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Does the type of enema administration affect time to complete bowel care in people with recent Spinal Cord Injury?
Expand descriptionAppropriate 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
Expand descriptionShort 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
Expand descriptionOVERALL 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
Expand descriptionThe 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
Expand descriptionDeficiency 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.
Expand descriptionPre-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.
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Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury
Expand descriptionThe primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce the rate of respiratory complications in acute tetraplegia. The secondary objectives of this study are to analyse whether this intervention also affects: (1) respiratory function, (2) quality of life and (3) mortality.
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The Lewy Body Study - an observational study that will assess the changes that occur in memory and thinking skills and changes that occur in the body of 100 participants with dementia with Lewy bodies over a 3 year period.
Expand descriptionLewy body diseases are a common form of neurodegenerative disorders which includes Parkinson’s disease (PD), Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). DLB and PDD are both termed Lewy body dementias, with many overlaps clinically and pathologically. Lewy body dementias also share many features with Alzheimer’s disease (AD). Dementia with Lewy bodies is a common form of dementia in older age (approximately 1 in 6 of all dementia cases), However there are very few longitudinal studies that investigate the changes that occur in the brain and in the body of people with DLB. People with DLB have an abnormal accumulation of the protein alpha-synuclein in their brain which may affect memory, thinking, behaviour, mood and movement. Many cases of DLB have multiple changes in brain pathology, such as vascular disease changes, or the accumulation of other proteins, such as amyloid and tau, that are found in Alzheimer’s disease. However it is not known what effect these changes have when there are also Lewy bodies present. In order to understand the disease process and offer potentially effective treatments in the future, these changes need to be investigated. The Lewy Body Study will establish an Australian cohort of 100 individuals diagnosed with DLB and follow them over the course of 3 years to investigate factors which may help to predict disease outcomes, and which may lead to effective treatments being available in the future. As comparison groups, 20 people diagnosed with PDD, 20 people diagnosed with AD and 20 healthy control participants will also be enrolled. So that the rate of disease changes can be monitored DLB participants will undergo clinical and cognitive (memory and thinking) assessments and health related questionnaires, a blood test and brain MRI scans every 12 months; and optional brain PET imaging scans. There is also an opportunity for participants to undergo cerebrospinal fluid collection (optional). DLB is currently widely under-diagnosed. The Lewy Body Study will provide the largest depository of DLB disease related data in Australia that will be made available to approved researchers both nationally and internationally to help further dementia research. We aim to establish whether there are any disease biomarkers (genetic, blood, imaging, cognitive) which may help improve the diagnosis rate of DLB which may in turn improve the treatments and outcomes for those diagnosed with this disease.
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Compare the efficiency of two treatments used to remove unhealthy tissue from non-healing leg ulcers
Expand descriptionChronic venous leg ulcers are a major health problem affecting approximately 1.1/1000 of the Western Australian population and previous community studies have shown that venous leg ulcers contribute to 50% of all wounds managed by community nurses. Although most leg ulcers will heal with compression bandages, approximately 20% fail to respond to this treatment possibly due to the presence of unhealthy tissue. Therefore this study is looking at two different types of debridement treatments used to breakdown the unhealthy tissue to encourage the dressings and compression bandaging to be more effective at healing the venous leg ulcers. Participants who have had a leg ulcer for more than 4 weeks but less than 5 years that have failed to respond to dressings and compression bandaging because of the presence of unhealthy tissue would be eligible to participate in the study. The participants after consent with be randomly assigned to either low frequency ultrasonic debridment or sharp debridement treatment on a weekly basis for a maximum of 12 weeks or less (if healing occurs before the 12 weeks) carried out by an experienced wound Nurse Practitoner and then have a silver dressing and compression bandaging applied. The wounds will be measured on a weekly basis using 3-dimensional laser digital planimetry system which is uploaded on a secured computer to allow automatic calculation of wound tissue volume including the percentage of reduction or increase. In addition the wound assessment and care plan will be completed using an electronic on-line secured platform (Comcare Wound Module) to analyse healing outcomes and costs for all treatments of all participants. Each participant will complete a quality of life assessment prior to commencement of treatment and on completion of the study. The study will analyse the healing rates for both debridement treatments, compare the healing rates of the two treatments to determine which treatment was more effective and analyse the cost of healing for the two treatments.
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Nasal High Flow therapy for Children with Acute Hypoxemic Respiratory Failure
Expand descriptionThis study aims to develop a multi-centre trial and to assess which children with acute respiratory failure benefit using Nasal High Flow Therapy (NHF). For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus NHF therapy. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if NHF therapy has a lower treatment failure rate in comparison to standard oxygen delivery reducing the hospital length of stay.