ANZCTR search results

Guidelines for the treatment of type 2 diabetes direct clinicians to individualise therapy in diabetes however there is little evidence to guide successful treatment in Young Adults with Type 2 Diabetes (YT2DM). This study will provide much needed evidence on which to base treatment decisions for YT2DM, a growing problem in our clinics. The outcomes of a physiologically sensible, innovative continuous glucose monitoring-guided rapid titration strategy which differs from usual care will provide new knowledge on the treatment for this high risk group. Further the fundamental physiologic effects of this strategy on beta cell function and early renal decline in YT2DM will provide further insights to guide therapeutic decisions for this high risk patient group. If positive, the results can be translated into wider practice and guide individualised therapy in addition to evidence based clinical practice guidelines for YT2DM. The global nature of the problem of YT2DM will ensure international interest and the investigators are well placed to facilitate dissemination of results to wider stakeholders and translation.

The purpose of the study is to determine whether higher threshold for commencing phototherapy will worsen the rate of rise in bilirubin in the first 72 hours of life in newborns born <32 weeks gestational age. We hypothesise that the higher threshold for phototherapy will result in similar trends in bilirubin levels, duration of phototherapy and number of infants reaching bilirubin levels <25umol/L below exchange threshold in both groups.

Background Blood glucose control is fundamental to the management of type 1 diabetes (T1D) to reduce rates of diabetes complications. Exercise studies have not been able to show a consistent benefit on blood glucose control in people with T1D. High-intensity interval training has been found to improve long term blood glucose control (HbA1c level) in people with type 2 diabetes. To our knowledge, there are no adequately-powered studies looking at the effect of HIIT exercise on HbA1c in people with T1D. Research Question In adults with type 1 diabetes who are overweight or obese, will 12-weeks of high-intensity interval training improve blood glucose control (HbA1c), cardiovascular risk factors and diabetes complications? Study aim This study will potentially show the first evidence that HIIT exercise can improve HbA1c without excess risk of hypoglycaemia (low glucose) in adults with T1D. Also, such exercise intervention may improve cardiovascular risk factors, and some aspects of traditional and novel diabetes complications including measures of non-alcoholic fatty liver disease, diabetic cardiomyopathy and cardiac autonomic neuropathy. Research design and methods In a randomised controlled trial (study period 1; 12 weeks) with subsequent partial cross-over (study period 2; 12 weeks), 30 sedentary adults with T1D who are overweight or obese will be randomised to the intervention group (12 weeks of supervised high-intensity interval training (HIIT) exercise, and then 12 weeks of unsupervised exercise) or the control group (12 weeks of usual care, and then 12 weeks of supervised HIIT exercise). The primary outcome will be HbA1c blood test at the end of the randomised controlled trial period (12 weeks exercise vs usual care), with a secondary outcome being to compare HbA1c with all 30 participants’ own baseline. The partial cross-over design allows all participants to benefit from undertaking the supervised HIIT, and has the advantage of increasing statistical power to secondary outcome measures. Further secondary outcomes include measurement of hypoglycaemia, hyperglycaemia and glucose variability using a glucose sensor, cardiorespiratory fitness using a treadmill fitness test, and cardiovascular risk factors such as blood pressure, cholesterol levels, weight, and body composition with a DEXA scan. Several diabetic complications will be examined for improvements after exercise, including diabetic cardiomyopathy and non-alcoholic fatty liver disease with cardiac and liver MRI, and cardiac autonomic neuropathy with bedside electrocardiography (ECG) testing. Importantly, changes in quality of life and fear of hypoglycaemia will be measured with validated diabetes-specific questionnaires.

This study aims to evaluate the safety and pharmacokinetic study of (Z)-Endoxifen escalated doses in healthy female volunteers. Who is it for? You may be eligible to join this study if you are a healthy female aged between 18 and 65 years of age. Study details: This is a placebo controlled, dose escalation study. The study will be conducted in two parts in a total of 6 cohorts. In Part A, each participant will receive twenty eight doses of (Z)-Endoxifen or placebo as a topical application to the breast. In Part B, participants will receive fifteen doses of (Z)-Endoxifen or placebo capsules orally. Three different dose levels of (Z)-Endoxifen will be investigated in each part of the study. In both parts, sequential cohorts will be exposed to increasing doses of (Z)-Endoxifen. By substituting Tamoxifen treatment with Endoxifen the study will help in providing an improved approach towards treating patients with breast cancer because it bypasses the CYP2D6 enzyme that is required for metabolic activation of Tamoxifen.

Surgical Site Infections (SSI), including infections of the skin, subcutaneous tissue and internal organs, are one of the most common serious complications of surgery and anaesthesia. They are a leading cause of re-admissions and prolonged hospitalisations and they substantially increase the cost of care. Rates of SSI for individual procedures vary widely depending on the population, size of the hospital, type of surgery, experience of the surgeon and methods used for prevention and surveillance. Overall, it is estimated that SSI develops in up to 15 percent of patients undergoing surgical procedures. Endoscopic gynaecologic surgery is a rapidly developing field. Laparoscopic surgery is nowadays used for many procedures that were traditionally performed via laparotomy. Up to date, there are no prospective studies that specifically evaluated the rates of SSI in laparoscopic gynaecologic surgeries or the preferred way of skin preparation to prevent them. Gynaecology units 1 and 2 of The Royal Women's Hospital perform over 700 laparoscopies annually. All patients who undergo planned surgery present to clinic before surgery. We aim to perform a Randomised Controlled Double Blinded Study comparing 3 solutions of skin preparation containing alcohol or aqueous based Povidone-Iodine or Chlorhexidine. Our hypothesis is that Incisional and organ/space SSI rates would be similar throughout all groups. Patients would be followed-up one and four weeks after surgery and SSI rates would be compared amongst groups. SSI would be documented and defined as per the CDC guidelines. We are aiming to examine if we rates of surgical site infections can be reduced by using a specific solution for skin preparation.

This project aims to test a comprehensive clinical approach to reducing cardiovascular risk in patients with severe mental illness. Alarming as it is that people with severe mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, depressive psychosis) have 13-30 fewer years of life expectancy than the rest of the population, of even greater concern is that this gap is widening. Most deaths in this group are from chronic physical illnesses especially cardiovascular disease. Guidelines on identifying and managing physical health risk factors are available but poorly implemented. The problem lies at the disjuncture between mental and physical illness. Mental health services do not routinely focus on the physical health of their patients, partly because they do not have clinical systems to integrate physical and mental health and primary care likewise. Similarly, patients have limited access to services and motivational interventions whose focus is to address physical health in the context of complex psychosocial issues. Our research team has used a rigorous process, including extensive piloting, to develop an intervention which delivers recommended physical health care to reduce cardiovascular risk and improve quality of life. Components of this intervention are integrated using the Flinders Program of chronic condition management which places the patient at the centre of their care and provides a recovery-oriented framework. The first project aim is to use a randomised trial to evaluate the effectiveness and cost-effectiveness of the intervention. The main outcome measures will be cardiovascular risk and quality of life. Patients will be recruited from the SA state clozapine register and psychiatric clinics. The second aim is to identify essential components, enablers and barriers at patient, clinical and organizational levels for national sustained implementation of recommended physical health care delivery to people with severe mental illness.

This study aims to evaluate the safety of nivolumab for relapsed or residual haematological cancers after blood or bone marrow transplantation Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed relapse or persistent haematological malignancy post allogeneic transplant. Study details All participants in this study will be administered a drug called nivolumab every 2 weeks for up to 48 weeks. Each time you will receive the same dose (3mg/kg) intravenously (through a vein). Assessments will be carried out throughout the 48 week period to evaluate occurrence of graft versus host disease and to measure tumour response to nivolumab therapy. Study significance There is a lack of effective treatment for relapse or persistence of haematological cancer after allogeneic transplant. This study will investigate a promising new approach to treat cancer for these patients, by using the harnessing the immune system to eliminate cancer cells.

An initial RCT undertaken by us in 2014 (N = 308) and a follow-up RCT undertaken in 2015-2016 (N = 557) investigated mindfulness with Year 8 students in Adelaide schools. We used a UK based 9-week mindfulness curriculum with lessons once per week (40-60 minutes). Surprisingly, we were unable to replicate promising findings from a controlled (but not randomised) trial using this programme (Kuyken et al., 2013) which found improvements in wellbeing, stress and depression that lasted for 3 months following the intervention. Our pilot trial has been published (Johnson, Burke, Brinkman and Wade, 2016) and the larger follow-up trial is currently under review. We hypothesised that the programme might have been too brief for the ideas to sink in, and that there might not have been enough practice in class of the meditations, relying too much on home practice (which was invitational). We also wondered if Year 8s might be too young to appreciate the relevance of these emotional tools given that they hadn't yet hit some of the increased stresses and strains of mid-late adolescence. Therefore, we are testing these ideas in the current RCT We will substitute an alternative, Belgian programme, which recently found both treatment and prevention effects for depression which lasted for 6 months in adolescents aged 13-20 in a school setting (Raes et al., 2014). This programme, which has just been translated into English, runs for a similar number of weeks (8) but has longer lessons (75-100 minutes weekly) allowing more time for guided practice in class (rather than relying on home practice), plus expanded opportunities for discussion and application to real-life scenarios. We will test this across three age groups (Year 8, mean age 13.5;Year 10, mean age 15.5; Year 12, mean age 17.5) to expand our investigation into whether the mindfulness approach operates differently within adolescent age bands. This will have direct relevance for where to insert these curricula in the school journey for maximum effect. Research Objectives 1. To examine the efficacy of an alternative curriculum (Mindfulness for Teens) on anxiety, depression, eating disorder risk factors, wellbeing and different facets of mindfulness 2. To investigate whether age affects these outcomes (i.e., are mindfulness programmes more effective at certain ages during adolescence?) 3. To investigate whether mindfulness programmes operate via different mechanisms according to stage of neurocognitive development (i.e., do we need to emphasise different components at different ages?)

Cricket is the most participated summer sport in Australia. It has increased in popularity over the past decade with the Twenty20 cricket rising as the most popular form. There is growing evidence that the injury rates in junior and amateur cricketers are higher as compared to professional cricketers. Yet, at the community level there are no standardized cricket specific injury prevention programs. Other sports such as Soccer, Rugby, AFL, Basketball, etc. all have implemented such programs at community level. Soomro et al 2016. showed that injury prevention programs (IPPs) are an effective tool to help reduce injuries in adolescent team sports. The pooled analysis of over 100,000 athletes in this study showed that IPPs reduced the risk of injury by 32%, Injury rate ratio (IRR = 0.68, 95% CI = 0.54-0.84, p <0.05). These programs reduce injury risk by improving neuromuscular strength, agility and limb coordination with a combination of strength, plyometric and balance exercises. Since majority of cricket injuries are of non-contact origin and concentrated around soft-tissues, therefore exercise based interventions and improvement of players’ fitness through appropriate training has been suggested to reduce such injuries. IPPs have been shown to improve strength ratios, thus reducing another contributing factor i.e. strength imbalance from the injury etiology. Considering the overwhelming evidence on the efficacy of IPPs, the development, implementation and clinically validating cricket specific IPP may potentially assist in reducing cricket related injuries.

Background: This NHMRC funded project (2016-2019) will address the fundamental lack of knowledge regarding the brain structure and function responsible for aphasia recovery and determine the best predictors of language improvement and treatment response in the sub-acute phase of brain recovery. Aims & Method: The specific aims of this research are to (1) Identify changes in brain activity from sub-acute to chronic phases in response to naming treatment versus usual care (2) Determine whether subacute brain activity predicts subsequent language recovery and successful treatment (3) Determine structural predictors of language recovery and treatment response (4) Develop a machine learning algorithm that accurately identifies individual patients who will recover language and make significant improvements. 90 participants with post-stroke aphasia will be scanned (at Herston Imaging Research Facility, RBWH campus) and tested on a battery of language tests at the sub-acute stage (1 month post-onset), then assigned to 8 weeks (3 times per week) naming and language treatment versus usual care and then scanned and retested at 3 and 6 months post-onset. 25 healthy older control participants will also be recruited and scanned. Outcomes: Using state-of-the art imaging techniques together with clinically meaningful markers of language function, this research will test for the first time whether brain structure and function in sub-acute stroke can reliably predict the recovery of specific language functions and treatment response.