ID

23191

Descrizione

Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01340599

collegamento

https://clinicaltrials.gov/show/NCT01340599

Keywords

versioni (1)
  1. 27/06/17 27/06/17 -
Caricato su

27 giugno 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Stage I Prostate Cancer NCT01340599

Inglese

Eligibility Stage I Prostate Cancer NCT01340599

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
prostate biopsy positive for cancer; clinically localized t1 and t2 stage disease expected, with biopsy specimen available for baseline biomarker measurements
Descrizione

Prostate carcinoma Biopsy Positive | Disease TNM clinical staging | Biopsy sample Available Biomarker Analysis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0677862
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C1879847
scheduled for a radical prostatectomy
Descrizione

Scheduled Radical prostatectomy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0205539
UMLS CUI [1,2]
C0194810
willing to sign an institutional review board (irb)-approved informed consent document and adhere to the protocol
Descrizione

Informed Consent | Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
willing and able to take oral medications
Descrizione

Able to swallow oral medication

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea constituents for the duration of the study
Descrizione

Tea Drinking To be stopped | Herbal Tea Drinking To be stopped | Supplement Containing Green tea Constituents

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0039400
UMLS CUI [1,2]
C0684271
UMLS CUI [1,3]
C1272691
UMLS CUI [2,1]
C0019233
UMLS CUI [2,2]
C0684271
UMLS CUI [2,3]
C1272691
UMLS CUI [3,1]
C2348609
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C1384640
UMLS CUI [3,4]
C0729650
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
Descrizione

Hormone Therapy Prostate carcinoma | Operative Surgical Procedures Prostate carcinoma | Brachytherapy | Therapeutic radiology procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0600139
UMLS CUI [3]
C0006098
UMLS CUI [4]
C1522449
recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization
Descrizione

Consumption Tea cups/day | Supplement Containing Green tea

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0039400
UMLS CUI [1,3]
C0560654
UMLS CUI [2,1]
C2348609
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C1384640
signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
Descrizione

Sign or Symptom | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3540840
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205329
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205329
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0205329
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0205329
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205329
UMLS CUI [8,1]
C0027765
UMLS CUI [8,2]
C0205329
UMLS CUI [9,1]
C0234387
UMLS CUI [9,2]
C0205329
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205318
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205318
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205318
UMLS CUI [13,1]
C0014130
UMLS CUI [13,2]
C0205318
UMLS CUI [14,1]
C0024115
UMLS CUI [14,2]
C0205318
UMLS CUI [15,1]
C0018799
UMLS CUI [15,2]
C0205318
UMLS CUI [16,1]
C0027765
UMLS CUI [16,2]
C0205318
UMLS CUI [17,1]
C0234387
UMLS CUI [17,2]
C0205318
serum creatinine >= 1.5 x upper limit of normal (uln)
Descrizione

Serum creatinine raised

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700225
alanine aminotransferase (alt) >= uln
Descrizione

Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
aspartate aminotransferase (ast) >= uln
Descrizione

Aspartate aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
alkaline phosphatase (alp) >= uln
Descrizione

Alkaline phosphatase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201850
albumin (alb) =< lower limit of normal (lln)
Descrizione

Albumin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201838
total bilirubin >= uln
Descrizione

Serum total bilirubin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
known malignancy at any site within the last five years; with the exception of basal cell carcinoma (bcc)
Descrizione

Malignant Neoplasm Site Any | Basal cell carcinoma Excluded

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C2828389
participation in a research trial within the past three months
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
any condition that would interfere with the ability to give informed consent or comply with the study protocol
Descrizione

Condition Interferes with Informed Consent | Condition Interferes with Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
Descrizione

Hypersensitivity Tea product | Hypersensitivity Tea product Inactive ingredient

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039400
UMLS CUI [1,3]
C1514468
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039400
UMLS CUI [2,3]
C1514468
UMLS CUI [2,4]
C1552019
concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (nsaid) agent two or more times per week
Descrizione

Non-Steroidal Anti-Inflammatory Agents U/day Frequency

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0439603
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Similar models

Eligibility Stage I Prostate Cancer NCT01340599

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Biopsy Positive | Disease TNM clinical staging | Biopsy sample Available Biomarker Analysis
Item
prostate biopsy positive for cancer; clinically localized t1 and t2 stage disease expected, with biopsy specimen available for baseline biomarker measurements
boolean
C0600139 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0677862 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C1879847 (UMLS CUI [3,3])
Scheduled Radical prostatectomy
Item
scheduled for a radical prostatectomy
boolean
C0205539 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
willing to sign an institutional review board (irb)-approved informed consent document and adhere to the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Able to swallow oral medication
Item
willing and able to take oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Tea Drinking To be stopped | Herbal Tea Drinking To be stopped | Supplement Containing Green tea Constituents
Item
willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea constituents for the duration of the study
boolean
C0039400 (UMLS CUI [1,1])
C0684271 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
C0019233 (UMLS CUI [2,1])
C0684271 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
C2348609 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C1384640 (UMLS CUI [3,3])
C0729650 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Prostate carcinoma | Operative Surgical Procedures Prostate carcinoma | Brachytherapy | Therapeutic radiology procedure
Item
prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0006098 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Consumption Tea cups/day | Supplement Containing Green tea
Item
recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization
boolean
C0009830 (UMLS CUI [1,1])
C0039400 (UMLS CUI [1,2])
C0560654 (UMLS CUI [1,3])
C2348609 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C1384640 (UMLS CUI [2,3])
Sign or Symptom | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled
Item
signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
boolean
C3540840 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0014130 (UMLS CUI [5,1])
C0205329 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6,1])
C0205329 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0027765 (UMLS CUI [8,1])
C0205329 (UMLS CUI [8,2])
C0234387 (UMLS CUI [9,1])
C0205329 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0023895 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C0018939 (UMLS CUI [12,1])
C0205318 (UMLS CUI [12,2])
C0014130 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0024115 (UMLS CUI [14,1])
C0205318 (UMLS CUI [14,2])
C0018799 (UMLS CUI [15,1])
C0205318 (UMLS CUI [15,2])
C0027765 (UMLS CUI [16,1])
C0205318 (UMLS CUI [16,2])
C0234387 (UMLS CUI [17,1])
C0205318 (UMLS CUI [17,2])
Serum creatinine raised
Item
serum creatinine >= 1.5 x upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) >= uln
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
aspartate aminotransferase (ast) >= uln
boolean
C0201899 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase (alp) >= uln
boolean
C0201850 (UMLS CUI [1])
Albumin measurement
Item
albumin (alb) =< lower limit of normal (lln)
boolean
C0201838 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin >= uln
boolean
C1278039 (UMLS CUI [1])
Malignant Neoplasm Site Any | Basal cell carcinoma Excluded
Item
known malignancy at any site within the last five years; with the exception of basal cell carcinoma (bcc)
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in a research trial within the past three months
boolean
C2348568 (UMLS CUI [1])
Condition Interferes with Informed Consent | Condition Interferes with Protocol Compliance
Item
any condition that would interfere with the ability to give informed consent or comply with the study protocol
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Hypersensitivity Tea product | Hypersensitivity Tea product Inactive ingredient
Item
hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
boolean
C0020517 (UMLS CUI [1,1])
C0039400 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0039400 (UMLS CUI [2,2])
C1514468 (UMLS CUI [2,3])
C1552019 (UMLS CUI [2,4])
Non-Steroidal Anti-Inflammatory Agents U/day Frequency
Item
concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (nsaid) agent two or more times per week
boolean
C0003211 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
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