ANZCTR search results

This is a Phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZE74-0282 in patients JAK2 V617F mutated hematologic diagnosis who have undergone prior therapy or who have declined this. Who is it for? You may be eligible for this study if you are aged over 18 years old with a confirmed JAK2 V617F mutant hematologic malignancy and have previously received or have declined prior therapy. Study details The study will be run in 2 parts: Part 1 will be dose escalation and determination of maximum tolerated dose (MTD) in patients with select hematologic malignancies that have JAK2 V617F mutations. Part 2 will be dose expansion to identify the optimal and recommended phase 2 dose (RP2D) of ZE74-0282. ZE74-0282 will be administered orally once daily or twice daily in continuous 28-day treatment cycles. Treatment may continue for up to 24 cycles. Participants will undergo regular safety assessments, including vital signs, blood and urine tests, and other clinical evaluations. Eligibility criteria for both Part 1 and Part 2 is the same, however participants enrolled in Part 1 of the study will not be permitted to enrol in Part 2 of the study. It is hoped this research will determine the maximum RP2D dose of ZE74-0282 that can be administered safely without causing severe reactions. Following completion of the expansion portion of the study and identification of the RP2D, based on the safety and efficacy data, the study may be amended to transition to different cohorts of disease, earlier lines of therapy and combination therapies.

Individuals suffering Parkinson's disease (PD) often exhibit the symptom of hypomimia, known as facial masking. This symptom is characterised as difficulty in changing facial expression in response to different emotions and is evident as a secondary sign of PD in the early stages of the disease process. Analysis of facial expressions recorded via video is a non-invasive and promising diagnostic tool for the early detection of PD. This study proposes to use expression analysis recorded as a video utilising computer vision and machine learning techniques as a non-invasive method to identify Parkinson's disease. Data collection for the PhD project was completed December 2024 for this project with a final reported submitted and approved by RMIT HREC 24/10/2024. Data collection continues as part of the broader project which includes: ACTRN12623000220662 A comparative clinical study of a handwriting app for the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers ACTRN12623000219684 A comparative clinical study of a voice recording app for the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.

Despite the potential for exercise as an effective therapeutic approach for people with gastrointestinal (GI) disorders, often studies on exercise and GI disorders explore the patient’s well-being and disease activity without objective inflammatory markers. To strengthen the development of exercise as a management strategy, the acute exercise-induced response and interaction with GI disorders warrants investigation. Therefore, the purpose of this study was to investigate the acute exercise-induced inflammatory response in individuals with GI disorders; specifically, IBD and IBS, and compare these responses to healthy controls (HC). We hypothesis that people with GI disorders will elicit an acute anti-inflammatory response with an increase in the post exercise period (immediately and 2h post).

The aim of this study is to investigate the acceptability, feasibility and preliminary efficacy of a Hub-and-Spoke, Peer-led communication aphasia group program in a regional health setting. A mixed-methods, waitlist control, randomised controlled trial and process evaluation was used. Participants included a minimum 12 people with aphasia and 12 close others, with each pair randomly allocated to either the treatment or control arm. By drawing on trained peers from the community the Hub-and-Spoke, Peer-led CAG model offers a way to address the specific challenges faced by people living with aphasia. Hub-and-Spoke, Peer-led CAGs hold potential to improve access to tailored community-based supports for people with chronic aphasia.

This study aims to investigate the optimal duration of on-shift naps during night shifts to improve safety and productivity. While on-shift naps can boost performance at night, they may temporarily reduce alertness upon waking and require additional downtime away from work tasks. In a controlled laboratory setting, participants will complete four conditions in a within-subjects, repeated measures, counterbalanced design: no-nap; 15-min nap; 30-min nap; 60-min nap. We hypothesise that increasing the duration of naps will result in an overall increase in whole of shift performance and productivity, despite greater short-term safety impairment from sleep inertia post-nap. The findings will support evidence-based guidelines for on-shift napping to support workplace productivity and safety with minimal disruption to operational efficiency.

Females diagnosed with fibromyalgia are at high risk of obesity and poor health-related quality of life. Effects of resistance exercise training for strength improvements, Improved pain and body composition are not clear and quality methods for resistance training are lacking for women with fibromyalgia. Further investigation for measurements of strength, severity of pain and body composition outcomes in women with fibromyalgia are required. It is proposed that a 26- week, cross-cover trial of resistance training interventions will provide outcomes for strength, pain and body composition in women with fibromyalgia.

Who is it for? This study is intended for patients undergoing an endoscopic resection procedure (Endosocpic Mucosal Resection, EMR or Endoscopic Submucosal Dissection, ESD) for dysplasia or early cancer in the oesophagus. When a resection involves >/= 75% of the oesophageal lumen, the chance of a stricture and difficulty swallowing can approach 100% Study details: The aim is to assess whether the injection of this fat helps prevent the extent of these strictures Eligible patients undergoing this procedure have a portion of fat removed by liposuction from another part of their body and this fat is then injected into the defect after the resection takes place. There is no randomisation involved and the study is open (non-blinded). Follow up involves checking on swallowing and endoscopies to assess stricture rates (this is part of routine care) There are several things we do to try and prevent strictures after these procedures, including repeated gastroscopies and stretching of the narrowed portion of the oesophagus (food pipe), known as dilation, as well as using steroids either injected directly into the oesophagus (food pipe) at the site where the abnormal tissue was removed or in tablet form, to reduce the inflammation that leads to the narrowing forming. We would like to find a safer, more effective way to prevent the narrowing in the oesophagus (food pipe) from forming after this procedure, or to reduce the severity of the narrowing that develops. Recent studies have shown that injecting a small amount of your own fat into areas of inflammation and scarring in the body may improve healing. This has been looked at in healing tissue openings around the anus, and in healing after patients undergo plastic surgery. It has not been looked at in the oesophagus before and we hope we can develop strategies to help our patients by reducing the amount of stricture formation after oeosphageal endoscopic resection.

This study will use a single-case experimental design to investigate how pain-related outcomes and stress change during participation in the StressModex intervention for individuals with acute or sub-acute whiplash-associated disorders. Daily assessments of pain interference and stress (primary outcomes), along with pain intensity and pain bothersomeness (secondary outcomes), will be used to determine when changes occur across different phases of the intervention. Cross-lagged correlation analyses will be conducted on daily data to investigate whether stress operates as a mechanism of change in pain-related outcomes. Qualitative interviews will explore changes in pain-related beliefs, perceived pain controllability, and associated behavioural and emotional responses. The study will also evaluate whether stress, pain, neck disability, perceived recovery and related psychological factors improve from pre- to post-treatment and whether any observed improvements are maintained at six-month follow-up. The feasibility of using a wrist-based heart-rate monitor for daily HRV collection will also be assessed both qualitatively and quantitatively. Physiological stress, indexed by daily heart rate variability (HRV), will be examined to characterise its trajectory during treatment and assess its potential role as a mechanism underlying changes in pain-related outcomes.

Infants born preterm are at high risk of developing cognitive, behavioural and emotional deficits later in life. One in three infants born before 32 weeks of pregnancy exhibits a language delay, with communication difficulties persisting into adulthood. While advances in neonatal medicine have resulted in decreased mortality for preterm infants, neurodevelopmental problems in survivors have remained unchanged. We propose a parent driven intervention focused on increased exposure to parents’ speech to promote language development in the preterm infant, giving those most vulnerable the greatest chance to thrive.

The FLUDRO-SHOCK trial is a large international randomised controlled double-blinded study aiming to improve treatment for people with septic shock—a life-threatening condition caused by severe infection. Patients with septic shock receive a steroid called hydrocortisone, but it is unclear whether adding another steroid, fludrocortisone, improves their chances of recovery and survival. This study will test two doses of fludrocortisone (50 mcg and 100 mcg) against a placebo to see which works best. It will also explore whether a person’s unique immune response, based on their genes, affects how well the treatment works. The trial will involve up to 2,200 critically ill adults in intensive care units across Australia and other countries. Researchers will track survival, organ recovery, and quality of life for up to a year. The goal is to find the most effective and personalised way to use steroids in septic shock, potentially saving lives and improving long-term outcomes.