ANZCTR search results

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

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33057 results sorted by trial registration date.
  • Preventing Adverse Drug Reactions in Older Australians

    In Australians 65 years and older, 19% of hospital admissions to medical wards are associated with serious side-effects from medications. Almost 90% of these admissions are preventable through safer use of medicines. The research team have developed a novel method of identifying people at risk of these problems. In this study hospital pharmacists will assess the risk of serious side-effects in people admitted to hospital and make recommendations to reduce this risk to hospital staff, general practitioners and pharmacists. We will test whether this strategy reduces the risk of these events compared to standard care in the 12 months following hospital discharge. We hypothesize that ADR risk assessment on admission to hospital and communication of this risk, with recommendations that target the specific risk factors identified, will reduce the incidence of ADRs occurring during admission and in the 12-months post-discharge.

  • Paint the Pain: Investigating the physiological, psychological, and social impacts of a visual art creation on individuals living with chronic pain

    This study aims to investigate the biopsychosocial impacts of visual arts on individuals with chronic pain. Twenty participants on the waiting list of pain management program at Royal Prince Alfred Hospital will be recruited and randomised into intervention and control groups. The intervention group will receive five sessions (3hrs/session) of art observation and reflective art creation at the Art Gallery of NSW. Stress and inflammatory bio-marker (saliva cortisol-level) and several patient reported outcome measures will be recorded before, during and after the intervention. Each art-making session will be followed by a semi-structured group discussion. The discussions will be recorded for further analysis. The control group will continue with their usual medical care. We hypothesise that this research will identify : (a) whether making visual art produces physiological benefits for chronic pain sufferers, and (b) whether art-making is experienced as beneficial by chronic pain sufferers and identify why or why not.

  • GP-led deprescribing in community living older Australians: A pragmatic, mixed methods, exploratory controlled trial

    There is an urgent and growing need to minimise iatrogenic harm from potentially inappropriate polypharmacy (PIP) in ageing populations with multimorbidity. ‘Deprescribing’ aims to minimise PIP. It is the process of clinician-supervised identification and withdrawal (or dose reduction) of medicines where the harms exceed the benefits in the context of an individual patient’s care goals, current function, life expectancy, values and preferences. General practitioners (GPs), with tacit knowledge of, and an ongoing relationship with, their patients, play a central role in coordinating and delivering healthcare to older patients who are prescribed medicines for multiple health conditions. Research suggests that patients are receptive to discontinuing medicines if their general practitioner feels it is appropriate and worthwhile. This study aimed to assess the feasibility, effectiveness and safety of a multi-faceted GP-led intervention to minimise PIP in community-living older Australians. Unlike most other deprescribing studies, this intervention leveraged the existing therapeutic relationship between GPs and their usual patients and used an individually-tailored versus a drug class-specific approach to deprescribing. Recognising the time constraints for GPs in routine care and the potential facilitative role of pharmacists in deprescribing, GPs had the option of referring patients to one of the participating pharmacists for a Home Medicines Review to augment the deprescribing process in this study.

  • An experimental study of the influence of choice (versus no choice) of placebo treatment on reported side effects (nocebo effects) in healthy participants

    This study will use sham placebo treatments, ostensibly a benzodiazepine medicines being tested to assess their effectiveness for experimentally-induced anxiety, to assess the influence of choice of treatment (no choice, choice of 2 treatments, choice of 10 treatments) on the nocebo effect (assessed via self-reported physical symptoms that are described as benzodiazepine side effects). To assess the development and magnitude of the nocebo effect, placebo-treated participants will be compared to a no treatment control condition. It is hypothesised that a nocebo effect will be seen across the three groups of placebo-treated participants. It is also hypothesised that, compared to the no choice group, the 2 choice group will report lower physical symptoms scores, and the 10 choice group will report higher or at least equivalent physical symptoms scores.

  • GoodForm: An intervention to enhance body image and prevent doping and supplement use in adolescent boys

    The overall aim for this project is to conduct a randomised controlled trial to examine the efficacy of GoodForm, an education program that aims to reduce body dissatisfaction, appearance and performance enhancing substance [APES] use, and lenient attitudes towards doping in sport) in 600 boys aged 14-5. This program will run within the Health and Physical Education curriculum. Boys have typically been overlooked in body image research, and there are no effective intervention programs for boys. There is evidence that body image, the use of supplements, and attitudes towards doping in sport are interrelated and contribute to anabolic steroid use in adolescent boys. The theoretical frameworks underpinning body image and intentions to use supplements are very different for boys and girls. We will focus only on boys in order to confirm approaches that can be used to target these behaviours in a single sex setting to fill this gap in the literature. In this research, we will ask teachers of grade 9 and 10 boys to implement GoodForm, the 4 session program that we have developed. We will measure body image, use and intentions to use APES, and attitudes towards doping in sport before and after boys receive the program to determine impact. This is the first trial of an antidoping program that targets the behaviours that might lead to boys using muscle-building supplements in the world.

  • Lifestyle Intervention: Pilot Study for people with schizophrenia treated with either clozapine or another antipsychotic medication

    Most people who have schizophrenia and are treated with either clozapine or another antipsychotic medication, are at increased risk of getting metabolic syndrome and cardiovascular disease. The research study is looking at whether a simple change in lifestyle including engaging in regular physical activity and modifying diet can help to improve the quality of physical and mental health of people with schizophrenia.

  • What is the impact of dousing water on the skin on the rate of dehydration during a simulated heatwave?

    In an extreme heat context, dehydration has been demonstrated to increase cardiovascular strain and exacerbate core temperature rises. Naturally then, when heatwaves strike in areas where access to clean drinking water is limited, human health suffers. Although clean drinking water is often in short supply in these areas, there may be plentiful access to water that is not safe to consume, but can be doused on the skin, taking the place of sweat. We therefore wish to investigate whether dousing of water on the skin may slow an individual’s rate of dehydration, thereby reducing the amount of fluid they must consume to offset any hydration related exacerbations of physiological strain. To achieve this, we will compare resultant dehydration, as well as thermal and cardiovascular outcomes during a four hour passive heatwave exposure (45°C/ 15% relative humidity) during three different interventions: 1. Full fluid replacement, sham dousing (FFR-S) (comparator) 2. Quarter fluid replacement, sham dousing (QFR-S) 3. Quarter fluid replacement, optimal dousing (QFR-F) Participants will complete only one exposure each, and will fit into one of three age brackets: 1. 18-40 years 2. 45-55 years 3. 65 + years The research hypotheses going into this study are: 1. Resultant dehydration will be less in QFR-F than in QFR-S. 2. Heat related thermal and cardiovascular strain will be least inn FFR-S, followed by QFR-F and greatest in QFR-S. 3. During FFR-S and QFR-S the 65+ years age group will have a greater change in core temperature than the 45-55 years age group who will have a greater change in core temperature than the 18-40 years age group. During QFR-F all age groups will have similar changes in core temperature.

  • Exploring the effect of Continuous Positive Airway Pressure (CPAP) treatment withdrawal on markers of brain health and memory and thinking skills

    This feasibility study aims to explore whether the withdrawal of Continuous Positive Airway Pressure (CPAP) therapy affects markers of brain health (such as oxidative stress) and/or memory over a 14-day period. The study will also identify the time point at which CPAP withdrawal has the greatest effect on markers of brain health to facilitate planning for a larger randomized controlled trial. We hypothesize that CPAP withdrawal will result in an increase in oxidative stress in treatment compliant OSA patients. Furthermore, we also hypothesize that increases in oxidative stress will be negatively associated with sleep dependent memory consolidation and greater affective symptom severity over time.

  • Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer

    The purpose of this study is to determine the effect of androgen deprivation therapy, a treatment commonly prescribed in prostate cancer patients, on the effectiveness of medical imaging techniques. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic prostate cancer. Study details: Participants are required to undergo 2 PSMA Scans, the 1st within 28days prior to starting treatment with the medication enzalutamide and the 2nd 14 days after starting enzalutamide. Participants will be required to undergo a physical exam with the Dr which will include a blood test to assess kidney function. The outcome of this study will have important implications for the diagnostic and therapeutic management of metastatic prostate cancer.

  • Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.

    This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in healthy, lean males. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in healthy lean males.

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