ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • An investigation in atrial remodelling and the risk of arrhythmias in endurance athletes

    Atrial fibrillation (AF) is the most common sustained heart rhythm problem that increases the chance of stroke and heart failure and currently represents a growing socioeconomic burden in our ageing population. Amongst the established risk factors of age, hypertension and diabetes, exercise is increasingly recognised as a powerful modulator of AF risk. Low and moderate intensity exercise is an important therapy in the prevention and treatment of AF but, at the other end of the spectrum, intense endurance exercise has been associated with a 5-fold increase in AF risk. The reasons for this excess are not known but may relate to the profound atrial remodelling that occurs with endurance athletic training. The rate at which AF occurs in retired elite endurance athletes will be compared with non-athletes who are matched for health status, age and gender. We will assess the extent to which exercise-induced changes in heart shape, function and electrical properties represent a short-term or permanent process. This will be assessed by comparing three groups: (1) young athletes adapting to elite training, (2) middle-aged athletes during end of career detraining, and (3) retired athletes with more than 10 years of competition at national or international level. A group of athletes with arrhythmias will also provide a meaningful comparison group to determine which characteristics are shared amongst groups. To study the changes in heart structure and function we will use the latest echocardiographic and cardiac magnetic resonance imaging techniques. The study is being conducted by a team of researchers at St Vincent's Institute of Medical Research, the South Australian Health and Medical Institute and a research team in Belgium led by A/Professor Andre La Gerche.

  • Effect of intermittent pneumatic compression on muscle tissue oxygenation: a randomised cross-over controlled volunteer study

    Intermittent pneumatic compression (IPC) has been widely used as a means to prevent venous thromboembolism in hospitalised patients. Whether IPC should be considered different from thromboembolic deterrent stockings and is not contraindicated in patients with peripheral-limb vascular insufficiency is uncertain. This study assesses whether (1) IPC can improve peripheral-limb muscle tissue oxygenation (StO2), and (2) a sequential-compressions mode is better than a single-compartment compression in improving StO2. Twenty volunteers will be randomised to have their left or right arm treated with a sequential or single-compartment IPC for 10 minutes, using the contralateral arm without IPC as an intra-participant control. After a 5-min wash-out period, the procedure is repeated on the same arm using the alternative mode of IPC. StO2 on the hand thenar muscle is monitored every 2-min for 10-min using a near infra-red spectroscopy tissue oxygen saturation monitor.

  • Breathing platform for relaxation

    This study aims to assess the usability of a breathing platform for relaxation. Healthy participants will be used and required to fill in questionnaires during and at the completion of the study based on the ease of use of the system.

  • Soluble fibre metabolites in healthy adults- Part B

    Soluble fibre is a source of plasma short chain fatty acids (SCFA), which are known to have antiinflammatory properties. This study will investigate the plasma short chain fatty acid (SCFA) yield over 10 hours following consumption of two different oligosaccharide blends in healthy adult males and females. This information will be used in the design of future clinical intervention trials.

  • The effect of high-polyphenol olive oil in cardiovascular risk markers in healthy adults

    Purpose of study Extra virgin olive oil, a key ingredient of the cardioprotective Mediterranean diet, is considered a healthy source of dietary fat due to its high content of monounsaturated fatty acids and antioxidant polyphenols. However, while consistent, promising evidence exists, the unique contribution of polyphenols to the cardioprotective effect of olive oil is not fully established. This study will examine the effect of high-polyphenol extra virgin olive oil versus low-polyphenol olive oil on markers of cardiovascular disease risk that are related to cholesterol metabolism and total antioxidant capacity as well as measures of cognitive function. Hypothesis: Compared with a low polyphenol olive oil, a high polyphenol olive oil intervention will result in improved measures of HDL cholesterol efflux and total antioxidant capacity in a healthy adult population. Objectives 1. Efficacy. Efficacy outcomes include HDL cholesterol efflux, total antioxidant capacity, cholesterol levels (total, HDL, LDL, triglycerides), cognitive performance, and blood pressure. 2. Safety. Safety outcomes include adverse and serious adverse events directly attributable to the intervention period. 3. Adherence. Adherence outcomes will include biomarkers related to monounsaturated fat intake, bottle count, self-report checklist, and patient interview.

  • Omega-3 supplements for improving peripheral nerve health in type-1 diabetes

    Diabetic neuropathy is the most common complication of diabetes mellitus, affecting >50% of individuals with the condition. The Diabetes Control and Complications Trial demonstrated that intensive blood glucose control could reduce the incidence of neuropathy and potentially slow progressive nerve damage; however, there are currently no clinical therapies for attenuating the onset or progression of neuropathy. Omega-3 supplements have potential general health benefits, however their effect on peripheral nerves is currently unknown. There is growing scientific evidence that dietary supplementation with omega-3 essential fatty acids, may be of benefit in improving peripheral nerve integrity. This randomised, double-masked, placebo-controlled clinical trial to assess the effects of a six-month period of supplementation with omega-3 PUFAs on small nerve fibre structure and function, measured both in the eye and the extremities of the body, in individuals with type-1 diabetes. The effects omega-3 supplements will be compared with a control group, who will consume an olive oil supplement. If shown to be effective, omega-3 supplements could be an adjuvant therapy (additional to achieving optimal glucose control), for treating diabetic neuropathy, for which there are currently no other treatments.

  • The “NATURE” Trial: Nutritional Adjunctive Treatment Used for Recovery in Early psychosis

    To date, randomized clinical trials have only assessed the efficacy of single-nutrient supplementation in early psychosis. Research in other populations has indicated that combining various nutrients within multi-ingredient ‘nutraceuticals’ can result in greater benefits for mental health than single-nutrient supplementation, and is less likely to cause nutritional imbalances. This project will be the first internationally to assess the feasibility and efficacy of a multi-ingredient nutraceutical for treating young people with early psychosis. The novel formula contains a range of food-derived nutrients including vitamins, minerals, antioxidants and amino-acids. Each of these nutrients, in isolation, have already been indicated as potentially effective adjunct treatments for mental health conditions, perhaps through restoring nutritional deficiencies, and targeting abnormal brain processes implicated in the disorders. We hypothesize that combining these nutrients within a single nutraceutical, and administering this in early illness (when nutrients are most effective), may present a novel adjunctive treatment for improving outcomes of early psychosis. This pilot study will assess the feasibility and effectiveness of a multi-ingredient nutraceutical, designed to act as an adjunctive with standard antipsychotic treatment, in order to improve physical and mental health outcomes in people with early psychosis. Specifically, we will be performing a randomized controlled trial to test the hypothesis that adjunctive treatment with a nutrient-enriched fruit flavoured drink mix can reduce negative symptoms in young people with early psychosis.

  • Randomised Controlled Trial Addressing Wound Debridement Frequency and Healing Outcomes in Diabetic Foot Ulcers

    This study will examine the effect of wound debridement frequency on the healing of foot ulcers in people with diabetes. The study will take place in up to 2 different sites, the Diabetes Centre High Risk Foot Service at Royal Prince Alfred Hospital (RPAH) and the High Risk Foot Service at Concord General Repatriation Hospital (CGRH). Foot ulcers most often develop because diabetes can cause damage to the nerves and/or blood vessels of the feet. An important part of treatment is a procedure called debridement. This is when the Podiatrist or the Nurse removes hard skin from the edge of the ulcer and unhealthy tissue, called slough or necrotic tissue, from the base of the ulcer. This is done using a scalpel blade and/or curette and/or forceps; each are special instruments to help to remove unhealthy tissue. While debridement is considered best practice and is performed safely and with good effect on wound healing, and is part of the standard care patients recieve at this service, there is very limited evidence to tell us how often this should be done and whether the frequency with which it is done affects how the ulcer heals. The purpose of this study is therefore to look at whether debridement performed on a weekly basis versus every 2 weeks affects the healing of diabetes-related foot ulcers. As of April 2018, there are 5 participating treatment sites; Concord, Royal Prince Alfred Hospital, St George Hospital, John Hunter and Bankstown Hospitals. Northern Sydney Hospitals, Royal North Shore and Hornsby have submitted site specific approval to become additional sites for this study.

  • Psychological Coaching for Patients Undergoing Total Knee Replacements

    People may have different outcomes after having a knee replacement; some may experience fast and untroublesome recovery while others may experience pain, dissatisfaction and problematic outcomes in spite of successful surgical procedures. Many studies have shown that various psychological factors may have a large influence on recovery and the outcomes of knee replacement. To date, psychological coaching is not part of standard treatment in hospitals for managing outcomes post-surgery for knee replacements. This study will assess the effectiveness of a six session psychological coaching program specifically modified and designed for patients undergoing knee replacements. This program was designed based on interviews with previous patients who have undergone a knee replacement, and based on previous research literature. Participants will be randomised to either receive the 6 sessions of psychological coaching in addition to standard care, or to receive standard care only. The psychological coaching program will start 2 weeks before surgery, and conclude 4 weeks after surgery. All participants will fill out questionnaires asking about physical and psychological variables, 5 times over a period of 12 months. Participants will also measure their range of motion in their knees at these 5 points. The control group will complete questionnaires at the same times as the coaching group: 1) 2 weeks before surgery, 2) 4 weeks after surgery, 3) 3 months after surgery, 4) 6 months after surgery, 5) 12 months after surgery. Outcomes of patients who receive psychological coaching will be compared to the outcomes of patients who receive treatment as per usual in hospitals to assess the effectiveness of the program. We hypothesize that patients receiving psychological coaching will have better outcomes compared to patients who receive standard treatment.

  • A pilot randomised controlled trial comparing placebo to continuous erector spinae block for patients having surgery of the torso

    Surgery on chest, abdomen, pelvis and hip (torso) is commonly performed worldwide. Adequate pain relief is essential for smooth recovery and avoidance of complications after surgery. Commonly, strong painkillers containing morphine or morphine like drugs (opioids) are used to treat pain following surgery. Opioids have side-effects such as drowsiness, nausea and vomiting. Furthermore, opioids can impair respiratory function, resulting in reduced oxygen in the bloodstream. Opioids are also highly addictive, and it has become apparent that when patients use these drugs to treat pain following surgery, a proportion continue to take the drugs well beyond the period that they are required to do so because of pain. In other words, the use of opioids to treat acute pain following surgery is a potential pathway to persistent use of opioids and even addiction. In the United States, a leading cause of death is opioid overdose following a legal prescription. There are signs in Australia that similar events are occurring, for example our population are increasingly being prescribed stronger longer lasting opioids and there have also been an increase in opioid-related deaths. In this research, we will be examining whether a regional anaesthesia technique called erector spinae block is effective in both reducing pain and patients’ requirements for highly addictive opioids. Erector spinae block uses local anaesthetic to block the pain and therefore it should reduce the need for opioids, however, this is technique is new and therefore should be subject to rigorous scientific evaluation. The erector spinae block uses ultrasound to guide injection of local anaesthetic between the muscle layers of the back. The nerves that supply the chest, abdomen, pelvis and hip are located between these muscles. By numbing these nerves, this technique has the potential to reduce pain after surgery on the torso. This study is a placebo-controlled randomised controlled trial and involves patients being allocated into two groups. Each group has a different treatment, erector spinae block either with local anaesthetic (active treatment) or with saline (salt water mixture, placebo). A catheter (thin plastic tube) will be inserted into the plane and regular boluses will be given up to 24 hours after the operation, with solutions administered depending on the patient allocation group. To ensure the groups are similar, each patient is allocated to a group by chance (random) before surgery takes place. The patients have an equal chance of being allocated to either the treatment group or placebo group. We plan to recruit 80 patients into the study.The main outcomes to be measured are pain score, opioid use and other outcomes that are important to the patient. These include patient-rated quality of recovery and satisfaction 24 hours after the operation. We expect that patients who received erector spinae block will have reduced pain scores and improved quality of recovery.

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