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Learning Independent Floor Transfers (LIFT): A pilot feasibility study of a floor transfer training program embedded within a home-based community rehabilitation program for adults at risk of falls
Falls are common following a hospital admission and many people are unable to get up despite being uninjured, leading to complications from remaining on the ground for a long time, ambulance callouts to assist the person up off the floor but without transport to hospital, or a fear of falling and loss of independence. The LIFT study aims to co-design a training program (LIFT program) that teaches people how to get up off the floor and evaluate its feasibility in adults recently discharged from hospital who are at risk of falls. The LIFT program will be embedded during usual-care physiotherapy home visits as part of a community rehabilitation program. Participants will be assessed on their ability to independently get up off the floor before and after the six-week intervention. Semi-structured interviews and focus groups will be used to explore participants and therapists’ satisfaction and the practicality of delivering the program. It is hypothesised that floor transfer training is practical and acceptable to deliver within a home-based community rehabilitation program, and after 6-weeks of training the majority of participants will be able to independently get up off the floor, with or without using a chair.
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"N-of-1" single participant trials of 4-aminopyridine (4-AP) as precision therapy for the treatment of neurologic manifestations associated with KCNA1 (Kv1.1) and KCNA2 (Kv1.2) epilepsies.
This trial is a treatment specific appendix in a modular component of the Precision Therapies in Monogenic Epilepsies (PRIME) master protocol, for a series of N-of-1 studies of precision therapies in monogic epilepsies. It uses a within-participant, controlled, multi-crossover design to test the hypothesis that 4-AP, a potassium channel blocker, improves seizure control and/or ataxia associated with epilepsies due to gain-of-function (GoF) variants in the voltage-gated potassium channel genes KCNA1 (Kv1.1) and KCNA2 (Kv1.2).
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Assessment for coronary artery vasospasm as a cause for patients with unexplained cardiac arrest.
A national, multi-centre observational study is proposed to evaluate the prevalence of coronary artery vasospasm in patients with unexplained cardiac arrest. Patients over the age of 18 years who have suffered an unexplained cardiac arrest (n=60) will undergo invasive functional angiography with acetylcholine challenge to assess for coronary artery vasospasm as a potential cause for their cardiac arrest. A small control group of patients with explained cardiac arrest (n=10) will also undergo functional coronary angiography as a comparator. The primary end point is the percentage of patients with a diagnosis of coronary artery vasospasm as defined by the Coronary Vasomotor Disorders International Study Group (COVADIS) criteria. The secondary end point is the association of risk factors leading to a diagnosis of coronary artery vasospasm. We expect this study will show a significant percentage of patients with a diagnosis of coronary artery vasospasm as a potential cause for their cardiac arrest, which will allow for targeted treatment in the prevention of further cardiac arrest, leading to improved patient outcomes.
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The evaluation of a conversation treatment program for people with Parkinson's and their partners.
The overall aim of this project is to trial a conversation therapy program to improve the quality of conversations between people with Parkinson's and their communication partners. This therapy program was co-designed with people with Parkinson's and their communication partners in the previous phase of this PhD project. Aim1: To evaluate the feasibility and effectiveness of the treatment program through a clinical trial. Aim 2: To evaluate the acceptability, clinical, and social validity of the treatment program, from the perspectives of the people with Parkinson’s and their partners who received the intervention.
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The effectiveness of the Invisalign Palatal Expander System versus conventional maxillary expander in widening the upper jaw in pre-adolescents
Invisalign has released a new 3D-printed product (Invisalign Palatal Expander System – IPES) to replace traditional jackscrew-based expander plates in children 6-11 years of age. Instead of relying on a jackscrew-type system to open the jaws, it involves sequential wear through a series of 3D-printed removable plates of progressively greater width. It has recently (early 2024) been launched in global markets, with relevant approval granted from regulatory bodies (TGA & FDA). It has been marketed as equally effective but more comfortable and stress-free to use compared to traditional metal jackscrew-based expansion plates. No external studies have validated these claims.
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SUBDUE-3: A Phase 0 study of SUB-urothelial DUrvalumab-Zirconium to investigate local and systemic distribution of Durvalumab when injected in the sub-urothelium in adult subjects with muscle invasive bladder cancer or high-risk non-muscle invasive bladder tumours.
This study aims to investigate the local (bladder wall) and systemic (liver, kidney, lung, bone marrow) distribution of durvalumab with a radioactive isotope when injected in the sub-urothelium for Bladder Cancer (SUBDUE-3) Who is it for? You may be eligible to join this study if you are aged 18 years or above with a diagnosis of muscle invasive bladder cancer or high-risk non-muscle invasive (T1, high grade Ta, carcinoma in-situ) bladder tumours and scheduled for a cystectomy. Study details All participants will receive a single dose of 89Zr-Durvalumab injected to their bladder. Participants will have positron emission tomography (PET) imaging at pre-determined timepoints to visualise the distribution of the drug over time up to 7 days post injection. Blood samples will be taken and any adverse events will be recorded for up to 2 weeks post-cystectomy. It is hoped that SUBDUE-3 will contribute to the further understanding and development of immunotherapy treatments being delivered directly into the wall of the bladder with the aim of achieving bladder preservation in localised bladder cancer. This trial will contribute to the understanding and further development of sub-urothelial immunotherapy as a potential treatment for patients with bladder cancer.
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Impact of CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) on parenting stress, empowerment and efficacy, and quality of life in caregivers of children with cerebral palsy.
For parents of children with disabilities, including cerebral palsy (CP), navigating the complex National Disability Insurance Scheme (NDIS) system to develop an evidence-based package of therapies for their child is challenging. Parents tell us that they need to develop advocacy skills and have a greater understanding of what constitutes evidence-based therapies in order to successfully navigate the NDIS system and choose from 182 available therapies and over 1000 service providers. Currently, there are no capacity building programs for parents of children with disabilities that are peer-driven and peer-led. We will iteratively co-develop and test a novel web-based multi-component knowledge platform on EDX called CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills and Support Program) comprising (a) webinars and interactive consumer-led virtual groups for families of newly diagnosed children with CP entering the NDIS systemCP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) will reduce parental stress, increase parental empowerment, self efficacy and family quality of life for parents of young children with cerebral palsy. CP-KASP will be acceptable, feasible and adoptable with high levels of fidelity.
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Practice Nurses to Augment the Clinical Evaluation and cAre of people at high-risk of Heart Failure (PANACEA-HF) Trial
When left undiagnosed and untreated, Heart Failure (HF) is a complex, chronic condition associated with poor quality of life, recurrent hospital admissions and premature mortality. Consistent with a recent Strengthening Medicare Taskforce Report, this project is applying the latest point-of-care technology (including an Artificial-Intelligence guided cardiac imaging) to enhance the pivotal role of Primary Health Care Nurses (PHCNs) to cost-effectively detect and then care for people with HF in primary care. In a two-phased approach, >1000 at risk people across 3 urban, regional and rural communities, will be screened for previously undetected HF. Those found to have HF, will then be invited to participate in a trial of standard GP care versus a Practice Nurse-coordinated, multidisciplinary, primary care surveillance and intervention program. We hypothesize that those people assigned to the Practice Nurse coordinated care program will experience better health outcomes than those assigned to receive standard GP care. During minimum two-years follow-up we will compare the health outcomes (including need for hospital care and quality of life) of those exposed to standard care versus the Practice Nurse-led care program.
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A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-645 in Healthy Volunteers
This is a study of an orally administered drug called K-645. This study, which will be conducted in healthy volunteers is a randomized, double-blind,placebo-controlled, single ascending dose study with a primary purpose of assessing the safety and tolerability of single doses of K-645.
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Implementation of the Choose to Move program in Sydney Australia for people aged 50 and over
Choose to Move (CTM) is a 3-month program that provides motivation and support to adults aged 50 and over to become more physically active and socially connected. CTM was successfully developed and implemented in Canada and has shown to successfully increase physical activity, mobility and reduce social isolation in older adults. The purpose of this study is to adapt this program to suit adults aged 50 and over living in Sydney who are particularly inactive and not well supported by existing programs. This will be through a process of adaptation (co-design implementation strategies to adapt the program for older adults in Sydney), program implementation and delivery (build organisation capacity, support delivery partners on implementation and deliver 3-month intervention) and evaluation (describe and assess implementation strategies used to achieve ‘best fit’ and to measure CTM program benefits for various health outcomes to the older person). We hypothesise: 1. The Choose to Move program and implementation strategies will require minor adaptations to suit the needs of people aged 50 and over in Sydney. 2. The Choose to Move program will be implemented with fidelity. 3. The Choose to Move program will be acceptable and well attended by people aged 50 and over in Sydney. 4. The Choose to Move program will provide benefits to health outcomes to people aged 50 and over in Sydney.