ANZCTR search results

Up to 80% of people discharged from the ICU experience various physical, cognitive, and/or psychological complications and enduring impairment, termed ‘post intensive care syndrome’ (PICS). The prevalence and burden of PICS remains uncertain, and current interventions are not effective longer-term; further research into prevention, early diagnosis and intervention of this syndrome is considered internationally is a priority. The interlinked aims of this study are 1. To describe the predictors, correlates and prevalence of PICS, and 2. To use this information to develop screening, diagnostic and outcome measures for use in research and clinical practice.

This study aims to determine if there is any association between endometrial cystic spaces identified on ultrasound and the incidence of endometrial hyperplasia (abnormal uterine cell growth that may or may not become cancerous), and the incidence endometrial cancer in women with abnormal uterine bleeding. Who is it for? You may be eligible for this study if you are aged 30 or older, have been diagnosed with abnormal uterine bleeding and you have been referred to the Royal Women's Hospital (Melbourne) for a hysteroscopy dilatation and curettage (HDC) procedure, or an endometrial biopsy. Study details All participants who choose to enrol in this study will be asked to complete a 15 minute online health questionnaire, and undergo a transvaginal pelvic ultrasound to determine the presence or absence of endometrial cysts. The ultrasound scan will be performed or directly supervised by a senior ultrasound specialist. Where possible this visit will be timed to occur on the same day as the hysteroscopy to avoid a further trip to hospital. It is hoped this research may improve health outcomes by allowing for early identification of endometrial hyperplasia or cancer, which could have additional positive impacts on the future management of women with endometrial cysts.

The purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut (which can be a problem), and to identify people who are likely to respond to therapy. This study aims to compare the data collected from the Atmo gas capsule with conventional breath testing for bacterial imbalance/overgrowth. The results from the study may help show that the capsule is better than either a breath test, or taking samples through endoscopy for determining if someone has Irritable Bowel Syndrome (IBS) or Small Intestinal Bacterial Overgrowth (SIBO), and how likely they are to respond to therapy.

This project is a retrospective case-series of patients who have undergone periacetabular osteotomy with a single orthopaedic surgeon. All surgical patients performed at one institution received i-Factor during their surgery, surgical patients performed at other institution received standard care. The use of i-Factor was standard clinical practice for Mr Balakumar at the time of its use. The primary aim of this project is to compare bone healing timeframes between this two groups of patients. The secondary aim of this project is to compare surgical complications (for example infection rates) between these two groups. Medical notes and standard post-operative X-Rays will be reviewed.

This is an open label study in patients: previously treated with intravitreal ranibizumab or aflibercept for at least six months; on a 4 to 8 weekly injection regimen with at least one failed attempt to extend their treatment interval; who have persistent retinal fluid at their current treatment interval or have recurrent retinal fluid if the treatment interval is extended. Eligible participants will switch their study eye treatment to bevacizumab and have three, monthly, loading doses before commencing a treat and extend regimen where the treatment interval will be extended based on the investigators assessment of disease activity and predetermined criteria normally used in clinical practice. The study will run for 18 months: Six months recruitment with a 12 month treatment period) Following enrolment participants will be evaluated monthly. At each follow up they will have a clinical ophthalmic examination including intra-ocular pressure measurement, assessment of best corrected visual acuity, macular OCT and fundus photography. A quality of life questionnaire (NEI VQF-25) will be completed at baseline and at study. completion. Fluorescein angiography will be performed when clinically indicated.

Protocol MSC-OAK-002 is a prospective, observational study that runs concurrently with Protocol MSC-OAK-001 (ANZCTR No. ACTRN12617001095358) Up to 40 subjects with a documented diagnosis of osteoarthritis of the knee, confirmed by X-ray and MRI during Screening, and who have met the eligibility criteria for Protocol MSC-OAK-001 will be offered the opportunity to enrol in this observational study. Following provision of written informed consent and confirmation of eligibility, eligible subjects will commence both protocols on the same day. Subjects enrolled in Protocol MSC-OAK-001 will be on-study for Months 0-3. Subjects enrolled in Protocol MSC-OAK-002 will be on-study for Months 0-12. All potential subjects will be required to provide written informed consent prior enrolment. The study is expected to confirm the safety of donor stem cell treatment in osteoarthritis and also the confirm the most effective treatment dose for pain, functional and structural benefit.

Although the underlying causes of Alzheimer’s disease (Alz) remain unknown, there is clear evidence the disease process disrupts connections in brain networks underpinning cognition. Research, including our own, indicates this dysfunctional connectivity is proximate to the cognitive symptoms of Alz. Treatment approaches which have aimed to reduce disease protein burden in Alz have consistently failed to improve cognition; perhaps understandably, as none of these approaches attempt to restore dysfunctional connectivity. In contrast, we propose a therapeutic approach, using non-invasive brain stimulation, which directly targets activity in relevant neural networks in order to restore optimal connectivity and improve cognition. Theta Burst Stimulation (TBS) is an efficient and potent form of transcranial magnetic stimulation (TMS). It has been shown to modulate activity throughout large-scale cortical networks, enhance cognition and produce lasting behavioural improvements. We have conducted a proof-of-concept study demonstrating that 6-weeks of TBS applied to key regions of affected networks can alter connectivity and produce significant memory improvement in patients with mild to moderate Alz. We are now proposing to conduct a 30-week randomised controlled trial, with both acute and maintenance treatment phases and a 3 and 6-month follow up. We aim to confirm our proof-of-concept and to extend these findings by demonstrating whether standalone TBS can produce sustained gains in cognition and associated improvements in function and quality of life.

Advance Personal Planning (APP) is a process whereby an individual discusses and documents their values and preferences about future health, financial and personal matters, in case he or she later experiences loss of capacity. People have a legal right to engage in advance personal planning, in case they later lose the ability to make or communicate decisions. People can legally appoint others to make decisions on their behalf and record wishes in documents. APP is particularly important for older adults, as they can face complex decisions due to frailty, loss of capacity and frequent hospitalisations. Few people plan ahead, even though it can reduce the likelihood of financial exploitation, family conflict and unwanted medical care. This cluster randomised control trial (RCT) will test a community action approach to increase the uptake of APP by older people in regional NSW communities. Communities will be randomly allocated to the usual care (n=5) or intervention arm (n=5). Older people residing in each community will be recruited via community organisations and asked to complete a survey assessing APP participation, knowledge, attitudes and capabilities at baseline, 12 and 24 months later. Communities randomly allocated to this condition will not receive any intervention. Information on designated outcomes will be collected from older people to provide benchmarking for intervention communities. A community action intervention will be implemented in each intervention community, comprised of community forum, establishment of Coalition Groups and a comprehensive toolbox of intervention strategies. These include: inter-professional workshops, community information sessions, distribution of education materials and public media campaigns. Impact of the intervention on APP uptake, knowledge, attitudes and capabilities will be assessed at baseline, 12 and 24 months. Acceptability, utility and exposure to intervention strategies will also be examined in intervention communities. The goal is to provide a model of community action that can be replicated in other communities to build capacity and collaboration across social services and improve the wellbeing of older people.

Giant cell arteritis is an inflammatory condition affecting the blood vessels of the head and neck, and it requires prompt diagnosis and treatment. The current gold standard for diagnosis involves an operation to biopsy the superficial temporal artery and examine this tissue specimen under the microscope by a pathologist. A new technology called confocal laser endomicroscopy (CLE) has recently been developed to aid intra-operative diagnosis of various conditions. It involves applying a laser microscope to the tissue of interest during a surgical procedure to create a digital histological image. CLE has been investigated in gastroenterology, and other fields of Neurosurgery involving brain tumours with promising results. However, it is yet to be investigated in the diagnosis of giant cell arteritis. This study aims to evaluate the clinical utility, sensitivity and specificity of intra-operative CLE in the diagnosis of giant cell arteritis. Patients who are undergoing a superficial temporal artery biopsy are eligible for this study. If CLE is found to be accurate, then this may obviate the need to perform a biopsy of the superficial temporal artery during the operation. This will expose patients to less harm, and therefore has the potential to change surgical practice moving forward.

This study is investigating the effectiveness of an individualised, preoperative exercise and education program on post-operative complications in patients undergoing major abdominal cancer surgery. Who is it for? You may be eligible for this study if you are aged 18-80 years and are undergoing elective major surgery for advanced or recurrent gastrointestinal cancer (i.e. pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy). Study Details Participants will be randomly allocated (by chance) to either: (i) progressive preoperative exercise and education program, delivered over 4 to 8 weeks prior to surgery (ii) usual care (nutritional counselling, advice on smoking cessation and reduction of alcohol intake) Participants will then be followed up to 3 months post-surgery and will be asked to complete self-administered questionnaires at different time points to collect information on health complications and quality of life. This trial seeks to determine the effectiveness and cost-effectiveness of the preoperative exercise program, on reducing postoperative complications, length of intensive care and hospital stay, and improved quality of life, which will provide policy decision-makers with evidence to support reimbursement of preoperative exercise programs.