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Autism is a condition with early-onset difficulties in social communication and unusually restricted, repetitive behaviors. It is being increasingly diagnosed in the last 10 years and is currently diagnosed in 1 in 59 children. Children with Autism need lifelong support for their symptoms and associated conditions. Current options for improving their behavioral issues are limited or only partially effective. Beneficial bacteria that commonly live in the gut promote health by suppressing the growth of harmful bacteria, and improving immune function of the gut. Humans have been consuming probiotics (beneficial bacteria) for hundreds of years in the form of various foods. . Research suggests that the proportion of beneficial bacteria in the gut is reduced (called as ‘dysbiosis’) in children with autism, and may explain their symptoms. We plan to study whether probiotic supplementation will improve the proportion of beneficial bacteria in the gut of children with autism. Such an effect may improve their behavioral symptoms

The purpose of the study is to validate the cardiac and respiratory vital signs form the Saiiv Medical vital signs monitoring kit against gold standard vital signs monitoring devices which have been approved by the Therapeutic Goods Administration (TGA).

This is a 12-week trial involving a 7-week wellbeing program. The trial will recruit staff from Prince of Wales Hospital in Sydney (primarily nurses, but anyone employed at the hospital will be eligible to join), and the aim will be to measure the participants' levels of wellbeing over time and to determine whether the 7-week program is effective at increasing their wellbeing, compared to an alternative program.

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in developed countries. Although CVD mortality rates have declined markedly over the past 3 decades, the burden remains high in many countries, and the rising prevalence of obesity and diabetes may impact on these trends. Some conditions such as coronary heart disease and stroke are significant contributors to the burden of CVD mortality. Previous international studies such as the WHO-led MONICA study investigated the contribution of changes in case fatality and event rates to trends in myocardial infarction related mortality. No recent studies have provided international comparisons across these important measures. The results of this study will show how effective changes in treatment and prevention for CVD are at a whole-population level, and the ability to compare these data across countries enhances interpretation of the relative contributions of each.

Physical activity is an important component of treatment for people living with Major Depressive Disorder (MDD) and is known to reduce symptoms of mental illness. There is a growing interest in the use of telehealth to improve access to health services. However, to our knowledge, there has not been research to date examining the use of telehealth by exercise physiologists to deliver physical activity interventions to adults with MDD. We therefore aim to determine the acceptability and feasibility of a 5-week exercise physiology intervention, involving weekly sessions delivered via videoconference to adults living with MDD. We hypothesise that this intervention will be feasible and acceptable to adults with depression. In addition, we hypothesise that this 5-week physical activity intervention delivered via telehealth will be associated with improvements in symptoms of depression and anxiety, sleep quality and increased activity levels at post-intervention.

Japanese encephalitis (JE) is a mosquito-borne disease caused by Japanese encephalitis virus (JEV), an arbovirus from the flavivirus genus, family flaviviridae. It is estimated that in 2015 JEV caused more than 100,000 JE cases and 25,000 deaths worldwide. JE is endemic in Asia and Papua New Guinea, and outbreaks have occurred in the Torres Strait Islands. Although the current recommendation is that travellers spending one month or more in endemic regions during the wet season consider vaccination against JEV, there have been many reports of JEV infection in travellers after much shorter trips, including those limited to popular tourist destinations. Effective JE vaccines with low rates of local and systemic adverse events have become available in recent years (e.g. Imojev® [live attenuated recombinant JE vaccine, Sanofi-Aventis], JEspect® [inactivated vero cell vaccine, Valneva). Despite this, the uptake of JE vaccines by travellers remain low. An internal clinical audit of over 1000 medical records at an Australian travel medicine clinic revealed that less than 30% of travellers to JE endemic areas received the vaccine. The high cost of the main vaccine used in Australia (approx. AU$ 300 for Imojev®) is likely to be one of the main reasons for the low uptake. JE vaccines are administered via subcutaneous (SC) or intramuscular (IM) injections; however, intradermal (ID) administration of other vaccines using smaller doses have been shown to be as effective as SC administration for other viruses, e.g. yellow fever (another flavivirus) and rabies. ID administration is widely used for rabies vaccines, and is now recommended by the World Health Organization for both pre- and post-exposure prophylaxis. We conducted a systematic review and meta-analysis and found that the odds of seroconversion after JE vaccine were similar when administered SC or ID (using 20% of SC dose). However, none of the vaccines used in studies included in the meta-analysis are currently available in Australia. The ID route would be certainly less expensive than the SC and IM routes of administration, and potentially increase vaccination uptake among travellers. Therefore, we aim to explore whether ID could potentially be an economical yet effective route of administration for JE vaccine. Our hypothesis is that the seroconversion rate with 0.1ml ID Imojev® (i.e. 20% of the standard SC dose) would be similar to the standard dose of 0.5ml via SC.

Crohn’s disease can be complicated by perianal fistulising Crohn’s disease, a highly morbid condition which can cause perianal pain, sepsis, and faecal incontinence. Infliximab is the most effective medical treatment for perianal fistulising Crohn’s disease. In patients who lose response to infliximab or relapse, therapeutic drug monitoring allows doctors to decide whether to increase the infliximab dose or to switch to another drug. Therapeutic drug monitoring is a process that involves measuring infliximab drug levels in the blood and measuring the presence of antibodies against infliximab. How therapeutic drug monitoring can be used to prevent a relapse and sustain Crohn’s disease remission is currently not clear. This research project aims to analyse whether optimal dosing strategy of infliximab to achieve fistula healing in patients with complex perianal fistulising Crohn’s disease by comparing two treatment arms: the standard care arm and the proactive therapeutic drug monitoring arm. We will compare rates of fistula healing, fistula closure, healing as seen on magnetic resonance imaging (MRI), patient-reported outcomes and quality of life between the two groups. Patients will be screened for suitability for infliximab therapy by their gastroenterologist, who perform a number of examinations, tests and procedures, and will review your medical history. Eligible patients will be randomly allocated to either the proactive therapeutic drug monitoring arm or the standard care arm. Patients in the standard care arm will receive the standard dose of infliximab and patients in the proactive therapeutic drug monitoring arm will have infliximab dosing is adjusted based on the infliximab levels in their blood. Patients will be assessed for response based on their symptoms, physical examination of the perianal area, blood tests, imaging results including MRI and patient-reported outcomes including quality of life assessments. In both arms patients will be required to attend regularly for reviews, infliximab infusions and investigations. The maximum duration of this study will be approximately 54 weeks (1 year) from the time you decide to participate. At each study visit, patients will undergo a clinical evaluation, routine blood tests, blood collection for infliximab level testing, and/or a stool specimen collection for faecal testing.

Despite no clear evidence, transgender women are told to stop their feminising estrogen treatment several weeks before gender surgery, but can cause severe ‘menopausal symptoms’ with hot flushes, depression and distress compounding an already stressful preparation for and recovery from major surgery. This study will assess the safety of continuing estrogen gel around the time of surgery. We hypothesise that estrogen gel will reduce 'menopause symptoms' and improve quality of life, and will be safe to continue around gender surgery.

Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians. High blood glucose levels in Indigenous Australians are a major driver of diabetes complications. In non-Indigenous populations, knowledge gained from continuously monitoring blood glucose levels has led to behavioural change and a reduction in blood glucose levels in individuals with diabetes. Continuous monitoring of blood glucose levels has never been studied in Indigenous Australians. There is an urgent need to find effective ways of improving blood glucose control in this population. The aim of this pilot study is to compare to usual care (SMBG), continuous use of real-time flash glucose monitoring in Indigenous Australians with type 2 diabetes, to determine if flash glucose monitoring will improve HbA1c, achieve blood glucose targets and reduce hypoglycaemic episodes. This study will also evaluate whether flash glucose monitoring is effective, feasible, acceptable and cost-effective in this population. Participants will be randomly assigned to blood glucose monitoring by flash glucose monitoring (Abbott Freestyle Libre) or conventional SMBG. 40 volunteers will be recruited to participate in the pilot study. Participants’ involvement in the study will last 6 months.

Study Title: A project that aims to determine the efficacy of using an actively managed discharge care plan for promoting enhanced communication. Study Population: Participants will be male or female with diabetes coming from priority populations (but are not limited to): • People experiencing homelessness • Aboriginal and Torres Strait Islander peoples • Culturally and linguistically diverse people Participants will be recruited through the Diabetes outpatient clinics at the lead site: Royal Prince Alfred Hospital and recruitment from partner sites, Prince of Wales Hospital and St Vincent’s Hospital. Study tool: Actively managed discharge care plan with calling criteria for Primary Care Physician (PCP) to ensure continuity of care and care coordination. Sample size: 100 participants Lead study site: Royal Prince Alfred Hospital Study duration: 2 years Study Start: 25JAN2021 (recruitment) Study Endpoints: This program aims to assess the feasibility of enhancing communication with the PCP across the CESPHN region for improved health outcomes to decrease patient’s hospital readmission and follow-up.