ANZCTR search results

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.

Asthma and other conditions can co-exist in patients with Chronic Rhinosinusitis with Nasal Polyps, which can adversely affect patient outcomes. It is uncertain if it is of benefit or cost effective for these patients to routinely see a Respiratory Physician. This study will answer this question. Patients who are planning to have Sinus Surgery treatment will be randomly allocated to two groups: One group will receive the Usual Care from their Ear Nose and Throat Surgeon. The other group will receive Precision Care, and will attend for an appointment with a Respiratory Physician and be assessed for asthma or other respiratory conditions and other medical conditions that they may have. These patients will then receive treatment for these conditions. It is proposed that patients receiving precision care will report greater improvement in their Chronic Sinusitis symptoms 12 months post surgery.

This trial aims to 1) determine the effect of Cognitive Bias Modification for Interpretation (CBM-I) on pain severity and pain interference in people with endometriosis, and 2) investigate whether imagery can enhance the effects of CBM-I. Participants eligible for this study are those who 1) are aged 18 or above, 2) have a confirmed or provisional endometriosis diagnosis, 3) experience pain associated with endometriosis,,4) have access to the internet and a computer or smartphone over a 3-month study period, 5) are fluent in English. Participants will be randomly allocated (by chance) to receive one of two (CBM-I) interventions or a placebo. CBM-I is an online intervention that aims to alter the way that people interpret ambiguous information. Participants will receive four cognitive bias modification sessions over 30 days and will be required to answer a number of questionnaires before the intervention phase, and both 14 and 90 days after the intervention phase is completed. It is hoped that this study may demonstrate that CBM-I is effective in reducing pain outcomes in people with endometriosis. It also hoped that this study may help to reduce psychological distress (depression, anxiety and stress), fear or progression, and improve quality of life for people with endometriosis pain..

Having a stroke is a life-changing event. Many survivors are left with significant impairments that affect their long-term independence. For many, this can limit their participation in activities which they enjoyed before their stroke. In metropolitan Australia, stroke patients receive an average of 42 days of therapist-guided stroke rehabilitation. Many people in regional and rural areas receive much less. Environmental enrichment is the combination of physical, cognitive and social activities. Previous experimental models of stroke have shown that this can increase brain plasticity, which is an important process for re-learning skills and function after stroke. Group-based (peer-supported) programs can provide a sense of community through sharing information, providing tools for coping, and creating an outlet for stroke survivors and caregivers. This may contribute to improved physical function and psychological outcomes after stroke. The aim of the project, “ Exercising, Socialising and Thinking: an Environmental Enrichment Model (ESTEEM) After Stroke", is to build a sustainable group program based on environmental enrichment for use in community venues by stroke survivors and their carers. The ESTEEM Program has been co-produced in collaboration with people with lived experience of stroke including stroke survivors, carers, health professionals and service providers. Overall ESTEEM project hypothesis: We hypothesise that, compared to stroke survivors receiving usual care in the community, stroke survivors who receive the model of environmental enrichment will have greater physical function and quality of life.