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A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers and Patients with Huntington’s Disease
This study is a first-in-human multi-center, Phase 1, randomised, double blind, placebo controlled study to evaluate the safety and tolerability of SKY-0515 in patients with Huntington’s Disease (HD). The study has 2 parts: Part C (i) a non-interventional observational arm and Part C (ii) where two dose levels (3mg and 9mg) will to be evaluated in HD patients. Part C (i): Participants will be required to attend 2 clinic visits over a period of 28 days. Health information and blood samples will be collected at these 2 visits. No treatment is given in this part of the study. Upto 50 participants will be enrolled. Following completion of Part C [i], participants will be invited to participate in the treatment portion of the study - Part C [ii], based on eligibility. Part C (ii): Enrolled HD patients will be randomised to 3 parallel treatment arms to receive 3mg study drug ,9mg study drug or placebo for a period of 1 to 3 treatment cycles (each cycle is 28days).
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Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)
To assess the Tolerability and Safety of inhaled CMS and the profile while, comparing once daily (QD) with twice daily (BID) Administration for 28 days, The study will be measured by safety and respiratory tolerability events.
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Low-Intensity Transcranial Focused Ultrasound for the Treatment of Obsessive-Compulsive Disorder
This study aims to assess the safety and potential effectiveness of low-intensity transcranial focused ultrasound for the treatment of obsessive-compulsive disorder. You may be eligible for this study if you are aged between 18 and 50 years and you have been diagnosed with moderate to severe Obsessive-Compulsive Disorder (OCD) for more than 12 months. Transcranial ultrasound stimulation (TUS) will be delivered via the NeuroFUS system. This uses focused ultrasound sonication, delivered to the scalp, to stimulate neural activity in cortical and subcortical regions of the brain. In total, participants will receive six sessions of stimulation [80 second stimulation sessions of theta burst patterned TUS], delivered to two brain regions for three sessions each in the resting state, and during a symptom-inducing task. The duration of the participant participation is 10 week plus 4 weeks follow-up.
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Mindfulness and personality in the general population
Generally, practicing mindfulness has been found helpful for positive and negative affect in the general population. However, it is as of yet unclear what the most effective dose of mindfulness practice is, and how this differs across individuals and personality types. This study seeks to determine whether some individuals (based on personality) find different lengths of a mindfulness practice more helpful than others. In this study, the impact on positive and negative affect of two different lengths of mindfulness practice (and a no-practice control group) are compared across personality types. Data will be collected online from an adult general population sample, building on an approach that has proven feasible in the Principal Investigator’s previously published research. The current study should help future mindfulness-based programs to better personalize the mindfulness practices they offer, resulting in better outcomes for their participants.
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Bridging the gap in physical activity and diet support for breast cancer survivors in Australia: a randomised controlled trial in primary care
The purpose of this study is to test if receiving supportive text message program called EMPOWER-SMS GP from a general practice can help improve breast cancer survivors’ physical activity and other health outcomes compared to not receiving any messages. We also want to know the barriers and enablers to implementing this program into general practice, based on feedback from participants and general practice staff members. Who is it for? You may be eligible for this study if you were diagnosed with breast cancer, finished surgery, chemotherapy and/or radiation therapy within the past 3 years, have a mobile phone and attended =1 general practice appointment within 2 years. Study details Participants in this study will be randomised (50/50 chance) into two groups. One group will receive four text messages per week at random times and days in addition to their usual care for 6 months. The other group will receive usual care alone for the 6-month period, and will be offered the text message program after that time. All participants will complete number of questionnaires at the start of the study and again at 6-, 12-, 18- and 24*- months (*if funding and time allow). It is hoped EMPOWER-SMS GP will help breast cancer survivors’ feel better after treatment, will be easily integrated into general practice workflows and will be acceptable and useful for participants and general practice staff members.
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Clinical study assessing the preliminary efficacy and safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care
This study will assess the anti-cancer activity of RXC004 given alone in participants with advanced pancreatic cancer whose cancer has worsened following therapy with current standard of care. You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437) and have RNF43-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care. All participants will be treated with RXC004. RXC004 capsule strengths are 0.5 mg and 1.0 mg capsules to be taken at a dose of 2mg daily, taken orally and fasted. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. It is hoped that this study will help increase treatment options for patients with advanced pancreatic cancer.
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Australian Lung Screen Trial for Aboriginal and Torres Strait Islander Peoples
This Study aims to understand the best way to offer Australian Aboriginal and Torres Strait Islander Peoples lung cancer screening. Who is it for? You may be eligible to join this study if you are an Aboriginal or Terres Strait Islander person aged between 50 to 80 years old, and at high risk for developing lung cancer. Study details. All participants who complete an eligibility questionnaire and are found to be at high risk of developing lung cancer will be offered a low dose CT chest scan. Participants will be invited to complete a Lung Health Questionnaire, a Quality-of-Life questionnaire on enrolment then an annual health assessment questionnaire for up 10 years. Participants who do not meet the eligibility criteria for a low dose CT chest scan will be invited to participate in the Annual Health Assessment by agreeing to complete a questionnaire every year for up to 10 years. It is hoped that this research project will contribute to lung cancer screening research to detect lung cancer so it can be treated early.
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Telehealth vs face-to-face consults in patients attending a Urological Oncology Clinic. A Randomised Controlled Trial.
This is a study that will be used to evaluate how effective Telehealth is for patients who are already being followed up in a urological oncology clinic. You may be eligible for this study if you are already a patient who is regularly followed up at the Crown Princess Mary Cancer Centre in Westmead Hospital for a urological cancer condition. Unfortunately, if you are not yet known to the clinic or are awaiting to see a urologist for your first visit, you will not be eligible to participate. Study Details Patients who are eligible for the study will be contacted and informed about the trials aims and methods and informed consent will need to be provided should they wish to participate. Following this, participants will be randomised prior to their next follow up appointment to either a Telehealth group or the standard face-to-face appointment type. They will be notified of their allocation 24 hours prior to their appointment. At the end of the follow up appointment, participants will be asked to completed a validated questionnaire that will help quantify their responses with regards to effectiveness, services provided, efficiency and timing of the appointment, and overall satisfaction. These scores will be de-identified and anonymous. By participating in this trial, we will be able to compare how effective patients find Telehealth vs face-to-face consultations for those suffering from common urological malignancies. We also will assess to see if there are any barriers to the widespread adoption of Telehealth for these common health conditions and if any adverse effects are encountered. This knowledge can help potentiate Telehealth's adaptation to other fields of surgical and medical disciplines as well as providing timely and more efficient care to a greater number of patients within the local health district.
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'My Toddler and Me' group program: A hybrid effectiveness-implementation trial testing outcomes for caregivers and toddlers aged 12-24 months
This project aims to evaluate the effectiveness of 'My Toddler and Me', a group-based parenting intervention adapted from Parent-Child Interaction Therapy for Toddlers, in improving outcomes for caregivers and their toddlers (12-24 months old). Additionally, it seeks to assess implementation outcomes to inform future scaling. Furthermore, the study will investigate the role of biological factors, specifically OXTR polymorphisms, in predicting social-emotional and behavioural issues in toddlers and their response to the 'My Toddler and Me' program. The study will recruit 120 parent-child dyads, randomly allocating them to either the 'My Toddler and Me' program or a waitlist control condition. Parents will complete a series of parent-report questionnaires at baseline, post-treatment/waitlist, and a 3-month follow-up.
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ARCHIMEDES study: Investigating the role of clonal haematopoiesis in atherosclerosis progression
Clonal haematopoiesis of indeterminant potential (CHIP) is the technical term to describe the expansion of blood cells that results from changes to the genetic code that occur during normal ageing. We are only now beginning to understand what the implications of CHIP are for human health. CHIP has been linked to increased risk of cardiovascular disease. The aim of this study is to examine the blood vessels in the heart and factors in the blood to see if people who have CHIP have faster progression of atherosclerotic cardiovascular disease and other cardiovascular risk factors.