ANZCTR search results

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

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30847 results sorted by trial registration date.
  • Online Cognitive Behavioural Therapy for Death Anxiety: A Randomised Controlled Trial

    This study primarily aims to evaluate whether a novel online CBT program for fears of death significantly reduces death anxiety amongst individuals with an anxiety-related disorder, compared to a waitlist control group. Given participants in the pilot study demonstrated clinically reliable reductions in death anxiety and other clinical measures after completing the program, we expect a statistically significant reduction in death anxiety amongst individuals with an anxiety disorder compared to the waitlist control will be observed. The study will also explore whether any improvements in death anxiety are associated with improvements in broad mental health. Furthermore, this study also seeks to obtain qualitative and quantitative feedback on the program, to guide further development. This will be critical to improve the program for future phases of the clinical trial. Given prior user evaluations of online interventions with a similar structure and design to the current program (Helgadottir et al., 2009; Menzies et al., 2023), it is hypothesised that the present intervention will be perceived as user-friendly, clear, acceptable, and efficient.

  • SUSTAIN- Strengthening Care for Children (SC4C), Strengthening Care for Children, A stepped-wedge translational trial of paediatric care in GP practice to assess the impact on hospital burden.

    Paediatric referrals to hospital emergency (ED) and outpatient departments (OP) have been increasing over the past years, overburdening emergency services and often resulting in long waiting times for non-urgent appointments. Inappropriate paediatric referrals to ED or OP requiring long distance travel or extended waiting times to see a specialist could be avoided, with more children potentially benefitting from better quality of healthcare provided closer to home. The SUSTAIN project aims to strengthen child healthcare provided by general practitioners (GPs) through virtual support offered by paediatricians to GPs across urban and rural NSW. The online support provided to GPs in their practices, includes; fortnightly telehealth GP-paediatrician co-consultations, monthly online lunch and learn sessions led by the paediatrician, and weekday access by GPs directly to the paediatrician via phone/email. GPs who take part in the study will also enrol in the Sydney Child Health Program (SCHP), a modular online GP educational course in child health, usually taking a year to complete. The study aims to determine whether support offered by the paediatrician and the SCHP can alter GP referral practices and improve quality of care and GP confidence. The study will also evaluate whether there is a change in families’ trust in GP-provided healthcare for their children. Long term sustainability and cost effectiveness of this model of care will also be evaluated. If the results of the study demonstrate improvements in these areas, the evidence may be used to convince government and policymakers to support this model of paediatrician-GP integrated care state-wide and even nationally.

  • Evaluation of safety and effectiveness of a nebulised phage cocktail in patients with chronic rhinosinusitis (CRS)

    Chronic rhinosinusitis (CRS) is a debilitating and costly disease. Consistent inflammation and infection of the sinuses causes headaches, facial pain, blockage of the nose and discharge from the nose. The cause of this condition is not fully understood, and is difficult to treat, with surgery often being recommended. But even after surgery, symptoms return, and repeat surgeries may be needed. CRS patients are often prescribed oral antibiotics for recalcitrant infections. Antibiotics may reduce the bacterial load but are ineffective at eradicating the infection completely. This, and the worldwide issue of antibiotic resistance, are impetus to develop alternative treatments, including a novel bacteriophage cocktail that has been shown to be safe and effective when incorporated into a sinonasal rinse in a pilot clinical trial (ACTRN12616000002482). However nasal irrigations have limitations their ability to penetrate the sinuses, and it is also estimated that a large proportion of the active product is lost without mucosal contact. Therefore, we developed a unique specifically designed device that can effectively deliver phages into the sinonasal cavities. We aim to conduct a double-blinded randomised controlled trial, comparing use of a novel bacteriophage cocktail administered using this specially designed nebuliser to standard-of-care oral antibiotics, in their ability to eradicate therapy refractory S. aureus in CRS patients. 66 participants would be assigned to one of two arms. Arm 1 would receive phage cocktail through the nebuliser twice daily for 28 days, and would receive placebo oral antibiotics twice daily for 14 days. Arm 2 would receive placebo cocktail through the nebuliser twice daily for 28 days, and culture directed oral antibiotics twice daily for 14 days. Participants would visit their doctor at day 1, 7, 14, 21, 28, and at 3- and 12-months post intervention. A health economic analysis of the period before and after the treatment would also take place to compare the cost of phage treatment to standard-of-care

  • Do environmental upgrades in the ICU affect patient's lived experience, sleep, and long-term outcomes?

    Improvements in medical care and technology have contributed to an overall reduction in ICU mortality over the last 10-15 years. As an increasing number of patients are surviving, the focus of ICU research is gradually shifting from survival to quality of survival. Research has demonstrated that an admission to ICU (especially if prolonged) is associated with an increasing risk of developing delirium, depression, anxiety, distress, hallucinations, cognitive changes, and decreased quality of life and function that can last for years after ICU discharge. Reduced and poor sleep quality is commonly experienced by patients in ICU. Disrupted sleep and sleep deficit have been found to contribute to lingering delirium, hormonal imbalance, mental changes such as memory formation, impaired immune function, and the development of a catabolic state. Neurocognitive disturbances have been reported to persist after discharge from ICU, and alterations to circadian patterns are associated with a decrease in overall well-being and a prolonged recovery from critical illness. Preventing and treating sleep disturbance in ICU may reduce morbidity and mortality. Environmental factors in ICU have been shown to affect the body’s natural production and release of melatonin (a hormone that influences the sleep and wakefulness cycle), thereby disrupting sleep architecture and leading to sleep deficits. This study investigates the impact of an improved ICU environment on the quality of sleep and, consequently, the speed of recovery and decrease the incidence of post-intensive care syndrome.

  • Emotional Freedom Techniques (Tapping) for Building Forgiveness

    This research is being conducted to investigate the impact of a single session of Emotional Freedom Techniques (EFT) on Forgiveness. Emotional Freedom Techniques is likened to a version of psychological acupuncture but without the use of fine needles, It uses a tapping technique (with two fingers) to stimulate pressure points on the face and upper body, and incorporating a cognitive element that involves the individual stating his/her concern aloud as he/she performs the tapping. While the studies indicating EFT is effective for stress reduction is robust, research has not yet examined the impact of EFT for forgiveness.

  • First-in-human Testing of a Multi-Analyte Sensor Platform for Glucose/Lactate/Oxygen/Choline in People with Diabetes

    Continuous Glucose Monitoring (CGM) systems have been commercially available for several years and have been of benefit in patients with diabetes. Advances in CGM technology have resulted in increased accuracy, reliability and ease of use. This has enabled continuous glucose data that is collected by CGM to control insulin delivery in people with diabetes via the development of technology called Closed Loop (CL) insulin delivery systems. More recently it has been suggested that these CL systems may benefit from multiple inputs in addition to glucose, such as lactate (lactic acid), that may help the system predict events such as exercise. At the same time, it is recognized that the burden and intrusiveness associated with the use of technology in people living with diabetes needs to be minimized. The development of a sensing platform that can measure multiple analytes in one platform is needed to enable the measurement of analytes in addition to glucose, without adding extra technological burden. Novel technology developed by PercuSense lends itself to the cost-effective measurement of multiple analytes. The company has demonstrated feasibility of glucose, lactate, oxygen and choline sensing in non-human models. In this study, we aim to conduct the first in human studies with PercuSense technology incorporating a multi-sensing single insertion device. n this study participants will have 2 investigational sensors inserted into the arm, as well as a commercially available glucose sensor into the arm. The investigational sensors will not provide glucose or other analyte information to participants, and so decisions regarding their diabetes treatment will be made as usual and participants may continue to wear their own glucose sensor if they wish to do so.

  • Intrinsic foot muscle morphology and function in tennis players

    The International Tennis Federation’s 2021 Global Tennis Report tells us that a staggering 87 million people play tennis, with competitors from 142 countries competing in the 2020-2021 period (International Tennis Federation Academy, 2021). However, as the number of tennis players increases, so does the number of reported foot and ankle injuries (Kemler et al., 2022). The impact of these injuries has become of particular interest, as they are reported to be the most common severe injury in tennis players (Robison et al., 2021). Further, there is an increasing body of literature surrounding the significance of the intrinsic foot muscles (IFMs) in these injuries. Thus, a critical issue for exploration is the impact of these foot and ankle injuries on the IFMs of tennis players. By understanding this, a more detailed and accurate management plan for performance optimisation, injury prevention and therapy in both recreational and advanced tennis players can be developed (Di Giacomo et al., 2018). Therefore, the purpose of this study is to determine if there is an association between foot muscle morphology and functional performance of selected IFMs in tennis players who have, and have not, experienced previous foot or ankle injuries. Research Questions: The specific research questions this study aims to answer are as follows: 1. What is the relationship between foot and ankle injuries and the size of the IFMs in tennis players using ultrasound measurements? 2. What is the relationship between foot and ankle injuries and the functional performance of the selected IFMs in tennis players using measurements obtained on a novel biofeedback device? 3. What is the difference between the structural and functional performance of the IFMs in tennis players with and without foot and ankle injuries at an advanced and recreational level? Di Giacomo, G., Ellenbecker, T. S., & Kibler, W. B. (2018). Tennis Medicine A Complete Guide to Evaluation, Treatment, and Rehabilitation (1st 2018. ed.). Springer International Publishing. https://doi.org/10.1007/978-3-319-71498-1 ITF Academy. (2021). 2021 ITF Global Tennis Report https://www.itf- academy.com/?view=itfview&academy=103&itemid=1473 Kemler, E., Valkenberg, H., & Verhagen, E. (2022). More People More Active, But There is a Counter Site. Novice Athletes are at Highest Risk of Injury in a Large Population-based Retrospective Cross-sectional Study. BMJ Open Sport & Exercise Medicine, 8(1). https://doi.org/https://doi.org/10.1136/bmjsem-2021-001255 Robison, H. J., Boltz, A. J., Morris, S. N., Collins, C. L., & Chandran, A. (2021). Epidemiology of Injuries in National Collegiate Athletic Association Women's Tennis: 2014–2015 Through 2018–2019. Journal of Athletic Training, 56(7), 766-772. https://doi.org/10.4085/1062-6050-529-20

  • Determining the utility of uraemic toxins in peritoneal dialysis to optimise patient care

    Peritoneal dialysis (PD) removes toxins that rise during kidney failure. Historically, we looked at removal of small water-soluble molecules as a surrogate marker of dialysis effectiveness. However, given its poor relationship with patient outcomes, recent guidelines have moved away from these targets and is now focusing on patient reported outcomes. Moreover, protein-bound uraemic toxins (PBUT), which are poorly removed in dialysis, may have more of a role in patient outcomes. Additionally, studies in haemodialysis and chronic kidney disease have shown that high-fibre diet may help reduce the generation of these PBUTs but studies are lacking in the PD population. We will determine effects of PBUT removal on patient outcomes (quality of life measure using EQ-5D-5L, symptoms and mood score using IPOS-renal and an assessment of physical function including hand-grip strength and timed chair-to-stand test) and preservation of residual kidney function. We will also look at the effects of increased fibre intake on PBUT levels and above-mentioned patient outcomes in a group of PD patients. We hypothesise that a high fibre diet will reduce PBUT generation in the PD population. We hypothesise that this reduction in PBUT levels will correlate with better patient outcomes and preservation of residual kidney function.

  • Examining the efficacy of different iron supplements in women

    Iron deficiency is one of the most common health conditions globally, and disproportionally affects women, comparative to men (Pasricha et al., 2021). Specifically, the menstrual cycle can negatively affect iron regulation, with low-estrogen periods of been prohibitive for iron absorption and menstrual blood loss resulting in a direct, and often substantial loss of body iron (McKay et al., 2022). Additionally, high exercise volumes can also be detrimental to iron status, with direct iron losses (via GI bleeding, haemolysis and sweat) and exercise-induced decreases in iron absorption been contributors to the high prevalence of iron deficiency in athletic populations (Peeling et al., 2008). Accordingly, female athletes need to combat both the sex- and exercise-associated challenges to iron regulation, making them a ‘high risk’ cohort for iron deficiency. One approach for correcting an iron deficiency is to use oral iron supplementation. A conventional supplementation regime consists of daily ferrous sulphate dose (~100 mg of elemental iron), usually found in combination with a source of vitamin C which typically increases an athlete’s iron stores by 30-50% over a 6–8-week period (Dawson et al., 2006; Hinton et al., 2000). However, it is not uncommon for individuals to report high levels of gastrointestinal distress from this treatment, especially athletes. Other formulations have been identified which claim to reduce the side effects associated with iron ingestion. One such formulation, is an iron(III)-hydroxide polymaltose complex (Maltofer), which has shown good efficacy and reduced side effects in pregnant women (Ortiz et al., 2011), however it’s use in athlete cohorts has not yet been determined. Accordingly, this study will assess to efficiency of different iron formulations in different cohorts of women with varying exercise loads and menstrual statuses. It is hypothesised that both supplements will be equally effective at increasing iron stores, however Maltofer consumption will be associated with lower GI complaints. Furthermore, we hypothesise that iron stores will be repleted faster in generally active, compared to athlete cohorts, and that menopausal women will have the greatest increase in their iron stores after 12 weeks. Collectively, this work may highlight the need to develop athlete-specific strategies for the treatment iron deficiency. The aims of this project are: 1. To assess the efficacy of two different iron formulations (Ferrograd C and Maltofer) on the treatment of low iron stores in women. 2. To compare the efficacy of oral iron supplementation in different cohorts of women. 3. To assess the relationship between iron status, supplement efficacy and the TMPRSS6 rs855791 (2321 C>T) polymorphism in women.

  • The effects of two doses of alcohol on eye movement behaviour during driving

    This project investigates how low and moderate doses of alcohol affects eye movement patterns during simulated driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication

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