1994 #2} within the past 2 years.
boolean
C0038586 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Retour au début de la page 

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