ID

37840

Beschreibung

Reducing Breast Cancer Recurrence With Weight Loss; ODM derived from: https://clinicaltrials.gov/show/NCT01112839

Link

https://clinicaltrials.gov/show/NCT01112839

Stichworte

Versionen (1)
  1. 27.08.19 27.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. August 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01112839

Englisch

Eligibility Breast Cancer NCT01112839

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of breast cancer (stages i (≥1 cm), stage ii, or stage iiia, b, c excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
Beschreibung

Breast Carcinoma TNM Breast tumor staging | Distant metastasis Excluded | Disease length | Therapeutic procedure Initial Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332196
UMLS CUI [3]
C0872146
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205265
UMLS CUI [4,3]
C0205197
bmi between 25 to 45 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
able to comply with all required study procedures and schedule
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious medical condition or psychiatric illness
Beschreibung

Medical condition Serious | Mental disorders Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
inability to be moderately physically active
Beschreibung

Moderate physical activity Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4482418
UMLS CUI [1,2]
C1299582
obesity of known endocrine origin (e.g., untreated hypothyroidism, pcos)
Beschreibung

Obesity of endocrine origin | Hypothyroidism Untreated | PCOS

Datentyp

boolean

Alias
UMLS CUI [1]
C0267992
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0032460
currently enrolled in a weight loss program
Beschreibung

Enrollment Weight Reduction Program

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3179079
current use of weight loss medication or supplements
Beschreibung

Weight-Loss Agents | Weight loss Supplements

Datentyp

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0242295
previous surgical procedures for weight reduction
Beschreibung

Bariatric Surgery Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C0205156
planning weight loss surgery in the next 2 years.
Beschreibung

Bariatric Surgery Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C1301732
6+ months use of meds likely to cause weight gain or prevent weight loss
Beschreibung

Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0043094
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1262477
planned surgical procedure that can impact the conduct of the study
Beschreibung

Operative Surgical Procedure Planned | Impact Possible Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C4049986
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C2732579
currently pregnant/breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
planning to become pregnant within the next 2 years
Beschreibung

Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
have plans to relocate from area within 2 years
Beschreibung

Relocation of home Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
family relative or close friend is a trial staff member or a study participant
Beschreibung

Relative Clinical Trial Staff Member | Close friend Clinical Trial Staff Member | Relative Study Subject | Close friend Study Subject

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1552089
UMLS CUI [2,1]
C0682339
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1552089
UMLS CUI [3,1]
C0080103
UMLS CUI [3,2]
C0681850
UMLS CUI [4,1]
C0682339
UMLS CUI [4,2]
C0681850
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Beschreibung

Condition Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Ähnliche Modelle

Eligibility Breast Cancer NCT01112839

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Distant metastasis Excluded | Disease length | Therapeutic procedure Initial Completed
Item
diagnosis of breast cancer (stages i (≥1 cm), stage ii, or stage iiia, b, c excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0872146 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205265 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
Body mass index
Item
bmi between 25 to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with all required study procedures and schedule
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious | Mental disorders Serious
Item
serious medical condition or psychiatric illness
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Moderate physical activity Unable
Item
inability to be moderately physically active
boolean
C4482418 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Obesity of endocrine origin | Hypothyroidism Untreated | PCOS
Item
obesity of known endocrine origin (e.g., untreated hypothyroidism, pcos)
boolean
C0267992 (UMLS CUI [1])
C0020676 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0032460 (UMLS CUI [3])
Enrollment Weight Reduction Program
Item
currently enrolled in a weight loss program
boolean
C1516879 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
Weight-Loss Agents | Weight loss Supplements
Item
current use of weight loss medication or supplements
boolean
C0376606 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
Bariatric Surgery Previous
Item
previous surgical procedures for weight reduction
boolean
C1456587 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Bariatric Surgery Planned
Item
planning weight loss surgery in the next 2 years.
boolean
C1456587 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Preventing Weight loss
Item
6+ months use of meds likely to cause weight gain or prevent weight loss
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0043094 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1262477 (UMLS CUI [2,3])
Operative Surgical Procedure Planned | Impact Possible Completion of clinical trial
Item
planned surgical procedure that can impact the conduct of the study
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C4049986 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
currently pregnant/breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy, Planned
Item
planning to become pregnant within the next 2 years
boolean
C0032992 (UMLS CUI [1])
Relocation of home Planned
Item
have plans to relocate from area within 2 years
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Relative Clinical Trial Staff Member | Close friend Clinical Trial Staff Member | Relative Study Subject | Close friend Study Subject
Item
family relative or close friend is a trial staff member or a study participant
boolean
C0080103 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,3])
C0682339 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1552089 (UMLS CUI [2,3])
C0080103 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C0682339 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
Condition Study Subject Participation Status Inappropriate
Item
any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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