ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Effects of a short message service to improve compliance with fasting in patients undergoing elective surgery

    We performed an audit to determine the extent of prolonged and excessive fasting amongst elective surgery patients. We aimed to compare the actual fasting times of elective surgery patients to the recommended fasting times as per our institution’s guidelines. Additionally, we completed a quality improvement project aiming to determine whether notification of fasting times by short message service (SMS) the day before surgery would improve fasting times and reduce excessive fasting. We hypothesised that the usage of an SMS reminder one day prior to surgery would assist patients in adhering to fasting guidelines and thus reduce excessive fasting.

  • The effect of Colchicine on the release of Neutrophil Extra-cellular Traps after Percutaneous Coronary Intervention in Acute Coronary Syndrome Patients..

    Percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients is associated with a higher incidence of peri-procedural myocardial infarction. An increased release of neutrophil-derived inflammatory products is known to contribute to this process. Colchicine is a well-established anti-inflammatory drug, however its role in attenuating post-PCI release of activated neutrophil-mediators is not well known. This pilot study aims to investigate whether peri-procedural colchicine would suppress local release of Neutrophil Extracellular Traps, and its components Human Neutrophil Elastase and Myeloperoxidases, in both ACS and stable angina pectoris patients.

  • Effectiveness of an expert-moderated peer-to-peer online support group versus an information website alone for people with knee osteoarthritis: A feasibility study and pilot randomised controlled trial

    The overall project aim is to investigate the effectiveness of adding an expert-moderated, peer-to-peer online support group (OSG) to an information website for people with clinically diagnosed knee osteoarthritis (OA). This study will investigate the feasibility of conducting the RCT by exploring fidelity (to trial and intervention protocols), satisfaction and engagement with the planned interventions, outcomes and costs. The primary objective will be to determine the feasibility of delivering the intervention in a trial setting and of recruiting and retaining participants. In terms of outcome measures, we will explore the impact of the intervention on psychological determinants that can explain self-management and lifestyle behaviour change. We will also measure behaviour and health outcomes as part of the feasibility assessment. The study will include two nested qualitative studies that will explore the type and content of posts, and the perceptions and experiences of participants in the OSG. We will conduct a two-arm, pragmatic parallel-design randomised controlled pilot trial (RCT) in 60 volunteers (20 in control group, 40 in intervention group) from around Australia who have clinical knee OA. The study will be run from the Centre for Health, Exercise and Sports Medicine at the University of Melbourne.

  • Preparing an effective school-based physical activity implementation strategy for scale-up: a randomized noninferiority trial.

    This study will compare two versions of the Physically Active Children in Education (PACE) intervention in increasing the minutes of planned weekly physical activity scheduled by classroom teachers. The aim is to determine whether an adapted PACE (i.e., delivery of teacher training by in-school champions rather than expert project officers) is statistically noninferior to the original PACE (i.e., delivery of teacher training by expert project officers). Forty eight schools in the HNE region have been randomly allocated to either the adapted PACE or original PACE group, and follow-up measurements will be taken at 12 months.

  • Buffered bicarbonate solutions for abdominal surgery

    The purpose for fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart, kidney and liver complications, improvements in time to mobilize, and a shorter duration of hospital stay. During abdominal surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during major abdominal surgery is Hartmann’s solution. This is standard fluid therapy for all patients undergoing liver major abdominal surgery at Austin Health. Hartmann’s solution has certain limitations in that it contains certain electrolytes (an essential mineral for normal health) as part of its normal content. One of these electrolyte is called lactate. Lactate is however reliant on the liver for its metabolism, which is why this fluid is not used in patients undergoing major liver surgery, including liver transplantation. However, during major abdominal surgery, there can be an additional stress from the surgery on the liver, which can in turn, affect the normal functioning of the liver. If the liver does not function normally, then lactate cannot be completely metabolized (broken down). This can affect normal acid base balance or body homeostasis. In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Hartmann’s solution during major abdominal surgery. The bicarbonate buffered solution contains no “lactate” and may have a more favourable effect on the “acid-base” balance

  • Buffered bicarbonate solutions for liver transplantation

    The purpose for this fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart and kidney complications, improvements in time to mobilise, and a shorter duration of hospital stay. During surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during liver transplantation is Plasmalyte solution. This is standard fluid therapy for all patients undergoing liver transplantation at Austin Health. Plasmlayte solution has certain limitations in that it contains certain electrolytes (also called “anions”) that are reliant on the liver for metabolism. During liver transplantation, as the liver does not function normally, this can affect normal “body-balance”. In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Plamalyte solution during transplantation. This solution contains no “anions” and may have a more favourable effect on the “acid-base” balance.

  • An observational study of concussion in adults to improve recovery and outcomes

    This is an observational research study to identify markers that can predict poor outcome following a concussion. Following a concussion injury, information will be collected on the individual's injury and medical history, and they will participate in an exercise tolerance test, MRI scan, neuropsychological test and blood test. We hypothesize that performance on tests at the time of the injury will help predict which individuals will likely have a delayed or complicated recovery. Identifying individuals at risk of a poor recovery will help doctors modify their management of the injury appropriately, and save those likely to recovery normally from unnecessary follow-up visits.

  • Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness

    This trial aims to investigate the use of psilocybin (a psychedelic compound) in conjunction with psychotherapy for the treatment of anxiety and depression in terminally ill patients. Who is it for? Adults aged between 18-85 years with a life threatening illness and currently under the care of a specialist physician are eligible for the study. Criteria for prospective participants includes psychological distress that was brought on by their life-threatening illness. Study details Participants will be rigorously screened, throughly prepared and supported throughout the treatment with two specialist clinicians present at all times throughout the treatment. Participants will be randomly allocated (50/50 chance) to either receive the active medication (Psilocybin 25mg) Arm 1 or a placebo (Niacin 100mg) in Arm 2. The medication or placebo will be taken once in the first arm of the study and have psychotherapy sessions with a health professional before, during and after the dose of medication/placebo. The next dose is 7 weeks later, where all participants will take the active drug, Psychotherapy sessions will take place before, during and after. All participants are followed for 26 weeks following the second dose and will be involved in interviews and questionnaires throughout the study period. Participants are followed up for 26 weeks after the second dose to ensure that we examine all changes that continue after treatment. Questionnaires and interviews are conducted throughout the study to fully understand the impact of the treatment and to monitor for safety. It is hoped that this research could potentially offer a new treatment for terminally ill patients experiencing depression and anxiety, and hopes to alleviate psychological suffering at end of life.

  • Strong culture, healthy lifestyles: an afterschool Aboriginal cultural activity program to promote healthy lifestyles in children

    The primary purpose of this study is to determine if being part of an afterschool Aboriginal cultural activity program, which is developed and run by Aboriginal people, can make children healthier. Specifically, this study aims to evaluate the feasibility, acceptability and potential efficacy of an afterschool cultural program in promoting culture connectedness, positive healthy behaviours and educational outcomes, including physical activity, healthy eating, spiritual and socio-emotional well-being and positive school- and home-related behaviours, among Aboriginal children and their siblings aged 5-13 years. It is hypothesised that the afterschool cultural program will give children opportunities to learn culture, connect to Country and engage in activities that promote physical, social, emotional and spiritual health.

  • Smartphone application-based behavioural intervention for cardiac rehabilitation and the effect on hospital readmissions: The ToDo-Cardiac Rehabilitation (ToDo-CR) randomised control trial

    Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease with physical activity (PA) being a core component. Despite this, studies have found that PA levels are low and sedentary behaviour (SB) is high in CR patients. The aim of this randomised control trial (RCT) is: 1) to test the efficacy of a behavioural smartphone application (Vire DoACTIVE) and a 6-month online behaviour change program (ToDo-CR) in decreasing SB and increasing PA levels in CR participants (compared to routine CR alone); 2) to explore if this behavioural change intervention is effective at reducing the risk of repeat cardiac events, all cause hospital admissions and emergency department visits over 12-months post commencing CR. We propose to conduct a multi-centre RCT over 12-months with 144 participants from the Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital CR programs. It is hypothesised that the intervention will increase PA levels, decrease SB and reduce repeat cardiac events, readmissions to hospital and emergency department visits.

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