Search results for "Clinical Trials and Supportive Activities"
showing 10 items of 16 documents
A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis
2018
The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of C-C chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. A randomized, double-blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score [NAS] ≥4, and liver fibrosis (stages 1-3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2-point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis and no worsening of fibrosis; improvement in fibrosis by ≥1 stag…
Impact of elosulfase alfa in patients with morquio A syndrome who have limited ambulation: An open-label, phase 2 study.
2017
Efficacy and safety of elosulfase alfa enzyme replacement therapy (ERT) were assessed in an open-label, phase 2, multi-national study in Morquio A patients aged ≥5 years unable to walk ≥30 meters in the 6-min walk test. Patients received elosulfase alfa 2.0 mg/kg/week intravenously for 48 weeks. Efficacy measures were functional dexterity, pinch/grip strength, mobility in a modified timed 25-foot walk, pain, quality of life, respiratory function, and urine keratan sulfate (KS). Safety/tolerability was also assessed. Fifteen patients received elosulfase alfa, three patients discontinued ERT due to adverse events (two were grade 3 drug-related adverse events, the other was not drug-related), …
Mitochondrial targeting as a novel therapy for stroke
2018
Stroke is a main cause of mortality and morbidity worldwide. Despite the increasing development of innovative treatments for stroke, most are unsuccessful in clinical trials. In recent years, an encouraging strategy for stroke therapy has been identified in stem cells transplantation. In particular, grafting cells and their secretion products are leading with functional recovery in stroke patients by promoting the growth and function of the neurovascular unit – a communication framework between neurons, their supply microvessels along with glial cells – underlying stroke pathology and recovery. Mitochondrial dysfunction has been recently recognized as a hallmark in ischemia/reperfusion neur…
Promoting influenza prevention for elderly people in Hong Kong using health action process approach: study protocol.
2018
People 65 years or older are at greater risk of serious complications from the seasonal influenza compared with young. To promote elderly people’s behavioral compliance toward influenza prevention, the aim of the current project is to develop, implement, and evaluate a theory-based low-administration-cost intervention building on a leading psychological theory, the Health Action Process Approach (HAPA). The target group is Hong Kong Chinese elderly people aged 65 or older who rarely or never adopt any preventive actions. This project will be conducted in three phases over 24 months. In phase 1, intervention program will be developed building on the HAPA theoretical framework which comprises…
Intraocular Pressure Telemetry for Managing Glaucoma during the COVID-19 Pandemic
2021
Purpose To evaluate in glaucoma patients the feasibility and use of remote monitoring of intraocular pressure (IOP) with an implanted telemetry sensor during the coronavirus disease 2019 (COVID-19) lockdown. Design Cross-sectional study. Participants Patients previously implanted with a telemetric IOP sensor (Eyemate; Implandata GmbH) were included. Methods Intraocular pressure measurements acquired by the patients during the lockdown were collected by physicians who were located remotely. A questionnaire was sent to 10 participating study centers to evaluate the clinical impact of remote monitoring of IOP via the IOP sensor system. Main Outcome Measures Number of patients who obtained home…
Effects of a weight management program delivered by social media on weight and metabolic syndrome risk factors in overweight and obese adults: A rand…
2017
Author(s): Jane, Monica; Hagger, Martin; Foster, Jonathan; Ho, Suleen; Kane, Robert; Pal, Sebely | Abstract: IntroductionThe aim of this project was to evaluate the effectiveness of using social media to augment the delivery of, and provide support for, a weight management program delivered to overweight and obese individuals during a twenty four week intervention.MethodsParticipants randomly divided into either one of two intervention groups or a control group. The two intervention groups were instructed to follow identical weight-management program. One group received the program within a Facebook group, along with a support network with the group, and the other intervention group receive…
BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update.
2022
Treatment for hepatocellular carcinoma (HCC) has experienced major advancements since the last update of the official Barcelona Clinic Liver Cancer (BCLC) prognosis and treatment strategy published in 2018. Advancements in the field have emerged in all areas, but in this manuscript, we present those that have primed a change in the strategy and comment why some encouraging data in select interventions are still considered immature and in need of further research to gain their incorporation into an evidence-based model for clinicians and researchers. Finally, we describe the critical insight and expert knowledge that is needed to take clinical decisions in individual patients so that the rec…
Using physical education to promote out-of school physical activity in lower secondary school students : a randomized controlled trial protocol
2019
Background Given the documented decline in levels of physical activity in early adolescence, promoting physical activity in young people is a priority for health promotion. School physical education (PE) is an important existing network in which participation in physical activity beyond school can be promoted to the captive young people. The objective of current article is to present the protocol for a PE teacher-delivered theory-based trial to promote secondary school students’ participation in physical activity out-of-school contexts. The intervention will be guided by the trans-contextual model explaining the processes by which PE teachers’ support for autonomous motivation in the classr…
Investigating dose-response effects of multimodal exercise programs on health-related quality of life in older adults.
2019
Background: Older adults are at risk of multiple chronic diseases, most of which could be prevented by engaging in regular physical activity. Frailty is a state of increased vulnerability to diseases. Worsening symptoms of frailty, such as decrease in physical functionality, can compromise health-related quality of life (HR-QOL). Previous findings suggest that frailty moderates the relationship between physical activity and HR-QOL, yet intervention findings are limited, particularly in dose–response analyses. Hence, this study was conducted to test if lower-dose physical activity (120 minutes/week) would provide the same benefits in health outcomes (physical functionality and HR-QOL) as hig…
Minimal manifestation status and prednisone withdrawal in the MGTX trial
2020
ObjectiveTo examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).MethodsThis study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody–positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18–65 years at enr…