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SKIBI – Supporting Kids In Brain Injury
Study objectives: 1.To investigate children and families perspective on their experience when a family member has a brain injury 2.To understand if children perceive their needs were met as a significant other in the journey of a person with a brain injury. 3. To gain information on children and families perceptions of the optimum support system that should be offered including what, how, when and where. The aim of this research is to involve consumers, with a lived experience of Acquired Brain Injury (ABI), in how sub-acute Services can best support and educate children about brain injury. Qualitative interviews with children and family members will be the first phase of research which will aim at eliciting information about their lived experience of brain injury, any perceived lack of support/information and how services could have best supported their children. The second phase of the research (not included in this stage of the trial– another application/grant will be sought) is expected to thereafter develop an age-appropriate children’s brain injury education program or ‘tool’ which will encapsulate the topics reported through the qualitative interview. The purpose of this research is to address the gaps in resources and tools that professionals can use when supporting and educating children after a parent or significant person in their lives has a brain injury. Children can be a ‘forgotten’ component in someone’s rehabilitation as practitioners are often unsure of how to age-appropriately educate them as there are minimal resources available. This research will compile the information direct from consumers as to how brain injury in the family has affected them, how their lives have changed, how they feel, how they coped, how their relationships have been affected and what would have helped them understand brain injury better through their loved ones recovery/rehabilitation. With this information, not only will consumers have felt heard, they would have contributed essential information that will form the basis of the second phase of research which will be developing an education program or ‘tool’ that can be used in any sub-acute brain injury rehabilitation setting across the world. To ensure rigour of this research, 1. Interviews will be audiotaped and transcribed. 2. It will be important to ensure truth value, credibility and dependability by taking care that all descriptions reported are accurate. Each participant will be provided with a summary of their interview summary to check before coding begins (Krefting 1991). 3. Any discrepancies following member checking by participants will be altered ready for analysis. 4. Field notes consisting of observations during the audiotaped interviews need to be developed (Patton 1990). The three researchers will meet regularly to undertake coding (open, followed by axial, followed by selective) until all agree that all possible hypotheses have been considered and consensus has been reached.
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Can metformin be safely used in patients with heart failure?
Type 2 diabetes increases the risk of heart failure by 50%. The risk of increased cardiac events in patients who are have diabetes and heart failure are high. Metformin has been shown to reduce all cause mortality in cardiovascular patients, especially reducing the risk of event such as myocardial infarction. To address this urgent health problem, we aim to investigate the safety of low dose metformin in these patients. This study will consist of a study into the safety and pharmacokinetics of metformin in this patient group. In the first arm patients (n=50) will receive 500 mg of metformin once per day for the first 3 days and then increased to 1000 mg (500mg twice daily) from day 4 up to 12 weeks. We hypothesis that low dose metformin can be safely given to heart failure patients.
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CASSETTE - Clindamycin Adjunctive therapy for Severe Staphylococcus aurEus Treatment Evaluation – An investigator-initiated, multi-centre, parallel group, open labelled pilot randomised controlled trial
The primary objective of this pilot study is to determine if 7 days of clindamycin in combination with standard therapy will lead to a faster resolution of systemic inflammation than standard therapy alone in adults and children with severe methicillin-susceptible S. aureus (MSSA) infection. We hypothesise that the addition of lincosamides (clindamycin) to standard therapy will lead to more rapid resolution of local and systemic inflammation due to blockade of exotoxin production by Staphylococcus aureus(SA). The results of this pilot study will be used to determine the feasibility and refine study design of a definitive randomised controlled trial assessing the effects of adjunctive lincosamide on patient-centred outcomes in children and adults with severe MSSA infection.
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Ultrasound Therapy in Peyronie’s Disease: a non-invasive treatment.
The health of penile tissue is dependent on adequate blood flow. In Peyronie’s disease, fibrous plaques develop in the muscular tissue of the penis as a result of reduced blood flow, caused by aging, diabetes or trauma such as surgery for prostate cancer.. The hardened plaques can be firm to feel,cause pain, prevent normal stretching and cause curvature of the penis, making sexual activity difficult or if severe enough, not possible. The negative impact on quality of life is significant and more than 70% men with PD experience depression or relationship difficulties as a result. Currently, Peyronie’s disease is treated with surgical intervention or penile implant surgery, which may cause further scar tissue development, penile shortening and erectile dysfunction. Therapeutic ultrasound is commonly used to treat soft tissue trauma in musculoskeletal injuries and has no know side effects. It reduces inflammation, minimizes tissue damage, improves blood flow and helps soften scar tissue. The purpose of this study is to assess if therapeutic ultrasound assists in the resolution of Peyronies Disease. Rationale: To date, treatment for Peyronie’s disease has been invasive or mostly ineffective. Surgical correction for example, shortens the penis and contributes to further fibrosis and scarring. Less invasive techniques such as injections have had mixed results and sometimes cause pain, inflammation and increased scarring. In a recent case, complete resolution of Peyronie’s disease occurred as a result of therapeutic ultrasound use, as analyzed under Doppler scan (Dr Kaard).In addition, Ms Milios has observed promising results in her clinical practice. There is also some evidence in the literature of older studies that ultrasound might be a useful therapy (Miller, HC, Ardizzone J. Urology 1983 22(6) 584-85, Frank IN, Scott WW. The ultrasonic treatment of Peyronie’s disease.1971 J o Urol 106 : 883) The pathophysiological mechanisms by which ultrasound might be effective are currently unknown ,but in theory relate to the piezoelectric force that bombards the fibrotic tissue via high intensity vibration and heating to a depth of up to 5cm (1 MHz soundhead). In summary, there are clinical case reports and some non-randomized and uncontrolled experimental evidence that ultrasound might be helpful in the treatment of Peyronie’s Disease.
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Naturopathic Approaches to the treatment of Irritable Bowel Syndrome
We aim to conduct an international prospective observational before and after study on naturopathic approaches to IBS. This will allow us to better describe naturopathic approaches to this disorder, establish the feasibility of building an international consortium of academic naturopathic clinics as well as the feasibility of recruiting participants. Our ultimate goal is to follow this observational study with a randomized active controlled trial using the same consortium and benefiting from lessons learned during this study. Our primary aims are descriptive. We aim to describe naturopathic approaches to IBS as well as establish pilot data on before and after changes in validated IBS instruments. Secondary aims include the feasibility of recruitment and operations across more than 9 sites in 4 countries; the establishment of an international research network of naturopathic teaching clinics; qualitative data gathering around the experience of patients seeking naturopathic care for IBS; and comparing the consensus results of our delphi panel of naturopathic IBS experts to the care received at the teaching clinics.
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Peer mentoring for eating disorders patients - evaluation of a pilot program
Eating Disorders Victoria (EDV), the Austin Hospital and St Vincent’s Hospital are partnering to develop, pilot and evaluate a peer mentoring program for people with eating disorders exiting hospital programs. This program is intended to address a service gap for people who require additional support to sustain recovery while living independently. It uses a peer support model, harnessing the experience of people who have recovered from eating disorders, with regular de-briefing and supervision. The aims of this research are to evaluate the outcomes of the pilot program on both mentees and mentors. Patients leaving the Austin Hospital or Melbourne Clinic, or tranisitioning to/from BETRS day program will be linked with an EDV peer mentor who has recovered from an eating disorder. They will participate in a semi-structured mentoring program with regular activities and one-on-one mentoring (3-hour, fortnightly sessions). These sessions will run over 6 months. In addition, participants (mentees and mentors) will undertake feedback and de-briefing sessions throughout the program.
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The effect of Aquatic "water-based" exercise on exercise capacity and quality of life in people with Chronic Heart Failure and/or a chronic respiratory disease
This study will investigate the effect of an aquatic or water-based exercise program on exercise capacity and quality of life in people with chronic heart failure and/or a chronic respiratory disease. People will be recruited to the study after their initial assessment with the Chronic Disease Community Rehabilitation Service at Royal North Shore, Ryde and Hornsby Ku-rin-gai Hospitals. The participants will attend a 45-60 minute exercise session in the hydrotherapy pool at the Graythwaite rehabilitation centre twice/weekly for eight weeks that focuses on endurance, lower limb and upper limb strengthening in a similar manner to traditional pulmonary and heart failure gym classes. Outcome measures including six-minute walk distance, leg strength (measured by five sit to stand test), quality of life and levels of anxiety and depression will be retrieved from participants medical record after completion of the program as these measures are routinely performed as part of the CDCRS service. An additional qualitative satisfaction survey will be completed by all participants at the end of the program to evaluate the new program. All staff involved in the program will also complete a qualitative survey at the end of their involvement with the study.
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What are the possible benefits of Robotic-Assisted Gait Training and how much training is needed: A pilot randomised clinical trial with children with Cerebral Palsy.
Gait disorders in children can result from a number of conditions including cerebral palsy (CP), myelomeningocoele and traumatic brain injury. Such disorders can have a profound effect on the components of walking, as well as the functional participation of children in their home, school and other natural environments. Robotic-Assisted Gait Training (RAGT) is an emerging option in physical rehabilitation for adults and children with disorders impairing their ability to walk. RAGT devices such as the Lokomat®Pro support an individual on a treadmill while the robotic exoskeleton moves the lower limbs to simulate walking. There have been positive results from the use of RAGT in adult spinal cord injury and stroke populations for improvement in gait speed and endurance; however, the outcomes were not always better than traditional physiotherapy. Currently, there is weak and inconsistent evidence that RAGT may benefit children with CP with recommendations that higher level research investigates the role and potential of RAGT in this population. Additionally, many studies have failed to consider the impact of RAGT on participation outcomes. A limitation of the current literature is that no study has investigated different training schedules (frequency and intensity) of RAGT in children with CP and there is no consensus on the best schedule to promote functional improvement. Therefore, this study aims to investigate how RAGT should be prescribed and its impacts on body structure and function, activity and participation domains of the ICF. This research has the potential to aid in the development of clinical practice guidelines for the use of RAGT in children with CP. Aims of research This project will pilot test robotically-assisted gait training (RAGT) in children with cerebral palsy to: 1. Establish the most effective dosage for RAGT in terms of a) frequency and b) intensity of session, to induce clinically meaningful improvement in lower limb functioning, (as measured by the outcome measure listed in 'procedures and measurement') 2. Establish the measurements of outcome that demonstrate the most improvement from baseline after treatment to capture relative effectiveness across the ICF domains. Hypotheses: 1. In children with CP, we hypothesise that a relationship exists between increased intensity and/or frequency of RAGT sessions and clinically meaningful improvement in lower limb performance (on ICF outcome measures). 2. We hypothesise that the greatest change in outcome measures will occur in the group with the higher dosage of RAGT therapy.
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Treatment of disordered sleep and anxiety in primary school-aged children
This study aims to determine whether changes in REM sleep stability (during treatment for insomnia) can account for reductions in anxiety in primary school-aged children. Compared to children in the control group, we expect children in the treatment group to show improvements in sleep, anxiety and REM sleep stability..
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Exercise for diagnosis and treatment of heart dysfunction among breast cancer patients
The chemotherapy medications used for breast cancer treatment are important for achieving a cure but a potential side effect is that they can affect heart function. Current tools used to assess your heart function during and following breast cancer treatment cannot accurately predict those who will go on to develop heart problems. Aerobic fitness is an important predictor of outcomes in people with certain forms of heart disease, and having a particularly low level of aerobic fitness (termed functional disability) appears very closely linked with the risk of developing heart failure. Importantly, functional disability also reflects an exercise capacity that would limit your ability to perform basic activities of daily living such as walking briskly, climbing stairs or gardening. We are conducting a study which aims to identify how anthracycline chemotherapy affects your exercise capacity and risk of functional disability. We would also like to assess how the standard test used to measure your heart function at rest compares to state of the art MRI imaging of the heart in being able to predict your risk of becoming functionally disabled. Furthermore, we are testing whether exercise training during and following your chemotherapy is helpful in protecting against functional disability. Who is it for? You may be eligible to join this study if you are between the ages 40 and 75 years old, have been diagnosed with breast cancer and are scheduled for Anthracycline-based chemotherapy. What is involved? You will be participating in a randomised controlled research project. You will be randomly assigned to one of two groups (just like a coin toss); the control group which receives usual care for your breast cancer, or the exercise group which participates in a 12 month supervised exercise intervention plus usual care. You will have an equal chance of being randomised into either the exercise or usual care group. You will then undergo a series of assessments at the Baker Heart and Diabetes Institute within two weeks of starting your chemotherapy (Baseline), after finishing chemotherapy (4 months) and again at 12 months after starting chemotherapy. Each round of testing will be split across two days, and last between 1.5-3.5 hours each. This means you will visit the Baker Heart and Diabetes Institute on 6 occasions, totalling approximately 15 hours. The testing sessions will include assessment of your heart function, exercise capacity, body composition, muscle strength/function, cognitive function and quality of life. The exercise program will consist of three to four sessions 60-minute exercise sessions per week of moderate-high intensity endurance (i.e cycling, walking, jogging) and resistance exercise aimed at improving your heart and muscle function. The training program will be prescribed by an Accredited Exercise Physiologist (AEP) who is experienced in prescribing exercise for individuals undergoing cancer treatment.