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Tranexamic Acid for severe endometriosis surgery
Expand descriptionTranexamic acid is a medication that can help reduce bleeding by stopping the breakdown of blood clots. It has been shown to reduce bleeding from many types of surgeries (such as heart, knee, hip, trauma and some gynaecological surgeries). When it has been used to reduce bleeding in surgery, tranexamic acid has not caused an increase in bad outcomes (adverse events). No one has yet done a study to see if tranexamic acid also helps to reduce bleeding in keyhole surgery for severe endometriosis. If less bleeding occurs using tranexamic acid during these surgeries it may also help to make operations shorter and less likely to have complications. We predict that tranexamic acid will reduce blood loss in keyhole surgery for severe endometriosis. This study is a randomized controlled research project where we randomly put people who are going to have endometriosis surgery into two groups. One group will get the treatment (tranexamic acid) during the surgery and the other group will get a placebo (a medication with no active ingredients). This is a double-blinded study which means both the participants and their doctors do not know which treatment the participants are receiving. We will weigh the blood loss from the surgeries to compare between the two groups if the tranexamic acid does indeed reduce blood loss in this type of surgery. We will also see if there are other differences between the groups such as the time it takes to finish the surgery, the rates of complications and how long the participants need to stay in hospital.
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Effects of a weight training exercise program of the 'good arm' on the 'bad arm' after stroke
Expand descriptionIn this study, we investigate the effects of strength training of the non-affected arm on the affected arm after stroke. It has previously been shown that training of one arm can increase the strength in the trained and the untrained arm. We will test the strength in both arms before, during and after the training program. As a secondary outcome measure, we will test sensorimotor performance with the KinArm exoskeleton and test if our program has an effect on activities of daily living with the stroke-impact-scale.
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A Self-Managed Exercise Program for People with Stroke - THE TASK PROJECT
Expand descriptionThis study aims to investigate whether an exercise program (TASK), with a self-management approach is feasible in terms of assisting people living in the community with stroke to exercise on an ongoing basis. Self-management in a complex condition like stroke is difficult. For self-management to be successful, an individual requires knowledge and skills, as well as the self-efficacy to be able to manage their exercise over the long term. We propose applying a more structured approach to self-management that includes training, resources and ongoing support – the TASK program. The proposed study includes two stages. In the first stage, participants will undertake the TASK program as physiotherapist-supervised practice. This practice is institution-based, supervised by physiotherapists and designed to progressively build knowledge and skills, and empower the person to exercise independently at home. In the second stage, participants will undertake TASK as self-directed practice, in which participants complete TASK independently at home. Throughout this stage participants will be provided with equipment, resources and ongoing remote support to complete the exercises. We anticipate the TASK program will remove barriers for people with stroke to self-manage their exercise upon discharge from formal rehabilitation and enhance their confidence to be more physically active in daily life. If the TASK program proves to be successful, physiotherapists will have an engaging, accessible and easy to deliver tool to a population where ongoing intervention is lacking – therefore enabling ongoing exercise.
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The effect of different calf exercises on pain and function in Achilles tendinopathy: a protocol for a pilot and feasibility trial (the LOADIT trial)
Expand descriptionObjectives: To determine the feasibility of conducting a future definitive randomised trial to assess the efficacy of specific load-intensity and time-under-tension exercise interventions for reducing pain in mid-portion Achilles tendinopathy. Design: Single-centre, outcome assessor-blind, feasibility factorial randomised pilot trial. Setting: Interventions provided in a university/ gym setting. Participants: Total number of 48 male participants with Achilles tendinopathy, recruited from the community. Interventions: Participants will be randomised into one of the four factorial arms that include high (6 repetitions to failure) or low (18 repetitions to failure) load-intensity calf exercise, and each will be performed with high (6 second per repetition) or low (2 seconds per repetition) time under tension. Exercise will be home-based and performed 3 times per week over 12 weeks. One exercise session per week will be monitored via telerehabilitation (videoconference). Main outcome measure: The primary outcomes will be study processes used to determine feasibility of a future definitive randomised trial. Process outcomes will include recruitment and retention rates, adherence to interventions, response rates to self-reported questionnaire outcomes, adverse events, and participants’ and telerehabilitation observers’ experiences with the interventions. Clinical outcomes including patient rated pain, function, global satisfaction, health-related quality of life, physical activity, kinesiophobia, pain catastrophic thinking as well as measures of plantarflexion motor function will be collected to explore the rate of change over 6 and 12 weeks in patients while completing a loading protocol with varying parameters for mid-portion Achilles tendinopathy. Discussion: This study will determine the feasibility of a future definitive randomised trial examining the efficacy of specific load-intensity and time-under-tension exercise interventions for Achilles tendinopathy.
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An efficacy study in humans for chemically attenuated malaria parasites
Expand descriptionThis study is examining the safety, immunogenicity and efficacy of chemically attenuated P. falciparum 7G8 parasitised red blood cells. Study participants designated for vaccination (n=10/group), will receive three doses of 3 x 10^5 (Group C), 3 x 10^6 (Group B) or 3 x 10^7 (Group A) purified, tafuramycin-A attenuated P. falciparum 7G8 parasitised red blood cells, with the doses administered 28 days apart. Vaccinated study participants (n=10/group) and the unvaccinated infectivity controls (n=2/group) will receive a single inoculum of 1,800 P. falciparum 7G8 parasitised red blood cells 28 days following the final vaccination to assess the efficacy of the vaccine. Samples collected during the study will be evaluated for immunogenicity. Passive and active follow-up will be used to assess safety and tolerability. Determining the safety, immunogenicity and efficacy of the Tafuramycin-A treated malaria parasites is important as they form the basis of a novel malaria vaccine approach.
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Mindful M.A.T. Time for Preschoolers - Pilot Study: Mindful Movement, Attention/Awareness, and Thoughts Time
Expand descriptionThis pilot study will evaluate a play-based, 12-week, teacher-delivered preschool mindfulness program, compared to teaching-as-usual. The program includes specific mindfulness-based activities, games, props and books. The program is designed to improve young children’s executive functioning and social-emotional wellbeing, using both direct child assessment and parent/teacher report.
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Laser therapy prior to treatment by stenting for blocked heart arteries
Expand descriptionCoronary artery disease affects an estimated 1.2 million Australian and over 47,000 stents are inserted in Australia each year. This is a double-blind, randomized, placebo-controlled clinical trial intended to evaluate if photobiomodulation (low level laser applied to the skin) reduces the damage to heart muscle during elective coronary artery stenting Participants will receive either an active laser treatment of an 808nm laser or a placebo laser for a similar length of time Participants will be block randomised and stratified on the basis of lesion description and SYNTAX score Into low and high risk groups. Participants will be excluded if they are under the age of 18 years, pregnant or receiving treatment for haematopoietic malignancy The primary outcome measure is the change in troponin levels between the prior and the 24 hour measures. After discussion with the cardiology working group it was decided that a 30% reduction in troponin rise in this intervention would be considered clinically significant. It was estimated that a sample size of 520 would have sufficient power. An interim analysis will be performed after 260 participants to check if sample size is sufficient The Student’s dependent samples t-test will be used to compare mean values of continuous variables approximating a normal distribution. For non-normally distributed variables ordinal logistical regression will be used.
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Toddler Fracture Immobilisation Study
Expand descriptionA Toddler’s Fracture is a fracture of the lower part of the ‘shin’ bone (tibia) in toddler’s or young children aged less than 8 years. The fracture is usually found in the lower 2/3 of the tibia in most cases and is undisplaced and has a spiral pattern. It often occurs after minimal trauma or a twisting injury. Most often, children with these injuries present to an emergency department with refusal to weight bear or walk, but have few other clinical signs. Historically, an above knee plaster of Paris (AK POP) is applied for 4-6 weeks to treat these injuries. An above knee plaster can cause significant disruption to the lives of the child and family as it not only affects bathing and mobility but also requires multiple visits to the hospital. These may be for complications such as broken casts and pressure areas or for routine fracture clinic appointments with the orthopaedic team. A controlled ankle motion walking boot or CAM boot is an orthopaedic device prescribed for the treatment and stabilization of severe sprains, fractures, and tendon or ligament tears and acts like a plaster cast to provide stability to a fractured bone or unstable joint, or to immobilise soft tissue injuries. CAM boot immobilisation would, theoretically, be preferential to parents and children and would allow bathing and regular prams and strollers to be used instead of the required modifications needed for above knee plaster casts. We aim to show that children have improved activities of daily living when immobilised in a CAM boot compared to an AK POP, without any detrimental effect on healing. We will also be looking at the amount of pain children experience in the two groups and parental satisfaction with the immobilisation technique used. Finally, we will assess and compare the cost of the two treatments, including time taken off work or school/day-care, and the number of hospital visits required.
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The outcome of a new vascular stent in patients with arterial disease in the legs
Expand descriptionThe newer generation TIGRIS GORE nitinol stent observed in this study has been used successfully in many practices in Australia. Given the clinical equipoise surrounding the optimal choice of stent in the treatment of femoropopliteal artery disease, it is routine practice for some surgeons and centres to choose to use this stent for their patients. This study will act as a registry for patients who receive a GORE TIGRIS stent in treatment of their peripheral artery disease, and serve to provide further data for use of this stent in a real-world setting.
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A study to determine the safety and tolerability of an intravitreal steroid in the treatment of dry Age Related Macular Degeneration.
Expand descriptionTest the safety of a new medication in the treatment of Age Related Macular Degeneration. A Phase Ib, study of safety and tolerability of Intravitreal Fludrocortisone Acetate (FCA) in Patients with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration