MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia
Benign Prostatic HyperplasiaPhase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo. Subproject MCS-2: alpha-blocker naïve subjects Subproject MCS-3: subjects responding poorly to alpha-blocker
Minimally Invasive Surgical Therapy for BPH
Benign Prostatic HyperplasiaThe primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
Laser Prostatectomy Database and Registry
Benign Prostatic HyperplasiaEnlarged ProstateSTATEMENT OF PURPOSE: Transurethral resection of the prostate (TURP) is the standard surgical intervention for obstructive benign prostatic hyperplasia (BPH) in all but the largest of glands, which are typically treated with open simple prostatectomy. Recently, new generation lasers (holmium and potassium titanyl phosphate [KTP]) have been utilized for BPH treatment. Long-term follow-up of laser prostatectomy outcomes must be documented to fully characterize the degree of voiding improvement achievable by these new techniques, the durability of these outcomes, and the safety profiles of these procedures.
JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome...
Benign Prostatic HyperplasiaChronic ProstatitisBenign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part related to prostate enlargement and obstruction. The standard medical therapy for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ specific phenotype) is the third most prevalent prostate disease after prostate cancer and BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of life of patients and economic costs to society. Clinical phenotyping allows for prediction of the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg. BPH and CP/CPPS).
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary...
Bronchopulmonary DysplasiaThis is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)...
Benign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms (LUTS)This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.
SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
BPHBenign Prostatic HyperplasiaTo compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations
A Study in Men With Benign Prostatic Hyperplasia
Benign Prostatic HyperplasiaThe purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)
Molecular Analysis of the Sloane Project
DCISLCIS2 moreThe Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater). The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer. All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional ~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis. The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.
Nevanimibe HCl for the Treatment of Classic CAH
Congenital Adrenal HyperplasiaThis is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.