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ANTIC Study: A Nutrition Trial in Chronic obstructive pulmonary disease (COPD)
The aim of the ANTIC study is to identify one or more promising nutrition interventions targeting the gut-lung axis to reduce inflammation in COPD. This will be a 3-way crossover trial, with each intervention period run for 4 weeks, with a 4-week washout between each intervention. Interventions to be tested are: • Inulin, 6 grams twice daily with food • High Amylose Maize Starch, 10 grams twice daily with food • Control period, usual dietary intake.
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BRAIx RCT: A study on the safety and efficacy of reader replacement with artificial intelligence in population breast cancer screening
This research study is investigating the safety and efficacy of using artificial intelligence (AI) in Australian breast cancer population screening by determining if using AI improves mammogram reading accuracy and timeliness and reduces reading workload. Who is it for? You may be eligible for this study if you are a woman aged 40 years and over who is eligible to participate in population-based mammography screening in Victoria and South Australia. Study details Participants will be randomly allocated to have their mammograms read by an AI-integrated system, or by the current mammogram reading standard of care (independent reading by two blinded radiologists and a third if discrepancy). The AI-integrated system will replace one of the independent radiologists with an AI reader (BRAIx AI Reader) while maintaining the arbitration radiologist reader if needed. Data will be collected on screen-detected breast cancer rates and radiologist workload. It is hoped that findings from this study will help researchers evaluate the clinical utility of implementing AI within breast cancer population screening systems in an Australian setting.
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Stereotactic Ablative Radiotherapy (SABR) One Stop Service for Lung Cancer: A pilot study for early-stage Non-small cell lung cancer (NSCLC).
This pilot study is assessing the feasibility of delivering quality assured single-fraction (SF) stereotactic ablative radiotherapy (SABR) pathway for early-stage non-small-cell lung cancer (NSCLC) in a ‘One-Stop’ visit to Peter MacCallum Cancer Centre. Who is it for? You may be eligible for this study if you are over the age of 18 and are referred for SF SABR, have early stage (T1-T2 N0M0) NSCLC, based on CT and/or PET/CT imaging. Study details Participating in this research involves undergoing your SABR treatment according to a different timeframe to what would normally happen. It also involves completing a short anonymised survey after your treatment to provide feedback on your experience of the treatment. Your next visit is for the simulation scan which the treatment team uses to plan and design your treatment. This happens whether or not you are participating in the study. However, if you are not on the study, you go home after this scan and the team works on the plan in the background. You are called back for treatment approximately two weeks later and undergo treatment as an outpatient. If you choose to participate in the study your treatment will happen within the same visit, customised to one of two options based on your travel requirements: (1) If most convenient to attend for a morning planning CT scan, treatment will be delivered in the afternoon. There will be a gap of roughly 4-6 hours between scan and treatment. You are free to leave the hospital during this time. Total time in the hospital may be anywhere from approximately 2-8 hours on that day. (2) If most convenient to attend for an afternoon planning CT scan, treatment will be delivered the next morning. You will also meet with one of our nurse specialists who will also discuss arrangements for your followup after the treatment and give you printed information about this and the experience survey. You will be provided with a $50 voucher for the ‘Super Eight’ café on the ground floor at Peter Mac to cover the cost of beverages and/or meals on the day of your attendance. A follow-up consultation with your radiation oncologist will also be arranged approximately two weeks later. This can be arranged as a ‘virtual’ telehealth appointment if you prefer. It is hoped this research will contribute to the development of streamlined, patient-centred treatment pathways and improve access to timely, high-quality SABR, potentially enhancing health outcomes for patients with early-stage NSCLC.
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Feasibility, acceptability and preliminary efficacy of implementing streamlined colonoscopy surveillance practices in South Australia for individuals who are at an increased risk for bowel cancer (the SCOPES program).
This study aims to improve colorectal cancer prevention by implementing a streamlined digital surveillance program, the SCOPES program, across five hospital networks in South Australia. Who is it for? You may be eligible for this study if you are an adult patient at one of the participating hospital networks in South Australia and are scheduled to undergo a lower gastrointestinal procedures (e.g. colonoscopy, flexible sigmoidoscopy, colorectal surgery) or if you have recently had a surveillance colonoscopy. Study details The SCOPES program will streamline surveillance colonoscopy practices using data linkage, natural language , and rule-based algorithms to ensure guideline-compliant care with colonoscopy frequency recommendations. The program's effectiveness will be assessed by comparing surveillance recommendations, patient experiences, and cost-effectiveness before and after implementation. Additionally, a statewide clinical data collection will be established to support ongoing research and quality improvement. It is hoped that findings from this study will help enhance consistency, reduce disparities in care, and improve patient outcomes in colorectal cancer surveillance.
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Dose-response study of probiotics in sick term and late preterm infants: the PRINS-2 trial
This research is about finding the optimal dosage of probiotics for sick newborn babies with gestational age greater or equal to 35 weeks, admitted to Neonatal Intensive Care Unit (NICU) of Perth Children’s Hospital. Their sickness could have been either due to a medical illness or a surgical condition. We will find out if a dose higher than 3 billion probiotic bacteria per day reduces the load of harmful bacteria and increases the load of beneficial bacteria in their gut. We will measure the gut bacteria by examining their stool (poo) samples using sophisticated laboratory investigations. Specifically, we will compare the dose of 3 billion bacteria against doses of either 6 or 9 billion bacteria per day. We think that babies who receive higher dose of probiotics will have better intestinal bacteria profile and better overall health.
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Impact of educational videos about osteoarthritis, diet, and weight management
We will undertake a randomised online study evaluating two newly co-designed brief educational videos against a publicly available control video on the topic of osteoarthritis and diet/weight management. The aim is to understand whether communication strategy surrounding diet/weight management matters to people with osteoarthritis’ diet-related outcomes, including intentions, motivation, perceived behavioural control, implementation planning, beliefs about diet and osteoarthritis, aloneness/belongingness and validation, expectation of improvement of osteoarthritis pain, and engagement with further recommended resources. We hypothesise that the new videos (paired together or alone) will lead to greater improvements in diet-related intentions than the control video.
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A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered ZE75-0267 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ZE75-0267 in Healthy Volunteers
This is a double-blind, placebo-controlled study to assess the safety of ZE75-0267 and how this drug acts in the body in healthy volunteers. ZE75-0267 may be indicated for use in patients with Parkinson's disease, but a trial of the drug in healthy volunteers is needed before trials in Parkinson's disease patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive single or multiple doses of ZE75-0267 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of ZE75-0267 that can be administered safely without causing severe reactions. Once the dose of ZE75-0267 has been determined in healthy volunteers, a trial investigating the efficacy of ZE75-0267 as a treatment for patients with Parkinson's disease may proceed.
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A multi-centre, prospective study for investigation of ex vivo quantitative micro-elastography images acquired from breast tissue.
The purpose of this study is to develop a dataset of micro-elastography images co-registered to ex vivo images of breast tissue. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ carcinoma and you are eligible for breast conserving surgery based on clinical evaluation by the Investigator. Study details The images will be acquired from fresh breast specimens using the ORM-P2 system - a new handheld imaging device being developed for margin assessment using micro-elastography during breast conserving surgery. Participants undergoing breast conserving surgery who consent to the study will have their fresh breast specimens collected from theatre and scanned using the ORM-P2 investigational device, prior to routine pathology testing. It is hoped this research will determine whether use of the ORM-P2 device is effective at developing a dataset of co-registered quantitative micro-elastography ex vivo images of breast tissue.
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The Effects of Childhood Adversity on Perinatal Outcomes and Health Outcomes in the Subsequent Generation: A Cohort Study of Maternal and Child Health Service Use (I-CALM)
The Intergenerational Childhood Adversity and Lifetime Morbidity (I-CALM) study extends a previously approved project (MUSP-CALM) that linked a prospective birth cohort recruited at the Mater Hospital in the 1980’s to administrative health data of emergency department (ED) presentations, hospital admissions and contacts with mental health services up to 31 December 2020 (HREC/2022/QMS/83690). MUSP-CALM sought to study the effects of childhood adversity on health outcomes up to 40 years old. With I-CALM, we now seek to anonymously link the same birth cohort to the Perinatal Data Collection (PDC) to a) study their obstetric history and the perinatal history of their children and, b) link children’s perinatal records to their ED presentations and hospital admissions in the same way as we did with their mothers. The new I-CALM dataset will resultantly include two generations of data regarding heath service use, as well data on the 1st generation’s (children of the original mothers) agency reported child maltreatment data, socio-economic information (both already in the CALM dataset). This will enable the study of intergenerational health outcomes in the 2nd generation (grandchildren of the original mothers) relative to the childhood adversity experience by their mothers. The results from this study will provide evidence of intergenerational risk factors for health service use, which could tailor preventative interventions and/or inform risk tools able to identify at-risk individuals in the next generation. We hypothesise that maternal childhood adversity are associated with increased health service use and community mental health service use of their children compared to children with mothers who did not have childhood adversity. We also hypothesise that maternal childhood adversity is associated with higher instances of perinatal complications compared to mothers without previous childhood adversity.
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REAFFIRM: a Regional tEletrial Assessing Feasibility oF clinical educatIon + Reinforcement for Menopause care
Fifty-one percent of our current Australian population were born with ovaries and 6 million are now aged 40 or over; ie. at or approaching perimenopause and menopause, but very few clinicians have actually received training or education regarding menopause and its care. This study to aims to determine if the simple intervention proposed (combining education, reinforcement and telehealth) is a feasible approach to raise menopausal-awareness & training of your average primary care clinician (& patients too). This is especially important in rural/remote areas where telehealth follow-up may be significantly easier and patients are unlikely to have the option, and/or much longer wait times, to see menopause-specialist GPs who tend to be metropolitan-based.