ANZCTR search results

The READY study is a double-blinded randomised controlled trial with two parallel arms. A 2 week web-based employee decision aid tool and a control website. Participants will have open access to the website for 2 weeks, this is to assist the participants in being able to make a decision by understanding that the decision aid tool will come to an end at the 2 week period with an expectation of a decision to be made at this point as informed in the PIS. Assessments will occur at baseline, post-intervention (immediately after intervention) and follow-up 6 weeks post-intervention.

In Australia cashew nut allergy is the most common of the tree nut allergies in adolescents. The 2016 revised Australasian Society of Clinical Immunology and Allergy (ASCIA) infant feeding and allergy prevention guidelines recommend: all infants should be given allergenic foods including peanut butter, cooked egg, dairy and wheat in the first year of life. However there is no specific mention of tree nut foods, like cashew nut spread. This is because we still need to establish evidence of the effect of regularly eating tree nuts or tree nut spreads in early childhood as a tree nut allergy prevention strategy. Cashew nut spreads are now readily available in supermarkets. With the texture of a paste like peanut butter, they could feasibly be introduced into the diets of infants once they have established the developmental readiness for eating solid foods. We propose to investigate two different doses of cashew nut spread regularly eaten by infants from 6 months of age onwards. This study will enable us to examine whether babies regularly eating cashew nut spread should be further investigated as a cashew nut allergy prevention strategy in a larger multi-centre randomised controlled trial. This evidence will contribute towards providing specific recommendations to also include tree nut spreads introduction during infancy in allergy prevention guidelines.

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.

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.

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.

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.

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.

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

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.

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.