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CONSERVE II – Preventing Iatrogenic Anaemia in Malignant Haematology Inpatients: a pilot randomised controlled trial
This study aims to test the feasibility of implementing and evaluating blood conservation strategies in blood cancer patients admitted to hospital. Who is it for? You may be eligible for this study if you are an adult inpatient with a haemotological malignancy commencing a chemotherapy protocol. Study details Participants will be randomly allocated to either receive blood conservation strategies (including smaller discard and blood collection volumes) when blood samples are obtained from their Central Venous Access Device (CVAD), or standard of care blood sampling protocols. Questionnaires assessing feasibility and clinical data regarding markers of anaemia will be collected. It is hoped that findings from this study will help determine the impact of hospital-acquired anaemia on patients’ anaemic status and symptoms and will lead to a larger, definitive trial of this.
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Pilot Trial of Mindfulness-Integrated Cognitive Behavioural Therapy for Adults with Attention-Deficit Hyperactivity Disorder and Depression and/or Anxiety
This pilot trial aims to measure feasibility, accessibility, and efficacy of mindfulness-integrated cognitive behavioural therapy (MiCBT) for adults with ADHD who are experiencing depression and/ or depression. The therapy will be delivered in weekly group sessions and participants will be asked to practice seated meditations twice per day. The guided meditations aim to increase participants' ability to mindfully observe and not react to physical sensations that arise from thoughts and emotions, and then to apply this skill to stressful situations in their own lives, and in line with their own therapy goals.
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A pilot study to evaluate the impact of an intensive TheraPutty® hand exercise intervention on strength and function in people with Inclusion Body Myositis (IBM)
Inclusion Body Myositis (IBM) is a rare, inflammatory myopathy characterised by progressive weakness primarily in the quadriceps and deep finger flexor muscles. There are currently no disease modifying drugs available to treat IBM. Current therapy is centred around symptomatic management, with exercise a mainstay of the treatment approach. However, information and evidence related to hand exercise is minimal, despite hand grip and finger strength being impacted significantly. This study aims to determine the effectiveness of a 12-week intensive ‘at-home’ hand therapy program using TheraPutty® on hand strength and function for people with IBM. This is a single arm study, with all enrolled participants undertaking the same 12-week hand exercise program. The study will evaluate the impact on strength and function as well as the tolerability and acceptability of the intervention for participants.
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Robotic Arm Intervention for Stroke rEcovery (RAISE): A pilot randomised controlled trial
This pilot feasibility study will assess delivery of high dose motor retraining through the use of a novel exoskeleton device. The use of robotic technologies can improve upper limb outcomes post stroke, providing stroke survivors with repetitive and task-specific motor retraining. Additionally, robotic technologies can provide opportunities for active practice for stroke survivors with severe upper limb weakness and provide immediate feedback to stroke survivors and clinicians on motor performance, supporting engagement in therapy and providing opportunities to personalise intervention. This study will also provide information on the feasibility and acceptability of the use of this particular technology, which will be used to inform a larger, fully powered clinical trial.
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Augmentation of large to massive rotator cuff tears with dermal allograft: a single blinded randomised controlled trial
This study is a prospective, single-blinded, randomised controlled trial (RCT) designed to evaluate the efficacy of the ArthroFlex dermal allograft patch augmentation in the surgical repair of large (>2.5 cm) to massive rotator cuff tears. Participants will be randomized (1:1) into two groups: standard repair (control) or repair with ArthroFlex augmentation (intervention). Outcome measures, including MRI-based structural integrity, functional scores and strength analysis, will be assessed at 6-, 12-, and 24-months. Patients and outcome assessors will be blinded to group allocation, while the surgical team performing the procedure will not be blinded due to the nature of the intervention. The primary hypothesis is that patients receiving ArthroFlex augmentation will demonstrate superior pain and functional outcomes, compared to standard repair technique.
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Effect of XPERIENCE advanced surgical irrigation on Cutibacterium Acnes contamination in shoulder arthroplasty
The current study seeks to assess if the XPERIENCE® Advanced Surgical Irrigation (XASI) wash can reduce the incidence of Cutibacterium acnes (C. Acnes) pathogen contamination in shoulder arthroplasty surgery. XASI is an antibacterial irrigant employed at the time of surgery, and is currently in use in arthroplasty cases at Hollywood Private Hospital. Recruited patients will be randomized into two groups: 1) specimen swabs taken before receiving 500ml of XASI (Group 1), or 2) receiving 500ml of XASI before specimen swabs are taken (Group 2). Swabs will be taken from six different sites from around the skin incision and surgeon’s instruments. Swabs will then be transported to a single microbiology processing centre for analysis of C. Acnes antibacterial load. It is hypothesized that the XASI wash will reduce the incidence of bacterial contamination of C. acnes in the surgical field of patients undergoing primary shoulder arthroplasty.
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ISAAC: Invasive Strep A: defining the role of Antibiotic prophylaxis in Contact management
Invasive group A Strep (iGAS) is a severe infection that can lead to death or lifelong disability in people of all ages. When someone is diagnosed with iGAS, their household members have a much higher risk (2000x) of developing the same infection within the next month, a condition known as secondary iGAS, similar to the risk associated with meningococcal disease. While close contacts of meningococcal disease cases are routinely prescribed preventive antibiotics, only mother-baby pairs are routinely given preventive antibiotics for secondary iGAS, leaving a lack of guidance for other household members. The ISAAC study aims to understand if other household contacts of iGAS cases should also be prescribed preventive antibiotics. The study also aims to find out if taking a single dose of oral azithromycin is better than not taking any antibiotics at all, and if taking this shorter, single-dose oral antibiotic course could be as effective as the currently recommended longer or injectable antibiotic courses. Because these options are either long or painful, a single once-off oral medication (that you swallow) might be more preferable to household members. The trial aims to inform the public health management of invasive Strep A (iGAS) infections. Currently, household contacts are at a 2000 fold higher risk of also becoming unwell with iGAS in the 30 days after an initial case of iGAS. We think antibiotics are important to reduce this risk, but need to demonstrate both effectiveness of antibiotics and which antibiotic is the best to use. These are the main two questions of the trial. By generating evidence on the need for preventive antibiotics among household contacts of iGAS cases and exploring alternative antibiotic options, the ISAAC study hopes to better inform public health authorities and doctors across Australia on how to best manage iGAS cases.
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Microbiome in Transplant and Cellular Therapy Outcomes.
This study will assess multiomics of intestinal microbial composition and the relationship with other metabolic components, including short-chain fatty acids (SCFA) and immune cell function, which will inform for improvements of health outcomes in Transplant and Cellular Therapy recipients.
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Group interventions for parent-child dyads impacted by parental disturbances of self organisation: A Bayesian Adaptive trial.
This study aims to examine the impact of two different group interventions for parents who are presenting with mental health concerns. In particular the trial aims to see if any group is more effective for parents who present with disturbances of self organisation (DSO). DSO consists of emotional dysregulation, negative self concept and difficulties in interpersonal relationships. In addition, it hopes to test if any group is better at supporting improved parent-child relationships.
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Buzzy Bee for Pain in Babies
Newborn infants admitted to a neonatal intensive care unit (NICU) are exposed to multiple episodes of painful stimuli. These are in the form of heel-prick blood sampling, venepuncture, intravenous line insertion and injections. Cold and mechanical distraction methods such as Buzzy® have been trialled in older children as a non-pharmacological method to reduce pain by the gate control mechanism. This study aims to investigate the efficacy of Buzzy® to reduce pain felt by newborn infants from and heel-prick blood sampling. For this study, only the vibration component will be used. The device will be attached prior to heel prick and activated according to the randomisation arm. Video recording of the entire event pre, during and post procedure for a total duration of 10min, will be taken and assessed by experts blinded to the intervention for documenting pain scores and analysing the difference if any.