ANZCTR search results

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

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31071 results sorted by trial registration date.
  • Sodium-glucose co-transporter 2 inhibition prior to atrial fibrillation ablation: A pilot randomised controlled trial

    Atrial fibrillation (AF) is common, and makes people often feel symptoms, or have complications such as stroke. Doctors have many options for AF treatment, but these all have drawbacks. Tablets for AF often have side effects, and AF ablation is the most effective option we have, but unfortunately comes with risks of major complications. Researchers have therefore been looking for other options. SGLT2 inhibitors are medications, which are used to treat diabetes. Unexpectedly, this drug class was shown in a trial of 17,160 patients with heart failure, to reduce the rates of AF. This class of medication was developed as a diabetes medication, working on the kidney to increase the amount of sugar that the body gets rid of into the urine, and therefore lowering the sugar levels in the body. These medications have also been shown to reduce cardiovascular death, reduce heart failure and reduce renal failure. Researchers and doctors don’t exactly understand all the different ways that these medications lead to benefits, in particular how they reduce AF. There may be many different pathways in the body that impact the way that cells work. This project is to try and examine if dapagliflozin (an SGLT2 inhibitor) changes the electrical properties of the heart, to try and explain the reduction in AF that has been shown in trials.

  • Sodium-Glucose Co-Transporter 2 inhibition prior to cardiac surgery and postoperative atrial fibrillation: a pilot randomised controlled trial

    Post-operative atrial fibrillation is a heart rhythm disorder that is a major clinical problem, affecting 15-30% of patients undergoing cardiac surgery. It is associated with high rates of stroke, and increased mortality. Post-operative atrial fibrillation is thought to be caused by abnormalities in the physiological function of the atrium around the time of surgery. The current application is for a pilot open-label randomised controlled trial assessing the impact of sodium-glucose co-transporter 2 inhibitor pre-treatment on cardiac electrophysiology studies performed during cardiac surgery in 16 patients. The rationale for the study is that this medication has been shown in a very large randomised controlled trial (Wiviott SD et al. NEJM 2019 "DECLARE-TIMI 58" trial) to decrease incident atrial fibrillation by 19%. We therefore reason that these medications may potentially mediate this effect. The aim of the current study is to determine if pre-treatment will improve the electrical function of the atrium, or change the rates of postoperative atrial fibrillation.

  • Exploring the educational, self-monitoring and self-management needs of community dwelling patients living with indwelling urinary catheters: a mixed methods study

    The purpose of the research is to explore the educational, self-monitoring and self-management needs of patients living with indwelling urinary catheters in the community, from the perspective of the patients, carers and clinicians. Findings from this study will help to understand knowledge and attitudes towards indwelling catheters and how these shape behaviours and practices. Furthermore, understanding the needs of both patients and nurses will provide a foundation for the development of an acceptable, feasible and sustainable educational package for patients to self-monitor and self-manage their urinary catheters. The information will also assist clinicians to develop a patient-centred bundle of care aproach to meet patients needs and minimise anxiety and fear around catheters. Future educational interventions developed as a result of this project will improve clinicians’ confidence in providing catheter care to patients/carers and improve patients’ self- monitoring and self-management practices and thus minimise catheter associated complications and unnecessary hospital presentations.

  • Royal Womens Hospital (RWH) anogenital distance in adult women undergoing gynaecological surgery study

    Endometriosis is a common problem, affecting approximately ten percent of women of reproductive age. It has negative effects on quality of life through pelvic pain, dysmenorrhoea and infertility. Current clinical examination and ultrasound techniques are not effective in diagnosing superficial endometriosis. This leaves laparoscopy, an invasive surgical procedure, as the current gold standard for diagnosis of endometriosis. Recent studies have shown a correlation between shorter anogenital distance (AGD) and the presence of endometriosis. This study aims to further examine this correlation, in the hope that AGD may be used as a clinical tool to predict the presence or absence of endometriosis in women considering laparoscopy. This study will aim to define an average anogenital distance in a cohort of women undergoing gynaecological surgery. It will also aim to investigate the relationship between anogenital distance and gynaecological conditions of interest, particularly endometriosis, and other patient factors that might be associated with a shorter or longer than average AGD. We will invite premenopausal women aged 18-50 undergoing gynaecological procedures with a general anaesthetic at the RWH to participate. They will be recruited pre-operatively and asked to complete an online survey to determine relevant demographic and health information. Their AGD measurements will be taken by the treating gynaecological team during their procedure and recorded. If the patient is undergoing laparoscopy, the operation notes and any histopathology results will be reviewed to determine the presence or absence of endometriosis. This study is hoped to add evidence of the correlation between short AGD and endometriosis. It will also help determine what the average AGD is in the adult gynaecological patient population, and other factors such as age, obesity, ethnicity, etc that may be associated with differences in the AGD.

  • To validate a phosphate food frequency questionnaire using dietary recalls and test for reproducibility in people with end stage kidney failure on dialysis.

    The primary objective of this observational study is to validate a phosphate-specific FFQ by comparison with two 24 hour multi pass recalls in a cohort of individuals with end stage kidney failure undertaking dialysis.

  • "Watch Me Grow Integrated approach - WMG- I”: A web-based developmental surveillance approach for uptake of childhood screening and intervention

    Delayed identification of childhood developmental and behavioural problems and its impact on school readiness have been consistently reported. Whilst Australia has an excellent State-based Child Health and Developmental Screening and Surveillance program its utilisation in children under 5-years is < 20%. Poor uptake is due, in part, to parental access issues, perceived usefulness and the clinical complexities of referrals and managements. At present there is no proven system to improve surveillance attendance and its impact on costs and school readiness. In this study we hope to test the efficacy of integrating a web-based comprehensive developmental surveillance and child health nurse triage supported system in primary care to determine if it effectively engages parents improving long-term attendance, early intervention and school readiness.

  • Intensive long-term rehabilitation for people living with chronic spinal cord injury: a feasibility trial

    This study will measure whether an intensive, long-term rehabilitation program can be delivered safely and effectively to people living with chronic spinal cord injury in Australia. It will also measure whether long-term intensive rehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury.

  • The effect of intra-infusion exercise on chemotherapy side effects

    The purpose of this study is to determine whether intra-infusion exercise (exercise during chemotherapy infusion) can also improve chemotherapy side effects and physical activity levels in patients with breast, colorectal and ovarian cancer. Who is it for? You may be eligible for this study if you are aged between 18-75 years old, have been diagnosed with Stage I-III breast, colorectal or ovarian cancer, and are currently undergoing or are planned to undergo chemotherapy. Study details The study consists of four chemotherapy treatment sessions with the first being used to obtain baseline measures, followed by three intervention sessions. After the initial baseline session, participants will be randomised (i.e. allocated by chance) to either an intra-infusion exercise group or usual-care control group. For each of the three intervention sessions, the exercise group will perform 20 minutes of moderate intensity aerobic exercise during the chemotherapy infusion period. The control group will continue with routine clinical care. During the recovery period, the exercise group will be provided with exercise education by an accredited exercise physiologist. The control group will be involved in an education session during the infusion with the accredited exercise physiologist to receive the same exercise education as the exercise group. All participants will wear an Actigraph (a movement-detecting device) for one week following the baseline and post-intervention session and complete a 7-day symptom diary following each intervention session. A Fitbit will be worn continuously by the participant for the duration of the study to capture daily physical activity. Participants will also fill out a number of questionnaires before and after completion of the study. Participants will be asked if they would like to participate in an optional exit interview with a member of the research team at the end of the study. It is hoped that this study may demonstrate that intra-infusion exercise reduces chemotherapy side effects, improves quality of life, and increases physical activity levels in patients with breast, colorectal or ovarian cancer undergoing chemotherapy.

  • Pilot trial of the impact of financial incentives on women quitting smoking in pregnancy.

    Smoking throughout pregnancy causes irreversible harm to both the mother and fetus. Although smoking rates have declined considerably, rates of smoking during pregnancy remain steady among socioeconomically disadvantaged populations. The Northern Area Local Health Network (NALHN) serves a substantially disadvantaged population with approximately 1 in 4 women smoking during pregnancy. Standard practice at NALHN is to refer women to the Quitline, yet it is widely acknowledged by women and health professionals that women rarely engage with the service (Fletcher et al. 2021, unpublished). Studies exploring the use of financial incentives in antenatal care to encourage smoking cessation have shown promising results. This project will explore the feasibility and acceptability of using financial incentives in antenatal care at the NALHN antenatal services

  • Effects of a probiotic food supplement on depressive symptoms in adults

    Depression is a serious health condition that has a considerable negative impact on both physical and mental health. It is one of the leading causes of disease worldwide and represents a huge burden on health care costs. The possible therapeutic impact of dietary changes on mental illness has been receiving increasing attention. Dietary intervention for the treatment of major depressive episodes has shown promise. Some of the many biological pathways by which dietary improvement may influence depressive illness focus on inflammatory and oxidative stress pathways, as well as brain plasticity, while more recently new evidence has focused on the gut microbiota. The intestinal microbiota plays a crucial role in the bidirectional communication between the gut and brain (i.e. the so-called gut-brain axis). Probiotic supplementation can be viewed as a form of controlled dietary intervention that allows modification of the microbial environment. Recent demonstration that probiotic administration has positive effects on depressive feelings in healthy populations (Marotta et al 2019) suggests its possible role in the management for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. The present study extends current knowledge on the beneficial effects of probiotics on mood (i.e., depression) and other aspects of psychological well-being, (e.g., anxiety, quality of life) and explores potential mediating factors (e.g., biomarkers of inflammation, stress and changes in the gut microbiome). The research question being addressed is whether 3-months of supplementation with the Biome Lift™ Probiotic can reduce severity of depressive symptoms? For this double-blind, placebo-controlled trial, patients with subthreshold depression will be randomly assigned to an experimental or control group, involving a daily dose of probiotic or placebo, respectively, for 3-months. The findings of this study will contribute to the better understanding of the role that probiotic administration and consequent gut microbiota changes have on the gut-brain axis and their involvement in the etiology of depression and other psychological outcomes.

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