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A practice based trial of a combination of nutritional interventions: probiotics, glutamine and fish oils in patients experiencing psychological distress.
Mental health problems affect one in five Australians every year. Psychological distress may be a risk factor for more serious mental health conditions. Recent research on the microbiome of the gastrointestinal tract suggests a complex interaction between this community of bacteria and the health and mental well-being of the host. Lack of balance in the microbiome is often indicated by mild digestive discomfort. This study investigates a combination of nutrients that have been found to benefit the gastrointestinal tract (glutamine), the microbiome (probiotics) and support healthy mood balance (fish oil) in 10 individuals who suffer mild digestive symptoms and psychological distress. This study aims to investigate the effects of this combination of nutrients on perceptions of psychological distress in these 10 specific individuals. The data from the placebo phase and the ‘active treatment’ phase will be compared for each individual participant and will also be combined to explore some preliminary more general findings that will help with the design of future studies in this area.
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Dual or single tendon anterior cruciate ligament reconstruction: a randomized controlled trial (DOSTAR study)
This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two hamstring autograft constructs: 1) a graft constructed by folding a single hamstring tendon (harvested from the semitendinosus) four times (ST, 4 strand), or 2) a graft constructed by folding two hamstring tendons (harvested from the semitendinosus and gracilis tendons) two or three times (STG, 4/6 strand) (dependent on achieving the required minimum graft diameter). Patient outcomes will be collected and compared between the two surgical autograft cohorts over a 24 month post-operative period. This will include hamstring donor site morbidity (primary outcome variable), a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength, and single limb hop capacity, and radiological assessment of ACL graft integrity and hamstring graft site regeneration.
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Comparing the post-operative clinical and radiological outcome between surgical rotator cuff repair and scaffold augmentation for symptomatic rotator cuff tears in the shoulder
This study seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (current standard, control arm) versus scaffold augmentation (using the REGENETEN scaffold, experimental arm) for symptomatic partial thickness rotator cuff tears in the shoulder. Patient outcomes will be collected over a 24-month post-operative period and will include a range of subjective and functional outcomes, radiological measures and patient satisfaction. It is hypothesized that using the REGENETEN scaffold to augment/cover the symptomatic partial thickness rotator cuff tear will lead to improved early post-operative functional recovery, compared to the current standard surgical repair.
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GATOR: Development of a detailed database for collection of clinical data in patients with newly diagnosed GAstro-oesophageal Cancer
The purpose of this study is to create a database of early and late stage gastro-oesophageal cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or over, have gastro-oesophageal cancer and are a patient at one of the participating sites. Study details All enrolled patients will contribute data to the development of the web database. Data captured will include presentation and disease characteristics, patient characteristics, surgical and/or drug treatments administered, survival and treatment outcomes. Data will be collected for up to 10 years and will be updated regularly by study personnel throughout the patient’s treatment and follow-up from their medical record. It is hoped this research will contribute important information about all patients with gastro-oesophageal cancer and help to inform future treatment decision-making for clinicians.
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Testing safety and efficacy of a live bacterial therapy for the treatment of Helicobacter pylori infection
The aim of this study is to evaluate safety and efficacy of SVT-1C4610 as a monotherapy treatment for eradicating H. pylori infection. The treatment consists of carefully selected bacterial species that have demonstrated bactericidal activity against H. pylori in vitro. Bacteria are part of a healthy gut microbiome, including the stomach. An altered balance of bacteria in the gut is observed in people with H. pylori infection. When H. pylori is eradicate from the stomach, the gastric microbiota is observed to rebalance to a more healthy state. Proposed mechanisms for the bacterial species in eradicating H. pylori infection include competition for adhesion sites on the gastric epithelium, improved gastric mucosal barrier function, production of antimicrobial peptides against H. pylori, down regulation of inflammatory cytokines that are induced by H. pylori and by binding to H. pylori forming complexes that can be removed from the stomach via the gastrointestinal tract. There is evidence that monotherapy with high doses of beneficial bacteria is successful in eradicating H. pylori in a certain number of cases and several studies have found a greater response to eradicating H. pylori when standard treatment is given together with beneficial bacteria. This study will help determine how effective a high dose of SVT-1C4610 is as a stand-alone therapy in eradicating H. pylori and reducing symptoms.
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DETECT Schools Study: Understanding the impact of COVID-19 in Western Australian Schools
The State Government is partnering with Telethon Kids Institute in a study (the DETECT School Study) to learn more about undetected SARS-CoV-2 infection among school students and staff without symptoms.It is hoped that this study will provide a greater understanding of any role that schools play in the transmission of the disease and help us to understand how students, parents and staff are coping in this challenging environment. Three study Modules will be used to address these overarching objective and the specific module aims and intended outcomes are as follows. Module 1 - SARS-CoV-2 asymptomatic testing Aim: Document the prevalence of SARS-CoV-2 infection in a cohort of randomly selected school students/staff for testing who are not reporting any clinical symptoms of SARS-CoV-29 (asymptomatic). Module 2 – SARS-CoV-2 index case response Aim: To determine the secondary attack rate of SARS-CoV-2 when detected in a school setting. Case detection includes asymptomatic cases detected in Module 1 and symptomatic cases from Module 1 schools (after presenting to a community testing facility for symptomatic testing). Module 3 – Psychosocial impact of COVID-19 Aim: Document the psychological and social circumstances and their prevalence in a cohort of students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12).
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Sources of a Resilient Mindset in Health Professionals During COVID-19: The SOAR Study
Health professionals around the world face unprecedented uncertainty during the COVID-19 pandemic, and a resilient mindset is needed to both ameliorate stress and facilitate growth experiences during this difficult time. Resilience involves responding to a potentially highly disruptive event adaptively such that psychological and physical functioning is relatively preserved, and there is capacity for positive growth. The purpose of this study is to interview frontline health professionals to explore lived experiences of resilience during the COVID-19 pandemic. Specifically, we will focus on exploring modifiable sources of resilience, including psychological and lifestyle factors that Australian healthcare workers are drawing on to navigate the challenges of working through the COVID-19 pandemic.
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The effects of 12 weeks of resistance training combined with 5:2 intermittent fasting or continuous energy restriction on body composition, strength, compliance and gut microbiome.
Energy restricted diets are commonly undertaken with the aim of losing weight, specifically body fat. However, weight loss commonly leads to the loss of lean body mass as well. The primary purpose of this study is to compare the effects resistance training with either continuous energy restriction or 5:2 intermittent fasting on lean body mass in healthy individuals, when overall energy deficit and protein intake is similar. Our hypothesis was that 5:2 intermittent fasting would result in better preservation of lean body mass during weight loss.
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Comparing traditional Placement With placement using electrocArdiography for central Vascular access dEvices trial (P Wave Trial)
It is hypothesised that inserting a central venous access devices (CVAD) using intra-cavitary electrocardiography (IC ECG) compared to traditional anthropometric guided insertion is more accurate resulting in shorter procedure times, less catheter malpositions and cost savings. CVAD malposition can lead to significant patient injury including heart rhythm disturbances, vessel or heart wall erosion or significant thrombosis. The aim of this study was to compare the IC ECG method for CVAD insertion with traditional CVAD placement in a broad patients population.
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Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 7: Tremelimumab
This study will determine if an immunotherapy drug (called tremelimumab) has an effect on progression-free survival in patients with rare or neglected cancers. This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. Who is it for? You may be eligible for this study if you are an adult with and advanced and/or metastatic solid cancer. Study details Participants will receive the study drug (Tremelimumab) via intravenous infusion every 4 weeks for 6 cycles. Participants will complete imaging, clinical and safety assessments throughout the study. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tremelimumab will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study