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Self-administered acupressure for the management of allergic rhinitis
This randomised controlled trial aims to investigate the efficacy and safety of self-administered acupressure for the management of allergic rhinitis. Acupressure is a subtype of acupuncture without needle insertion. It applies fingers to press points on the body. The study consists of 1-week run-in, 4-week treatment and 4-week follow-up period.
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Effects of endurance training on muscle adaptations in males.
The project aims to investigate the effects of different types of endurance exercise typically performed by endurance athletes on changes in mitochondria (note: Mitochondria are our muscles’ “power houses”, producing the energy required to enable your muscles to contract). This will allow us to understand what type of endurance exercise increases the mitochondrial reticulum (network of interconnected mitochondria) and what type of exercise stimulates a higher quality control (recycling of mitochondria). The information obtained from this research has implications for both performance and health, as it will allow better prescribe exercise and to best promote mitochondrial adaptations.
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Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson’s Disease
This study aims to see whether using melatonin assists with sleeping in patients with Parkinson’s Disease.IMET stands for Individual Medication Effectiveness Tests. An IMET is a new way of working out whether the medication is working for the individual taking the medicine. Most projects that test the effectiveness of medicines give information about the effects of that medication on groups of people. IMETs give information about the effectiveness of the medicine only for the person doing the test. The IMET will take twelve weeks, and use active and placebo (inactive) medication. Placebo and active medication look exactly the same, but the placebo is not active and has no effect. The IMET team will arrange things so that neither you nor your study doctor, will know what medication you will be taking at any one time. But everyone will know that you will be taking either medication for periods of two weeks at a time, and in a random order.
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Health Technology Assessment of the Clarity Autoscan system: Motion correction and margin reduction in the radiation therapy treatment of prostate cancer
The primary purpose of this trial is to evaluate the safety, clinical outcomes, patient preferences and economic benefits of reduced margins for radiation therapy for prostate cancer, with the use of the Clarity Autoscan ultrasound system. Who is it for? You may be eligible to participate in this trial if you are aged 50 or over and have been diagnosed with prostate cancer, for which you are scheduled to commence radiation therapy treatment. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either a reduced margin around the prostate during radiation therapy of 3-5mm, or to receive the standard margin of 7-10mm. All patients, regardless of allocation will have fiducial markers inserted prior to commencement of treatment, and will have the Clarity Autoscan ultrasound monitoring prostate motion throughout treatment, increasing the accuracy of treatment. The allocated treatment protocol will continue for all radiation therapy treatment sessions (up to 39). Researchers will ask participants for their preference regarding monitoring during radiotherapy, and the acceptability of the Clarity Autoscan system. Participants will also be followed up for up to five years post treatment to assess side effects and for one year to evaluate the cost-effectiveness of the motion monitoring. It is hoped that the findings from this trial can be used to inform a health technology assessment reviewing the safety, efficacy and cost-efficacy of reduced margins during radiotherapy for prostate cancer using the Clarity Autoscan system.
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Examining the Therapeutic Effects of Bacopa monnieri Supplementation and Cognitive Training on Brain Health, Cognition and Everyday Function in Healthy Older Adults.
This study aims to determine if Bacopa monnieri supplementation improves brain health, cognition and well-being in older adults undergoing regular cognitive training. 36 healthy adults aged 55 years or above, will be asked to complete 3 hours of cognitive training at home a week for 12 weeks, while consuming either 320mg of Bacopa monnieri extract or placebo per day. Participants are asked to attend three testing sessions at Swinburne University Hawthorn campus, which includes a screening and practice visit (approx. 2 hours) where consent is obtained, eligibility assessed and participants familiarised with study measures and procedures, and a baseline visit and final visit (3 hours each, 12 weeks apart) where study outcomes are assessed. Procedures measuring treatment efficacy include brain imaging using MRI, blood collection for bio-markers of inflammation and brain health, cognitive assessment of memory, reaction time and attention, and questionnaires assessing mood and everyday functioning.
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Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy.
Sulforaphane is a naturally occurring compound belonging to the isothiocyanate group. It can be obtained naturally through cruciferous vegetables with broccoli sprouts being one of the richest sources. Sulforaphane obtained through ingested broccoli sprouts are activated by myrosinase, a chemical that is released by chewing of the vegetable. Myrosinase is also present in the gut flora of individuals and mediates the conversion of precursor compound to bioavailable sulforaphane. Previous studies in humans has demonstrated the antioxidative, anti-inflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe sulforaphane may have a potential clinical utility in maternity care as a ‘low risk’ intervention for the treatment of pre-eclampsia. The aim of the research project is to evaluate the pharmacokinetics (PK) of sulforaphane obtained through the ingestion of a natural broccoli sprout supplement in a cohort of healthy women 24-36 weeks pregnant with one baby, n=6 Participation involves the ingestion of two tablets (together) of the broccoli sprout supplement with associated PK blood sampling at nine pre-determined time points, one just prior to ingestion of the supplement and then following at: 15, 30, 60, 90, 120, 240, 480, 720 minute intervals.
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Genotype and Adeno-Associated Virus (AAV) Immune Status of Patients with Inherited Blood Diseases (Haemophilia A and B)
The current method of treating patients with bleeding disorders such as haemophilia A and haemophilia B is by injection of recombinant factor VIII or IX, respectively. Even though there is evidence that prophylactic (continuous) injection of factor prevents long-term complications of the disease, cost is prohibitive. The cost for “on-demand” treatment is approximately $100,000, or more, per year for many adults. Some patients form “inhibitors” (neutralizing antibodies against coagulation factor) which increases the amount of factor needed for treatment, and the associated expense. In view of the cost, inconvenience of injections and the potential for inhibitor formation, effective alternative therapies would be welcome by hemophilic patients. One research approach for haematological diseases involves gene transfer. A research effort towards clinical gene transfer for haemophilia, including Professor John Rasko at RPAH, has focused on viral vector delivery systems based on the adeno-associated virus (AAV). Clinical trials over the past decade have demonstrated the utility of AAV vectors for the delivery of normal factor transgenes to muscle and liver. However, immune responses against AAV capsid (the viral vector “coat”) have prematurely terminated factor expression, most likely by immunologically “clearing” vector-transduced hepatocytes. Initial data indicates that approximately 50% of the haemophilia patient population has pre-existing immunity to AAV, as measured by serum antibodies. Clinical studies incorporating immune modulation have been approved, but there is a need to know the AAV immune status of a number of patients, prior to proposing the research study to patients. Therefore, this study intends to screen a number of patients with haemophilia A and B in order to determine their immune system response to AAV, and the genotype of their disease-causing mutation. Depending on the results of these tests, participants may be offered the opportunity to participate in interventional gene therapy trials for their particular disease.
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Footwear for self-managing knee osteoarthritis symptoms: the Footstep Trial
Knee osteoarthritis is a major problem in Australia and there is no cure for the disease. Non-drug strategies that help people to self-manage the condition are needed. Different types of shoes influence forces acting across the knee joint. We know that increased knee forces can contribute to the knee pain associated with knee osteoarthritis, and that high forces can increase the risk of the disease worsening over time. It is recommended that clinicians provide advice on “appropriate” footwear for people with knee osteoarthritis. However, there is little evidence from clinical trials to determine which shoes are best for self-managing knee osteoarthritis. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on knee osteoarthritis symptoms. To do this, we will allocate people via a random process into two different groups. Participants in each group will be provided with 2 pairs of different shoes to wear daily for 6 months. To ensure that this is a fair and unbiased evaluation, we will not disclose the differences in the shoe classes between the two groups until the end of the study. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help determine which shoes are best for people with knee osteoarthritis and will guide clinicians in providing appropriate evidence-based footwear advice for their patients. The findings of this study will be published in medical journals and be presented at conferences.
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One session Virtual reality exposure therapy for specific phobias of blood, injection and injury
This RCT will evaluate the acceptability and efficacy of a one-session Virtual Reality Exposure Therapy intervention targeting fears of blood, injection and injury, by comparing one-session of VRET with a waiting list control group (WLC). This study will also explore individual difference factors that predict better response to VRET, the mediators of response to VRET as well as the effect of the intervention on comorbid symptoms (e.g., depression), cognitions and emotions.
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A Phase I, randomised, double blind, placebo-controlled, single ascending dose study to evaluate the safety and tolerability of allogeneic adipose-derived mesenchymal stem cells injected into patients with osteoarthritis of the knee.
This Phase I, dose escalation trial will evaluate the safety and tolerability of Magellan Biologicals’ allogeneic (obtained from a donor) adipose-derived mesenchymal stem cells (MAG200) when injected into the knees of patients with osteoarthritis of the knee. This is the first time MAG200 will be given to human subjects who are not genetically related to the donor of the stem cells. Up to 40 volunteers aged between 18-65 years, will be enrolled. A maximum of four dose levels of MAG200 will be tested with 10 subjects in each dose level cohort; 8 subjects receiving MAG200 and 2 receiving placebo. The subjects and study team will not know which treatment a subject receives. Dosing will commence at the lowest dose level of MAG200 and a Safety Review Team will review the safety data of each dose level cohort before allowing progression to the next dose level to occur.