ANZCTR search results

We are conducting a clinical trial to compare the outcomes of two different treatments: i) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises); and ii) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises) plus the subsequent use of a mobile app for 24 weeks. Participants in both groups will receive exercise-based care by a physiotherapist. This will involve two telehealth consultations with a physiotherapist (using Zoom video-conferencing) over two weeks, for prescription of an individualised strengthening exercise program. Participants in both groups will receive resistance bands for exercising. After completing the physiotherapy consultations, participants will be encouraged to continue with their home exercises for the next 24 weeks. Around half of participants will be randomly allocated to download and engage with a mobile app (on their smartphone or tablet) as well, for the 24 week home exercise period. Outcomes will be collected by web-based survey at baseline and 26 weeks after randomisation, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks after randomisation.

Vasopressor infusions are an essential for management of circulatory shock and are traditionally administered via CVC, though administration via PIVC has also been described. Whether delivery of vasopressor via PIVC is comparable in terms of safety and efficacy to delivery via CVC is currently unknown. We hypothesize that administration of vasopressor medications via PIVC over a short duration, in controlled doses and with appropriate monitoring is safe and effective compared to that via central venous catheter in terms of patient outcomes. This pilot phase 2 study will enroll 40 patients (20 in each group) who are admitted with shock needing vasopressor infusions. Eligible patients will be identified, and once consent is obtained they will be randomized to either an early (short duration of vasopressors via PIVC) or late (longer duration of vasopressors via PIVC) CVC group. The primary endpoints of the study will be feasibility of the protocol and days alive and out of hospital at day 60.

To compare the drug delivery and distribution for inhaled flecainide as compared with the intravenous formulation of the drug with is approved for treatment of atrial fibrillation.

The objective of the study is to assess at whether a bedside Echocardiogram (cardiac ultrasound) improves patient satisfaction of the emergency department performance. Adults with low risk chest pain will be recruited to intervention and control groups. The intervention group will receive a bedside echocardiogram and the outcome measure will be to assess patient satisfaction. An Echocardiogram is not routinely part of the chest pain assessment in ED. The hypothesis of the study is that participants with chest pain who receive an echocardiogram will have higher satisfaction scores compared to those who do not receive an echocardiogram.

Transgender men are treated with testosterone to align their physical appearance with their gender identity and improve mental health. Although the current evidence does show improvements in mental health, there is a lack of high-quality data in this field. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to an immediate testosterone therapy compared to a delayed testosterone therapy group (which due to standard care clinic waiting times is an approximately 3 month wait to commence testosterone therapy). We aim to establish the influence of testosterone therapy on gender dysphoria, depression, suicidality and quality of life in transgender men newly commencing testosterone therapy.

The aim of this study is to investigate the effects of a novel dietary supplement (3DFC) on psychological functioning and other health related outcomes including mood, wellbeing, biochemical parameters, heart rate variability and gut symptoms in adults aged 18-55 years with elevated stress, anxiety and depression symptoms. The 3DFC supplement developed by the principal trial sponsor (Anatara Lifesciences) contains elevated levels of sodium butyrate and is designed to be metabolised by the gut microbiota. The 3FDC supplement has the potential to produce benefits in the outcomes described. The CSIRO will lead a 6-week randomised, double-blind placebo-controlled trial consisting of two intervention arms: 1) the 3DFC dietary supplement; and 2) placebo control. It is expected that the 3FDC supplement will lead to a greater reduction in anxiety and depression subscale scores on the Hospital Anxiety and Depression Scale compared to a placebo over the 6 week period.

Peripheral arterial diseases (PADs) are a collection of chronic occlusive conditions affecting adults, which predominately occur due to atherosclerosis and affects approximately 15% of the Australian population. Lipoprotein (a) [Lp(a)] is an emerging risk factor for PAD and atherosclerosis. Multiple studies have demonstrated a causal relationship between elevated Lp(a) and the development of atherosclerotic cardiovascular disease, calcific aortic valve disease and inflammation. The role of Lp(a) in restenosis in PAD is unclear, however Lp(a) is implicated in promoting atherosclerosis progression, thrombosis and inflammation which are all pathological processes thought to be critical in stimulating PAD progression and the need for surgical intervention. The primary aim of this study is to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy.

BrighterSide is a newly developed mobile phone app for adults with suicidal ideation. The app helps users develop and practice strategies to manage suicidal thoughts. It includes five modules based primarily on cognitive behavioural therapy (CBT) and dialectical behaviour therapy (DBT), with elements of acceptance and commitment therapy (ACT) and positive psychology. Each module includes psychoeducation and associated activities. The app includes a safety planning feature where users are encouraged to list their personal warning signs, activities/techniques they find helpful to manage distress, and contact details for support people. It also includes a ‘check-in’ feature that auto-appears when a user accesses the app for the first time each day. The check-in asks users how they are feeling today, whether they have thoughts of harming themselves, whether they feel able to keep themselves safe, and (if not) a link to their safety plan, contact numbers, and calming/distracting activities. This trial will assess the efficacy of the BrighterSide app in reducing severity of suicidal thoughts. The primary outcomes will be measured by comparing scores on the Suicidal Ideation Attributes Scale (SIDAS) between an intervention group and a waitlist control group at baseline, 6 weeks and at 12 weeks. Secondary outcomes include self-harm and coping ability. It is hypothesised that participants in the intervention group, relative to the control group, will report at follow-up: (1) greater reductions in suicidal ideation, (2) fewer incidents of self-harm/suicide attempts, (3) greater improvements in coping ability.

Exercise performance is impaired in hot conditions compared with temperate conditions. During exercise in such thermally stressful conditions, fluid loss through sweat production to liberate heat from the body is accelerated, which can adversely impact cardiovascular and thermoregulatory function and ultimately hinder exercise performance. To increase the total fluid pool available for sweat production, ingestion of nutritional aids such as glycerol and sodium prior to exercise may increase total body water above normal body water levels (i.e., euhydration) prior to exercise, which is known as hyperhydration. This topic requires further investigation to determine if hyperhydration is a viable preparation strategy for endurance running in hot conditions. The hypothesis for this study is that the combined ingestion of glycerol and sodium will result in a significantly greater fluid retention than that of glycerol or sodium ingested separately.

Osteoarthritis is a leading cause of disability with no cure. Current therapies are limited, with end-stage osteoarthritis treated with costly total joint replacement. There is an urgent unmet need for an effective disease-modifying drug to reduce the burden of the disease. Obesity and obesity-related metabolic and inflammatory factors are risk factors for knee osteoarthritis with people with osteoarthritis at increased risk of cardiovascular disease morbidity and mortality. Metformin, a safe, low-cost, well-tolerated first-line therapy for type 2 diabetes for over 60 years, affects these pathways with evidence from animal and human studies that metformin may reduce pain of knee osteoarthritis and reduce cardiovascular risk. We propose to test this in a randomised double-blind placebo-controlled trial in participants with knee osteoarthritis and obesity. AIMS: To determine whether metformin reduces knee pain over 6 months compared with placebo in people with knee osteoarthritis who are obese. PARTICIPANTS: 102 participants with knee osteoarthritis and obesity INTERVENTION: Metformin (2000 mg) once daily COMPARATOR: Identical placebo once daily OUTCOME: Change in knee pain assessed by visual analogue scale at 6 months SIGNIFICANCE: The repositioning of metformin, a cheap, safe, old drug for this new indication, offers an unprecedented opportunity to significantly and immediately impact the management of osteoarthritis in Australia and worldwide. It has very high potential for rapid translation being a safe, easy to use medication with medical practitioners who have repeatedly called for effective treatments for knee osteoarthritis familiar with its use. Metformin has the potential to significantly reduce disease burden and healthcare costs, while improving quality of life and reducing cardiovascular risk in people with knee osteoarthritis.