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.
  • The use of a smartphone app to monitor activity and participation in patients undergoing cardio-thoracic surgery

    We are assessing the feasibility of using a smartphone app to monitor patients activity and participation. We will ask patients to install a smartphone app on their phone. Patients will install our app on their phone at least 7 days pre-op. The app will report step and GPS data and allow participants to respond to a questionnaire, data will be reported anonymously to a secure cloud database. They will then undergo surgery. We will follow them up for 6 months. before asking them a satisfaction questionnaire and deleting the app from their phone

  • Evaluating the effectiveness of a modified dialectical behaviour therapy (DBT) group program in treating adolescents and young adults experiencing substance misuse

    Dialectical Behaviour Therapy (DBT) has been proven to be an efficacious treatment for borderline personality disorder (BPD) (Linehan, 1993; McMain et al., 2009). However, generalisability of this outcome within adolescents and young adults with co-morbid substance abuse and mental health concerns within a residential care setting in Australia has not been investigated. The primary aim of this study is to evaluate the clinical effectiveness of a Modified Dialectical Behaviour Therapy (DBT) Group Program embedded within a residential program in treating adolescents and young adults aged 16 to 24 years, experiencing substance misuse over time compared to a control group that did not receive the DBT Group Program. The secondary aim is to identify the factors that predict who is most likely to benefit from such treatment, particularly in terms of improved vocational outcomes (employment and education). Additionally, the cost-effectiveness of this modified DBT program will be evaluated. Finally, client and therapist satisfaction will also be explored through the study. Evaluation of the effectiveness of the DBT program in treating young people with co-morbid substance abuse and mental health concerns – one of the most difficult cohorts to treat – is an important first step in improving mental health care for this population. This research will advance the knowledge in the field by providing evidence for the importance of continuously improving service and quality person-centred care, taking into account factors that could contribute to positive treatment outcomes. This project will be conducted at Triple Care Farm (TCF, Mission Australia in partnership with the University of Wollongong (UOW).

  • The effect of different sports beverages on recovery from endurance exercise.

    The food and fluid provided during the post-exercise period plays an essential role in recovery and adaptation processes. There has been a considerable amount of research investigating the ideal quantity and quality of nutrients (e.g., carbohydrate, protein, electrolytes and water) for optimising the key recovery processes (i.e., repair, healing, growth, glycogen re-synthesis and rehydration) individually. This has lead to the development of recovery nutrition guidelines and recommendations, as well as commercially available recovery supplements. Considering dairy milk has similar nutritional properties to recovery nutrition guidelines and recommendations, there is emerging evidence suggestion dairy milk has the potential to optimise recovery from prolonged exercise. Therefore, the aim of this study is to compare the effects of dairy milk to other sports recovery beverages, on aspects of recovery.

  • Do low-calorie sweeteners influence intestinal glucose absorption in patients with type 2 diabetes?

    Despite increasing use of low calorie sweeteners (LCS) in western diets, and an association between regular, heavy consumption of LCS containing beverages and an increased risk of developing Type 2 Diabetes Mellitus (T2DM), it has only been recently established by our group that LCS supplementation impairs glycaemic control in healthy subjects ACTRN12615000866505. This occurs via augmented intestinal glucose uptake and is likely to involve negative changes in gut microbiota that impair host control of glycaemia. Patients with T2DM are intuitively likely to be at higher risk of these changes due to higher consumption of LCS, defective control of intestinal sweet taste sensors, and augmented glucose uptake, but whether this is the case, and the degree of increased risk, is yet to be determined.

  • Virtual surgery pre-planning for paediatric lower limb deformities

    Paediatric bone deformities can result from congenital conditions or acute injuries and often require orthopaedic intervention. For example, a femoral de-rotation osteotomy may be performed to address the in-toeing gait observed in a child with cerebral palsy, or this procedure may be performed to correct the out-toeing gait pattern caused by a slipped capital femoral epiphysis fracture. These orthopaedic procedures are highly complex and involve multi-plane correction requiring a high level of surgical expertise and experience. In this project, we will: - Develop tools to rapidly produce personalised computational models of paediatric patients with bone deformities, - Develop technology to perform virtual surgical simulations to optimize surgical pre-planning, - Develop technology to simulate post-operative walking function, - Design and manufacture surgical cutting guides using 3D printing, - Utilize 3D printed surgical guides in surgery to streamline the translation of the virtual plan to surgical execution, - Evaluate surgical outcomes and accuracy of pre-operative surgical predictions of post-operative function. The primary aim of the proposed research is to determine the efficacy of virtual surgery and personalised cutting guides for the surgical treatment for children with bone deformity in Queensland. We expect the inclusion of virtual surgery and 3D printing of surgical guides will result in improved anatomical alignment and improved post operative walking kinematics.

  • Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

    This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest dose, the same has been selected for the study.

  • Brief Psychoeducational Workshop for High-school students

    The mental health of young people is important now more than ever as mental health disorders have formed a significant burden in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). However early intervention has been promising in preventing the trajectory of future diagnosable conditions as well as enabling adolescents to fulfil their potential Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Perfectionism has recently gained attention for being a major aspect in sustaining the growth and maintenance of many disorders and underling a series of pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its trans diagnostic nature positions perfectionism to be an ideal target for early intervention. Self-compassion is a construct gaining prominence over recent years and shown to be an important predictor of wellbeing (Barnard & Curry, 2011) as well as directly targeting the key features of perfectionism (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to treating oneself with care and understanding when facing personal mistakes, shortcomings and failures (Neff, 2003). Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). Self-compassion looks to be a healthy way of targeting perfectionism. This intervention research project examines a self-compassion and CBT based program which is brief (delivered over x4 90 minute modules weekly). We are using a cohort-controlled trial to compare year 7 students who receive the intervention to year 6 students who act as a control group and complete the same outcome measures at the same time, but are not exposed to the intervention. We are interested in the efficacy of the program for mental health, perfectionism, self-compassion and emotion regulation outcomes.

  • A cluster randomised controlled trial of a consumer behaviour intervention to reduce the average energy, saturated fat, sugar and sodium content of the online canteen lunch orders of primary school students: The 'Click & Crunch' Trial.

    The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies such as menu labelling, positioning, feedback, incentives, prompts, and price into an online canteen ordering system in reducing the average energy, saturated fat, sugar and sodium content of student lunch orders. The study will employ a clustered randomised controlled design. NSW primary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed through a nutritional analysis of lunch order purchases recorded by the online ordering system at baseline and 12 months follow-up.

  • A Rapid Diagnosis Discussion (RaDD) tool for reducing misdiagnoses of patients presenting to emergency rooms with abdominal pain

    Errors in diagnosis, including delays and receiving an incorrect diagnosis, have serious consequences for patient safety and patient outcomes. Whilst system factors play a role in diagnostic errors, cognitive biases have been identified as being a significant contributor to diagnostic error. Evidence suggests that to address cognitive bias in diagnostic decision-making, getting a second opinion and asking questions designed to challenge bias may be effective at reducing diagnostic error. The purpose of this project is to address cognitive bias in diagnostic decision-making in Emergency Departments (ED). To do this, an intervention will be trialled which involves performing a second independent review of all abdominal pain cases presenting to Box Hill Hospital Emergency Department, followed by a structured discussion to prompt questions, broaden thinking and challenge assumptions. Following the first clinician’s assessment, an independent review will be conducted by a second clinician in the ED followed by a structured discussion between the first clinician and the second opinion. The second part of this intervention, the structured discussion, will be guided by a standard set of questions. Existing ED practices typically involve repeated ad hoc clinical examination by multiple clinicians, so it is anticipated that patients presenting to the ED with abdominal pain will not notice a change in their care, or find this process burdensome. References Blumenthal-Barby, J., & Krieger, H. (2014). Cognitive biases and heuristics in medical decision making: A critical review using a systematic search strategy. Medical Decision Making, 35(4), 539-557. Croskerry. (2003). The importance of cognitive errors in diagnosis and strategies to minimize them. Academic medicine, 78(8), 775-780. Graber, M. L., Franklin, N., & Gordon, R. (2005). Diagnostic error in internal medicine. Arch Intern Med, 165(13), 1493-1499.

  • Impact of a tailored exercise program on prostate cancer patients treated with androgen deprivation therapy: A pilot interventional study in the Australian regional setting

    This study is assessing the impact of an exercise program on quality of life and physical function in prostate cancer patients being treated with hormone therapy. Who is it for? You may be eligible for this study if you have biopsy proven prostate cancer and are currently on hormone therapy i.e. androgen deprivation therapy. Study details All participants will undertake an exercise program consisting of 3 one-on-one sessions with an exercise physiologist, followed by 14 weeks of group training and home-based exercises. Participants will answer a number of questionnaires, perform a number of physical function tests, and have their body composition assessed using a body composition scan. It is hoped this study will demonstrate the effectiveness of exercise in improving patient quality of life and daily function, particularly in patients from rural/regional settings.

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