ANZCTR search results

The SALAD Trial is a Randomised Controlled Trial assessing the effect of local anaesthetic delivered to the shoulder joint by a catheter inserted during surgery on post-operative pain control. Post operative pain relief makes patients more comfortable, can increase rate of recovery and reduce the risk of long-term dependence on opioid pain relief. The aim of this study is to see whether local anaesthetic delivered into the shoulder joint after surgery in addition to usual pain relief reduces pain compared to usual pain relief alone. This study is a collaboration between three departments at Royal Prince Alfred Hospital (RPAH): Department of Anaesthetics, Department of Orthopaedic Surgery, and Surgical Outcomes Research Centre (SOuRCe). All participants will undergo arthroscopic rotator cuff repair surgery followed by insertion of a subacromical cathether for the administration of local anaesthetic or placebo. The first dose of local anaesthetic or placebo is administered in the Post Anaesthesia Care Unit (PACU) as the pump is connected. Participants will be randomised to receive either local anaesthetic or placebo. We hypothesise that in patients undergoing primary arthroscopic rotator cuff repair procedures, there is a significant reduction in post-operative pain and opiate usage for patients who receive a Programmed Intermittent Bolus of Local Anaesthetic into the subacromial space via a subacromial catheter compared to patients who receive a placebo infusion into the subacromial space only.

This is a Phase I, randomised, double-blind, placebo-controlled, ascending dose study, with an adaptive patient arm. Healthy volunteers (HVs) and/or patients with Type 1 Diabetes will be enrolled and randomised to 6 cohorts: - Cohort 1: 6 partcipants randomised at a ratio of 2:1 (active: placebo) - Cohorts 2 to 6: 8 participants in each cohort at a ratio of 3:1 (active: placebo). SAB-142 is currently being developed as a disease-modifying therapeutic agent to delay the onset and progression of T1D. The purpose of this study is to test the safety of SAB-142 when given to healthy volunteers or Type 1 diabetes patients. The starting dose will be 0.03 mg/kg with 5 dose levels planned (up to 4.5 mg/kg). Dosing in each cohort will commence with two sentinel participants, with one of the two sentinels randomised to receive SAB-142 and the other randomised to receive placebo. The sentinel participants will be monitored in the clinic for at least 7 days and at least 3 days of available safety/tolerability data will be reviewed by the Safety Review Committee (SRC) prior to dosing the remainder of participants in each cohort. In the event that adaptive design criteria are met, dosing of HVs will cease, and the study will transition to an adaptive T1D patient part of the study. In this case, T1D patients will be enrolled and randomised (6 participants in each cohort, ratio 2:1 active: placebo). The starting dose for the T1D patients will be equivalent to the next dose level from the last dose administered to the HVs full cohort, or will be equivalent to the last dose level administered to the HVs if a transition to the T1D patients is recommended after the sentinel cohort. The decision to escalate between dose levels and proceed to the next cohort in HVs or to move to the adaptive T1D patient arm of the study, will be made by the SRC following review of available safety and tolerability data from Day 1 up to Day 14 for all participants in the cohort.

Therapeutic drug monitoring (TDM) is recommended for anti-tuberculosis (TB) drugs. Some drugs can penetrate into saliva and urine sufficiently enough to be used as alternative sampling. Our primary aim is to develop a salivary pharmacokinetic model for levofloxacin. The secondary objectives are to study the salivary penetration ratios for TB drugs, determine the relationship between the genotype of NAT2 and isoniazid level, and determine the feasibility of using saliva or urine for TDM. A prospective, open-label, observational study will be conducted in 30 adult patients receiving TB drugs. Plasma, saliva, and urine samples will be collected around week 2 for drug analysis. The population PK model will be developed using Nonlinear Mixed Effects Modeling (NONMEM®). Expected outcomes include a salivary pharmacokinetic model for levofloxacin, the relationship between NAT2 genotype and isoniazid level, and an assessment of the feasibility of using saliva and/or urine for TDM of TB drugs.

This project aims to examine the efficacy, feasibility and acceptability, of an emotion-focused cognitive therapeutic intervention, Imagery Rescripting, in improving clinical symptoms for individuals with generalised anxiety disorder (GAD). It is expected that a 10-week individualised Imagery Rescripting intervention will produce reductions in clinical symptom severity among individuals with a primary diagnosis of GAD. The research questions that this study seeks to address are: 1. Do individual participants with GAD report benefits of participation in Imagery Rescripting? 2. Is the intervention acceptable to clinicians and participants? 3. Are participants or clinicians likely to report any harms or adverse events associated with delivering Imagery Rescripting among individuals with GAD? 4. What types of mental images do participants with GAD describe during Imagery Rescripting, and how are these images thematically related to their current worries? 6. What are the estimated recruitment and retention rates during the intervention and follow-up periods?

The aim of this study is to test the feasibility of technology-assisted dietary assessment and advice to improve overall diet quality in patients awaiting elective cardiac surgery.

This is a prospective single site study evaluating the additive value of a diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference mpMRI scan in men who have undergone Focal therapy for prostate cancer with Irreversible Electroporation (IRE) procedure. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you are scheduled to undergo a primary focal IRE (Nanoknife®) procedure as part of your cancer treatment. You should also have undergone both a PSMA PET/CT scan and an mpMRI scan prior to any surgical treatment as these images will be used for comparisons. Study details All participants who choose to enrol in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 12 months of undergoing the IRE procedure to treat their cancer. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and a biopsy (tissue sample) of any remaining tissue. It is hoped this research will determine whether adding a PSMA PET/CT scan to the current standard of care mpMRI scan is able to better detect residual/recurrent clinically significant prostate cancer. If the PSMA PET/CT scan is found to be a helpful addition to the current mpMRI scan, or is found to be more accurate in detecting prostate cancer than the mpMRI scan, a larger trial involving a greater number of patients with prostate cancer may be undertaken.

Multivitamin supplements have been reported to be the most commonly taken dietary supplements in Australia (Australian Bureau of Statistics., (2020-21). Supplement users were also found to have higher intakes, in their diet (from food only), of fibre and more vitamins and minerals (except zinc and vitamin B12) than non-supplement users. Additionally, intakes of all vitamins and minerals were higher when the contribution from supplements was added into overall intakes. This demonstrates the potential benefits of multivitamins to supplement overall nutrient levels, with the aim of supporting overall health and wellbeing (Burnett et al., 2017). To best support the health and wellbeing of Australians, Swisse conducted a targeted reformulation of their Ultivite Multivitamins to ensure that they were meeting the present needs of Australian adults as evidenced in the population data. This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences whilst taking the Swisse Ultivite Multivitamin products. Presently, the rigorous clinical trials and scientific evidence that is used to support relevant indications, in line with TGA requirements and approval, does not reflect a real-world environment. Research of this nature is not intended for regulatory submission/dossier nor for pack claims, but rather seeks to explore typical product use and understanding of participant perspective in an environment that is not tightly controlled. In order to replicate a real-world setting, the use of randomization, blinding and placebo is not included, and the limitations of the study design have been greatly considered. Overall, the study aims to generate complementary evidence on user experiences for Swisse Ultivite Multivitamins for the purpose of publication and potential use in advertising claims.

This is an open-label pilot study to assess XW10508 MR safety, tolerability and efficacy in patients with Major Depressive Disorder. The hypothesis is oral XW10508 MR tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.

Addictive eating is a behaviour that contributes to excess energy intake (calories) and is associated with overweight and obesity trajectories, a major health problem affecting over 60% of young adult Australians and is a key risk factor for cardiovascular disease (CVD). Moreover, addictive eating is associated with depression and anxiety, which is the leading cause of disability and premature death in Australia. In these instances, food may be used to reinforce comfort and/or to stabilise mood. Approximately one in five individuals with CVD suffer from depression, while one in four suffer from anxiety. Our research illustrates that these comorbidities (obesity and mental health) cluster together, which if better understood, could be targeted more effectively through better identification and assessment to trial tailored novel interventions for addictive eating. Current guidelines for obesity and CVD focus on reducing energy and saturated/trans-fat, rather than eating behaviours. Despite the extent of obesity and CVD, interventions to treat CVD risk factors are only moderately effective in the short-term. There is a need for effective behavioural approaches for addictive eating for CVD prevention. The proposal builds upon previous research (ACTRN12619001540101, ACTRN12621001079831) to determine the feasibility of a personality-based intervention for young adults with addictive eating, in a 3-month trial. It will be delivered using technologies, including telehealth, a website, text messages and email. This approach means the program can be delivered anywhere in Australia to individuals in any location. This trial will enable a better understanding of the relationship between CVD and problematic eating behaviours, assist the generation of new treatment principles and enhancement of identification and assessment of at-risk individuals and transitioning them to the right intervention for their condition.

This study aims to investigate the potential of a new PET imaging tracer, [68Ga]Ga-FAPI-04 (Fibroblast Activation Protein Inhibitor), for imaging pancreatic cancer and malignant pleural mesothelioma (lung cancer) compared to the current standard imaging tracer [18F]FDG. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with either pancreatic cancer which is locally advanced or recurrent/progressive or malignant pleural mesothelioma and have been referred by your treating doctor to have a fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan (or FDG PET scan). Study details All participants who choose to enrol in this study will be asked to undergo one PET scan with the [68Ga]Ga-FAPI tracer. This involves one additional visit to hospital within one week of your FDG PET scan. At this visit, a needle is inserted into a hand or arm vein and a small amount of the radioactive [68Ga]Ga-FAPI is injected. Participants will rest for up to 3 hours while the [68Ga]Ga-FAPI travels through the blood stream and is taken up by pancreatic cancer cells or mesothelioma cells before being positioned on the bed of the PET scanner. The time in the scanner is around 30 minutes and the total time required for this visit will be up to 4 hours. This additional PET scan is for research only and will not be used to change your treatment. Over the next 12 months, your medical records will be accessed to follow up your clinical treatment and any other imaging performed. This will not involve any additional appointments for you. It is hoped this pilot study will confirm that advanced pancreatic cancer and mesothelioma cancer cells express Fibroblast Activation (FA-protein) on the cell surface and can be imaged with [68Ga]Ga-FAPI PET imaging. If so, future research will examine using the FAPI agent with a different radioactive tag which could kill the cancer cells instead of imaging them.