ANZCTR search results

The overall aim of this research project is to conduct an open label sequential treatment pilot study to assess alternate thyroid replacement treatments to standard levothyroxine (LT4) treatment. Participants will be aged 18-60 years taking greater than or equal to 100mcg daily LT4 monotherapy for hypothyroidism at stable dose. Participants will receive 21 weeks of levotriiodothyronine/ liothyronine (LT4/LT3) combination treatment followed by 21 weeks of desiccated thyroid extract. Dose adjustment will occur 7-weekly, based on results of serum thyroid function testing. The primary outcome of the pilot study is to assess the feasibility and design of a large-scale randomized trial of thyroid hormone therapies with specific trial design aspects to be studied including recruitment; adherence to treatment regimen; participant and staff satisfaction with protocol; completeness of data; and adherence to study protocol. The secondary outcome is to assess the number of dose adjustments required for stable thyroid function using a dose adjustment algorithm. Participant reported outcomes will look at the difference in thyroid-specific quality of life scores measured at the end of each study phase compared with their baseline score.

Sarcopenic obesity (the presence of low muscle mass/strength and high body fat) is associated with increased falls and fracture risk in older adults. Functional intensity training may reduce falls and fracture risk in sarcopenic obesity. Participants will be randomised allocated to either a home-based program or home based aerobic exercise control group while undergoing a dietary weight loss program. The project will investigate whether a 24 week home based functional impact training program results in significant improvements in physical function, bone quality and insulin sensitivity compared with home based aerobic exercise program (control) in 116 sarcopenic obese community dwelling older adults undergoing weight loss through dietary intervention.

We have developed a smartphone App to support participation in decision-making for adults with stage 5 chronic kidney disease who are currently receiving haemodialysis. The App is called the SUCCESS App. It includes information about: • Diet • Fluids • Physical activity • Medicines • Emotional wellbeing • Supportive care • Health literacy skills The purpose of this study is to investigate whether the SUCCESS App supports adults with chronic kidney disease to make decisions about their health, and helps increase knowledge, skills and quality of life.

This study is aiming to explore the effect of a synbiotic formulation (combination of prebiotic and probiotic) on gastrointestinal chemotherapy symptoms in patients with solid tumours. Who is it for? You may be eligible for this study if you are aged 50 to 75 years old, have a solid tumour cancer, and are starting chemotherapy treatment. Study details Study participants will be randomly allocated (by chance) to one of two arms. One group will receive a synbiotic formulation taken twice daily for two weeks at the start of the first chemotherapy cycle, while the other group receives a placebo formulation taken twice daily for two weeks at the start of the first chemotherapy cycle. After a two week break from treatment, a second chemotherapy round will take place, with group one given a placebo formulation and group two given a synbiotic formulation. This sequence will repeat in the third and fourth chemotherapy cycles. Incidence and severity of gastrointestinal symptoms will be monitored using FACT-C questionnaire , Bristol stool score and LPS assay. We hope that this research will improve health outcomes such as gastrointestinal symptoms alleviation from chemotherapy and better tolerability of chemotherapy leading to improved quality of life.

Atropine eye drops are known to affect pupil reactions and the ability of the eyes to focus on near objects. This study will quantify the effects of different concentrations of atropine eye drops on these ocular structures when given daily or in an alternate day dosing schedule.

Aboriginal and Torres Strait Islander people die from acute coronary syndrome (ACS), the life-threatening manifestation of ischaemic heart disease, at younger ages than non-indigenous Australians. The reason for this is unknown, as are the risk factors for ACS in Aboriginal and Torres Strait Islander people. This lack of knowledge limits the usefulness of emergency department (ED) risk assessments for Indigenous patients with suspected ACS, which have been developed using data from a general population and are not specific for Aboriginal and Torres Strait Islander people, despite evidence of clear differences in risk for coronary artery disease (CAD) (the underlying cause of ACS) based on ethnic background in no- Aboriginal and Torres Strait Islander cohorts (African-American, Hispanic, Caucasian, Asian). Chest pain risk assessment allows for rapid diagnosis and treatment of ACS and prevention of over-investigation in patients deemed to be "low-risk". In the absence of evidence, current guidelines recommend a cautions approach and consider Aboriginal and Torres Strait Islander patients with chest pain at higher risk of ACS than non-indigenous patients. We will conduct a prospective, cross-sectional study of Aboriginal and Torres Strait Islander people who present to the Cairns Hospital Emergency Department with chest pain. The primary aim is to determine the rate of CAD, measured by coronary artery imaging. Eligible patients will be asked to consent to provide access to their clinical data for the duration of the study. Participants will receive usual clinical care in the ED and be classified as either "high-risk" or 'not high risk". All "not high-risk" participants will undergo an exercise stress test as part of usual care, followed by coronary artery imaging. All patients will be followed-up after two months to record the subsequent occurrence of cardiac death, acute myocardial infraction, urgent/emergency revascularisation, and cardiac re-presentation to the ED and primary care physicians. The cost of health care utilisation over the two months follow-up will also be determined. Participants will be classified as having clinically significant coronary artery disease (>50% stenosis in at least one coronary artery) or not, and as having ACS or not. Demographic and clinical characteristics will be compared between patient groups. We will recruit 80 patients, which will allow us to measure and expected rate of coronary artery disease of 6.3% with 3% precision. The expected findings from this study will 1) allow ED doctors to determine a baseline level of risk of ACS for Aboriginal and Torres Strait Islander patients who present with chest pain, and 2) provide preliminary information necessary for the design of large- scale research studies with the goal of determining specific risk factors and determine optimum investigative strategies for ACS in Aboriginal and Torres Strait Islander people.

The iSEARCH Trial will determine if, in women in labour at term receiving oral 50 mg SC vs placebo given in less than or equal to 3 doses, reduces a primary composite endpoint, determined up to 28 days after birth, of ten perinatal outcomes related to intrapartum hypoxia.

In order to enhance person-centered care of individuals with dementia specific training for health professionals should go beyond just knowledge acquisition, and also target empathy and attitudes . Artificial Intelligence (AI)-Enhanced Virtual Reality (VR) technologies can facilitate learning experiences that simulate adaptable scenarios of real-life practice from both patient and practitioner perspectives. The aim of this project is to develop and pilot test an AI-enhanced VR dementia training program for physiotherapy practitioners and students. This training has the potential to enable an empathetic approach to care, and improved perceptions of people with dementia.

The INJECT pilot feasibility study is comprised of a patient self-management psychological intervention to address needle distress in adults receiving haemodialysis foe end stage kidney failure. the intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of 6 learning modules which will provide strategies patients can apply to manage needle distress. There is also an option to use virtual reality (VR) technology as a distraction during dialysis. Patients will be supported by nurse practitioners and a research officer during the intervention. The goal is for patients to feel empowered in self-managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning. This structured and novel intervention enhancing patient self-management and empowerment represents a major advance in addressing needle fear and reducing this aspect of the psychological burden experienced by dialysis patients. It can be translated rapidly into clinical practice and may benefit other patients receiving frequent needles as part of therapy, for example for cancer. It is inexpensive and feasible to deliver across sites. Partnership with patients and nurses at all stages ensures the intervention is useful and successfully implemented into clinical care.

A randomized placebo-controlled pilot trial on palmitoylethanolamide (PEA) and curcumin for pain management in patients with chronic non-cancer pain. The overarching aim of this study is to evaluate the efficacy of a combined herbal/nutritional supplement for pain management and quality of life (QOL) indices for patients with chronic pain. Primary Objective • Evaluate the effect of combined PEA/curcumin capsules on pain management in patients with chronic pain in comparison to placebo. Secondary Objectives • Evaluate the effect of combined PEA/curcumin capsules on associated QOL parameters and daily functioning in patients with chronic pain in comparison to placebo. • Compare pain medication consumption between PEA/Curcumin group and placebo group • Evaluate safety of combined PEA/curcumin capsules with existing pain medication.