ID

37926

Description

Intervention Study of Depression in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01256008

Lien

https://clinicaltrials.gov/show/NCT01256008

Mots-clés

Versions (1)
  1. 31/08/2019 31/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

31 août 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Breast Cancer NCT01256008

Anglais

Eligibility Breast Cancer NCT01256008

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 20-65 years;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
Description

Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
a week after breast cancer surgery;
Description

Status post Breast Carcinoma Surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0543467
with complaints and symptoms of depression or anxiety
Description

Complaints Depressive disorder | Symptoms Depressive disorder | Complaints Anxiety | Symptoms Anxiety

Type de données

boolean

Alias
UMLS CUI [1,1]
C0277786
UMLS CUI [1,2]
C0011581
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0011581
UMLS CUI [3,1]
C0277786
UMLS CUI [3,2]
C0003467
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0003467
hamd-17 ≥ 8 points or / and hama ≥ 8 points;
Description

Hamilton Depression Rating Scale 17 Item | Hamilton Anxiety Rating Scale Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3541258
have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
Description

Reading skills | Depression self rating scale Completion

Type de données

boolean

Alias
UMLS CUI [1]
C0871220
UMLS CUI [2,1]
C0451108
UMLS CUI [2,2]
C0205197
informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous diagnosis of mental disorder or bipolar disorder; alcohol and drug abusing history;
Description

Mental disorders | Bipolar Disorder | Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0038586
use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
Description

Antidepressive Agents | Antipsychotic Agents | Psychological therapy | Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0841584
UMLS CUI [4]
C2348568
patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
Description

Cardiovascular Disease | Liver Dysfunction | Renal dysfunction | Disease Serious

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0086565
UMLS CUI [3]
C3279454
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
hearing, visual or understanding impairment;
Description

Hearing impairment | Visual Impairment | Comprehension Impairment

Type de données

boolean

Alias
UMLS CUI [1]
C1384666
UMLS CUI [2]
C3665347
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C0221099
severe depression, suicidal tendencies;
Description

Severe depression | Suicidal tendency

Type de données

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2]
C0235196
can not or will not comply with clinical treatment programs based on the physicians'
Description

Treatment Compliance Unable | Treatment Compliance Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4319828
UMLS CUI [2,2]
C0558080
judgment
Description

ID.14

Type de données

boolean

exit criteria:
Description

Discontinuation criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0243161
persons with poor compliance during the trial period;
Description

Poor compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0032646
persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
Description

Depressive disorder Increased | Suicidal tendency Serious | Intervention Urgent Required

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205217
UMLS CUI [2,1]
C0235196
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0439609
UMLS CUI [3,3]
C1514873
persons who are believed have other circumstances and should be suspended by physicians
Description

Life circumstances Study Subject Participation Status To be stopped

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680082
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1272691
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Similar models

Eligibility Breast Cancer NCT01256008

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 20-65 years;
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma
Item
pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
boolean
C0678222 (UMLS CUI [1])
Status post Breast Carcinoma Surgery
Item
a week after breast cancer surgery;
boolean
C0231290 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Complaints Depressive disorder | Symptoms Depressive disorder | Complaints Anxiety | Symptoms Anxiety
Item
with complaints and symptoms of depression or anxiety
boolean
C0277786 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
C0277786 (UMLS CUI [3,1])
C0003467 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0003467 (UMLS CUI [4,2])
Hamilton Depression Rating Scale 17 Item | Hamilton Anxiety Rating Scale Questionnaire
Item
hamd-17 ≥ 8 points or / and hama ≥ 8 points;
boolean
C3639712 (UMLS CUI [1])
C3541258 (UMLS CUI [2])
Reading skills | Depression self rating scale Completion
Item
have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
boolean
C0871220 (UMLS CUI [1])
C0451108 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Bipolar Disorder | Substance Use Disorders
Item
previous diagnosis of mental disorder or bipolar disorder; alcohol and drug abusing history;
boolean
C0004936 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Antidepressive Agents | Antipsychotic Agents | Psychological therapy | Study Subject Participation Status
Item
use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
boolean
C0003289 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0841584 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
Cardiovascular Disease | Liver Dysfunction | Renal dysfunction | Disease Serious
Item
patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
boolean
C0007222 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C3279454 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Hearing impairment | Visual Impairment | Comprehension Impairment
Item
hearing, visual or understanding impairment;
boolean
C1384666 (UMLS CUI [1])
C3665347 (UMLS CUI [2])
C0162340 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
Severe depression | Suicidal tendency
Item
severe depression, suicidal tendencies;
boolean
C0588008 (UMLS CUI [1])
C0235196 (UMLS CUI [2])
Treatment Compliance Unable | Treatment Compliance Unwilling
Item
can not or will not comply with clinical treatment programs based on the physicians'
boolean
C4319828 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4319828 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
ID.14
Item
judgment
boolean
Discontinuation criteria
Item
exit criteria:
boolean
C1444662 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Poor compliance
Item
persons with poor compliance during the trial period;
boolean
C0032646 (UMLS CUI [1])
Depressive disorder Increased | Suicidal tendency Serious | Intervention Urgent Required
Item
persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
boolean
C0011581 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0235196 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0439609 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Life circumstances Study Subject Participation Status To be stopped
Item
persons who are believed have other circumstances and should be suspended by physicians
boolean
C0680082 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
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