ANZCTR search results

We propose a world-first dietary intervention clinical trial to investigate whether anthocyanins can sustainably delay or prevent memory loss progression in people at high risk for dementia. Anthocyanins (which provide deep-red and purple-blue pigmentation in plants and fruits) show promise for their pro-cognitive effects and therapeutic potential for diseases that manifest cognitive impairment. Our clinical trials have already demonstrated that consumption of anthocyanin-rich fruit significantly improves both short- and long-term memory, and verbal fluency in older adults with mild to moderate Alzheimer’s dementia (AD) and mixed dementia. However, it is unknown whether anthocyanins can prevent the progression of cognitive decline in persons with mild cognitive impairment. The findings of this study will be critical to underpin dietary advice that better informs prevention of dementia in Australia and allow translation to dietary advice on plant-based foods for better brain health

We are looking for 108 people with multiple sclerosis (MS) in Australia to measure the effects of transcranial magnetic stimulation (TMS for short) on MS. TMS can non-invasively and painlessly activate nerve cells in the human brain and can be used to change nerve cell activity. MBS is currently used to treat depression but has only been used for MS in the research setting. What’s involved: A total of 23 visits over the study duration of 4 to 5 months. 1. A full medical history, physical examination, and extended disability status score (EDSS). This will take about 30 minutes. 2. You will be randomly assigned to a treatment group, and will have a 67% chance of being in the MBS group and 33% chance of being in the placebo group. The placebo is a fake MBS, it looks and feels like the real thing, with no brain stimulation. You will not know which group you are in until the study is completed. 3. Daily MBS or placebo sessions (Mon-Fri) for 4 to 5 weeks, at a time convenient to you. A total of 20 sessions, each one takes about 15 minutes. We will monitor side effects, new symptoms and changes in your medications. You can continue taking your current medications whilst in this study but must tell us about any changes, any GP, hospital or emergency visits, any COVID-19 symptoms or tests. 4. Magnetic Resonance Imaging (MRI) before and after your 20 MBS or placebo sessions. Each MRI takes about an hour. 5. A series of questionnaires before and after your 20 MBS or placebo sessions. You will repeat these again online after 3 months. Questionnaires take about 30 minutes to complete and include. a. hospital anxiety and depression score (HADS), 14 questions b. quality of life assessment (AQoL-8D), 35 questions c. fatigue severity scale (FSS), 9 questions d. sleep quality assessment (PQSI & NRS), 7 questions 6. MS Functional tests: Timed 25-foot walking test (T25-FW), Symbol Digit Modality Test (SDMT) and 9 Hole Peg Test (9HPT) before, during and after your MBS or placebo sessions. You will complete 3 practice sessions before starting the trial. These tests will assess arm and leg mobility as well as brain function and processing speed. The three tests take about 30 minutes to complete. You can use a walking stick or aid during the walking test. The aims of the study are; 1. To determine whether magnetic brain stimulation improves the MS functional composite score for people living with MS. 2. To determine if magnetic brain stimulation; - is safe & tolerable in people with MS. - improves quality of life in people with MS. - reduces anxiety and depression in people with MS. - reduces fatigue in people with MS. - improves sleep quality in people with MS 3. To determine if magnetic brain stimulation can effectively promote remyelination in people with MS, and if remyelination correlates with improvements in functional or patient reported outcomes.

This study is a single-group pilot intervention that aims to evaluates the feasibility, satisfaction, and effectiveness of an 8-week, one-on-one telehealth-supervised exercise program for people with Systemic Lupus Erythematosus (SLE). It is hypothesised that fatigue, quality of life, and muscular strength will improve following the program, however, it is unknown whether participants will be satisfied with the telehealth-supervised exercise program and willing to continue with this type of program.

The study will evaluate the effectiveness of a new, brief interactive online Cognitive Behavioural Therapy program for individuals who experience difficulty with binge eating, named Brief Binge Eating eTherapy or Brief BEeT. Brief BEeT consists of four, one-hour interactive, multi-media sessions with the behavioural components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring. The study will examine whether engaging with Brief BEeT results in a significant decrease in individuals' binge eating in those with bulimia nervosa or binge-eating disorder.

Despite the key role of exercise in preventing the cardiovascular complications that shorten life expectancy in people with type 1 diabetes (T1D), children with T1D are less active and less physically fit than their peers. Evidence for how to change this situation is lacking. A validated method to systematically measure activity levels in youth with T1D is thus needed. This project therefore seeks to assess the validity, in youth with T1D, of three currently available child physical activity questionnaires by measuring their performance against objective accelerometry and in so doing, and thus identify a valid self-report questionnaire tool for measuring physical activity in youth with T1D for clinical use. We intend to embed the best of these tools into clinical care for youth with T1D. Applications envisioned include the (i) longitudinal assessment of activity levels in youth (ii) educating youth on exercising safely, (iii) design intervention trials to find optimal methods to increase exercise levels at all ages, and (iv) to prescribe personalised and specific exercise for those whose physical activity levels fall over time.

When performing head and neck surgery, the skin at the site of the surgical incision is prepared with antiseptic solution to help prevent wound infections. There is good evidence that the iodine-containing solution povidone iodine (PVI) is effective at reducing the rate of post-operative wound infection. The solution can be applied either by painting or spraying the surgical site, although there is very little evidence to suggest which method is superior at preventing wound infections. This research project aims to test whether the spray-on method is as good as or better than the paint-on method at preventing wound infections.

Given the rarity of nonagenarians (age > 90 years) undergoing open cardiac surgery requiring cardiopulmonary bypass, there is a dearth of research describing their characteristics, comorbidity burden, perioperative course. Consequently, there is little evidence to guide and inform patient selection, clinical practice and enhance recovery pathways in this vulnerable patient cohort. Accordingly, this case series study aims to provide a detailed description of nonagenarians undergoing open cardiac surgery at four teaching hospitals in our state. Specifically, we aim to describe the demographics of nonagenarians undergoing cardiac surgery, their perioperative paradigm, their postoperative outcomes. In turn, this may help facilitate the selection of nonagenarians for surgery, help guide perioperative management, and allow for focused allocation of hospital resources. Who is it for? You may be eligible for this study if you are an adult patients over 90 years of age who underwent open cardiac surgery for for any indication at Austin Health, Warringal Private Hospital, Epworth Eastern Hospital or Epworth Richmond Hospital in Victoria, Australia Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent cardiac surgery at the above Hospital from 1 January 2012 to 31 December 2019. It is hoped that this research will help to provide a better understanding of outcomes associated with open cardiac surgery in this unique patient cohort.

There has been recent interest in understanding the costs associated with post-operative complications of patients undergoing radical cystectomy (removal of the entire bladder). Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo radical cystectomy. Who is it for? You may be eligible for this study if you are an adult who underwent a radical cystectomy. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a radical cystectomy at the Austin Hospital between 1 Jan 2012 and 31st July 2021. It is hoped that this research will help to provide a better understanding of the costs associated with major surgery.

Pain is the most common symptom experienced by people at the end of life in an inpatient hospice setting. In nearly all cases, a person who is dying receives analgesics, usually opioid, including bolus injection of breakthrough analgesic to manage incidental pain. Our aim is to evaluate the safety, efficacy, usability and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients. 1. Safety – evaluate the safety of a novel method for administering breakthrough analgesics by monitoring adverse events associated with equipment, adherence to regulatory practices, audit of prescribing and administration practices 2. Efficacy – assessment and comparison of opioid dose, total MED, time in motion and use of other medications for breakthrough dosing such as anti emetics and anxiolytics 3. Usability – survey of staff about use of equipment and the method of administration 4. Acceptability- survey of staff, family, carers about experience

Based on the graft healing after maxillary sinus augmentation, the fraction of new bone formation is hypothesized to be positively correlated to the area of resident bone walls in contact with the bone graft and negatively correlated to the volume of the graft. The inter-relation of these parameters on new bone formation has never been investigated. As such, the ratio of surface area in contact with the graft and the graft volume will be explored in this study.