ANZCTR search results

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

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31102 results sorted by trial registration date.
  • Assessing the role of conjunctival and lid margin sensitivity has in ocular discomfort

    The research study aims to investigate the sensitivity of the eyelid margin and the conjunctiva (a thin layer on the white part of your eye) using an instrument called the Liquid Jet aesthesiometer, which uses small drops of saline to stimulate your eye. Participants will be invited to take part in this study to help us better understand what the role the conjunctiva and lid margin have in eye discomfort, and to analyse the repeatability of this new instrument.

  • Evaluation of the effect of tailored frailty interventions aimed at addressing frailty in older people: Frailty in Older people, Rehabilitation Treatment, Research Examining Separate Settings - The FORTRESS study.

    FORTRESS is a three-year research study which will take a validated frailty screening tool and an evidence-based intervention for frailty, and operationalise them together in the acute hospital setting, with follow up in the community and general practice setting in partnership with the local Primary Health Networks. It will use a randomised stepped wedge design to measure the effectiveness over 12 months of the frailty intervention on hospital readmissions (primary outcome), frailty status, and quality of life. A hybrid type III trial approach will allow us to test the implementation strategy (Implementation Facilitation) at the same time as observing the outcomes of the intervention (screening for frailty and use of appropriate interventions). Participants (n=732) will be people aged 75 years and over admitted to six acute wards in two hospitals, one in Northern Sydney and one in Southern Adelaide. It will use the FRAIL Scale as a screening tool, and the Asia Pacific Clinical Practice Guidelines for the Management of Frailty to direct the interventions. Cost-effectiveness of the intervention will also be measured. This research study aligns with Objectives 4 and 5 of the NHMRC Initiative Frailty in Hospital Care: Complex Health Care requirements. It addresses the impact of the frailty intervention on older people presenting to hospital with an acute illness, accident or trauma, and how integrated and coordinated in-hospital and post-hospital interventions can support frail older people to achieve the best possible health recovery outcomes.

  • Comparison of patient pain levels between total knee replacement recipients who undergo kneecap resurfacing and those who don't.

    This will be a randomised prospective study aiming to evaluate and compare patient reported outcome measures (PROMs) in patients who have their patella resurfaced during Total Knee Arthroplasty (TKA) and those who don’t. Patients will be randomised by computer generated block randomisation to receive patella resurfacing or not to receive patella resurfacing. The four surgeons performing the arthroplasty procedure are experienced in both interventions.Patients will be blinded to the intervention. We hypothesis that there will be no statistically significant difference between patients who undergo patella resurfacing during a SAIPHTM knee replacement and those who do not undergo resurfacing.

  • Effects of sports-hydration drinks on hydration and exercise performance while cycling in the heat

    High amylose resistant starch hydration solutions have been found to improve hydration in clinical populations suffering from dehydrating conditions, such as cholera. The high amylose resistant starch solution is now the preferred oral rehydration therapy used by the World Health Organisation in developing countries. Due to its' hydrating properties, it has been suggested that this formulation may be of benefit to athletes. Unlike other oral sports oral rehydration solutions, the new high amylose resistant starch solution is consumed in 6-8 hours prior to exercise participation. This solution promotes water absorption in the large intestine by creating short chain fatty acids which are the product of the fermentation of resistant starches. Therefore, The aim of this study is to assess the effects of a high amylose resistant starch sports-hydration solution on hydration status and exercise performance in a hot and humid environment. We will do this by having participants cycle in a hot and humid environment for two hours at a power output of equal to 50% of maximal oxygen uptake before completing an all out 10-minute time trial.

  • Functional imaging-guided radiotherapy dose escalation in rectal adenocarcinoma: a feasibility study

    The aim of this study to assess the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer. Who is it for? Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent neoadjuvant radiotherapy (+/- chemotherapy) may be eligible for this study. Study details Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of treatment prior to the usual 5-6 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment. A key part of the study is also to assess any treatment-related toxicity and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects. It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment given with concurrent chemotherapy and therefore reduce the need for surgery for patients.

  • Evaluating the influence of Yoga, Cognitive Behaviour Therapy and Standard Care on Quality of Life and Healthcare Costs in Endometriosis

    Afflicting more people than breast and prostate cancer, diabetes, and AIDS combined, endometriosis is a highly burdensome disease costing Australians more than $7.7 billion. In addition to pain, common symptoms include fatigue, anxiety and depression, and reduced quality of life (QoL). Poor psychological prognosis has led to urgent calls for treatments that address mental health to prevent further degradations in QoL. We will evaluate the efficacy and cost effectiveness of 1) yoga, and 2) cognitive behaviour therapy (CBT), compared to 3) standard care receiving patient education. Our systematic review identified that yoga and CBT hold promise in improving pain and mental health in endometriosis. Yoga is likely to improve wellbeing via the benefits of movement, and relaxation through breath regulation and meditation, potentially benefiting inflammation, stress, pain, and emotion regulation. CBT is purported to improve QoL by correcting maladaptive thoughts, developing self-efficacy and coping, and increasing engagement in life tasks. However, thus far only pilot studies exist. We propose a step change in our understanding of the potential impact of yoga and CBT by undertaking a full-scale randomised controlled trial using gold-standard methodology. We will provide high quality evidence for CBT and yoga and their impact on endometriosis.

  • Assessing the Impact of Episodic Future Thinking Training for Adults with Clinical Depression.

    Depression is the leading cause of disability worldwide; however, the effect of current front-line treatments for depression is only modest. One reason for these modest outcomes is that knowledge of the cognitive mechanisms maintaining disorders are not well known. One cognitive process recently shown to be impaired in depression is future thinking. Future thinking involves generating mental representations of events that one might be personally involved in, and is crucial to healthy functioning. For example, imagining future thinking is involved in decision-making, setting goals, planning actions, problem-solving, and regulating emotions. The aim of the current study is to evaluate a future thinking training program in a sample of clinically-depressed individuals (aged 18-65), and examine its effects on future thinking and related cognitive, emotional and behavioural variables. This project will provide new insights into ways of targeting specific cognitive vulnerabilities in depression. This will be an online randomized, controlled trial with two arms: 1) future thinking training, and 2) wait-list control. Participants will complete all outcome measures at baseline, then 1 month and 3 month follow-up time-points. It is hypothesised that: • The future thinking training group will report significantly higher future thinking characteristics of specificity, detail and imagery post-intervention, and at 1 and 3 month follow-ups, relative to a usual care group. • The future thinking training group will report significantly higher anticipated and anticipatory pleasure. • Changes in future thinking characteristics between baseline and post-intervention will predict changes on anticipated and anticipatory pleasure between post-intervention and 3 month follow-up.

  • The Mind Your Mate Study: A randomised controlled trial of an online peer intervention to prevent mental health and substance use problems in adolescents

    Anxiety, mood and substance use disorders have significant social and economic impacts, largely attributable to their early age of onset and chronic disabling course. It is therefore critical to intervene early to prevent these chronic and debilitating trajectories. This project is a world-first effectiveness trial of an online peer intervention (Mind Your Mate) to prevent mental health (focusing on anxiety and depression) and substance use problems in adolescence. It is hypothesised that compared to students in the control condition, those allocated to receive the peer intervention will show significantly lower symptoms of anxiety, depression and substance use, and an increased willingness to seek help for these problems. The online peer intervention includes one introductory classroom lesson, plus a downloadable mobile application (app) that will be used for the duration of 12 months. A CONSORT compliant randomised controlled trial (RCT) of the peer intervention will be conducted with all students in Year 9 in 14 NSW high-schools, with approximately 1,400 students (n=100 students per grade, per school). Schools will be randomly allocated to receive; 1) the online peer intervention, or 2) waitlist control (health education as usual). Students will be followed-up for one year, with assessments at baseline, and 6- and 12-months.

  • Uvulopalatopharyngolasty: does the specific surgical technique improve post-operative apnoea hypoxia index?

    Aims: This is a prospective cohort study with a primary aim to determine whether Mr Fogarty’s UPPP technique results in improved post-operative AHIs. Secondary aims include analysis of participants’ pre- and post-operative experience of sleep disordered breathing, Research activities: The research participants will be asked to undergo both pre-operative and three months post-operative sleep studies through the Albury Wodonga Private Hospital. Patients will also be asked to complete the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire (FOSQ-10) both pre-operatively and at three months post-operatively. No other participant follow-up will be required beyond the usual surgical post-operative practice.

  • Does The Visual Appearance Of The Tendon Effect Pain and Function During Hopping In People With Achilles Tendinopathy (AT)?

    The perception of health of the body and the estimation of the capacity of the body is informed by visual information from the body. It has been shown that creating the visual illusion of a muscled and fit looking back increased the participants feeling of strength and confidence in the back. This seems to also affect the pain experience. Pain during a lifting task was dramatically less when viewing an embodied image of a strong back than when viewing a normal image of the back .We have demonstrated a similar phenomenon with exercise induced muscle pain. Participants rated their pain as greater when viewing a magnified image of the thigh during contraction of the injured thigh muscles compared with viewing the thigh normally. We interpreted this as the magnified image suggesting a more swollen and therefore more injured muscle. We wish to see if other visual information than suggests a more sensitised structure similarly influences pain intensity without the confounding effect of visual distortion, particularly in clinical pain. Other researchers have shown that changing the colour of the body part changed sensitivity in an experimental pain model. Making the body part appear red, suggesting inflamed tissue, increased sensitivity whereas making the part appear blue had no effect on sensitivity. We hope to explore this phenomenon to see if, and to what extent, it exists in AT, and to simultaneously investigate the effect of this type of visual information on tendon function – something which no study of visually manipulation has done before. The aim of this study is therefore to examine the effect of augmented visualisation on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they view a video image of their leg under normal conditions and compare these results with an augmented vision condition in which the tendon is painted red. To control for the confounding effect of a change in tendon colour we will have an additional control condition in which the tendon is painted blue.

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