ANZCTR search results

The overall aims are to assess changes in cardiac function and sympathetic nervous system activity at rest and during exercise with empagliflozin in patients with type 2 diabetes without established heart disease. We hypothesised that: - 3 months treatment with empagliflozin will be associated with a measurable improvement in exercise capacity as reflected by peak oxygen consumption during maximal exercise (VO2peak) in addition to key physiological variables during exercise (heart rate reserve, blood pressure and ventilatory efficiency) in type 2 diabetes subjects without overt clinical heart failure. - Empagliflozin is associated with changes in sympathetic nervous system activity that may cause changes in cardiovascular function.

This study aims to determine the effectiveness and clinical outcomes of non-operative treatments offered to patients who have a triangular fibrocartilage complex (TFCC) injuries. Injury to the triangular fibrocartilage complex has been observed as a common cause of both short and long-term wrist pain, loss of wrist function and impact on quality of life. Currently, it is common practice for health care providers to initially recommend non-surgical or “conservative treatments” for patients. Treatments can include immobilising the wrist using a splint to relieve pain; injection of corticosteroid to reduce inflammation and provide pain relief; and hand therapy exercises to help manage pain and improve function. This study will investigate whether splint immobilisation, corticosteroid injection or a combination of the two, contribute to the efficacy of hand therapy, in relieving symptoms and improving function in patients with TFCC tears. Adults presenting with a MRI confirmed TFCC tear, between 6 weeks and 12 months from primary injury will be invited to participate in the research study. Participants will be randomly allocated to one of four groups: Group A: will receive hand therapy Group B: will receive a thermoplastic, volar wrist splint + hand therapy Group C: will receive a corticosteroid injection to the wrist + hand therapy Group D: will receive a wrist splint + corticosteroid injection + hand therapy. Participants will be asked to complete an electronic survey consisting questions specific to wrist pain and function. The survey will be completed in-person before treatment and at 6 weeks and 12 weeks after intervention commencement. The investigation will be conducted at the Brisbane Hand and Upper Limb Research Institute at the Brisbane Private Hospital.

The aim of the study will be to investigate the effects of caffeine (3 mg/kg 60 min pre-exercise) on vertical jump performance, movement velocity in resistance exercise, muscular endurance, and power output. Additionally, the aim is to explore if the inter-individual variation in responses to caffeine ingestion influenced by variations in genotype. The study hypothesis is that individuals classified as AA genotype will experience greater improvements in exercise performance following caffeine ingestion than those with AC and CC genotypes.

This is a proof of concept pilot study to evaluate the safety and tolerability of autologous adipose-derived mesenchymal stem cells (ADMSC) administered intravenously for the treatment of small joint osteoarthritis. A secondary objective will be to assess efficacy with pain and functional assessment over a 12month follow-up period.

The purpose of this trial is to assess whether combination toothpaste and mouthwash containing cannabidiol (CBD) can improve symptoms of Gingivitis compared to placebo. This is a double-blind, placebo-controlled, between-subject study design comprising of four visits in which gingivitis is assessed using the gum bleeding index (GBI; A screening visit, Baseline (Day 5), Day 10 and Day 35). Healthy participants will visit the dental clinic for initial assessment for suitability of inclusion in the study. If the participant is not excluded he/she will be assessed on the Gingivitis Bleeding Scale (GBI), instructed not to use dental hygiene (brushing teeth or using mouthwash) for 5 days and to return for their next visit (Baseline/Day 5). The participant will then be randomized to the trial and provided with treatment (CBD toothpaste/mouthwash or placebo toothpaste/mouthwash) which they will use for the next 30 days. On Days 10 (after 5 days of treatment) and Day 35 (after 30 days of treatment) they will return for another GBI assessment. The study duration is 35 days (from screening visit to 30-day follow-up visit). Treatment (brushing teeth and using mouthwash) will occur three times a day for 30 days in total.

The purpose of the study is to investigate if completing an online program for perfectionism reduces symptoms of perfectionism, anxiety, depression, eating disorders, and non-suicidal self-injury, and increases well-being in adolescents. It is expected that adolescents who do the online program will have greater reductions in perfectionism, symptoms of anxiety, depression, eating disorders, and non-suicidal self-injury, and increases in well-being than adolescents not doing the program. It is also expected that the symptoms will remain reduced 3 and 6 months after the program finishes. Participants will be randomised into one of two groups; the online program for perfectionism group or a waitlist control group. Those in the online program for perfectionism group will be given access to the online program where they will log in once a week for eight weeks (8 modules in total). The program is based on the second edition of the book "Overcoming Perfectionism: A self-help guide using cognitive behavioural techniques" (Shafran, Egan, & Wade, 2018). Participants doing the online program for perfectionism will submit one homework sheet for each module and will receive brief personalised feedback on their work. Participants in the waitlist control group will be given the option to complete the program once data collection has finished.

Background: Osteoarthritis (OA) is a common, painful and disabling condition. Venlafaxine, a centrally acting antidepressant, has demonstrated analgesic effects in other chronic pain conditions. Primary aim: To determine the effectiveness, safety and tolerability of venlafaxine (75-150mg daily) compared to placebo in reducing pain in knee OA patients using a randomised, placebo-controlled double-blind design over 12-week. Primary hypothesis: Compared with placebo, in knee OA pain patients, 12-week treatment with venlafaxine will lead to a 10mm reduction in pain (assessed by 100mm visual analogue scale (VAS)). Significance and Innovation: Positive results will have a substantial and immediate impact on OA pain management. It will provide compelling evidence that venlafaxine can reduce pain in OA patients. Such findings can be easily translatable into clinical practice, as venlafaxine is low cost, well tolerated and currently available in Australia.

This study aims to the efficacy of using an online platform to deliver a group-based physical activity intervention for first responders (police, fire and ambulance workers) and their partners/carers. By nature of their occupation which involves repeated exposure to potentially traumatic events, first responders are at a significantly increased risk of experiencing poor mental and physical health, including developing depression, anxiety and post-traumatic stress disorder, as well as premature cardiovascular disease. These health conditions are also associated with lower levels of physical activity and higher levels of sedentary behaviour. This study will recruit a convenience sample of self-identified sedentary first responders and their self-selected support partners to a 10-week PA program delivered through a private Facebook group. We will deliver education on pre-determined topics related to PA and diet and provide participants with an activity tracker (Fitbit). Peer support members from previous iterations of the intervention will also help deliver the content. Promoting PA among first-responders may help to reduce the burden of mental and physical ill health facing this underserviced population. Results may also have implications for the provision of PA in rural and remote settings.

Melatonin has multiple therapeutic benefits. It has anti-oxidant and anti-hypertensive properties, it synchronises the circadian system and also promotes sleep. These are all pathways that could be targeted to slow cognitive decline. Previous randomised controlled studies have all targeted patients with developed dementia/AD in whom the cognitive decline may be too far advanced to modify clinical trajectory. We therefore propose using Melatonin in participants with Mild Cognitive Impairment (the prodromal phase of dementia) who report reduced sleep quality to target modifiable risk factors in this population at risk of for future cognitive decline. The study participants will be 40 older adults (aged 60-80 years) with multi-domain Mild Cognitive Impairment (non-amnestic or amnestic) with subjective sleep disturbance. Participants will be randomised to either daily melatonin or placebo, but both the participants and the experimenters will be blind to which treatment they are on. Primary outcomes include feasibility, acceptability and adherence. Secondary outcomes include the effect of melatonin on brain oxidative stress and sleep disturbance while neurocognition, memory, glucose, mood, blood pressure and other inflammatory biomarkers will also be measured.

The purpose of this study is to compare blockade of the adductor canal and the posterior branch of the obturator nerve to blockade of the femoral nerve for patients undergoing arthroscopic anterior cruciate ligament reconstruction. The primary outcome is pain, measured as opioid consumption and pain scores during the first 24 postoperative hours. The secondary outcome is quadriceps strength.