ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Fast-track cardiac anaesthesia for coronary artery bypass graft surgery.

    The purpose of this study is to identify whether fast track cardiac anaesthesia is superior to usual care anaesthesia for patients undergoing primary coronary artery bypass grafting surgery. Who is it for? The study will include adult patients undergoing coronary artery bypass grafting surgery. This is a retrospective analysis of patients who underwent primary coronary artery bypass grafting (CABG) surgery via midline sternotomy who were managed by a fast-track protocol (fast-track group) or via usual care (usual care group). Fast track cardiac anaesthesia is a program using methadone with non-opioid adjuvant infusions (magnesium, ketamine, lidocaine, and dexmedetomidine) in patients undergoing CABG. Study details This study will evaluate the total mechanical ventilation time in hours adjusted for the hospital, body mass index, category of surgical urgency, cardiopulmonary bypass (CPB), and European System for Cardiac Operative Risk Evaluation (EuroSCORE II). We will evaluated other outcomes such as time taken to tracheal extubation, pain within the first 24 and 48 hours postoperatively, and postoperative opioid requirements within the first 24 and 48 postoperative hours. We will evaluate postoperative complications. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of fast track surgery in patients undergoing primary coronary artery bypass grafting surgery.

  • Feasibility of push notifications in the management of heart failure: a randomised pilot trial (NOTIFY-HF)

    This trial will utilise information from Boston Scientific Cardiac Implantable electronic Devices remote monitoring and Heart Logic Algorithm and the NOTIFY-HF smart phone web-application to assist in the early identification of fluid overload. Evidence shows that heart failure decompensation events begin 4-6 weeks before the development of symptoms such as breathlessness or fluid retention. The aim of this research project is to use this information obtained from your device via remote monitoring to provide feedback via push notifications to participants on their heart failure status. The app, NOTIFY-HF, will provide a weekly update in an easy-to-understand manner with the hope of instigating behavioural changes that result in improvements in heart failure management. The central hypothesis of the study is that push notifications guided by HeartLogic data will promote behavioural change that leads to improvements in heart failure.

  • Chronic pain following paediatric tonsillectomy

    Prospective questionnaire following paediatric tonsillectomy at 3 and 12 weeks determining presence, impact and risk factors of pain following paediatric tonsillectomy.

  • Proof of concept study of RECCE®327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs)

    This is a Phase I/II proof-of-concept study of RECCE®327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs). It is designed to establish effect size, patient tolerability and ease of use of a topical application in an ambulatory sample of patients. The study has been designed to provide proof of concept regarding the effect and tolerability of the study drug. We hypothesise that this will provide pilot data to guide sample size for future trials in the same patient group using the same assessment tools.

  • Does the addition of high-intensity single muscle group training improve exercise training efficiency in heart failure?

    Background: Skeletal muscle alterations significantly contribute to exercise intolerance in heart failure (HF). Small muscle mass training, localised to the quadriceps femoris muscle group, has been proposed as an intervention to target these HF-related changes. The application of this training paradigm in HF is supported by a recent literature review that found improvements in whole-body exercise capacity, quadriceps muscle strength and health-related quality of life (QoL) in those with reduced ejection fraction. Since this training involves only one muscle group, it places a lower demand on the central circulation than whole-body exercise, thereby permitting a near-maximal intensity protocol. Hence, this proposed study will evaluate high-intensity small muscle mass training (HISMT) isolated to the knee extensor muscles in a conventional clinical context, with the aim to determine the additive effects of integrating HISMT within a standard HF rehabilitation program. Methods: This randomised, controlled, single-blind trial will aim to recruit 70 clinically stable participants aged 18 years and over with a HF diagnosis and New York Heart Association class I to III. Participants will be randomly allocated to either: (i) standard training (ST) alone: combination of upper and lower extremity cardiovascular and resistance-based exercises; or (ii) HISMT plus modified ST: bilateral, isolated knee extensor HISMT in addition to a modified version of the ST, so that the total volume of work will be similar to ST alone. The training interventions will be conducted twice weekly for 12 weeks in an outpatient setting. Outcome measurements will be performed at baseline and following the 12-week intervention period. The primary outcome measure will be exercise capacity (six-minute walk test), with secondary measures being physical performance (timed up and go test and 30-second sit-to-stand test), muscle strength (quadriceps maximal voluntary isometric contraction, knee extensor five-repetition maximum and hand grip strength), and health-related QoL (Kansas City Cardiomyopathy Questionnaire). Discussion: This study will assess whether there are greater improvements with incorporating knee extensor HISMT within a traditional HF rehabilitation program. It is hypothesised that the addition of HISMT will confer superior outcomes. In addition to extending current knowledge relating to small muscle mass training, the study will provide a unique perspective on the effects of HISMT within routine clinical practice, thus enabling the optimisation of exercise prescription for the HF patient population.

  • Chest x-ray versus low dose high resolution computed tomography in screening Queensland workers for occupational dust lung disease.

    This study is a comparative study investigating how ILO chest x-ray compares to low dose high resolution computed tomography (LD HRCT) for early diagnosis of occupational lung disease. As part of this study participants will be asked to undergo a LD HRCT scan, which is new technology using very low levels of radiation. HRCT scans are better at diagnosing early stage of occupational lung diseases than chest radiography. This study will answer the question about whether the low radiation dose HRCT scan used in this study picks up more early stage lung diseases such as black lung, emphysema and silicosis. No Australian evidence has been collected to demonstrate the use the use of LD HRCT in the screening of occupational lung diseases.

  • The MAGPIE Study: Multi-cancer genomic risk assessment to target screening in general practice

    The MAGPIE Study: What is the purpose of this research? This research aims to transform early detection of Australia’s four most common cancers (colorectal, breast, prostate, melanoma) by identifying those at risk more accurately and encouraging all Australians to do the right cancer screening tests for their personal risk. We can do this by offering in general practices a new genomic test that predicts future risk of cancer. This risk information will be used to tailor screening recommendations, then to have a discussion to encourage the right decisions about screening for each patient. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 59 years who have not previously been diagnosed with bowel, breast, prostate cancer or malignant melanoma. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of multi-cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self-collected saliva swab. After 2-3 weeks the participant will meet with the researcher at the GP practice or by method of telehealth appointment to discuss the DNA test results. They will be given a report summarising their multi-cancer risk and screening recommendations to be discussed with their GP. Follow up questionnaires will be sent to all participants at 1, 2 and 6 months after recruitment. It is hoped that this study will determine whether providing participants with their personalised cancer risk factors has a positive impact upon their willingness to undergo cancer screening procedures. If this study does show a positive effect, it will facilitate provision of DNA testing for cancer risk in general practice and therefore personalised population cancer screening for all Australians.

  • Preparing, Planning and Prehab for Stem Cell Transplant: A Multidisciplinary Approach

    This study aims to develop and test a multidisciplinary prehabilitation (prehab) program for patients with acute myeloid leukaemia and myelodysplastic syndromes who are being offered an allogeneic haematopoietic cell transplantation (allo-HSCT) at the Royal Adelaide Hospital (RAH). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), you are being treated at the RAH and you have been offered a stem cell transplant (allo-HSCT) procedure as a treatment. Study details All participants who choose to enrol in this study will be given access to the specially designed prehab program. The program will commence immediately after completion of chemotherapy and prior to the scheduled stem cell transplantation procedure. The program will involve multiple areas, including diet and nutrition guidance, a supervised twice-weekly exercise program, advice from a social worker, an educational and occupational therapy needs assessment session, and a session with a psychologist. These sessions will be delivered over an 8-week period and participants will continue to receive their treatment as usual from allied health staff both before, during and after consenting to partake in this project. Participants may be referred to social work, physiotherapy, occupational therapy, exercise physiology, cancer psychology or other available allied health services at any point following their cancer diagnosis depending on their needs. It is hoped this research will demonstrate that the prehabilitation program is feasible and has a positive effect on participants physical and mental wellbeing. If the program is feasible, this study will provide key findings to inform a future large scale randomised controlled trial, and provide information required to underpin ongoing prehab for allo-HSCT patients. This innovative model of multi-disciplinary prehab has strong potential to be adapted for other patient populations across the cancer program at the RAH.

  • Verifying if aerobic training protocols benefit the heart in subacute stroke

    The benefits of aerobic exercise for people with stroke are well established, and worldwide clinical practice guidelines recommend aerobic exercise training across all phases of stroke recovery. But aerobic exercise is not routinely prescribed by therapists, and when it is prescribed, it is often at sub-optimal levels that does little to improve the fitness of people with stroke. For many, it is their aerobic deconditioning that limits their walking ability and engagement in physical activity more so than their neuromotor impairment. This is a significant problem. Walking is not only fundamental for physical independence but is so important for health that it has been called the 6th vital sign. Aerobic exercise at sufficient intensity to challenge the neuromotor and cardiopulmonary systems can improve walking endurance and enhance cardiovascular health post-stroke. Most randomized controlled trials (RCTs) of aerobic exercise post-stroke have employed moderate intensity continuous training (MICT, i.e., 40-60% heart rate reserve [HRR]) to good effect. This is why MICT is recommended in national and international guidelines. There is, however, emerging evidence that more vigorous aerobic exercise training (i.e., >60% HRR) can improve walking and enhance stroke recovery, but sustaining such higher intensities of exercise can be difficult. High intensity interval training (HIIT), which involves short bursts of vigorous aerobic exercise (i.e., >60% HRR) alternated with active or passive recovery periods, may be a feasible approach to eliciting the benefits of vigorous aerobic exercise training in a manner acceptable to patients and providers. Since females are less likely to achieve independence after rehabilitation and are less likely to be discharged home, there could also be sex and gender differences when testing such an approach. In this pilot RCT to be administered at Epworth HealthCare, we will: 1) Examine data on safety, feasibility, and acceptability to plan for an international trial. 2) Evaluate the effects of 10 weeks of HIIT or MICT on walking speed, cardiorespiratory fitness and quality of life during the subacute phase of stroke recovery. 3) Evaluate sex differences on stroke outcomes.

  • Effects of quinine, alone and combined with dietary nutrients, on gut function and blood glucose in healthy volunteers

    The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter agonist, quinine on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions in healthy individuals, We have found in one of our recent studies that quinine, given as a bolus in doses of 300 or 600 mg (in 10 ml water), potently slowed gastric emptying and lowered postprandial blood glucose. Moreover, we observed more potent blood glucose lowering effects when quinine was administered intraduodenally than intragastrically, suggesting that interaction of quinine with small intestinal receptors is required for potent effects. Therefore, based on these findings, this study aims to characterise the dose-related effects of intraduodenal quinine at these doses, on energy intake.

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