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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, Benign Prostatic Hyperplasia male adults > 40 years old severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention no improvement after or intolerance of medical treatment for at least six months prostatic volume > 30 cm³ female less than 40 years old eGFR < 45 ml/min * m² suspicion of prostatic malignancy prostatic malignancy acute prostatitis or cystitis hydronephrosis bladder stone or bladder diverticulum urethral stenosis major surgery within 4 weeks prior to the screening visit
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol Subjects must be diagnosed with clinically definite SPMS or PPMS and be judged to be in generally good health by the investigator based upon the results of the medical history, laboratory tests (liver and renal function), physical examination, 12-lead electrocardiogram performed during Screening Subjects must be Male or female aged 18-70 at baseline Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive Evidence of significant upper limb dysfunction as defined by a 9HPT of 15 seconds (dominant or non-dominant hand) Female subjects with reproductive capabilities must have a negative serum pregnancy test at baseline and agree to using an acceptable form of contraception for the duration of the study (barrier, coil or oral contraceptives only) Allergy/sensitivity to study medications or their ingredients Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study Subjects unable to provide written informed consent Subjects with a history of epilepsy or previous seizures (including provoked seizures) Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements Subjects with an AST or ALT ≥ 3 x ULN on liver function tests Subjects have clinically significant ECG findings as judged by the investigator, in particular evidence of a cardiac conduction defect Significant upper or lower limb arthritis as considered by the investigator to interfere with study assessments Significant cognitive impairment as considered by the investigator to interfere with study assessments Subjects with clinically significant upper limb ataxia considered by the investigator to interfere with ability to complete study outcome measures
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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 At least one prior negative prostate biopsy Prostate-specific antigen (PSA) > 4 ng/ml Known prostate cancer Contraindications against MRI Contraindications against prostate biopsy
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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 Adult women, 18 years of age or older, currently diagnosed with LUTS with a significant component of voiding symptoms The Patient must be diagnosed with one of the following: hesitancy, intermittency, difficulty in bladder emptying, or straining to void Patients must have had an AUA Symptom Score of 13 or higher Obstruction component of AUA Symptom Score (Items 1, 3, 5, and 6) had to be 5 points or higher Patients that are currently taking alpha-blockers or anticholinergics must discontinue the drugs at least 2 weeks prior to Visit 1 Patients should show compliance of greater than or equal to 80% with placebo usage Patients should be surgically sterile, or 2 years postmenopausal, or practicing a medically acceptable method of birth control Patients must have a negative urine Beta Human Chorionic Gonadotropin (beta-HCG) Patients must be able to provide written informed consent prior to participation in the study in accordance with regulatory requirements Patients must be judged by the investigator to be reliable and should comply with all tests and examinations stipulated in the protocol Patients who presented with an active urinary tract infection or who had presented with two or more culture positive urinary tract infections within 6 months of the study Patients with significant prolapse beyond the hymenal ring, per the investigator's judgment Patients who had taken anticholinergic medications for the treatment of other urologic conditions and had not discontinued their use 2 weeks prior to study entry Patients who had a history or active condition of renal or urethral calculi, urethral colic, mechanical outlet obstruction (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) 3 months prior to study entry Patients with a history of bladder, vaginal or urethral surgery in the last 6 months Patients who have a history of microscopic hematuria and not had a recent work-up including cystoscopy and upper urinary tract study (within 6 months of screening) or a diagnosis of a condition that may the patient in the opinion of the investigator Abnormal urinalysis as defined by the following mid-stream, clean-catch specimen results A bacterial colony count of greater than 100,000/ml More than 10 leukocytes per high power field with more than two granular casts per high power field More than 10 red blood cells (non-menstrual tainted urine sample) per high power field
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Prostatic Hyperplasia Male outpatients aged 50-80 years LUTS suggestive of BPH Medical history: storage symptoms (frequency, urgency) for at least 6 months Urinary Chart At least 8 micturitions per 24 hours on average, over the week of the screening period (check urinary chart at Visit 2) Urgency (strong desire to void): at least once per 24 hours on average, over the week of the screening period (check urinary chart at Visit 2) I-PSS ≥ 13 at randomisation (Visit 3) Qmax: > 4 ml/sec at randomisation (Visit 3), with a voiding volume of at least 150 ml Prostate Specific Antigen (PSA) < 2.5 ng/ml or between 2.5 and 10 ng/ml, if cancer is ruled out with the usual procedures of each centre (Visit 1; results before Visit 3) Written Informed Consent for participation to the study Patients with a known history or a diagnosis at the time of the screening visit (Visit 1) of the following conditions Urological disturbances Medical history of pelvic surgery Palpable bladder at the physical examination, or residue urinary volume > 400 ml Known neurological bladder disorder Bladder neck stenosis Urethral stricture Bladder or prostatic cancer Bladder stone Severe diverticulum of the bladder
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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, Hypertension primary care physicians registered in TelessaúdeRS (Center for Telehealth) primary care physicians who use smartphone or tablet not to work in primary care
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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, Helicobacter Pylori Infection H. pylori infected patients who have willingness to receive eradication therapy (1) history of gastrectomy, (2)gastric malignancy, including adenocarcinoma and lymphoma, (3) previous allergic reaction to antibiotics (amoxicillin, clarithromycin), N-acetyl cysteine and prompt pump inhibitors (dexlansoprazole), (4)contraindication to treatment drugs, (5) pregnant or lactating women, (6) severe concurrent disease. (7) phenylketonuria (8) Patients who cannot give informed consent by himself or herself
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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): 40.0-75.0, Prostate Cancer Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing Minimum tissue volume of 20 microns of prostate biopsy core tissue should be available (40 microns preferable) The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report Patients being managed by Active Surveillance for low stage prostate cancer Men greater than 75 years old (generally not considered for repeat biopsy) Most recent biopsy was a saturation biopsy (> 24 tissue cores) Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction Subjects who had been previously tested with ConfirmMDx
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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): 0.462-0.769, Establish Normative pH Values in Neonates Infants in the Newborn Intensive Care Unit with an NG Tube Infants with congenital or genetic abnormalities Infants with gastroschesis Infants with upper airway abnormalities Infants receiving any supplement or medication know to alter pH gastric contents Infants receiving Enfamil liquid human milk fortification Infant who are NPO status
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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 Patients' age ≥50 years 2. LUTS secondary to BOO due to BPH who failed medical treatment 3. International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8) 4. Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment. 5. ASA (American society of anaesthesiologists) score ≤3. 6. TRUS prostate size (from 30 to 80ml) Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease 2. Active urinary tract infection, 3. Presence of active bladder cancer (within the last 2 years) 4. 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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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 Voiding Dysfunction Urinary Incontinence Significant Overactive Bladder Symptoms Based on scoring 1 or 2 on the Urgency Perception Scale On the symptoms domain of the KHQ More than 8 voids per day on frequency volume chart +/ or more episodes of nocturia 2. Pressure flow studies demonstrate a maximum flow rate of less than 15ml on a minimum voided volume of 200ml with a high or normal detrusor pressure at maximum flow or post-void residual of 200ml or over 3. Patients must be able to give informed consent for the study Presence of concurrent urodynamic stress incontinence. 2. Patients with bladder pathology or haematuria of unknown origin. 3. Patients with neurological disorders (as these may affect voiding). 4. Symptomatic pelvic organ prolapse requiring intervention 5. Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin
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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 Tract Infections Hospitalized male and female patients ≥ 18 years Clinical diagnosis of either complicated urinary tract infections (cUTI) with or without pyelonephritis or acute uncomplicated pyelonephritis cUTI diagnosed with a history of ≥ 1 of the following Indwelling urinary catheter or recent instrumentation of the urinary tract Urinary retention (caused by benign prostatic hypertrophy) Urinary retention of at least 100 mL or more of residual urine after voiding (neurogenic bladder) Obstructive uropathy Azotemia caused by intrinsic renal disease (blood urea nitrogen and creatinine values greater than normal laboratory values) OR Pyelonephritis and normal urinary tract anatomy, ie, acute uncomplicated pyelonephritis AND At least 2 of the following signs or symptoms Chills or rigors or warmth associated with fever (temperature greater than or equal to 38 degrees Celsius) Flank pain (pyelonephritis) or suprapubic/pelvic pain (cUTI) Urine culture identifies only a Gram-positive pathogen and/or a Gram-negative uropathogen resistant to IPM Urine culture at study entry isolates more than 2 uropathogens or patient has a confirmed fungal UTI Asymptomatic bacteriuria, the presence of >10^5 CFU/mL of a uropathogen and pyuria but without local or systemic symptoms Patient is receiving hemodialysis or peritoneal dialysis
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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, Benign Prostatic Hyperplasia Males aged ≥40 years, weighing ≤200 Kg and able to provide written, informed consent. 2. Documented symptoms of BPH-LUTS for 6 months or more. 3. For patients regularly taking their prescribed BPH medication, dose should have been stable for at least 6 months for 5-alpha reductase inhibitors and 3 months for other BPH medications. 4. For patients who have withdrawn from regularly taking their prescribed BPH medication, there should have been a 6 month washout period for 5-alpha reductase inhibitors and 3 months for other BPH medications. 5. Have a total International Prostate Symptom Score (IPSS; Qs 1-7) of ≥ 15 at both V1 and V2 with a difference between those visits of ≤ 4 points. 6. Prostate volume of 30 mL (inclusive). 7. Maximum urinary flow rate (Qmax): 5 mL/sec (assessed on two voids each of ≥ 150mL). 8. Prostate-specific antigen (PSA) ≤10 ng/mL. 9. Post-void residual (PVR) volume ≤200 mL measured by a urinary catheter or bladder ultrasound according to local standard practice. 10. Prostatic urethral length (PUL) of between 30 m (inclusive) as measured by TRUS. 11. Willing and able to comply with photosensitivity precautions Any minimally invasive or surgical treatment within the last 12 months, and is not currently undergoing intraprostatic injections for BPH or any other prostatic condition. In any case, all enrolled subjects must have, at Baseline cystoscopy, an appearance/presentation of the prostate that is consistent with BPH and compatible with possible response to the study test treatment. 2. Subjects weighing >200 Kg. 3. Subjects with a history or current evidence of any of the following: 1. A bladder disease or condition co-exists, such as idiopathic over-active bladder (OAB) and is evaluated by the Investigator as the predominant etiology for the subject's voiding symptomatology. A score of 4 points or greater on the 3 item OAB Awareness Tool (OABV3) or a high rate of urinary frequency (>13xday and/or 4x/night) would require investigator specific evaluation in ascribing these symptoms to a bladder condition as opposed to lower urinary tract obstruction. i) If the former is the assessment, then the subject requires from the study. ii) If the latter is the assessment, then the subject may be deemed eligible for inclusion. The subject explanation must be captured in the patient source documents. 2. Active urinary tract infection i.e. must have a screening urinalysis without signs of infection or negative urine culture. Must not have had a previous symptomatic urinary tract infection within 4 weeks of the study. 3. Urethral stricture or any other anatomical feature that would complicate catheterisation. 4. Interstitial cystitis. 5. Predominant prostate middle lobe, as determined by the Investigator. 6. Prostate or bladder cancer or bladder carcinoma-in-situ in particular, evidence from digital rectal exam (DRE) of prostate abnormalities suggestive of cancer in the last 12 months. 7. Any other absolute indication for urosurgical intervention (such as acute or frequent retention, currently untreated bladder or urethral stones, urethral strictures/bladder neck contracture (BNC)). 8. Damage to the bladder neck which could interfere with study procedures. 4. PSA level in excess of >10 ng/ml. If the PSA measurement is 2.5-10 ng/ml and/or has shown a clinically significant concerning increase in the last 6 months, local standard of care must be pursued to ensure the possibility of prostate cancer has been followed up and ruled out prior to study entry. 5. Subjects who had had a prostate biopsy within 6 weeks prior to Screening. 6. Any neurological condition affecting the bladder or a history of a neurogenic or chronically decompensated bladder i.e. neurogenic bladder, Parkinson's disease, history of chronic prostatitis within the last 5 years. 7. Prior treatment for urinary incontinence. 8. Requirements for daily incontinence pads or devices. 9. Subjects in whom nocturia is due to etiologies other than their BPH-LUTS, such as neurogenic bladder, diabetic neuropathy, neurocongestive heart failure, hepatic failure, nephritic syndrome, sleep disorder. 10. Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study i.e. unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriche's syndrome. 11. Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant. 12. Unwilling to use contraception for 3 months following administration of study medication or with an interest in future fertility. 13. A prolonged QTcF interval at baseline and/or who are currently taking medication that prolongs QT interval ("prolonged QTcF interval" defined as > 450 ms). 14. Known sensitivity to porphyrin-type drugs or known history of porphyria. 15. Any contraindications to use of the study treatment. 16. Active alcohol or drug abuse. 17. Subject has clinical laboratory test results outside the reference ranges of the testing laboratory that are deemed to be clinically significant. Subjects with isolated test results that are outside the specified ranges and that are assessed as clinically insignificant will be allowed at the discretion of the Investigator, after discussion with the Sponsor's Medical Monitor/Study Physician, if appropriate. If a subject has 1 isolated test result outside the specific range that is deemed potentially clinically significant, rescreening may be allowed at the discretion of the Investigator, after discussion with the Medical Monitor/Study Physician 18. Subjects with known disorders of coagulation, apart from those receiving anticoagulant / antithrombotic / antiplatelet therapy in whom the dose of such medication must have been stable for at least 1 month prior to randomisation. In those receiving Vitamin K antagonists (warfarin, acenocoumarol, phenindione, etc) the INR value at baseline should be <3.0. 19. Inability or unwillingness to comply with the required photosensitivity precautions during the three weeks following study treatment. 20. Subjects taking medications with a recognised propensity for causing photosensitivity (such as amiodarone, tetracyclines, sulphonamides) that cannot be discontinued for the initial study period, namely from 14 days prior to administration of study medication until 28 days afterwards. 21. Subjects with medical or investigation results deemed unfit for study treatment, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study. 22. Subjects who have received an investigational medicinal product within 30 days or 5 half-lives of the investigational product prior to study entry (defined as the start of the Screening Period). 23. Subjects who are incapable of giving informed consent or complying 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): 0.0-999.0, Stage I Prostate Adenocarcinoma AJCC v7 Stage II Prostate Adenocarcinoma AJCC v7 Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core, either random or targeted, in the most recent biopsy All prior biopsies must meet the following: =< 50% of the total number of random biopsy cores positive for cancer Gleason score =< (3+4) Clinical stage =< T2a by digital rectal exam (DRE) Biopsies performed at outside institutions should have Gleason score confirmed at the study site by a genitourinary (GU) pathologist to ensure Pre-intervention biopsy tissue (most proximal to enrollment) with sufficient tumor tissue to cut 5-10 unstained slides confirmed to be available upon request Screening serum PSA < 20 ng/mL; for men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL Neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL) Stable platelet count >= 75,000/mm^3 (>= 75 k/uL) Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome) Have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy Patients who have prostate cancer with distant metastases Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient; such illnesses/conditions may but are not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Positive for human immunodeficiency virus (HIV) or active infections for hepatitis B, and/or hepatitis C, based on medical history Prior solid organ or bone marrow transplant Immunodeficiency or splenectomy Chronic immunosuppressive therapy within 30 days of screening Inflammatory eye disease requiring steroid treatment within 28 days of screening Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Weakness Adult patients requiring mechanical ventilation for more than 48 hours Respiratory failure present The physician caring for the patient determines that the patient is too unstable Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine) Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure) Presence of a cardiac pacemaker or implanted defibrillator Use of neuromuscular blocking agents within the 48 hours preceding testing History of a preexisting neuromuscular disease Presence of profound and uncorrectable hypokalemia (less than 2.5) or hypophosphatemia (less than 1.0) Pregnancy If the patient is a prisoner If the patient is institutionalized
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostate Hyperplasia Lower Urinary Tract Symptoms Patients' age ≥50 years 2. LUTS secondary to BOO due to BPH who failed medical treatment 3. International prostate symptom scores 8 (IPSS) >15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8) 4. Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment. 5. ASA (American society of anaesthesiologists) score ≤3. 6. TRUS prostate size (>/=80ml) Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease 2. Active urinary tract infection, 3. Presence of active bladder cancer (within the last 2 years) 4. 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): 50.0-70.0, Ketone Body Metabolism Brain Metabolism Healthy BMI 20-30 kg/m2 smoking alcohol abuse severe comorbidity blood donation 6 month prior claustrophobia
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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): 40.0-89.0, Prostatic Hyperplasia Patient has provided signed informed consent Patient is aged greater than or equal to 40 and less than or equal to 89 years of age Patient has a prostate size between 90g and 200g, as determined by MRI Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment Patient has an IPSS score of at least 13 at baseline Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment Patient either: refuses surgical treatment OR is contraindicated for surgical treatment Patient meets ONE of the following baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months History of prostate, bladder, or rectal cancer History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies History of open bladder, rectosigmoid colon, or other pelvic surgery Patient is unwilling to discontinue alpha blockers 1 month after study treatment Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia Active prostatitis or urinary tract infection Cystolithiasis within the past 3 months Serum creatinine > 1.7mg/dL
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Nocturia Age ≥ 18. 2. Subject is willing and able to complete the micturition diary and sleep questionnaires correctly. 3. Symptoms of overactive bladder (OAB) (urinary frequency and urgency with or without urgency incontinence) for at least 3 months, with an IPSS ≥ 12. 4. Moderate sleep disturbance with a mean score on the Jenkins Scale > 7. 5. Micturitions/24 hrs ≥ 8; total excretory volume of <3L. 6. Washout period of 2 weeks for any drugs not listed in the exclusions Subject is using prohibited medications which cannot be stopped safely at the screening visit. Subject is excluded if using restricted medications not meeting protocol-specified (i) Phytotherapy for benign prostatic hypertrophy (BPH) or a 5-alpha reductase inhibitor within 3 months. (ii) Alpha blocker within 2 weeks. (iii) Taken an oral alpha agonist, tricyclic antidepressants, and anticholinergic or cholinergic medication within 2 weeks of the first screening visit with the following exception: topical anticholinergic eye drops used for glaucoma or inhaled anti-cholinergic used for chronic obstructive pulmonary disease (COPD). (iv) Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 3 months. 2. Post void residual volume > 350 mL. 3. Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control. 4. Subject has neurogenic bladder. 5. Any prior invasive intervention for LUTS (including bladder paralytics such as botulin toxin) 6. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test). 7. Subject has an indwelling catheter or practices intermittent self-catheterization. 8. Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease, diabetic neuropathy or any neurological diseases known to affect bladder function. 9. Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs. 10. Two documented independent urinary tract infections of any type in the past year. 11. Patient with a diagnosed sleep disorder (ie. Obstructive Sleep Apnea) undergoing evaluation and treatment requiring change in care within 30 days of screening visit. 12. Subject has moderate to severe hepatic impairment [ALT (SGPT), AST (SGOT) or GGT value greater than 3 times the upper limit of normal in the clinical center lab; confirmed on a second measurement]. 13. Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine greater than 2.0 mg/dl). 14. PSA (prostate specific antigen) level greater than 10 ng/ml at the first screening visit (if male). 15. Subject has severe uncontrolled hypertensionas defined by a systolic pressure ≥180 mmHg and/or diastolic pressure ≥120 mmHg. 16. Subject has a clinically significant abnormal ECG or has a known history of QT prolongation or currently taking medication known to prolong the QT interval. 17. Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive ingredients. 18. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. Men with a history of prostate cancer regardless of curability are not eligible. 19. Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives. 20. Unable to follow protocol directions due to organic brain or psychiatric disease. 21. 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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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, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic at study entry Have been treated with a stable dose of an alpha1 blocker (tamsulosin 0.2 mg once daily or silodosin 4 mg twice daily) for at least 8 weeks prior to screening, and continue the same alpha1 blocker at the same dose for the entire duration of the study Are Japanese men Have prostate volume ≥20 milliliters (mL) estimated by transabdominal or transrectal ultrasound at screening Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥12 at screening and baseline Have moderate LUTS with urinary peak flow rate (Qmax) ≥4 to ≤15 mL/second at baseline, while meeting both of the following Prevoid total bladder volume ≥150 to ≤550 mL as assessed by ultrasound Minimum voided volume ≥125 mL Demonstrate ≥80% compliance with alpha1 blocker treatment* during the screening period, documented at baseline *Tamsulosin: (Number of doses taken / Number of days to be treated) × 100 Prostate-specific antigen (PSA) >10.0 nanograms (ng)/mL at screening PSA ≥4.0 to ≤10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist Bladder post-void residual (PVR) ≥150 mL by ultrasound determination at screening History of any of the following pelvic conditions Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection Pelvic radiotherapy Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery Lower urinary tract malignancy or trauma Lower urinary tract instrumentation (including prostate biopsy) within 30 days of screening History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening
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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): 55.0-999.0, Prostate Cancer Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics PSA less than or equal to 10 ng/dl and Gleason's 7 (4+3 or 3+4) or Gleason's 6 and Age greater than 55 years old and Clinical Stage T1 or T2 Clinically localized (no evidence on clinical or imaging studies of advanced disease) No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable Known history of hypogonadism
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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, Weakness of functional independence before hospital admission (Barthel scale > 70 points) Invasive mechanical ventilation < 72 hours Signed informed consent Neuromuscular disease (peripheric or central neurologic disorder) Presumed fatal evolution in 48 hours Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism) Admission due to cardiac arrest Pregnancy Thrombopenia less than 50.000 Severe agitation Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm
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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 Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians. 2. Age ≥ 18 years. 3. The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period. 4. The ability to give informed consent and complete self-reported questionnaires electronically. Table 1: LUTS Appropriate for Study Daytime frequency Nocturia Urgency Incontinence/leakage (various types) Poor or absent sensation of bladder filling Slow/weak stream Splitting or spraying Intermittent stream/Double voiding Hesitancy Gross hematuria. 2. Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis. 3. Primary complaint is pelvic pain. 4. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia. 5. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy). 6. Current sexually transmitted infection. (deferral; subject can enroll after negative culture) 7. Ongoing symptomatic urethral stricture. 8. History of lower urinary tract or pelvic malignancy. 9. Current chemotherapy or other cancer therapy. 10. Pelvic device or implant complication (e.g., sling or mesh complications). 11. Current functioning neurostimulator. 12. Botox injection to the bladder or pelvic structures within the preceding 12 months. 13. In men, prostate biopsy in the previous 3 months. 14. In women, pregnancy. 15. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy. 16. Augmentation cystoplasty or cystectomy. 17. Presence of urinary tract fistula. 18. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.). 19. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease). 20. Difficulty reading or communicating in English
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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, Metastatic Prostate Cancer Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately Age ≥ 18 years at the time of consent Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 14 days prior to registration Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative Documented histologically or cytologically confirmed adenocarcinoma of the prostate Ongoing androgen deprivation therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or bilateral orchiectomy. Subjects who have not undergone orchiectomy must plan to continue GnRH analogue therapy for the duration of the trial All subjects on oral anti-androgen therapy must have been off therapy for at least 4 weeks prior to registration (6 weeks for bicalutamide) to an anti-androgen withdrawal response. Patients who received secondary anti-androgen therapy and did not exhibit a >50% PSA decline, or subjects with any rise in PSA, objective or symptomatic progression following anti-androgen withdrawal will not be required to meet this withdrawal requirement Documented metastatic disease with prostate-specific antigen (PSA) progression, radiographic progression, or both, despite receiving luteinizing hormone releasing hormone (LHRH) analogue therapy or orchiectomy with a serum testosterone level of 50 ng/dL or less PSA progression is defined as three successive rising PSA values with an interval of at least one week between determinations Radiographic progression is defined by Response Evaluation in Solid Tumors (RECIST) 1.1 or at least two new lesions on bone scan Prior enzalutamide or other next-generation androgen receptor (AR) targeting therapy Prior PARP-inhibitor therapy History of or active central nervous system (CNS) metastases. Subjects with neurological symptoms must undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to brain metastasis Radioisotope or external beam radiation exposure in the last 4 weeks. Exposure to strontium, regardless of when exposure occurred Prior radiation to 25% or more of the bone marrow Treatment with any investigational agent within 28 days prior to registration Known significant immunodeficiency as determined by the site investigator Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, or other cancer for which the subject has been disease-free or stable for at least one year Prolonged QTc over 470 ms
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Benign Prostate Hyperplasia Subject signed informed consent form (ICF) 2. Age 50 and above 3. Male with symptomatic BPH. 4. IPSS symptom severity score ≥ 10 5. Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial. 6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound) 7. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP) 8. Subject able to comply with the study protocol 9. Normal Urinalysis and urine culture Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression; 11. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes 12. A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention 13. Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease); 14. Confirmed or suspected bladder cancer; 15. Recent (within 3 months) cystolithiasis or hematuria; 16. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology; 17. An active urinary tract infection. 18. Enrolled in another treatment trial for any disease within the past 30 days. 19. 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; 20. Previous pelvic irradiation, cryosurgery or radical pelvic surgery; 21. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate 22. History of prostatitis within the past 5 years. 23. Median lobe obstruction of the prostate. 24. Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). 25. Any serious medical condition likely to impede successful completion of the study 26. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study. 27. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period. 28. Baseline PSA ≥ 10 ng/ml. 29. Positive DRE. 30. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy
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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, Multiple Sclerosis Man or woman between 18 and 60 years old Patient with one or more type of inflammatory events of Central system suggestive of demyelinating disease (multiple sclerosis, neuromyelitis optical Devic extensive myelitis) No treatment with corticosteroids for less than 1 month Need for a lumbar puncture performed in the etiologic Need a brain MRI performed within the etiologic Patient who signed informed consent Secondary progressive MS Any cons-indication for lumbar puncture Any contra-indication to MRI Minor patient or patient major under guardianship
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia persistent moderate to severe LUTS as determined by International Prostatic Symptom Score (IPSS) >8 peak urinary flow rate of less than 12 mL/s an enlarged prostate gland on digital rectal examination history of previous surgery for BPH presence of urethral stenosis urinary tract infection prostate or bladder cancer history of pelvic surgery or radiotherapy neurological diseases urinary retention BPH-associated complications requiring surgical treatment including bladder stone, and bilateral hydronephrosis
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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): 1.0-70.0, Genetic Blood Group (bg) Polymorphism in U Negativity and St(a) of MNSs Existing biomaterial (gDNA), or Existing health related data for blood group U (n max=2) and eligible for (venous) blood sampling of 20 mL, or Existing blood group pheno and genotyping data indicating St(a)+ and eligible for (venous) blood sampling of 20 mL (n max=2), or Adequate blood group profile serving as reference (n max =4 & n max =4'000) and eligible for (venous) blood sampling of 20 mL Ineligible for venous blood sampling of approx. 20 mL
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer Age ≥18 years Biopsy proven adenocarcinoma of the prostate Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included Planned radical prostatectomy at MSKCC Multiparametric MRI of the pelvis (performed or planned) as routine care Patients meeting any of the following will not be eligible for study entry Hematologic Platelets <75K/mcL ANC <1.0 K/mcL Hepatic laboratory values Bilirubin >2.0 x ULN (institutional upper limits of normal) AST/ALT >2.5 x ULN Renal laboratory values o Creatinine > 2.0 x ULN Claustrophobia interfering with MRI and PET/CT imaging
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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, Benign Prostatic Hyperplasia Patients evaluated in the Urology Service because of BPH, candidate to TURP Signed informed consent Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score > 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI Patient must meet ONE of the following 1. Baseline Prostate Specific Antigen (PSA) <4 ng/mL (no prostate biopsy required) 2. Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA > 15% of total PSA (no prostate biopsy required) 3. Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA <15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy) 4. Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) Active urinary tract infection Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study Biopsy proven prostate or bladder cancer The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study Patients with digital rectal examination (DRE) findings suspicious for prostate cancer Patients with baseline PSA levels > 10 ng/mL Patients with baseline PSA levels >4 ng/mL and < 10 ng/mL AND free PSA < 15% of total PSA Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc) Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition Allergy to iodinated contrast agents
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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): 45.0-80.0, Prostatic Hyperplasia Benign Prostatic Hyperplasia (BPH) Prostatism Lower Urinary Tract Symptoms (LUTS) Prostatic Hypertrophy Hyperplasia Male Urogenital Diseases Genital Diseases, Male Patients between ages 45-80 years Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate cancer or urethral cancer Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study Patients who are classified as New York Heart Association Class III (Moderate), or higher Patients with history of prior pelvic irradiation Hypersensitivity reactions to contrast material not manageable with prophylaxis Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50
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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): 16.0-999.0, Community-acquired Pneumonia Fever with or without respiratory symptoms New infiltrate on chest radiograph Pneumonia Severity Index (PSI) score ≤ 70 (risk classes I and II) PSI risk classes III-V Age ≥65 years Comorbidity (diabetes, chronic obstructive pulmonary disease, chronic renal disease, neoplasia, immunosuppression including HIV infection, chronic heart failure or cirrhosis) White blood cell count ≥20.0 x 109/L Pleural effusion Bilateral infiltrates Previous failure or allergy to macrolides or quinolones Need for oxygen 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): 5.0-14.0, Overactive Bladder Male or female ≥ 5 years old and ≤14 years old, and that completed the initial randomized study (Foxy2014) OAB diagnostic according to the International Children Continence Society (ICCS) and less than 65% of the expected mean bladder capacity for age is confirmed (30 + (age in years x 30) mL) on a 3-day voiding diary Weight and height are within the normal percentile (3rd to 97th percentile) and weight is ≥ 20 kg (3rd percentile of a 8 y.o. child, boy or girl), according to the CDC growth chart Ability to swallow pills Subjects/parents (vs. legal guardian) agree to participate to the following study and sign the informed consent Subjects/parents (vs. legal guardian) are able to comply with the study requirements and with the medication restrictions. Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. Sexually active male subjects agree to use a barrier method of birth control with female partner for the duration of the study and at least one month after ending study treatment. Sexually active male subjects agree to use a condom for the duration of the study and for at least one month after ending study treatment and the female partner to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment Subject has a diagnostic of dysfunctional voiding Post-voiding residue > 20 cc Polyuria (> 75 ml/kg/b.w./24 hours) Nephrogenic of central diabetes insipidus Constipation at screening (if the patient is treated and the treatment is successful, the patient will be eligible to the study) Urinary tract infection at visit 2-3-4. If UTI is present at the screening visit, the UTI must be treated and the success of the treatment must be documented with a negative urinalysis at visit 2 QTc interval greater than 460 ms, or any increase of 30 ms on follow-up EKG (mean of 6 separate EKG-3 from visit week-2 and 3 from visit week 0). If a patient meets those in the first month (initial dose), he will be excluded from the study. If the QTc change is noted after the up-titration, the dose will be decreased and EKG will be repeated within 1 week to ensure normalization of QTc Clinically significant unstable medical condition or disorder Subject is pregnant or intends to become pregnant Serum creatinin more than or equal to 2 times the upper limit of normal
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-75.0, Chronic Kidney Disease male and female patients patients with subclavian long term central venous catheter patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions) pregnant; patients on oral coagulants; patients aged less than 18 years patients aged more than 75 years
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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, Lower Urinary Tract Symptoms Aged 40 years or older on the date of survey Able to read local language Able to access the internet and use a computer (with or without the help of an assisting person who may or may not be a family member) Provides of informed consent Is pregnant Diagnosed as having urinary tract infection by a physician in the past one month which may be cured or persisting
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Prostate Cancer age (>18 yrs/old) low risk prostate cancer defined as primary tumor stage according to AJCC 2010: T1-2a and Gleason Score-GLS: 3+3 and serum Prostate Specific Antigen-PSA: PSA<10 ng/ml); or among intermediate risk prostate cancer defined as clinical stage T2b-c or GLS 7 or PSA of 10-20 ng/ml, only patients with favourable characteristics: a single factor for intermediate risk AND GLS 3 + 4 AND <50% of biopsy cores containing cancer (12 cores as a minimum) prior radiotherapy concomitant androgen deprivation pt failure to consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 0.0-76.0, Prostatic Neoplasms Men with newly diagnosed prostate cancer who are categorized as Very Low, Low, or Intermediate risk by NCCN criteria Are age 76 or younger Men who are categorized as High or Very High risk by NCCN criteria Men who have already received counseling from their urologist about their treatment options and have decided to undergo treatment, active surveillance, or watchful waiting Men age 77 or older
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Hypogonadism Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL. 2. Adequate venous access to allow blood sample collections via venous cannula. 3. Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study. 4. Voluntarily provide written informed consent to participate in this study Subjects meeting any of the following will not be eligible: 1. Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness) 2. Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA. 3. BMI less than 18 kg/m2 or greater than 37 kg/m2 4. Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL. 5. History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures. 6. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation. 7. Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks. 8. Parenteral T-undecanoate therapy within the past 6 months. 9. Use of dietary supplements that may increase serum T, within previous 4 weeks. 10. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol. 11. Smokers unable to refrain from smoking during required confinement period. 12. History of, or current evidence of, abuse of alcohol or any drug substance. 13. Receipt of any research study drug within 30 days of study. 14. Blood donation within the 12 week period before the initial study dose. 15. Hematocrit less than 35% or greater than 50%. 16. History of clinically significant polycythemia following treatment with a testosterone replacement product. 17. Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates. 18. History of uncontrolled sleep apnea
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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 Hypertrophy Lower Urinary Tract Symptoms Patients selected for this study must meet all of the following Age ≥ 50 years Lower urinary tract symptoms secondary to BPH as defined by IPSS Symptom Index ≥ 12 Maximum Uroflow rate (Qmax) of ≤ 12cc per sec Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS) Patients meeting any of the following will be excluded from the study Age less than 50 years Prostate cancer Bladder cancer Severe, life-threatening allergy to iodinated contrast Bilateral internal iliac artery occlusion Causes of obstruction other than BPH such as stricture disease Neurogenic bladder or other causes of bladder atonia Post void residual greater than 250 cc Any contraindication to embolization, including
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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 Subjects must meet all of the to participate in this study Histologically documented adenocarcinoma of the prostate Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant low or high risk groups" or the "salvage low or high risk groups" as indicated below. In those cases where patients undergo a prostatectomy without any sampling of the pelvic lymph nodes, patients will be also considered eligible if they are found to have a negative pelvic CT or MRI scan which shows no evidence of lymphatic nodal metastases after the prostatectomy "Adjuvant High Risk Group" are those patients with an undetectable or persistent/decreasing PSA levels (before starting therapy) who MUST be able to start radiation therapy treatments within 6 months of radical prostatectomy with at least ONE of the 3 disease features Pathologic T2N0 (with no clinical evidence of metastases) and Gleason Score ≥ 8 Pathologic T3aN0 (with no clinical evidence of metastases) with Extra-Capsular Extension and Gleason Score ≥ 8 Pathologic T3bN0 (with no clinical evidence of metastases) with any Gleason Score "Salvage High Risk Group" are those patients who experience a PSA failure (defined as at least 1 detectable PSA level > 0.2 ng/ml or at least 2 consecutive increases in PSA levels over baseline which are at least 1 month apart after radical prostatectomy) with at least ONE of the 4 following features Pathologic T3bN0 disease (with no clinical evidence of metastases) Pathologic T2-3aN0 disease (with no clinical evidence of metastases) with Gleason Score ≥ 8 Subjects meeting any of the at baseline will be excluded from study participation Patients who have received prior pelvic irradiation are not eligible Any coexisting medical condition precluding full compliance with the study Patients with active infections or known infection with HIV. Testing for HIV status will not be required Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Pneumonia Blood Stream Infection Patient of 18 years of age or older 2. Expectation of hospitalization and receipt of polymyxin B of ≥ 48 hours 3. Receipt of intravenous polymyxin B for treatment of a bloodstream infection (according to CDC 55) and/or pneumonia 4. Provision of written informed consent by the patient or by the patient's health care proxy if the patient cannot give consent 5. Adequate venous access to enable collection of blood for determination of concentrations of polymyxin B and co-administered antibiotics Age <18 years 2. Currently incarcerated 3. Concomitant use of polymyxin B delivered directly into the respiratory tract 4. Cystic fibrosis 5. Known allergy to CMS/colistin or polymyxin B 6. Anticipated death within 48 h of commencing polymyxin B 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): 18.0-75.0, Drug Induced Liver Injury All patients with severe DILI (Drug Induced Liver Injury) Age more than or equal to 18 years Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive Patients with sepsis AMA positive Low Ceruloplasmin Transferrin saturation >45% Patients with Cirrhosis Patients with h/o jaundice prior to the intake of drug
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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, ph+ Acute Lymphoblastic Leukemia Get signed the informed consent of patients and family members 2. Age ≥ 18 one full year of life 3. Confirm the ph + ALL at molecular biology level 4. Normal heart and lungs function 5. Normal liver and kidney function Leukemia in the nervous system 2. Recurrent patients 3. Allergies associated with any drug in our research 4. At the same time with other organs' malignant tumours 5. participating in other clinical researches at the same time
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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, Cystic Fibrosis Cystic Fibrosis as documented by clinical features, and documentation of a positive sweat test or two disease causing mutation of the CF gene use of supplemental oxygen, FEV1 < 40% predicted, inability to discontinue inhaled antibiotics for 4 weeks hospitalization within 4 weeks prior to enrollment change in maintenance CF therapies within 4 weeks of enrollment severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ transplantation
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 40.0-65.0, BPH Age between 40 and 65 years Only Male included Has suffered from symptoms of BPH for at least the 6 months before Screening Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound Has an IPSS ≥ 8 at Screening and Baseline Patients willing to give informed consent in writing Neurogenic bladder dysfunction Has bladder neck contracture or urethral stricture Has acute or chronic prostatitis or urinary tract infection Has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam Participation in any other clinical trial with in the last 30 days Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening Urine flow< 5mls/sec Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month Has hematuria of unknown etiology Previous radiotherapy
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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): 18.0-80.0, Kidney Transplantation, Mannitol all patients with end stage renal diseases - Patients younger than 18 years of age or older than 80, alergy to mannitol, Pregnancy, Breast-feed -
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Overactive Bladder Benign Prostatic Hyperplasia (BPH) Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months I-PSS(S) score of ≥ 12 Maximum flow rate (Qmax) of 4 to15 mL/sec Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary Benign digital rectal examination (DRE) result Clinically significant outflow obstruction Significant post void residue volume (PVR >100ml) Prostate specific antigen (PSA) ≥10 ng/mL Previous or planned prostate surgery, including transurethral resection of the prostate (TURP) Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months Patient with a neurological cause for abnormal detrusor activity Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated Patients with any other complication which may cause voiding dysfunction Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
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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): 65.0-79.0, Obesity Weight Loss Age 65-79 years BMI=30-40 kg/m2 Confirmation of self-reported mobility disability, as assessed by phone screen/clinical staff Self-reported sedentary behavior Non-impaired cognitive function (MoCA>18) Stability of residence for next 2 years Willing and able to follow dietary protocol Willing to provide informed consent Approved for participation by study physician Not involved in another behavioral or interventional research study Weight loss or gain (±5%) in past 6 months Prior bariatric surgery Multiple food allergies Difficulty with hearing/vision that interferes with study participation Excessive alcohol use (>14 drinks/week) Smoker (>1 cigarette/d within year) Insulin-dependent or uncontrolled diabetes (FBG >140 mg/dl) Uncontrolled hypertension (BP>160/100 mmHg) Abnormal kidney tests (GFR<40, creatinine >2.0) Regular use of medications that may influence body weight or composition
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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, Benign Prostatic Hyperplasia Overactive Bladder assessed at Visit 1 (Screening) Men ≥40 years of age with history of overactive bladder (OAB) symptoms (frequency of ≥8 micturitions per day and urgency episodes of ≥2 per day) while taking tamsulosin hydrochloride for at least 2 months to treat LUTS due to BPH Subject has symptoms of OAB (urinary frequency and urgency with or without incontinence) for ≥3 months prior to Screening Subject has an International Prostate Symptom Score (IPSS) score ≥8 Subject has Prostate-Specific Antigen (PSA) <4 ng/mL or ≥4 but < 10 ng/mL with a prostate biopsy that is negative for cancer in the past 2 years Subject is willing and able to complete the 3-day diary (including urine volumes, vital signs measurements), and Quality of Life questionnaires Subject and the subject's spouses/partners who are of childbearing potential must be using a highly effective birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS). Birth control must be practiced from Screening and continue throughout the study and for 30 days after the final study drug administration. In addition, sperm donation will not be allowed throughout the study and for 30 days after the final study drug administration Subject agrees not to participate in another interventional study while on treatment. assessed at Visit 2 (Baseline) based on the 3-day diary Subject continues to meet all of Visit 1 (Screening) Subject must experience an average of 8 or more micturitions per day over the 3-day diary period assessed at Visit 1 (Screening) Subject has post-void residual volume (PVR) >200 mL Subject has maximum urinary flow (Qmax) <5.0 mL/second with a minimum voided volume of 125 mL Subject has hematuria >3 rbc/hpf that has not been fully evaluated Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, nitrites, or turbidity and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI, at Screening (Visit 1) the subject may be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture) Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.) Subject has diabetic neuropathy Previous open, robotic or minimally invasive prostate surgery (including transurethral procedures). Planned (scheduled) pelvic or prostate surgery during the study period Planned (scheduled) cataract surgery Subject with significant stress incontinence
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Prostatic Hyperplasia Greater than or equal to (>=) 50 years of age at the time of signing the informed consent form Male Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol Present in a General Practice setting for a reason unrelated to this study Positive IPSS score >=8 and/or positive BPE/BPO screening tool score >=3 History of BPH for which they have received test procedures, medical intervention and/or medicine History of prostate-related LUTS for which they have received test procedures, medical intervention and/or medicine History of prostatic surgery (including transurethral resection of the prostate (TURP), balloon dilatation, thermotherapy, and/or stent replacement) or other invasive or minimally invasive procedures to treat BPH Has other conditions that may cause urinary symptoms (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections, etc.) History or evidence of prostate cancer (e.g., positive biopsy or ultrasound, suspicious DRE and/or rising PSA) Current or prior use of the following: 5alpha-reductase inhibitors (finasteride or dutasteride); anti-cholinergics (e.g. oxybutynin, propantheline, tolterodine, solifenacin, darifenacin, mirabegron) alpha-adrenoreceptor blockers (i.e., indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin and silodosin), herbal products for urinary symptoms; Use of any investigational study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding the first study visit Use within previous 30 days at Visit 1 of: phosphodiesterase type 5 inhibitor (PDE-5) inhibitors for erectile dysfunction; anabolic steroids
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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, Cystic Fibrosis Parts 1 and 2: 1. Healthy, males and females between 18 and 55 years of age, inclusive, with a BMI of >19 and <30 kg/m2. 2. If sexually active, must meet the contraception requirements. Part 3: 1. Male and female subjects aged 18 years and older. 2. If sexually active, must meet the contraception requirements. 3. Diagnosis of CF. 4. History of pancreatic insufficiency. 5. Forced expiratory volume in 1 second (FEV1) ≥40% of predicted normal for age, sex and height at screening Parts 1 and 2: 1. Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that could adversely affect the safety of the subject. 2. Alkaline phosphatase, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at screening. 3. Use of prescription or non-prescription drugs within 21 days or five half-lives (whichever is longer) before the first dose of study medication, unless the medication will not interfere with the study procedures or compromise subject safety. 4. Pregnant or nursing females. 5. Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). 6. History of prolonged QT and/or QTcF interval. 7. ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening. 8. Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol screen at Day -1. 9. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units. 10. History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening. 11. Donation of 500 mL or more blood within 3 months before Day -1. 12. Participation in a clinical trial involving receipt of an investigational product within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day. 13. Current smoking or use of tobacco products or substitutes. Former smokers will be eligible, provided they have not smoked for at least 6 months before Day -1. 14. Use of any prescription and non-prescription medications that are inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 7 days before Day -1. Part 3: 1. History of any illness, or ongoing acute illness that could impact the safety of the subject or confound study results. 2. Abnormal liver function ≥3 x ULN: AST, ALT, total bilirubin. 3. A pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to the Baseline (Day 1) Visit 4. Use of herbal and dietary supplements within 21 days or five half-lives (whichever is longer) before the first dose of study medication, unless the medication will not interfere with the study procedures or compromise subject safety. 5. Pregnant or nursing females. 6. Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). 7. History of prolonged QT and/or QTcF interval. 8. ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening. 9. Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol screen at Day -1. 10. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units. 11. History of HIV, or positive HIV, hepatitis B or hepatitis C results at screening. 12. Donation of 500 mL or more blood within 3 months before Day -1. 13. Participation in a clinical trial involving receipt of an investigational product within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day. 14. Current smoking or use of tobacco products or substitutes. Former smokers will be eligible, provided they have not smoked for at least 6 months before Day -1. 15. Use of any prescription and non-prescription medications that are inhibitors or inducers of CYP3A4, within 7 days before Day -1
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Guillain-Barré Syndrome fulfill the diagnostic for GBS patients of the National Institute of Neurological and Communicative Disorders and Stroke (NINDS) [19] ≥ 18 years of age at diagnosis unable to walk unaided for more than 10 meters (GBS disability score ≥ 3) included within 2 weeks of onset of weakness unable to afford standard treatment with IVIg or standard PE Informed written consent previous severe allergic reaction to properly matched blood products evidence of healthcare associated infection present on admission (except aspiration pneumonia) severe concomitant illness or terminal underlying disease 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): 50.0-80.0, Benign Prostatic Hyperplasia 50 to 80 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 4. Anterior prostatic urethral length 2.5 0 cm by cystoscopy, as measured from bladder neck to verumontanum. TRUS will be accepted as a primary screening measure. 5. Failed or intolerant to medication regimen for the treatment of LUTS New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. exemptions for these patients are described in 4a, 5a and they are exempt from #6. Participants will be excluded from participating in this trial if they meet any of the following 1. Obstructive 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. Elevated Prostate Specific Antigen (PSA) (age 50-70 PSA ≥4; age 70+ PSA ≥6.5) unless negative biopsy within last 3 months, or a positive biopsy 4. Post-void residual volume (PVR) > 250 ml, if not in acute retention 4a. No maximum post void residual volume required if patient in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) 5. Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline. 5a. No maximum urinary flow or minimum voided volume required if participant in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) 6. History of chronic urinary retention. (New Zealand Only, up to 5 patients) 7. History of neurogenic bladder 8. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) 9. Concomitant Urinary Tract Infection (UTI) 10. Concomitant bladder stones 11. Confirmed or suspected prostate/bladder cancer 12. Previous pelvic irradiation or radical pelvic surgery 13. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate 14. Chronic prostatitis, or recurring prostatitis within the past 12 months 15. Serious concurrent medical conditions such as uncontrolled diabetes 16. Known allergy to nickel 17. Life expectancy less than 12 months 18. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function 19. Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure. 20. 5--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). 21. -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). 22. Future fertility concerns 23. Any severe illness that might prevent study completion or would confound study results
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-65.0, Overweight Main <= BMI < 30 kg.m2 Main ASAT <= 1,55 microkat/L ALAT <= 1,70 microkat/L gGT <= 2,55 microkat/L <= Creatinine <= 104 micromol/L (+ Bilirubin < 17,1 micromol/L (+ 7 <= Urea <= 8,3 mmol/L (+ us-CRP <= 5 mg/L (+ 70 <= Fasting glycemia <= 1,25 g/L (+ HbA1c <= 6% Medications for diabetes and/or dyslipidemia
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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): 36.0-72.0, Diabetes Mellitus, Type 2 Aged from 36 to 72 years of either gender; 2) BMI >28.0 kg/m2, and WC >90 cm (male), or WC >85 cm (female); 3) The patients were diagnosed with T2DM and the serological outcome (7.0%<HbA1c<10.0%) did not reach the therapeutic targets and oral metformin monotherapy (500 mg, bid po, ≥3 months prior to screening); 4) No smoking history, pulmonary disease nor pulmonary infection within a fortnight; 5) Did not have hepatopathy, nephropathy and gastrointestinal disease; and 6) Likely to have good compliance and able to visit our hospital for periodic assessments T1DM, gestation and lactation; 2) Renal inadequacy; 3) hypohepatia; 4) Intensive care with insulin treatment; 5) Intolerance to alogliptin and metformin; 6) Heart failure; 7) Had received antidiabetic agents; 8) Antihypertensive drugs can not control the BP adequately or severe uncontrolled hypertension; 9) Cholesterol-lowering drugs can not control the blood-fat adequately; and 10) Use of weight loss drugs. -
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Lower Urinary Tract Symptoms Men ≥45 years of age. 2. LUTS, based on IPSS total score ≥8 and <25 3. Peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec at screening 4. Post Void Residual (PVR) urine volume ≤ 200 mL at screening 5. PSA level at screening < 10 ng/mL. Subjects with a PSA > 4ng/mL and < 10 ng/mL are eligible only if prostate cancer has been ruled out 6. Subjects who understand and speak English 7. Able and willing to give informed consent and comply with all study protocol procedures (diaries and other study tools) Not suitable for medical intervention (e.g., requiring TURP, etc.) 2. History of interstitial cystitis, bladder stones, urethral stricture, current prostatitis, acute urinary retention requiring catheterization in the last 3 months, or any other condition suspected to be the cause of LUTS other than BPH 3. Screening serum Creatinine (Cr) or liver function tests [ALT (SGPT), AST (SGOT)] > 3 times the upper limit of normal (ULN) confirmed on a second measurement. 4. Cancer of the prostate or bladder by history or current diagnosis. 5. Prostate nodule(s) on screening digital rectal exam (DRE). 6. Prior surgical procedure of the urinary tract such as TURP, laser prostatectomy, photovaporization of the prostate 7. No minimally invasive surgery to the prostate such as TUMT or TUNA within the last 6 months. 8. Active urinary tract infection. 9. Unstable or uncontrolled medical or psychiatric condition. 10. Abnormal screening labs > 2 times the upper limit of normal (ULN) [for all parameters other than those listed for #3] 11. Myocardial infarction or CVA within the past 90 days. 12. Requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy, steroidal or immunosuppressive treatments. 13. Requiring chronic administration of aspirin at a dose >81 mg/day. 14. Known hypersensitivity to study drug ingredient(s) or allergy to berries. 15. Use of the following medications: alpha blockers (28 days of screening), herbal or nutritional BPH supplements (28 days of screening), OAB medications (28 days of screening), 5 alpha reductase inhibitors (175 days of screening), PDE5 inhibitors (permitted as needed for erectile dysfunction only, but not to exceed 1 dose per week and not to be dosed within 5 days of a visit) 16. Use of an investigational agent (drug, biologic, device, etc.) within 30 days of screening 17. Any reason or condition that in the judgment of the Clinical Investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 20.0-999.0, Urinary Bladder, Overactive Aged >=20 years at the time of signing the informed consent Subject has symptoms of OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented subject history Subject has not been adequately managed with one or more medications (that is, anticholinergics or beta-3 adrenergic receptor agonist) for treatment of their OAB symptom. 'Not adequately managed' is defined as: An inadequate response after at least a 4-week period of OAB medication(s) on an approved optimized dose(s), that is, subject is still incontinent despite medication(s) for OAB; or limiting side effects (that is, condition that subject reduced dosage or discontinued the medication due to side effect after at least a 2-week period of OAB medication(s) on an approved optimized dose(s)) Subject who experiences all of the following, in the 3-day subject bladder diary completed during the screening phase: 1. >= 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day 2. urinary frequency (defined as an average of >= 8 micturitions [toilet voids] per day, that is, a total of >= 24 micturitions) Subject is willing to use clean intermittent catheterization (CIC) to drain urine if it is determined to be necessary by the investigator (or subinvestigator) Body weight >=40 kilograms (kg) at screening Males or females: 1. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit Vasectomy with documentation of azoospermia Male condom plus partner use of one of the contraceptive options below: Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label; or oral contraceptive, either combined or progestogen alone. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. 2. Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine or serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. • Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until the study exit. This list of highly effective methods (approved in Japan) is provided below, and it does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Intrauterine device or intrauterine system that meets the SOP effectiveness including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Subject has given signed informed consent, including compliance with the requirements and restrictions listed in the consent form and in this protocol (example, using the toilet without assistance, complete bladder diaries and questionnaires, is able to collect volume voided per micturition measurements over a 24-hour period, and attend all study visits in the opinion of the investigator (or subinvestigator) Subject has symptoms of OAB due to any known neurological reason (example, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) Subject has a predominance of stress incontinence determined by subject history Subject has a history or evidence of any diseases, functional abnormalities or bladder surgery, other than OAB, that may have affected bladder function including but not limited to: 1. Bladder stones (including bladder stone surgery) within 6 months prior to screening or confirmed occurrence of bladder stones at the screening phase 2. Surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence or pelvic organ prolapse 3. Current use of an electrostimulation/neuromodulation device for treatment of urinary incontinence. Note: Use of any implantable device is prohibited within 4 weeks prior to initiation of screening phase and throughout the study period. Use of any external device is prohibited within 7 days prior to the start of the screening phase 4. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 5. Past or current evidence of hematuria due to urological/renal pathology or uninvestigated hematuria. Subjects with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction by the investigator (or subinvestigator). 6. Past or current history of bladder cancer or other urothelial malignancy, positive result of urine cytology or uninvestigated suspicious urine cytology results at the Screening phase. Suspicious urine cytology abnormalities require that bladder cancer or other urothelial malignancy has been ruled out to the satisfaction of the investigator according to local site practice. 7. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 8. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of >10 nanograms (ng)/mL at Screening. Subjects with a PSA level of >= 4 ng/mL but <= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator (or subinvestigator) according to local site practice. 9. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) Subject has a history of 2 or more urinary tract infections (UTIs) within 6 months of initiation of Treatment phase 1 (Week 0) or current administration of prophylactic antibiotics to prevent chronic UTIs Subject has a positive urine dipstick reagent strip test at initiation of Treatment phase 1 (Week 0) for nitrites or leukocyte esterase, or who are considered by the investigator (or subinvestigator) to have UTI Subject has a serum creatinine level >2 times the upper limit of normal (ULN) at screening Alanine aminotransferase (ALT) > 2xULN; and bilirubin > 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening Subject has current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: 1. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis 2. Chronic stable hepatitis B and C (example, presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody [HCVAb] test result within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry QT corrected (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block from the result of electrocardiogram (ECG) at screening. Notes: 1. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read 2. The specific formula that will be used to determine and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to or discontinue the subject from the trial Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis
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1
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Benign Prostate Hyperplasia Age between 50 and 80 years old. 2. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or 3. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or 4. Patients with history of acute retention of urine with or without previous treatment with Alpha-blockers. 5. Patients with QOL score ≥3. 6. Patients with Urine flow rate < 15ml/second or acute urinary retention. 7. Patients with evidence of prostatic enlargement determined by digital rectal examination or ultrasonography (USG), with a prostate size of not less than 40 grams Active urinary tract infection 2. Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other than basal or squamous cell skin cancer 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc) 4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition 5. Prostate size <40 grams on CT or MRI 6. Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate 7. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. 8. Unable to have MRI imaging (e.g. metal implant including pacemaker, replacement joint, etc) 9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months 10. Baseline serum creatinine level > 160 umol/L 11. Known upper tract renal disease 12. Cystolithiasis or chronic hematuria within 3 months prior to study treatment 13. Active prostatitis 14. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease 15. History of pelvic irradiation or radical pelvic surgery 16. Coagulation disturbances not normalized by medical treatment 17. Known major iliac arterial occlusive disease 18. Allergy to iodinated contrast agents 19. Hypersensitivity to gelatin products
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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, Amoxicillin Crystalluria The patients included will be all patients aged 18 years or more consecutive for which treatment by IHDA (> 150mg / kg / day) has been initiated in a unit participating in the study or within 48 hours before admission to this Service . for non-inclusion: Patients on dialysis or kidney transplant receiver will not be included Patients who did not receive treatment until at least the first urine direct examination and patients for whom it is not feasible for technical reasons will also be excluded
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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) [Inclusion Criteria] All of the following should be satisfied to be enrolled in this clinical trial. 1. A male at 50 years of age and older 2. A patient who satisfies the following clinical signs and symptoms of benign prostatic hyperplasia ① A patient with a volume of prostate gland (TRUS) > 30 cc ② A patient with moderate to severe lower urinary tract symptoms with IPSS ≥ 13 ③ A patient with 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL 3. A patient with 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. A patient with residual urine volume ≤ 200 mL 5. A patient with intention of not using drugs which may affect benign prostatic hyperplasia (5-alpha reductase inhibitors, drugs similar to LHRH, alpha blockers, alpha-beta blockers, anticholinergics, antidiuretic hormones, diuretics, PDE-5 inhibitors, beta-3 adrenoceptor antagonists, etc.), drugs affecting immune system (steroids, immunosuppressants), or health functional foods which may affect a prostate gland (saw palmetto, etc.) during the clinical trial period 6. A patient has to consent not to participate in other clinical trials as a subject during this clinical trial period. 7. Before enrollment to the study, a patient has to consent to avoid pregnancy by using condoms for 90 days after the end of study participation period and treatment. (However, this is not applied if the patient had vasectomy.) Also, a partner of the patient has to 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. (Consent should be obtained before visit 4, when necessary.) [ ] If any one of the following is applied, a patient cannot be enrolled in this clinical trial. 1. A patient who has hypersensitivity reactions to ingredients of this drug. 2. A patient who received 5-alpha reductase inhibitors other than a drug used in this clinical trial before randomization (within six months) 3. A patient who received drugs similar to LHRH other than a drug used in this clinical trial 4. A patient who has received an unapproved study drug in the past or the study drug for this clinical trial (One exception: a patient can be enrolled when the drug is considered by an investigator not to affect prostate and urinary function, and the patient is not participating in other ongoing clinical trial.) 5. If diagnosed with prostate cancer in the past or at present 6. A patient who was considered 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 (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder cancer, malignant tumor in lower urinary tract, etc.) 7. A patient who had surgeries or radiation therapies for prostate gland, bladder or pelvis, or who had invasive treatments for benign prostatic hyperplasia 8. A patient who has 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.) 9. A patient with moderate to severe liver hypofunction and severe kidney hypofunction (less than 30 mL/min of creatinine clearance) 10. A patient who receives drugs affecting immune system (e.g., immunosuppressives, steroids for systemic action, etc.) 11. Any other patients who are considered to be ineligible for this study by an investigator [Inclusion for Randomization] 1. A patient who satisfies the following clinical signs and symptoms of benign prostatic hyperplasia ① A patient with a volume of prostate gland (TRUS) > 30 cc * ② A patient with moderate to severe lower urinary tract symptoms with IPSS ≥ 13 ③ A patient with 5-15 mL/sec of maximum flow rate (Qmax) measured when urine volume was at least 125 mL 2. A patient with residual urine volume ≤ 200 mL 3. A partner of the patient has to 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): 18.0-999.0, Deep Vein Thrombosis Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant Signed informed consent Patient affiliated to a social security scheme pregnant or lactating Life expectancy <1 month Patient with distal DVT or asymptomatic DVT accidental discovery Patient who underwent venous unclogging in acute phase period in another study under administrative or judicial oversight, under guardianship
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-85.0, Benign Prostatic Hyperplasia Men aged>= 50 and <=85 years AND Moderate to severe LUTS defined as IPSS > 11, and QoL > 3 AND No improvement after an alpha blocker treatment line (Tamsulosin 0.4 mg p.d. during 1 month) AND Prostatic volume >=50 ml AND Affiliated to a French health insurance system Severe allergy to iodine contrast agent Treatment with 5-ARI on the last 6 months Suspected prostate cancer requiring specific management On-going prostatitis On-going urinary retention On-going acute urinary infection Acontractile detrusor Neurogenic lower urinary tract dysfunction Urethral stenosis Bladder diverticulum
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 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 any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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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, Blood Routine Examination You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study You may not participate in this study if you do not meet the above criteria
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Benign Prostatic Hyperplasia Male, 45 years or older Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second) All prostate volumes will be > 40gm PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate, bladder, or urethral cancer Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed Hypersensitivity reactions to contrast material not manageable with prophylaxis Patients with glomerular filtration rates less than 40 who are not already on dialysis Prostate volume <40 mL Patients with bilateral internal iliac arterial occlusion Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
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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): 18.0-65.0, Post Traumatic Stress Disorder Participants will be 18-65 years of age All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis at baseline and end of study. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. If results are outside of the normal reference range the study physician will be consulted to assess if clinically significant Subjects will need to satisfy DSM-5 for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment Subjects will need to be free of psychotropic medications or treatments that could impact results of this study as deemed by the PI for at least 1 week If the subject's primary psychiatrist or treating primary care physician are providing the subject with psychotropic medications they will be notified and a discussion about tapering current psychotropic medications prior to study enrollment will occur Subjects will be excluded if they have significant medical or neurologic conditions (other than mild to moderate TBI), specifically seizures, or movement disorders, 2. have substance abuse within 12 months of study enrollment, substance dependence within past three months, per DSM-5 (excluding caffeine and nicotine). The absence of substance use will be determined by self-report and confirmed by the results of urine toxicology at screening. 3. Women who are pregnant, breast-feeding, or planning to become pregnant while enrolled in this study will also be excluded. 4. Subjects with a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the Brexpiprazole or its ingredients. 5. The subject has a history of tardive dyskinesia. 6. The subject has clinically significant extrapyramidal symptoms (EPS) including akathisia. 7. The subject has epilepsy or a history of seizures, except for a single seizure episode (e.g., childhood febrile seizure, post traumatic, or alcohol withdrawal). 8. The subject has chronic, uncontrolled, or unstable clinically relevant medical conditions Including Uncontrolled hypertension defined as blood pressure greater than 180/90 Hypotension defined as a blood pressure less than 90/60 Moderate to severe hepatic impairment (Child-Pugh score ≥7) Moderate, Severe or End-Stage Renal Impairment (CrCL <60ml/min) Known CYP2DG Poor Metabolizers Heart failure NYHA Class III or IV Diabetes mellitus or HbA1c greater than 5.7% (which defines pre-diabetes) Hypertriglyceridemia defined as triglycerides greater than 200mg/dL Low white blood cell count (below lower range of normal)
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Constipation Age over 18 years Rome III defined constipation (frequency of defecation of less than three times a week, straining or sense of incomplete emptying associated with at least 25% of defecations. Lumpy, hard stools or anal digitation for at least 25% of defecations Failed Biofeedback Competent and willing to complete stimulation at home Competent and willing to complete the questionnaires and bowel diaries Rectal prolapse Active inflammatory bowel disease Pregnancy or intention to become pregnant during trial Spinal cord injuries/cauda equina syndrome Other implanted electrical devices Allergy to device components Neurological disorders
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 45.0-999.0, Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. 2. IPSS score of ≥ 15. 3. Qmax: Peak flow rate ≤ 15 ml/sec. 4. Post-void residual (PVR) < 300 ml. 5. Prostate transverse diameter > 30 mm. 6. Prostate volume between 20 to 120 gm. 7. Voided volume ≥ 125 mL 8. Subject able to complete the study protocol in the opinion of the investigator. 9. Life expectancy of at least one year History of any illness or surgery that may confound the results of the study or have risk to subject. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled or has been enrolled in another trial in the past 30 days. 5. Confirmed or suspected malignancy of prostate or bladder 6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease. 7. Previous pelvic irradiation or radical pelvic surgery. 8. Documented active urinary tract infection 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 catherization specimen) 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an ) 12. Subjects interested in maintaining fertility. 13. Use of concomitant medications to the following: 1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes). 2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 3. Use of 5-alpha reductase inhibitor within the last 6 months 4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing 14. Subject is unable or unwilling to go through the "washout" period prior to treatment. 15. Subject has chronic urinary retention. 16. Post-void residual volume > 300 ml. 17. Significant urge incontinence. 18. Poor detrusor muscle function. 19. Neurological disorders which might affect bladder or sphincter function. 20. Urinary sphincter abnormalities. 21. Bladder stones. 22. Evidence of bacterial prostatitis or symptoms of epididymitis 23. Renal impairment or serum creatinine > 2.0 mg/dl 24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well. 25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study. 27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum). 28. Biopsy of prostate within 30 days of procedure
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 30.0-80.0, BPH Nocturia BPH With Urinary Obstruction Prostatism Prostate Inflammation Documented history BPH for at least 1 year AUA SI greater than or equal to score of 15 Qmax < 15 ml/sec Severe nocturia Prostate Specific Antigen (PSA) > 4 ng/mL with documentation of non-malignancy History of illness or conditions that may interfere with study or endanger subject Use of prescription medication that may interfere with study or endanger subject within 30 days History of surgical procedures for BPH or documented prostate cancer Post-void residual urine volumes of > 350 cc PSA > 10 ng/mL Prostate cancer not ruled out by biopsy if PSA is consistently higher than 4 ng/mL
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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, HIV Infection Primary Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI Genotypic sensitivity to TDF, FTC and DTG Patient with medical care insurance Chronic infection Infection or co-infection with HIV-2
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Stricture Urethra Male subjects ≥ 18 years' old 2. Visual confirmation of stricture via cystoscopy or urethrogram 3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm 4. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) 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 UTI's. 6. IPSS score of 13 or higher 7. Lumen diameter <12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax <10 ml/sec Strictures greater than 2.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator 10. Previous radical prostatectomy 11. Previous pelvic radiation 12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL 14. 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.) 15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-70.0, Prostatitis Chronic Prostatitis Interstitial Cystitis Painful Bladder Syndrome Bladder Pain Syndrome Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board Agreement: Participant agrees to participate in study procedures Age: Participant is at least 18 years of age Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months Urethral conditions: Participant has an ongoing symptomatic urethral stricture Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome) Psychiatric conditions: Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.) Malignancy: Participant has a history of cancer (with the exception of skin cancer). Control group In addition to the listed above, additional for control subjects are as follows Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region for a period longer than 3 months within the preceding year
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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, Cancer of Prostate years of age Clinical suspicion for prostate cancer Elevated Prostate-specific antigen between: 2.0 ng/ mL No clinical history of a prior negative biopsy History of prior prostate biopsy Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment History of prostate cancer History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment No known hepatitis (all types) and/or HIV documented in patient's medical record Patients with history of concurrent renal/bladder tumors
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-85.0, Prostatic Hyperplasia, Benign Enlarged Prostate With Lower Urinary Tract Symptoms Prostate volume between 40 and 300 cm3 2. Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following a. IPSS greater than 18 b. IPSS Quality of Life (QoL) assessment greater than 3 c. Qmax less than 12 mL/sec 3. Refractory or intolerant to medical management 4. Ineligibility for or refusal of surgical management 5. One of the following a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL b. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA c. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA <25% of total PSA AND negative 12 core prostate biopsy in the past 12 months d. Baseline PSA >10 ng/mL AND negative 12 core biopsy within the past 12 months History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer. 2. History of rectal disease 3. Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing. 4. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing 5. Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm 6. Cystolithiasis within the past three months 7. Baseline serum creatinine greater than 1.8 8. Evidence of tortuous or atherosclerotic blood vessels 9. Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter 10. Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years 11. Coagulation disturbances not normalized by medical treatment 12. Allergy to iodinated contrast agents not responsive to steroid premedication regimen 13. Previous radical pelvic or rectal surgery, or pelvic irradiation 14. Prior surgical prostate intervention 15. Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment there has been a stable voiding pattern while medicated with the drug(s) for 6 months 16. Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period 17. Interest in future fertility 18. Mental condition or disorder that interferes with participants' ability to provide written informed consent 19. Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial due to increased risk of complications 20. Known immunosuppression 21. Life expectancy less than 6 months
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 65.0-999.0, Muscle Weakness ICU-acquired Weakness Patients age ≥65 years. 2. Acute respiratory failure (ARF, defined by expected mechanical ventilation for > 72 hours from the point of screening) 3. Elevated nutritional risk (NUTRIC score>5 see below) Over 72 hours from ICU admission. 2. Not expected to survive another 48 hours 3. Lack of commitment to full, aggressive care 4. Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula), 5. Pregnant women 6. Prisoners 7. Known allergy to study nutrients 8. Unable to walk prior to current illness
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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, Benign Prostatic Hyperplasia Males, aged ≥18 years old Having had discussion of urinary symptoms with their PCP between 15 days and 12 months prior to the date of the phone interview Able to read, speak and understand English Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview Participation in a clinical research study that evaluated urinary symptoms in the past 12 months Self-reported history of colorectal, bladder or prostate cancer Self-reported neurologic disorders that affect bladder function, e.g., neurogenic bladder disorders due to spinal cord injury/disease, multiple sclerosis, Parkinsons disease Self-reported history of radiation therapy to the lower abdominal and/or pelvic region
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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): 18.0-70.0, Overactive Bladder Overactive Detrusor Urgency-Frequency Syndrome UTI y/o-70 y/o Able to consent Urgency /Frequency Urge incontinence PUF score ≤ 4 Bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot" Pregnant Pelvic radiation Chronic pelvic pain Urinary retention Greater than Stage 2 prolapse Renal calculi Recurrent UTI (2 in 6 months) Immunosuppressed Neurologic disorder No antibiotics in the past 4 weeks
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-80.0, Prostatic Hyperplasia Sign the informed consent. 2. The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS>1 The lower urinary tract obstruction caused not by BPH 2. Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder. 3. using medications known to affect urination or had a severe concomitant disease
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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): 50.0-80.0, Benign Prostatic Hyperplasia Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate < 12ml/s Medically refractory BPE > 6 months (or unable/ unwilling to tolerate medical treatment due to side effects) Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA > 4 or high SWOP risk need prostate biopsy Urodynamics non-obstructed eGFR ≤ 45ml min-1m-2
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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): 18.0-65.0, Hepatitis B HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Prostatic Hyperplasia Patient is aged 50 years or older. 2. Patient has signed informed consent 3. Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment 4. Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible) 5. Patient has an IPSS score greater than or equal to 13 6. Patient either: i. Refuses surgical treatment ii. Is considered high risk for surgical treatment 7. Patient is either: i. Refractory to medical treatment ii. Contraindicated for medical treatment 8. Patient must meet ONE of the following Baseline PSA ≤ 2.5ng/mL Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required) Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months 9. Patient has a peak urine flow rate < 12ml/sec Active prostatitis or urinary tract infection 2. History of prostate or bladder cancer, or currently being evaluated for cancer 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function. 4. Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology 5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern. 6. Patient has taken antidepressant, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern. 7. Patient has taken alpha blockers within 4 weeks of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern. 8. Patient has taken 5-alpha reductase inhibitors within 3 months of study treatment AND has not been on the same drug for at least 6 months with a stable voiding pattern 9. History of open prostate surgery, radiofrequency, or microwave therapy 10. Previous open bladder or rectosigmoid colon surgery 11. Acute urinary retention requiring an indwelling catheter 12. Cystolithiasis within the past 3 months 13. Coagulation disturbances not normalized by medical treatment 14. Iodinated contrast allergy not controlled with 24-hour steroid preparation 15. History of pelvic irradiation 16. History of severe peripheral vascular disease or known major iliac arterial occlusive disease 17. Interest in future fertility 18. Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure 19. Acute urinary retention requiring an indwelling catheter 20. Life expectancy less than 6 months 21. History of rectal disease 22. Known immunosuppression either pathological or pharmacological 23. Presence of collateral vessel pathways potentially endangering normal anatomy during embolization that cannot be bypassed with the microcatheter 24. History of any illness or surgery that might confound the results of the study, by producing symptoms which may be confused with those of the disease process under consideration (e.g., Parkinson's, multiple Sclerosis), or which pose an additional risk to the patient
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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): 45.0-80.0, Benign Prostatic Hyperplasia (BPH) Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction History of inadequate response, contraindication or refusal to medical therapy for BPH Age from 45 through 80 years Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline BMI ≥ 42 IPSS total score <12 History of prostate cancer or clinically significant elevated PSA value History of bladder cancer actively treated within 2 years prior to the surgical procedure Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size) Active infection, including urinary tract infection within 72 hours of the treatment procedure Prostatitis treated with antibiotics within 1 year of the surgical procedure Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use Clinically significant abnormal serum creatinine measured within 30 days of treatment
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2
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Chronic Kidney Failure Dialysis Related Complication hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (Qb) ≥250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output <500 ml/die neoplastic diseases, autoimmune diseases, solid organ or bone marrow transplantation
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Bladder Dysfunction Neurogenic Bladder Patients who are a candidate for Deep Brain Stimulation (DBS) as standard care for neurologic symptoms and have a moderate or greater urinary bother American Urological Association Symptom Score (AUASS≥8) Pregnant, breastfeeding mothers and all individuals younger than 18 years of age will be excluded. Patients with history of urinary diversion or augmentation cystoplasty will also be excluded
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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): 20.0-90.0, Latent Cancer Prostate Age equals or more than 20 years old 2. Willing to sign the informed consent 3. Pathology-proved intermediate to high risk group prostate cancer patients (PSA > 10 ng/mL, or Gleason score 7-10, or clinical stage >T2a) OR Prior radiotherapy or prostatectomy for prostate cancer with biochemical recurrence defined as post prostatectomy: increase in PSA of > 0.2 ng/mL in two or more consecutive blood samples post radiotherapy: PSA levels of ≥ 2 ng/mL above the post-therapy nadir Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still. 2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast 3. Unable to give informed consent. 4. Allergy history to Ga68-PSMA ligand, significant abnormal lab data, and high risk to conduct examination after evaluations of PI
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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, Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit At screening visit, age under legal age of adulthood HbA1c <7.0% or greater than (>) 10% at screening Less than 1 year on continuous insulin treatment Use of insulin pump in the last 3 months before screening visit Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3 Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening Participants with T2DM Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline) At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM
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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 Lower Urinary Tract Symptoms Male Age ≥ 40 Bothersome LUTS Start of medical therapy for LUTS Either: 1. No previous LUTS/BPH treatment (medical or invasive), or 2. Under medical treatment In possession of a smartphone, tablet or computer with internet connection Access to email Fluent speaking and reading of the national language Signed informed consent Previous LUTS/BPH treatment with surgery Previous pelvic surgery or radiotherapy History of neurological disease History of bladder or prostate cancer Unable to provide informed consent Analphabet Unable to operate a smartphone/ tablet/computer Incapable of understanding the language in which the information for the patient is given
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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, Laser-Induced Scar Breast Cancer Endometrial Cancer Menopause Vaginal Atrophy Bladder, Overactive menopause i.e. age more than 50 years and absence of menstruation for twelve months breast cancer endometrial cancer symptoms of vaginal dryness dyspareunia rated as moderate or severe most bothersome symptoms use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to acute or recurrent urinary tract infections active genital infections i.e. herpes genitalis, candida previous reconstructive pelvic surgery pelvis organ prolapse stage 2 any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer psychiatric disorders precluding informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-65.0, Becker Muscular Dystrophy Ambulant patients with BMD diagnosis confirmed by genetic testing. 2. Able and willing to give informed consent in writing. 3. Able to perform 6MWT at screening with a minimum distance of 200 m and maximum distance of 450 m. 4. If in treatment with systemic corticosteroids and/or angiotensin-converting-enzyme (ACE) inhibitor , and/or β or α adrenergic receptor blocker, no significant change in dosage or dosing regimen (excluding changes related to body weight change) for a minimum of 6 months immediately prior to start of study treatment. 5. Patients must be willing to use adequate contraception. Contraceptive methods must be used from Randomization through 3 months after the last dose of study treatment Exposure to another investigational drug within 3 months prior to the start of study treatment. 2. Use of any pharmacologic treatment, other than corticosteroids, that might have an effect on muscle strength or function within 3 months prior to the start of study treatment (e.g., growth hormone). Vitamin D, calcium, and any other supplements will be allowed. 3. Surgery that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study. 4. Presence of other clinically significant disease that in the Investigator's opinion could adversely affect the safety of the patient, making it unlikely that the course of treatment or follow-up is completed, or could impair the assessment of study results. 5. A diagnosis of other neurological diseases or presence of relevant somatic disorders that are not related to BMD. 6. Platelet count, WBC count and hemoglobin at screening < Lower Limit of Normal (LLN). If laboratory screening results are < LLN, platelet count, WBC count and hemoglobin are to be repeated once, and if again < LLN become exclusionary. 7. Symptomatic cardiomyopathy or heart failure (New York Heart Association Class III or IV) or left ventricular ejection fraction < 50% at screening or with heart transplant. 8. Current liver disease or impairment, including but not limited to elevated total bilirubin (> 1.5 x ULN), unless secondary to Gilbert's disease or pattern consistent with Gilbert's disease. 9. Inadequate renal function, as defined by serum Cystatin C > 2 x the upper limit of normal (ULN). If the value is > 2 x ULN, serum Cystatin C will be repeated once, and if again > 2 x ULN becomes exclusionary. 10. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus at screening. 11. Baseline corrected QTcF > 450 msec, (as the mean of 3 consecutive readings 5 minutes apart) or history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome). 12. Current psychiatric illness/social situations rendering the potential patient unable to understand and comply with the muscle function tests and/or with the study protocol procedures. 13. Hypersensitivity to the components of study medication. 14. Sorbitol intolerance or sorbitol malabsorption, or the hereditary form of fructose intolerance. 15. Contraindications to muscle biopsy. 16. Contraindications to MRI/MRS (e.g., claustrophobia, metal implants, or seizure disorder). 17. Hypertrygliceridemia (<1.5 per upper limit of normal)* * at screening, patient with hypertrygliceridemia can be enrolled if in stable treatment and with controlled level of tryglicerides (i.e. within normal range) for at least 6 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): 50.0-999.0, Lower Urinary Tract Symptom Benign Prostatic Hyperplasia (BPH) A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included. B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS. C. Prostate volume > 50 mL. D. Urinary flow rate <15 mL / sec. E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate If patients meet any of the following they may not be entered into the study: A. Major pelvic disease, or other malignancies. B. Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL). C. Had Prostate surgery. D. Chronic bacterial prostatitis. E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction. F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration. G. White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable . H. Unable to follow-up by MRI 3 times. I. Unable to follow-up by ultrasound or CT scan. J. Unwilling to sign a written informed consent form. K. Allergic to Iodine or other injections. L. Acute bacterial prostatitis. M. Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis. N. Cases of biopsy proven prostate, bladder, or urethral cancer. O. Patients with glomerular filtration rates less than 40 who are not already on dialysis. P. Patients with bilateral internal iliac arterial occlusion. Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc). R. Patients with neurogenic or bladder atonia. S. Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue. T. Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.). U. Patients with urethral stents. V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery. W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization. X. Allergic to pharmaceutical excipients related to Microspheres
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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): 45.0-80.0, Recurrent Prostate Cancer Age >45 and Life expectancy >10 years Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions > 3 year interval since EBRT No late toxicity from prior EBRT > grade 2 Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml PSA Doubling time > 6 months Negative staging with CT scan of the abdomen/pelvis and bone scan Able to undergo multiparametric MRI with endorectal coil Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB) Not compliant with above Unable to give informed consent
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 18.0-999.0, Lower Urinary Tract Symptoms Follow in neuro-urology for lower urinary tract symptoms Appointment for urodynamic assessment detrusor overactivity micturition during or at the end of the filling cystometry
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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): 8.0-35.0, Aortic Coarctation Arterial Stiffness PULSE WAVE VELOCITY Functional Magnetic Resonance Imaging Vascular Endothelium Diagnosis of isthmic coarctation of the aorta Current age between 8 (to allow cooperation with study procedures) and 35 years (to avoid confounding by aging-related vascular dysfunction); and Treatment for CoA after 1994, after which all three modalities were in clinical use Residual CoA defined by a systolic upper-to-lower extremity BP gradient> 20mmHg Co-morbidities that may independently affect vascular function, including associated significant congenital heart disease, history of known vasculopathy, genetic syndromes or other cardiovascular risk factors History of two treatment types for CoA; and CoA types likely representing a different entity or patients amenable to one single treatment type (surgery), including atypical CoA site (such as mid-thoracic or abdominal), severe hypoplasia of the aortic arch, and an age of treatment <1 year of age
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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 lesion anterior urethral stricture less than or equal to 3 cm 4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual 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 UTI's (urinary tract infections). 6. IPSS (International Prostate Symptom Score) score of 13 or higher 7. Lumen diameter <12F by urethrogram 8. Able to complete validated questionnaire independently 9. Qmax <12 ml/sec 10. Guidewire must be able to cross the lesion Strictures greater than 3.0 cm long. 2. Subjects that have more than 1 stricture. 3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. Subjects who have a suprapubic catheter 5. Previous urethroplasty within the anterior urethra 6. Stricture due to bacterial urethritis or untreated gonorrhea 7. Stricture dilated or incised within the last 3 months 8. History of over active bladder or stress incontinence 9. Previous radical prostatectomy 10. Previous pelvic radiation 11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate 13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
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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 Follow in neuro-urology Lower urinary tract symptoms Can't speak French
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0
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The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative
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eligible ages (years): 50.0-999.0, Prostatic Hypertrophy are patient age greater than 50 years, maximum flow rate (Qmax) < 15 ml/second and an International Prostate Symptom Score (IPSS) ≥ 10 are known prostate cancer, bladder cancer, previous transurethral surgery, interstitial cystitis and neurogenic bladder confirmed after urodynamic studies
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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, Deep Vein Thrombosis Abdominal Aortic Aneurism Pneumothorax Gallbladder Diseases Hydronephrosis Pregnancy, Ectopic Ascites Pleural Effusion Pericardial Effusion Emergency department patient A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis Emergency medicine specialist or resident decides to perform a POCUS exam age under 18 not able to give informed consent in Finnish
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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, Sepsis Septic Shock Critical Illness Fluid Overload Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU) Informed consent Age < 18 years Pregnancy Do Not Resuscitate (DNR/DNI) with limitations of care Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease) Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds Patients that need immediate surgical treatment Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells < 50 mm2 Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency Patients with severe sepsis/septic shock transferred from another hospital Patients with features of sepsis/septic shock > 24 hours
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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, Spinal Cord Injuries Enlarged Prostate With Lower Urinary Tract Symptoms Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Be male 4. For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit 5. For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture 6. For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months Symptoms of urinary tract infections (frequent urination, stinging and pain at urination) 2. Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination) 3. For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract
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0
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