ANZCTR search results

The Diabetes Alliance intervention recognises that general practitioners (GPs) and practice nurses are often the first point of care, therefore best placed to diagnose and provide ongoing care to people with diabetes. For those living in metropolitan areas, diabetes care would typically include access to specialist consultations and a diabetes management team with multidisciplinary expertise to minimise long-term morbidity. Diabetes Alliance works in regional, rural, and remote areas to integrate hospital specialists with multidisciplinary expertise, with GP practices and GPs to enhance primary care capacity and capability. The aim is to share skills, knowledge, and resources to enhance diabetes care through three core activities: case conferencing, delivered directly to a small proportion of adults with diabetes; practice-level performance monitoring; and education and training sessions. The hypothesis is that enhanced capacity and capabilities will translate to clinical improvements in all patients with diabetes seen in the general practices who have received the Diabetes Alliance intervention.

This imaging sub-study will use FDG-PET/CT & CTA angiography (Carotid/ Arotic) to answer the question of if Colchicine administration will reduce vascular inflammation and improve plaque stability. Selected sites participating in the COLCARDIO-ACS (ACTRN12616000400460) and CASPER trials (ACTRN12621001408875) trials will be participating in this CAP sub-study. A sub-set of these sites will collect additional research blood for 40 participants.

Avatar-delivered education via an app is a novel approach to assist health care workers provide good quality education to adults after heart attack during the hospital admission, and may be more suitable than traditional written materials for adults with poor literacy. The app contains six modules based on the Heart Foundation’s Six Steps to Cardiac Recovery. This study will compare the app to usual care in a randomised, controlled trial. Study outcomes will include change in knowledge, attitude and beliefs around heart disease, change in quality of life, health care utilisation, response to heart attack symptoms and impact on heart disease risk factors.

Maintenance of Remission for Ulcerative Colitis with Faecal Microbiota Transplantation; the MR-UC-FMT trial is prospective clinical trial designed to determine the dosing interval of Faecal Microbiota Transplantation administered by enema with a view to maintain remission following induction with FMT and prednisolone. The study recruits patients with mild to moderate Ulcerative Colitis and enrols them into two phases of the trial. The first phase involves an 8 week course of prednisolone with a Faecal Microbiota Transplantation given via colonosopy at week 5 with a view to induce remission or adequate clinical response. Those patients who respond to treatment will be openly randomised to receive FMT via clinician administered enema every 4 or 8 weeks for a further 40 weeks (total 52 weeks). The study aims to test the hypothesis that: -FMT given more frequently via enema is more likely to result in the patient's microbiome becoming more similar to the FMT than the patient's baseline microbiome. -The therapeutic effect of FMT is that the bacteria in the patient's colon become the same as those in the transplant material. -The therapeutic effect of FMT is to improve the diversity of bacteria in the patient's colon -FMT is more effective if given with prednisolone for induction of remission. -FMT given more frequently improves outcomes including time to flare, weeks in flare and clinical or endoscopic remission at 28 and 52 weeks.

This pilot study aims to compare patient-rated outcomes and range of motion between patients who undergo surgical stiff elbow release, treated with an injection of botulinum toxin (botox) pre-surgery vs placebo. We hypothesized that the injection of botox into the biceps and brachialis immediately before surgery may result in greater range of motion (less stiffness) following surgical release.

Physical activity has the potential to improve the mental health and wellbeing of university students. Given the high prevalence of mental ill health diagnoses in university students when compared to individuals from other age groups, the Fit 4 Study program aims to use physical activity to help first-year undergraduate university students manage their experiences of psychological wellbeing, symptoms of depression, anxiety, somatic symptoms, loneliness, increase their use of physical activity, decrease amount of time spent engaging in sedentary behaviour, improve their academic performance (GPA), and bring benefits to their social group belonging.

Current first-line antibiotic therapies for bacterial vaginosis (BV) provide cure rates of 70-80% 1 month after treatment, but >50% experience BV recurrence within 3-6 months of completing recommended treatment. There is epidemiological and microbiological evidence supporting sexual exchange of vaginal bacteria (both optimal and non-optimal) between sexual partners. BV imposes a heavy burden on the healthcare system, as recurrence results in multiple presentations to clinical services and repeated antibiotic use. In addition, the obstetric and reproductive sequelae associated with BV have significant implications for healthcare expenditure. Effective therapeutic approaches are an urgent health priority. The LGBTQIA+ community have a higher prevalence of BV in many settings. Given the evidence of sexual exchange of bacteria between partners, treatment of only one individual in a partnership may result in re-infection when sex resumes post-treatment. Given the high rate of BV in the LGBTQIA+ community, we hypothesise that treating the regular sexual partner of people diagnosed with BV (the index) will reduce BV recurrence. All couples will have access to treatment which will be anatomically directed. We aim to recruit 74 couples (148 individuals) in Australia, and we are using single-arm design, where if both individuals have a vagina, they will both be offered first-line therapy with oral metronidazole. There is also provision for couples where a partner decides not to receive treatment, or has anatomy requiring combination-therapy. We will collect genital, oral and anal specimens from all participants before and after treatment, and then weekly for up to 9 weeks to see if the index gets their BV back again or not.

This is a randomized, double-blind, placebo-controlled, single ascending dose study. Approximately 48 men and women aged 18 to 70 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Week 24. The single ascending dose study includes 4 cohorts (50mg, 150mg, 300mg and 600mg) of subjects with mild to moderate hypertension (N = 12 per dose cohort).

This is a randomized, double-blind, placebo-controlled, single ascending dose study of BW-00112 when administered subcutaneously to subjects. Approximately 32 male and female subjects with elevated Low-density lipoprotein cholesterol , aged 18 to 65 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose) after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Day 85. There will be 4 separate and sequential dose cohorts. The population in Cohorts 1 to 4 (50mg, 150mg, 300mg and 600mg) will include subjects with fasting Low-density lipoprotein cholesterol levels > = 100 mg/dL and 100 mg/dL < = Triglycerides (fasting) < 500 mg/dL who are not on a lipid-lowering therapy.

Hyperbaric oxygen is the provision of oxygen in a compression chamber.The aim of this trial is to test the hypothesis that hyperbaric oxygen treatment (HBOT) may improve symptoms in people with Long-COVID . We will compare symptoms of those allocated to the HBOT to participants allocated to no HBOT.