ANZCTR search results

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

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31386 results sorted by trial registration date.
  • Clinician training models for HeLP (A Healthy Lifestyle program for Pain) to support older people with musculoskeletal conditions and comorbid chronic disease risks

    Thousands of older Australians with hip, knee and low back pain are referred for surgical consultation, wait extended periods without alternative evidence-based care, and 75% have three or more chronic disease risks (e.g., overweight, smoker). We previously found a Healthy Lifestyle program for Pain (HeLP) reduced disability and improved quality of life. Now we seek to test the best method to scale up the program. We will test if an Individual Self-Paced training model is as effective as a Group Training model on the use of HeLP in physiotherapy settings. We expect to find similar results between groups.

  • Use of pharmacogenomic testing in aged care

    In this project we will implement a genetic testing service in the residential aged care setting, looking specifically at genes involved in the processing of medications (i.e. pharmacogenomics). The aim of the project is to evaluate the feasibility of implementing this service using the RE-AIM framework. DNA samples of aged care residents will be collected via cheek swabs and sent to a commercial genotyping provider (myDNA) to generate a pharmacogenomic report. The report will be sent to the resident's pharmacist who will interpret it and make a recommendation regarding the resident's medication to their prescriber. Barriers and facilitators to implementing pharmacogenomics will be identified by interviewing stakeholders including residents, clinical staff, pharmacists and prescribers. A cost-benefit analysis will be conducted comparing medication-related harm in residents the did/did not partake in pharmacogenomic testing. We expect to understand the feasibility, clinical and financial utility of implementing pharmacogenomic testing in aged care.

  • A Phase 1 Drug-Drug Interaction Study to Assess the Interaction Potential of NB-4746 on CYP1A2 and CYP3A4 Substrates in Healthy Volunteers

    In this trial, we are trying to evaluate the potential interactions of an experimental new drug NB-4746 with other drugs that may be used by patients suffering from Motor Neurone Disease or Amyotrophic Lateral Sclerosis (ALS). NB-4746 blocks certain processes in nerve cells that promote axonal degeneration, and has shown potential for the treatment of neurodegenerative diseases in preclinical studies. This drug-drug interaction study is conducted to characterize the potential of NB-4746 to interact with caffeine and midazolam, two probe drugs dependent on CYP1A2 and CYP3A4 metabolism, respectively. Results from this study will support the design of future clinical trials in patient settings.

  • GROW SHARE: Social prescribing of permaculture for adults with mental illness

    For people with mental illness, social prescribing has demonstrated the ability to improve a person’s physical health, mental health, self-efficacy, enhance social participation, vocational and work readiness, decrease hospital admissions and improve quality of life. Permaculture has not previously been explored in combination with social prescribing for adults with mental illness. Permaculture is an ethics and values-driven approach to living that can be applied to all aspects of life, including mental health. This study will employ a multi-methods research design guided by a realist evaluation to assess what extent ‘GROW SHARE’ improves Quality of Life, psychological distress and loneliness. The impact on permaculture knowledge and skills and what works for whom, in what what circumstances, how and why will also be investigated. It is anticipated that this research will demonstrate preliminary evidence of the GROW SHARE social prescribing of permaculture program for people living with mental illness implemented at Primary and Community Care Services.

  • A Pilot, Two-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial of Intravenous Amino Acid Therapy in Vasopressor-Dependent Adults Admitted to the Intensive Care Unit

    Acute kidney injury is common in critically ill patients, especially in those requiring vasopressor therapy. We hypothesize that an intravenous infusion of amino acids in such patients will increase glomerular function without tubular injury when compared to a balanced crystalloid solution of equal volume. In this two-centre, pilot safety and efficacy randomised controlled trial we plan to enrol 60 adult patients with the study drug delivered via infusion while the participant is in the intensive care unit.

  • Implementation of a supportive care navigation tool for people diagnosed with pancreatic cancer

  • IMplementing clinical Pathways for Acute Care in Tasmania (IMPACT)

    By embedding implementation science principles, IMPACT will enable the incorporation of clinical pathways into contemporary, patient-centred models of care across Tasmanian emergency departments (EDs) and the broader health sector, thereby improving the quality, efficiency and experience of acute care. The project will engage with all relevant stakeholders (consumers, ED clinicians, other community- and hospital-based health professionals, and policy makers). The experience in Tasmania will inform the development of a national acute care implementation science laboratory. We will reduce variation in care, improve service delivery, outcomes and efficiency of acute care, reduce pressure on EDs, and generate new knowledge applicable to assisting Australians living in rural and regional communities, when they are at their most vulnerable.

  • A randomised controlled trial to evaluate the effects of marked weight loss combined with exercise training on metabolic, immunological, and imaging biomarkers of systemic and brain inflammation in participants undergoing bariatric surgery.

    This randomised controlled trial aims to evaluate the effects of marked weight loss, via bariatric surgery, combined with a personalised exercise intervention on markers of brain inflammation. This study will allow us to explore the link between excessive adiposity-induced systemic chronic inflammation, metabolic abnormalities, and neuroinflammation. We hypothesise that bariatric surgery, i.e., marked weight loss, and exercise will result in attenuated neuroinflammation (as measured by neuroimaging), improvements in cognitive function, improvements in immune-inflammatory markers, and improvements in cardiometabolic biomarkers at 12 months compared to control.

  • Safety, tolerability and pharmacokinetics of SSTK-101 in healthy volunteers

    SSKI-101 is a novel anti-SARS-CoV-2 IgY antibody spray that has been developed as a Class 3 - Medical Device under the TGA guidelines. It is for use 4 times daily through self-administration in the nose and mouth for prevention of COVID-19 in adults. The IgY neutralizing antibody is obtained from the egg yolk of hens immunised with a purified recombinant SARS-CoV-2 extracellular domain of the spike protein (S-ECD). SSKI-101 has the potential to prevent infection with SARS-CoV-2 by acting as a barrier to the virus entering the body through cells in the nose and mouth. Initial human studies have been undertaken and have been positive thus far. This human healthy volunteer Clinical study is designed to determine the safety and tolerability of SSTK-101 when administered in the nose and mouth and also to investigate whether SSTK-101 is absorbed systemically following administration to the nasal cavity and mouth. It is also being completed to assess further the preventative results.

  • The Effect of a Prehabilitation Exercise Program on Peritoneal Dialysis Outcomes: A Feasibility Study

    The physical function of people commencing peritoneal dialysis is poor as a result of their kidney disease. The choice of receiving peritoneal dialysis requires people to self-manage their treatment which includes being able to set up their home peritoneal dialysis machine, move large bags of dialysate fluid and connect to and disconnect themselves from the machine. Hence, they must maintain sufficient physical function to continue managing their peritoneal dialysis. In this cohort, poor physical function has adverse effects on the core patient outcomes of life participation, independence and peritoneal dialysis technique survival Pre-operative exercise, also termed prehabilitation, is defined as a process of improving the functional capability of a person prior to a surgical procedure. This study will establish the feasibility/acceptability of a prehabilitation-focused exercise program in people commencing peritoneal dialysis. The hypothesis is that by introducing exercise early into the treatment plan, people receiving peritoneal dialysis will be more able to incorporate, and maintain, a safe exercise program to maintain physical function, live well, and remain on peritoneal dialysis longer.

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