View clinical trials related to Hyperplasia.
Filter by:Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).
This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH). BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.
An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic CAH subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).
An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen. Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD.
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland, places pressure on the urethra and causes urination difficulties and bladder problems. Lower Urinary Tract Symptoms (LUTS) secondary to BPH is a common condition in aging men, with an overall prevalence of more than 50% in those older than 50 years of age. Men with LUTS often experience sexual dysfunction including ejaculatory loss, painful ejaculation, and erectile dysfunction, which among other complications can also lead to a decreased quality of life. Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in 1998, is a more recent step in the evolution of holmium laser prostatectomy. HOLEP offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. One noted drawback to HoLEP, and the primary reason why it has yet to become the new standard for treatment of symptomatic BPH, is the complexity of this procedure, with a prolonged learning curve. Modifications to the procedure have thus been explored in order to address this limitation. The "Top-Down" HoLEP technique is a novel technique which offers potential benefits to the Traditional HoLEP procedure, including decreased complexity, a reduced learning curve, with anticipated improved continence. This study will compare the operating time between the Top-Down Holmium Laser Enucleation of the prostate (HoLEP) and the Traditional HoLEP for the treatment of patients with symptomatic bladder outlet obstruction due to BPH in Northwestern Ontario.
Bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is a common problem, which impact patients' quality of life. It may lead to serious outcomes, including urinary tract infection, hematuria, bladder stones, urinary retention, hydronephrosis, and rarely renal insufficiency. Introduction of the Holmium laser enucleation of the prostate (HoLEP) represented a turning point in minimally invasive laser therapy for BPH as it achieves size-independent prostatic cavities similar to simple open prostatectomy with significantly lower perioperative morbidity. Recently, Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue. To date, no outcomes of the new Xpeeda laser fiber have been reported in the literature, which is striving for trials comparing XPS 180W with other competitors such as Holmium vaporesection with the new fiber Xpeeda. Therefore, this study is planned to compare both procedures in improving bothersome LUTS secondary to BPH, and to evaluate safety and cost effectiveness.
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .