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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-999.0, Prostatic Neoplasms Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents Use of medications or hormones that are known to affect serum PSA levels within 3 months of study enrollment Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment History of prostate cancer History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary tract symptoms within 6 months of study enrollment Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Blood Stream Infections Candida Hospitalized patients with bloodstream infections due to Candida species Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Advanced Prostate Cancer Lower Urinary Tract Symptoms Age > 50 years Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination Presence of lower urinary tract symptoms (LUTS)-IPSS >0 Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice Until into PMOS the patient has not been treated with GnRH analogue The patient, before into the study, has not been treated by surgery (radical prostatectomy) Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient Physician or patient can stop treatment at any moment, if any indications or reasons exist
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer Meeting 1 of the following Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2 Due for prostate biopsy or prostate biopsy performed in the last 6 weeks PSA < 15 ng/mL Histologically confirmed prostate cancer (Treatment Randomization) Clinical stage T1/T2 Re-biopsy after a period of active surveillance is at the discretion of the treating investigator Must meet 1 of the following risk (PSA test < 3 months prior to treatment intervention) Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Urinary Tract Infection Leiomyoma Patients who are at least 18 years of age Vaginal bleeding secondary to anatomic uterine leiomyomas confirmed at the Cleveland Clinic Fibroid and Menstrual Disorders Center Patients complaining of mass effect symptoms due to fibroids, and Patients undergoing either hysterectomy, myomectomy, or uterine artery embolization Patients who are pregnant, or Diagnosis of solitary or multiple intracavitary fibroids without subserosal or intramural leiomyomas present, or Prior or interval anti-incontinence procedure, or Patients with a urinary tract infection, or Patients taking anti-cholinergic medications, or Presence of an adnexal mass, or Unable or unwilling to complete a follow up survey at six months following treatment
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-55.0, Ulcerative Colitis Healthy adult non-smoking male volunteers between the ages of 18 to 55 years, inclusive Must provide a voluntary written informed consent prior to initiation of screening, must be capable of following the verbal and written study instructions, and be able to commit to any confinements and return visits during the entire period of the study Must have a body mass index (BMI) that is within 18 to 30 kg/m2 on the BMI Chart Must have a normal digital rectal examination at screening Must have normal colonic and rectal mucosa at the baseline flexible sigmoidoscopy (i.e., no bleeding, inflammation, edema, ulceration or other abnormal finding) Must have no clinically significant abnormal findings in their medical history, physical examination or clinical laboratory test results History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, or psychiatric disease History of allergic reaction or hypersensitivity to spinach, spinach tablet, spinach powder or spinach extract; and to latex, molds and mushrooms Subjects with abnormal digital rectal examination at screening Subjects with abnormal colonic and rectal mucosa at the baseline flexible sigmoidoscopy i.e., have bleeding, inflammation, edema or ulceration or other abnormal finding Subjects who used NSAIDs within 14 days prior to dosing History of pseudoallergic hypersensitivity to the food color additives, tartrazine (E102) and sunset yellow (E110), allergic asthma, aspirin intolerance, and severe or multiple allergies History of gout, pseudogout or hyperuricemia History of kidney stones Past medical history of significant colonic surgery, except for benign polyp removal Subjects with anatomical abnormalities of the colon, e.g., short bowel or other abnormalities
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-75.0, Left-Sided Ulcerative Colitis Proctosigmoiditis Outpatient males and females between 18 and 75 years. 2. Females of child bearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening and must be sexually inactive (abstinent) for 3 months prior to dosing and throughout the study or be using one of the following acceptable methods of contraception barrier methods (condom, diaphragm with spermicide) Intrauterine device (IUD) in place for at least 3 months surgical sterilization of the partner (vasectomy for at least 6 months); or hormonal contraceptives for at least 3 months prior to dosing. [Female subjects of childbearing potential must be advised to remain sexually inactive or maintain the same method of contraception for ≥7 days following the end of dosing of study treatment] 3. Patients newly diagnosed or with ongoing active distal ulcerative colitis of >3 months duration, confirmed by flexible sigmoidoscopy during screening, and extending 5 to 50 cm from the anal margin. Sigmoidoscopy must be conducted within not more than 3 +/ days before the Baseline (Day 0) Visit. 4. Patients with ongoing active distal ulcerative colitis of ≥3 months duration must be on a stable dose of oral mesalamine (5-ASA) for ≥2 months before the Baseline (Day 0) Visit. 5. Modified Mayo Score (Disease Activity Index) of ≥5 to ≤10 at Baseline, including a sigmoidoscopic inflammation grade score of ≥2 and a rectal bleeding score ≥2. 6. Negative stool test at screening to rule out parasites, bacterial pathogens and Clostridium difficile. 7. Able and willing to fill in (maintain) daily diary cards from Day -7 to Day 21 of the study. 8. Able to provide voluntary written informed consent prior to initiation of screening, must be capable of following the verbal and written study instructions, and be able to commit to the return visits during the entire period of the study History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, or psychiatric disease, that could compromise patient's ability to participate in the study, and/or interfere with absorption of the study drug or the interpretation of the study data. 2. Patients with a diagnosis of Crohn's disease. 3. Patients with a modified Mayo score of ≥11 at the Screening (Day -7 & Day -3) Visits. 4. Patients at immediate or significant risk of toxic megacolon; those with bowel stricture, colonic dysplasia, adenoma or carcinoma. 5. Use of botanical treatments and supplements for ulcerative colitis within 14 days prior to the Baseline Visit. 6. Patients with any enteric pathogens, ova or parasites, or Clostridium difficile toxin in stool. 7. Female patients with a positive pregnancy test or lactating at the Screening/Baseline Visits. 8. History of allergic reaction or hypersensitivity to spinach, spinach tablet, spinach powder or spinach extract; and to latex, molds and mushrooms. 9. History of gout, pseudogout or hyperuricemia, or kidney stones. 10. History of pseudoallergic hypersensitivity to the food color additives, tartrazine (E102), sunset yellow (E110) and FD & C Blue No.1 (Brilliant blue FCF; E133), allergic asthma, aspirin intolerance, and severe or multiple allergies. 11. Past medical history of significant gastrointestinal surgery including but not limited to colostomy, ileostomy, or previous colonic surgery other than appendectomy. 12. Patients with anatomical abnormalities of the colon, e.g., short bowel or other abnormalities. 13. Patients with any current infectious, ischemic, or immunologic disease with gastrointestinal involvement. 14. Patients with a history of failure to retain enemas. 15. Use of antibiotics for reasons related to the primary diagnosis or for other gastrointestinal-related conditions within 14 days of Baseline Visit. 16. Patients who used non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, within 14 days prior to Baseline Visit. Except aspirin ≤325 mg/day for cardiovascular prophylaxis. 17. Patients who used the following medications used for treating ulcerative colitis from the times indicated below to the end of Week 3 (Visit 6) Topical intrarectal corticosteroids or topical intrarectal mesalamine within 14 days of Baseline Visit Systemic corticosteroids (oral or injectable, including adrenocorticotropic hormone [ACTH]) within 30 days of Baseline Visit Immunosuppressant therapy (methotrexate, azathioprine, 6-mercatopurine or cyclosporine) within 60 days of Baseline Visit; and Biologic therapy (tumor necrosis factor-α inhibitors, monoclonal antibodies, etc.) within 90 days of Baseline Visit. 18. Patients with a history of active malignancy within the past 5 years except for squamous cell or basal cell cancers of the skin. 19. History of any clinical laboratory abnormality deemed significant by the Principal Investigator. 20. History of significant alcohol or drug abuse within one year prior to the Screening Visit. 21. Patients who tested positive at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV). 22. Exposure to any investigational or non-registered drug within 30 days prior to administration of study drug
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-999.0, Overactive Bladder Lower Urinary Tract Symptoms Community-dwelling men 2. Age 40 years or older 3. Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary Urinary flow rate < 8.0 mL/sec on a void greater than 125 ml. 2. Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate). 3. Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture). Patients will be referred for treatment with antibiotics and may be enrolled if OAB symptoms persist after the infection is resolved. 4. Transurethral resection of the prostate (TURP), simple prostatectomy, or other benign prostatic hypertrophy (BPH) related surgery within the past 5 years. 5. Current active treatment for prostate cancer. 6. History of radical prostatectomy. 7. Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device. 8. Poorly controlled diabetes (glycosylated hemoglobin >9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately. 9. Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated. 10. Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam). 11. Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis. 12. Impaired mental status. Patients who screen as probable dementia on the Mini-Cog. 13. Contraindications to the study drugs (tolterodine and tamsulosin) including history of postural hypotension with syncope, history of acute urinary retention requiring catheterization, narrow angle glaucoma, or history of gastric retention. 14. Hypersensitivity to tolterodine or tamsulosin. 15. Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks. 16. Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks. 17. If on a diuretic, dose has not been stable for at least 4 weeks. 18. If taking dutasteride or finasteride, dose has not been stable for at least 6 months. 19. If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed. 20. Full course of behavioral training
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) (as diagnosed by a qualified physician) >6 months at screening visit. Lower urinary tract symptoms (LUTS) those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or storage (irritative symptoms, such as frequency, urgency, nocturia) Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate Symptom Score (IPSS) >12. (The IPSS total score is defined as the sum of Questions 1 through 7 and does not the IPSS Quality of Life.) Taking into account the age and disease status, subjects determined to be in good health according to medical history, physical examination, electrocardiogram (ECG), and laboratory safety assessments Body mass index between 18 and 30 kg/m^2 inclusive Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least 1 week prior to dosing and through to follow-up Subjects with a serum prostate-specific antigen (PSA) <10.0 ng/mL. Subjects with a serum PSA greater than or equal to 4.0 and <10.0 ng/mL must have documentation of a negative histologic biopsy of carcinoma of the prostate within 12 months prior to screening History of radical prostatectomy, or other pelvic surgery or procedure, including any pelvic surgical procedure on the urinary tract apart from transurethral resection, pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract malignancy or trauma. History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening Current or previous history of malignant disease of the prostate Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or -inhibiting agents from 2 weeks prior to dosing and through the end of the study. Including herbal/food and other supplements, fruit, or fruit juices containing grapefruit or pomegranate components History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure Subjects with chronic stable angina treated with long-acting nitrates, subjects with chronic stable angina who required short-acting nitrates in the 90 days prior to screening visit, or subjects with angina occurring during sexual intercourse in the 6 months prior to screening Subjects having met the for unstable angina within 6 months prior to screening, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days prior to screening Any evidence of heart disease (New York Heart Association [NYHA] greater than or equal to Class III) within 6 months of screening A history of cardiac arrest
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-80.0, Benign Prostatic Hyperplasia Subject has provided informed consent and agrees to attend all study visits Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction Subject is willing to be randomized Subject is able to complete self-administered questionnaires Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for either the PVP or the TURP procedure and may be randomized into either arm Subject is 40 to 80 years of age Subject has an IPSS score greater than or equal to 12 measured at the baseline visit Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 150ml, and the Qmax is less than 15ml/s it may be used for the inclusion/ Subject has medical record documentation of a prostate volume of less than or equal to 100g by transrectal ultrasound (TRUS) (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is less than or equal to 100g, it may be used for the inclusion/ Subject is classified as American Society of Anesthesiologists (ASA) I, II or III Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured less than or equal to 30 days prior to the date of surgery Subject has a life expectancy of less than 2 years Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor Subject has an active infection (eg, urinary tract infection or prostatitis) Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis) Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within the 5 years prior to the informed consent date Subject has a diagnosis of lichen sclerosus
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-120.0, Prostate Cancer Histologically confirmed prostate cancer Stage D0 disease Tumor originally diagnosed as being limited to the prostate and now having a rising prostate-specific antigen (PSA) after definitive local therapy Must have undergone local treatment via prostatectomy or radiotherapy PSA values must be ≥ 0.2 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy PSA values must be ≥ 2.0 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after radiotherapy The first two PSA values along with a third value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value) No metastatic disease by baseline bone scan and CT scan of the abdomen and/or pelvis Life expectancy ≥ 6 months ECOG performance status 0-2
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Major Depressive Disorder Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company Patients who have not been treated for depression
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) BPH patients with LUTS Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia Patients with prostate cancer or suspected prostate cancer Patients who have any clinically relevant cardiovascular, hepatic or renal disorder
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hypertrophy Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria Outpatients aged 50 or over Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater) Patients with a residual urinary volume of 200ml or greater Patients with a history of prostatectomy Patients with a history of intrapelvic radiation therapy Patients with a history of prostatic hyperthermia Patients with prostate cancer or suspected prostate cancer Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. UTI Patients conducting self-catheterization Patients with renal impairment (serum creatinine of 3.0 mg/dl or greater) Patients with severe heptic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or with a total bilirubin of 3.0mg/dL or greater or AST/ALT 2.5 times higher than normal level Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 21.0-999.0, Prostate Cancer Participants must meet all of the following to be enrolled in this study. 1. Male aged 21 years or older. 2. Ability to provide signed informed consent and willingness to comply with protocol requirements. 3. Participants must agree to use condoms for a period of seven days after each injection, if engaged in sexual activity. Additional for Patients: i. Histologic diagnosis of prostate cancer by validated medical history. (Pathology report, if available). ii. Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI plus a Clinical Stage 3 and Gleason Score ≥ 8. iii. Karnofsky performance is ≥ 60. Additional for Healthy Volunteers: i. PSA laboratory assessment within normal range (PSA < 4 ng/ml). ii. Normal findings on a digital rectal examination. iii. Hemoglobin and hematocrit within normal range Participants must NOT meet any of the following to be enrolled in this study. 1. Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study. 2. Subject was administered a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment 3. Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations. 4. Participant is determined by the Investigator to be clinically unsuitable for the study. 5. Serum creatinine ≥ 2.0 mg/dl 6. Total bilirubin ≥ 2.0 mg/dl 7. Liver transaminases ≥ 1.5 x ULN 8. Platelet count < 150,000/mm3 9. Absolute neutrophil count (ANC) < 2,000/mm3. 10. Hematocrit < 30% or hemoglobin < 10 g/dl. 11. Abnormal coagulation profile (PT, PTT or INR) > 1.3 ULN unless on therapeutic anticoagulation. Additional for Patients: Patients will be excluded from the study if any of the following are observed: i. Androgen deprivation therapy or other forms of hormonal therapy not stable for a period of 14 days prior to screening. ii. Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants. iii. Subject on or expected to be starting cytotoxic chemotherapy during the study period. iv. Has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response. Additional for Healthy Volunteers: Healthy Volunteers will be excluded from the study if any of the following are observed: i. Have had any malignancies within 5 years other than basal or squamous cell carcinoma of the skin. ii. History of known prostate adenocarcinoma, prostate surgery/biopsy, prostatitis and/or symptoms suggestive of or associated with possible prostatitis within 6 months of enrollment
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Attitude of Health Personnel The primary care physicians, who practicing western medicine, with the doctor licenses approved by the Department of Health in Taiwan The subjects who are unable to complete the survey independently
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, End Stage Renal Disease Main 1. Male and female subjects ≥ 18 years of age. 2. End-stage renal disease undergoing maintenance hemodialysis 3 to 4 times a week for at least 4 months and expected to remain on this schedule and be able to complete the study. Subjects on a cadaveric transplant list need not be excluded for this reason unless there is an identified donor. 3. Mean Hgb in the range of ≥ 9.5 to ≤ 12.0 g/dL during screening. 4. The difference between the maximum and minimum Hgb values during screening does not exceed 1.0 g/dL. 5. Mean ferritin ≥ 200 to ≤ 1000 µg/L during screening. 6. Mean TSAT ≥ 15% to ≤ 40% during screening. 7. Any and all serum albumin measured during the 2 months preceding randomization must be ≥ 3.0 g/dL. 8. Prescribed ESA dosing remaining in the range of ≥ 4,000 to ≤ 45,000 U/week epoetin or ≥ 12.5 to ≤ 200 µg/week darbepoetin during the 6 weeks preceding randomization. 9. Required IV iron at any time in the 6 months preceding randomization. Main Vascular access for dialysis is a catheter. 2. During the 6 months prior to randomization, infection of the vascular access to be used at the time of randomization. 3. Received a total of > 600 mg IV iron during the 6 weeks prior to randomization. 4. Received any amount of IV or oral iron during the 2 weeks prior to randomization. 5. Change in prescribed ESA dose: 1. Any change in prescribed ESA dose within 4 weeks prior to randomization. 2. The prescribed ESA dose at the time of randomization is > 25% higher or lower than the prescribed dose at 6 weeks prior to randomization. 3. Change in prescribed type of ESA (e.g., epoetin vs. darbepoetin) or route of administration within 6 weeks prior to randomization. 6. Actual ESA dosing missed or withheld for a cumulative total of ≥ 1 week for any reason during the 6 weeks prior to randomization. 7. Known cause of anemia other than anemia attributable to renal disease (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, etc.) 8. Scheduled kidney transplant or a donor has been identified but the transplant has not been scheduled. 9. Known ongoing inflammatory disorder (other than Chronic Kidney Disease), such as systemic lupus erythematosus, rheumatoid arthritis, other collagen-vascular diseases, etc. 11. Known active tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study. Subjects with hepatitis C, in the absence of cirrhosis, are not excluded from participation in the study if Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are below 2 times the upper limit of normal on a consistent basis during the 2 months preceding randomization. 12. Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study. 13. Cirrhosis of the liver based on histological or clinical (e.g., presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-90.0, Neurogenic Bladder Diseases of the Lower Urinary Tract: General Conditions patient of Balgrist University Hospital patient of University Hospital Zürich urodynamic examination written informed consent no written informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Size, volume,length of prostate
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lipid Metabolism Disorders Peroxidase; Defect no metabolic, malignant or kidney disorder, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Medical Education Physician in primary care training program Faculty member in primary care training program Advanced medical training in substance abuse management
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Obesity Chronic Kidney Disease Metabolic Syndrome Group I Patients with BMI> 30 and metabolic syndrome ( ATP III). Patient with BMI> 30 without metabolic syndrome. Normal healthy control healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ). Group II Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressives agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function Hemodialysis patients CKD: nondiabetic nephropathy duration hemodialysis 3-48 months Hb-11-13 g/dl well controlled hypertension ( < 140/90 mmHg) without ACEi, ARB, allopurinol treatment residual diuresis will be estimated for last 48 hours-between mid and next dialysis immunosuppressive agents, ACEi, ARB, allopurinol treatment diabetes mellitus not well controlled hypertension ( > 140/90 mmHg) proteinuria > 3,5 g/24 h
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Males, age ≧ 50 years Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) IPSS score ≧ 8 points and prostate volume ≧ 30 mL Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months Dutasteride combination therapy will be allowed by investigator's prescription Ability to understand and willingly provide written informed consent History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN) With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study Use of finasteride within 6 months of screening visit Use of dutasteride within 12 months of screening visit
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Infections, Urinary Tract Adult subjects least 18 years of age. N.B. Females of non-childbearing or childbearing potential may be enrolled. Females of childbearing potential must have a negative pregnancy test at study entry and must have practiced adequate contraception for at least 30 days prior to study entry. Additionally, the subject agrees to one of the following methods for avoidance of pregnancy during the entire study treatment period Abstinence; or Oral Contraceptive, either combined estrogen/progesterone or progesterone alone, PLUS an additional barrier method [ie, condom, occlusive cap (diaphragm or cervical/vault caps) or vaginal spermicidal agent (foam/gel/film/cream/suppository)]; or Injectable progesterone; or Implants of levonorgestrel; or Estrogenic vaginal ring; or Percutaneous contraceptive patches; or Intrauterine device (IUD) or intrauterine system (IUS) showing that failure rate is less than 1% in the IUD or IUS product label; or Has a male partner who is sterilized (vasectomy with documentation of azoospermia) Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Subjects meeting any of the following must not be enrolled in the study Concomitant infection requiring systemic antibacterial therapy other than study drugs at the time of randomisation Subject is known to have one or more of the following A urinary catheter that is not being removed during the study (or with an expectation that a catheter would be inserted during therapy with study drug and subsequently not removed during the study period; (intermittent straight catheterisation is acceptable) Complete permanent obstruction of the urinary tract A permanent indwelling catheter or comparable instrumentation including nephrostomy that will not be removed during IV study drug administration Suspected or confirmed prostatitis Suspected or confirmed perinephric or intrarenal abscess A UTI suspected or confirmed to be fungal in origin (with >= 10^3 fungal CFU/mL) A UTI suspected or confirmed to be due to a Gram-positive uropathogen(s), with >= 10^5 Gram-positive organism CFU/mL
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 12.0-75.0, Chronic Liver Disease All patients who were known to have cirrhosis of liver with portal hypertension, now decompensated with ascites/ jaundice/ bleed/ HE/ HRS Age <12 or > 75 years Autoimmune disorders HCC Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP) Multi organ failure Grade 4 HE HIV seropositivity / pregnancy Essential Hypertension Patients being taken up for transplant Refusal to participate in the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-72.0, Blood Stream Infection Any preterm neonates (>26 weeks and < 37 weeks of gestation by maternal dates) 2. Birth weight of at least 750 gm 3. Age ≤72 hours of life 4. Baseline blood cultures obtained 5. Expected survival > 48 hours (based on the clinical judgment by the physicians) Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings. 2. Neonate within first 24 hours of critical care 3. Life threatening congenital anomalies 4. Congenital skin anomalies 5. Hydrops Fetalis 6. Congenital infection of the skin 7. History of any previous treatment with the ointment 8. Newborns admitted for major surgical procedure with expected high rates of infectious complications. 9. Newborns with positive baseline blood cultures
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Bladder Cancer Open Phase 1. Has the patient given written informed consent and is the patient willing and able to abide by the protocol? 2. Is the patient 18 years old or above? 3. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 4. Does the female patient of childbearing potential have a negative serum pregnancy test at screening? 5. Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have multiple tumors (2-7) No single Tumor > 3 cm No history / evidence of Tis Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have A single tumor that is ≤ 3 cm No history / evidence of Tis 6. Is the patient able to retain bladder instillations for a minimum of 60 minutes? 7. Did the patient have upper urinary tract evaluation to urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening? 8. Is patient's urethra (including prostatic urethra in men) endoscopically free of any visible TCC? 9. For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening? 10. Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator? Double-Blind Phase 1. Was all visible tumor resected at the initial TURBT? 2. Does Central Pathology review of the patient's bladder tumor confirm Low grade Ta disease for multiple tumors (2 High Grade Ta disease for single tumor No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli Open Phase Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)? 2. Has the patient ever received apaziquone? 3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago? 4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT? 5. Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)? 6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma? 8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past? 9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years? 10. Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L? 11. Does the patient have a screening hemoglobin < 10 mg/dL? 12. Does the male patient have a serum PSA > 10 ng/mL? 13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive? 14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study? 15. Has the patient participated in an investigational protocol within the past 90 days? 16. Is the patient pregnant or breast feeding? 17. Does the patient have a life expectancy of <3 years? 18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except non-melanoma skin tumors stage 0 (in situ) cervical carcinoma undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer? 19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent? 20. Does the patient have tumor in a bladder diverticulum? 21. Does the patient have a known allergy to red color food dye?
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Vitamin D Deficiency All patients with Vitamin D level less than 20 ng/dl Patients who have received vitamin D injection in last 03 months Patients with hypercalcemia (corrected calcium > 10.6 mg/dl) Known Malignancy Known case of CLD or serum ALT > 3 times ULN Patients with creatinine > 2.0 mg/dl
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Malnutrition Heart Disease Patients undergoing cardiac surgery for revascularization, valve implant Patients with some degree of malnutrition or at risk of malnutrition according to the implementation of the Nutritional Risk Screening-2002 By letter of informed consent Patients with cancer diagnosis, liver disease, kidney disease Patients who decide to come out the study Patients who are transferred to other hospitals Patients with complications that prevent them from receiving enteral nutritional
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-95.0, Bladder Neck Obstruction Benign Prostate Hyperplasia Main IC Subject signed informed consent prior to the performance of any study procedures Male with BPH, who are at least 50 years of age and that were diagnosed with BOO IPSS symptom severity score ≥ 10 Peak urinary flow of < 12 ml/sec No pathology found with kidney US Prostatic urethra length < 30 mm Prostate volume < 35 cc Normal Urinalysis and urine culture Main EC Any prior prostate treatment Suspected or proved carcinoma of prostate Urethral stricture Urinary bladder stones Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy) Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever Any serious medical condition likely to impede successful completion of the study Intraoperative EC
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months Written informed consent prior to enrollment in the study IPSS ≥12 Prostate volume of 30 mL as determined by TRUS Maximum urine flow (Qmax) of 4 mL/sec Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors Unwilling or unable to undergo conventional surgical or available minimally invasive treatments Blood PSA values <10 ng/mL Inability to void at least 125 mL of urine PVR volume >200 mL Presence of or history of certain conditions that could interfere with study results or endanger subject Use of certain prescribed medications that could interfere with study results
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Men > 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH) International Prostate Symptom Score (IPSS) > 8 PSA < 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma) Post void residual urine < 150 mls Urinary Flow rate > 15 mL/sec Neurogenic bladder Urinary tract infection, Urinary stone(s), Urinary tract tumor Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months History of cataracts with planned surgery
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Trauma Massive Hemorrhage Trauma patient 2. Patient at the obvious age of equal or higher than 18 years of either sex 3. Major bleeding or occult bleeding with parameters of shock 4. Need for volume replacement therapy 5. Patient, who will be admitted to one of the participating hospitals Solely penetrating trauma 2. Solely head injury 3. In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume) 4. Patient with inevitable lethal course as evaluated by emergency physician 5. Need for CPR on the scene 6. Deep hypothermia (below 30°C) 7. Obviously pregnant women 8. Patient with known recent history of thromboembolic events within the last 6 months 9. Patient known to be on anticoagulant therapy 10. Patient with known refusal of a participation in this clinical trial
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Violence Participants included English and Spanish speaking caregivers of 2-12 year old children presenting to the pediatric primary care clinic for a well-child visit Parents who could not speak either English or Spanish
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-999.0, Prostate Cancer Men who have undergone prior trans-rectal biopsies Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy Previous history of prostate cancer treatment Men unable to have MRI scan, or in whom artefact would reduce quality of MRI Men unable to have general or regional anaesthesia Men unable to give informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Benign Prostate Hyperplasia Ability to give informed consent. 2. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH. 3. Failed medical treatment of BPH. 4. International prostate symptom scores (IPSS) > 15. 5. Peak urinary flow rate (Qmax) < 15 ml/sec. 6. Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc). 7. Patients in retention secondary to BPH (with cystometrogram (CMG) confirming adequate detrusor pressure if the bladder capacity at time of catheterization is in excess of 1000 ml) Inability to give informed consent. 2. Patient who have a neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease. 3. Active urinary tract infection. 4. Presence of active bladder cancer (within the last 2 years). 5. Known cancer prostate patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-999.0, Deep Vein Thrombosis Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization Calculated creatinine clearance (CLCR) < 30 mL/min Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer PSA > 4.0 ng/ml written informed consent age >18 patients with prostate cancer patients with prior prostate biopsy patients with contraindications against MRI or biopsy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Benign Prostatic Hyperplasia (BPH) Benign Prostatic Enlargement (BPE) Moderate-to-severe LUTS as determined by the International Prostate Symptom Score Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-95.0, Pneumonia Blood Stream Infection Hospitalized Adults (> 18 years to 95 years of age), at one of the study sites Diagnosis of BSI and/or pneumonia due to a preliminary result of gram-negative non-lactose fermenter that is oxidase negative; or a final results of XDR-A. baumannii; carbapenem-resistant Enterobacteriaciae; or XDR P. aeruginosa and/or patients with suspected BSI and/or HAP and who have had a prior history (within last 6 months) of XDR-GNB that was susceptible to colistin. o If final results do not indicate that the pathogen is an XDR-GNB, and identifies alternative treatment options, the patient would be eligible for the study if the subject is allergic to all the alternative treatment options Patients with polymicrobial respiratory or blood infections, including XDR-GNB and one or more pathogens, will be included in the study, as long as the XDR-GNB is determined to be a true pathogen (AB, CRE or PA). Other pathogens will be treated with antimicrobial agents as determined by the treating physician If more than one XDR-GNB study pathogens is identified as a study pathogen causing BSI and/or pneumonia, then the first study pathogen recovered will be considered as the primary study pathogen. If more than one study pathogen is recovered from the same culture, then the infection will be categorized as being caused by multiple study pathogens Patients with a life expectancy of > 24 hours Signed written informed consent and HIPAA Authorization form (US sites) Female patients who are pregnant Female patients who are nursing Patients who are prisoners Patients who are less than 18 years of age or greater than or equal to 96 years of age Patients with neutropenia (WBC < 500 cells/mm3) The presence of any of the following known clinical syndromes involving XDR-GNB as a pathogen which necessitate durations of antimicrobial therapies greater than 14 days: endocarditis, osteomyelitis, prosthetic joint infections, meningitis and/or other central nervous system infections Patients receiving valproic acid (with or without a known seizure disorder) Patients who received 72 hours or more of polymyxin treatment (intravenous or inhaled [pneumonia]) within 96 hours of enrollment Patients who have end-stage renal disease requiring hemodialysis, will be excluded from evaluation pertaining to nephrotoxicity in the per protocol population Patients with known Type 1 or other severe drug allergy to either of the study drugs or to β-lactams
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Urinary Tract Infection male patients with chronic (> 1 year) spinal cord injury bladder management by intermittent catheterization symptomatic urinary tract infection prostate pathology immunodeficiency antibiotic therapy missing informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-55.0, Fasting Healthy subjects, both sexes, age between 18 to 55 years old Weight with normal range according to accepted normal values for BMI (18-25 kg/m2) Give a written informed consent Acceptable medical history and physical examination Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts Acceptable electrocardiogram (ECG) result Negative result for serological tests of Hepatitis B, Hepatitis C and HIV Negative result for pregnancy test Smoker or alcoholism Pregnant woman or nursing mother Have history of hepatic, cardiovascular, gastrointestinal or renal disease Potentially sensitive to azithromycin or other related drugs Received any investigation drug within four weeks Donation or loss more than 450 mL of blood within 3 months prior to the screening
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-85.0, Benign Prostatic Hyperplasia (BPH) Male patient Between 45 and 85 years old Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2) Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2) I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary) Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2) Serum total PSA at randomisation visit (visit 2) ng/mL Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2) Urological history Urethral stricture disease and/or bladder neck disease Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection Indication of BPH surgery Stone in bladder or urethra Acute or chronic (documented) prostatitis Prostate and cancer cancer treated or untreated Interstitial cystitis (documented by symptoms and/or biopsy) Active upper tract stone disease causing symptoms
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism) Who have no contraindications to standard treatment with heparin and/or warfarin, and Who provide informed consent to participate Contraindication to compression stockings Limited lifespan (estimated < 6 months) Geographic inaccessibility preventing return for follow-up visits Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily Treatment of acute DVT with thrombolytic agents
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Castration Resistant Prostate Cancer Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study Be willing/able to adhere to the prohibitions and restrictions specified in this protocol Written Authorization for Use and Release of Health and Research Study Information has been obtained Male aged 18 years and above Able to swallow the study drug whole as a tablet Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration Have a baseline serum potassium of ≥ 3.5 milliequivalents per litre (mEq/L) Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels < 1.5 x upper limit of normal (ULN) Have a serum albumin of ≥ 3.0 g/dL Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated Known brain metastasis Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment Active or symptomatic viral hepatitis or chronic liver disease History of pituitary or adrenal dysfunction Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy Administration of an investigational therapeutic within 30 days of screening Have poorly controlled diabetes Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-999.0, Bladder Outlet Obstruction Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8) Patient or his/her legally acceptable representative has signed the written informed consent form Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up Patients with urinary retention, urodynamically proven detrusor underactivity or PVR ≥250 mL Patients with known active urinary tract infection, urinary stone or malignancy Patients with history of urethral injury or transurethral surgery for prostate or bladder Patients have laboratory abnormalities at screening including: 1. Aspartate aminotransferase (AST) >3 x upper limit of normal range 2. Alanine aminotransferase (ALT) >3 x upper limit of normal range 3. Patients have abnormal serum creatinine level >2 x upper limit of normal range Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial Patients participated investigational drug trial within 1 month before entering this study Patients with major psychiatric illness or drug abuse Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase (5AR) inhibitor within 6 months
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-55.0, Healthy Agree to all the purposes of the study by signing and dating the Informed Consent Male, aged between 20 and 55 years, clinically healthy BMI between 18.5 and 30 Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49% VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells Human serum ferritin between 36-262 mcg / L Counting of reticulocytes in peripheral blood ≤ 3% Serum erythropoietin < 30 mIU / mL Participation in clinical trials in the 12 months preceding the survey Body weight > 100 kg Presence of iron deficiency anemia Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study Administration of any drug in the 02 weeks prior to the start of the practical period of the study Clinical history of autoimmune or hereditary anemia Clinical history of chronic bleeding
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-55.0, Healthy Agree to all the purposes of the study by signing and dating the Informed Consent Male, aged between 20 and 55 years, clinically healthy BMI between 18.5 and 30 Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49% VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells Human serum ferritin between 36-262 mcg / L Counting of reticulocytes in peripheral blood ≤ 3% Serum erythropoietin < 30 mIU / mL Participation in clinical trials in the 12 months preceding the survey Body weight > 100 kg Presence of iron deficiency anemia Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study Administration of any drug in the 02 weeks prior to the start of the practical period of the study Clinical history of autoimmune or hereditary anemia Clinical history of chronic bleeding
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Prostatic Hyperplasia Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) . International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal ultrasonography). Total serum prostate specific antigen (PSA) ≥1.5 ng/mL and ≤10 ng/mL. Free-to-total PSA ratio > 20% Maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and post-void residual volume of < 150 mL Willing and able to give written informed consent and comply with study procedures throughout study Able to swallow and retain oral medication Able to express personal thought and feeling Ability to read and comprehend information on the Sexual Function Inventory History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious digital rectal examination). Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH. History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7 days History of acute urine retention (AUR) within past 3 months. Any causes other than BPH result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections). History of breast cancer or clinical finding suggestive of malignancy. Use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®), drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), drugs which induce gynecomastia or drugs which affect prostate volume, within past 6 months and throughout the study (other than as study medication). Do not use dutasteride within past 12 months. Do not use metronidazole for a long time. Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®, Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need phytotherapy during the study. Use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of screening visit and/or predicted to need any alpha blockers other than tamsulosin during the study. Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments. Hypersensitivity to any alpha-/beta-adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs. Concurrent use of drugs known or thought to have an interaction with tamsulosin and dutasteride. History of hepatic impairment or abnormal liver function tests at screening (defined ALT, AST, and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal). History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at screening. History of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least 5 years prior to screening are eligible. Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within past 6 months; medically uncontrollable diabetes or peptic ulcer disease History of postural hypotension, dizziness, vertigo or any signs and symptoms of orthostasis, which in judgments of investigator, could be exacerbated by tamsulosin History of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy. History of unsuccessful treatment with finasteride or dutasteride. Willing to have a child during the treatment period or within 6 months thereafter Having female partner who is a pregnant woman or in child-bearing age and refuse to use condom for sexual protection Willing to donate blood during treatment period or within 6 months thereafter. History or current evidence of drug or alcohol abuse within past 12 months. History of any illness might confound the results of the study or poses additional risk to the patient. Participation in investigational or marketed drug trial within 30 days preceding the screening visit and/or during the study treatment
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-60.0, Focus of Study of Healthy Adults Age 18-60 years Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg Positive urine pregnancy test or breastfeeding Concurrent use of medications affecting glucose or lipid metabolism Recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill, intrauterine device, DepoProvera) Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent Current use of phosphodiesterase 5 inhibitors or organic nitrates Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes Smoker
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Subject capable of understanding & complying with protocol requirements & signed the informed consent form 2. Minimum age 18 years 3. Histologically confirmed adenocarcinoma of the prostate with tumour tissue available for molecular analyses 4. At least one but no more than two previous taxane-based chemotherapy regimens. If docetaxel chemotherapy is used more than once, this will be considered as one regime. Patients may have had prior exposure to cabazitaxel treatment 5. At least 28 days since the completion of prior therapy, including major surgery, chemotherapy & other investigational agents. Clinically relevant sequelae should have resolved to grade 1 or less prior to recommencing treatment. For hormonal treatment & radiotherapy refer to the protocol guidelines 6. Documented prostate cancer progression as described in the protocol. 7. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists this must have been initiated at least 4 weeks prior to Cycle 1 Day 1 & must be continued throughout the study. 8. Eastern Cooperative Oncology Group Performance Status of 0, 1, 2 9. Life expectancy > 12 weeks 10. Able to swallow a whole tablet 11. Patient & the patient's partner of childbearing potential, must agree to use medically accepted methods of contraception during the course of the study & for 3 months after the last dose of study drug 12. Agreeable to have all the biomarker studies including the paired fresh tumour biopsies. 13. CTC count of 5 cells/7.5mls blood or more at screening. Note: For Part B, CTC count >5 cells/7.5mls blood is not mandatory if patient has measurable disease by modified and a lesion >2cm and PSA greater than or equal to 2ng/ml at screening. 14. Adequate bone marrow, hepatic & renal function as defined in the protocol 15. For Part B only, patients must have genomic defects associated with olaparib sensitivity identified by NGS by the central lab Surgery, or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1 2. Less than 28 days from any active anticancer therapy or investigational agents. For hormonal treatment & radiotherapy refer to the guidelines outlined in the 3. Prior treatment with a PARP inhibitor, platinum, cyclophosphamide or mitoxantrone chemotherapy 4. Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements 5. Any acute toxicities due to prior chemotherapy & / or radiotherapy that have not resolved to a NCI-CTCAE v4.02 grade 0 or 1 with the exception of chemotherapy induced alopecia & grade 2 peripheral neuropathy 6. Malignancy within the previous 2-years with a > 30% probability of recurrence within 12 months with the exception of non-melanoma skin cancer, in-situ or superficial bladder cancer 7. Patients with myelodysplastic syndrome/acute myeloid leukaemia 8. Patients with known symptomatic brain metastasis are not suitable for enrollment. Patients with asymptomatic, stable, treated brain metastases are eligible for study entry 9. Patients with symptomatic or impending cord compression unless appropriately treated beforehand & clinically stable & asymptomatic 10. Patients who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures 11. Patients receiving any of the following classes of inhibitors of CYP3A4 (see protocol for guidelines & wash out periods) 12. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication 13. Initiating bisphosphonate therapy or adjusting bisphosphonate dose/regimen within 30 days prior to Cycle 1 Day 1. Patients on a stable bisphosphonate regimen are eligible & may continue 14. Presence of a condition or situation, which, may put the patient at significant risk, confound the study results, or interfere significantly with participation in the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-55.0, Healthy Agree to all the purposes of the study by signing and dating the Informed Consent Male, aged between 20 and 55 years, clinically healthy BMI between 18.5 and 30 Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49% VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells Human serum ferritin between 36-262 mcg / L Counting of reticulocytes in peripheral blood ≤ 3% Serum erythropoietin < 30 mIU / mL Participation in clinical trials in the 12 months preceding the survey Body weight > 100 kg Presence of iron deficiency anemia Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study Administration of any drug in the 02 weeks prior to the start of the practical period of the study Clinical history of autoimmune or hereditary anemia Clinical history of chronic bleeding
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-55.0, Healthy Agree to all the purposes of the study by signing and dating the Informed Consent Male, aged between 20 and 55 years, clinically healthy BMI between 18.5 and 30 Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49% VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells Human serum ferritin between 36-262 mcg / L Counting of reticulocytes in peripheral blood ≤ 3% Serum erythropoietin < 30 mIU / mL Participation in clinical trials in the 12 months preceding the survey Body weight > 100 kg Presence of iron deficiency anemia Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study Administration of any drug in the 02 weeks prior to the start of the practical period of the study Clinical history of autoimmune or hereditary anemia Clinical history of chronic bleeding
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-60.0, Benign Prostatic Hyperplasia Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic hyperplasia. 2. Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer. 3. Total IPSS score (International Prostate Symptome Score) of 8 to 15. 4. Prostate volume of more than 30 cm3. 5. Maximal urinary flow rate of 10-15 mL/sec. 6. Micturition volume of 125-350 mL. 7. Residual volume of less than 100 mL. 8. Serum prostate-specific antigen (PSA) level of less than 4 ng/mL. 9. Use of and compliance with contraceptive methods during the trial and for 30 days upon completion of participation in the trial. 10. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc. 2. Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years. 3. Acute urinary retention (AUR) within 3 months before in the trial. 4. Neurogenic dysfunctions and bladder ears. 5. Urinary stone disease. 6. Urethral stricture, bladder neck sclerosis. 7. History of operative aids for pelvic organs. 8. Urogenital infections in the phase of active inflammation. 9. Systematic administration of agents exhibiting effects on bladder function and urine production. 10. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency. 11. History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride). 12. History of polyvalent allergy. 13. Allergy/intolerance to any component of drug agents used in the therapy. 14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency. 15. Administration of drugs specified as "Prohibited concomitant therapy", within 3 months before enrollment. 16. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial. 17. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity. 18. Legal incapacitation or limited legal capacity. 19. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure. 20. Participation in other clinical trials within 3 months before enrolment in this trial. 21. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 22. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted. 23. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 30.0-999.0, Prostate Cancer Normal Healthy Volunteers Males age 30 years or older No prior history of cancer Willing to get a PSA evaluated. Normal subjects will be eligible if their PSA is in the normal range for the particular lab where it is drawn. PSA drawn within 6 months (before) of the FMDHT PET scan will be accepted Ability to tolerate PET imaging Ability to understand and willingness to sign a written informed consent document. Prostate Cancer Patients Patients with histologically confirmed adenocarcinoma of the prostate Patients with a clinical staging CT at the time of the first [F-18]FMDHT scan Patients with at least one single focus of metastatic disease (bone/lymph node or soft tissue) confirmed on other clinical studies, preferably biopsy Patients with prior transurethral resection of the prostate are eligible Normal Health Volunteers Prior diagnosis of any cancer (except non-melanoma skin cancer). Prostate Cancer Patients Prior diagnosis of cancer except non-melanoma skin cancer Prior treatment (other than biopsy) for prostate cancer Received radiation therapy, hormonal therapy, surgery or cryotherapy for prostate disease
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostate Hyperplasia Male patients aged over 50 Clinically diagnosed benign prostate hyperplasia(BPH) ≤ IPSS ≤ 30 ml/sec ≤ Q max ≤ 15 ml/sec minimum voided volume ≥ 125 ml Post voided residual volume ≤ 250 Volunteer who singed on informed consent documents Past history of surgical procedure experience related to BPH Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time Past history of taking alpha blocker within 2 weeks before screening Past history of acute urinary retention within 3 months before screening Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy) Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture) Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.) Unstable and significant medical condition including below Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-999.0, Study Focus: Prescribing of Drugs Professionally active GPs of all Belgian primary care practices that have received a visit before by Farmaka and are located in the regions where academic detailers are currently active. No age or gender restrictions GPs who are not professionally active (anymore) in a practice located in a region were an academic detailer operates in the period of the visits on analgesics; GP's who have never received an academic detailing visit before
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Red Blood Cell Donation Males and Females ≥ 18 years of age Males ≥ 130 pounds, Females ≥ 150 pounds Males ≥ 5 feet, 1 inch, Females ≥ 5 feet, 3 inches Hemoglobin ≥ 13.3 g/dL Hematocrit ≥ 40% Donor Meets all as per sites' Research Blood Donation Record, Prior donation date (i.e. not less than 112 days for most recent double RBC unit donation, 56 days for most recent single RBC unit donation) Subject must provide informed consent using an IRB informed consent form prior to undergoing any study related procedures will be not fulfilling any of the criteria
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-79.0, Benign Prostatic Hyperplasia Patient is age 50 to 79, inclusive 2. Patient has signed informed consent 3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment 4. Patient has a baseline IPSS Score > 13 at baseline 5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI 6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused 7. Patient must be a candidate for TURP 8. Patient must meet ONE of the following Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required) Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no prostate biopsy required) Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy) Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) Active urinary tract infection 2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study Patients with digital rectal examination (DRE) findings suspicious for prostate cancer Patients with baseline PSA levels > 10 ng/mL Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc) 4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition 5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern • Dosage of these medications should not change during study participation unless medically necessary 6. Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern 7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern 8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate 9. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. 10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment 11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc) 12. Patient has an asymmetric prostate, with > 20% difference in size between lobes 13. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months 14. Baseline serum creatinine level > 1.8 mg/dl 15. Known upper tract renal disease 16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment 17. Active prostatitis 18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease 19. History of pelvic irradiation or radical pelvic surgery 20. Patient is interested in future fertility 21. Coagulation disturbances not normalized by medical treatment 22. Acute urinary retention requiring an indwelling catheter 23. Known major iliac arterial occlusive disease 24. Allergy to iodinated contrast agents 25. Hypersensitivity to gelatin products
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Predominant Storage Symptoms The following subjects can be included in this study if they answer the following they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC) Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator IPSS storage sub-score > 8 Subject expected to require at least 3 months treatment with solifenacin Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis) History of bladder obstruction not being adequately corrected Anticipate or plan to participate in another study during study period of 12 weeks from study entry
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-90.0, Lower Urinary Tract Symptoms men over 18 years old; 2. provide signed informed consent; 3. existence of lower urinary tract symptoms 4. agree not to use any lower urinary tract symptoms treatment at least one month; 5. suitable for receiving EECP treatment history of long drug abuse; 2. pelvic, spine, brain trauma or surgery; 3. endocrine, liver, lung, kidney disease, malignancies, hematological disorders; 4. Severe infection without effective control； 5. lower limbs deep vein thrombosis； 6. Large area of ulcerative rash； 7. unsuitable for receiving EECP treatment
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-17.0, Vitamin D Deficiency Thoracic Surgery Pediatric Disorders Heart Defects, Congenital Newborn (corrected gestational age between 36 weeks) up to 18 years Has CHD that will require surgery within the next 12 months CHD requiring surgical intervention with cardiopulmonary bypass Born at less than 32 weeks gestational age Corrected gestational age of less than 36 weeks Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery Patient has confirmed or suspected Williams syndrome Proposed surgery to take place at another centre (outside of CHEO)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-80.0, Laryngopharyngeal Reflux Oesophageal pH-impedance age : 18 to 80 years old Written consent Laryngopharyngeal symptoms (dysphonia, and/or globus and/or sensation, and/or pharyngeal pain, and/or cough) for 3 months at least No PPI for at least 15 days Social security affiliation Sinusitis or chronic rhinitis (in the previous year) Laryngeal trauma, tracheotomy or pharyngolaryngeal surgery pregnancy or absence of efficacy contraception breast feeding history of gastrointestinal pathology, diabetes, neurological condition cardio-vascular history requiring the taking of Plavix esomeprazole contraindication or intolerance
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-60.0, Congestive Processes Of The Pelvic Organs (Prostatostasis) Erectile Dysfunction Sexual Function Age 20-60 years Symptoms of prostatostasis lasting for at least 3 months during the past 6 months Pathological changes on uroflowmetry (maximum flow rate of less than 15 ml / s, average urinary flow rate of less than 12 ml / sec) TRUS Prostate volume more than 22 ml at TRUS TRUS picture of Prostatostasis I-PSS 7-20 IIEF-5) Contraindications and limitations to use of the drug Raylis listed in the instructions for medical use * Diabetes mellitus (type 1 and type 2, decompensation) Neurogenic disorders (acute cerebral circulatory disorders, Alzheimer's disease, spinal cord injury) A history of pelvic trauma Patients who had undergone radical prostatectomy and other surgical interventions on the pelvic organs Concomitant use of supplements to improve the erectile function, use of the anti-androgens, anti-depressants, finasteride Diagnosed BPH Current participation in a clinical trial and / or study medication for 30 days prior to Any form of substance abuse, mental disorder or condition which, in the opinion of the investigator, may complicate communication with the researcher The inability or unwillingness to comply with the scheme of visits according to protocol
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) Diagnosis of BPH and eligible for endoscopic BPH surgery including TURP, PVP, electrovaporization. 2. Prostate volumes 30 gm based on transrectal ultrasound 3. Men ≥ 50 years of age 4. IPSS symptom score ≥ 13 and IPSS bother score > 2 (see Appendix B for IPSS questionnaire) 5. Baseline peak flow rate Qmax ≤ 15 cc/s with voided volume at least 125 cc History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine > 1.4) 2. Neurogenic bladder, Parkinson's disease 3. Prior treatment for urinary incontinence 4. Micturition frequency AND urgency. Micturition frequency defined as > 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // < 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs > 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?" 5. Intravesical prostate lobe protrusion > 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe 6. Active UTI (i.e. must have a screening urinalysis without signs of infection or a negative urine culture) 7. PVR > 250 at time of enrollment or catheter dependent bladder drainage 8. History of chronic prostatitis within the last 5 years 9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment 10. History of known bleeding disorders (e.g. von Willebrand disease [VWD]) and subjects determined to have a bleeding disorder by prothrombin time (PT) and partial thromboplastin time (PTT) tests. 11. Prior BPH prostate procedures (e.g. TUMT, TUNA, water induced thermotherapy [WIT], TURP, PVP) 12. Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA > 10 ng/mL. Men with free PSA < 25% and PSA between 2.5 and 10 ng/mL may only be enrolled after a negative biopsy. If a prior prostate biopsy was performed within one year of enrollment and was negative for cancer, repeat biopsy is not required if in the investigator's judgment there is no clinical evidence to support biopsy reassessment. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is otherwise deemed eligible to participate in the study. 13. Men interested in future fertility 14. Declines or unable to provide informed consent 15. Non-English-speaker 16. Life expectancy estimated to be less than one year 17. Unable or unwilling to complete all required questionnaires and follow-up assessments 18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptom Male subjects > 50 years of age who have symptomatic BPH. 2. International Prostate Symptom Score (IPSS) score ≥ 13. 3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml. 4. Post-void residual (PVR) ≤250 ml. 5. Prostate volume > 30 and ≤ 80 gm History of clinically significant congestive heart failure (i.e. NYHA Class III and IV). 2. History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is <8.0% are allowed. 3. History of significant respiratory disease where hospitalization for the disease is required. 4. History of immunosuppressive conditions (e.g., AIDS, post-transplant). 5. Cardiac arrhythmias that are not controlled by medication or medical device. 6. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. 7. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. 8. Presence of a penile implant or stent(s) in the urethra or prostate. 9. Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate. 10. Currently enrolled in any other pre-approval investigational study in the USA (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)). 11. History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable. 12. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. 13. Previous pelvic irradiation or radical pelvic surgery. 14. Diagnosed with active Lyme Disease (borreliosis). 15. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment. 16. Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery. 17. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. 18. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months. 19. Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years. 20. Active or history of epididymitis within the past 3 months. 21. Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function. 22. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function. 23. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device. 24. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months. Stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible. 25. Post-void residual (PVR) > 250 ml. 26. Diagnosed or suspected bleeding disorder, or coagulopathies. 27. Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment. 28. Visible hematuria with subject urine sample without a known contributing factor. 29. Subject interested in maintaining fertility. 30. Use of beta-blockers, anticonvulsants, and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months). 31. At the time of baseline assessment, in the absence of a qualifying exception, subjects who are using or have used the following medications, and are unable or unwilling to discontinue using these medications for the prescribed washout period: 1. Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes). 2. Use of the alpha blockers for BPH and anticholinergics or cholinergics (except for topical anti cholinergic eye drops), or within 4 weeks of baseline assessment. 3. Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment. 4. Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment. 5. Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment. 6. Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment. 32. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter six months prior to baseline. A provoked episode now resolved is still admissible. 33. Compromised renal function defined as serum creatinine > 2.0 mg/dl. 34. Inability to provide a legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 35. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia History of LUTS for ≥6 months secondary to BPH Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer Be willing/able to adhere to the prohibitions and restrictions specified in this protocol 2. Have signed an informed consent document indicating that the subjects understand the purpose of and procedures required for the study and are willing to participate in the study 3. Written Authorization for Use and Release of Health and Research Study Information has been obtained. 4. Male age >/=18 years. 5. Histologically or cytologically confirmed adenocarcinoma of the prostate with no histological variants (such as small cell, sarcomatoid, pure ductal cancer, transitional cell carcinoma). 6. Pathology review at treating academic institution or member institution (Note: if patient's prostate biopsy was not read at the treating institution, it must be reviewed at the study site to confirm eligibility). 7. At least three core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements. Patients must have a Gleason score > 5 (total). 8. At least one of the following features: a) PSA > 10 ng/ml; b) PSA velocity > 2 ng/ml/year (defined as a rise in PSA of > 2 ng/ml in the preceding 12 month period); c) Gleason score >/= 7; d) Gleason score 6 if either PSA >/= 10 ng/ml or PSA velocity >/=2 ng/ml/year 9. Serum testosterone >200 ng/dL. For patients treated with up to 1 month of LHRH agonist, a testosterone measurement prior to the LHRH treatment will be used to determine and must have been > 200 ng/dL. 10. Urologist must agree that patient is suitable for prostatectomy. 11. No evidence of metastatic disease as determined by imaging procedures. 12. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 13. Hemoglobin >/= 10.0 g/dL independent of transfusion. 14. Platelet count >/=100,000/µL. 15. Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) >/= 1,500. 16. Creatinine clearance >/= 60 mL/min 17. Serum potassium >/= 3.5 mmol/L. 18. Serum albumin >/= 3.5 g/dL. 19. Liver function test with serum bilirubin </= 1.5x upper limit of normal (ULN) and ALT and AST </= 1.5x ULN. 20. Able to swallow the study drug whole as a tablet. 21. Patients must have normal coagulation profile and no history of substantial non- iatrogenic bleeding diathesis. 22. Agree to use a double-barrier method of contraception which involves the use of a condom in combination with one of the following: contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam, if having sex with a woman of child-bearing potential during the length of the study and for one week after abiraterone is discontinued and for at least three months after enzalutamide is discontinued. 23. Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection. 2. Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular BP results at the time of assessment for nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. 3. Requirement for corticosteroids greater than the equivalent of 5 mg of prednisone daily. 4. Poorly controlled diabetes defined by Hemoglobin A1C > 7.0 at screening. 5. Active or symptomatic viral hepatitis or chronic liver disease. 6. History of pituitary or adrenal dysfunction. 7. Clinically significant cardiovascular disease including: a) Myocardial infarction within 6 months of Screening visit; b) Uncontrolled angina within 3 months of Screening visit; c) Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months of the Screening visit results in a left ventricular ejection fraction that is >/= 50%; d) History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes); e) Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening Electrocardiogram (ECG) > 470 msec; f) History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; 8. (Exclusion #7 continued): g) Hypotension (systolic blood pressure < 86 mmHg or bradycardia with a heart rate of <50 beats per minute on the Screening ECG, unless pharmaceutically induced and thus reversible (i.e. beta blockers). 9. Other malignancy, except non-melanoma skin cancer, that is active or has a >/= 30% probability of recurrence within 12 months. 10. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug. 11. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH agonists/antagonists (*Note: LHRH allowed if begun within 1 month of Day 1). Patients having previous or current antiandrogen treatment of greater than 4 weeks in duration prior to Cycle 1 Day 1 are eligible with appropriate washout. 12. Prior systemic treatment with an azole drug within four weeks of Cycle 1 Day1. 13. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1. 14. Allergies, hypersensitivity, or intolerance to prednisone, LHRH analog or excipients of prednisone LHRH analog, and abiraterone acetate and enzalutamide. 15. Previous use of abiraterone acetate or other investigational CYP17 inhibitor (e.g., TAK-700). 16. Previous investigational antiandrogens (e.g., Enzalutamide, BMS-641988). 17. Patients receiving anti-coagulant therapy who are unable to stop prior to surgery. 18. Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study. 19. Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV). 20. Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing potential causes of death (such as but not limited to, unstable angina, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled hypertension). 21. Prior chemotherapy, radiation or immune therapy for prostate cancer. 22. Patients unable to tolerate transrectal ultrasound. 23. Concomitant therapy with any of the following: a) Chemotherapeutic, biologic, or other agents with anti-tumor activity against prostate cancer other than assigned study drug; b) Anti-androgens (steroidal or non-steroidal) such as cyproterone acetate, flutamide, nilutamide, bicalutamide, etc. other than assigned study drug; c) 5-alpha reductase inhibitors such as finasteride, dutasteride, anabolic steroids, etc.; d) Estrogens, progestational agents such as megestrol, medroxyprogesterone, DES, cyproterone, spironolactone > 50 mg/kg, etc.; e) Androgens such as testosterone, dehydroepiandrosterone [DHEA], etc.; f) Ketoconazole; g) Herbal products that may decrease PSA levels (e.g., saw palmetto) 24. Active infection or other medical condition that would make prednisone/ prednisolone (corticosteroid) use contraindicated. 25. Severe hepatic impairment (Child-Pugh Class C). 26. History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit). 27. History of significant bleeding disorder unrelated to cancer, including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease); b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of Screening visit; c) History of GI bleeding within 6 months of Screening visit
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer Men at risk of PCa scheduled for first biopsy with serum total PSA ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago Signed informed consent Previous prostate biopsy Confirmed PCa PSA > 20 ng/ml (or > 10 ng/mL if taking 5-alpha reductase inhibitors) Active urinary tract infection Presence/history of any confirmed cancer Recent prostatic surgery (past 6 months) History of pelvic radiotherapy
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Age ≥50 years Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months IPSS ≥15 Maximum urine flow (Qmax) of 5 mL/sec Prostate volume of 30 mL as determined by TRUS Serum prostate-specific antigen (PSA) values <10 ng/mL Post-void residual (PVR) <= 200 mL Inability to void ≥125 mL urine Prior surgery/MIST for BPH Presence of or history of certain conditions that could interfere with study results or endanger subject Use of certain prescribed medications that could interfere with study results
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Erectile Dysfunction Benign Prostatic Hyperplasia Men ≥ 45 years of age. 2. Sexually active, with a stable female partner with whom the participant expects to have a relationship for the entire duration of the study. 3. The participant has benign prostatic hyperplasia with lower urinary tract symptoms (BPH-LUTS) according to clinical diagnostic with ≥ 6 months of evolution at the screening visit. 4. Clinical history of erectile dysfunction (ED) (defined as the inability to achieve or maintain the penile erection to achieve a satisfactory sexual relationship) of at least 3 months of evolution. 5. Freely given informed consent at the screening visit (an essential requirement to participate in the study). 6. Bladder obstruction defined by maximal flow rate (Qmax) of 4-15 mI/sec (with a premicturition volume of 150 to 550 mL evaluated by ultrasound, with a minimum micturition volume of 125 mL) at Visit I immediately prior to active treatment initiation. 7. Total score of ≥ 13 points in the InternationaI Prostate Symptom Score (IPSS) questionnaire at Visit 1, immediately prior to active treatment initiation Participants that are currently taking nitrates, antiandrogens, estrogens, luteninizing hormone-releasing hormone agonist/antagonist, or anabolic steroids at study entry. Participants that are taking a stable dose level of testosterone are not excluded. 2. Post-void residual (PVR) volume ≥ 300 mL, as assessed by ultrasound at the Visit 1. 3. Prostate-specific antigen (PSA) ≥ 10.0 ng/mL at the Visit 1. 4. PSA of 4.0 0 ng/ml if free PSA is < 0,25 (25%) at Visit 1. 5. Clinical evidence of prostate cancer. 6. Glycosylated hemoglobin (Hb1Ac) > 10 % at study entry. 7. Patients who have undergone bladder catheterization due to acute urine retention. 8. Medical history or clinical evidence of any pelvic, bladder or urinary tract condition, or urinary retention that, as judged by the urologist, might compromise protocol compliance. 9. Any surgical procedure in the lower urinary tract (including prostate biopsy) within 30 days prior to the Screening Visit
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Osteoarthritis, Knee Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study Partial or total replacement of either knee joint, past or planned/expected during study duration. 2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Urinary Symptoms Systemic Sclerosis Adult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F) Those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-60.0, Whiplash Symptoms The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year They should be in the age group 18 to 60 years have been actively working up until the accident should not have had previous neck pain All patients should have had a plain X-ray and an MRI showing no specific changes The patients should present with pronounced neck pain with the origin in the midline The character of the pain should be dull, aching, and, with sudden movements, stabbing in the same area Palpation and pressure in that area should provoke deep pain Previous pain in the neck, previous surgery
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Signed informed consent Age 45 or older Medical history of LUTS/BPH Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks LUTS/BPH not adequately controlled by medical therapy with α-blockers Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week run-in period with tamsulosin 0.4 mg QD) Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS) Qmax < 15 mL/sec based on a minimum void of 125 mL Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study Agree to perform follow-up visits even in case of oral treatment discontinuation before study end Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy Prostate or bladder cancer, history of pelvic irradiation Active or recurrent urinary tract infections (more than 1 episode in the last 12 months) History of neurogenic bladder or LUTS secondary to neurologic disease Use of self-catheterization for urinary retention Post-void residual urine volume > 200 mL Haematuria which has not been appropriately evaluated to determine safe subject participation Renal insufficiency (serum creatinine >2.0 mg/dL)
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-79.0, Vascular Aging 79 years of age Ability to provide informed consent Score greater than 22 on the mini mental state exam Blood pressure greater than 100/60 mmHg for past 3 months Are taking any of the following medications/drugs: hormone replacement therapy, anti-hypertensives, nitrates, nervous system depressants, allopurinol, phosphodiesterase-5 inhibitors, blood thinners Are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or unstable cardiovascular disease Are hypersensitive to nitrates or nitrites Have glucose-6-phosphate dehydrogenase deficiency Have blood methemoglobin greater than 2% Have a BMI greater than 40 kg/m^2 Have a baseline FMD of greater than 6% Have not been post-menopausal for at least 1 year Perform regular vigorous aerobic/endurance exercise
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.083-16.0, Sepsis Bacteraemia Meningitis Abscess Pneumonia Osteomyelitis Cellulitis Gastro-enteritis With Dehydration Complicated Urinary Tract Infection Viral Respiratory Infection Complicated With Hypoxia Patients aged 1 month to 16 years with an acute illness for a maximum of 5 days are included consecutively Children are excluded if the acute episode was caused by a merely traumatic or neurological illness, intoxication, psychiatric or behavioural problem without somatic cause, or an exacerbation of a known chronic condition. If a physician includes children twice in the study within 5 days, the second registration is considered a repeated measurement on the same subject and is subsequently excluded from the analysis
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia (BPH) Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment Ability to understand and the willingness to sign a written informed consent Prostate volumes 40 gm. May 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months Men ≥ 45 years of age IPSS symptom score > 13 and IPSS bother score > 2 Peak flow rate Qmax≤ 12 with voided volume ≥125 cc History of prostate or bladder cancer, pelvic radiation, untreated bladder stones On alpha-blockers within the past 2 weeks unless on a stable dose of medication, with a stable urination pattern for 2 weeks prior to enrollment, and the willingness to stay on the same dose for the duration of the study, or until stopping is met at the 12 month f/u visit, and or/part of a trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR) On 5-alpha reductase inhibitors within the past 6 months unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping is met at the 12 month f/u visit On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping is met at the 12 month f/u visit On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study Daily use of a pad or device for incontinence required Urethral strictures, renal insufficiency (i.e. creatinine > 1.8) Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function Neurogenic bladder, Hypotonic Bladder Prior treatment for urinary incontinence
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-75.0, Prostatic Diseases Men who be referred a new urological outpatient and satisfy the following Wanted examined because of elevated PSA Not strong family history of prostate cancer It is taken biopsy as part of routine investigation. 2. Control group: Men referred to urological outpatient clinic, and who satisfy the following urination complaints Normal PSA examination shows prostate size> 40cc 3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following - symptoms that might indicate cancer suspicion in colorectum 4. Age> 40 years and <75 years known prostate cancer 2. Reduced consent 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-74.0, Benign Prostate Hyperplasia dysuria associated with BPH for at least 12 weeks before providing consent a total IPSS core of 13 or higher a QOL score of 3 or higher a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec a prostate volume of ≥20 mL A postvoid residual volume (PVR) of >350 mL A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study A cataract operation scheduled to be performed during the study period Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study Hypersensitivity to ASP4901 or tamsulosin hydrochloride Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-90.0, Lower Urinary Tract Symptoms Men seeking treatment for lower urinary tract symptoms none
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Benign Genital Diseases, Male Lower Urinary Tract Symptoms Prostatic Diseases Male patients ≥ 45 years-old Diagnosis of BPH based on clinical history, digital rectal examination, urine sediment, transrectal prostate ultrasound and PSA Use of a marketed alpha-blocker for LUTS/BPH in the previous 6 months Severe lower urinary tract symptoms at screening and baseline defined by all the following: IPSS (7 items) ≥ 20, QoL ≥ 3, Qmax < 12 mL/s and prostate volume ≥ 40 mL CTA shows that prostatic arteries are feasible for PAE Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment Written informed consent Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months History of prostate or bladder cancer or pelvic irradiation Active or recurrent urinary tract infections (more than 1 episode in the last 12 months) History of neurogenic bladder or LUTS secondary to neurological disease Advanced atherosclerosis and tortuosity of iliac and prostatic arteries Secondary renal insufficiency (due to prostatic obstruction) Large bladder diverticula or stones Detrusor failure Previous history of acute urinary retention
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-75.0, Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; 2. age≥18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier, 10. willingness to provide written informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-85.0, Benign Prostatic Hyperplasia (BPH) Male subject Between 45 and 85 years old Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream Subject naive to any prior treatment for LUTS due to BPH Prostate enlargement at digital rectal examination (DRE) suggestive of BPH I-PSS > 12 at enrolment visit and at visit QoL I-PSS score ≥ 3 evaluated at enrolment visit and at visit Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or or recurrent urinary tract infection, stone in bladder or urethra) Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus Known severe renal insufficiency or creatinine clearance < 30 ml/mn Known liver insufficiency or clinically significant abnormal liver function tests History of, or concomitant, cardiac arrhythmia or angina pectoris Orthostatic hypotension at enrolment or visit Known hypersensitivity to one of the constituents of the study drugs Is participating in another clinical trial
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-60.0, Diabetes Mellitus Type 1 UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV & HIV by PCR test before enrollment in the study and positivity for any of these parameters means of this patient from the study
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 30.0-65.0, Type 2 Diabetes Insulin Resistance High Insulin Requirements Type 2 diabetes Ages 30-65 years A1c between 7-9.5% within the past month On >100 units of insulin per day Willing to discontinue oral/injectable non-insulin hypoglycemic agents for minimum of 1 week prior to study Willing to avoid exercise 48 hours prior to study Willing to be fasting for up to 24 hours BMI between 25 and 38 kg/m2 • On systemic corticosteroids in preceding 3 months Heavy alcohol consumption (>21 drinks/week men, >14 drinks/week women) Unwillingness to stop alcohol consumption for 24 hours before each study visit Pregnant or actively trying to conceive Current diagnosis of active infection, cancer (other than basal cell carcinoma), vascular disease, organ failure Current transplant recipient
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-85.0, Benign Prostatic Hyperplasia Patient is aged 50-85 years Patient has signed informed consent Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS) Patient has an IPSS score greater than or equal to 13 Patient has a peak urine flow rate < 12 mL/sec Patient either Refuses surgical treatment Is considered high risk for surgical treatment Patient is either History of prostate or bladder cancer, or currently being evaluated for cancer History of prostate or bladder cancer, or currently being evaluated for cancer Patient has taken alpha blockers within 4 weeks of screening Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer History of open prostate surgery, radiofrequency, or microwave therapy Previous open bladder or rectosigmoid colon surgery TURP within the last two years Patient has nodularity or induration detected upon digital rectal examination (DRE) Neurogenic bladder or other neurological disorder impacting bladder function Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lymphoma, Non-Hodgkin Lymphoma Histologically-confirmed B-cell non-Hodgkin's lymphoma (Mantle Cell Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Diffuse Large B-cell Lymphoma, and Lymphoplasmacytic Lymphoma) Must have relapsed or refractory disease after 2 or more prior lines of therapy; 1 line of therapy is allowed, if it included an autologous stem cell transplant and at least 12 weeks have elapsed from Day 0. A line of therapy is defined as a course of therapy that is not interrupted by progressive disease Subjects must have measurable disease of at least 1.5 cm in diameter Age ≥ 18 years Life expectancy ≥ 3 months Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. FCBP definition: A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months Male subjects must agree to practice contraception for at least 90 days after the last dose of carfilzomib, and must agree not to donate sperm for at least 90 days after the last dose of carfilzomib Adequate bone marrow function Absolute neutrophil count ≥ 1.0 × 10^9/L Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior Cycle 1, Day 1 (subjects may be receiving red blood cell (RBC) transfusions in accordance with institutional guidelines) Progressive disease on bendamustine within 6 months of cycle 1, Day 1 Prior treatment with carfilzomib for lymphoma Patient has received other investigational drugs within 21 days prior to Cycle 1, Day 1. Exceptions allowed if greater than four half-lives of the experimental agent ) Prior radiation therapy or chemotherapy within 2 weeks prior Cycle 1, Day 1, monoclonal antibody therapy within 4 weeks Prior allogeneic transplant Active, uncontrolled central nervous system (CNS) involvement by lymphoma Pregnant or lactating females Major surgery within 14 days prior Cycle 1, Day 1 Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior Cycle 1, Day 1 Known human immunodeficiency virus infection
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-99.0, Prostatic Neoplasms Prostate Cancer Subject is greater than or equal to18 years old Platelet count > 50,000/mm^3 Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2 Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed Categories ARM 1 only ---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging ARM 2 only For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir For patients status post prostatectomy, a PSA >/=0.2 ng/ml Nonspecific or no evidence for disease on standard imaging modality Subjects for whom participating would significantly delay the scheduled standard of care therapy Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results Subjects with severe claustrophobia unresponsive to oral anxiolytics Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry Serum creatinine > 2 times the upper limit of normal Total bilirubin > 2 times the upper limit of normal Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Voiding Dysfunction Benign Prostate Obstruction Detrusor Underactivity "UPSTREAM Phase I" Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may surgery unable to pass urine without a catheter (urinary retention) relevant neurological disease, such as a stroke undergoing treatment for prostate or bladder cancer previously had prostate surgery not medically fit for surgery, or are unable to complete outcome assessments do not consent to be assigned at random to one of the pathways "UPSTREAM Phase II": PROMS (questionnaire) study component: Men randomised (enrolled) to the trial (Phase I) who were willing to be contacted for long term follow up, as indicated on their original (Phase I) consent form. NHS Digital data extraction study component: Men randomised (enrolled) to the trial (Phase I) PROMS (questionnaire) study component: 1. Patients who are not already randomised (enrolled) to the trial (Phase I) 2. (Phase I) participants who: 2.1. are not willing to be contacted about long term follow up 2.2. have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3. do not consent and/or are not willing or able to comply with essential study procedures of this further follow up (UPSTREAM Phase II) NHS Digital data extraction study component: 1. Patients who are not already randomised (enrolled) to the trial (Phase I) 2. (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their 18-month timepoint
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Pain men aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), inability to cooperate with pain assessment due to mental disorders
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2
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