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An evaluation of the effectiveness of continuous positive airway pressure therapy in participants with obstructive sleep apnoea and angina
Obstructive sleep apnoea (OSA) is increasingly recognized to be a risk factor for cardiovascular disease. Case reports have shown that these patients can manifest as suspected angina with no obstructive coronary artery disease (NOCAD). Recently, this condition has been demonstrated to be associated with coronary microvascular dysfunction and vasospastic angina in the Chinese and Japanese population. This association is unknown in the Australian population. The underlying mechanism remains poorly understood and appropriate therapies are limited. We will examine the relationship between symptomatic angina with NOCAD and OSA. The planned projects will provide more insights into the relationship between OSA and coronary/peripheral haemodynamics as well as whether therapy for OSA impacts on the angina burden.
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Exercise for men with prostate cancer on active surveillance
The aim of this project is to compare the effects of an exercise program compared to usual care on cancer progression in men with low-risk prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer. Study details This study will be conducted over 3 years. Participants will be randomised to either an exercise intervention or a usual care intervention. Participants who are randomised to the exercise intervention will take part in the following five stages of exercise intervention: - Stage 1: will consist of supervised resistance and aerobic exercise 3 times a week for 6 months. - Stage 2: Exercise sessions will be decreased to once a week for months 7 and 8. - Stage 3: Exercise sessions will decrease to 1 session every 2 weeks for months 9-10. - Stage 4: Exercise sessions will decrease to once a month for months 11-12 - Stage 5: Participants will be provided with support to continue their exercise program using local exercise facilities and encouraged to self-manage their exercise routine from months 13-36. Usual care participants will take part in a walking program and be provided with information on physical activity recommendations. All participants will be required to complete 4 follow up assessments at 6, 12, 24 and 36 months involving questionnaires, blood tests and other general health checks. This study will provide information on the potential benefits of exercise in delaying the progression of prostate cancer.
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Benefits of Education and Exercise Therapy for people with knee cap pain: BEEP Trial.
Background: Knee pain is the second most common musculoskeletal complaint, second only to back pain. Both education and physiotherapist led exercise have been reported to be effective. However, to date, there is little research evaluating the effectiveness of education alone, and how many people still need physiotherapy following receiving appropriate education. Population: 30 young people (18 - 40y/o) with knee pain. Outcome measures: Pain, function, muscle strength, movement pattern, psychosocial factors, knowledge and quality of life. Phase 1 intervention: 6 weeks of online and leaflet based self-directed education to teach how to manage pain including strategies and importance of exercises to improve pain. All outcome measures will be reassessed following the 6 week period. Phase 2: Those who do not rate themselves as completely recovered following phase 1 will receive further 12 weeks tailored education and exercise guidance from a physiotherapist. This treatment will be randomly provided via 1 of 2 protocols: (i) 8 sessions of one on one physiotherapy to allow progression of exercise into a gym program; or (ii) 8 sessions of physiotherapy delivered via Skype to guide home exercises and educate them about their condition. Both groups will be reassessed for all outcome measures at the completion of this 12 week period.
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Who is leading maternity teams? An observational study of leadership sharing in maternity teams and the relationship to teamwork performance.
Simulation training is used to develop both clinical and teamwork skills. Effective teamwork, including allocation of leadership is an important factor in providing high quality patient care in emergencies. This project aims to evaluate how maternity teams share leadership and during emergencies and determine if leadership sharing is related to teamwork and clinical performance.
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Does the type of enema administration affect time to complete bowel care in people with recent Spinal Cord Injury?
Appropriate neurogenic bowel management is critical to living well with Spinal Cord Injury (SCI). In the Sydney spinal nursing community current practice around how bowel care is delivered is divided. Some recommend daily low enemas (ie, standard micro-enemas), whilst others prefer administering the enema higher into the rectum using various pieces of equipment (i.e., high enemas). High enemas are more costly than low enemas and associated with potential complications. However, many believe that high enemas give a better bowel result and therefore the additional risk and cost is justified yet there is currently no evidence to support or refute these beliefs. Therefore, the aim of this study is to determine whether low enemas are as good or better than high enemas in people with a recent spinal cord injury.
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High amylase resistant starch to decrease stool output in people with short bowel syndrome
Short bowel syndrome is defined as not having enough bowel to be able to absorb enough nutrition from food to maintain body weight. Short bowel syndrome causes diarrhoea and large fluid losses as a result of not being able to absorb what has been eaten / drunk. This means many people with short bowel syndrome rely on intravenous nutrition and or hydration. Recent studies have shown that adding resistant starch (a form of carbohydrate found in food) to rehydration solutions that you drink can reduce diarrhoea in cases from a number of different causes. There are no studies investigating the use of resistant starch to reduce stool output in participants with short bowel syndrome. It appears as though resistant starch works when it is fermented by the bacteria that live in the large bowel. A by-product of this fermentation are short chain fatty acids (SCFA). SCFA’s increase the large bowel’s ability to absorb water and salts leading to less diarrhoea and fluid loss. The aim of this study is to determine if adding resistant starch to a rehydration solution that you drink can reduce diarrhoea and fluid loss in people with short bowel syndrome. If it is effective it may have the potential to reduce the amount of IV fluids needed for some people. Resistant starch is present naturally in some foods and is approved as a food additive to increase the dietary fibre content. This trial is aimed to determine if resistant starch can decrease diarrhea in people with short bowel syndrome. It is a 2 week trial. Participants will complete both the control and the intervention. In the treatment group you will be provided with 50g of starch powder to add to St Marks’s oral rehydration solution. You will be asked to drink 4 glasses of St Mark’s solution daily, each containing a tablespoon of the powder. In the control group participants will be asked to drink 4 glasses of St Mark’s solution daily without any additions. During each study period participants will otherwise eat and drink as normal and asked not to make any dietary changes during the study periods. During the trial period participants will be asked to record the number of bowel actions they have each day and on days 2, 4 and 7 you will be asked to weigh each bowel action with scales that will be provided to record a daily total. Results will be compared between groups
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Pilot study to determine the acceptability and tolerability of male partner treatment in women with bacterial vaginosis (BV) - stage 2
OVERALL AIM: This study aims to determine the feasibility and acceptability of treatment of male partners of women with bacterial vaginosis (BV). OTHER AIMS: To examine the impact of dual partner treatment (male and female treatment) for BV on BV-associated bacteria on the male and female genitalia for 3 months after treatment. BACKGROUND AND SIGNIFICANCE: BV is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. It can be associated with important complications such as miscarriage, premature birth, low birth weight, pelvic infection, and increased risk of HIV and sexually transmitted infections. We have shown that BV recurrence (getting the infection back again) in women is common even after they have taken the recommended antibiotic treatment. A number of investigators have shown that BV-associated bacteria (BVAB) are present in male partners of women with BV on the penile skin and at the end of the urethra, but men have no symptoms of BV and male partner treatment is not currently recommended by current treatment guidelines. Studies of recurrent BV indicate that reinfection from sexual partners may be contributing to the high rates of recurrence but this requires more evaluation. Metronidazole and topical clindamycin are both antibiotics approved for use in Australia to treat BV in women. As BV has not previously been thought to affect men they have not been licensed for use to treat BV in men. Clindamycin cream and oral metronidazole are therefore considered is an experimental treatment for BV in men. This means that they are being tested to see if they are an effective treatment to get rid of BV-associated bacteria in men. There are two treatment groups in this study. Participants will be given the opportunity to choose what group to participate in, providing the maximum number of participants allowed in that group has not been reached. 1. Dual partner treatment – both the female and her male partner will receive antibiotic treatment. 2. Female only treatment (maximum of 10 couples can participate) – only the female will receive antibiotic treatment. Her male partner will not be asked to take any antibiotics.
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Enhanced Recovery After Surgery (ERAS): Pilot Study of Carbohydrate (CHO) Loading Prior to Head and Neck Cancer Surgery
The ERAS Study is examining the potential of pre-operative carbohydrates to improve post-operative recovery. Who is it for? You may be eligible for this study if you are aged above 18 years and are undergoing major surgery with free flap reconstruction for head and neck cancer. Study details The first of two groups in this study will receive standard care and be followed up for a number of outcomes after their procedure, including weight, BMI, blood biochemistry, length of hospital stay and surgical outcomes. The next group will receive a program of carbohydrate loading the night before their procedure, and have the same outcomes assessed after their procedure. It is hoped this study will contribute to the development of a preoperative carbohydrate program for patients undergoing surgery for head and neck cancer.
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Vitamin D dosing study in Intensive Care Unit patients
Deficiency of vitamin D has been increasingly recognised as a significant public health problem, even in a sunny country like Australia. We and other groups have found that this deficiency is even more common and pronounced in critically ill patients in the Intensive Care Unit.(ICU) There is now scientific evidence suggesting that vitamin D has widespread roles outside its traditionally recognised role in bone health. Its deficiency has been associated with cardiovascular disease, some cancers, autoimmune and inflammatory diseases, etc. We therefore propose that supplementing vitamin D in critically ill patients while they are in the ICU, particularly those showing signs of an inflammatory response, may improve their outcomes. This needs to be studied in depth within the context of a well-designed, large clinical trial. As a variety of doses are currently used in clinical practice, the appropriate dose that is required, particularly in patients who are critically ill, is not known. The design of such trials can only be achieved by obtaining extensive background information on safety and the effects of supplementation using different doses, which are in common use, to determine which dose to use in further trials of critically ill patients and what effects can be achieved with this. Such studies are not available currently. Fortunately, vitamin D is a medication that can be used safely in a wide range of doses and we plan to use 2 doses within this range. In this study, 50 patients admitted to the ICU who meet certain criteria, suggesting that they have signs of the inflammatory response, will be randomly allocated to receive one of 2 single doses of vitamin D by intramuscular injection. We will collect a small quantity of blood for testing at baseline and on days 1,3,7 and 14 following the dose. We will measure vitamin D and metabolite levels and markers of inflammation in order to study whether target levels can be obtained with these doses and also what effect it has on the inflammatory response. We will monitor closely for any side effects, although these would be extremely unlikely in the doses that we propose to use. We will also collect information from the patients record on routinely collected clinical data and certain outome measures. All information collected and presented will be de-identified and all records will be securely maintained to ensure privacy. This study will provide us with vital information that we require for the next stage of this project, which is the development of a large study in a number of ICUs to explore the effects of vitamin D supplementation on outcome in this patient group. If shown to be beneficial, this could be an intervention that has a widespread global impact, including in low and middle income countries, as vitamin D is a cheap, safe and easily available medication.
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Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia.
Pre-eclampsia (PE) is a condition that occurs only in human pregnancy. The condition is a multi-system disorder and is typically recognised by the new onset of high blood pressure (‘hypertension’) after 20 weeks of pregnancy, which can also be accompanied by protein in the urine (‘proteinuria’). While the exact cause and mechanisms of PE have yet to be determined, we do know that the placenta (‘after birth’) plays an important part in development of the condition, and that once the baby has been born, and the placenta is then removed, a mother’s PE usually begins to get better. Consequently, the only effective treatment for PE at this time is to deliver the baby and unfortunately, for many mothers with PE, this will mean that their baby will need to be born early in their pregnancies i.e. preterm, between 24-36 weeks. As a result, PE has the potential to be a significant cause of problems, for both mothers and their babies, in the immediate and long term. Evidence derived from both the laboratory and also human studies, involving people who are not pregnant, has shown that sulforaphane, a compound that can be found naturally in broccoli sprouts, protects against cardiovascular disease and improves the health of blood vessels. For this reason, we believe that the administration of a broccoli sprout extract supplement containing sulforaphane, may offer a new ‘low risk, potential treatment for PE. Such a treatment would be highly beneficial to both the mother and her baby, since it could help doctors (obstetricians) to stabilize a mother’s PE and as a result, prolong the pregnancy. The aim of this project is to test whether a nutritional supplement containing broccoli sprout extract, which is high in sulforaphane, can prolong the time to delivery in pregnant women who have been diagnosed early onset preeclampsia.