ANZCTR search results

The purpose of this study is to assess the safety and tolerability of JNJ-90858638 compared with placebo after single and multiple ascending dose administration in healthy participants (Part 1 and 2).

This project translates and evaluates the implementation of evidence-based interventions into an integrated model of paediatric burn care working with NSW Aboriginal Community Controlled Health Services (ACCHS), the NSW State-Wide Burn Injury Service (SBIS) and The Children’s Hospital at Westmead (CHW) to provide co-ordinated optimal ongoing care for Aboriginal and Torres Strait Islander children. SBIS is delivering burn care training to participating ACCHS. The project creates a network of participating ACCHS to link in with the burns service at CHW. We will implement a burns education and integrated care model. This will entail upskilling community-based health providers in NSW Aboriginal Community Controlled Health Services (ACCHS) and the creation of a hub and spoke care network to facilitate patient referral and navigation between ACCHS and CHW burn service. We will evaluate program implementation and outcomes including the number of staff who are trained in burn care, the referral processes between ACCHS and CHW burn service and experience of parents and carers whose child has had a burn injury.

This trial is comparing a software companion (Aescia) against routine care for patients discharged from heart or lung surgery. The software companion (on a smartphone) will ask daily questions about recovery. The answers to these questions will be used to triage patients and "red flag" any to clinicians who may be demonstrating signs of developing postoperative complications. The goal is to reduce unplanned readmissions after discharge, improve patient confidence in their recovery, and reduce hospital length of stay after the primary surgery.

The Richards Trauma Process is a novel psychotherapy, already being offered by early adopters in Australia and elsewhere. Until now, it has not been formally studied to see whether it is acceptable to people suffering psychological distress, whether it is safe, and whether it helps relieve symptoms. This trial is a first step in gathering this evidence, and explored whether it is feasible to study TRTP in a community setting, and the acceptability, safety and potential effectiveness of TRTP.

This study will evaluate gastrointestinal events of a new tablet formulation of cabozantinib compared to the currently approved cabozantinib tablets in Adult Patients with Advanced or Metastatic Renal Cell Carcinoma Who is it for? You may be eligible to join this study if you are aged 18 years or above with documented histological or cytological diagnosis of advanced or metastatic renal cell carcinoma Study details Participants in this study will randomly allocated (by chance) to one of two groups: one group will take Azurity Cabozantinib 39mg tablets once daily for 12 weeks while the other group will take CABOMETYX® 60mg tablets once daily for 12 weeks. Incidence of diarrhea will be assessed using questionnaires and daily diaries. Other adverse events and treatment discontinuation will also be assessed. This study will help determine whether the new tablet is better tolerated and safer for the stomach and intestines. If results are favourable, the study will move to Phase 3 to confirm findings in a larger group of participants (to be registered separately).

In this randomised, double-blind, placebo-controlled study, 100 children aged 6 to 11 years experiencing low mood will be randomly assigned to receive a saffron extract (14mg twice daily) or a placebo for 6 weeks. Changes in mood (the primary objective) and sleep quality will be examined over time using child- and parent-report questionnaires. It is hypothesised that, compared to the placebo, saffron supplementation will lead to greater improvements in mood and sleep

Adenosine, lidocaine, and magnesium (ALM) therapy is a combination drug that has been shown to minimise surgery-induced inflammatory responses, improve tissue healing and reduce postoperative complications in experimental models of orthopaedic surgery. Although each of the ALM components are currently approved and used individually in the clinical setting, their combined use in humans has not yet been evaluated. Therefore, the purpose of this study is to conduct a first-in-human trial to evaluate the safety of a single dose of ALM therapy administered to the knee of adult patients whilst they are undergoing elective total knee arthroplasty (TKA) (Cohort 1) or anterior cruciate ligament (ACL) reconstruction surgery (Cohort 2). A total of 12 participants will be enrolled, with 6 participants in each surgical cohort. The primary objective is to evaluate safety, while secondary (exploratory) objectives include assessment of basic pharmacokinetics and early clinical effects to 6 weeks postoperative. This information is critical in determining ALM’s safety profile and to inform the design of a future clinical trial to determine the therapeutic dose range, and to assess efficacy of ALM therapy for orthopaedic applications.

This study aims to understand how Long-COVID affects adults in Australia over time. Participants will be followed for up to 36 months after COVID-19 infection to assess changes in symptoms, functional ability, quality of life, social and broader psychosocial, behavioural and financial impacts using validated tools. The study will also examine factors associated with persistent symptoms and recovery. The findings will contribute to improved understanding of Long-COVID trajectories and may inform policy, clinical guidelines, and the development of care models for Long-COVID.

Sleep is regulated via two distinct but interrelated processes: homeostatic sleep and circadian processes. Circadian rhythms involve light-sensory neuro-hormonal signalling to intracellular clock mechanisms throughout the body. Despite major advances in the mechanistic understanding of the circadian rhythms, practical methods for daily circadian tracking do not exist. Tracking circadian timing accurately is essential for optimising treatments. The effects of circadian rhythm treatments depend critically on timing; interventions like bright light therapy and exogenous melatonin can either advance or delay circadian rhythms, depending on when they are applied relative to the phase response curve. Current clinical practice does not measure circadian timing reliably, as sleep specialists rely on guessing if and when to administer treatments based on self-reported sleep diary data and symptoms. This project aims to validate an array of wearable sensors for continuous core body temperature monitoring as a practical, affordable, and feasible method for daily circadian rhythm tracking. It also investigates the effectiveness of circadian-informed personalised light therapy versus standard care in treating delayed sleep-wake phase disorder.

New treatment option for post-surgery bleeding in ENT surgery patients undergoing sinonasal surgery. The potential treatment is Oral Tranexamic Acid (TXA) which has been used in other surgical disciplines to control post-surgery bleeding. The purpose of this study is to determine the effectiveness of oral TXA in preventing postoperative bleeding following sinonasal surgery and thereby decreasing discomfort and complications in the post operative period. This research clinical trial is a placebo-controlled drug trial. Both the treatment and placebo will look identical and participant nor the trial doctors will know which group you have been assigned to. The medication will be administered from 8am day 1 post-surgery as capsules. Two capsules will be administered 3 times a day for 3 days. Each capsule contains either 500mg TXA or placebo. Participants are allocated in a random 2 :1 ratio, thereby there will be 2 out of 3 chances of receiving the TXA study medication and 1 in 3 chances of being allocated placebo.