ANZCTR search results

A Four-Part, Phase 1, First-in-Human, Single and Multiple-Ascending Dose and Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral SCY-247 in Healthy Subjects. The current study is the first clinical administration of SCY-247 to be conducted in healthy adult subjects. It is a 4-part study combining Part 1: single ascending dose (SAD), Part 2: multiple ascending dose (MAD), Part 3: loading and maintenance doses,

Recently, a monitor called the Newborn Infant Parasympathetic Evaluation (NIPE) has been used to study pain in children under 2 years of age, as it assigns a numeric value to the pain response. It does this by analysing the variability of the heart rate, and studies have shown that it accurately tells us when the child is reacting to pain during surgery. For many surgeries, laparoscopic (key-hole) approaches are becoming more widely used. However, this is limited research investigating pain in laparoscopic inguinal hernia repair surgeries. We recently conducted a small study that showed that the addition Local Infiltration (anaesthetic injected into the area being operated on) may reduce pain in comparison with Caudal Block (anaesthetic injected into the base of the spine) alone. Therefore, our study aims to compare differences in pain during and after laparoscopic inguinal hernia surgery between children who receive local infiltration and children who receive caudal blocks, using the NIPE monitor. If this study is effective, it will potentially allow us to better prevent children from experiencing pain after surgery, by balancing the anaesthetic and pain medications in a more focussed way. It will also potentially clarify if one of the anaesthetic methods is associated with reduced pain during and after surgery.

This study aims to examine (1) the efficacy of using body imagery rescripting to improve self-compassion compared to psychoeducation, and (2) the underlying mechanism of body image rescripting as a single-session intervention for self-compassion. Previous research has shown that body imagery rescripting increases self-compassion more than a psychoeducation task, while also reducing disordered eating, and improving body acceptance (Pennesi & Wade, 2018; Zhou et al., 2020). However, the mechanism behind these effects remains unclear. Understanding the mechanisms of such effective single-session intervention can shed light on specific targets to address in eating disorder early intervention and treatment.

Acute respiratory infections (ARIs) are a leading cause of hospitalisation and preventable death among Aboriginal infants. The first microbes encountered by the infant gut shape systemic immune development and future susceptibility to infection. Through an international partnership, we propose a randomised controlled trial to determine if neonatal probiotics can reduce the risk of ARI in the first year of life. Eligible infants aged <=3 days will be randomised into two groups where one group will receive orally the active probiotics treatment and another group will receive a placebo for 7 consecutive days total. Participants will be followed up at 1-, 4- and 7-months besides their baseline and post intervention visits and medical-review only at 12 months. Secondary aims will evaluate safety, the gut microbiome and immune development.

Armidale was selected for the settlement of Ezidi refugees as part of Australia’s humanitarian resettlement program. Approximately, 600 refugees settled in Armidale from February 2018. One of the most frequently presented health conditions is chronic low back pain. Chronic low back pain was the reason for 62% of total referrals to the physiotherapy service of Armidale Rural Referral Hospital. Therefore, it was decided that a group program was needed to meet this need. The program was offered to any Ezidi patients with chronic low back pain. The duration of the program is for 8 weeks. The program included exercise classes and education sessions. This program ran for a 6 month period time. At the end of the 6 month period, an evaluation of the program will take place to assess benefit of continuation of the program and necessary modifications. There have been no previously reported studies evaluating the effectiveness of a group program for refugee populations with chronic low back pain. This study aims to assess the acceptance and effectiveness of such a group program.

People living with rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to provide these antibiotics, called ‘SCIP’, which provides 10-weeks of protection. By partnering with the Mala'la Aboriginal Health Service Corporation we will offer SCIP to people in need of regular BPG in Maningrida, Northern Territory, Australia and evaluate how well it works for them, with the ultimate goal of using SCIP to lengthen life, reduce illness and disability from rheumatic heart disease. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.

The aim of the study is to explore the efficacy of the 7-week online Mindovergut.com optimal health and resilience program for individuals living with a gastrointestinal condition and low to moderate psychological distress. The Mindovergut.com resilience program is based on 7 modules (1 module per week). Each module (consisting of videos, text, handouts, and audio files e.g. relaxation tracks) is designed to be completed once a week, taking approximately 30 minutes, with associated homework-based activities taking a further 20-40 minutes per day. It is hypothesised that participants will report increased quality of life post intervention.

Bronchiectasis is a commonly seen chronic lung disease in our inpatient and outpatient services. The unmet needs of people with bronchiectasis are huge, with relatively few randomised controlled trials (RCTs) and evidence-based interventions. This pilot RCT aims to improve the outcomes of children and young adults with bronchiectasis. It will examine the benefits (or otherwise) of a novel medication, erdosteine. Erdosteine’s effects include (a) mucolytic action, modulation of mucus production and increasing muco-ciliary transport; with (b) antioxidant; (c) airway anti-inflammatory and; (d) bacterial anti-adhesion properties. This pilot RCT will answer: In children (aged 2-18 years) with bronchiectasis, does 2 weeks of treatment with erdosteine as an add-on therapy, compared to placebo, (i) reduce the duration of the acute respiratory exacerbation, (ii) improve quality of life (QoL) and/or (iii) increase the time to next respiratory exacerbation.

This project aims to test and implement the MindCare education program, an intervention designed to improve self-efficacy, health literacy, and dementia risk reduction knowledge among community members from Arabic-, Vietnamese-, Greek-, and Hindi-speaking backgrounds aged 40 and over. The program was developed using co-design methods with input from CALD communities and service providers, and is delivered by bilingual peer educators through community-based workshops. The trial will assess the impact of the MindCare program through a randomised controlled trial, comparing outcomes between the intervention group and a control group that receives basic healthy ageing advice. Key objectives include improving participants' confidence in managing their health, increasing knowledge of dementia prevention, and evaluating the program’s acceptability and effectiveness within community settings. The trial will also examine the influence of cultural and linguistic factors on the program’s success in promoting healthier lifestyles for dementia prevention. The study hypothesis is that participants who receive the MindCare intervention will show improvements in several key areas compared to those in the control group. Specifically, it is expected that the intervention group will demonstrate increased knowledge of dementia risk reduction, improved health literacy, enhanced self-efficacy, and greater changes in health-related behaviours and lifestyle for dementia prevention. These improvements will be compared to the outcomes of the control group, which will only receive basic healthy ageing advice.

The purpose of this study is to assess the safety and feasibility of the BiVACOR Total Artificial Heart (TAH) to support support adult, end-stage heart failure patient who are awaiting heart transplantation. Patients that may be eligible patients for this study will be adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. survival on the original BiVACOR pump at six months post implant or survival to cardiac transplantation if occurring prior to six months post pump implant. This study will be conducted in up to 5 patients in up to two hospital sites in Australia.