ANZCTR search results

A first-in-human, single-ascending dose study to determine the safety, tolerability, pharmacokinetics (PD) and pharmacodynamics (PD) of ABS-101 in healthy adult participants. Results of the study will be used to determine the starting dose for subsequent studies in either healthy volunteers and/or patients. As this is a study in healthy volunteers to evaluate safety and tolerability there is not study hypothesis to evaluate.

This research will evaluate the effectiveness and implementation of the eHEEADSSS digital psychosocial screening tool for young people presenting to 3 Emergency Department sites. The eHEEADSSS identifies patient strengths and risks relevant to Home, Education and Employment, Eating and Exercise, Activities, Drugs and Alcohol, Sexuality and Gender, Suicide, Depression and Self-harm, and Safety. Participant patient administrative data will be used to evaluate the effectiveness and implementation of the eHEEADSSS. Participant consent will be waived to allow for the use of patient data for the purposes of intervention evaluation.

Syphilis is an important public health threat in Australia. Benzathine penicillin G (BPG) is the current treatment of choice of non-CNS syphilis infection. Primary, secondary or early latent syphilis is treated with 2.4 million units (MU) of intramuscular BPG injections, while late latent syphilis requires 2.4MU weekly for 3 consecutive weeks. IM BPG injections are associated with significant pain and discomfort for recipients. Consequently, treatment uptake is low, especially where multiple doses are required. Subcutaneous (SC) delivery of BPG is potentially a more efficacious alternative to the current IM injection. Our team has demonstrated acceptability and a superior pharmacokinetic profile in healthy volunteers. Additionally, a small cohort of patients with syphilis reported SC delivery of BPG as a preferred alternative. This study aims to further demonstrate safety and tolerability of a single 7.2MU dose of BPG given as a subcutaneous infusion for the treatment of syphilis. Secondary objectives include demonstrating efficacy of 7.2MU BPG as subcutaneous infusion for the treatment of syphilis and to estimate the proportion of patients with penicillin concentrations above the target concentration of 18mg/mL. Primary outcome is the assessment of safety and tolerability including serious adverse events and reactions. Secondary outcomes are the change in nontreponemal specific serology at 6 months, plasma penicillin concentrations at 6 weeks and the proportion of participants with treatment failure requiring re-treatment at 6 months. We aim to recruit 35 patients with confirmed syphilis infection or contacts of confirmed syphilis infection who would require empirical treatment, at the M Clinic. This study will incorporate self-guided online surveys exploring participant experiences receiving subcutaneous infusion of BPG for syphilis treatment. Participants will be followed up for 24 weeks from day of treatment.

Hyperglycaemia and post-transplant diabetes mellitus (PTDM) are common in heart and lung transplant recipients. PTDM has been associated with unfavorable transplant-related outcomes including increased rates of infection, rejection, graft dysfunction and mortality. To prevent unnecessary transplant-related morbidity and mortality, accurate and sensitive screening tests are required to optimize the diagnosis of PTDM in heart and lung transplant recipients. The proposed study will examine whether use of a simple and inexpensive CGM (FreeStyle Libre2) is non-inferior to the more cumbersome 75-gram OGTT to diagnose PTDM in transplant recipients without a known diagnosis of diabetes at least 12 months after heart or lung transplantation.

This study observes the vancomycin treatment (up to four days) for 100 critically ill patients who are prescribed the antibiotic in the ICU with the Nutromics Sensor Device. These patients will have blood sampling across their vancomycin treatment period, in line with their prescribed treatment regimen (intermittent or continuous dosing). This study will compare vancomycin concentrations measured in interstitial fluid with the Device to those measured in blood samples, and will characterize the performance (ie: stability and precision) of the Device.

Over the past six years, Northern NSW (NNSW) has experienced three disastrous floods and two seasons of bushfires. Chief amongst the mental health impacts is the extremely disabling condition of post-traumatic stress disorder (PTSD). Previous research has estimated that there are 1000s of people with disaster-related PTSD in NNSW. This reflects a broader trend observed in regions hit by climate-related disasters worldwide, where the psychological aftermath often lingers far beyond the physical recovery period. Hence, there is an urgent need for accessible, effective, and culturally sensitive interventions designed to address the complex manifestations of PTSD in disaster-affected populations. Recent research suggests that teaching compassion skills in a compassion group program can be an effective non-trauma-based approach to addressing PTSD. Group-based compassion programs seem particularly appropriate for people who have been dislocated in post-disaster contexts since social connection is the best predictor of good outcomes post-disaster, and compassion for self and others promotes social connection. Stemming from an innovative adaptation of compassion science principles, the present clinical trial focuses on two compassion-focused interventions Arts-Based Compassion (ABC) and Nature-Based Compassion (NBC) programs, tailored to meet the specific needs of flood-affected individuals in NNSW. These programs are scalable, cost-effective, and able to be delivered on a group basis. Therefore, the primary aim of this 14-week randomised clinical trial is to assess the effectiveness of the ABC and NBC interventions in reducing PTSD symptom severity and promoting wellbeing, social connection, resilience, nature-relatedness, and post-traumatic growth in NNSW residents experiencing climate-related PTSD. Secondary aims are to gather evidence for the development of cost-effective and scalable treatments for natural disaster-related PTSD.

Traditional patient monitoring on the ward involves nursing staff measuring vital signs every 4 hours, and evidence shows that breathing rate is the first indicator of a deterioration in health. However, patients may start to deteriorate between the 4-hourly checks and the likelihood of this is higher in the bariatric population who may also have other conditions. Early mobilisation helps with patient recovery. Portrait Mobile is a wearable, wireless monitoring system that sends a signal back to a central monitor at the nursing station, providing a continuous overview of vital signs. Alarms help the medical staff to detect deterioration as it is happening so they can intervene and treat before it gets worse. The purpose of the research project is to see whether the Portrait Mobile monitoring system helps with the earlier detection of deterioration in patients recovering on the ward after bariatric surgery, leading to improved safety.

Summary A Phase 1b Study Evaluating the Safety and Tolerability of CLB-4000 with or without Peg-IFNa-2a in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are an adult aged between 18 and 60 years old with chronic hepatitis B. Study details This is a Phase 1b, multicenter study designed to assess the safety and tolerability of repeated intramuscular (IM) administration of CLB-4000 (a fixed antigen concentration of 250 µg CLB-405 and 250 µg CLB-505, adjuvanted with multiple dose levels of TQL-1055) in noncirrhotic adults with CHB taking a stable dose of a standard of care nucleoside/nucleotide analogues (NUC) for viral suppression. To further boost the immune and antiviral responses, additional cohorts will evaluate CLB-4000 with Peg-IFNa-2a. Subjects with all HBV genotypes and either HBV-e antigen positive or negative status are included. CLB-4000 will be administered alone and in participants who will also receive Peg-IFNa-2a. Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. Subjects participating in Peg-IFNa-2a arms of the study will self-administer or have a caregiver administer a weekly subcutaneous injection of Peg-IFNa-2a 180 mcg for 8 weeks during a run-in period and then for 16 weeks during the CLB-4000 treatment phase following injection training and instructions on proper storage and disposal by a clinician. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months or, for subjects participating in Peg-IFNa-2a arms, 13 months.

This study aims to determine whether E-EDV-D682 in combination with the adjuvant treatment, EDV-GC is safe and effective and to identify the most responsive cancer indications (advanced EGFR-expressing solid tumors) to the E-EDV-D682/GC treatment. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. A life expectancy greater than 3 months, measurable disease per iRECIST criteria, adequate haematological, renal, hepatic and cardiac function. You must have positive EGFR expression on local IHC or liquid biopsy. Study details In Phase I of the study a safety assessment will be performed on 3 participants from each cancer indication. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 20 participants for each cancer indication. The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with iRECIST to determine treatment response. Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment free week in which tumour burden is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the funding from this study will help determine the safety and efficacy of EGFR targeted EDVs carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate

This pilot study aims to reveal the profiles of extracellular vesicles (EVs) and their associated proteins in periodontal diseases (refers to diseased groups) before and after treatment follow-up (3, 6 , 12, 18 and 24 months). Host and non-host EVs from periodontally healthy (without follow-ups as no need to follow up) will be used as controls. Whole oral samples (saliva, GCF and plaque) will be used as controls. There are two general aims for this project: Aim 1: Diagnosis and prognosis values of EVs and their associated proteins in periodontal disease groups Compare the differences in host and microbial derived EVs and their EV content expressions between periodontally healthy periodontitis and periodontitis undergoing treatment over a 1-year observation period Aim 2: EV profiles after in vitro biofilm culture Examine the microbial EV microbiome and proteome profiles in samples from both healthy and diseased groups following in vitro biofilm culturing It is hypothesised that host and microbial EVs and EV content are differentially expressed in diseased patients compared with periodontally healthy patients, and correlates with the severity of periodontitis. Furthermore, it is hypothesised that EVs will be positively correlated with improvements in clinical parameters after periodontal treatment.