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A feasibility randomised control trial of prolonged virtual reality cycling in people with knee osteoarthritis
Despite all treatment guidelines recommending exercise, 9 of 10 Australians with knee osteoarthritis (OA) are inactive. Most undergo surgery without trying exercise, despite evidence that exercise can delay/prevent surgery. However, exercise often hurts, reducing initial/sustained exercise engagement. Clinicians promise that pain will reduce over time as fitness increases/weight reduces. While evidence supports this promise, sustaining exercise is difficult. Arthritis Australia's Exercise Report identifies improving exercise engagement as key to improving osteoarthritis outcomes and Australia's National Arthritis Strategic Action Plan calls for new ways to increase uptake of exercise in people with arthritis. New virtual reality technology holds promise and may assist with reducing exercise barriers to increase exercise uptake/engagement. Using a parallel-group, randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 2 weekly in-person treatment sessions with a physiotherapist for a period of 6 weeks. Primary outcomes include the WOMAC and perceptually-regulated exercise.
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A Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis
The immune checkpoint inhibitors (ICI) are a form of cancer treatment that have resulted in significant improvement in the outcomes of the management of a number of malignancies. They work by activating the immune system and thereby promoting the destruction of cancer cells. The use of ICIs is limited by a group of side-effects known as immune related adverse events (irAEs). One of the more common irAEs is the development of inflammation of the large intestine known as ICI colitis. The treatment of ICI colitis is mostly aimed at suppressing the immune system and ‘switching off’ the overactive immune cells that are causing the inflammation. The use of treatments that suppress the Immune system may themselves result in significant side-effects by increasing the risk of infection. Immune suppression may have a detrimental impact on the outcome of the cancer being treated, by reducing the ability of the patient’s immune system to control the cancer. Who is it for? You may be eligible for this study if you are an adult who is receiving treatment for a solid cancer, who has experienced onset of colitis symptoms within 6 months of treatment commencement. Study details Participants in this study will be able to choose if they wish to receive the intervention or are considered part of the 'control' group. Participants who choose to receive the intervention will undergo a colonoscopy where they will receive a faecal transplant. If a participant chooses not to receive the intervention, they will continue with standard treatment as determined by their doctor. All participants will then be followed up for 8 weeks and asked to complete questionnaires and provide additional blood and stool samples. It is hoped that this study will help assess the efficacy and safety of Faecal Microbiota Transplant as first-line therapy in the treatment of ICI colitis.
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Time Toxicity and its Relationship with Quality of Life in Patients Undergoing Phase 1 Oncology Clinical Trials
Management of cancer is a rapidly evolving field, and it occurs in 4 stages: phase 1 (P1) to phase 4. P1 clinical trials are designed to test drug pharmacokinetic profiles and toxicity. However, most often patients enrol in these trials for potential therapeutic benefits. P1 trials often require participants to frequently interact with the health care team for various investigations and treatment. This time they spend interacting with the health care team has the potential to reduce quality time that participants could have utilised otherwise. This is called 'Time Toxicity' and it is defined as the time a participant spends organising and obtaining treatment including in/out-patient visits, hospitalisations, emergency care for side effects, travel and wait times, and follow-up tests. TT reported in participants undergoing cancer treatment has shown to carry a substantial burden, but its impact on the quality of life in participants undergoing P1 trials is not well explored. As such, it is often overlooked as a deciding factor in the consenting processes for the P1 trials. We aim to measure TT and assess its impact on the quality of life of participants enrolled in P1 oncology clinical trials through patient-reported outcomes. Who is it for? You may be eligible for this study if you are an adult with cancer who is going to take part in a phase 1 cancer clinical trial. Study details All participants in this study will continue with their phase 1 clinical trial, and will be asked to complete a diary for 3 months to report their time toxicity. Participants will also be asked to complete questionnaires and take part in a one-on-one interview describing their experiences and expectations at the start of the phase 1 clinical trial and after the three months (or earlier). It is hoped that this study will provide data that can help clinicians, patients, and families make the right treatment decisions.
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Patient-Reported Outcomes in Practice for Enhanced Learning and Research (PROPELLER): A national prospective clinical quality registry of orthopaedic care
The PROPELLER registry is a database that collects clinical data on patients undergoing orthopaedic treatment for musculoskeletal injuries and disorders. It aims to monitor short and long-term patient outcomes associated with surgery and non-surgical treatments using patient reported outcomes, radiological findings, and rates of complications or revisions. The registry will support observational studies to identify factors that are associated with treatment success in patients undergoing orthopaedic treatment. The findings from the PROPELLER registry will inform future hypotheses and clinical research, potentially leading to changes in healthcare practices, systems or policies within the field of orthopaedics. By comparing its findings with those of other groups, the registry hopes to contribute to a broader understanding of musculoskeletal disorders.
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What is the uptake of the COVID-19 and influenza vaccines in people with severe mental illness?
People with severe mental illness (SMI) such as schizophrenia are among the groups most vulnerable for a severe course of COVID-19 illness. Factors that contribute to worse outcomes include concomitant medications, poorer premorbid general health, physical comorbidity, reduced access to medical care, and environmental and lifestyle factors such as lower socio-economic status, overcrowding, smoking, or obesity. The COVID-19 pandemic also highlighted the importance of the annual Commonwealth-funded programme of free influenza vaccination in people over the age of 65 years old and other vulnerable groups. Given that people with SMI are more likely at all ages to be eligible for the flu vaccination because of their high rate of physical comorbidity, reduced uptake will be especially clinically significant. Thus, in both COVID-19 and influenza, it is important to investigate whether vaccination has any effect on differences in subsequent COVID-19 & influenza-related morbidity and mortality between people with SMI and the general population.
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Helping young people with chronic medical conditions experiencing anxiety and depression
Children and adolescents with ongoing medical conditions (example, epilepsy, asthma) often experience mental health problems due to their illness and other factors. A lot of the time when children are having mental health problems, they have symptoms of both anxiety and depression. Our project aims to test if a transdiagnostic therapy can help tackle this issue. Transdiagnostic means that the therapy can help treat the mental health problem that the child has (example, anxiety) and any other related mental health problems, like depression. Through this project, we want to learn whether this new therapy can help in reducing anxiety and depression symptoms in children and adolescents with these ongoing medical conditions. We are hoping to recruit 60 children and adolescents (8-17.11 years) with chronic medical conditions, who also present with anxiety or depressive symptoms. These children will be recruited from the Royal Children’s Hospital Clinical Psychology Service. By understanding its effectiveness, we aim to offer this therapy to more families who could benefit from it.
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Assessing the Impact of a Therapist-Assisted AI Chatbot on the Awareness of Risky Gambling Behaviours and Overcoming Barriers to Seeking Help Among South Australian (SA) Gamblers
The overarching research question is ‘Does a therapist-assisted AI chatbot coach increase SA gamblers awareness of risky gambling behaviours and overcome barriers to seeking help?’ As a pilot study, we are not hypothesis testing, instead, we are interested in the acceptability and feasibility of providing the intervention, the AI chatbot online for South Australian gamblers. Acceptability of the chatbot and its content will be created and tested using a co-design process with gamblers and SA Gambling Help services. Our aims are to, engage and assess, engage and coach the AI chatbot, design content to target multiple gambling products through co-design, and finally pilot the chatbot by recruiting help seekers through social media.
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Investigating high blood pressure and gut leakiness
High blood pressure, or hypertension, is a highly prevalent chronic disease, affecting 1 in 3 people in Australia. It is a disease where the blood inside the heart and blood vessels is pumped with more force than normal. This adds stress to these important organs, increasing the chance of having a heart attack or a stroke. We have shown that changes in the gut bacteria happen in hypertension. We think that these changes in the gut bacteria may disrupt intestinal permeability, also known as “leaky gut”. But we don’t know much about the relationship between blood pressure and leaky gut. This research will measure blood pressure and gut leakiness in people with normal and high blood pressure. By learning about the relationship between gut leakiness and blood pressure, we may be able to design drug and diet therapies that make the gut less leaky, to help people with high blood pressure. This research does not involve being given any treatments (e.g. drugs, special diets) for blood pressure.
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Tirzepatide in Type 1 Diabetes: Cardiometabolic Effects (TIRTLE)
Cardiovascular disease and its risk factors are prominent issues in T1D. There is a need to identify therapies that can address weight, glycaemia and other cardiometabolic indices in T1D. In T1D, whether tirzepatide, a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist improves weight, glycaemia and cardiometabolic health has not been previously studied. The TIRTLE study is a randomised controlled clinical trial in adults with type 1 diabetes.
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SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies
The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions listed below. 1) Recurrent glioblastoma 2) Non-metastatic castration-resistant prostate cancer 3) Metastatic castration-resistant prostate cancer 4) Metastatic castration-sensitive prostate cancer 5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation 6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women 7) HER2-negative advanced breast cancer after failure of anthracycline 8) Deep vein thrombosis (DVT) 9) Post Myocardial Infarction (MI) 10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD) 11) Non-valvular atrial fibrillation 12) Previous Myocardial Infarction (MI)/Stroke 13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM) 14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF) "Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition. Who is it for? You can participate in this study if your medical condition is listed above and there is more than one standard of care options available for your health condition. Based on your own preference, you will either be a member of the randomised cohort or the non-randomised cohort. Participants in the randomised cohort will have their SoC option specified by a randomisation system. Participants in the non-randomised cohort will directly choose their SoC option in collaboration with their doctor. The study will also collect information on participant's experiences receiving the SoC option, as well as collect information on outcomes associated with the treatment they receive. The study plans to enrol approximately 200 participants in Australia.