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A Sequential Multiple Assignment Randomised Trial (SMART) of personalised treatment for Bulimia Nervosa and Binge Eating Disorder - TailorED
Expand descriptionThe TailorED study will test personalised interventions for bulimia nervosa and binge eating disorder. Participants who respond to established first line cognitive behavioural therapy guided self help treatment after four weeks (that is, participants whose objective binge eating episodes reduce by at least 70%) will be randomly allocated to: a) continue with a guide as they complete a further six weeks of cognitive behavioural therapy guided self help treatment, or b) to complete a further six weeks of cognitive behavioural therapy guided self help treatment with 'light contact' from a guide. Light contact means 5-10 minutes of non-clinical weekly contact via email, text message or phone to ensure participant has what they need to complete the program. Participants who are non-rapid responders to established cognitive behavioural therapy treatment (that is, objective binge eating episodes do not reduce by at least 70%) will be randomly allocated to continue with 16 weeks of either: a) an extended dose of guided cognitive-behavioural therapy guided self help treatment, or b) a transcranial magnetic stimulation treatment package, or c) a personalised psychotherapy treatment package.
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STATEsMAN- A Phase 2 trial of SaciTuzumAb TirumotEcan (sac-TMT) in patients with MetastAtic castration resistant prostate cancer (mCRPC)
Expand descriptionThis is a study to investigate whether Sacituzumab tirumotecan (an antibody-drug conjugate) will be an effective treatment for metastatic castration resistant prostate cancer participants. Who is it for? This study is for participants who have histologically confirmed adenocarcinoma of the prostate and who have progressed after being treated with Androgen Deprivation Therapy. Study Details: There is only one treatment available as part of this study, All participants who choose to enrol will be offered the same treatment. Sacituzumab tirumotecan will be given to participants via an infusion into a vein, once every 2 weeks. Participants will need to attend the treating hospital to receive this treatment. They will also undergo additional assessments like blood test, urine test, vital signs and CT/PSMA PET scans. Participants will be asked to undergo a PSMA PET/CT imaging at the time that they enrol in the study, then at 8 weeks, 16 weeks, 26 weeks and then at 12-weekly increments. Participants will also be asked to complete a quality-of-life questionnaire throughout the study. It is hoped the result of this study will be used to inform and design randomised phase III trials of sacituzumab tiromotecan.
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Amino acid infusion versus placebo to determine if renal outcomes are improved after pulmonary organ transplantation
Expand descriptionAcute kidney injury (AKI) occurs in up to two-thirds of patients after lung transplantation, and renal replacement therapy is required in 10%. Amino acid infusion has been shown to reduce AKI in cardiac surgical patients. No trial of amino acid infusion has taken place in lung transplant. The AIRPORT study will determine feasibility of a larger definitive trial and investigate efficacy using markers of kidney function.
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Treating first responder’s trauma symptoms following a recent critical incident: A Randomised Controlled Trial of Eye Movement Desensitisation and Reprocessing Protocol for Recent Critical Incidents (EMDR-PRECI) compared with Psychosocial Skills Training
Expand descriptionThe aim of this study is to assess and compare the effectiveness of two different early -intervention treatments to reduce posttraumatic stress in paramedics following recent exposure to a traumatic event. The treatments that will be offered in the study are Eye Movement Desensitisation and Reprocessing (i.e., EMDR-PRECI) therapy and Psychosocial Skills Training. It is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms in relation to the recent critical incident, both immediately following treatment and at follow-up. Similarly, it is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms associated with other trauma events, both immediately following treatment and at follow-up.
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Accuracy of robotically enhanced glenoid prosthesis positioning for total shoulder arthroplasty.
Expand descriptionThe primary purpose of this study is to evaluate the effectiveness of a robotic-assisted approach in accurately placing the glenoid component during reverse total shoulder arthroplasty (rTSA) surgery. We aim to determine whether the use of the Mako robotic system can lead to better surgical outcomes compared to traditional patient-specific instrumentation methods. Our hypothesis is that robotic assistance will improve the precision of glenoid component placement, resulting in fewer errors and better functional recovery for patients. This study will assess key outcomes such as the accuracy of glenoid placement, the range of motion in the shoulder, and overall patient satisfaction after surgery. By understanding the benefits of robotic technology in shoulder surgery, we hope to enhance surgical techniques and improve long-term results for individuals requiring shoulder replacements. Participants in this study will contribute to groundbreaking research that could change how shoulder surgeries are performed in the future.
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Feasibility, safety, and usability assessment of the Wellumio Axana portable magnetic resonance device for diagnosis of stroke
Expand description- Neuroimaging for stroke diagnosis is limited to many Australians. - This study is a first-in-human study of a portable low field magnetic resonance imaging device named 'Axana' to diagnose stroke, ultimately in the pre-hospital and emergency department setting. - This study aims to test the feasibility and safety of this device in a stroke and healthy cohort in the hospital setting.
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Testosterone for Low Sexual Desire in Premenopausal Women: A randomized, double-blind, placebo-controlled trial: The SYBIL study
Expand descriptionLow sexual desire with associated distress is the most common sexual dysfunction in women, with a prevalence in Australian premenopausal women in the order of 8%. Testosterone has been shown to be an effective treatment of low sexual desire with associated personal distress in postmenopausal women. However, while small studies suggest a potential benefit of testosterone for premenopausal women aged 35 to 45 years with low desire, the available data is insufficient to support its use in premenopausal women. Specifically, improvement in sexual desire, arousal and satisfaction with AndroFeme1® 10mg/day, was seen in a double-blind, placebo controlled pilot study of 34 women aged 35 to 45 years. Sexually-related personal distress was not evaluated in this study. In a separate study, another transdermal skin spray preparation improved the frequency of satisfying sexual events in premenopausal women compared with placebo, sexual desire did not improve and associated distress was not evaluated. However, testosterone blood levels in premenopausal women decline by about 25% between the ages of 18 to 39 years and continue to decline with age, but with little, or no change over the menopause transition. Therefore whether testosterone therapy is effective for the treatment of low sexual desire and associated personal distress in premenopausal women aged 35 to 50 years warrants investigation.
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ADAPT-ED - Adaptive trial of emergency department interventions for back pain
Expand descriptionCurrent evidence on optimal pain management in the ED is limited, with opioids often prescribed without robust data on safety and effectiveness. Some studies have suggested that opioids, like oxycodone, can increase the risk of adverse events, and potential risks of misuse and dependency. There is a need to establish whether non-opioid analgesics can provide effective pain relief. ADAPT-ED addresses these gaps by testing multiple analgesic strategies within a single trial framework and adopting an adaptive design that enables efficient identification of effective treatments and early discontinuation of ineffective ones.
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A pilot study to determine the feasibility of a study investigating whether angiotensin II can improve renal and lung outcomes in patients having lung transplantation surgery
Expand descriptionKidney injury is common after lung transplantation surgery. Most commonly a drug called noradrenaline is used to maintain blood pressure around the time of the operation. Other research has suggested a new drug called angiotensin II may be of benefit. In this study we aim to carry out research to determine whether a large study of angiotensin II in lung transplantation is feasible.
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CHAPTER: Clonal Haematopoiesis assessment: prevention, treatment, and research.
Expand descriptionThe researchers will see people with CH, or who may have CH. For people who may have CH, the researchers will organise testing to confirm the condition after providing counselling. People with CH who agree to participate in the study will also have monitoring of their CH, assessment of the risk of heart diseases, and personalised support. The researchers will also measure people’s understanding of CH and how they feel after learning about CH. Researchers will then record the relevant information from people with CH in a central database over time to track long-term outcomes. The information collected from the study will help create a blueprint for doctors to provide care for people with CH in the future, and guide further research into CH.