ANZCTR search results

Burn wound infections continue to cause significant health problems for patients following a range of burn injuries. Current therapeutic options are sub-optimal and are often associated with delayed wound healing. We therefore plan to study the antibiotic, RECCE®327 to assess the clinical effectiveness and safety of this agent for the treatment on infected chronic burn ulcers. The study is exploratory and will deliver the new RECCE®327 antimicrobial via an innovative spray-on formulation, specially developed for this study. We plan to study two dosing schedules with ten participants receiving daily and a further twenty receiving three times a week application of the spray-on RECCE®327 antibiotic, over a 14 day study period. If this exploratory study suggests clinical effectiveness and no toxicity signal, we then plan to undertake a much larger study of the novel RECCE®327 antibiotic comparing it to standard care.

This trial aims to evaluate the feasibility of using 89Zr-TLX250 PET/CT in the detection of localized and metastatic urothelial carcinoma or bladder cancer. Who is it for? You may be eligible for this trial if you are aged 18, able to provide informed consent, and histologically diagnosed with bladder cancer or urothelial carcinoma or known metastatic urothelial carcinoma or bladder cancer. Study details Participants will be screened through FDG PET/CT scan and baseline procedures (physical examination, general blood test, vital signs, medical and surgical history, and previous medications), within 28 days of selection to day 0). At day 0, participants will receive an injection of 89Zr-TLX250, followed by a diagnostic PET/CT scan on day 5 ± 2 days after 89Zr-TLX250 administration. Participants will be followed up at day 14 post-scan for a telephone consult regarding safety evaluation. It is hoped that information from this trial will help evaluate the effectiveness of 89Zr-TLX250 PET/CT in detecting primary bladder cancer and upper tract urothelial carcinoma.

This study aims to improve mental health outcomes for those with anxiety and depression by using an innovative text messaging intervention to supplement therapy. We hope to develop a scalable intervention via psychological flexibility-based text messages, which does not require personal contact, and can be delivered remotely. This study will involve a randomised controlled trial to determine the efficacy of the text messaging intervention. Clients of a psychology clinic will be allocated to a control (treatment as usual) or intervention group (treatment as usual plus text messaging intervention). Text messages will be based on Acceptance and Commitment Therapy and will be delivered daily for 8 weeks. We hypothesise that the intervention group will have improved wellbeing compared to the control group after 8 weeks.

Lab studies suggest that sugammadex can reduce plasma oestrogen and progesterone concentrations to the equivalent effect of 1 missed dose of the pill. However, there has been no investigations of this in real life patients.

The main objective of this study is to determine whether transanal irrigation is quicker than standard bowel care for adults who have a spinal cord disorder. Another important outcome is to see whether transanal irrigation can reduce the amount of bowel accidents and constipation that people with spinal cord disorder experience. Finally, the study wishes to know if people report an improvement in their quality of life if they use transanal irrigation.

‘Food is medicine’ programs incorporate provision of healthy foods into the medical system to help improve population diets and complement pharmacologic treatment of non-communicable diseases. Healthy ‘Food Farmacy’ is one such approach, which allows physicians and other health professionals to prescribe healthy food for lower-income or food-insecure patients, in combination with nutrition education and related social support to synergistically improve health behaviour. This is a pilot healthy Food Farmacy trial that will recruit food-insecure patients with poorly-controlled type 2 diabetes (T2D) via physician consultations at hospital sites in Sydney. Participants will be prescribed food boxes comprising of healthy foods such as whole grains, fruits, vegetables, nuts/nut butters, and low-fat unsweetened dairy products; which will be provided to them weekly over 3 months. In addition, participants will be provided simple recipes as well as fortnightly dietary consultations on nutrition education and cooking tips. The primary outcome of interest in this pilot study is to understand the effects of the Food Farmacy intervention on dietary behaviour in patients. In addition, this trial will assess the feasibility and acceptability of the intervention by collecting feedback from key stakeholders. Finally, effects of the Food Farmacy on food security, clinical risk factors and household behaviours will be explored before and after the intervention.

The ageing population is growing at a fast pace, and is associated with increased rates of common health issues such as cardiovascular disease, diabetes and obesity, however, optimal dietary intake can have a positive effect on these health issues most common in older age. Limited amounts of certain amino acids – namely branched-chain amino acid (BCAA: isoleucine, leucine and valine), tryptophan, methionine – have been linked with poor health outcomes in older age. In this study we aim to determine the effects of branched chain amino acids (BCAA) supplementation by itself, combined with tryptophan, or combined with methionine on appetite and short-term metabolic outcomes in individuals aged 65-80. We expect that that compared to the control diet, those on a diet supplemented with BCAA will have an increased appetite and energy intake, whereas those on a diet supplemented with BCAA and tryptophan will not show this increase in appetite. Supplementation of BCAA + methionine will have similar effect to BCAA on its own.

SIR1-365 is a potent and selective allosteric kinase inhibitor of RIP1 with favorable drug-like properties in vitro and in vivo. RIP1 inhibitors may be beneficial for the treatments of degenerative diseases including neurodegenerative and systemic inflammatory diseases. In vitro work has shown weak inhibition of SIR1-365 on the activity of CYP450 isoform 3A4. Thus, the objective of this study is to evaluate the effects of SIR1-365 after a single oral dose of 300 mg on the activities of CYP450 isoform 3A by comparing the PK profiles of midazolam (the sensitive index substrate for CYP450 isoform 3A) when administered alone or together with SIR1-365.

This trial aims to determine feasibility and preliminary efficacy of a 12-week online yoga program in women with breast cancer-related lymphoedema, and to evaluate its impact on coping skills and quality of life. Who is it for? You may be eligible for this study if you are 18 or above, have completed chemotherapy or radiotherapy for breast cancer, and have breast cancer-related lymphoedema. Study details Participants will attend one 60-minute yoga session per week via Zoom. The first session will be one-on-one, followed by 11 group sessions with a maximum of 6 participants. Participants will also be given pre-recorded sequences that can be practised for 15 minutes every day of the 12-week program. A number of questionnaires will be given for completion before and after the 12-week program, as well as arm measurements and range of motion tests to assess for improvements in lymphoedema symptoms. It is hoped that this study may demonstrate that yoga classes delivered online can improve arm volume (circumference), range of motion, self-efficacy, coping and quality of life in individuals with breast cancer-related lymphoedema.

The purpose of this pre-post comparison study is to provide preliminary evidence for any effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on a range of intermediary cardiovascular risk markers in sleep clinic patients with OSA. Intermediary cardiovascular risk markers (peripheral and central blood pressure, arterial stiffness, endothelial function, autonomic function, and blood biomarkers) will be assessed at 3 and 6 months post OAT implementation. Efficacy of OAT in controlling OSA at the end of the study and adherence to OAT over the study period will be assessed via usage data downloaded from embedded adherence chip. Analysis will be performed to assess the influence of baseline cardiovascular risk status (hypertension, Framingham risk score) and treatment effectiveness (efficacy and usage) on changes in cardiovascular risk markers over the treatment period. The recruitment target (including allowance for drop outs) will be 105 participants. This is to ensure sufficient complete responders to OAT are recruited in the sample. There are known variations in OAT efficacy. Previous research suggests that <40% of OSA patients are complete responders to treatment, 30% have minimal clinical response and the remainder have some clinical benefit. We aim to have a minimum of 30 complete responders in the sample. Data from this observational study will be used to inform future trials of OSA therapy for cardiovascular disease prevention.