ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Caring for HEalthy Engaged Resilient staff: A wellness training program for emergency department nurses

    Stress is very common in nursing and has a number of adverse consequences. The aim of this study is to pilot the feasibility of a brief workplace wellness intervention to emphasize the development of behaviours to strengthen the physical and mental health of emergency nurses. In this randomised controlled trial participants will be allocated to either control or intervention. The intervention group will receive a 5 week series of 1 hour classes guided by a Clinical Psychologist which teaches strategies to enhance resilience. Participants will be surveyed prior to starting the program, at the completion of the program and again 3 months later to assess the effect of the intervention on stress, professional quality of life, workplace engagement and resilience.

  • The objective Behavioural Assessment of Breaks in SITting and risk of developing gestational diabetes during pregnancy - the BABy-SIT in pregnancy study

    The prevalence of gestation diabetes mellitus (GDM) is increasing worldwide, with current Australian prevalence rates estimated to be between 13-16%. Little is known about how to prevent GDM in high risk individuals. Strategies to date have largely focused on structured exercise programs. However, the results from these trials have shown little success possibly due to low adherence rates. Recently, studies suggest that sedentary behaviour during pregnancy is associated with increased risk for abnormal glucose tolerance, gestational diabetes and preeclampsia. This suggests that strategies that target a reduction in sedentary time could be an additional, or alternative approach to GDM prevention. However, before such interventions are developed, it is important to investigate the associations of objectively measured sedentary time and sleep patterns on blood glucose and GDM risk. This study aims to examine various descriptors of sedentary behaviour (total sedentary time, prolonged sedentary bouts, number of breaks in sitting) which will help to inform the design of early targeted sedentary behaviour interventions to reduce GDM incidence. Hypothesis: We hypothesise that measurement of sedentary time in pregnant women at 18-28 weeks gestation will be associated with higher fasting and post-challenge glucose levels during the screening test for GDM

  • Effect of Adenomyosis on In Vitro Fertilisation - Embryo Transfer (IVF-ET) outcomes.

    Adenomyosis is a condition characterised by the presence of endometrial lining/glands and stroma in the muscle wall of the uterus with surrounding swelling. Typically patients present clinically with a combination of abnormal uterine bleeding, secondary period pain and a tender enlarged uterus in the fourth and fifth decades of life. Infertility is a less common presentation, however as many women are delaying having children into their late thirties and fourties, adenomyosis is increasingly encountered during the clinical work up of infertile women. A definitive link between adenomyosis and infertility has not been established, however several studies have demonstrated a strong association between the two. A recent study looking at uterine wall thickness found that in vitro fertilisation and embryo transfer (IVF-ET) outcomes decreased with increasing uterine wall thickness and findings suggestive of adenomyosis, however two small trials of IVF-ET in patients with adenomyosis found no difference in pregnancy outcomes compared to matched cases. , There is therefore limited and conflicting evidence for the effectiveness of IVF-ET in patients with adenomyosis. The aim of this trial is to evaluate the outcomes of IVF-ET (InVitro Fertilisation - Embryo Transfer) in patients with an ultrasound diagnosis of adenomyosis. The primary hypotheses are that: 1. IVF-ET success rates (clinical pregnancy & live-births) will be different in women with adenomyosis compared to those without adenomyosis based on ultrasound. 2. That the above finding will be true regardless of whether adenomyosis is the only cause or one of multiple causes of infertility in the female. The secondary hypotheses are that: 1. The presence of adenomyosis will be associated with altered 1a. Implantation rates. 1b. Miscarriage rates per clinical pregnancy. 1c. Ectopic pregnancy rates per clinical pregnancy.

  • A randomised controlled trial of the effects of dietary prebiotic foods and probiotic supplements on adult mental health and cognition: The "Gut Feelings" trial

    Objective: To determine whether 8-week administration of dietary prebiotic foods and/or probiotic supplements reduces symptoms of psychological distress in non-clinical adults with low mood and poor diet quality, relative to placebo. Secondary aims are to measure the relationship between treatment response and changes in cognition, well-being, health-related quality of life, sleep, and bowel health, and to determine whether treatment response is mediated by changes in gut microbiota. Hypotheses: It is hypothesised that both probiotic and prebiotic treatments will be superior to placebo, while the synbiotic treatment will potentially be superior to all others, in the reduction of psychological distress. It is also predicted that this pattern will remain consistent for measures of cognition, well-being, quality of life, bowel health and sleep. Finally, we hypothesise that treatment response will be mediated by changes in gut microbiota (showing lower levels of psychological distress versus higher levels of psychological distress in placebo). Design: An 8-week randomised controlled trial comparing the efficacy of a probiotic supplement versus a high-prebiotic diet versus a synbiotic treatment (probiotic + high-prebiotic diet) versus placebo in 128 healthy adults with poor mood and low dietary quality. The probiotic supplementation component will be double-blinded. Participants are community-dwelling adults aged 18-65 years who meet eligibility requirements for poor mood and low dietary quality.

  • The Vitamin C after Cardiac Surgery Study

    Patients after cardiac surgery often develop a low blood pressure because of the inflammation associated with surgery and bypass. This low blood pressure is mostly due to the small blood vessels losing their normal tightness. This condition is called “vasoplegia”. When vasoplegia occurs after cardiac surgery, it can lower the blood pressure to dangerous levels, which can lead to organ malfunction and may even be life-threatening. In order to maintain safety under such a situation, intensive care doctors administer drugs that tighten blood vessels. These drugs are called vasopressors. Such vasopressors can restore safe levels of blood pressure. However, they have significant side effects. Thus, it would be desirable to restore a safe blood pressure without the use of such vasopressor drugs. Over the last few years, evidence has emerged that high dose vitamin C injected into the blood stream can restore the normal tightness of blood vessels and is free of side effects. This makes treatment with vitamin C potentially desirable in cardiac surgery patients with vasoplegia. However, no studies have assessed whether vitamin C at high dose is effective in this setting. Thus, we propose to conduct a pilot study to test whether vitamin C at high dose can improve blood pressure and decrease the need for vasopressor drugs in patients with vasoplegia after cardiac surgery.

  • A Dementia Risk Reduction Study for People Experiencing Cognitive Problems in Day to Day Life

    The Body, Brain, Life Program for Mild Cognitive Impairment (BBL-MCI) is an online lifestyle modification program for people with Mild Cognitive Impairment (MCI) and subjective cognitive decline (SCD). MCI is a condition in which there are cognitive deficits in memory and other areas of thought, but these deficits are not sufficient to meet the criteria of a dementia diagnosis. SCD is condition where people are aware of and are concerned about minor cognitive deficits in day to day life, most often memory. People with MCI and SCD are at increased risk of dementia and there is some overlap in these groups, both are being included in this project. The aim of the study is to reduce dementia risk in these high risk groups and prevent further cognitive decline. The project will involve 4 online informational modules and 3 practical components. The online modules will be comprised of: A module on dementia literacy and risk factors; physical activity; diet and cognitive engagement. The practical components will enable participants to integrate physical activity, diet and cognitive engagement into their everyday lives. There are two research aims in this project: (i) Evaluate the effectiveness of BBL-MCI in the prevention of cognitive decline in individuals with MCI/SCD (ii) Evaluate the effectiveness of BBL-MCI to reduce overall risk for Alzheimer's disease and dementia as measured on the ANU-ADRI.

  • Shifting the Risk Study (Investigating meal timing and heart health in shift workers)

    Shift workers face a 40% higher risk of heart disease and type-2 diabetes compared to day workers. Night shift workers are likely to change their sleeping and eating patterns to suit their work schedule. Therefore, the purpose of this study is to look at the effects of changing meal times at night on the heart health of shift workers. Briefly, the study involves two periods: 1) where participants are asked to avoid eating during a specified time period of the night and 2) where participants are asked to maintain their usual eating habits. We will then test to see the difference in participants’ blood fats, sugars, and other cardiovascular risk markers between these two periods.

  • The impact of mindfulness versus attention training on pain outcomes: What moderates the efficacy?

    This study will compare two brief interventions to see whether attention training or a mindfulness-based task is more efficacious in improving pain outcomes in healthy control participants.

  • Triple therapy for new onset Type 2 Diabetes Mellitus (T2DM)

    In the majority of people with newly-diagnosed type 2 diabetes, the standard medical treatment starts with metformin, followed by the addition of other medications if blood glucose levels remain elevated. The purpose of this study is to evaluate the possible risks and the effectiveness of using three different tablets together to normalise blood glucose levels in adults with newly-diagnosed type 2 diabetes, compared with starting treatment with one tablet, and adding the other two tablets sequentially if blood glucose levels remain above normal. All of the tablets are already available for the treatment of type 2 diabetes, but the use of all 3 together in newly diagnosed diabetes has not been studied. Participants will be randomly assigned by a computer to receive treatment with metformin, saxagliptin and dapagliflozin together at the onset of the study, or to commence treatment with metformin, and add saxagliptin and dapagliflozin sequentially if their blood glucose levels remain above normal. Approximately 20 volunteers will be recruited to participate in the study. Participants’ involvement in the study will last 12 months, and include 5 study visits at the research site. Participants will have an initial medical assessment, and receive information about blood glucose self-monitoring, diet and lifestyle habits. They will then be randomly assigned to receive metformin 2000mg daily, saxagliptin 5mg daily and dapagliflozin 10mg daily either concurrently, or sequentially over 12 months. Participants will visit the research site every 4 months during the treatment period for monitoring. During these visits, participants will be weighed, have their blood pressure checked and blood glucose readings reviewed, and have a fasting blood and a urine test. At the beginning and end of the 12 month treatment period, participants will be also be asked to undergo testing of their blood glucose levels in response to a meal. Once all participants have completed the study, the study results will be analysed and released.

  • Personalised pelvic floor Muscle Training for Urinary incontinence after Prostatectomy

    The aim of this study is to evaluate efficacy of a personalised pelvic floor muscle training program on urinary incontinence after radical prostatectomy. Who is it for? Individuals may be eligible to join this study if you aged 30-70 years and are scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Study details Study participants will be allocated by chance to one of the three groups, Urethral muscle training, Conventional training or No training. Urethral muscle training will involve an individualised program of pelvic floor muscle training that relies on the principles of motor skill training of the striated muscles that control urethral pressure with ultrasound imaging used for assessment and biofeedback. Participants in both treatment groups will attend up to 10 sessions of pelvic floor muscle training supervised by a physiotherapist, and participants in the No treatment group will not receive treatment. Participants in the treatment groups will attend a session 1-2 weeks prior to surgery and will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). This study will provide new insight into whether individualised pelvic floor muscle training is more effective than current treatments or no treatment for management of post-prostatectomy incontinence.

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