Informed Consent
Item
ability to understand and the willingness to sign a written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of prostate Local | Radical prostatectomy Curative treatment Primary
Item
subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy.
boolean
C0007112 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Lithium Absent | Absence Pharmaceutical Preparations Containing Lithium
Item
subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment.
boolean
C0023870 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0023870 (UMLS CUI [2,4])
Age
Item
subjects >/= 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance status of </= 1.
boolean
C1520224 (UMLS CUI [1])
Renal function | Glomerular Filtration Rate
Item
adequate renal function defined as gfr (glomerular filtration rate) >/= 50 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Use of Contraceptive methods
Item
use of adequate contraception
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
ECG normal
Item
ecg (electrocardiogram) within normal limits.
boolean
C0522054 (UMLS CUI [1])
Vitamin supplement New Absent | Herbal medicine New Absent
Item
subjects must agree not to take any new vitamin supplements or herbal remedy during the study period.
boolean
C0681579 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2240391 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Intake Lithium Carbonate | Status pre- Prostatectomy Scheduled
Item
subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy.
boolean
C1512806 (UMLS CUI [1,1])
C0085217 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0033573 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Investigational New Drugs
Item
subjects who have received any investigational medication within 30 days of first lithium dose.
boolean
C0013230 (UMLS CUI [1])
Hormone Therapy Prostate carcinoma | Chemotherapy Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma
Item
subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer.
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
subjects with known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Lithium Carbonate Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0085217 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])