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Filter by:This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. In Vietnam, since 2014, Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam. However, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. The objective of this study is to assess the quality of life, the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure.
Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities. There is currently limited evidence on the incidence and associations of postoperative AKI in elderly patients following liver resection. This study will evaluate the incidence and associations of AKI in elderly patients after liver resection and its impact on postoperative mortality.
Main objective: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise. Secondary objectives: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test). Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet. Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .
Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).
This prospective observational study evaluates the association of peri-procedural changes in renal regional oxygen saturation and post-procedural acute kidney injury in patients undergoing transcatheter aortic valve implantation.
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular: 1. Assess the benefits of the device to intended users when supervising a trainee who is performing UGRA scanning. 2. Assess the benefits of the device when intended users perform UGRA scanning. 3. Assess risk mitigation by the intended users when performing UGRA scanning.