ID

17002

Beschreibung

Function of Catecholamines in the Brain During Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00082030

Link

https://clinicaltrials.gov/show/NCT00082030

Stichworte

Versionen (1)
  1. 19.08.16 19.08.16 -
Hochgeladen am

19. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Depression NCT00082030

Englisch

Eligibility Depression NCT00082030

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00082030
Criteria
Beschreibung

Criteria

mdd sample: 40 subjects (ages 18-45) with remitted mdd will be selected. mdd is defined by the dsm-iv criteria, and one of the following additional criteria:
Beschreibung

Major Depressive Disorder Sample | Age | Major depression in remission

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0150095
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0270461
1. history of two or more major depressive episodes, or
Beschreibung

major depressive episode Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C1265611
2. history of one major depressive episode and a family history for major depression. remission is defined as a period of at least three months during which the subject has not taken any antidepressant agents, with the hamilton depression rating scale (hdrs; 21-item) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom.
Beschreibung

Single major depressive episode | Major Depressive Disorder Family history | Remission | Antidepressive Agents | Hamilton rating scale for depression | Depressive Symptoms Quantity Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0241889
UMLS CUI [3]
C0544452
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0451203
UMLS CUI [6,1]
C0086132
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C2826293
unaffected mdd relative sample:
Beschreibung

Major Depressive Disorder Sample Relative Unaffected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0150095
UMLS CUI [1,3]
C0080103
UMLS CUI [1,4]
C2986417
40 healthy relatives of mdd probands (ages 18-45) will be recruited. subjects will be screened to ensure that they have no history of psychiatric illness.
Beschreibung

Major Depressive Disorder Study Subject | Relative Healthy | Age | Screening Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C0080103
UMLS CUI [2,2]
C3898900
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0220908
UMLS CUI [4,2]
C0004936
unaffected bd relative sample:
Beschreibung

Bipolar Disorder Sample Relative Unaffected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C0150095
UMLS CUI [1,3]
C0080103
UMLS CUI [1,4]
C2986417
healthy relatives of bd probands (ages 18-45) will be recruited. subjects will be screened to ensure that they have no history of psychiatric illness.
Beschreibung

Bipolar Disorder Study Subject | Relative Healthy | Age | Screening Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C0080103
UMLS CUI [2,2]
C3898900
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0220908
UMLS CUI [4,2]
C0004936
healthy control samples:
Beschreibung

Control Groups Healthy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C3898900
healthy subjects (ages 18-45) without a known personal or first-degree family history of psychiatric disorders in first-degree relatives will be selected.
Beschreibung

Healthy Volunteers | Age | Mental disorders First Degree Relative

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1517194
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any subject who appears incapable of providing informed consent will be excluded from the study.
Beschreibung

Informed Consent incapable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1550518
subjects who take effective antidepressant medication
Beschreibung

Antidepressive Agents Effective

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1280519
subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 months prior to the studies.
Beschreibung

Antidepressive Agents | Pharmaceutical Preparations Changing Neurochemistry monoamine | Pharmaceutical Preparations Changing Function Cerebrovascular | Pharmaceutical Preparations Changing Cardiovascular function

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0699841
UMLS CUI [2,4]
C0599682
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0031843
UMLS CUI [3,4]
C1880018
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0007227
subjects who have:
Beschreibung

ID.13

Datentyp

boolean

1. psychosis to the extent that the ability to provide informed consent is in doubt
Beschreibung

Psychotic Disorder Informed Consent Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders
Beschreibung

Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy | Hypertensive disease | Cardiovascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0031843
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1384516
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0031843
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1384516
UMLS CUI [5]
C0020538
UMLS CUI [6]
C0007222
3. a history of drug (including benzodiazepines [bzd]) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm iv criteria) longer than 2 years
Beschreibung

Substance Use Disorders | Benzodiazepines abuse | Substance Dependence Lifetime

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0005064
UMLS CUI [2,2]
C0013146
UMLS CUI [3,1]
C0038580
UMLS CUI [3,2]
C4071830
4. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies)
Beschreibung

Pregnancy Pregnancy Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
5. current breast feeding
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
6. smokers
Beschreibung

Smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C0337664
7. serious suicidal ideation or behavior
Beschreibung

Feeling suicidal Serious | Suicidal behavior Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C0205404
8. general mri exclusion criteria (e.g., subjects with metallic implants that are ferromagnetic will be excluded from the fmri scanning). subjects must exhibit no or only moderate alcohol use. subjects with current excessive use of alcohol (greater than 4 ounces/day for men and greater than 3 ounces/day for women) are ineligible for participation, as such drug use confounds the results
Beschreibung

Exclusion Criteria MRI General | metallic implant Exclusion fMRI | Alcohol consumption | responsible alcohol use | Excessive alcohol consumption Interferes with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0205246
UMLS CUI [2,1]
C3693688
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0376335
UMLS CUI [3]
C0001948
UMLS CUI [4]
C0001948
UMLS CUI [5]
C0678252
UMLS CUI [6,1]
C0560219
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683954
9. smokers are ineligible because of the evidence for interactions between nicotine and depression, and the possibility of withdrawal symptoms that may affect behavioral and neural responses to cd
Beschreibung

Smoker | Nicotine Interaction Depressive disorder | Withdrawal Symptoms Affecting Behavioral response Conduct Disorder | Withdrawal Symptoms Affecting Response neural Conduct Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0337664
UMLS CUI [2,1]
C0028040
UMLS CUI [2,2]
C1704675
UMLS CUI [2,3]
C0011581
UMLS CUI [3,1]
C0087169
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0004927
UMLS CUI [3,4]
C0149654
UMLS CUI [4,1]
C0087169
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0871261
UMLS CUI [4,4]
C3714606
UMLS CUI [4,5]
C0149654
10. history of suicidality and other axis i diagnoses beside major depressive disorder
Beschreibung

Suicidality | Axis I diagnosis | Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C3166387
UMLS CUI [2]
C0270287
UMLS CUI [3]
C1269683
11. lactose intolerance
Beschreibung

Lactose Intolerance

Datentyp

boolean

Alias
UMLS CUI [1]
C0022951
12. women not using a reliable contraception method. finally subjects who have had an upper respiratory tract infection in the last week will be excluded as this may impact sense of smell.
Beschreibung

Gender Contraceptive methods Lacking | Upper Respiratory Infection Impact Smell Perception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0041912
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0037361
subjects beyond age 45
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
individuals whose first major depressive episodes arose after other medical or psychiatric conditions
Beschreibung

major depressive episode First Post other medical condition | major depressive episode First Post Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C3843040
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0004936
subjects showing significant side effects during ampt depletion such as dystonic reactions will receive adequate treatment and will be excluded from the study
Beschreibung

Side effects Significant During AMPT Depletion | Therapeutic procedure Dystonic reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001688
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0051427
UMLS CUI [1,5]
C0333668
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0541919
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Ähnliche Modelle

Eligibility Depression NCT00082030

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00082030
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Major Depressive Disorder Sample | Age | Major depression in remission
Item
mdd sample: 40 subjects (ages 18-45) with remitted mdd will be selected. mdd is defined by the dsm-iv criteria, and one of the following additional criteria:
boolean
C1269683 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0270461 (UMLS CUI [3])
major depressive episode Quantity
Item
1. history of two or more major depressive episodes, or
boolean
C0024517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Single major depressive episode | Major Depressive Disorder Family history | Remission | Antidepressive Agents | Hamilton rating scale for depression | Depressive Symptoms Quantity Clinical Significance
Item
2. history of one major depressive episode and a family history for major depression. remission is defined as a period of at least three months during which the subject has not taken any antidepressant agents, with the hamilton depression rating scale (hdrs; 21-item) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom.
boolean
C0024517 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0544452 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C0451203 (UMLS CUI [5])
C0086132 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
Major Depressive Disorder Sample Relative Unaffected
Item
unaffected mdd relative sample:
boolean
C1269683 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
C0080103 (UMLS CUI [1,3])
C2986417 (UMLS CUI [1,4])
Major Depressive Disorder Study Subject | Relative Healthy | Age | Screening Mental disorders
Item
40 healthy relatives of mdd probands (ages 18-45) will be recruited. subjects will be screened to ensure that they have no history of psychiatric illness.
boolean
C1269683 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0080103 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0220908 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Bipolar Disorder Sample Relative Unaffected
Item
unaffected bd relative sample:
boolean
C0005586 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
C0080103 (UMLS CUI [1,3])
C2986417 (UMLS CUI [1,4])
Bipolar Disorder Study Subject | Relative Healthy | Age | Screening Mental disorders
Item
healthy relatives of bd probands (ages 18-45) will be recruited. subjects will be screened to ensure that they have no history of psychiatric illness.
boolean
C0005586 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0080103 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0220908 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Control Groups Healthy
Item
healthy control samples:
boolean
C0009932 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
Healthy Volunteers | Age | Mental disorders First Degree Relative
Item
healthy subjects (ages 18-45) without a known personal or first-degree family history of psychiatric disorders in first-degree relatives will be selected.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent incapable
Item
any subject who appears incapable of providing informed consent will be excluded from the study.
boolean
C0021430 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
Antidepressive Agents Effective
Item
subjects who take effective antidepressant medication
boolean
C0003289 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
Antidepressive Agents | Pharmaceutical Preparations Changing Neurochemistry monoamine | Pharmaceutical Preparations Changing Function Cerebrovascular | Pharmaceutical Preparations Changing Cardiovascular function
Item
subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 months prior to the studies.
boolean
C0003289 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699841 (UMLS CUI [2,3])
C0599682 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0031843 (UMLS CUI [3,3])
C1880018 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0007227 (UMLS CUI [4,3])
ID.13
Item
subjects who have:
boolean
Psychotic Disorder Informed Consent Limited
Item
1. psychosis to the extent that the ability to provide informed consent is in doubt
boolean
C0033975 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy | Hypertensive disease | Cardiovascular Diseases
Item
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1384516 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0031843 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1384516 (UMLS CUI [4,3])
C0020538 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
Substance Use Disorders | Benzodiazepines abuse | Substance Dependence Lifetime
Item
3. a history of drug (including benzodiazepines [bzd]) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm iv criteria) longer than 2 years
boolean
C0038586 (UMLS CUI [1])
C0005064 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0038580 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
Pregnancy Pregnancy Test
Item
4. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies)
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Breast Feeding
Item
5. current breast feeding
boolean
C0006147 (UMLS CUI [1])
Smoker
Item
6. smokers
boolean
C0337664 (UMLS CUI [1])
Feeling suicidal Serious | Suicidal behavior Serious
Item
7. serious suicidal ideation or behavior
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Exclusion Criteria MRI General | metallic implant Exclusion fMRI | Alcohol consumption | responsible alcohol use | Excessive alcohol consumption Interferes with research results
Item
8. general mri exclusion criteria (e.g., subjects with metallic implants that are ferromagnetic will be excluded from the fmri scanning). subjects must exhibit no or only moderate alcohol use. subjects with current excessive use of alcohol (greater than 4 ounces/day for men and greater than 3 ounces/day for women) are ineligible for participation, as such drug use confounds the results
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
C3693688 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0376335 (UMLS CUI [2,3])
C0001948 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0678252 (UMLS CUI [5])
C0560219 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
Smoker | Nicotine Interaction Depressive disorder | Withdrawal Symptoms Affecting Behavioral response Conduct Disorder | Withdrawal Symptoms Affecting Response neural Conduct Disorder
Item
9. smokers are ineligible because of the evidence for interactions between nicotine and depression, and the possibility of withdrawal symptoms that may affect behavioral and neural responses to cd
boolean
C0337664 (UMLS CUI [1])
C0028040 (UMLS CUI [2,1])
C1704675 (UMLS CUI [2,2])
C0011581 (UMLS CUI [2,3])
C0087169 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0004927 (UMLS CUI [3,3])
C0149654 (UMLS CUI [3,4])
C0087169 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0871261 (UMLS CUI [4,3])
C3714606 (UMLS CUI [4,4])
C0149654 (UMLS CUI [4,5])
Suicidality | Axis I diagnosis | Major Depressive Disorder
Item
10. history of suicidality and other axis i diagnoses beside major depressive disorder
boolean
C3166387 (UMLS CUI [1])
C0270287 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Lactose Intolerance
Item
11. lactose intolerance
boolean
C0022951 (UMLS CUI [1])
Gender Contraceptive methods Lacking | Upper Respiratory Infection Impact Smell Perception
Item
12. women not using a reliable contraception method. finally subjects who have had an upper respiratory tract infection in the last week will be excluded as this may impact sense of smell.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0041912 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0037361 (UMLS CUI [2,3])
Age
Item
subjects beyond age 45
boolean
C0001779 (UMLS CUI [1])
major depressive episode First Post other medical condition | major depressive episode First Post Mental disorders
Item
individuals whose first major depressive episodes arose after other medical or psychiatric conditions
boolean
C0024517 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C3843040 (UMLS CUI [1,4])
C0024517 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0004936 (UMLS CUI [2,4])
Side effects Significant During AMPT Depletion | Therapeutic procedure Dystonic reaction
Item
subjects showing significant side effects during ampt depletion such as dystonic reactions will receive adequate treatment and will be excluded from the study
boolean
C0001688 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0051427 (UMLS CUI [1,4])
C0333668 (UMLS CUI [1,5])
C0087111 (UMLS CUI [2,1])
C0541919 (UMLS CUI [2,2])
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