ANZCTR search results

This pilot study is evaluating the feasibility of providing an oral prebiotic fibre supplement during treatment for acute leukemia. It will assess tolerance and whether prebiotic supplementation can improve the microbiome and reduce complications. Patients may be eligible to join this study if they are aged 18 years and older undergoing treatment for acute leukemia at the Royal Brisbane and Women’s Hospital (RBWH). Participants in this study will be randomly allocated to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from the start of induction treatment until the end of their consolidation treatment. The control group will receive usual care. It is hoped that prebiotic supplementation will support the microbiome and improve health outcomes for participants undergoing acute leukemia treatment.

Residential aged care facilities are at higher risk of COVID-19 and airborne pathogen (influenza, RSV) outbreaks and their consequences. Upper room GUV (UR-GUV) light has the potential to substantially reduce the transmission of airborne pathogens, including viruses, by inactivating them when in contact with the ultraviolet C (UV-C) light emitted from the device. The advantages of UR-GUV are that it can potentially deliver high levels of effective air changes (or clean air), such that transmission may be interrupted; and that it does not rely on interventions requiring behavioural uptake or modification. This study aims to determine if in RACFs in metropolitan Melbourne and Greater Geelong, Victoria, Australia, the installation of UR-GUV in common rooms reduces the event (“incidence”) rate of COVID-19 among residents, compared to standard practices alone over 12 months. This is an open-label cluster randomised controlled trial (cRCT) conducted in real-world setting, using routine systems for infection control and prevention. The study plans to recruit up to 60 residential aged care facilities, mostly from large multi-facility aged care providers. Half (30) of the facilities will be intervention facilities with UR-GUV installed. The other half will be control facilities with no UR-GUV installed but will continue standard of care. The study involves the routine collection of COVID-19, influenza and RSV case data over a 12-month period in these intervention facilities and compare it with cases in the control facilities. The study will also measure the effectiveness of GUV at reducing other respiratory illnesses. These findings will help inform the role of UR-GUV as part of a suite of available interventions to prevent and manage COVID-19, other respiratory illnesses and enhance preparedness for future airborne pathogen threats and pandemics.

The Kite trial is a clinical trial of adults (18+) with bipolar disorder I or II who are currently experiencing a major depressive episode. The primary research aims to determine if a 3-week course of low-dose ketamine administered twice- weekly is an effective treatment for adults with moderate-to-severe bipolar depression, in addition to treatment-as-usual. Participants must be taking a mood-stabilising medication for the duration of the trial. 98 male and female participants will be recruited. In the Randomised Controlled Trial (RCT) phase, participants will be randomly assigned to receive either low-dose ketamine or an active control treatment (midazolam) via subcutaneous injection, twice a week for three weeks. Change in depression symptom scores will be assessed at the end of week 3. After completing this phase, some participants will advance to a second phase where they will receive a further 3 weeks of twice- weekly open label ketamine treatment to further evaluate its safety profile and effectiveness. All participants will complete follow-up assessments at Day 39 and Day 81. The research aims to offer valuable data on ketamine's potential benefits in treating depression in people with bipolar disorder.

In the inpatient peri-operative setting, people with diabetes are at risk of dysglycaemia precipitated by a number of factors, for example prolonged fasting, use of blood glucose lowering agents, stress, fever, infection and pro-inflammatory state. In addition, delayed BGL monitoring and medication errors relating to insulin and oral hypoglycaemic agent doses and administration can cause further fluctuations in BGLs and contribute to increased hospital length of stay and surgical complications. Standard POC glucose testing requires manual input by nurses into the EMR, which can lead to error and delay in transcription of the BGL value. The standard POC BGL testing also does not enable easy auditing of BGL data, so that interventions to improve BGLs are difficult as they require time consuming manual audits of sequential BGLs over time e.g. to assess adherence to protocol in treatment of hypoglycaemia. This is a prospective pre- and post-intervention observational study to determine whether early identification of dysglycaemia, using a blood glucose meter with Wi-Fi connectivity to the EMR and an early identification system can facilitate prompt assessment and management to improve patient outcomes. The patient outcomes are, comparing use standard care POC BGL testing with Wi-Fi connectivity glucose meters, the mean proportion of BGLs per patient in the hospital inpatient target range of 5-10 mmol/l , the mean proportion and number of patient days with hypoglycemic incidents and with hyperglycaemic incidents, the average length of stay, 28 day readmission rates, and post-operative complications including but not limited to surgical site infections. We will also measure time to first assessment of dysglycaemia by the glucose control team, both from admission and from arrival on one of the surgical wards. We hypothesise that use of the connectivity glucose meter will identify patients who require clinical intervention earlier and will improve glycaemic control, post-operative surgical outcomes, decrease the mean length of stay and decrease 28-day readmission rates.

The purpose of this study is to investigate whether physical exercise can improve the response to radiotherapy and enhance the effectiveness of treatment in prostate cancer patients. Who is it for? You may be eligible to join this study if you are a male aged 18 years or over, have a diagnosis of localised or locally advanced prostate cancer, and are scheduled to receive conventional or moderately hypofractionated external beam radiotherapy. Study details: Participants in this study will receive a supervised exercise intervention for the duration of their radiotherapy treatment (4-8 weeks). The exercise program involves aerobic and resistance exercises undertaken 3 times per week in an exercise clinic setting. The exercise sessions are 1 hour in duration and take place at exercise clinics affiliated with Edith Cowan University or the Exercise Medicine Research Institute in the Perth metropolitan area. All participants will complete assessments at baseline (i.e. before starting radiotherapy) and after completion of their radiotherapy treatment in order to evaluate treatment response, tumour progression, the effect of exercise on aerobic fitness and muscle strength, as well as health-related quality of life. It is hoped this research will contribute to new knowledge that will help improve treatment outcomes and survivorship care for prostate cancer patients by demonstrating the benefits of engaging in physical exercise while undergoing external beam radiotherapy.

This is a prospective, open-label, multi-center Phase 1 study to evaluate the safety and tolerability of a single, unilateral intravitreal injection of escalating doses of PBI-671 Gel for Injection (PBI-671) in subjects with advanced glaucoma). Phase 1 follows a standard dose escalation model with two doses to determine the Maximum Tolerated Dose (MTD) of PBI-671 and recommended Phase 2 dose (RP2D). An Extension Cohort of up to 7 subjects dosed at less than or equal to the MTD may also be enrolled in the Phase 1 study, if the Sponsor and Safety Review Committee (SRC) elect to add additional subjects to further characterize dose levels.

This study is a prospective single-group cohort study to evaluate the safety and tolerability of a modified ketogenic diet as an adjunct preventative treatment in adults with chronic migraine.

This Research Project will involve a randomised control trial of an online mindfulness training program (MTP) designed specifically for medical students studying at UWA and University of Notre Dame, Fremantle, to assess the feasibility and effectiveness of the program with regards to reducing perceived stress and improving mindfulness, self-compassion and study engagement. The MTP has been developed to include brief, daily mindfulness meditation practices and brief, weekly video teachings on the applications of mindfulness meditation for medical students. The program will be delivered via an online platform. This delivery mode aims to minimise the time required by busy medical students to invest in the program while providing stress management and self-care skills that are traditionally not taught as part of medical school training. The program will be evaluated using both quantitative, including quantitative surveys before and after the program. We hypothesise that students who participate in the intervention will have improved levels of perceived stress, mindfulness, self-compassion and study engagement compared to controls who do not at the end of the 8-week program compared to baseline, with a number of intervention participants maintaining those improvements at 6-months post-intervention.

Early sepsis diagnosis is challenging for clinicians due to the non-specific nature of symptoms and the cross-over between clinical signs and symptoms of sepsis and those of other mild self-limited infections. Current diagnostic criteria for sepsis in children perform poorly, causing clinicians to rely on their own experience and judgement to diagnose sepsis. They must balance the risk of over-treatment, un-necessary hospitalisation, and overuse of broad spectrum antibiotics with the risk of delayed treatment, which is a known contributor to poor outcome and death from sepsis. The lack of clear diagnostic criteria also results in variable estimates of sepsis prevalence, severity, outcomes, cost, difficulty benchmarking care, and inconsistent enrolment strategies for clinical trials. The Biomarkers in Sepsis (BASIS) study will identify novel biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification. These will have the potential to save lives through commercialisation into point-of-care tests.

The Strength Study is a Phase 3 clinical trial evaluating the efficacy and safety of L-carnitine in treating muscle fatigue and weakness in children with Neurofibromatosis Type 1 (NF1). Children with NF1 often experience reduced muscle mass, muscle weakness, and motor function issues, impacting their quality of life. NF1 deficiency can lead to the accumulation of intramyocellular lipids in muscles. L-carnitine helps transport fatty acids into mitochondria for energy production and has been used to treat disorders of fatty acid metabolism. This study will assess L-carnitine's effects over 12 to 25 weeks in children aged 8 to 12 with NF1, measuring improvements in muscle strength and activity. The primary measures will include Z-score changes on functional assessments, hand-dynamometry, and data from the GENEActiv Actigraph.