ANZCTR search results

This will be a single-centre, randomised, double-blind, placebo-controlled, and sequential cohort study to evaluate the safety, tolerability, PK and PD of single and multiple ascending doses of SIR9900 after oral administrations in healthy adult volunteers. Male and female healthy adult volunteers aged 18 to 64 years inclusive at the time of screening are eligible for recruitment. Part 1 SAD participants (except cohort 3) will have a screening period of up to 28 days and be required on-study for approximately 2 weeks post-dose. Part 1 SAD cohort 3 (FE) and Part 2 MAD participants will have a screening period of up to 28 days and be required on-study for approximately 3 weeks post-dose. SIR9900 is a potent and selective allosteric RIPK1 inhibitor being developed for the potential treatment of inflammatory, autoimmune, and degenerative diseases, particularly in the central nervous system.

The current study aims to investigate the outcomes, benefits and feasibility of a brief evidence-based eating disorder prevention program within an Australian youth mental health service (at headspace Camperdown). This program is the Body Project program, which is a well-established eating disorder (ED) prevention program. The study aims to investigate the feasibility of this program in a sample of young Australians (between ages 12-25). Specifically, this study aims to compare outcomes (including body image concerns/outcomes, eating disorder symptomatology and general psychological distress) between the those who complete the Body Project program at headspace (our Treatment Group) and those who do not complete the Body Project program but who do continue to access their standard care at headspace (Treatment-as-usual Control group), and compare outcomes pre-treatment, post-treatment and at one month follow-up. By conducting this study we hope to assess the potential utility of such a brief and low-cost program within the headspace centre setting which, if found to be effective, could be rolled out nationally (to the 150+ headspace centres around Australia) as an early intervention approach to preventing the development of eating disorders amongst Australian youth. We hypothesise that our study results will demonstrate that attending the Body Project group program embedded into the headspace youth mental health service model will effectively reduce symptoms of eating disorders, body image concerns and psychological distress for young Australians at risk of developing an eating disorder.

In this study, we are trying to find out if a novel, inexpensive, non-invasive medical device might reduce pain associated with blood test. We are aiming to recruit participants who are undergoing regular blood tests in the setting of a fertility clinic. Given this is a pilot trial, we plan to recruit up to 40 participants and randomise them into the medical device group, or the control group. We hypothesise that our non-invasive device will reduce or eliminate pain associated with venepuncture, whilst not compromising the success probability of obtaining adequate blood sample.

The Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP) will be an electronic registry of well characterised patients with severe eosinophilic CRSwNP who receive mepolizumb treatment. It will be a national, multi-centre, observational post-marketing surveillance registry. Patients will receive mepolizumab via the Australian Commonwealth Government Pharmaceutical Benefits Scheme (PBS) or outside of the PBS restrictions. Patients will be identified for participation across multiple clinics in Australia. The central registry team will manage participant recruitment and data collection via a central telehealth model. Participants will be characterised at baseline (before starting mepolizumab) and have 12 months follow-up. The registry will provide insight into CRSwNP patient characteristics , report on mepolizumab use (effectiveness, safety) and be a databank for future research.

Sublocade (buprenorphine) is currently approved only for intra-abdominal subcutaneous injection for the treatment of opioid treatment disorder. However, intra-abdominal subcutaneous injection is sometimes poorly tolerated by patients because of certain discomfort. Using the same product in different sites may actually have a similar rate and extent of buprenorphine release. However, the rate and release profile of alternative injection sites (e.g., deltoid (shoulder) or thigh or buttock) compared to abdominal (stomach) injection is unknown. This study aims to evaluate the rate and extent of buprenorphine release and its tolerability from different injection sites in 50 patients who are on treatment for opioid use disorder. Eligible participants will be randomized to receive first injection sites and baseline samples will collected. Subsequent doses will be given in order abdomen, thigh, buttock, and deltoid. Serial blood samples will be collected after the injection for each subsequent injection.

The current evidence suggests that the optimal length of a sequence of night shifts may depend on the intensity of light that shiftworkers are exposed to during the night. If so, then OHS guidelines that recommend a blanket limit on night shifts of a maximum of 2-4 in a row may inadvertently expose shiftworkers to a higher level of fatigue-related risk than is necessary in some workplaces. In this project, we will test the proposition that shorter sequences of night shifts may be suited to workplaces where shiftworkers operate in dim light and are less likely to adapt to a nocturnal schedule, whereas longer sequences of night shift may be suited to workplaces where shiftworkers operate in normal indoor light and may be more likely to adapt to a nocturnal schedule. The project will include a multiple-day night work simulation study with three conditions. The only difference between conditions will be in the light intensity during night shifts – dim (10 lux), moderate (100 lux), and normal (350 lux) – as experienced by truck drivers, hospital-based healthcare practitioners, and control room operators, respectively. The data will be used to test three hypotheses: 1. Body clock time will get progressively later, i.e., delay, with each successive night shift, and the daily rate of delay will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 2. The quantity/quality of daytime sleep will progressively increase with each successive night shift, and the daily increases will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 3. Night-time alertness will decline with each successive night shift in the dim light condition, remain stable in the moderate light condition, and increase with each successive night shift in the normal light condition.

This study is investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single ascending dose of BW-20805 in healthy volunteers in 4 dose level cohorts. Approximately 32 men and women aged (more than equal to) 18 to (less than equal to) 60 years who fulfill the inclusion and exclusion criteria will be enrolled at one site in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose), and return for outpatient visits through Week 24. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20805 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 and the control group will receive BW-20805 doses of 50mg, 150mg, 300mg, and 600mg, or placebo respectively.

Generalised joint hypermobility (GJH), defined as Beighton 6/9 or more, is prevalent in approximately 34 % of children and adolescents globally and associated with symptoms in about one in five of these children. Generalised Hypermobility Spectrum Disorder is the combination of Beighton 5/9 or greater for post-pubertal and 6/9 or greater for pre-pubertal children and adolescents together with musculoskeletal manifestations including joint pain, pes planus, hindfoot valgus, poor proprioception, joint laxity and instability. Children with symptomatic GJH can experience joint laxity or joint instability and reduced strength and endurance during walking and other physical activities. Children also frequently report soft tissue injuries and pain following exercise, particularly in the lower limbs. Longitudinal studies have shown that children with GJH are more likely than their non-hypermobile peers to experience persistent chronic pain 3 to 5 years later. In addition, children with symptomatic GJH can experience functional impairments such as difficulties with motor development, and impaired proprioception. Overall symptomatic GJH may negatively impact a child’s participation, including school attendance, poor academic performance, reduced quality of life and psychosocial function. To date no study has investigated the impact of custom-made orthotics on pain, functioning, fatigue and quality of life in children with GJH and lower limb pain. This study therefore investigated the safety of and outcomes following custom-made orthotic use with podiatric recommended footwear in children with GJH and lower limb pain through before and after assessment of pain, functioning, fatigue and quality of life over a three-month period.

Age-related increases in reactive oxygen species (ROS) production by skeletal muscle mitochondria have been linked to the failure of exercise responses in aged muscle. These changes limit the efficacy for exercise to maintain or improve muscle health in old age. Interventions that decrease mitochondrial ROS levels may improve the capacity of aged skeletal muscle to respond to exercise. The mitochondria-targeted antioxidant MitoQ is designed to accumulate in mitochondria and decrease ROS. The purpose of this study is to determine the effect of MitoQ supplementation on mitochondrial ROS levels and function and acute exercise responses in skeletal muscle from older individuals. Study hypotheses MitoQ supplementation will increase mitochondrial respiration and decrease mitochondrial ROS levels in skeletal muscle from older individuals. MitoQ supplementation will augment exercise responses in skeletal muscle from older individuals.

This study is investigating the effect of intrathecal morphine compared to standard care with oral and intravenous opioids on the quality of recovery after robotic-assisted radical prostatectomy. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with prostate cancer, and are scheduled for robotic-assisted radical prostatectomy, and have no allergy to morphine. Participants undergoing robotic-assisted radical prostatectomy will be randomly allocated (by chance) to one of two groups: one group will be prepared for spinal anaesthesia and receive morphine administered through spinal injection and the other group will be prepared for spinal anaesthesia but will not receive a morphine injection. Both groups will receive standard care of oral and intravenous pain medications (opioids) from admission to discharge, as appropriate. Participants recovery, pain levels and oral morphine medications will be monitored in the first 24 hours post-surgery. Side effects will be monitored for the duration of the hospital stay. It is hoped that this research will help improve postoperative recovery after robotic-assisted radical prostatectomy.