ANZCTR search results

Cancer pain is a prevalent and distressing symptom, with opioids being the primary treatment. However, individual responses to opioids vary greatly, causing unpredictable pain relief and adverse effects. Approximately 30-40% of cancer patients experience "opioid failure," necessitating an "opioid switch" due to inadequate pain relief or toxicity. This study will investigate biological measures (biomarkers) to develop precision opioid prescribing for cancer patients. Who is it for? You may be eligible for this study if you are an adult who has incurable/advanced cancer with pain related to cancer and you are currently taking opioid medications to treat your cancer pain. Study details All participants in this study will be seen several times, and this may be either during or in addition to their usual care - once at the time of enrolment into the study, then at 2, 4, 6, and 8 weeks after their enrolment. Participants who are identified as candidates for opioid switching will also be seen at 72 hours before the opioid switch, at the time of the switch and again within 3-14 days after the opioid switch. On each of these days participants will be asked for clinical information and to complete some questionnaires about their symptoms (questions about pain relief, side effects and levels of function) and given questionnaires to complete regarding their symptoms and pain levels. One blood test will also be taken during this time, which includes samples for opioid levels in the blood, markers of inflammation and genetic markers. If participants undergo opioid switch, an optional additional blood test will be taken to measure opioid levels in the blood. It is hoped that this research will determine whether it is possible to provide more personalised pain relief based on a patient’s clinical, biological and genetic information. The effect of the opioid switching on pain levels up to 2 months after the medication change will also be assessed to determine whether the change has any impact on participants pain levels.

This study is prompted by our recent questionnaire review of 153 Masters Footballers (soccer) aged >=35 years which showed several concerning findings: Cardiac risk factors were common in the Masters footballers, and one in five reported possible cardiac symptoms in the prior year but only one quarter of them sought medical attention (Francis MA, Buckley T, Tofler AR, Tofler GH. Masters age football and cardiovascular risk. Intern Med J. 2022;52:369-378). Gaps existed in knowledge and optimal responses. However, there was strong support for further education and preventative measures, which informs the present study. Using a before-and-after evaluation we will determine in Masters football players whether an online educational program can improve cardiac health awareness, including cardiac knowledge, attitudes and behaviours, compared with a control group. Based on the results, our longer-term goal is to implement the online program widely, for example, at the beginning of each football season.

This research study in BV patients is testing the safety, tolerability, and efficacy of tablet formulations of an investigational drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) with or without the Essential Elements Zn and Mn, when it is given intravaginally (into the vagina) during patients’ primary treatment with oral antibiotics and for 11 weeks post antibiotics. Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of recurrent Bacterial Vaginosis (BV). The overall goals of this study are to evaluate a trend on the effect of Low Iron MTbLF-with and without Essential Elements Zn and Mn- for the prevention of recurrence of BV, the delay in time to retreatment of recurrent BV with antibiotics, and the evaluation of different diagnostics to follow recurrence during the treatment and follow up period. BV patients will receive antibiotic treatment (oral metronidazole daily for 7 days) per standard-of-care for symptomatic BV with co-administration of study drug and for 11 weeks after antibiotics. Patients will self-administer daily doses of study drug for 12 weeks. They will self-collect four vaginal swabs weekly at home for the duration of the 12-week study drug administration and then the 12-week follow up period. A series of vaginal swabs will be collected by a healthcare practitioner during 3 in-clinic visits that will take place in the 12-week dosing period and during the 2 in-clinic visits that will take place in the 12-week follow up period. Patients will use a patient diary to record symptoms, dosing of study drug and other study-related information daily during study drug administration (weeks 1 to 12) and twice a week during weeks 13-24.

Our study aims to determine the effectiveness of a new treatment for coronary microvascular dysfunction, a common but currently under-recognised and under-treated disease where the microscopic blood vessels of the heart do not function properly. We are comparing current standard of care to standard of care PLUS empagliflozin, a novel anti-diabetic drug which has shown great promise in this field in animal models. We hope to record baseline measurements of microvascular resistance (the key marker of CMD), as well as novel and established non-invasive measurements using CT scans and machine learning, symptom burden, quality of life, and levels of inflammation and cardiovascular risk factors, as recorded on blood tests. The blood tests, surveys, CT scan, and angiogram will then be repeated at the end of the participant's involvement in the trial at six months to assess for any interval change in these factors. "This study aims to see if using a commonly employed drug, first discovered for the treatment of diabetes, has a positive effect on improving a condition where the microscopic blood vessels of the heart are diseased or otherwise do not function normally."

The aim of this trial to determine if the addition of a small amount of sterile sodium bicarbonate to the lignocaine immediately prior to use will neutralise the acid preservative (buffering) and subsequently reduce the pain associated with the injection. Participants in this trial will be women who have had an unassisted vaginal birth of a cephalic singleton infant at term without an epidural and experienced a second degree perineal injury. Second degree perineal injures are the most common type following vaginal birth and are routinely sutured by either midwives or doctors. This will be a randomised placebo controlled trial. Prior to the injection of local anesthetic the lignocaine will be mixed with either sodium bicarbonate 8.4% (9:1) or the placebo control of sodium chloride 0.9% (normal saline). The addition of normal saline will not neutralise the effect of the acid preservative. The primary outcome for the study will be the difference in self reported pain scores of the injection.

This project, co-designed with clinician and patient consumers of current sleep diagnostic practices, aims to generate data to support consumer-led, and cost-effective reform of obstructive sleep apnoea (OSA) screening and diagnosis. The study will address three major problems with current OSA diagnostic practices: 1) high cost of current diagnostic polysomnography (PSG) tests, 2) a significant number of patients are misdiagnosed by single-night diagnostic tests due to variability in disease severity, and 3) current PSG tests are difficult to access, time-consuming , and require consumer participation to achieve good results. Simpler, less intrusive, and accessible multi-night OSA assessments are needed to improve diagnostic accuracy and patient outcomes at reduced costs. This project will use a randomised controlled trial design, including health economics, to compare multi-night screening and diagnostic method outcomes with current diagnostic practices.

One of the most common healthcare associated infection are catheter associated urinary tract infections. Emerging evidence suggesting the benefits of cleaning the meatal area with an antiseptic prior to urinary catheterisation, may help reduce the risk of these infections. We aim to evaluate the efficacy of cleaning the urethral meatal area with antiseptic prior to urinary catheter insertion for the prevention of catheter-associated urinary tract infections. We hypothesise that the use of chlorhexidine 0.1%, compared to saline for cleaning the urethral area prior to catheterisation will reduce the risk of infection. We will compare the use of saline against chlorhexidine (0.1%) in a double blind randomised control trial.

The purpose of this study is to evaluate the acceptability of the DialyAssist device to patients receiving haemodialysis and further to evaluate whether it improves the dialysis experience. After informed consent, people receiving haemodialysis will complete assessment of the specific effect having an arteriovenous fistula has on their quality of life using the VASQoL instrument. Those who agree to trying the new device will use the device for six sessions and repeat the VASQoL instrument. Scores on item 2 (“In the last week I am satisfied with how my line / fistula/ graft feels during dialysis.”) will be compared before and after using the device.

This project aims to explore the acceptability and feasibility of a novel therapeutic group yoga program for clients of a specialist Eating Disorder Service at Barwon Health alongside their usual treatment. Research Questions 1. Is an adjunctive therapeutic group yoga program, that includes consumers and carers, alongside treatment as usual (TAU) for the treatment of eating disorders feasible, acceptable and safe? 2.Does an adjunctive therapeutic group yoga program that includes consumers and carers alongside TAU yield additional clinical improvements for people in treatment for an eating disorder? Sub study – Research Question 1. What are the potential secondary or co-benefits for carers who attend a group yoga program to support their consumer in ED recovery?

This is a double blind, placebo-controlled multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in patients with established atherosclerosis, Up to approximately 52 participants with established atherosclerosis will be randomised into this study. The study will be conducted with a multiple dose phase (Part A) and a cohort expansion phase (Part B). Part A cohorts will contain up to 8 participants each with 6 participants receiving BRB-002 and 2 participants receiving placebo. Part B will be a dose expansion phase where a further 20 participants tested with the optimal dosing regimen determined during Part A. For each cohort, a Safety Review Committee (SRC) will review all emerging safety, tolerability, PK and PD data. The next planned cohort will be initiated only after it is confirmed by the SRC that the latest cohort dose was safe and tolerated.