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A study investigating different combinations of Cytarabine, Midostaurin, Pracinostat and Venetoclax in elderly patients with Acute Myeloid Leukaemia to extend remission.
Expand descriptionThe purpose of this study is to investigate the combination and efficacy and safety of Low dose Cytarabine, Venetoclax, Midostaurin and Pracinostat in patients with acute myeloid Leukaemia (AML). Who is it for? You may be eligible for this study if you are an adult over 60 years of age who has been diagnosed with AML, with no previous chemotherapy treatment. Study details Participants in this study will receive the following treatments: Depending on which Part of the trial is open for recruitment, patients eligible after screening will be registered to either 1. Part 1 - The dose finding Run-in phase 2. Part 1A - Run in phase or 3. Part 2 - The randomised phase 2 study The Run-Phase patients will receive either: LDAC (Low dose cytarabine) + venetoclax + midostaurin or LDAC (Low dose cytarabine) + venetoclax + pracinostat The part 1A run in phase patients will receive venetoclax + azacitidine + midostaurin The Randomised Phase patients will receive: 1. LDAC + venetoclax (Tablets) + midostaurin (Tablets) a. LDAC 20mg/m2 subcutaneously daily D1-10 of each cycle. b. Venetoclax (Tablets) RP2D (ramp up in cycle 1 only) c. Midostaurin (Tablets) RP2D or 2. LDAC + venetoclax + pracinostat a. LDAC 20mg/m2 subcutaneously daily D1-10 of each cycle. b. Venetoclax (Tablets)RP2D (ramp up in cycle 1 only) c. Pracinostat (Tablets) RP2D or 3. LDAC + venetoclax a. LDAC 20mg/m2 subcutaneously daily D1-10 of each cycle. b. Venetoclax 600mg (Tablets)D1-28 (ramp up in cycle 1 only) All participants will undertake blood tests, bone marrow biopsies and questionnaires. This study aims to establish whether the combination of treatments, can control the disease more effectively for a longer duration.
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A comparison between five-days per week versus daily dialysis in patients starting peritoneal dialysis on clinical outcomes and quality of life
Expand descriptionIn order to prolong peritoneal dialysis [PD] technique survival, clinicians not only need to focus on protecting patient’s residual kidney function and peritoneal membrane integrity, they also need to address the impact of PD on patient’s daily living. One potential solution is the use of incremental PD (5 days a week dialysis). We have designed an investigator-initiated study to answer the following questions: Is incremental PD a feasible dialysis prescription? • Can PD patients be safely maintained on incremental PD • How long does incremental PD last, until needing daily PD By having regular peritoneal membrane resting, does incremental PD • Maintain residual renal function and urine output? • Improve patient’s life participation? • Better preserve peritoneal membrane function? The study will recruit adult patients who have commenced peritoneal dialysis in the previous 3 months and has been designed to fit in with PD patients' standard of care so minimal additional pathology testing will be required. We expect the incremental dialysis group to report better quality of life and demonstrate non-inferiority in terms of safety data and peritonitis rates.
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Cognitive impairment in patients with lymphoma
Expand descriptionThe purpose of this study is to assess the feasibility of collecting data on cognition over the course of treatment and recovery in patients with newly diagnosed aggressive lymphoma Who is it for? You may be eligible for this study if you are an adult who has been newly diagnosed with aggressive lymphoma, that is undergoing treatment at Austin Health. Study details All participants in this study will complete their usual treatment as prescribed by their doctor. Participants in this study will be assessed at three timepoints over the course of their treatment and recovery – one before treatment starts, one halfway, and one at the end of the treatment period. The assessment session will involve some tests to assess cognitive function and, in those participants willing to participate, a MRI brain scan and/or a PET/CT brain scan. It is hoped that this research will help determine if a larger study looking at cognitive function during chemotherapy for lymphoma is possible, adding to an underexplored area of cancer research.
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Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial
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The DAFF Study – Direct Current Cardioversion for acute onset Atrial Fibrillation in the Emergency department and the need for Fentanyl.
Expand descriptionThis study aims to evaluate the need for Intravenous Fentanyl to provide Procedural analgesia during Direct Current Cardioversion for the treatment of acute onset Atrial fibrillation. Patents will be randomised to receive a pain relief medication (Fentanyl) or a placebo (Salt water) at the commencement of the procedure. All other elements of the procedure are the same. when the patient emerges and can state their name, the clinician will ask the patient to rank their perception of pain. This will be repeated at 10 minutes from the time the patient was able to state their name. The two groups will be compared to see if the patients receiving the Fentanyl rated their pain differently , to those that did not receive pain relief. This study aims to redefine and change clinical practice, avoid use of treatments when they are not indicated, improve patient safety by reducing harm from unnecessary treatments or interventions.
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Genicular Nerve Block for Pain Management in Patients with Knee Osteoarthritis: A Randomised Double-blind Placebo Controlled Trial
Expand descriptionKnee Osteoarthritis affects many people, causing significant pain and immobility. At present, there are very few effective treatments available to managing pain in patients with osteoarthritis. This study is designed to investigate a new treatment, called a 'Genicular nerve block'. This study aims to demonstrate that 'Genicular nerve block' is a safe and effective method for treating knee osteoarthritis.
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Group Based Acceptance and Commitment Therapy (ACT) for Improving Wellbeing following Primary Medical Intervention for Breast Cancer: A Follow-up Randomised Control Trial
Expand descriptionThe purpose of this study is to test the effect of Acceptance and Commitment Therapy on wellbeing. Who is it for? You may be eligible for this study if you are aged 18 or over, and have had treatment for breast cancer within the last 2 years. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group (comparator) will continue treatment as usual, and will be able to access the intervention after a 3 month wait. The other group will immediately commence the intervention. The intervention, called Acceptance and Commitment Therapy involves six 90min group sessions, one session per week, with a psychologist. The intervention also involves some homework tasks between sessions. As part of the study, all participants will complete questionnaires. It is hoped that this study will contributed to improved quality of life in breast cancer survivors.
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A Phase 2 study to evaluate the safety and tolerability of ACT001 in treating adults with Progressing Fibrosing Interstitial Lung Disease (PF-ILD), including Idiopathic Pulmonary Fibrosis (IPF)
Expand descriptionThe current treatment options for patients with progressing Fibrosing Interstitial Lung Disease (PF-ILD), including Idiopathic Pulmonary Fibrosis (IPF) is limited and specific cohorts of patients cannot tolerate the approved treatments. Following the demonstration of activity in animal models for respiratory fibrotic diseases, this study will evaluate the safety and biological activity of ACT001 in adult patients. The study design will utilise a daily dose of ACT001, either alone or in combination with standard of care anti-fibrotic therapy, with evaluate safety, anti-inflammatory and anti-fibrotic activity in patients with stable disease state and evaluate any change in their respiratory function of a 12 month treatment period. The outcomes of this study are intended to support the biological activity of ACT001 so as to provide outcomes that can be translated into future research.
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Preventing falls in mental health: a pilot RCT
Expand descriptionThe purpose of this study is to evaluate if a tailored fall prevention program can reduce falls, reduce the risk factors for falls and improve balance, strength, confidence and the home environment for older people with a mental illness living in the community. The intervention in this study will be adapted from the Stepping On fall prevention program, which has been shown to reduce falls in typical older people living in the community. By adapting this program to the needs of older people with a mental illness, we hypothesise that these adaptations will results in improved falls and other fall-related outcomes.
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Imagery rescripting among young women at risk of developing an eating disorder
Expand descriptionThis study examined whether there is any superiority between two approaches to imagery rescripting (IR), namely rescripting disorder-specific negative body images into positive ones (i.e., body IR), or rescripting a past unpleasant experience associated with negative beliefs about self not specific to disordered eating (i.e., general IR), in a population of young women at risk of developing an eating disorder.