Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects...
CAH - Congenital Adrenal HyperplasiaThis is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in approximately 12 pediatric female and male subjects (14 to 17 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH).
Developmental Hip Dysplasia and Physical Therapy
Hip DysplasiaCongenitalDevelopmental Hip Displasia (DDH) can cause various degenerations or compensatory adaptations in the spine and knee joint, especially in the hip joint. As a result of adaptations and degeneration, these individuals may experience difficulty in walking and functional activities, lack of stabilization, decreased muscle strength and activation, and loss of balance at varying levels. This situation necessitates a holistic, multifaceted rehabilitation in individuals with hip dysplasia. There is no study in the literature that shows a specific physiotherapy and rehabilitation program applied to individuals with DDH. The aim of this study was to investigate the efficacy of classical physiotherapy method in patients with DDH and to compare the efficacy of classical physiotherapy and core stabilization exercise training in treatment.
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers...
Benign Prostatic HyperplasiaThis study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic...
Benign Prostatic HyperplasiaA dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.
Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
Prostate ObstructionProstatic Hyperplasia2 moreTransurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications. Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses. PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA). A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
Breast Atypical Ductal HyperplasiaBreast Atypical Lobular Hyperplasia3 moreThis study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.
Observational Study to Compare Two Prostate Laser Enucleation Techniques in Terms of Urinary Incontinence...
Prostatic HyperplasiaBenign1 moreBenign prostatic hypertrophy or prostatic adenoma is a benign tumour that develops in the central part of the prostate. Prostatic adenoma can result in the progressive appearance of a difficulty in evacuating the bladder or frequent urges to urinate and other complications (lithiasis, haematuria, urinary retention, etc.). Surgery is indicated when medical treatment is no longer effective and in the case of complications. The endoscopic techniques for treating prostate adenoma, PLASMA and HOLEP, are recognised and recommended by the French Association of Urology and the European Association of Urology (EAU) as Gold Standard techniques in view of the good results reported in the literature, the low rate of complications compared to the other techniques, and the reduced hospitalisation rate. For prostate volumes less than 80cc, there is no difference between HOLEP and Bipolar Plasma Enucleation of the Prostate (BTUEP) in terms of International Prostate Symptom Score (IPSS), Qmax, and reoperation rate at 12 months. The surgeon's experience is the most important factor influencing the risk of complications for HOLEP. Urinary incontinence after HOLEP according to Houssin et al. is 14.5% at 3 months and 4.2% at 6 months, the risk factors identified were surgeon experience and the existence of diabetes. Comparative evaluation of the two techniques is less frequent, hence the interest of our prospective and multicentre study. In this study, the investigators hope to demonstrate a better outcome of the PLASMA technique in terms of post-operative residual urinary incontinence.
Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign...
Benign Prostatic HyperplasiaBenign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity. The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization...
Transurethral Resection of ProstateArtery Embolization2 moreThe purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)
Benign Prostatic HyperplasiaLower Urinary Tract SymptomTo evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).