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Pathways for Aboriginal & Torres Strait Islander hearing health: The PATHWAY Project
Ear disease, and its associated hearing loss, are more prevalent in Aboriginal and Torres Strait Islander children. While ear and hearing health services are available, it can be hard for families to attend these services. This project seeks a clear understanding of the out of pocket health care expenditure and referral process from the perspectives of Aboriginal and/or Torres Strait Islander parents and families of young children between the ages of 0 - 8 years with a history of ear disease.
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CLL11 - A study to evaluate the efficacy of Epcoritamab consolidation in high genomic risk and Measurable Residual Disease (MRD)-positive Chronic Lymphocytic Leukaemia (CLL) patients after first-line venetoclax and obinutuzumab
The purpose of this study is to evaluate if treatment with epcoritamab will improve outcomes compared with historical value through increased conversion to U-MRD4 (cohort 1) and reduced loss of U-MRD4 (cohort 2) for patients diagnosed with CLL. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with CLL or SLL Study details This is a multi-centre single arm non-randomised phase II study in 2 distinct cohorts of patients: Cohort 1: Patients that are MRD4+ (defined as >10-4 on peripheral blood samples) at 3 months after completion of Ven-Obin, irrespective of pre-treatment genomics. Cohort 2: Patients with CLL with adverse-risk genomics (defined as TP53 aberrancy and/or unmutated IGHV) detected before treatment and achieving undetectable MRD4 (U-MRD4) at 3 months following completion of Ven-Obin induction. Both cohorts will receive the following treatment: - Epcoritamab will be administered as a subcutaneous injection on a 28-day cycle. In Cycle 1 epcoritamab will be administered on days 1, 8, 15 and 22, following the ramp-up schedule. - From cycle 2 onwards, epcoritamab will be administered on day 1 of each cycle. During treatment, patients will have the following assessments : · Haematology: Haemoglobin, WBC, Platelets · Biochemistry: Urea, creatinine and electrolytes · Assess AEs A total of 38 patients is planned, 14 in cohort 1 and 24 in cohort 2. Each patient will be followed for 4 years post completion of trial treatment, unless withdrawn previously. The total trial duration is expected to be 7 years. All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. It is hoped this research will determine if Epcoritamab treatment can improve outcomes for patients diagnosed with CLL.
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Moderately accelerated pacing in patients with cardiac amyloidosis
Patients with a restrictive cardiomyopathy, such as in cardiac amyloidosis, have poor heart function due to the increased stiffness of their heart. These patients usually compensate by increasing their heart rate. In patients with pacemakers, the ability to increase their own heart rate naturally is usually impaired. This trial is aiming to assess if using the pacemaker to increase the patient's heart rate results in better heart function and quality of life in patients with cardiac amyloidosis who have pacemakers. It is hypothesized that patients with an accelerated pacemaker rate will have an improvement in the function of their heart and quality of life compared to those with a lower pacemaker rate.
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A trial to assess direct transfer from methadone to CAM2038 (buprenorphine) in patients with opioid dependence
This study is looking at a new experimental approach for transferring patients from methadone to CAM2038. The purpose of the study is to test if patients with opioid dependence who are treated with a methadone dose of above 30 mg per day to 100 mg per day can be transferred to CAM2038 without reducing the dose of methadone before they start CAM2038. After starting CAM2038 treatment, the methadone dose is then reduced over several days. The main outcome of the study is to see how many participants that proceed to the standard treatment dosing with CAM2038 after one week of treatment with both CAM2038 and methadone. The study hypothesis is that patients can start treatment with CAM2038 without having to reduce their methadone dose below 30 mg before the first dose of CAM2038.
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An assessment of the safety, efficacy and patient satisfaction of Intravenous antibiotics administered at home as a continuous infusion through a peripheral intravenous cannula, by 4 Australian Hospital in the Home (HITH) services
This will be a multicentre (4 Australian HITH services) prospective cohort study where the patient population will be Hospital in the Home (HITH) patients prescribed short term (<2 weeks) continuous antibiotics as an infusion via a Peripheral Intravenous Cannula (PIVC). Patient demographics and comorbidities will be recorded along with prospective data collection on initial PIVC insertion reason and process details, with PIVC and patient outcomes recorded until the time of PIVC removal. A written, short patient survey will also be conducted to establish patient perception and satisfaction of this type of treatment. This means of continuous intravenous antibiotic infusion via a PIVC will be compared to anticipated PIVC complication rates generally (PIVC inserted for any reason) as reported in the literature and to anticipated Peripherally Inserted Central Catheter (PICC) complication rates.
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SToPPING Acute Rheumatic Fever (ARF) skin Trial
This research study is looking at the ability of the Roche Diagnostics cobas Liat device to reliably and accurately detect Group A Strep (GAS) infection in skin sores. Currently, this device is approved for testing of GAS throat infections. Throat and skin infection with GAS bacteria is common in childhood, but repeated infections can lead to Acute Rheumatic Fever (ARF) and Rheumatic Heart Disease (RHD). Early diagnosis and therefore treatment of GAS infections are key to preventing ARF and RHD, particularly in places with high rates of infections. Analysed and deidentified results from this study will be shared with the study collaborator to support their submission of an application to the Therapeutic Goods Administration to obtain approval for this test to be implemented in clinics for detecting skin infections across Australia.
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REST: Randomised trial of an intervention targeting self-Efficacy to self-manage cancer-related fatigue in people with a primary brain Tumour
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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.