ANZCTR search results

Neuropathic pain and symptoms are chronic debilitating problems that commonly affect people with advanced kidney disease. Most currently available treatments are taken orally, and may be associated with significant side effects. Also, people with advanced kidney disease are on many medications, and adding additional medications increases the risk of drug interactions. Topical magnesium may represent an alternative treatment for these bothersome symptoms and due to local application, the risk of side effects and drug interactions may be lower. The objective of this study is to determine the effectiveness of daily application of topical magnesium oil for the treatment of neuropathic symptoms (pain, numbness, cramping) in people with stage IV or V chronic kidney disease. The study will also examine the impact of using magnesium oil on quality of life, blood magnesium concentrations and any adverse effects from using magnesium oil. This study will run for a period of 12 weeks, with follow up scheduled every 4 weeks.

The Compressive Redistribution Air Blanket (CRAB) is a recent invention with a primary aim of treating adrenaline resistant anaphylactic shock. Improved understanding of adrenaline resistant anaphylactic shock suggests the primary cause of hypotension is the venodilation, not vasodilation. Venodilation decreases Central Venous Pressure (CVP) resulting in poor cardiac filling and poor cardiac output. Adrenaline is a potent vasoconstrictor but does not significantly effect venodilation. When the CRAB is inflated to the pressures of just 20-40cm H2O the venous system in the abdomen and legs will be compressed and it is believed this will increase the central venous pressure, increase venous return to heart and restore blood pressure. This is a phase 1 clinical trial. The objective is to document the comfort / safety of the CRAB and find the relationship between CRAB Pressure and rise in CVP. In addition, it will be compared to current standard of care which increase CVP, the straight leg raise and Trendelenburg position. Twenty healthy volunteers will arrive fasted on the day of the study and have a midline line catheter inserted under ultrasound guidance in an arm vein to monitor the central venous pressure. A series of 2 minute inflations at 10,20,30 and 40 cmH2O and deflations will be monitored with CVP, ECG, BP & SaO2, and an assessment of comfort after each inflation. The protocol will be repeated after food, drink and IV hydration.

The current study will evaluate the impact of sleep inertia on cognitive performance and subjective sleepiness/fatigue, measuring overall impairment and time course, during the first hour after waking at 400h and 1600h, relative to background performance and active control group, across days of sleep restriction. Further, this study will aim to determine the effectiveness of reactive countermeasures (light and odor) to reduce the impact of sleep inertia on cognitive performance and subjective sleepiness/fatigue. It is hypothesised that the impact of sleep inertia on cognitive performance will be greatest upon waking and will dissipate over the first hour of wake. Due to the cumulative effect of sleep restriction, performance will be successively worse upon waking from day one to four and return to a lower baseline each day.

The overall aim of this study is to assess the preliminary efficacy and feasibility of cognitively demanding physical activity breaks in secondary schools. More specifically, this study will assess the effect of cognitively demanding classroom physical activity breaks on adolescents' cognition, and academic achievement. The majority of research in physical activity and cognition has investigated the quantitative aspects of physical activity, such as duration and intensity. Alternatively, the qualitative characteristics of physical activity, such as task complexity, novelty and activity context, have received less attention. Emerging research on cognitively demanding physical activity, using the qualitative characteristics of physical activity, seems to promote changes in cognitive performance. The outcomes from this research will benefit current and future generations of young Australians as physical activity levels decline dramatically during adolescence, and only 15% of Australian adolescents are sufficiently active. Finding ways to promote physical activity in adolescents is particularly important considering that physical inactivity is linked with a range of diseases such as obesity, Type II diabetes, and a range of mental health disorders. Of note, stress and anxiety among youth are increasing in recent decades, particularly among older adolescents. Schools are ideal settings for the promotion of physical activity because they have the necessary facilities, equipment, personnel and are accessible to young people. Our proposed study, focusing on the promotion of physical activity for adolescents has the potential to create new knowledge and reduce the burden of physical inactivity. This project will offer a significant contribution to the field by emphasising the impact of cognitive demanding physical activity. In addition, our proposed intervention may enhance adolescents' cognitive outcomes, as well as their mathematical engagement.

Chronic pain is a common problem but often undiagnosed and untreated in people with dementia due to their cognitive impairment and limited communication ability, leading to reduced quality of life and increased healthcare costs. The efficacy and economic value of interventions to reduce pain in people with dementia remains unclear due to a lack of clinically useful pain assessment tools for this group. This study will (1) determine the feasibility of an artificial intelligence-based application (PainChek) to measure pain in people with dementia; (2) identify the optimal dosage and efficacy of a social robot (PARO) intervention; and (3) develop a checklist of cost-effectiveness measures. A sample of 45 residents with dementia will be randomly allocated to Intervention Group 1 (15-minute PARO intervention, 2×/day) or Intervention Group 2 (15-minute PARO intervention, 1×/day), or the Control Group (15-minute Plush Toy, 1×/day), for 4 weeks and follow-up at week 8. Primary outcomes include the feasibility of using the PainChek to evaluate the intervention efficacy and cost-effectiveness needs within a larger trial. Secondary outcomes are neuropsychiatric symptoms, medication use and participants’ quality of life. This novel project will improve pain management in people with dementia, and potentially reduce treatment costs.

Prospective randomised study comparing the use of a portable balance testing device prototype versus the currently available clinic-based devices in the diagnosis of vestibular disorders causing vertigo. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard vestibular workup or into the interventional group which will use the portable diagnostic device. If a diagnosis is not made in the interventional group, the participant will undergo the standard vestibular workup. The portable device allows to capture the eye movements during the vertigo attacks.

Patients undergoing allogeneic stem cell transplantation frequently require enteral (nasogastric) feeding however the best formula to provide is unclear. Some research has found that the type and diversity of gastrointestinal bacteria (microbiome) may be linked to differences in health outcomes after transplant. Prebiotic fibre may assist in increasing the diversity of the microbiome and the abundance of beneficial bacteria. The aim of this pilot study is to investigate the use of a prebiotic fibre containing enteral feed and its effect on the microbiome and health outcomes after transplantation. This study will recruit 10 participants who are receiving the standard fibre free enteral feed and 20 participants to receive a prebiotic containing feed. Data on clinical outcomes will be collected as well as stool and blood samples before transplant and 2 weeks post, to assess changes in the microbiome. This research will help in improving care for future patients by increasing knowledge on the best enteral feed formula to provide after stem cell transplantation.

This 12 week trial aims to investigate the feasibility, acceptability and effectiveness of an innovative physical activity metric [Personal Activity Intelligence (PAI)] for 30 Defence force personnel and/or their immediate family following cardiac rehabilitation. Rather than counting steps, or trying to self-quantify a mix and match of different exercise types and intensities, people will have a simple target (100 Personal Activity Intelligence Score/week) that takes into account the ‘dose’ of exercise in the context of their individual body response recorded through a smartwatch. We hypothesise PAI monitoring will improve physical activity levels and intensity, general psychological well being and adherence. This approach has the potential to improve heart health and prevent long-term comorbidities and hospital re-admissions, thereby reducing healthcare costs and saving lives.

Gout is the result of high levels of uric acid in the blood depositing in the joints. It can also deposit in the kidneys and is associated with kidney disease, cardiovascular disease and death. The treatment for gout is tablets that lower uric acid in the blood stream, but most people with gout aren’t prescribed uric acid lowering therapies, or simply don’t take their medications. People with diabetes have are more at risk of developing gout than people without diabetes, due to high levels of uric acid in the blood. This study aims to identify the extent to which current diabetes medications may lower uric acid; with the hope of avoiding the need to add additional therapies to treat gout in people who already take many medicines. This is likely to increase adherence to gout therapy in people with diabetes, improving outcomes and decreasing the long term complications of gout including joint pain and death form cardiovascular disease.

The aim of this study is to investigate whether use of an imaging technique, indocyanine green angiography (ICGA), during reconstructive breast surgery after mastectomy (removal of all breast tissue) can reduce a major complication. This complication is dead breast skin tissue (necrosis) of the overlying breast skin (mastectomy skin flap). This occurs because there is inadequate blood flow to the skin resulting in breakdown. This can result in further surgery, poor cosmetic results, delay in chemotherapy or radiotherapy, and increased costs to the healthcare system. Who is it for? You may be eligible for this study if you are aged 18 years or older, are scheduled for unilateral (one-sided) or bilateral (both sides) nipple- or skin-sparing mastectomy followed by breast reconstruction. Study details Participants will receive a mastectomy and breast reconstruction using ICGA to assess blood flow to the skin flap and make adjustments such as delay reconstruction surgery or remove dying skin. Participants will return for a follow-up assessment at 7 days, 30 days and 90 days post-surgery involving a clinical assessment of the surgical site, and will be monitored for re-admission to hospital or any other complications for 12 months post-surgery. It is hoped that this study may demonstrate that the use of intraoperative ICGA in breast reconstruction surgery following mastectomy will decrease the incidence of mastectomy skin flap necrosis compared to surgery without use ICGA, which may help to reduce complications and improve cosmetic outcome.