ANZCTR search results

The aim of the Noah Medical FRONTIER Study is to assess the safety, efficacy and feasibility of the Galaxy Robotic Bronchoscopy System for the sampling of small peripheral pulmonary (lung) nodules that are suspected of being cancerous. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a moderate to high risk of lung cancer based on clinical, demographic, and imaging information, you have had a lung CT scan within 30 days of the pending bronchoscopy procedure and your specialist has indicated that your nodules are of an appropriate size and shape for biopsy via bronchoscopy. Study details All participants who choose to enrol in this study will undergo pre-operative and post-operative procedures in line with the standard method of lung nodule biopsy. Prior to your procedure this involves having a physical examination, medical history and CT scan of the Chest performed. Following your procedure you will be monitored for any side effects of the biopsy process and also have a Chest X-Ray to assess your lungs and the area that has been biopsied. Participants in this study will then have one of their nodules biospied using the Noah Medical Galaxy Robotic Bronchoscopy System. The Galaxy system reads the pre-operative CT scan and uses this information to locate a suspicious nodule for biopsy. If the robotic system is unable to locate and reach the pulmonary nodule, standard of care methods using probes inserted via a conventional bronchoscope will be used to sample the pulmonary nodule. Participants who chose to enrol will be followed at 24-28 hours post-operation and then 7 days following their procedure. If a diagnosis is unable to be made at this time participants will be required to be followed up at 6 months to check on the progress of their pulmonary nodule. It is hoped this research will determine whether use of a novel robotic biopsy system is safe and feasible for use in patients with a moderate to high risk of lung cancer. If the robotic system is found to be safe and effective for biopsy of suspected cancer nodules, it may be used more widely for the treatment of future lung cancer patients

This study aims to assess the feasibility and safety of using a novel technique (i.e. radio-nuclide tracer [radioactive dye] that is injected directly into the bowel during a routine colonoscopy) to understand how a specific portion of the colon functions. The aim of the study is to see how the colon situated in the left upper quarter of your abdomen, near the spleen (i.e., splenic flexure) manages to drain its tissue fluid (i.e., lymph). So far, lymphatic drainage of this part of the colon remains incompletely understood. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been scheduled for a standard care colonoscopy (i.e. to investigate the reason for presentation to a surgeon), and are in good general health without a clinically significant medical history. People who have been diagnosed with colon or rectal cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will undergo a standard colonoscopy procedure. As part of this study, participants will have a small volume of a radioactive tracer injected into their colon (large intestine) for additional imaging. The research phase of the colonoscopy and injection is anticipated to take 15 minutes. Within one to two hours after the injection has been made, participants will then be taken to the SPECT-CT scanner to have additional images taken of their bowel. This imaging procedure is anticipated to take one hour. Participants will be able to return home after the SPECT-CT. A study investigator will then contact all participants via phone call at 1 day, 7 days and 30 days after the imaging procedures to check on their health and determine any potential side effects of the injection. It is hoped this research will contribute to our knowledge, insight and understanding of the lymphatic drainage of the healthy (non-cancerous) splenic flexure, using the most practical method available. Having knowledge of lymphatic drainage in healthy splenic flexures, we can then then explore the lymphatic drainage in individuals with cancer in the splenic flexure in future studies. We hope that these future studies will also improve understanding and optimise surgical management of splenic flexure cancers, leading to improved outcomes for these patients.

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).