ANZCTR search results

This double blind, placebo controlled, first-in-human study will assess the safety, tolerability of single and multiple oral doses of MRX-5 tablets in healthy men or women of non -child bearing potential and also to assess the pharmacokinetic (PK) profile of MRX-5 and its metabolite MRX-6038, and to compare the PK of a single dose of MRX-5 administered fed vs. fasted conditions. Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 55 years old. Approximately 84 healthy participants will be enrolled in this study. (60 subjects in Part 1 and 24 subjects in Part 2) The total participation in the study will last around 5 weeks which consists of Screening visit, Admission and treatment period and Follow up visit.

This study will look at the effects of wearing surgical and N95 masks have in patients with respiratory failure currently using non-invasive ventilation. The aim of the study is to see whether this affects your oxygen or carbon dioxide levels as well as measures of comfort. The hypothesis of this study is there will not be a clinically important change in oxygen saturation and Transcutaneous carbon dioxide when wearing a surgical mask and N95 mask compared to no mask. There may be some changes in subjective comfort and breathlessness.

The prevalence of ocular allergies is increasing worldwide, affecting individuals’ quality of life and causing a significant socioeconomic burden. Allergic conjunctivitis can be managed using a range of treatment options. Ocular inflammatory cell (e.g., dendritic cell) play a substantial role in initiating the immune response in the setting of ocular allergies. The proposed study will be single centre, double-blinded, randomised, placebo-controlled, parallel group clinical trial. All participants will go through a washout period for 1 week using topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) before starting the trial interventions. This study consists of three arms; arm 1 will be given topical ketotifen 0.025% eyedrops; arm 2 will be given prednisolone sodium phosphate 0.5% eyedrops; the placebo group will be given topical 0.4% polyethylene glycol 400, 0.3% propylene glycol eyedrops. All participants will remain on the trial interventions for 14 days. Assessment of the trial outcomes will take place pre-treatment, 24 hours, 7 days and 14 days after starting the treatment, 7 days and 14 days post-treatment. Both investigators and participants will be double-blinded to the group and treatment allocation until the results have been analysed.

Individuals living with a severe mental illness experience a significantly reduced life expectancy when compared to the general population, attributable in part to increased rates of cardiovascular diseases and metabolic syndromes that are associated with psychotropic medication use and poor health behaviours (e.g., low physical activity levels, poor diet quality and high sedentary time). There is a concerted effort to preserve (and improve) the physical health of individuals living with mental illness, with exercise increasingly advocated as part of mental health care due to the positive effect exercise has on physical and psychological health. One of the challenges for exercise services is to provide best practice exercise therapy, and support consumers to establish and maintain positive health behaviours in a client-centred and efficient manner. This trial will implement an effectiveness-implementation hybrid design to determine the feasibility and effectiveness of supported exercise therapy within transdiagnostic tertiary mental health care services. The aims are: • To determine the feasibility of implementation of low and high-support exercise therapy in a transdiagnostic tertiary mental health service. • To assess the preliminary effectiveness of low and high-support exercise therapy on consumer health outcomes including physical health outcomes, health behaviours, and quality of life.

Multiple system atrophy (MSA) is a rare, severe and life-threatening adult-onset neurodegenerative disease, characterized by a combination of parkinsonism, cerebellar ataxia, and autonomic dysfunction. At present, only symptomatic therapy is available for the treatment of MSA, and most of the prescribed medications are being used in an off-label manner. YA-101 is being developed for the treatment of subjects with MSA, a serious and life-threatening condition with a high, unmet clinical need. The safety, tolerability, PK, and food effect of YA-101 will be evaluated in HV in Parts 1 and 2 of this study. The study will be conducted in healthy volunters aged between 18-65 years . Besides the one food effect (FE) cohort, each cohort in Part 1~Part 2 is randomized, placebo-controlled, double-blinded to establish safety and tolerability in healthy volunteers (HV) following single ascending dose (SAD) and multiple ascending dose (MAD). A total of 60 participants will be enrolled in Australia. Duration of the study Part 1 HV SAD: Total duration of study is up to 8 days with 1-day treatment Part 2 HV MAD: Total duration of study is up to 21 days, 14-day treatment Part 2 HV FE: Total duration of study is up to 11 days with 1-day treatment

This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform.Characterisation studies to help guide development of the Nutromics Sensor Device platform will provide invaluable information to Research and Development (R&D) teams. Since this is a minimally invasive patch based platform, with minimally invasive needle, characterisation of adhesive, ergonomics and human factors will be crucial.

Traditionally, many dancers and instructors use light aerobic activity combined with static stretching as a warm-up. There is limited research investigating how a warm-up affects dance performance, particularly for range of motion, jump height, force production and muscle activation for unilateral jumps and dance specific skills. The aim of this research is to compare a dynamic warm-up to a traditional dance warm-up and determine how this affects dance performance. Participants will each complete 3 separate days of testing, each one beginning with warm-up that includes either static stretching, dynamic stretching and no stretching (control). It is hypothesised that dancers will demonstrate superior performance when a dynamic warm-up is used compared to a traditional dance warm-up. The outcomes will be valuable as it will allows dancer and dance instructors to implement more evidence-based training to produce optimal results.

The study aims to investigate whether the use of mindfulness applications that incorporate peer support improves perinatal mental health outcomes. An exploratory sequential mixed method design consisting of two phases will be used in the study. The first phase involves qualitative study conducted through a focus group to explore women's knowledge and experiences of support groups and mindfulness. Phase one findings will inform the design and structure of the intervention in phase two. In the second phase, a pilot study using a quasi-experimental one-group pre-post test design will be used to assess peer support combined with a mindfulness app on anxiety, depression, mindfulness practices, perceived social support, and salivary cortisol levels. Peer support groups intervention aim to bring women together for mutual support and use of the mindfulness-based app (Headspace) activity together.

The HEPATA Trial is designed to deliver comprehensive evidence for TP-IAT inclusion on the Australian Medicare Benefits Schedule. This will provide activity based funding enabling equitable access to this therapeutic intervention to all Australians and dramatically improve outcomes and prognosis for all HP patients. It will also inform the generation of clinical guidelines for treatment of hereditary pancreatitis with TP-IAT. This study is designed to deliver comprehensive evidence for Total Pancreatectomy and Islet-Auto Transplantation (TP-IAT) inclusion on the Australian Medicare Benefits Schedule for patients with hereditary pancreatitis Who is it for? You may be eligible to join this study if you are less than 75 years old and have molecular genotype-confirmed hereditary pancreatitis (PRSS-1, SPINK-1, CFTR, CTRC) and symptoms of pancreatitis Study details All participants in this study will undergo a total pancreatectomy procedure performed by a hepatobiliary surgeon. The pancreas will then be prepared for transport to the islet cell isolation facility by a renal surgeon. Islet cells are isolated for transplantation the same day. A radiologist transplants the isolated islet cells back (via infusion) into the patient. Participants will then be followed-up and assessed regularly at 3, 6, 12, 24 and 36 months post-procedure to determine impact of TP-IAT on glycemic control, pain and quality of life. It is hoped that this research project will provide evidence to support an application for activity based funding for the TP-IAT procedure through the Australian Medicare Benefits Schedule. This would ensure all Australians have access to this treatment in the future

Diabetes-related foot ulceration (DFU) affects 56,000 Australians yearly, with one person every hour undergoing a foot/leg amputation. DFU healing is complex and multi-factorial. Our research is focused on diets in DFU healing, which is currently under-researched and highly topical. The research team have added to the literature significantly, demonstrating Australian Adults with DFU have poor quality and variety of dietary intake, have micronutrient deficiencies, and individuals with DFU taking supplementation have significantly increased likelihood of healing. However, we do not currently understand best nutrition intervention to support wound healing in those with diabetes. Therefore, this trail was co-designed with people with DFU and wound clinicians to increase acceptability and feasibility. We propose a a 6-week superiority pilot multicentre, double blinded, parallel-group randomised controlled trial that will determine if a personalised dietary intervention in combination with a food box improves wound healing in those living with a DFU.