ANZCTR search results

We propose a randomised, controlled, feasibility study to determine the effectiveness of Vitamin C in the prevention of Complex Regional Pain Syndrome (CRPS) following lower limb surgery. This feasibility study will observe whether the proposed protocol is practical and replicable, and determine whether further study in this area needs to be adapted. We also expect to find a decrease in incidence of CRPS following administration of Vitamin C after surgery.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tepotinib in a population of participants with metastatic non-small cell lung cancers (NSCLC) harbouring METex14 skipping mutations identified using comprehensive genomic profiling (CGP). Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed metastatic NSCLC. Your tumour will need to harbour METex14 skipping mutations identified using CGP. Study details: Participants will receive tepotinib treatment. The tepotinib is to be taken orally, at 500mg once daily (days 1 to 21 in a 21-day treatment cycle). Tepotinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 6 weekly intervals from first treatment until 18 weeks, and then 12 weekly intervals until progression. Safety and tolerability of treatment will be assessed at 3 weekly intervals. Health related quality of life during treatment will be assessed at 3 weekly intervals and then every 9 weeks after end of treatment for 12 months, and then every 12 weeks until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tepotinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Osteoporosis is a degenerative disease of the bone, which although occurs in older ages, has its roots in earlier life stages. Women are in general more susceptible to osteoporosis-related bone fractures than men, especially during the perimenopausal period, when the decrease in their oestrogen levels accelerates bone loss. Nevertheless, the increase of life expectancy in developed countries puts older men in a high risk of bone fractures too, especially after the age of 65 years. The adequate intake of certain nutrients that are essential for bone metabolism, such as calcium and vitamin D, plays an important role in maintaining bone mass. As such, supplementation with calcium and/or vitamin D has been reported to exert a significant favourable effect on bone metabolism and bone mineral density (BMD). Nevertheless, the low-grade inflammation induced by a shift in the balance of gut bacterial composition has been reported to impair the absorption of dietary calcium and other important nutrients, while at the same time it seems to stimulate bone resorption through an accelerated activity of osteoclasts. In this regard, it is now clear that the gut microbiome modulates bone haemostasis in mice, by regulating the immune system and osteoclast formation. The implication of this observation is that the modulation of the microbiome and/or inflammation may provide a new approach in the inhibition of age- and menopause-related bone loss and the prevention of osteoporosis. Aim: The aim of the proposed study is to examine the effect of a 12-month supplementation with a probiotic supplement that combines three strains of Lactobacillus on bone metabolism as well as on volumetric and areal BMD in Australian early postmenopausal females, aged 45-65 years, with an increased risk for osteoporosis.

Participants that have completed all study visits on Linked study: ACTRN 12620000916943, (Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA)) AND have an overall reduction in the Apnoea Hypopnoea Index (AHI) will be granted the option to participate in the IHLOSAOLE1 study. This will enable participants who had an overall reduction in OSA to continue to take the investigational product for a further 6 months (24 weeks). The participants will complete PSGs at the sleep clinic, Sleepiness, mood and quality of life questionnaires AHI, daytime somnolence, mood and quality of life scores will be compared to baseline to observe if efficacy is maintained over the 6 month period.

This randomised controlled double blinded clinical trial assess the impact of sublingual misoprostol on blood loss during myomectomy surgery - both abdominal or laparoscopic. We hypothesis that sublingual misoprostol reduces intraoperative blood loss during myomectomy.

The purpose of the study is to determine to what extent early time restricted feeding with or without multimodal exercise improves metabolic health and reduces the risk of developing Type 2 Diabetes. Hypothesising that those within the early time restricted feeding plus exercise group will have more pronounced metabolic health benefits over those in the early time restricted feeding intervention alone. Additionally, the secondary purpose of the study is to determine whether either early time restricted feeding with or without exercise will induce a shift in circadian rhythm, hypothesising that both groups will induce a shift in circadian rhythm.

Shock is a clinical syndrome which is characterised by cellular and tissue hypoxia due to either inadequate oxygen delivery, increased oxygen demand, or a combination of these processes. It may present on a clinical spectrum ranging from occult hypoperfusion (with preserved blood pressure) to fulminant circulatory collapse. Prompt haemodynamic support of patients with shock is vital to prevent and potentially reverse multi-organ dysfunction. In addition to treating the underlying disease process, intravenous fluid administration constitutes an essential part of the initial management. However, often fluid resuscitation is insufficient and hypotension persists. In this clinical setting vasopressor and/or inotropic medications can be considered. The efficacy of these drugs has largely been assessed though their impact on haemodynamic end-points. Head-to-head comparison between these agents assessing for major clinical outcomes, such as mortality, is limited. However, in small studies of cardiogenic shock, noradrenaline appears to be superior to adrenaline. We aim to compare the efficacy of noradrenaline and adrenaline in the pre-hospital setting in a population experiencing cardiogenic shock

This study aims to determine if hands-on pressure applied by paramedics to patches during defibrillation of patients in cardiac arrest will help to improve survival.

LU-TEMP is a single-site pilot clinical trial of combination therapy with lutate and temozolomide for participants who have inherited from their parents a gene change called succinate dehydrogenase (SDH) and who have a tumor called pheochromocytoma or paraganglioma. The trial asks the question of whether combination therapy with lutate and temozolomide can reduce disease progression and improve survival. Who is it for? You may be eligible to be involved in this trial if you have pheochromocytoma or paraganglioma associated with a gene change called succinate dehydrogenase and are 18 years or older. Study details Participants will be enrolled in the study, attend standard of care treatment and follow up visits at 3 months after the completion of treatment. The intervention is an intravenous infusion once every 6 weeks and an oral capsule on days 10-14 of every 6 week cycle. Participants are asked to complete additional quality of life surveys. The total duration of follow up is 24 months as participants will receive a brief phone call at 24 months. The data will be used to improve treatment of participants living with pheochromocytoma or paraganglioma. It is anticipated that if the objectives of this pilot study are met successfully, a larger Phase 2 study will follow.

Anxiety is common in autistic adults and can be more disabling than the core features of autism. Medications for anxiety are often prescribed for autistic adults but their effectiveness or side effects in this population are not well known. Research findings in non-autistic populations may not apply to autistic adults. This study aims to find out whether the drug sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. We will compare the use of sertraline in autistic adults with placebo, a non-active identical capsule. We are interested to see whether the treatment improves symptoms of anxiety, enhances quality of life, and is effective in the longer term. We are also interested in understanding side effects of the treatment. We will run this trial in five geographical regions in England and Western Australia. We aim to include 75 people in Australia (total study population will be 306 internationally) who will be allocated at random to receive either encapsulated sertraline or identical inactive placebo, which they will be asked to take for up to 12 months. They will be asked to complete questionnaires about themselves, their anxiety and mental health, use of services, and any adverse effects they may experience at several time points. The results will help understand whether sertraline is an acceptable treatment and whether it is better or not than placebo in the treatment of anxiety in autistic adults.