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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, Localised Prostate Cancer Locally Advanced Prostate Cancer Locally Recurrent Prostate Cancer Benign Prostatic Hyperplasia Shared for all groups Language spoken: Finnish, English or Swedish Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Potential prostate biopsies obtained > 6 weeks before HIFU/TULSA-PRO treatment (or at the discretion of PI) Eligible for MRI Eligible for spinal or general anesthesia (ASA 3 or less) Succession of urethral catheterization/Patency of prostatic urethra confirmed if needed with pre-HIFU cystoscopy Group-specific Group 1. Localized PC prior to RP All localized PC patients planned for robot assisted laparoscopic prostatectomy (RALP) with normal standards of care are eligible for this study (EAU guidelines) MRI-visible biopsy proven PC (biopsies obtained < 6 months before treatment) Group 2. Locally symptomatic locally advanced and/or metastatic prostate cancer in need of palliative surgical intervention for all groups Prostate calcifications >1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI Prostate cysts >1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI History of chronic inflammatory conditions (e.g. inflammatory bowel disease) affecting rectum (also includes rectal fistula and anal/rectal stenosis) Contraindications for MRI (cardiac pacemaker, intracranial clips etc.) Uncontrolled serious infection Claustrophobia Hip replacement surgery or other metal in the pelvic area Severe kidney failure (glomerular filtration rate (GFR) <30ml/min/1.73m2) usage of gadolinium in contrast-enhanced imaging unless justifiable based on the clinical judgment of the responsible radiologist and/or urologist Known allergy to gadolinium
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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, BPH Male 2. Age > 40 3. Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA) 4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects 5. Moderate to severe LUTS as defined by IPSS score >18 6. Peak urine flow rate (Qmax) <12 mL/sec 7. Capable of giving informed consent 8. Life expectancy greater than 1 year Severe vascular disease 2. Uncontrolled diabetes mellitus 3. Immunosuppression 4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. 5. Complete urinary retention 6. Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis. 7. Confirmed or suspected bladder cancer 8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology 9. Ongoing urogenital infection 10. Previous pelvic radiation or radical pelvic surgery 11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (> 10 ng/mL or > 4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy). 12. Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000 13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
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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, Acute Respiratory Tract Infection Urinary Tract Infections Primary care physicians in Switzerland board certified with FMH (Foederatio Medicorum Helveticorum) title in general internal medicine or paediatrics & adolescent medicine, above the 25th percentile of antibiotic prescribing, consulting with at least 100 patients per year and with individual Zahlstellenregister number There are no
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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 Infection All patient at ICU Diagnosed nosocomial infection Patients exist already infected before admission at hospital
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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, Red Cell Survival in Healthy Volunteers Subject Up to 12 subjects will be enrolled for a maximum of 6 eligible subjects in the pilot study to provide preliminary RBC survival data to support a subsequent adequately powered study capable of addressing the two objectives as stated above Age ≥18 years, of either gender Normal health status (as determined by the Investigator review of medical history and blood donor physical exam) Weight over 140 lbs Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST,total bilirubin, BUN, creatinine). Values outside of normal reference range if considered not to be clinically significant may be allowed with a protocol exception Minimum hemoglobin levels of 13 g/dL for female and 14 g/dL for male subjects Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, WNV and Zika virus Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods Meet or exceed AABB guidelines for blood donation (with the exception of travel deferrals) Clinically significant acute or chronic disease (as determined by the Investigator) History of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies or autoimmune disease History of congenital red cell disorders including glucose-6-phosphate dehydrogenase (G6PD) deficiency Positive Direct (DAT) and Indirect antiglobulin test (IAT)at study entry Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days Treatment with any medication known to affect RBC viability Pregnant or nursing female Male subjects or female subjects of childbearing potential not using effective contraception Participation in another clinical study currently or within the past 28 days Prior exposure to treated or BioRBCs
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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 Male, 45 years or older. 2. The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc. 3. All participants have signed the informed consent form. 4. Clinical data comes from 23 selected hospitals spread across China Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 2. Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor. 3. Known neurogenic or congenital lower urinary tract dysfunction. 4. Known urinary tract, prostate or pelvic surgical history. 5. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 6. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 7. Patients with poor compliance or cognitive competence
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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, BPH Subject signed informed consent prior to the performance of any study procedures Male with symptomatic BPH: IPSS symptom severity score ≥ 10 Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc Prostate volume 25 ml to 80 ml (as assessed by TRUS) Subject that is able to complete the study protocol Normal Urinalysis and urine culture Previous prostate surgery Prostate cancer Urethral stricture Bladder stones An active urinary tract infection Obstructing median lobe demonstrated by IPP grade 3 (>1 cm) as assessed by TRUS Neurological conditions potentially affecting voiding function A post void residual (PVR) volume > 250 ml measured by ultrasound Previous diagnosis or treatment for Over Active Bladder Acute Urinary Retention
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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 Benign Prostatic Hypertrophy Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy 2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH) 3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml 4. Post-void residual (PVR) ≤ 250 ml 5. Prostate volume 20 gm as determined by TRUS 6. Prostatic urethra length is 35 mm as determined by TRUS 7. Able to complete the study protocol in the opinion of the investigator Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment 2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential 3. Presence of a penile implant or stent(s) in the urethra or prostate 4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate 5. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy 6. Confirmed or suspected malignancy of prostate or bladder 7. Active or history of epididymitis within the past 3 months 8. Previous pelvic irradiation or radical pelvic surgery 9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen) 10. Visible hematuria with subject urine sample without known contributing factor 11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function 12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms 13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes) 14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment 15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment 16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment 17. Post-void residual volume > 250 ml or catheter dependent bladder drainage 18. Overactive bladder (OAB) or urge incontinence 19. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec) 20. Current bladder stones or prostatic calculi 21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure 22. History of cancer in non-genitourinary system which 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 23. History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion 24. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires 25. Expected life expectancy < one year 26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements 27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study 28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study 29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel) 30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study 31. Device that corresponds with the subject's prostate size per the IFU is not available 32. Intravesical prostatic protrusion (IPP) > 1 cm 33. Current uncontrolled diabetes (hemoglobin A1c > 7%) 34. Unable or unwilling to provide all the protocol-required semen samples 35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel
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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, Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Leukemia Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorder Non Hodgkin Lymphoma Hodgkin Lymphoma Leukemia I. Acute myelogenous leukemia (AML) Complete first remission (CR1) at high risk for relapse such as any of the following Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder Therapy-related AML White cell count at presentation > 100,000 Presence of extramedullary leukemia at diagnosis Any unfavorable subtype by FAB or WHO classification High-risk cytogenetics (e.g. those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) or high risk molecular abnormalities Requirement for 2 or more induction to achieve CR1 Any patient with newly diagnosed AML with intermediate risk cytogenetics who elects allograft with curative intent over consolidation chemotherapy Indolent NHL or Hodgkin lymphoma with POD after most recent salvage chemotherapy Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis Any diagnosis without prior immunosuppressive chemotherapy within 3 months of intended admission for transplant Prior checkpoint inhibitors/ blockade in the last 12 months Two prior stem cell transplants of any kind One prior autologous stem cell transplant within the preceding 12 months One prior allogeneic stem cell transplant within the preceding 24 months Prior radiation therapy with 400cGy or more of TBI Active and uncontrolled infection at time of transplantation HIV infection
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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 Male, 45 years or older. 2. The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc. 3. Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study. 4. The presence of bladder outlet obstruction during pressure-flow study. 5. International Prostatic Symptom Score (IPSS) ≥ 12 at screening. 6. Prostate volume ≥ 30 ml (using a transrectal ultrasound approach). 7. Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening. 8. Subject is able to communicate and complete the questionnaires properly. 9. Written informed consent Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor. 2. Patients with arrhythmia or history of cardiac pacemaker implantation. 3. Known lower urinary tract or pelvic surgical history. 4. Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 5. Known neurogenic or congenital lower urinary tract dysfunction. 6. Rigid or flexible cystoscopy examination within the past 7 days at screening. 7. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 8. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 9. Patients with poor compliance or cognitive competence
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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, Prostate Cancer Bladder Outlet Obstruction Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c) PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding IPSS at baseline ≥ 8 Witten informed consent Curative treatment of PCA intended Contraindications for MRI Renal impairment (GFR < 30ml/min) Allergy to i.v. contrast medium Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE
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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 Step 1 Male 18 years and older Voluntary signed informed consents of the patient before any study-specific procedure Histologically confirmed prostate adenocarcinoma Presence of bone and/or soft-tissue and/or visceral metastases through CT scan, MRI, scintigraphy scan Progressive disease assessed by PSA, CT scan, MRI or bone scan according to the PCGW3 PSA progression is defined as a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir, which is confirmed by a second value obtained 1 or more weeks later. Bone scan: at least two or more new lesions are seen on bone scan compared with a prior scan Patient with no or moderate symptoms (no need for continuous opioid treatment) Effective castration confirmed by testosterone plasma level < 50 ng/dL ECOG performance status: 0-2 Life expectancy > 3 months Step 1 Pure small cell carcinoma of the prostate or predominant histology of neuro-endocrine carcinoma Confirmed brain and/or leptomeningeal metastases Previous treatment with docetaxel or any other anticancer treatment for castration-resistant prostate carcinoma (previous docetaxel for hormone-sensitive metastatic disease is allowed) Previous treatment with ABI or any other 17 B hydroxylase inhibitor or enzalutamide Treatment with first-generation antiandrogen (ciproterone acetate, bicalutamide, flutamide, nilutamide) performed on the day of baseline or within previous four weeks, due to possible anti-androgen withdrawal response. (This criterion does not apply for subjects, who have never responded to anti-androgen treatment) Patient co-morbidities Patients with the following hereditary diseases: galactose hypersensitivity, Lapp lactase deficiency Cirrhosis Child-Pugh B or C Active or symptomatic viral hepatitis
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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, Ketones Dietary Supplements Not taking any medications affecting glucose metabolism Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females) Diagnosed with diabetes Diagnosed with heart disease Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition) Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet Current consumption of ketone supplements Pregnant or planning to become pregnant during the study (if female)
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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, Direct Costs Excluding Capital Equipment Purchase Operator (Surgeon) Completed Questionnaire Operative Parameters (Time, Bleeding Etc) Complications (Post-op Retention, Bleeding, Re-admission to Hospital, Infection Etc) 3 Month Efficacy Evaluation (Compared to Baseline) Using Validated Symptom Assessment Tools (See Outcome Metrics for Details) Male at least 45 years of age Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml IPPS symptom score ≥ 12 at screening visit Prostate volume on DRE estimated to be > 30cc Voluntarily signed informed consent agreement prior to the performance of any study procedures Any prior invasive intervention for BPH PSA level greater than 10 ng/ml at screening without either a negative biopsy or documented explanation of why no biopsy was performed Medical condition unfit for surgery History or current evidence of carcinoma of the prostate Documented bacterial prostatitis within the past 3 months Known severe bleeding disorder Unable to follow protocol directions or sign informed consent due to organic brain or psychiatric disease History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol
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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): 18.0-72.0, Prostate Cancer Localized prostate cancer suitable for active surveillance 1. Histologically confirmed adenocarcinoma of the prostate, with Gleason Score 6 or less prostate cancer. No limit in the percentage of cancer in each core or percentage of positive cores. 2. Male, 18 years or older 3. Able to swallow the soft gelatin capsule form of the drug which is ~6mm long. 4. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0. 5. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). 6. ECOG Performance Status 0 or 1. 7. Patient has elected Active Surveillance as preferred management plan for prostate cancer. 8. Written informed consent obtained prior to any patient participation. 9. Participant is accessible and compliant for follow-up. 10. Prostate biopsy requirements: 1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores. 2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit. 11. Voiding requirements: IPSS score of at least 15 and Qmax < 15 cc/s. 12. Adequate hematopoietic function as demonstrated by hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions Platelet count ≥100,000 platelet/mm3 (100 x 109/L) White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC) ≥1.5 x109/L 13. Adequate hepatobiliary function as demonstrated by Total bilirubin level within normal limits Alanine aminotransferase (ALT) levels within normal limits Adequate renal function as demonstrated by creatinine level within normal limits or creatinine clearance within normal limits Coagulation profile (PT, PTT, INR and TCT) within normal limits 14. If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, partner use of diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of OMN54 Unwillingness or inability to undergo serial prostate biopsy or MRI. 2. History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years. 3. Previous surgical intervention for BPH 4. Active uncontrolled infection, including known history of HIV, hepatitis B or C 5. Concurrent uncontrolled hypertension 6. Congestive Heart Failure 7. Hepatic disease (cirrhosis, hepatitis, hepatocellular carcinoma or liver failure of unknown etiology) 8. Renal disease (glomerulonephritis, nephropathy, polycystic kidney disease) 9. Patients requiring new treatment of BPH (either medical or surgical) are not eligible. 10. Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption. 11. Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54); soy; any of the plants belonging to the Ganodermataceae family, e.g., reishi mushroom (Ganoderma lucidum, lingzhi); any plants belonging to Labiatae or Lamiaceae families, e.g., culinary herbs including basil, mint, rosemary, sage, savory, marjoram, oregano, thyme, lavender, and perilla; or Aneustat™ (OMN54) excipients. 12. Concurrent administration, or exposure within 30 days, of Investigational drugs and devices Chemotherapy Radiation therapy Immunotherapy
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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, Urethral Stricture Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty. 5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's). 6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present) 7. Lumen diameter ≤ 12F by urethrogram 8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present) 9. Guidewire must be able to cross the lesion Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture). 2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3. 3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment. 4. Previous urethroplasty within the anterior urethra 5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation) 6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 8. Diagnosis of untreated and unresolved BPH or BNC 9. Untreated stress urinary incontinence (SUI). 10. History of diagnosed radiation cystitis. 11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years 12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator. 13. Diagnosis of chronic renal failure and treatment with hemodialysis 14. New diagnosis of OAB (overactive bladder) within the last six (6) months 15. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.) 16. Dependence on Botox (onabotulinumtoxinA) in urinary system 17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate 18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO) 20. Previous hypospadias repair 21. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment 22. 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 23. Unwilling to use protected sex for thirty (30) days' post treatment 24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential. 25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed. 27. Current active infection in the urinary system 28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes 29. 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. 30. Visible hematuria in subject's urine sample without known contributing factor 31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment
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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 Bladder Outlet Obstruction Refractory LUTS (lower urinary tract symptoms) secondary to BPH benign prostate hyperplasia) I-PSS greater than 15 QOL score 3 or greater Qmax less than 15 ml per second or patients with acute urinary retention secondary to BPH in whom trial of voiding failed Prostate size on preoperative TRUS of 40 to 150 ml Patients with neurological disorder Active urinary tract infection, active bladder or prostate cancer
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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, Spasticity as Sequela of Stroke over 6 weeks after stroke onset MAS (modified Ashworth scale) greater than 2 in finger flexor neuromuscular junction disease or motor neuron disease phenol or alcohol block for the target limbs within 6 months before screening botulinum toxin injection within 3 months before screening history or plan for tendon lengthening surgery significant contracture ormuscle atrophy at the target joint or muscle concurrent treatment with intrathecal baclofen hypersensitivity or allergy to study drug or its components pregnancy or planned pregnancy, breastfeeding abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine
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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 Bladder, Overactive Lower Urinary Tract Symptoms Pelvic Pain Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology 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): 16.0-999.0, Lower Urinary Tract Symptoms Men aged 16 years and over Men who present to their GP with a complaint of one or more bothersome lower urinary tract symptoms (LUTS)# Men able and willing to give informed consent for participation in study Men able and willing to undergo all index tests and reference test, and complete study documentation This would men on current treatment, but who are still symptomatic Men with neurological disease or injury affecting lower urinary tract function Men with LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease Men with other contraindications to urodynamics e.g. Heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed Men with indwelling urinary catheters or who carry out intermittent self-catheterisation Men whose initial assessment suggests that clinical findings are suggestive of possible prostate or bladder cancer* recurrent or persistent symptomatic UTI** retention e.g. palpable bladder after voiding' Men unable to consent in English or Welsh where a suitable translator is not available. This is a multi-centre study based in primary care, and we cannot guarantee translation facilities at all sites According to standard NHS cancer pathways. If later deemed unlikely, then eligible for study participation
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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 Symptoms Benign Prostatic Hyperplasia All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG Patient age ≥ 18 years Informed consent provided -Cognitive impairment not allowing Informed Consent or adequate data assessment
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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, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Patient has signed informed consent Patient age is 18 years or older at time of informed consent Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Patient is unable or unwilling to provide follow-up information Patient is undergoing prostatic artery embolization for reasons that do not symptomatic benign prostatic hyperplasia with lower urinary tract symptoms Any other reason the investigator deems cause for
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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 Symptoms Erectile Dysfunction Obstructive Sleep Apneas Syndrom managed at the sleep unit at Reims University Hospital for the diagnosis of sleep apnea syndrome by nocturnal airway polygraphy or polysomnography major accepting participation in the study (signed non-opposition form) refusing to be included in the study minors not speaking French or not able to read (inability to complete the questionnaires specific to 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): 18.0-999.0, Overactive Bladder Male and female aged ≥18 years Patients persistent with OAB symptoms ≥3 months The patient able to complete the 3 days voiding diary correctly An average of ≥8 micturitions per 24 hours An average ≥1 urgency episode per 24 hours An average ≥1 nocturia episode per 24 hours Clinically significant stress or mixed urinary incontinence Abnormal detrusor activity with known neurological diseases Pregnant and lactating women or those who intended to become pregnant during the study Clinically significant bladder outflow obstruction (PVR >100ml), symptomatic urinary tract infection, bladder stones, diabetic neuropathy Significant hepatic, renal or other medical diseases Previous pelvic radiation therapy and malignant disease of the pelvic organs Patients with any condition that contraindicate the use of mirabegron or solifenacin medication (urinary retention, uncontrolled narrow angle glaucoma) Patient has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mm Hg and/ or average diastolic blood pressure ≥ 110 mm Hg
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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, Terlipressin Blood Loss All patients older than 18 years of age ASA classification class I and II Patients assigned for Whipple procedure Preoperative renal failure Severe liver dysfunction (Child-Turcotte-Pugh grade C) Hyponatremia (Na+ <132mmol/l) Severe valvular heart disease Heart failure Symptomatic coronary heart disease Bradycardic arrhythmia (heart rate < 60/min) Peripheral artery occlusive disease (clinical stadium II-IV) Uncontrolled arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment) Pregnancy
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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, Metastatic Prostate Cancer Histologically confirmed diagnosis of prostate cancer Age ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3 Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease Ability to understand and willingness to sign a written informed consent document Wiling to comply with clinical trial instructions and requirements History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin Presence of prostate brachytherapy implants Administration of another radioisotope within five physical half-lives of trial enrollment Radiation or chemotherapy within 2 weeks prior to trial enrollment Serum creatinine > 3 times the upper limit of normal Serum total bilirubin > 3 times the upper limit of normal Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal Inadequate venous access
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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, Ejaculation Abnormal BPH With Urinary Obstruction Prostatic Hyperplasia Prostate Disease Prostate Obstruction Age >50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )>15 and quality of life score (QOL)< 3. 4. Maximum flow rate of uroflometry <10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation. 6. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO Bleeding disorders and patients on anticoagulant treatment 2. Histologically proved cancer prostate 3. Neurogenic voiding dysfunction 4. Lower urinary tract malignancy 5. Preoperative ejaculation or sexual dysfunction 6. Presence of stricture urethra 7. Unfit for spinal anathesia -
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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): 45.0-999.0, Benign Prostatic Hyperplasia All subjects are required to meet the following in order to be considered eligible for participation in this trial: 1. ≥ 45 years of age 2. Baseline IPSS score > 13, and a baseline Quality of Life (QoL) question score > 3 3. Prostate volume 25 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days and prostatic urethral length between 2.5-4.5 cm. 4. Failed or intolerant to medication regimen for the treatment of LUTS Subjects will be excluded from participating in this trial if they meet any of the following 1. Obstructive intravesical median prostatic lobe or high bladder neck 2. Urethral stricture, meatal stenosis, or bladder neck obstruction either current, or recurrent requiring 2 or more dilatations 3. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer 4. Elevated risk of prostate cancer 5. Post-void residual volume (PVR) > 250 ml 6. Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline 7. History of chronic urinary retention 8. History of neurogenic bladder 9. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction 10. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test) 11. Concomitant bladder stones 12. Confirmed or suspected bladder cancer 13. Previous pelvic irradiation or radical pelvic surgery 14. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate 15. Chronic prostatitis, or recurring prostatitis within the past 12 months 16. Serious concurrent medical conditions such as uncontrolled diabetes 17. Known allergy to nickel 18. Life expectancy less than 24 months 19. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function 20. Patients taking coumadin 3 days or less prior to procedure and have INR value > 1.5 on day of procedure. ASA and clopidogrel must be ceased 7 days prior to the procedure 21. 5 alpha reductase inhibitors within 6 months of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) 22. alpha blockers within 2 weeks of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) 23. Future fertility concerns 24. Any severe illness that might prevent study completion or would confound study results
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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): 50.0-999.0, Lower Urinary Tract Symptoms males older than 50 years, with LUTS Urinary tract infection Bladder tumor o lithiasis changes in LUTS treatment during the analysis period (pharmacological or surgical) urethral manipulation during the analysis period (catheterization or cystoscopy)
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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, BPH With Urinary Obstruction BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms 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 ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml. 4. Post-void residual (PVR) ≤300 ml. 5. Prostate volume >80 cm3 to ≤150 cm3 Urology: 1. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate. 2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery. 3. Verified acute bacterial prostatitis within last 12 months documented by culture. 4. Active or history of epididymitis within the past 3 months. 5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device. 6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible. 7. Subject interested in maintaining fertility. 8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months): 1. Beta-blockers; 2. Anticonvulsants; 3. Antispasmodics; 4. Antihistamines; 5. Alpha blockers for BPH and anticholinergics or cholinergics; 6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia)); 7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)); 8. Estrogen, drug-producing androgen suppression, or anabolic steroids; 9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis) 9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible 10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment. 11. Visible hematuria with subject urine sample without a known contributing factor. 12. Presence of a penile implant or stent(s) in the urethra or prostate 13. 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. Gastroenterology: 14. Previous pelvic irradiation or radical pelvic surgery. 15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. Nephrology: 16. Compromised renal function defined as serum creatinine > 2.0 mg/dl. 17. Hydronephrosis (Grade 2 or higher). Oncology: 18. Prostate cancer testing: 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 Males 50-59 years PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25% Males 60+ years PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25% 19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable. 20. 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 enrollment. Cardiology: 21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV). 22. Cardiac arrhythmias that are not controlled by medication and/or medical device. 23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. Pulmonology: 24. History of significant respiratory disease where hospitalization for the disease is required. Hematology: 25. Diagnosed or suspected bleeding disorder, or coagulopathies. 26. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment. Endocrinology: 27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed. Immunology: 28. History of immunosuppressive conditions (e.g., AIDS, post-transplant). Neurology: 29. 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. 30. 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 (< 25% of accepted and established nomograms). General: 31. Currently enrolled in any other pre-approval investigational study in the US (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.). 32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. 33. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements
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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): 20.0-80.0, Overactive Bladder Syndrome Male patients with BPH and undergo TURP or TUIP. 2. Patients void smoothly after catheter removal. 3. No active urinary tract infection. 4. No gross hematuria or blood clot obstruction. 5. Patient or his care giver can complete voiding diary and report symptoms Patients have overt neurological diseases such as cerebrovascular disease, senile dementia or spinal cord injury. 2. Patients have severe medical disease and completely immobile. 3. Patients have PVR larger than 150ml. 4. Patients do not have OAB after TURP
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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, Liver Cirrhoses Cirrhosis as diagnosed by clinical, biochemical, radiological or histologic Cirrhosis Child C class (10 score) 2. L3 SMI value < 45.4 3. Hand Grip Strength < 33.67 Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being pregnant
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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, Healthy Healthy adult subjects Subjects taking diuretics Subjects who have known kidney disease Subjects with history of known nephrolithiasis
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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, Prostatic Hyperplasia, Benign Male ≥ 40 years of age Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation Post-void residual (PVR): ≤ 250 mL Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound Urodynamic investigation proven bladder outlet obstruction Signed informed consent Previous invasive prostate intervention (TURP, laser, ablation, etc.) History of prostate or bladder cancer Indwelling Foley catheter or clean intermittent catheterization (CIC) PSA of ≥ 3.0 ng/mL without negative biopsies Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy Other conditions / status Active urinary tract infection / prostatitis Macroscopic haematuria without a known contributing factor Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy) Concurrent malignancy except basal skin cancer
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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): 18.0-90.0, Overactive Bladder Patients with >8 micturitions >1 nocturia >6 urgency or >3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary active urinary tract infection a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies residual volume of 100 cc or more any medications for OAB, benign prostatic obstruction polyuria (>3 l per 24 hour) endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria neurological or psychological disease disease prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality history of transobturator or transvaginal tape or pelvic organ prolapse surgery pelvic radiation or 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): 35.0-80.0, Prostate Cancer men > 35 years age and <80 years of age 2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy 3. staging by standard procedures show localized disease (<cT4) 4. PSA < 50ng/ml 5. Access to the rectum for trans rectal ultrasound 6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen 7. Signed written informed consent prior to any screening procedures being performed Patient with absence of diagnosis of prostate cancer 2. Patient with metastatic prostate cancer 3. Patient with rectal amputation 4. Patient with contraindications for MRI 5. Patient in urgency situation, adult under legal protection, or unable to give his 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): 40.0-999.0, Prostatism Erectile Dysfunction requirements for all subjects 1. Men at least 40 years of age 2. Screening IPSS QoL must be 4-6: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6) 3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations 4. Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment Required for target efficacy subset Meets criterion for at least moderate ED: IIEF-5 (erectile function) score <13 or: Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20 Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil. 2. Current severe side effects from any drug 3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study. 4. Women
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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, Urinary Tract Infection Have documented clinical signs and/or symptoms of complicated urinary tract infection (cUTI) at diagnosis*. *Clinical signs and symptoms of cUTI either: 1. Pyelonephritis, as indicated by at least 2 of the following Documented fever (temperature greater than 38 degrees Celsius) accompanied by symptoms of rigors, chills, or "warmth" Flank pain Costovertebral angle tenderness on physical exam Nausea or vomiting Dysuria, urinary frequency, or urinary urgency OR 2. Complicated lower UTI, as indicated by at least 2 of the following new or worsening symptoms of cUTI Dysuria, urinary frequency, or urinary urgency Documented fever (temperature greater than 38 degrees Celsius) accompanied by symptoms of rigors, chills, or "warmth" Documented hypothermia (temperature less than 35.5 degrees Celsius) Suprapubic pain or pelvic pain Have a documented history of any moderate or severe hypersensitivity or allergic reaction to all five oral therapy options. 2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy effective against complicated Urinary Tract Infection (cUTI) in addition to study drug. 3. Have received more than 48 hours of a potentially therapeutic antibiotic for treatment of the current cUTI within 72 hours before randomization*. *Except if the following apply: 1. The subject has a known baseline urinary pathogen (urine culture positive) and has failed prior therapy clinically (persistence of criteria) AND 2. The pathogen is known to be non-susceptible to the previous therapeutic regimen used or the urine culture remains positive with a density of greater than or equal to 50,000 CFU/mL or greater than or equal to 10,000 for catheterized patients. 4. Women breastfeeding or donating breast milk. 5. Have intractable UTI infection at baseline that the investigator anticipates would require more than 7 days of study drug therapy. 6. Have complete, permanent obstruction of the urinary tract*. *Patients with complete permanent obstruction expected to be medically or surgically treated prior to End of Treatment (EOT) are eligible. 7. Have confirmed fungal UTI at time of randomization (with greater than or equal to 10^3 fungal CFU/mL). 8. Have suspected or confirmed perinephric or intrarenal abscess. 9. Have suspected or confirmed prostatitis, epididymitis. 10. Have an ileal loop or known vesico-ureteral reflux. 11. Have a current urinary catheter that is not scheduled to be replaced before EOT*. *Intermittent straight catheterization or replacement of new nephrostomy catheters is acceptable. 12. Have planned inpatient urological intervention(s) for suspected infected kidney stone or any other planned urological procedure with anticipated antibiotic prophylaxis between randomization and End of Treatment (EOT). 13. Have bacteremia with a uropathogen causing cUTI. 14. Have an estimated or calculated Creatinine Clearance (CrCl) less than or equal to 20 mL/min or currently receiving hemo or peritoneal dialysis at screening. 15. Have any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data*. *Including any rapidly progressing disease or immediately life-threatening (acute hepatic failure, respiratory failure or septic shock). 16. Have participated in any interventional trial of an investigational product within 30 days before the proposed first day of study drug administration. 17. Plans to participate or currently enrolled in any interventional study of an investigational agent for the duration of the trial. 18. Previous randomization in this trial. 19. Any recent (less than 4 weeks) history of trauma to the pelvis or urinary tract. 20. Prior fosfomycin use in the past 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): 0.0-18.0, Catheter Related Blood Stream Infections Pediatric patients with a port catheter Treated with systemic vancomycin and/or vancomycin "lock" Age > 18 years Active downgrading of care
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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, Renal Cancer Metastatic advanced renal clear cell carcinoma confirmed by pathology: high-volume disease without systemic treatment(including primary lesion unable to surgery, multiple lymph node metastases or distant metastases), or achieved disease progression after treatment by the anti-angiogenesis therapy (TKI or mTOR inhibitors) or by cytokines or combination therapy Predicted survival >=3 months At least 1 measurable lesion High-volume disease（meet one of the following criteria）:1. More than 3 sites of lesions with or without primary lesions, and at least 1 lesion routine CT or spiral CT scan >=3cm; 2. Unresected primary lesions (> 10cm), accompanied by 2 metastatic lesions; 3. After nephrectomy, single metastasis, at least 3 metastases, and at least one lesion > 2cm; 4. After nephrectomy, multiple metastatic(>3 organs) and at least one lesion > 2cm Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components Severe cardiovascular and cerebrovascular diseases, uncontrollable severe hypertension and diabetes, severe renal insufficiency or uremia Long-term use of immunosuppressive agents after organ transplantation Immunosuppressive drugs are currently in use People with a clear and serious infection Predicted survival<3 months Patients with T cell lymphoma, myeloma Patients with autoimmune diseases HIV positive, or other immunodeficiency diseases
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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, Bloodstream Infection All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours All adult (≥18 years of age) Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing) Positive blood culture in the prior week with same Gram stain result Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result Previously enrolled in the study Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded Died or were transitioned to comfort care within 24 hours of enrollment Negative Gram-stain Not admitted to hospital for ≥ 24 hours following blood culture positivity
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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 Patients must be 18 years of age or older Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma Patient must agree to abstain from other clinical studies during the study period Patients younger than 18 years of age Patients with chronic or pre-existing indwelling stents Patients currently receiving anticholinergic or alpha blocker therapy Patients with chronic opioid or analgesic usage Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia Patients with an active untreated urinary tract infection Patients who are currently pregnant or nursing Patients with allergies or contraindication to either tamsulosin or hyoscyamine Patients on active chemotherapy Patients currently receiving other investigational therapy
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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 Male gender Age ≥ 50 years Prostate volume 30 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS) Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound) Medication history Not on BPH related medication for the past 6 months If on BPH related medication On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern Previous BPH procedure Median prostatic lobe or high bladder neck Urethral stricture, meatal stenosis, or bladder neck obstruction either current, or recurrent requiring 2 or more dilatations Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer Cystolithiasis within the prior 3 months History of neurogenic bladder or urinary retention with PVR >1000mL Serum creatinine >1.8 mg/dl or upper-tract disease which compromises renal function Current or recent Urinary Tract Infection (UTI) or disease Known allergy to nickel
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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): 18.0-99.0, Renal Transplant Infection Age ≥18 years of age at the time of study entry Recipient of a deceased or living donor kidney transplantation Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day) Patient is less than or at 8 weeks post transplant with a negative serum BK Virus screen at 3-4 weeks post transplant Patient has a tacrolimus drug dose/concentration of > 1 with therapeutic tacrolimus levels Women of childbearing potential defined as all women physiologically capable of becoming pregnant, must have reviewed Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) and have a negative pregnancy test upon study entry Female (and male) subjects with reproductive potential must agree to use a highly effective method of birth control for the duration of the study. Please note that according to the US product information for MMF/MPA, two reliable forms of contraception must be used simultaneously unless female sterilization, male sterilization, post-menopausal status or total abstinence is the chosen method Inability or unwillingness of a patient to give written informed consent or comply with study protocol History of graft loss from acute rejection within 1 year after any previous kidney transplant History of previous liver, heart, pancreas, or lung transplant History of cellular rejection of current allograft prior to enrollment Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study entry Female subjects who are pregnant or breast feeding Participation in any other studies with investigational drugs or regimens in the preceding year from the time of study entry Any condition or prior treatment which, in the opinion of the investigator, precludes study participation Patients requiring the use of azathioprine or a class of drugs that inhibit the mammalian target of rapamycin (mTOR inhibitors) Patients with active peptic ulcer 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): 18.0-999.0, Benign Prostatic Hyperplasia Patients must be 18 years of age or older 2. Patients must present to clinic with a diagnosis of benign prostatic hyperplasia with lower urinary tract symptoms 3. Patients must be scheduled to undergo a holmium laser prostate surgery (enucleation or ablation) Patients who are under 18 years of age are not eligible. 2. Patients who have a diagnosis of bladder cancer are not eligible. 3. Patient who have a diagnosis of prostate cancer are not eligible. 4. Patients with an elevated prostate-specific antigen (PSA) suggesting prostate cancer are not eligible unless patient has prior negative prostate biopsy. 5. Patients who have acute prostatitis, a prostate abscess, or neurogenic bladder are not eligible
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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): 18.0-90.0, Muscle Weakness Patients will be recruited in the Intensive Care Unit of the Royal Liverpool University Hospital. All patients will be over 18, and have a critical illness that requires mechanical ventilation with an initial period of sedation. This study will focus on patients with a definite or suspected case of sepsis from any source. Sepsis has been recently redefined as: "Life threatening organ-dysfunction caused by dysregulated host response to infection" whilst septic shock has become a subset of sepsis, defined as: "circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality(44). For the purposes of this study, a patient will be regarded as septic if they have evidence of infection-related organ failure (e.g. sepsis-associated coagulopathy, altered mental state, cardiovascular dysfunction, acute kidney injury, and altered liver function) and require invasive mechanical ventilation with either definite or suspected evidence of infection. This is to allow prompt treatment with FES rather than waiting for a positive microbiological result to be obtained. Within the definition of sepsis "from any source" a list of following is illustrative but not exhaustive Urogenital sepsis (including urosepsis, pyelonephritis, endometritis and chorioamnionitis) Pneumonia (including community acquired, hospital acquired, and aspiration pneumonia. Ventilator associated pneumonia would be excluded.) Neurological infections such as encephalitis and meningitis Cellulitis, osteomyelitis and infections of soft tissue NOT affecting the lower limb Surgical infections, including post-operative laparotomy with evidence of peritoneal soiling, and evidence of infection prior to the operation, in patients who require 2 or more organ system support after the operation Intra-abdominal sepsis, including biliary sepsis, hepatitis, and acute pancreatitis. In the case of acute pancreatitis, evidence of infection is required to fulfil the criteria. Acute pancreatitis with sterile tissue/fluid samples would not be suitable Patients under 18 Patients who decline consent Pregnancy Neuromuscular disease Rhabdomyolysis Lower limb trauma Patients unlikely to survive to 96 hours post admission Consent unobtainable within 48 hours of admission Morbid obesity (BMI>40) Presence of a pacemaker or Implantable Cardiac Defibrillator (ICD)
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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, Lower Urinary Tract Symptoms Benign Prostate Hyperplasia Benign Prostatic Hypertrophy With Outflow Obstruction Male Presenting with lower urinary tract symptoms Indication for transperineal laser ablation Signed informed consent form Age < 18 years Previous or active treatment for prostate cancer (active surveillance is not seen as active 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): 0.0-999.0, Antibiotic Prescribing Audit and Feedback Ontario primary care physicians Prescribe more antibiotics by volume than 75% of Ontario primary care physicians A College of Physicians and Surgeons of Ontario number in 2017-2018 None
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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, Complicated Urinary Tract Infection Acute Pyelonephritis Male and female subjects at least 18 years of age 2. Able to provide informed consent 3. Able to ingest oral tablets for the anticipated treatment duration 4. Have a diagnosis of cUTI or AP as defined below: a. cUTI definition: At least Two of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]) ii. Dysuria, urgency to void, or increased urinary frequency iii. Nausea or vomiting, as reported by the subject iv. Lower abdominal, suprapubic, or pelvic pain And at least One of the following risk factors for cUTI: i. Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents, or other urinary tract prosthetic material), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters that have been in place for >24 hours prior to Screening must be removed or replaced prior to collection of the Screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated) ii. Current known functional or anatomical abnormality of the urogenital tract, including anatomic abnormalities of the urinary tract, neurogenic bladder, or post-void residual urine volume of ≥ 100 mL within the past 6 months iii. Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to EOT) iv. Known intrinsic renal disease with blood urea nitrogen (BUN) >20 mg/deciliter (dL), or blood urea >42.8 mg/dL, or serum creatinine (Cr) >1.4 mg/dL v. Urinary retention, including urinary retention in men due to previously diagnosed benign prostatic hyperplasia (BPH) b. AP definition: Acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination. And at least One of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature >38.0°C [>100.4°F]) ii. Peripheral white blood cell count (WBC) >10,000/mm3 or bandemia (≥15% immature polymorphonuclear neutrophils (PMNs), regardless of WBC count) iii. Nausea or vomiting, as reported by the subject iv. Dysuria, urgency to void, or increased urinary frequency Note: Subjects who meet the definition for cUTI (Inclusion Criterion 4a) and also have flank pain or costovertebral tenderness should be randomized as cUTI rather than AP. 5. Have an adequate urine specimen for evaluation and culture obtained within 24 h prior to randomization with evidence of pyuria that includes at least one of the following: 1. At least 10 WBCs per high power field (hpf) in urine sediment 2. At least 10 WBCs per cubic millimeter (mm3) in unspun (non centrifuged) urine 3. Positive leukocyte esterase (LE) on urinalysis Note: Subjects may be randomized and administered investigational product (IP) prior to knowledge of urine culture results. 6. Expectation, in the judgment of the Investigator, that the subject will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study 7. Willing to comply with all the study activities and procedures throughout the duration of the study 8. Subjects must agree to use a highly-effective method of birth control; male subjects must agree to use an effective barrier method of contraception from Screening through late follow-up (LFU) and for 90 days following the last dose if sexually active with a female of childbearing potential (FOCP); female subjects must not be pregnant or nursing, and must commit to either sexual abstinence or use at least two medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from Screening through LFU and for 90 days following the last dose Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy, including but not limited to the following: 1. Perinephric or renal corticomedullary abscess 2. Uncomplicated urinary tract infection (uUTI) (acute cystitis that does not meet the cUTI disease definition, see Criterion 4a) 3. Polycystic kidney disease 4. Recent history of trauma to the pelvis or urinary tract 5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis 6. Chronic vesicoureteral reflux 7. Previous or planned renal transplantation 8. Previous or planned cystectomy or ileal loop surgery 9. Known or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia) 10. Confirmed or suspected infection that is caused by a pathogen that is resistant to either IP (e.g., carbapenem-resistant pathogen), including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis) 2. Gross hematuria requiring intervention other than administration of IP or removal/placement of urinary tract instrumentation 3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required relieving an obstruction or placing urinary tract instrumentation) 4. Creatinine clearance (CrCl) of <50 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL]) 5. Anticipated concomitant use of non-study antibacterial drug therapy between randomization and the LFU Visit that would potentially effect outcome evaluations of cUTI/ AP, including but not limited to antibacterials with potential activity versus uropathogens, antibacterial drug prophylaxis, and antibacterial bladder irrigation 6. Anticipated concomitant use of gastric acid-reducing medications between randomization and end-of-treatment (EOT), including proton pump inhibitors, histamine-2 receptor antagonists, and antacids 7. Receipt of more than a single dose of a short-acting potentially effective antibiotic within 72 h prior to randomization; no more than 25% of subjects will be enrolled who meet the above criterion Exception: Subjects who received more than a single dose of short-acting potentially effective antibiotic within 72 h prior to randomization may be eligible for enrollment if they meet all of the following 1. In the opinion of the Investigator they have failed the prior antibiotic therapy (e.g., have worsening signs and symptoms of cUTI/AP) 2. Have a documented uropathogen (growth in urine culture >105 CFU/mL) that is resistant to the prior antibiotic therapy 3. Have a documented uropathogen that is carbapenem-susceptible 4. Receives approval from the Medical Monitor to enroll the subject 8. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN) or total bilirubin >3x ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy) 9. Any signs of severe sepsis, including shock or profound hypotension defined as systolic blood pressure <90 mmHg or a decrease of >40 mmHg from baseline that is not responsive to fluid challenge 10. Pregnant or breastfeeding women 11. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures) 12. Receipt of any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to randomization 13. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-defining illness, or known cluster of differentiation 4 (CD4) count <200/mm3 within the past year 14. Presence of immunodeficiency or an immunocompromised condition including neutropenia (<1,000 neutrophils/mm3 obtained from the local laboratory at Screening), hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long term use of systemic corticosteroids (e.g., ≥20 mg/day of prednisone or systemic equivalent for at least 2 weeks) 15. A mean QT interval corrected using Fridericia's formula (QTcF) >480 msec based on triplicate ECGs at Screening 16. History of significant hypersensitivity or allergic reaction to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (Mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry) or any contraindication to the use of ertapenem 17. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia) 18. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT 19. Unable or unwilling to comply with the protocol 20. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator
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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, Hip Arthropathy Regional Anesthesia Patients undergoing primary hip arthroplasty ASA 1, 2, and 3 Patients age ≥18 years Patient refusal Inability to understand and sign consent Infection at the injection site Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics Contraindication or patient refusal to get spinal anesthesia Thrombocytopenia (platelets < 100,000) Coagulopathy (INR > 1.4) Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery ASA 4 and 5
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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 Lower Urinary Tract Symptoms Patients must be 18 years of age or older Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence Patients must be diagnosed with prostate cancer by pathological tissue analysis Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer Patients who are under 18 years of age are not eligible Patients who have a diagnosis of bladder cancer are not eligible Patients with prior treatment for prostate cancer are not eligible Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible Patients with known metastatic prostate cancer are ineligible Patients who are enrolled in other surgical or international trials at the time of this study are not eligible
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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, Infraclavicular Brachial Plexus Block Adults aged 18 to 80 years Amercian Society of Anesthesia physical status I, II, III Patients undergoing upper limb surgeries (with/without sedation) Ability to provide written informed consent Patient refusal Known history of sensitivity or contraindications to study drugs Pregnant patients Infection at the site of administration of block Significant blood coagulation disorders Neurological deficits involving brachial plexus Patients on any medication which is known to have drug interactions with the study drugs Patients who receive general anesthesia/ narcotic supplements
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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 Prostatic Hyperplasia Patients who have been diagnosed with benign prostatic hyperplasia by a urologist Have been treated with conventional first-line western medicine for more than three months Patients with moderate to severe benign prostatic hyperplasia (IPSS score >12 points) Participate voluntarily in the study At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture A history of genital trauma or surgery affecting the muscle or nervous system Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function Unable to sign a consent form or unable to communicate with researchers
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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, Lower Urinary Tract Symptoms patients with lower urinary tract symptoms patients with Suprapubic catheter History of radical prostatectomy or cystoprostatectomy Clinical evidence of urethral stricture, prostatitis Patients with bacterial growth on urine culture
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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): 40.0-90.0, Benign Prostatic Hyperplasia (BPH) moderate-to-severe lower urinary tract symptoms (IPSS ≥ 12) poor efficacy or tolerance to medical therapy for BPH transrectal ultrasound prostate volume between 30 and 120 ml ability to express written informed consent previous surgical treatments for BPH indwelling bladder catheter or clean intermittent catheterization bladder stones severe detrusor hypocontractility (BCI <50) or detrusorial acontractility urethral strictures neurological bladder not replaceable anticoagulant or antiplatelet drugs for severe cardiological comorbidity bladder cancer diagnosis or clinical suspicion of prostatic cancer
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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, Urethral Stricture Urethral Stricture, Anterior Lower Urinary Tract Symptoms Anterior Urethral Stricture Male subjects ≥ 18 years old 2. Visual confirmation of stricture via cystoscopy or retrograde urethrogram 3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm 4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs). 5. IPSS score of 13 or higher 6. Lumen diameter <12F by urethrogram 7. Able to complete validated questionnaire independently 8. Qmax <15 ml/sec 9. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long 2. Subjects with greater than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Previous urethroplasty within the anterior urethra 5. Stricture due to bacterial urethritis 6. Stricture due to untreated gonorrhea 7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO) 8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization) 9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult 10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician 11. Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician 12. Prior diagnosis of overactive bladder (OAB) 13. Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician 14. Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence 15. Previous pelvic radiation 16. Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks 17. Diagnosed with chronic renal failure, at the discretion of the physician 18. A dependence on Botox (onabotulinumtoxinA) in the urinary system 19. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 20. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 21. Previous hypospadias repair 22. Diagnosis within the last 5 years of carcinoma of the bladder or prostate or suspicion of prostate cancer (e.g. abnormal DRE or high PSA) at the discretion of the physician 23. 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 24. Unwilling to use protected sex for ≥30 days post treatment 25. Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential. 26. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements 27. Active infection in the urinary system 28. History of diabetes not controlled with a hemoglobin A1-C >7.0% 29. 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. 30. Visible hematuria with subject urine sample without known contributing factor
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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, Bloodstream Infections Bloodstream infection with a Gram-negative organism from at least one blood culture draw. Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2) The blood stream infection fulfils the as a hospital acquired or healthcare associated infection as per the following definitions Hospital acquired Blood stream infection occurring greater than 48 hours after hospital admission, assessed as symptoms or signs of infection not present at time of hospital admission Healthcare associated Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following Patient has an intravascular catheter/line that is the source of infection Attended a hospital or haemodialysis clinic or received intravenous chemotherapy in the previous 30 days were hospitalized in an acute care hospital for two or more days in the previous 90 days resided in a nursing home or long-term care facility Refractory shock or comorbid condition such that patient not expected to survive more than 7 days Patient with history of moderate to severe hypersensitivity reaction to a cephalosporin Patient with Gram-positive bacteraemia including a significant Gram-positive pathogen (a Gram-positive skin contaminant in one set of blood cultures may not regarded as significant) Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion) Known pregnancy or breast-feeding Patient is receiving peritoneal dialysis
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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, Interstitial Lung Disease Interstitial Pneumonia Interstitial Fibrosis Autoimmune Diseases written informed consent to participate in the study diagnosis of one of interstitial lung diseases/autoimmune diseases as described below age < 18 years withdrawal od consent pregnancy lactation infectious disease 4 weeks prior
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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, Deep Vein Thrombosis Thromboses, Venous Thrombosis Embolism Postthrombotic Syndrome Pulmonary Embolism case of venous thrombosis of a limb or pulmonary embolus
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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): 21.0-999.0, Depressive Symptoms Coronary Heart Disease History of coronary heart disease English or Spanish Speaking Elevated Depressive symptoms (PHQ9 ≥10) Under the care of a psychiatrist (e.g., for schizophrenia) Diagnosis/history of psychosis or schizophrenia Diagnosis/history of bipolar disorder Attempted suicide Non-English or Spanish speaking Dementia or severe cognitive impairment Non-elevated depressive symptoms Alcohol or substance abuse Pregnancy
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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, Pelvic Floor Myofascial Pain Pelvic Pain Myofascial Pain Adult (>18yo) Women Patients found to have pelvic floor myofascial pain of at least 4/10 in severity at any of the four sites (right obturator internus, right levator ani, left levator ani, left obturator internus) Age <18 Non-English speaking Current diagnosis of dementia Limited physical mobility that would prevent full participation in pelvic floor PT Prior use of vaginal cryotherapy Chief complaint or known history of pelvic pain
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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): 50.0-75.0, Prostate Cancer PSA MRI Men being screened for prostate cancer in the project 'Prevention of Obesity-related Cancers' 2. Age 50-75 3. Screening naïve, defined as no blood taking for PSA within past 5 years AND no prostate biopsy within past 5 years 4. PSA 4-50 ng/mL 5. Agree for non-contrast MRI scanning of prostate Men who are contraindicated for MRI( Pacemaker in-situ, Metallic implants which are not MRI-compatible, or Claustrophobia) 2. Prior history of prostate cancer
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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 Adult Chinese male patients with age > 18 years old 2. Clinical suspected to have prostate cancer, based on abnormal digital rectal examination or elevated serum PSA level Patient refused or unable to provide consent for 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): 20.0-999.0, Hip Fractures Cognitive Impairment Subjects are: 1. age 60 years or older, 2. admitted to CGMH due to one-side hip fracture, and being diagnosed as needing surgery, 3. assessed as having cognitive impairment by the Chinese Mini-Mental State Examination (CMMSE) (CMMSE score < 21 with < 6 years education, or CMMSE < 25 with ≥ 6 years education; Yip et al., 1992), 4. having a primary family caregiver, 5. living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju province) Family caregivers: 1. age 20 years or older, 2. responsible for providing direct care to or supervising care received by the patient Subjects are 1. cognitively intact by CMMSE, 2. without a primary family caregiver, 3. terminally ill, 4. severe cognitive impairment such that they are completely unable to follow orders (CMMSE < 10; Yip et al., 1992)
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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, BPH BOO - Bladder Outflow Obstruction Age 50 or older 2. Verified BPH with prostate size of at least 30 grams or of 25 mm. 3. Signed Informed Consent 4. Failure, intolerance or patient non-compliance of medical treatment 5. Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec) 6. Patient's voided volume of at least 125 ml in uroflow test 7. Patients not eligible for surgery or refusing surgery Known sensitivity to Nickel 2. Active Prostatitis 3. Urethral strictures 4. Prior surgery of prostate (simple or radical) 5. Currently active bladder tumor 6. Suspected neurogenic urinary bladder 7. Suspected a-contractile bladder 8. Enlarged median lobe of prostate. 9. Bladder Neck stricture or contracture 10. Urethral pathology: diverticula, strictures, tumors, fistula 11. Clinically Significant urinary tract infection 12. Uncontrolled bleeding disorders 13. Uncontrolled diabetes mellitus 14. Severe medical diseases precluding a minimally invasive procedure 15. Present active urinary stone disease 16. Patients who are under anticoagulants therapy
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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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, Prostate Hypertrophy Holmium Laser Thulium Laser Bipolar Diathermy Prostate Enucleation Patients' age >50 years Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8) Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment Transrectal ultrasound TRUS estimated total prostate size 80-250cc Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease Active urinary tract infection (positive urine culture) till treatment Presence of bladder cancer (within the last 2 years) Known prostate cancer 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): 40.0-70.0, Prostatic Hyperplasia Male patients presenting with lower urinary tract symptoms to urology outpatient clinic 2. According to the European Association of Urology Guidelines: 1. International prostate symptom score> 8 2. Prostate volume> 40 ml 3. Q max <15 ml /sn 3. Patients who did not receive any treatment for lower urinary tract symptoms and applied for the first time 4. Patients who have not undergone lower urinary tract surgery Patients who had undergone medical and surgical treatment for lower urinary tract symptoms 2. Patients with accompanying urethral stricture 3. Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...) 4. Patients with spinal cord trauma 5. Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation)
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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, Stroke Adult patient Having had a first confirmed, ischemic or hemorrhagic stroke Managed in the participating stroke center Whose return home directly from the stroke center is planned Presenting a modified Rankin score of 1 to 3 when deciding to leave the stroke center Having given its written consent Whose main residence is located in the Rhône department of France Aphasic patients may be included if a caregiver can follow up with the case manager Patient residing in an institution prior to stroke Supported in the gerontological field before stroke Inability to communicate by telephone with the case-manager and absence of a caregiver to follow up by telephone with the case-manager
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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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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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, Prostate-Specific Antigen Patients with a PSA determination requested in a routine health examination from primary health centers from the Health Department 17 and 19, in the Valencian Community (Spain) Patients who have been previously diagnosed with prostate cancer Patients who are being followed for previous high PSA values
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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, Rheumatoid Arthritis Patients who diagnosed of rheumatoid arthritis as of ACR/EULAR 2010 All patients age range is 18-80 years Renal failure Hepatic insufficiency Diabetes mellitus Other collagen vascular diseases History of smoking and consumption of alcohol
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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 1.1.1 Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory. 2.1.1.2 Must have prostate cancer with high risk features defined as Gleason 8 and higher OR PSA > 20 ng/mL OR Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b 2.1.1.3 Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT 2.1.1.4 Men age greater than or equal to 18 years. 2.1.1.5 ECOG performance status <2 2.1.1.6 Patients must have adequate organ and marrow function as defined below Hemoglobin greater than or equal to 9 g/dL leukocytes greater than or equal to 3,000/mcL platelets greater than or equal to 100,000/mcL total bilirubin <2 X normal institutional limits AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits creatinine <2 X normal institutional limits OR eGFR greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 2.1.1.7 Ability of subject to understand and the willingness to sign a written informed consent document. 2.1.1.8 Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible. 2.1.1.9 Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT 1.2.1 Any investigational agents in the past 28 days prior to enrollment. 2.1.2.2 Clinical stage T4 (tumor invades adjacent structures except seminal vesicles). 2.1.2.3 Distant metastatic disease on conventional imaging studies (computed tomography (CT) of the abdomen and pelvis and 99mTc-methylene diphosphonate bone scan (bone scan)). NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds (34, 35), pelvic lymph nodes below 2 cm in the short axis are allowed. 2.1.2.4 Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry. 2.1.2.5 Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy. 2.1.2.6 Contraindication to MRI or PET Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry Prior reaction to 18F-DCFPyL Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T Severe claustrophobia unresponsive to oral anxiolytics 2.1.2.7 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 2.1.2.8 Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy. 2.1.2.9 A malignancy within the past 3 years for which prostatectomy is a contraindication. 2.1.2.10 Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging. 2.1.2.11 PSMA-targeted imaging within 6 months prior to the date of 18F-DCFPyL PET/CT imaging. 2.1.2.12 Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection. 2.1.3 Recruitment Strategies
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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, Stroke Weakness of Extremities as Sequela of Stroke All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging. 2. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 3. Depressed patients will be included in the study 4. Patients able to stand alone 5. Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21) Aphasic patients unable to communicate 2. Confused patients 3. Patients medically unstable 4. Patients unable to stand alone 5. Refusal 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): 45.0-90.0, Voiding Disorders Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS IPSS (International prostate symptom score lower than 12) Nocturia equal or less than 2 on a two day bladder diary Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12 Improvement in IPSS in at least 3 points for storage symptoms Nocturia equal or less than 2 on a two day bladder diary Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure IPSS higher than 8 Nocturia more than 2 Delta change in IPSS score less than negative 3 points Men with Neurogenic bladder Urethral stricture Prior BOO procedures History of urinary retention with indwelling foley catheter or intermittent catheterization Additional for Group 1 and 2 (Subjects with BPH and LUTS) History of bladder cancer within 5 years History of treatment for prostate cancer other than active surveillance Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition
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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): 40.0-999.0, BPH Subject signed informed consent form (ICF) Age 40 and above Male with symptomatic BPH IPSS symptom severity score ≥ 13 Peak urinary flow of < 12 ml/sec Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound TRUS) Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation) Subject able to comply with the study protocol Normal urinalysis and negative urine culture A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention Confirmed or suspected bladder cancer Recent (within 3 months) cystolithiasis or hematuria Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology An active urinary tract infection Enrolled in another treatment trial for any disease within the past 30 days Previous colo rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used Previous pelvic irradiation, cryosurgery or radical pelvic surgery Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the 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): 40.0-999.0, BPH With Urinary Obstruction Male Patients suffering from LUTS secondary to infravesical obstruction from BPH failed medical treatment International Prostate Symptom Score (IPSS) > 13 a peak urinary flow rate (Qmax) < 15 ml/sec a prostate size ≥ 80 gm presence of a urethral stricture neurological disorder bladder cancer prostate cancer previous history of bladder neck surgery or TURP
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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, Prostate Cancer Recurrent Prostate Cancer Willing and able to provide signed informed consent and HIPAA authorization for the release of personal health information Males aged 18 years and above Prior local therapy with prostatectomy or EBRT/brachytherapy is required Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months Absolute PSA >=1.0 ng/mL at screening Must have at least one of the following genetic alterations identified using archival tissue (i.e. prostate needle biopsy prior to radiation therapy or prostatectomy specimen) Microsatellite instability (MSI-high) status by clinical grade testing MMR protein loss (MSH2, MSH6, MLH1, PMS2) by immunohistochemistry Inactivating mutation of MSH2, MSH6, MLH1 or PSM2 by clinical grade genomic testing Tumor mutational burden >= 20 mutations/megabase (TMB >=20 muts/Mb) by clinical grade testing Metastatic disease or currently active second malignancy Prior androgen deprivation therapy (ADT) in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (>150 ng/dL) Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) within the past 2 weeks is not permitted. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months Involvement in the planning and/or conduct of the study (applies to both BMS staff and/or staff at the study site) Participation in another clinical study with an investigational product during the last 4 weeks/28 days Patients should be excluded if they have had prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Patients should be excluded if they have an active, known or suspected autoimmune disease (e.g. inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, lupus, celiac disease). Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recure in the absence of an external trigger Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone daily equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease Permitted therapies topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g. contrast dye allergy) or for treatment of nonautoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergen) is permitted As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen
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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) A male at 50 years of age and older 2. Clinical signs and symptoms of benign prostatic hyperplasia 1. A volume of prostate gland (TRUS) > 30 cc 2. Moderate to severe lower urinary tract symptoms with IPSS ≥ 13 3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL 3. PSA level < 10 ng/mL (however, if 4 ng/mL < PSA < 10 ng/mL, a person with a biopsy result, confirming that he does not have prostate cancer) 4. Residual urine volume ≤ 200 Ml 5. Consent not to participate in other clinical trials as a subject during this clinical trial period. 6. Consent of patient and patient's partner a. Patient Consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (Not applied if the patient had vasectomy.) b. Patient's partner (Consent should be obtained before visit 4, when necessary.) Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized Hypersensitivity reactions to ingredients of this drug. 2. Taking drugs that affect the results of clinical trials. ex) 5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, steroids, immune suppressants, saw palmetto, etc. 3. Taking drugs of an unapproved study drug in the past or the study drug for this clinical trial 4. Diagnosis with prostate cancer in the past or at present 5. Diagnosis by an investigator to have an influence to an evaluation on urine flow symptoms due to other previous or current diseases besides benign prostatic hyperplasia 6. Surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia 7. Severe medical condition which may be cause problem to conduct the clinical trial (e.g., chronic heart failure (CHF), difficult-to-control diabetes (HbA1c > 7%), mental disorder, drug, or alcohol abuse, etc.) 8. Moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance) 9. Any other subjects who are considered to be ineligible for this study by an investigator [Inclusion for Randomization] 1. Clinical signs and symptoms of benign prostatic hyperplasia 1. Volume of prostate gland (TRUS) > 30 cc * 2. moderate to severe lower urinary tract symptoms with IPSS ≥ 13 3. 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL 2. Residual urine volume ≤ 200 mL 3. Patient's partner (Consent should be obtained before visit 4, when necessary.) - Consent to avoid pregnancy by using contraceptive devices or oral contraceptives during the patient's participation in clinical trial and for 90 days after the end of treatment, except if the partner reaches menopause or is surgically sterilized. (* In case that additional TRUS examination has been performed after screening, a decision should be made based on the latest result.)
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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): 18.0-69.0, HCC HBV Coinfection older than 18 years and less than 69 years old; 2. HBsAg positive HCV antibody negative and HIV antibody negative; 3. HBV-DNA>200 IU/mL; 4. BCLC（Barcelona Clinic Liver Cancer） staging O and A stage; 5. Platelet100×10^9/L; 6. Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis; 7. Creatinine clearance rate≥ 70 mL/min; 8. Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (<3 months); 9. No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC; 10. The patients agree to participate in the clinical trial The image found extrahepatic lymph nodes or visceral metastasis, the existence of large vascular invasion, the existence of bile duct embolus in the first operation; 2. The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs; 3. Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on; 4. contraindications to surgery; 5. Patients with poor compliance and not adhered to the follow-ups; 6. Patients refused to participate in the 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): 0.0-0.082, Blood Stream Infections All patients admitted to the Neonatal intensive care unit (NICU) during study period and administered any antibiotic were included in the study Patients Who have no antibiotics during their length of stay
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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): 51.0-85.0, Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Over 50 years old BPH confirmed by mpMRI Uroflowmetry indicating obstructive pathology Surgical risk moderate-elevated Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS) Signature of the information sheet and of the informed consent to the treatment, at the execution of the multiparametric MRI and the administration of the paramagnetic contrast medium MRI signs of malignancy confirmed by biopsy investigation Urethral stenosis Serious coagulation disorders Inadequate compliance Ischemic pathology in the previous six months Presence of pacemakers Active phase inflammatory pathology Presence of III dominant prostate lobe Contraindications to the execution of MRI (claustrophobia, auricular implants, metal prostheses and other contraindications included in the specific informed consent) Paramagnetic contrast medium allergy
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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): 18.0-99.0, Bleeding Stricture Grade III and grade IV hemorrhoid Anal fistula, rectal polyo\p
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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): 12.0-999.0, Cystic Fibrosis Key Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a gating or residual function mutation (F/G and F/RF genotypes) Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height Key Clinically significant cirrhosis with or without portal hypertension Lung infection with organisms associated with a more rapid decline in pulmonary status Solid organ or hematological transplantation Other protocol defined Inclusion/
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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, Multiple Sclerosis Lower Urinary Tract Symptoms Neurogenic Bladder Overactive Bladder Urinary Incontinence Urinary Urge Incontinence Diagnosis of Multiple Sclerosis Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence) Failed prior first and second line therapy (behavioral and pharmacotherapy) Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms Patients performing Intermittent Catheterization are Eligible Indwelling catheters (urethral or suprapubic) Currently pregnant or planning pregnancy Unable to attend weekly office visits for PTNS Urodynamic findings of bladder outlet obstruction History of: bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 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): 18.0-100.0, Colon Cancer Any patient who understands, agrees to participate and signs the informed consent older than 18 years-old electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened duration of the surgical act less than 180 minutes Prior anesthetic assessment of ASA I-III International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker) Open surgery or conversion to open surgery Performing periodic anesthesia or being ASA IV Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months) Moderate-severe prostate clinic (IPSS> 19) Presence of positive urine culture in men in preoperative tests Urinary infection clinic in women with positive urine culture Previous history of acute urine retention be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization men who underwent prostate surgery patients with a history of treatment for urological tumor
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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 High probability of a blood stream infection; this is based on the presence of SIRS [Bone et al. 1992] defined by more than one of the following clinical manifestations: 1. a body temperature greater than 38°C or less than 36°C 2. a heart rate greater than 90 beats per minute 3. tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mm Hg 4. an alteration in the white blood cell count, such as a count greater than 12,000/µl, a count less than 4,000/µl, or the presence of more than 10 percent immature neutrophils ("bands"). and the assessment of the treating physician according to the patient's situation that the SIRS is caused by an infection (e.g., patients after treatment with cytotoxic drugs) indication for antimicrobial treatment Intended use of one of the following antimicrobial agents: piperacillin/tazobactam; vancomycin; meropenem; ampicillin/sulbactam; flucloxacillin; ceftriaxone; caspofungin (according to the decision of the project coordinator, use of other antimicrobial agents may also be included if anticipated to be used frequently) Age: 18 years or older (no upper limit) Willing and capable to provide written consent prior to enrolment after ample information has been provided expected chances to successfully carry out venipunctures to obtain the blood samples required for the study are inadequately low according to the assessment of the physician Anemia CTCAE grade >2 (i.e., Hb <8.0 g/dL / 4.9 mmol/L) the clinical status of the patients suggests that the anticipated treatment of the patient or other conditions would make participation on the study inappropriate (e.g., terminally ill patients); the respective assessment is done by the treating physician
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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 Prostatic Hyperplasia Post-Op Complication Embolization Therapeutic Transurethral Resection of Prostate Syndrome LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS > 8) and QoL = or >3 and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment or BPH using permanent or intermittent catheterization Prostate volume > 50 ml Signed informed consent Urological disorders: evidence of clinically significant prostate cancer [as defined by START criteria] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2 Known severe reactions to iodine-based contrast or gadolinium-based contrast Previous prostate operation CT examination reveals no access to the prostate arteries
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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): 50.0-70.0, Benign Prostatic Hyperplasia Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH) International prostate symptoms score (IPSS)≥ 8 Peak urinary flow rate (Qmax)<15ml/sec for a voided volume of 150 ml or more Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram) Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm History of prostate cancer/raised PSA>4 ng/ml Previous prostate surgery /Periurethral surgery Patient undergone surgery to the bladder neck/Bladder neck contracture Urethral stricture History of LUTS not due to benign prostatic hyperplasia (BPH) Postvoid residual urine volume of >150ml Bladder stone Active urinary tract infection which might affect micturition Large intravesical protrusion > 2 cm Known hypersensitivity or history of active substance abuse
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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): 40.0-100.0, To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland Age >40 Age <40 Pregnancy Urinary tract infection in the past 4 weeks
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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
|
eligible ages (years): 18.0-80.0, To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers Night workers defined as any workers, who, during night time, work at least three hours of their daily working time as a normal course or who work at night at least 1/4 of their working time during the accounting period (definition by the Polish Labour Code) Non night workers Urinary tract infection in the past 4 weeks
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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, BPH With Urinary Obstruction Male Patients suffering from LUTS secondary to infravesical obstruction from BPH failed medical treatment International Prostate Symptom Score (IPSS) > 13 a peak urinary flow rate (Qmax) < 15 ml/sec a prostate size ≥ 75 gm presence of a urethral stricture neurological disorder bladder cancer prostate cancer previous history of bladder neck surgery or TURP
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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
|
eligible ages (years): 40.0-80.0, Benign Prostatic Hyperplasia mild to moderate LUTS due to BPH for at least 6 months at the initial visit no previous therapy or are still symptomatic despite the current use of alpha-blockers International Prostate Symptom Score (IPSS) > 19 Prostate cancer Urethral stenosis
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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, Obesity BMI ≥30 kg/m² Age of ≥18 and <60 years Written informed consent before study entry Willingness to introduce a dietary change to lose weight Serum calcium ≥2.7 mmol/l Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products Pregnancy or lactating women Having given birth in the last year or planning a pregnancy in the next 6 months Menopause (as defined by FSH levels ≥30 IU/l) Disorders associated with androgen excess and/or menstrual irregularities except PCOS (overt thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors) Malabsorption syndrome Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, …), obesity pharmacotherapeutic agents, or calcium supplements in the last 3 months before study entry Regular intake of calcium supplements in the last 3 months before study entry Lifestyle changes (changes in physical activity) or weight reduction (≥10% of body weight) in the last 3 months before study entry
|
0
|
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, Bloodstream Infections patients with positive blood cultures hospitalized between August 2016 and October 2019 documented refusal of the general consent outpatients patients hospitalized in other hospitals patients with known bacteremia diagnosed in another hospital
|
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, Detrusor, Underactive Detrusor Underactivity Adult male or female, at least 20 years of age. 2. History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms. 3. No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments. 4. Voiding difficulty (complains of difficulty emptying the bladder). 5. UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic. 6. Post void residual ≥ 100 mL. 7. Bladder capacity > 200 mL and < 800 mL. 8. Pressure flow Urodynamic testing demonstrating impaired detrusor contractility or areflexia without evidence of BOO, with maximum detrusor pressure Pdet at Qmax (Pdet@Qmax) of < 20 cmH2O and Maximum flow rate (Qmax) < 15 mL/sec for female, and BCI < 100 and BOOI < 40 for male. 9. Total UAB Questionnaire Score ≥ 3. 10. Females of child-bearing potential agree to use reliable birth control for the entire study duration. 11. Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires. 12. Free of active urinary tract infection. 13. Free of bladder outlet obstruction on enrollment. 14. Patient or his/her legally acceptable representative has signed the written informed consent form. 15. Subject on clean intermittent catheterization (CIC) should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception. 2. Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment 3. Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months. 4. History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months. 5. Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations/accurately report medical history, and/or urinary symptoms). 6. History of spinal cord injury affecting urinary function. 7. Patients with uncontrolled acute urinary tract infection. An active urinary tract infection as evidenced by positive urine culture at the time of baseline assessment. If a UTI is confirmed in the baseline sample (e.g., positive urine culture containing > 100,000 cfu/mL in midstream urine), the run-in period should be stopped. After successful treatment of the UTI, the patient can be rescreened and if eligible enroll in the study. If the patient has asymptomatic bacteriuria (i.e., a positive urine culture without clinical signs and symptoms of a UTI), the patient should not be excluded. 8. Currently taking medication(s) that may affect urination, including prescription drugs (i.e. anticholinergics, tricyclic antidepressants, bethanechol), over the counter drugs, dietary and/or herbal supplements, adrenergic antagonists. Alpha adrenergic blockers are allowed to use in a stable condition (longer than 1 month and keeping use during the study period). 9. Pelvic organ prolapses beyond the introitus (e.g., cystocele, rectocele). 10. Prior mesh surgery for stress urinary incontinence or pelvic prolapse. 11. Any other condition which per investigators' judgement, may affect the patient's safety (e.g. significant cardiovascular disease, asthma or other breathing disorders). 12. Patients with bladder outlet obstruction on enrollment. 13. Patients with any contraindication to be urethral catheterization during diagnostic test or treatment or follow-up period. 14. Patients have laboratory abnormalities at screening including: ALT > 3 x upper limit of normal range AST > 3 x upper limit of normal range Serum creatinine level > 2 x upper limit of normal range. 15. Patients with any other serious disease considered by the investigator not in the condition to enter the trial. 16. Patients with cortisone treatment 6 week before first LESW therapy. Other single item of Lab examination also can be retested per Investigator's discretion if abnormality. Patient will be rescreened and randomized into the study once confirmed eligible
|
0
|
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
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) Age ˃ 50 years Prostate volume 20-70 mL (on ultrasound) IPSS(International Prostate Symptom Score) ˃ 12 Qmax(Peak Flow Rate) ˂ 15 mL/s PVR(post-void residual urine) ˂ 350 mL Obstructive median lobe Active urinary tract infection PSA (Prostate Specific Antigen) ˃ 10 ng/mL (unless negative prostatic biopsy) Prostatitis within past 1 year History of urinary retention Previous BPH surgery
|
2
|
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, BPH Lower Urinary Tract Symptoms Male ≥ 50 years of age International Prostate Symptoms (IPSS) ≥12 Peak urinary flow rate (Qmax): <15 ml Prostate volume: ≥ 30 ml, measured by transrectal ultrasound Post-void residual (PVR): <400 ml Signed informed consent MRI signs of malignancy confirmed by biopsy investigation urethral stenosis serious coagulation disorders inadequate compliance ischemic pathology in the previous six months active phase inflammatory pathology
|
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, Biochemical Recurrent Prostate Cancer Histopathological confirmation of prostate adenocarcinoma confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease Biochemical progression after definitive surgery or radiation defined as follows For patients following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir For patients following radical prostatectomy: a rise in PSA >= 0.8 ng/mL PSA <= 30 ng/mL Rising PSA must be confirmed by 3 values a minimum of 1 week apart. All 3 values must be obtained over a period greater than 1 month PSA doubling time of 5-15 months Negative CT scan/MRI and Tc99 bone scan for metastatic prostate cancer. (Only Tc99 will be used to detect bone lesions, CT/MRI would be used to detect soft tissue lesions) Presence of findings on PET scan (i.e., NaF PET scan) suspicious for metastatic prostate cancer in bone. Note: while lymph node findings would be allowed and provide the opportunity for the assessment of any abscopal effects, PET scan findings suggesting visceral disease will be excluded Testosterone >= 100 ng/dL Patients with immunocompromised status due to Human Immunodeficiency Virus (HIV) infection or other immunodeficiency diseases because this is a trial with a primary endpoint looking at immune response, requiring functional immune systems Patients who test positive for HBV or HCV Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of treatment initiation. Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, intraarticular, and topical agents) is allowed Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant) Serious intercurrent medical illness that, in the judgement of the investigator, would interfere with patient s ability to carry out the treatment program Subjects required other medications known to alter PSA including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative therapies (e.g., phytoestrogens and saw palmetto) History of prior chemotherapy History of prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium 223 dichloride) Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) of treatment initiation Major surgery within 28 days prior to treatment initiation
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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): 50.0-75.0, Cardiovascular Risk Factor Ability to provide informed consent 75 years of age Systolic blood pressure 120-159 mmHg Diastolic blood pressure <100 mmHg Sedentary to recreationally active Body Mass Index <35 kg/m^2 Postmenopausal women must be >1 year since last menses Current smoker Pregnant or planning to become pregnant Dyslipidemia (Total cholesterol >240 mg/dL, LDL >160 mg/dL) Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, unstable coronary heart disease, stroke, heart failure, diabetes, neurological disorders) Taking a medication or supplement that would impact study outcomes Following an extreme dietary pattern or planning to change to one (e.g., low carbohydrate, carnivore, vegetarian/vegan) Not weight stable in the prior 3 months (>2 kg weight change)
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0
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