ID

31619

Description

BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With Bone Mets; ODM derived from: https://clinicaltrials.gov/show/NCT00872157

Lien

https://clinicaltrials.gov/show/NCT00872157

Mots-clés

Versions (1)
  1. 13/09/2018 13/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

13 septembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00872157

Anglais

Eligibility Prostate Cancer NCT00872157

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have histologically confirmed adenocarcinoma of the prostate, with clinically significant bone metastases exhibiting castrate-resistant progression. progression is defined as any of the following: 1) new lesions or obviously worsening lesions on bone scan within the previous three months; 2) a psa doubling time of < 3 months; 3) new or progressive symptoms requiring a change in therapy that are referable to the cancer; 4) new extra-osseous lesions within the past 3 months
Description

Adenocarcinoma of prostate | Secondary malignant neoplasm of bone | Castrate-resistant progression | Lesion New Bone scan | Lesion Worsening Bone scan | Prostate-Specific Antigen Doubling Time | Symptoms New Relationship Malignant Neoplasms | Progressive symptoms Relationship Malignant Neoplasms | Therapy change Required | Lesion Extraosseous New

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C0153690
UMLS CUI [3,1]
C1328504
UMLS CUI [3,2]
C0242656
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0205314
UMLS CUI [4,3]
C0203668
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0332271
UMLS CUI [5,3]
C0203668
UMLS CUI [6,1]
C0138741
UMLS CUI [6,2]
C2986483
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C0205314
UMLS CUI [7,3]
C0439849
UMLS CUI [7,4]
C0006826
UMLS CUI [8,1]
C0240807
UMLS CUI [8,2]
C0439849
UMLS CUI [8,3]
C0006826
UMLS CUI [9,1]
C3665894
UMLS CUI [9,2]
C1514873
UMLS CUI [10,1]
C0221198
UMLS CUI [10,2]
C2986507
UMLS CUI [10,3]
C0205314
2. have progression in the face of a serum testosterone of less than 50 ng/dl, and have either failed or refused chemotherapy
Description

Disease Progression | Serum testosterone measurement | Chemotherapy failed | Chemotherapy Refused

Type de données

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0428413
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1705116
3. have an eastern cooperative oncology group (ecog) performance status 0, 1 or 2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
4. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 140,000/mm^3; hemoglobin >/= 9.0 g/dl (without transfusion or growth factor support), unless the patient is < 6 weeks from last cancer therapy in which case transfusion is allowed.
Description

Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Hemoglobin measurement | Transfusion Absent | Growth Factor Support Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5,1]
C0005841
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0018284
UMLS CUI [6,2]
C1521721
UMLS CUI [6,3]
C0332197
5. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2* the upper limits of normal
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
6. have adequate renal function defined as serum creatinine </= 1.5* the upper limits of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in the absence of hematuria, patients must have either a negative urinalysis for protein (i.e. no more than "trace" by dipstick) or a 24 hour urine collection showing less than 1,000 mg of protein/24 hour. in the presence of hematuria, patients may have up to 2,000 mg of protein/24 hour.
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Hematuria Absent | Urine dipstick for protein Negative | Protein measurement, urine, quantitative 24 hour | Relationship Hematuria Present

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C2711451
UMLS CUI [5,1]
C0018965
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0430371
UMLS CUI [6,2]
C1513916
UMLS CUI [7]
C0202204
UMLS CUI [8,1]
C0439849
UMLS CUI [8,2]
C0018965
UMLS CUI [8,3]
C0150312
7. have adequate cardiovascular function as defined by: i) a normal beta-natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal electrocardiography (ecg). alternatively, patient not meeting all of these criteria is still eligible if he has both i) an echocardiogram showing an ejection fraction (ef) of 45% or greater (and no more than "mild" diastolic dysfunction) and ii) a brain natriuretic peptide (bnp)of < 200
Description

Cardiovascular function | Brain natriuretic peptide normal | Absence Sign or Symptom Heart Disease | ECG normal | Cardiac ejection fraction Echocardiography | Mild diastolic dysfunction | Brain natriuretic peptide measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0578149
UMLS CUI [2]
C1095992
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C3540840
UMLS CUI [3,3]
C0018799
UMLS CUI [4]
C0522054
UMLS CUI [5,1]
C0232174
UMLS CUI [5,2]
C0013516
UMLS CUI [6]
C2751808
UMLS CUI [7]
C1095989
8. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
9. age >/= 18 years old
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. small cell prostate cancer
Description

Small cell carcinoma of prostate

Type de données

boolean

Alias
UMLS CUI [1]
C1300585
2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
Description

Infectious process Worsening Due to Investigational Therapy | Investigational Therapy Affecting Infectious process

Type de données

boolean

Alias
UMLS CUI [1,1]
C0745283
UMLS CUI [1,2]
C0332271
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0949266
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0745283
3. any of the following in previous 6 months: new york heart association (nyha) class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
Description

Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Myocardial Infarction | Determined by Electrocardiography | Determined by Serological aspects

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0034065
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0521095
UMLS CUI [7,2]
C1623258
UMLS CUI [8,1]
C0521095
UMLS CUI [8,2]
C0220911
4. significant co-morbidity that could affect the safety or evaluability of participants, including: a) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (please see further explanation in the treatment plan below)
Description

Comorbidity Affecting Patient safety | Comorbidity Affecting Evaluation | Uncontrolled hypertension chronic | Increased systolic pressure Stable | Increased diastolic pressure Stable | Therapeutic procedure Resistant | Exception Relationship Iatrogenic etiology | Exception Relationship Pain | Exception Relationship Cause Reversible

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0205191
UMLS CUI [4,1]
C0277884
UMLS CUI [4,2]
C0205360
UMLS CUI [5,1]
C0277889
UMLS CUI [5,2]
C0205360
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0332325
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0439849
UMLS CUI [7,3]
C0544071
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0439849
UMLS CUI [8,3]
C0030193
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0439849
UMLS CUI [9,3]
C0015127
UMLS CUI [9,4]
C0205343
5. (# 4 cont'd) b) uncontrolled diabetes mellitus (defined as hgb a1c > 8.5, or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation, or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated),c) lung disease requiring supplemental oxygen, d) known chronic liver disease, or e) hiv infection
Description

Diabetic - poor control | Hemoglobin A1c measurement | Hypoglycaemic episode Symptomatic | Increased glucose level Quantity | Exception Iatrogenic etiology | Exception Cause eliminated | Lung disease Requirement Supplemental oxygen | Chronic liver disease | HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C0745153
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0017747
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0544071
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0015127
UMLS CUI [6,3]
C0849355
UMLS CUI [7,1]
C0024115
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C4534306
UMLS CUI [8]
C0341439
UMLS CUI [9]
C0019693
6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. (non-obstructive hydronephrosis in setting of prior urinary diversion is allowed.)
Description

Bilateral hydronephrosis | Hydronephrosis Involving Kidney Solitary | Nephrostomy Absent | Stent Indwelling Absent | Hydronephrosis Associated with Urinary Diversion allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0521622
UMLS CUI [2,1]
C0020295
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0022646
UMLS CUI [2,4]
C0205171
UMLS CUI [3,1]
C0278314
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0038257
UMLS CUI [4,2]
C0439848
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0020295
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0042020
UMLS CUI [5,4]
C0683607
7. overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
Description

Psychotic Disorders | Mental handicap | Informed Consent Unable | Compliance behavior Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C1306341
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0332268
8. patients must not require ongoing therapy with non-steroidal anti-inflammatories (nsaids),other than low-dose (i.e. 81 mg or less) aspirin daily, i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids for the duration of their participation in the trial
Description

Anti-Inflammatory Agents, Non-Steroidal | Exception Aspirin Low Dose U/day | Vancomycin Intravenous | Aminoglycosides | Pharmaceutical Preparations Nephrotoxic | Avoidance NSAIDs

Type de données

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0042313
UMLS CUI [3,2]
C1522726
UMLS CUI [4]
C0002556
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1514118
UMLS CUI [6,1]
C0870186
UMLS CUI [6,2]
C0003211
9. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
Description

Other medical condition compromises Evaluation Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0013230
10. unwillingness to maintain adequate contraception measures for the entire course of the study
Description

Contraceptive methods Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
11. any therapy for prostate cancer (other than ongoing androgen deprivation or associated hormonal therapies such as diethylstilbesterol, low-dose dexamethasone, megace, etc) in the two weeks prior to starting bmtp-11
Description

Therapeutic procedure Prostate carcinoma | Exception Antiandrogen therapy | Exception Hormone Therapy | Exception Diethylstilbestrol | Exception Dexamethasone Low dose | Exception Megace | Status pre- Start BMTP-11

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279492
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012203
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0011777
UMLS CUI [5,3]
C0445550
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0700004
UMLS CUI [7,1]
C0332152
UMLS CUI [7,2]
C0439659
UMLS CUI [7,3]
C2830059
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Similar models

Eligibility Prostate Cancer NCT00872157

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Secondary malignant neoplasm of bone | Castrate-resistant progression | Lesion New Bone scan | Lesion Worsening Bone scan | Prostate-Specific Antigen Doubling Time | Symptoms New Relationship Malignant Neoplasms | Progressive symptoms Relationship Malignant Neoplasms | Therapy change Required | Lesion Extraosseous New
Item
1. have histologically confirmed adenocarcinoma of the prostate, with clinically significant bone metastases exhibiting castrate-resistant progression. progression is defined as any of the following: 1) new lesions or obviously worsening lesions on bone scan within the previous three months; 2) a psa doubling time of < 3 months; 3) new or progressive symptoms requiring a change in therapy that are referable to the cancer; 4) new extra-osseous lesions within the past 3 months
boolean
C0007112 (UMLS CUI [1])
C0153690 (UMLS CUI [2])
C1328504 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C0203668 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C0332271 (UMLS CUI [5,2])
C0203668 (UMLS CUI [5,3])
C0138741 (UMLS CUI [6,1])
C2986483 (UMLS CUI [6,2])
C1457887 (UMLS CUI [7,1])
C0205314 (UMLS CUI [7,2])
C0439849 (UMLS CUI [7,3])
C0006826 (UMLS CUI [7,4])
C0240807 (UMLS CUI [8,1])
C0439849 (UMLS CUI [8,2])
C0006826 (UMLS CUI [8,3])
C3665894 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C0221198 (UMLS CUI [10,1])
C2986507 (UMLS CUI [10,2])
C0205314 (UMLS CUI [10,3])
Disease Progression | Serum testosterone measurement | Chemotherapy failed | Chemotherapy Refused
Item
2. have progression in the face of a serum testosterone of less than 50 ng/dl, and have either failed or refused chemotherapy
boolean
C0242656 (UMLS CUI [1])
C0428413 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
ECOG performance status
Item
3. have an eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Hemoglobin measurement | Transfusion Absent | Growth Factor Support Absent
Item
4. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 140,000/mm^3; hemoglobin >/= 9.0 g/dl (without transfusion or growth factor support), unless the patient is < 6 weeks from last cancer therapy in which case transfusion is allowed.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0005841 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0018284 (UMLS CUI [6,1])
C1521721 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
5. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2* the upper limits of normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Hematuria Absent | Urine dipstick for protein Negative | Protein measurement, urine, quantitative 24 hour | Relationship Hematuria Present
Item
6. have adequate renal function defined as serum creatinine </= 1.5* the upper limits of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in the absence of hematuria, patients must have either a negative urinalysis for protein (i.e. no more than "trace" by dipstick) or a 24 hour urine collection showing less than 1,000 mg of protein/24 hour. in the presence of hematuria, patients may have up to 2,000 mg of protein/24 hour.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
C0018965 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0430371 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
C0202204 (UMLS CUI [7])
C0439849 (UMLS CUI [8,1])
C0018965 (UMLS CUI [8,2])
C0150312 (UMLS CUI [8,3])
Cardiovascular function | Brain natriuretic peptide normal | Absence Sign or Symptom Heart Disease | ECG normal | Cardiac ejection fraction Echocardiography | Mild diastolic dysfunction | Brain natriuretic peptide measurement
Item
7. have adequate cardiovascular function as defined by: i) a normal beta-natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal electrocardiography (ecg). alternatively, patient not meeting all of these criteria is still eligible if he has both i) an echocardiogram showing an ejection fraction (ef) of 45% or greater (and no more than "mild" diastolic dysfunction) and ii) a brain natriuretic peptide (bnp)of < 200
boolean
C0578149 (UMLS CUI [1])
C1095992 (UMLS CUI [2])
C0332197 (UMLS CUI [3,1])
C3540840 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0522054 (UMLS CUI [4])
C0232174 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
C2751808 (UMLS CUI [6])
C1095989 (UMLS CUI [7])
Informed Consent
Item
8. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
boolean
C0021430 (UMLS CUI [1])
Age
Item
9. age >/= 18 years old
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of prostate
Item
1. small cell prostate cancer
boolean
C1300585 (UMLS CUI [1])
Infectious process Worsening Due to Investigational Therapy | Investigational Therapy Affecting Infectious process
Item
2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
boolean
C0745283 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0949266 (UMLS CUI [1,4])
C0949266 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0745283 (UMLS CUI [2,3])
Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Myocardial Infarction | Determined by Electrocardiography | Determined by Serological aspects
Item
3. any of the following in previous 6 months: new york heart association (nyha) class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0521095 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
C0521095 (UMLS CUI [8,1])
C0220911 (UMLS CUI [8,2])
Comorbidity Affecting Patient safety | Comorbidity Affecting Evaluation | Uncontrolled hypertension chronic | Increased systolic pressure Stable | Increased diastolic pressure Stable | Therapeutic procedure Resistant | Exception Relationship Iatrogenic etiology | Exception Relationship Pain | Exception Relationship Cause Reversible
Item
4. significant co-morbidity that could affect the safety or evaluability of participants, including: a) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (please see further explanation in the treatment plan below)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0277884 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0277889 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0332325 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0439849 (UMLS CUI [7,2])
C0544071 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0439849 (UMLS CUI [8,2])
C0030193 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0439849 (UMLS CUI [9,2])
C0015127 (UMLS CUI [9,3])
C0205343 (UMLS CUI [9,4])
Diabetic - poor control | Hemoglobin A1c measurement | Hypoglycaemic episode Symptomatic | Increased glucose level Quantity | Exception Iatrogenic etiology | Exception Cause eliminated | Lung disease Requirement Supplemental oxygen | Chronic liver disease | HIV Infection
Item
5. (# 4 cont'd) b) uncontrolled diabetes mellitus (defined as hgb a1c > 8.5, or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation, or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated),c) lung disease requiring supplemental oxygen, d) known chronic liver disease, or e) hiv infection
boolean
C0421258 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0745153 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0017747 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0544071 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0015127 (UMLS CUI [6,2])
C0849355 (UMLS CUI [6,3])
C0024115 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C4534306 (UMLS CUI [7,3])
C0341439 (UMLS CUI [8])
C0019693 (UMLS CUI [9])
Bilateral hydronephrosis | Hydronephrosis Involving Kidney Solitary | Nephrostomy Absent | Stent Indwelling Absent | Hydronephrosis Associated with Urinary Diversion allowed
Item
6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. (non-obstructive hydronephrosis in setting of prior urinary diversion is allowed.)
boolean
C0521622 (UMLS CUI [1])
C0020295 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0022646 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
C0278314 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0038257 (UMLS CUI [4,1])
C0439848 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0020295 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0042020 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
Psychotic Disorders | Mental handicap | Informed Consent Unable | Compliance behavior Lacking
Item
7. overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
boolean
C0033975 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Anti-Inflammatory Agents, Non-Steroidal | Exception Aspirin Low Dose U/day | Vancomycin Intravenous | Aminoglycosides | Pharmaceutical Preparations Nephrotoxic | Avoidance NSAIDs
Item
8. patients must not require ongoing therapy with non-steroidal anti-inflammatories (nsaids),other than low-dose (i.e. 81 mg or less) aspirin daily, i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids for the duration of their participation in the trial
boolean
C0003211 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608320 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0042313 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0002556 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1514118 (UMLS CUI [5,2])
C0870186 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
Other medical condition compromises Evaluation Investigational New Drugs
Item
9. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Contraceptive methods Unwilling
Item
10. unwillingness to maintain adequate contraception measures for the entire course of the study
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Therapeutic procedure Prostate carcinoma | Exception Antiandrogen therapy | Exception Hormone Therapy | Exception Diethylstilbestrol | Exception Dexamethasone Low dose | Exception Megace | Status pre- Start BMTP-11
Item
11. any therapy for prostate cancer (other than ongoing androgen deprivation or associated hormonal therapies such as diethylstilbesterol, low-dose dexamethasone, megace, etc) in the two weeks prior to starting bmtp-11
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012203 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
C0445550 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0700004 (UMLS CUI [6,2])
C0332152 (UMLS CUI [7,1])
C0439659 (UMLS CUI [7,2])
C2830059 (UMLS CUI [7,3])
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