ANZCTR search results

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

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31247 results sorted by trial registration date.
  • Estimating prevalence of impaired skin surrounding devices: the EPISODE study

    This observational study will explore the prevalence and risk factors of central venous access device (CVAD) associated skin injury and the types of skin injuries which occur in cancer patients. Who is it for? You may be eligible to join this study if you are aged 16 years or above, are receiving care within a Cancer Care Services inpatient unit, and have a CVAD in place. Study details All participants in this study will have the skin surrounding their CVAD device assessed by a study nurse once per week, or twice per week if there are any signs of skin injury, for the duration of their hospital admission. Nurses will also note any management/treatment received for the CVAD-associated skin injury if present. It is hoped that the results of this study will help researchers to understand the prevalence of CVAD-associated skin injuries, in order to support the development of evidence-based solutions for their prevention and treatment in the future.

  • Cancer Care: The risk factors of venous access failure.

    This observational study will evaluate causes of catheter failure in cancer care patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been admitted to a cancer care service inpatient unit, and have had a peripheral venous catheter (PVC) inserted within 48 hours of admission. Study details All participants in this study will be reviewed by a research nurse second daily throughout their hospital admission. Information will be collected about risk factors, such as antibiotic use, flushing regime, dressing types and catheter types; and catheter related outcomes such as PVC failure, insertion of a Central Venous Access Device (CVAD), adverse events, and hospital length of stay. Participants in the study who experience peripheral catheter failure will be compared against those who did not, to identify the risk factors associated with this failure and how this can be mitigated. Patients who go on to receive Central Venous Access Devices (CVADs) will also be compared to those who do not, in order to explore the decision-making processes that go into transitioning to long-term devices (as well as the outcomes of these decisions e.g. CVAD success or failure).

  • Comparison of behavioural sleep interventions to reduce infant sleep disturbances and improve parental mental health

    The cumulative impact of infant sleep and settling problems is consequential for both the infant and their parents. Options to improve infant sleep disturbance most commonly include behavioural sleep interventions. A large amount of research has focused on extinction based sleep interventions (controlled crying) that are typically centred on ignoring an unwanted behaviour (night time crying) to allow the infant to settle on their own. However, majority of parents find controlled crying unpalatable. Recently, there has been an increased focus on finding alternatives that focus on responding to infant cries rather than ignoring them (cue-based or responsive methods). These methods have not been directly and empirically tested against controlled crying are not systematically available. The aims of this study are to investigate the differences between two forms of infant sleep interventions (controlled crying and responsive methods) compared to a control group, on infant sleep disturbance and parental and infant well-being. These aims will be achieved by providing parents with education on infant sleep based on which intervention group they have been assigned to. After these sessions, parents will undertake this intervention in their own home and complete the outcome measures to determine the success of each intervention.

  • Can N-acetylcysteine (NAC) supplementation enhance altitude training in elite runners?

    Elite athletes regularly incorporate living and training at altitude into their programs to enhance physiological and performance adaptations. It can be logistically difficult and expensive for Australian athletes to gain the benefits of altitude training. Current options available in Australia are limited to relatively low levels of natural altitude or the use of artificial hypoxic environments. Preliminary data suggests that supplementation with the antioxidant n-acetylcysteine (NAC) may boost the erythropoeitic response (i.e. increase red blood cell production) to hypoxia and support the immune system during strenuous training blocks. However, to date, the efficacy of NAC to enhance these physiologic systems has not been determined in an applied sports setting. This investigation, part of a series of studies will be the first to comprehensively examine the acute effects of NAC supplementation to augment the physiological adaptations to hypoxic exposure in elite athletes. It will also contribute to the existing knowledge regarding the ergogenic effect of NAC on repeat sprint cycle performance and add further real-world data to the debate regarding the potential blunting of cellular adaptations with antioxidant supplementation. Importantly, it will also provide valuable information to physiologists, coaches and athletes regarding the prescription and periodisation of NAC supplementation and the optimal integration of hypoxic interventions to produce peak performance during targeted competitions.

  • Can N-acetylcysteine (NAC) supplementation enhance altitude training in elite swimmers?

    Elite swimmers regularly incorporate living and training at altitude into their programs to enhance physiological and performance adaptations. Although altitude training and research has been undertaken previously in swimming the use of a novel dietary supplement to enhance adaptation to altitude training at accessible altitudes would be highly beneficial. Typical training locations in Australia for swimming at altitude typically require additional time and resources to achieve similar physiological adaptations to higher altitudes overseas. Additionally swimming can add an additional hypoxic stressor to altitude training that NAC may help support and hence reduce the risk of illness or overtraining seen when swimmers travel to altitude. Preliminary data suggests that supplementation with the antioxidant nacetylcysteine (NAC) may boost the erythropoeitic response (i.e. increase red blood cell production) to hypoxia and support the immune system during strenuous training blocks. However, to date, the efficacy of NAC to enhance these physiologic systems has not been determined in an applied sports setting. This investigation, part of a series of studies will be the first to comprehensively examine the acute and medium term effects of NAC supplementation to augment the physiological adaptations to hypoxic exposure in elite athletes. It will also contribute to the existing knowledge regarding the ergogenic effect of NAC on performance and add further real world data to the debate regarding the potential blunting of cellular adaptations with antioxidant supplementation. Importantly, it will also provide valuable information to physiologists, coaches and athletes regarding the prescription and periodisation of NAC supplementation and the optimal integration of hypoxic interventions to produce peak performance during targeted competitions in elite swimmers.

  • Can N-acetylcysteine (NAC) supplementation enhance exposure to altitude in well-trained cyclists?

    Athletes regularly incorporate living and training at altitude into their programs to enhance physiological and performance adaptations. It can be logistically difficult and expensive for Australian athletes to gain the benefits of altitude training. Current options available in Australia are limited to relatively low levels of natural altitude or the use of artificial hypoxic environments. Preliminary data suggests that supplementation with the antioxidant n­acetylcysteine (NAC) may boost the erythropoeitic response (i.e. increase red blood cell production) to hypoxia and support the immune system during strenuous training blocks. However, to date, the efficacy of NAC to enhance these physiologic systems has not been determined in an applied sports setting. This investigation forms part of a series of studies will be the first to comprehensively examine the acute effects of NAC supplementation to augment the physiological adaptations to hypoxic exposure in elite athletes. It will also contribute to the existing knowledge regarding the ergogenic effect of NAC on repeat sprint cycle performance in well trained cyclists and add further real-­world data to the debate regarding the potential blunting of cellular adaptations with antioxidant supplementation. Importantly, it will also provide valuable information to physiologists, coaches and athletes regarding the prescription and periodisation of NAC supplementation and the optimal integration of hypoxic interventions to produce peak performance during targeted competitions.

  • The Efficacy of Ajapa Japa Meditation on Symptoms of Anxiety Disorder

    This research proposal makes four hypotheses: 1. The practice of Ajapa Japa meditation will reduce the levels of anxiety symptoms experienced by participants; 2. The practice of Ajapa Japa meditation will improve the quality of sleep experienced by participants; 3. The practice of Ajapa Japa meditation will improve the participants’ quality of life; & 4. The practice of Ajapa Japa will increase the participants’ trait mindfulness.

  • A 3-week diet intervention to improve mood and inflammation in young adults with depressive symptoms

    There has been a rapid global shift in dietary composition, from diets high in complex carbohydrate and fibre, to the Western diet, high in saturated fat, sugar and processed foods. This was highlighted recently by Australia’s largest ever diet survey, the CSIRO Healthy Diet Score, 2016, which showed of 86,611 respondents, only 20% were compliant with Australian Diet Guidelines (Hendrie et al, 2016). Consumption of Western diet has been accompanied by considerable adverse health consequences, with the effects on the brain now increasingly recognised. Unhealthy diet patterns are associated with increased risk of depression e.g. a meta-analysis of 20 observational studies showed healthy diet was associated with reduced odds of depression (Lai et al, 2014). But these studies were carried out in community populations so reverse causality cannot be ruled out. Experimental manipulation of diet is the next step in determining a cause-effect relationship. Given diet is one of the few modifiable risk factors for depression, this would offer a low-cost, low-risk, evidence based therapeutic and preventative strategy. However, treatment studies investigating diet as an effective adjunct treatment for depression are scarce. This study aims to investigate whether a 3-week diet intervention can improve depressed mood in young adults. Eighty four participants will be allocated to receive a diet intervention or maintain their diet as usual. Participants in the diet intervention group will be instructed to increase intake of fish, fruits, vegetables, nuts, seeds, natural diary and wholegrain cereals, and decrease refined carbohydrate, sugar, fatty or processed meats and soft-drinks. Recommendations are based on the Australian Guide to Healthy Eating , personalised feedback from CSIRO diet score, incorporate BeyondBlue behavioural tips for eating well, and administered by a registered dietician face-to-face and on video to re-watch as needed. They will be provided a sample meal plan and recipes. Those in the diet as usual group will be instructed to continue their diet as usual. Participants will attend the laboratory at baseline and after 3 weeks to complete measures of mood, memory, food questionnaires, body measurements, photospectrometry, and a urine sample. If shown to be effective, this type of intervention could provide an adjunct treatment strategy for improving depressed mood in an at risk population - young adults.

  • Evaluating the effectiveness of practicing yoga during haemodialysis for fatigue in patients with end stage kidney disease.

    This study will be a two-group parallel design randomised controlled trial (RCT). The primary aim of this study is to evaluate the effectiveness of practicing yoga during haemodialysis (HD) (i.e. intradialytic yoga) for improving fatigue, physiological and psychological health outcomes in patients with end stage kidney disease (ESKD) receiving treatment in hospital or satellite dialysis facility settings. We hypothesise that patients with ESKD who practice intradialytic yoga for 3 sessions per week over a 12-week period will experience a 23% reduction in symptoms of fatigue by the end of the RCT period compared with usual care alone. We also hypothesise that intradialytic yoga will be associated with: reduced symptoms of post dialysis fatigue; improved quality of life; improved patient engagement in dialysis therapy plans including self care, self-management and adherence; and changes in biochemistry. Data will also be collected on participants’ beliefs about the treatment intervention, the recruitment rate, drop out rate, adherence to the intervention and safety. Participants will be recruited from 2 dialysis facilities in Brisbane Queensland via posters, flyers and site visits by the Chief Investigator. Participation will involve attending an initial intake session during routine dialysis treatment time, followed by being randomly allocated to: 1) intradialytic yoga; or 2) usual care alone. Participants will be asked to provide consent to access confidential data recorded in medical records including medical and renal health history such as blood test results, body weight measurements and routine HD observations such as blood pressure. Participants will also be asked to complete a number of questionnaires and a post dialysis fatigue diary. These will be given at: 1) the start of the study; 2) half way (at 6 weeks); and 3) at the end of the study (week 12). Data collected from medical records and questionnaires will enable the research team to evaluate the effectiveness of the intervention for the needs of ESKD patients. Following the intervention period, participants in the intradialytic yoga group will be invited to participate in an interview to enquire about their experiences of yoga during the study.

  • A Probiotic and Magnesium orotate combination for the treatment of depression.

    The primary purpose is to develop our published pilot work. This study will evaluate the efficacy of a combined supplement combining orotate and probiotics using a placebo controlled randomsied treatment trial for the treatment of depression. The study hypotheses relate to: 1. participants taking the active supplement will have significantly reduced symptom scores compared with the placebo group. (psychiatric assessments). 2. participants taking the active supplement will have reduced dysbiosis and blood inflammatory markers compared with the placebo group. Changes in dysbiosis will be assessed by fecal testing and changes in systemic inflammatory markers will be assessed by by blood tests.

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