ANZCTR search results

The use of smart watch technology to improve the management of patients presenting with fast irregular heart rates (AF) in the Emergency department (ED). Participants will be given a Alivecor single lead ECG device to monitor their heart rhythm every 6 hours for the next 48 hours. If after 48 hours the heart rhythm has reverted to normal no further visits to ED are required. If they remain in AF they will return to the ED for an elective cardioversion to restore a normal heart rhythm. The aim of the study to the improve the management of these patients in ED and reduce the number of visits to ED.

Creatine monohydrate (CrM) is widely available as a nutritional supplement in Australia that mainly used as an ergogenic aid for sportsmen and women. Pre-clinical studies suggest dietary creatine supplementation during pregnancy may protect the fetus from acute in utero hypoxic events. While there is evidence to support the safety of creatine use in non-pregnant women of reproductive age, there is limited evidence on the pharmacokinetics (PK) of CrM in women of reproductive age and no information on the PK of CrM in pregnancy. To address these knowledge gaps safely, we have designed an open-label parallel-arm pharmacokinetic trial that will occur in three stages; where the first two stages will trial different CrM doses, starting with the lowest anticipated therapeutic dose. The third stage will trial the optimum dose (to be confirmed) over a multi-day period in the third trimester of pregnancy. Overall, This study will inform the optimum dosing of creatine monohydrate in late pregnancy (3rd trimester). This dosing regimen could be used in subsequent studies assessing the efficacy of maternal dietary creatine supplementation to improve pregnancy outcomes.

Our study will evaluate the feasibility of active Virtual Reality gaming (AVRG) in increasing engagement and adherence to physical activity (PA) in young men with mild to moderate depression. This randomised controlled trial is an important first step before undertaking larger trials to better understand factors affecting recruitment, engagement and adherence, retention and safety, as well as effects on depressive symptoms and lifestyle behaviour. The scalability of VR gaming in the community, means potential for increased access and reach, particularly during The COVID-19 pandemic has increased in social isolation and decreased access to fitness facilities, highlighting the need for accessible and acceptable options for physical activity participation. The scalability and popularity of AVRG among young males is a strength of potentially using this as a depression treatment for this hard-to-reach population with the lowest help-seeking rates but the highest incidence for mental illnesses.

Starpharma is developing a nasal spray intended to inactivate severe acute respiratory virus 2 (SARS-CoV-2), the virus that causes coronavirus disease of 2019 (COVID-19). The nasal spray contains 1% w/w SPL7013, a molecule with broad spectrum antiviral and virucidal activity. SPL7013 is able to physically block SARS-CoV-2 attachment to cells and therefore inhibit infection. The primary objective of this clinical investigation is to assess the safety and tolerability of 1% SPL7013 Nasal Spray applied to the nasal mucosa of healthy volunteers 4 times a day for 14 days.

Preschool wheeze is among the most common causes of hospital admission in young children worldwide. Current prevention strategies are ineffective and parents and paediatricians identify developing effective treatments to prevent hospital admission as a research priority. Compelling evidence from animal, laboratory and clinical studies support the hypothesis that OM-85 has the potential to reduce the risk of hospital admission due to preschool wheeze. This trial has been designed and powered to address this question, which is critical to both consumers and the health system.

Endometriosis is a common yet under-recognised chronic disease. Endometriosis occurs when cells similar to those that line a persons uterus grow in other parts of their body, usually around the pelvis. Although endometriosis is often effectively managed, it can lead to debilitating chronic and persistent pelvic pain and compromised fertility. It can also significantly impact the social and economic participation and psychosocial health of those affected. it is estimated that 11.4% (more than 830 000) Australian people are living with endometriosis; however, delays in diagnosis and lack of definitive research on the domestic burden of disease suggest the number could be far higher. Surgery for endometriosis is a common procedure and randomised, placebo controlled trials have shown a benefit at 6 and 12 months following surgery, with variable changes noted in these studies in the first few months. People with endometriosis frequently report a worsening of pain following their surgery, however there are no data reporting immediate outcomes, effect on menstruation or the likely changes to expect in these first few months. Our aim is to investigate the immediate effect of surgery on people's symptoms and provide that information in publicly available forums to improve the education and understanding of how women experience symptoms in the immediate post-operative phase of care. It is important to note that we are not establishing the long-term outcomes since these are reported in other studies.

We do not fully understand why Type 2 Diabetes (T2D) risk is, disproportionately higher in people from culturally and linguistically diverse backgrounds. Because of this knowledge gap, opportunities for early intervention are reduced and more lives will be lost. This study will identify if impaired non-fasting lipid metabolism is an early feature of T2D risk in Chinese immigrants in Australia. The metabolic phenotype of Chinese immigrants at risk of T2D is distinct from other ethnic groups. People from China develop T2D at a lower body mass index (BMI) and younger age than Caucasians. Traditional Western-based screening measures may not adequately capture the risk factors for T2D in this population. Chinese immigrants are Australia’s largest group of non-English speaking migrants. Recent evidence supports assessment of lipid profiles in T2D risk assessment in Chinese populations. We propose this mechanistic study as the first step in addressing the knowledge gap. We will conduct an acute high fat meal challenge to assess post-prandial lipid metabolism in Chinese adult participants. A group of age-matched Caucasian participants will be recruited as a comparison and we will employ a cross-over design. Each participant will attend two testing days, the first where they will be given a high-fat meal challenge and then second where they will be given a high-carbohydrate meal challenge. Aim: To demonstrate that Chinese-immigrants at risk for T2D have (a) an exaggerated lipid response to a high fat meal challenge and (b) a unique lipid phenotype compared with Caucasians. Hypothesis: Chinese-immigrants will exhibit a different post-prandial lipid profile compared with age and weight-matched Caucasian controls.

Transgender individuals seeking feminisation (transfeminine individuals) are treated with estrogen and anti-androgen (testosterone blocker) to align their physical appearance with their gender identity. There has been increasing interest in the potential use of progesterone for transfeminine individuals, given anecdotal reports of improved mood and breast development. This randomised placebo-controlled cross-over trial is a trial of micronised progesterone in transfeminine individuals treated with estradiol therapy. We aim to establish the influence of progesterone on sleep, psychological distress and total testosterone concentration.

PARTICIPANTS: Children (> 5 years) and adults with pulmonary fibrosis (PF) related to short (<10th centile) telomere length (PF-ST) (n=50). This subgroup have mutation/s in the telomerase enzyme which maintains telomere length. PF-ST patients have a prognosis far worse than their long telomere counterparts. Survival is worse than most cancers, with death within 2 years. INTERVENTION: A synthetic androgen, danazol (400mg capsule bd), or placebo (2:1 randomisation) for 12 months, administered in addition to standard of care. Danazol is a synthetic hormone which augments telomerase activity and hence lengthens telomeres. In a small group of haematology patients with short telomere syndromes (Townsley et al. NEJM 2016) danazol impressively attenuated telomere attrition, and in the subgroup of patients with PF (n=10) there was apparent stabilisation of lung function for up to 2 years, completely at odds with expected PF-ST natural history. COMPARATOR: Identical placebo. OUTCOMES: Change in absolute telomere length (base pairs) and lung function (forced vital capacity) over 12 months; safety (treatment emergent adverse events); survival.

Irritable bowel syndrome (IBS) is a very common condition that has a big impact on quality of life. IBS and common mental health disorders (like anxiety and depression) are strongly linked. In fact, more than 30% of people with IBS also have anxiety and more than 20% have depression. Changing diet can be very helpful for improving IBS symptoms but some specific diets can be difficult to follow. An alternative dietary approach, which will be investigated in this study, has been found to improve depressive symptoms. The diet may also have positive affects for the gut microbiome (the micro-organisms found in the gut), which is also important in IBS, and for other health outcomes. This study aims to test if this diet can be followed and is acceptable for people with IBS and current symptoms of anxiety or depression. It also aims to understand whether this diet could improve gut as well as mental health symptoms, and how it might do this. The results of this study may contribute to the clinical management of people with IBS and mental health problems.