ANZCTR search results

This study aims to test the efficacy of prucalopride for the management of gastrointestinal symptoms of systemic sclerosis (scleroderma), We hypothesise that prucalopride will reduce the burden of gastrointestinal symptoms in patients with systemic sclerosis (scleroderma) compared to placebo. The primary outcome of interest in this study is patient symptoms and the effects of treatment on people's perceived burden of gastrointestinal symptoms. In addition, we will undertake testing of the changes in whole gut transit time, measured by serial x-rays, and gut microbiome (assessed by faecal specimen) in response to treatment.

This study is assessing the feasibility of group dysphagia therapy for people with swallowing difficulties following treatment for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a been diagnosed with head and neck cancer which has been treated with surgery or radiotherapy plus or minus chemotherapy with curative intent and have had persistent dysphagia for 6 months after treatment completion. You must have been cleared for intensive swallow rehabilitation by your treating medical or surgical team. Study details All participants will receive swallowing therapy conducted in a group setting alongside others with swallowing difficulties following head and neck cancer treatment. Therapy will consist of 1 hour weekly group therapy sessions, and individual home practice, focusing on swallowing progressively challenging foods and fluids. Therapy will be closely guided by the speech pathologists. The therapy sessions will occur for 9 consecutive week, with the 10th week being a focus group exploring participants views on the benefits and challenges of the group approach. Swallowing will be comprehensively assessed before and after the program, either with videofluroscopy (x-ray based) or FEES (endoscopy), this ensures safety and guides the best individualised rehabilitation. Additionally, participants will be asked to complete questionnaires exploring the impact of their swallowing difficulties on their day to day life. This research will explore whether swallowing therapy is feasible to be conducted in a group setting, it is anticipated this approach provide peer support a motivating environment to enhance engagement with therapy. This feasibility study will evaluate the feasibility of delivering an intensive group-based swallow therapy program for patients with dysphagia persisting beyond 6 months after treatment for head and neck cancer.

One in two older adults presenting to emergency departments will be admitted to hospital with 41% of all hospital inpatients aged 65 years and over. Hospitalised older adults are at risk of complications such as falls, prolonged hospital admissions and functional decline. Functional decline occurs due to multiple factors including pre-existing frailty combined with periods of sedentary behaviour and reduced activity in hospital. We aim to complete a prospective randomised controlled trial to assess the effect of physical activity measurements with visual feedback (i.e. access to the bedside application for the intervention group) compared to no feedback (control). This project is significant as it will enable us to trial a functional maintenance intervention i.e. using the SENS motion® and the bedside application while considering patient acceptability and clinical utility.

The INCLUSIVE study aims to improve the health, well-being, and care of older Australians experiencing cognitive decline, based on input from people with lived experience of cognitive decline and their support networks. The aim of this trial is to test the effects of a 15-week intergenerational program on the quality of life and well-being through a trial. The intergenerational program brings together older adults experiencing cognitive decline and preschool children (aged 4-5) for structured activities involving physical, thinking/memory, and social activities. The program will be delivered at pre-school centres in the community. Each session is 1.5 hours long. Older adults experiencing cognitive decline will be recruited from the community and screened for eligibility. Once their eligibility is ascertained and they complete their initial assessments, they will be randomised to one of two study groups - the intervention or control group. The intervention group will receive their program as soon as sufficient older adults and children have been recruited and assessed at the pre-school site. For the control group, there is no change to their usual activities during their first 15-weeks. After their 15-week usual activity period and completion of their follow-up assessments, they will then receive the 15-week intergenerational program. The program they receive may differ slightly as adjustments may have been made depending on the feedback received from the intervention group.

The main purpose of this study is to see how safe and tolerable OV329 is when compared with placebo in participants who have focal epilepsy when it is added to current antiseizure therapy. OV329 works by lowering the risk of seizures. It does this by blocking a specific protein in the brain called GABA-AT, which slows down how fast the brain breaks down a calming chemical called GABA. With more GABA in the brain, the nervous system becomes more balanced and stable, making seizures less likely. The study consists of an approximate 16 week period including screening, 4-8 weeks of baseline, 8 weeks of treatment, 1 week of tapering and a 2 week follow up period. OV329 is an oral capsule and during the treatment period the dose will be 7mg (1 x 5mg and 2 x 1mg capsules) daily.

Children frequently fall over and fracture their forearm. Most forearm fractures are routinely put into a plaster cast and are sent to fracture clinic for follow-up. Recent studies show that removable wrist splints work well for stable fractures in that they provide rigidity but can be removed for comfort and hygiene purposes. This pilot study will explore the use of wrist splints to manage distal forearm fractures in children. It will primarily test whether we can successfully recruit enough families to participate in a larger trial but will also inform estimates on safety of wrist splints. If wrist splints are a suitable alternative to casts this could also help the health care service, which can better focus on children with more complex fractures. If this pilot study shows we can efficiently recruit participants and that the treatment appears to be safe, this would provide the foundation for a larger clinical trial to evaluate effectiveness of splints compared to casts. Given that upper arm fractures in children are a common reason for presentation, a change in practice to splint use could have global impact.

Children are spending increasing amounts of time with screens. Both International and national guidelines suggest limits for screen time for children 5-12 years old, still many children exceed these limits. However, time is only part of the issue, and other factors also need to be considered. Therefore, it is essential to support their parents to promote healthier habits in their children when interacting with screens. This study aims to evaluate the efficacy of the Healthy Screentime Habits Seminar (HSHS) through a randomised controlled trial (RCT) involving 500 parents of children aged 5 to 12 years old. It is expected that, when compared to waitlist group, parents who participate in HSHS would report improved parent, child, and family outcomes at post-intervention and 3-month follow-up. The initial evidence of the efficacy of the seminar would inform future research and scaling up implementation.

This study is being conducted to evaluate the safety, tolerability, and pharmacokinetic profile of single escalating doses of CLIP-100 administered as an injectable lipolysis agent into the subcutaneous abdominal fat of healthy adult participants. Up to 25 healthy participants with subcutaneous fat in the abdominal region will be enrolled in five escalating dose cohorts.

People receiving peritoneal dialysis (PD) are expected to record considerable clinical and dialysis-related information at home. This study aimed to assess the feasibility and clinical outcomes of a novel smartphone application (App), PD-Buddy, developed to facilitate timely and accurate PD data collection and sharing with the PD healthcare team.

OV4071 is an investigational product being tested for neurological disorders. Part B is a food effect cohort of eight participants being administered a single dose on Day 1, followed by a washout period of at least 7 days and a second single dose administered on Day 8 or later under fasted and fed conditions.