ANZCTR search results

We will investigate if exercise is effective in increasing muscle strength in people with Prader-Willi syndrome (PWS). We will conduct a phase II, multi-site, double-blind, randomised controlled trial with 6-month follow-up. Sixty participants with PWS aged 13 to 60 years will be randomised to receive one of two exercise programs. Participants will exercise twice a week for 24 weeks at their local gym supervised by an exercise health professional (usually a physiotherapist). We will measure muscle strength, muscle mass, functional strength, physical activity, community participation, and health-related quality of life at baseline (week 0), after the intervention (week 25) and 6 months later (week 52): We will recruit participants through PWS advocacy groups, specialist PWS clinics, and PWS registries and clinical databases.

Overactive sympathetic nervous system (SNS) signaling to major metabolic organs plays a pivotal role in the development & progression of Metabolic Syndrome (MetS) into several concurrent cardiometabolic disorders. Given the close relationship between the MetS & overactive SNS signaling, a minimally invasive treatment approach targeting inhibition of SNS to central metabolic organs (kidney & liver) is being proposed. The objective is to evaluate the safety of hepatic or renal artery denervation or a combination of both in a single intravascular procedure intended to improve one or more cardiometabolic parameters for hypertension (HTN) & glycaemic control. 45 patients with HTN with coexistent type-2 diabetes who qualify & consent, will be assigned to one of the 3 arms.

Zenker diverticulum is a herniation of the oesophageal mucosa resulting in pouch formation which can result in dysphagia and spontaneous regurgitation. Treatment with flexible endoscopic myotomy demonstrates lower morbidity compared to previous modalities. However, there is no established standard approach with unknown optimal technique. While the principal is to cut the cricopharyngeal muscle, a careful balance needs to be achieved to not cause perforation, while noting that an incomplete myotomy leads to higher recurrence rates. Intra-procedural measurement of distensibility across the Zenker's using the endoscopic Functional Lumen Imaging Probe (FLIP) could allow real-time determination of whether further incision will be required. Through retrospective review of medical records we hope to determine the feasibility of intra-procedural FLIP measurements in these patients, and assess whether there is a correlation between changes of distensibility following myotomy with symptoms and pouch size. We expect approximately 10 patients and hope to show that intra-procedural measurements will help to guide extent of myotomy to minimise risk of perforation as well as recurrence.

The purpose of this study is to determine if a multimodal (exercise, nutrition and nursings support) prehabilitation program for patient undergoing major gastrointestinal cancer surgery for curative intent can be built into routine care. Who is it for? Patients with stage I-III or limited stage IV colorectal or upper gastrointestinal cancer undergoing curative intent surgery at concord repatriation general hospital. Study Details The study will involve both an exercise and diet program 2-4 weeks prior to major gastrointestinal surgery. All participants will receive the intervention. 1.Exercise: The exercise component will involve supervised and tailored 60-minute group-based exercise sessions per week using a combination of resistance and aerobic exercises delivered by an accredited exercise physiologist. In addition, 3 x homebased exercise training. 2. Nutrition: The nutritional component will involve Oral high protein supplements (Fresubin® Protein Energy) containing 20g protein, recommended to be consumed daily within one-hour post exercise to capitalize on muscle synthesis (day one until two days prior to surgery). In addition, nutritional advice will be provided delivered by a dietitian to achieve adequate oral protein intake. 3.Nursing support: One (15-20 minute) nurse-led phone support session per week of intervention Assessment Involvement in the study will involve a variety of body measurements and questionnaires, including questions about quality of life and patient satisfaction. It is hoped this study will further insight into how prehabilitation can decrease length of stay, lead to better surgical outcomes, whilst evaluating the change in functional, nutritional and psychological status.

Fatigue is one of the most common and debilitating symptoms in patients on dialysis. The prevalence of fatigue ranges from 55% to as high as 97% in adult patients on dialysis and is associated with impaired quality of life and increased mortality. Fatigue is also consistently ranked as critically important by patient on dialysis, even higher than death. Our global Standardised Outcomes in Nephrology (SONG) initiative, involving over 2000 patients receiving dialysis, caregivers, and health professionals across 100 countries, established fatigue as a critically important core outcome. Lifestyle (including exercise) interventions was the top priority identified through the research priority setting partnership. Evidence for exercise interventions remains very uncertain due to factors such as the plethora of measurements used to assess fatigue and small sample size. A patient workshop was convened to identify and prioritise exercise interventions for the M-FIT study to ensure acceptability and feasibility. M-FIT is a multi-centre, adaptive randomised comparative effectiveness trial of three structured exercise programs and a control in patients receiving dialysis. The primary outcome of this trial is fatigue as measured by FACIT-Fatigue at 12 weeks. Secondary outcomes include additional measures of fatigue, quality of life, mood, life participation, body composition, exercise capacity, neuromuscular fitness, balance, physical activity, sleep, exercise adherence, SONG core outcomes, hospital admissions, cost-effectiveness, app usability, preference and safety.

This study is assessing whether or not an alternative intracytoplasmic sperm injection (ICSI) technique (PIEZO ICSI) in patients undergoing assisted reproductive technology treatment results in improved embryo fertilisation and utilisation rates. We hypothesis that as PIEZO ICSI is a gentler insemination method we will see increased fertilisation and embryo utilisation rates following PIEZO ICSI compared with conventional ICSI.

The purpose of this research project is to test whether it is safe to administer a new vaccine (AMV002) in combination with an immunotherapy drug called Durvalumab (MEDI4736) in patients with HPV-related cancer of the tonsil or base of tongue where the cancer has either returned after treatment (recurrent) or spread to other parts of the body (metastases) and now considered incurable. The new vaccine (AMV002) is aimed at promoting the body’s own immune system to develop antibodies that attack cancer cells that have been infected by the human papillomavirus. Durvalumab is an immunotherapy drug, and has been used in the treatment of several other cancer types and aims to overcome the cancer’s ability to dampen down the body’s immune response to the cancer itself. Who is it for? You may be eligible to join this study if you are aged 18 and above, have recurrent and/or metastatic HPV-related Head and Neck Cancer Study details If you meet all the criteria to take part in the study, you will be assigned to receive the AMV002 and Durvalumab treatment. You will be supplied with a schedule of your required study visits during the treatment and for the follow-up periods of the study. In particular, on three separate occasions, you will receive two injections (vaccinations) with the vaccine administered at 4 weekly intervals (i.e. 2 injections of 0.5mg AMV002 per patient on days 0, 28 and 56). The vaccination will be carried out by injecting 0.2mL of vaccine into the skin on your forearm(s) using a standard sterile single-use needle and syringe. Durvalumab (MEDI4736) will be administered by IV infusion (1500 mg/patient) on Days 7, 28 and 56. You will additionally complete a maintenance treatment peiod. This period will involve 13 visits (visits 7 to 19). Durvalumab (MEDI4736) will be administered (1500 mg/patient) every four weeks for 12 months (or until stopping criteria are met). Safety/tolerability, immunogenicity and efficacy will be assessed at regular intervals during the interventions using clinical examinations and blood tests. If the study shows that it is safe to administer both drugs at the same time, and blood tests reveal that the vaccine can lead to the production of the antibodies to help fight the cancer, then this combination will be tested in larger human trials to confirm its benefit. Ultimately this approach may become the standard way in which we treat this type of cancer and may form the basis for the treatment of other cancer types.

Australia’s children are among the least active in the world. Physical inactivity is a particularly big problem for children with intellectual disabilities. Schools are ideal places to promote physical activity. This school-based intervention, iPLAY4i, will involve two key steps: we will train participating teachers in how to promote physical activity at school; and we will also support a few extra teachers while they try to promote a better culture of physical activity within the school. We hypothesise that this intervention will lead to benefits for children with intellectual disabilities, specifically: higher physical activity, higher physical fitness, better fundamental movement skills, and higher confidence, motivation, and wellbeing.

Hepatitis B is the most common liver infection in the world and is caused by the hepatitis B virus (HBV). HBV enters the body and travels to the liver via the bloodstream. In the liver, the virus attaches to healthy liver cells and multiplies. The liver is the main site of HBV replication. Hepatitis B infection can lead to cirrhosis (scarring of the liver), liver cancer, or liver failure, if it is not diagnosed and managed appropriately. The purpose of this study is to test IMC-I109V in people with chronic hepatitis B virus (HBV) infection. The main goal of the study is to assess the safety and effectiveness a new treatment, called IMC-I109V. IMC- I109V has been developed to treat HBV by activating the body’s own immune system to fight the virus.

The proposed research aims to evaluate the Fearless Me! program, a CBT program specifically designed for children with ID and anxiety in a clinical group setting. The program was designed to be applied in an individual or group format. Thus far, the program has been evaluated with moderate success in a group format in a school setting, with clinical and non-clinical presentations (Hronis, et al. 2019). Fearless Me! is currently being assessed in an individual format for children with anxiety and ID, however, the program has not been tested in a clinical sample through a group format. It is hypothesised that the intervention will result in better mental health outcomes, including reduced levels of anxiety, improved quality of life and improved emotional development.