ANZCTR search results

This study aims to explore the efficacy of in-person and online MBSR for improving mental health and metabolic profile in diabetes patients living in regional and rural north Queensland using a RCT design. Our study will answer three research questions: 1) Is in-person MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 2) Is online MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 3) Are mental health benefits observed after 4- and 6-week interventions?

This is a first-in-human, single-centre, randomised, double blind, three-part single and multiple ascending dose study to assess the safety and tolerability of OXT-328 and how this drug acts in the body in healthy volunteers. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of OXT-328 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with CIPN.

The REAL study is a pilot randomised, placebo-controlled clinical trial investigating the effects of green rooibos tea extract supplementation (dose = 500mg of rooibos extract) on anxiety levels in mildly to moderately anxious adults. The study incorporates a one week baseline period, 8-week intervention period and 2-week follow up.

A sudden worsening of respiratory symptoms in Chronic obstructive Pulmonary Disease (COPD) is called a flare up. These flare ups are caused by respiratory infections. Exercise programs can reduce the number of people experiencing a flare up of COPD by as much as 40%. We don’t yet know why this happens. Key reasons why people with COPD have flare ups include weakened body defences (immune system) against respiratory infections. Measuring responses to safe, but foreign substances like vaccines provide one of the best ways to test how well the immune system defends against infections. We intend to find out if it is possible to use the flu or COVID-19 booster vaccines to understand how exercise changes the immune system of people with COPD. The project will recruit 45 volunteers with COPD. The project will split the volunteers into 3 groups: 1) 8 week exercise program before receiving a flu or COVID-19 vaccine; 2) 8 week exercise program before receiving a flu or COVID-19 vaccine and a single exercise session immediately after vaccination; 3) no exercise before or after flu or COVID-19 vaccine. We will collect blood and saliva from volunteers at the start of the project, before vaccination and on three occasions after vaccination.

Study Purpose: The purpose of this research is to establish whether 72 hours of antibiotics is superior to 24 hours of antibiotics in preventing infections of surgical wounds. Who is it for? You may be eligible for this study if you are an adult male or female Undergoing head and neck tumour resection and primary free flap reconstructive surgery for upper aerodigestive tract defects. Study details Participants will be randomly assigned to either 72-hour or 24-hour peri-operation antibiotic prophylaxis groups. Post head and neck operation and free flap reconstructive surgery, they will be monitored from postoperative day 1 to day 30 for incidence of surgical site infection using methods like culture, biochemical tests, radiological imaging, clinical diagnosis and Clavien-Dindo Classification of Surgical complications. It is hoped this information will improve perioperative management so that the best possible outcomes from surgery are achieved for patients having these major procedures.

The purpose of the study is to assess the efficacy of smartwatches to investigate patients with palpitations. These are commonly worn by members of the general public, and because they are worn continuously may be able to capture an ECG at the time of palpitations. This may have a benefit over Holter monitors, as these are only worn for a 24-hour period - therefore if the palpitations occur outside the 24-hour monitoring period, patients will not receive a diagnosis.

The primary purpose of this study is to investigate the effects of sodium butyrate in the treatment of anorexia nervosa. We hypothesise that there will be a significant difference in a) improvement of ED symptoms from baseline to end of treatment, and b) increase in BMI from baseline to end of treatment.

When a central venous access device (CVAD – incorporates both centrally and peripherally inserted central catheters) is inserted, it breaches the body’s protective barrier – the skin. Together with the patient’s intrinsic risk factors associated with their illness (e.g., cancer and deranged metabolic function such as in critical illness), this places them at risk of persistent bleeding at the catheter exit site and systemic infections. These complications are highly correlated; bleeding at the insertion site causes dressing disruption, which is associated with an increased risk for central line-associated bloodstream infections (CLABSI). Potassium ferrate haemostatic discs and powder (StatSeal®, Biolife, Sarasota, Florida) contain a strong haemostatic agent which has primarily been used to promote haemostasis post-interventional vascular procedures and interventional cardiology. The haemostatic disc and powder also has the option of being applied at the CVAD skin exit site, however, its role to prevent haemostasis and promote dressing integrity (thereby reducing the risk of infection with longer-dwelling venous access devices), is yet to be explored. To provide further evidence and inform clinical practice, it is important to address this evidence-practice gap and test the safety and efficacy of the potassium ferrate products in promoting haemostasis and preventing dressing disruption for CVADs.

Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the ICU. In patients with adequate tissue perfusion, an agent that could treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge would be useful. The ideal agent would either be a bolus IV agent or an oral agent. There are several possible etiologies of hypotension in the ICU. The most frequent causes include septic shock, vasoplegia from inflammatory conditions, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, terlipressin may prove to be a useful adjunctive medication to successfully increase blood pressure. We hypothesize that terlipressin treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and ICU length of stay (LOS) without increasing hospital length of stay or putting the patient at risk of being readmitted to an ICU.

This study aims to enhance the efficacy and acceptability of a Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplant at The Peter MacCallum Cancer Centre (Peter Mac). The Prehabilitation Exercise service has been established at the Peter Mac for several years. Our research team engaged in a co-design process with former patients and Peter Mac staff to identify priority areas for improvement and design solutions. This research study will implement the co-designed solutions, evaluate them and make additional improvements where necessary. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have been diagnosed with a Haematological Cancer and are awaiting Bone Marrow Transplant at The Peter MacCallum Cancer Centre, and have been referred to the prehabilitation program. Study details All participants will have access to the prehabilitation exercise service as part of standard care. This includes access to an individualised exercise program and supervised exercise sessions delivered either face-to-face or via telehealth. Improvements developed as part of co-design include staff training modules focused on delivering trauma-informed exercise support and delivering engaging online exercise classes, additional printed resources for patients to support uptake of exercise, support for staff to better utilise exisiting exercise prescription software (simple set), and an online education hub. This study will be implemented in two stages: Package 1 will include standard care plus all of the co-designed components, except for the online education hub, while Package 2 will include standard care plus all co-designed components and the online education hub. Package 2 will be implemented 9-12 months after the study commences, after Package 1 completion. Participants will be followed-up within two weeks prior to their bone marrow transplant to assess efficacy and acceptability of each package. The majority of the assessments completed (e.g., 6 minute walk test) are completed as part of standard care. Study specific assessments include questionnaires on intervention acceptability. It is hoped that this research project will lead to an optimised prehabilitation model of care at the Peter Mac, and pave the way for trialling the optimised model of care across multiple health services.