ID

31340

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00427674

Nyckelord

Versioner (1)
  1. 2018-08-16 2018-08-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 augusti 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Parkinson Disease NCT00427674

Engelsk

Eligibility Parkinson Disease NCT00427674

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
health control:
Beskrivning

Healthy Control Inclusion criteria

Datatyp

boolean

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

Age

Datatyp

boolean

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

Informed Consent

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
parkinson disease:
Beskrivning

Parkinson Disease Inclusion criteria

Datatyp

boolean

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

Age

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hoehn and Yahr Stage

Datatyp

boolean

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

Informed Consent

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Study Subject Participation Status Excluded

Datatyp

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.
Beskrivning

Laboratory test result abnormal | Illness | Mental disorders

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Substance Use Disorders | Narcotic Abuse

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Tillbaka till toppen

Similar models

Eligibility Parkinson Disease NCT00427674

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial