ANZCTR search results

Complications after major surgery are common and decrease survival in the short and long-term. Tissue hypoxia (low oxygen) is established as a driver of postoperative complications. All complex cells can adapt to low oxygen conditions, over a period of hours to days, by activating the highly conserved hypoxia inducible factor (HIF) pathway. Roxadustat is a first-in-class oral prolyl hydroxylase inhibitor that increases HIF signalling and is currently marketed for the treatment of anaemia in chronic kidney disease. Brief preoperative Roxadustat exposure stands to prime cells to function well under the anticipated hypoxic stress of major surgery, a clinical insult that is unique due to its precise timing. In particular, Roxadustat may enhance immune cell function and healing in the hypoxic microenvironment of the surgical wound, thereby reducing the burden of surgical site infection. Hypothesis: A definitive phase 3 randomised controlled trial of preoperative roxadustat vs placebo in patients undergoing major noncardiac surgery is safe, feasible and justified.

Why this study is important? Healthcare-associated infections (HAIs) are acquired as a direct or indirect result of healthcare. Infections associated with healthcare are not inevitable, and prevention programmes have been successful at reducing the incidence of some HAIs. In Australia, we have estimated 160,000 patients contract a HAI annually. Furthermore, one in ten patients today have an infection acquired in hospital. Non-ventilator hospital-associated pneumonia (HAP) is the most common type of HAI, accounting for approximately one third of these infections, with an estimated 50,000 patients affected each year in Australian public hospitals alone. HAP is associated with increased length of stay in hospital, increased morbidity, mortality, and healthcare costs.Approximately 19% of patients with HAP require transfer into an intensive care unit (ICU), with mortality reported at 18%. Patients with HAP are eight times more likely Our study will: Evaluate the effectiveness and cost-effectiveness of the intervention Develop educational and digital resources and evaluate these as part of the trial Estimate excess length of stay in hospital associated with HAP Describe the patient’s experience of a having a HAP Understand the clinician’s experience of implementing the intervention Assess the impact of HAP on quality of life

This RCT experimental design with mixed methods aims to investigate a play-based intervention before, during and after a vaccination procedure. Play based modalities may be useful to prepare children for vaccinations to reduce fear responses and improve coping through age-appropriate health education initiatives. Parents will also be invited to assess their child’s coping before and after the vaccination. Play assessments will be utilised to assess children’s play ability and coping resources. These assessments will then inform the pre-vaccination play therapy intervention. This research is the first of its kind that uses eye tracking technology and play therapy methods.

little is known about the gastrointestinal effects of these sweeteners, particularly in people with irritable bowel syndrome (IBS). This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet. The low FODMAP diet restricts intake of six sugars - fructose, lactose, oligosaccharides (fructans and galactooligosaccharides), and sugar polyols (sorbitol, mannitol). These six sugars are well known to trigger symptoms in people with IBS, and their collective reduction via a low FODMAP diet relieves symptoms in around 3/4 people with the condition.

This study aims to evaluate if the use of the T-stat oximeter device for breast cancer patients undergoing DIEP flap reconstruction procedures can improve post-operative sleep quality. Patients above the age of 18 year old who are diagnosed and treated for breast cancer and are about to undergo a DIEP flap reconstruction procedure are eligible for this study after appropriate consent is obtained. Participants will be randomised into either the control group or interventional group and are required to complete surveys at different timepoints of the study that evaluates sleep quality and quality of life. Control group patient will be monitored with current gold standard of care via observational and sonography ultrasounds while intervention group patients will under monitoring via the T-stat device. Results of this study aims to better future care for breast cancer patients and reduce post-operative sleep disturbance related complications.

This project aims to co-design, develop and pilot test a modified oral health assessment toolkit (M-OHAT) and referral system appropriate for aged care residents. Co-deisgn participants (preregistered study https://osf.io/2kynu) will review the existing OHAT and discuss oral health needs, drivers, and barriers to broader implementation. Utilising the data from the co-design workshops, OHAT modifications and a comprehensive training package will be developed for non-dental staff members at residential aged care facilities. The M-OHAT training and tool will be piloted for acceptability and validity with residents and staff of Australian residential aged care facilities.

This is a double-blind, placebo-controlled, First-in-Human Study study to assess the safety of ZE63-0302 ,and how this drug acts in the body in healthy volunteers. ZE63-0302 may be indicated for use in patients with Acute Myeloid Leukaemia (AML), but a trial of the drug in healthy volunteers is needed before trials in AML patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Participants with a prior cancer diagnosis are not eligible for inclusion in this study. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive a single or multiple doses of ZE63-0302 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. It is hoped this research will determine the maximum dose of ZE63-0302 that can be administered safely without causing severe reactions. Once the dose of ZE63-0302 has been determined in healthy volunteers, a trial investigating the efficacy of ZE63-0302 as a treatment for patients with AML may proceed.

The current study evaluates the use and effectiveness of simulated workplaces, replicating real job tasks and experiences, to progressively rebuild one's capacity to return to work following an injury. To date, few return-to-work services in Australia adopt this approach. This study will therefore add to the current evidence-base by examining the preliminary effects of rehabilitation based on work simulation tasks. These data will be used to inform a future larger-scale, controlled trial.

The prevalence of chronic fatigue is high in Australia. There is a need for better understanding of underlying disease patho-physiology and reliable assessments of treatment effectiveness. This intervention study aims to assess the treatment effect of Electromagnetic Frequency (EMF) therapy for patients with chronic fatigue using the viral reactivation test, a combination of the cytology-based Circulating Rare Cell (CRC) blood test, and viral marker testing for dormant viruses such as Epstein Barr Virus (EBV), Cyto-megalo-virus (CMV), or Herpes Simplex Virus (HSV). Who is it for? You may be eligible for this study, if you have chronic fatigue. Study details Patients will undergo an intial EMF session of 60-90 min to assess treatment effectiveness of the chosen patient-specific frequency program. Effectiveness will be assessed by blood tests measuring the number of viral reactivated Circulating Rare Cells (CRC) before and 1 day after treatment. If successful, the patient will discuss with their health practitioner a 12 week treatment plan, which may involved twice weekly EMF sessions for 12 weeks. A follow-up CTC test at 3 and 6 months is scheduled to assess treatment effectiveness in the context of long-term clinical outcome. It is hoped, that this study will provide insight into the effectiveness of EMF therapy for viral reactivated chronic fatigue, with the aim to reduce viral reactivation and improve symptoms and quality of life.

The prevalence of cancer diagnosis is high and attributable to 30% of all deaths in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. This intervention study aims to assess the treatment effect of Electromagnetic Frequency (EMF) therapy for patients with cancer using the Circulating Tumour Cell (CTC) in cancer patients. Who is it for? You may be eligible for this study, if you have been diagnosed with cancer. Study details Patients will undergo an intial EMF session of 60-90 min to assess treatment effectiveness of the chosen patient-specific frequency program. Effectiveness will be assessed by blood tests measuring the number of Circulating Tumour Cells (CTC) before and 1 day after treatment. If successful, the patient will discuss with their health practitioner a 12 week treatment plan, which may involved twice weekly EMF sessions for 12 weeks. A follow-up CTC test at 3 months is scheduled to assess treatment effectiveness in the context of long-term clinical outcome. It is hoped, that this study will provide insight into the effectiveness of EMF therapy for cancer, with the aim to reduce CTC count, reduce tumour size and cancer spread, and improve symptoms and quality of life.