ANZCTR search results

This study is investigating a new cancer treatment drug, ELVN-002, that may be used for patients with lung cancer. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old. Please note that this study will not be enrolling patients with lung cancer. Study details This registration is for Part A of a 3-part study investigating ELVN-002. Participants in this study will be randomly allocated (3:1) to receive a single dose of ELVN-002 or a placebo. ELVN-002 will be given to you in capsule form. There will be 6 different dose levels tested. One cohort will also be asked to take a second single dose of ELVN-002 on Day 10 after consuming a high fat breakfast (food effect, FE cohort). Total participation will last up to 7 days and 13 ± 1 for FE cohort to the clinic for physical examination and vitals assessments and to collect blood and urine samples. It is hoped that this research will help determine the dose that ELVN-002 can be safely given to patients with lung cancer.

This is a Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study evaluating the safety, tolerability, Pharmacokinetics and Pharmacodynamics of SGB-3403 subcutaneously administered in Healthy Subjects. The primary purpose of this study is to evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single ascending dose in healthy volunteers. The secondary purpose of this study is to characterize and evaluate the pharmacokinetics and pharmacodynamic effect of SGB-3403 following subcutaneous administration. The SAD phase will enroll 37 healthy participants to be split into 5 cohorts. Cohort 1 will comprise 5 subjects (3 active, 2 placeboes) whilst the remaining 4 cohorts of the SAD phase will consist of 8 participants (6 active, 2 placeboes). Single doses of 30, 100, 300, 500, and 800 mg of SBG-3403 administered subcutaneously will be evaluated. Participants will complete a total of 3 overnight stays [admission on D-1 to post-dose on D3, followed by 9 follow-up visits on Day 5, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85, then every 4 weeks until LDL-C level returns to = 80% of baseline, but not exceed 180 days after the last study drug administration.. Each cohort commences only if previously collected data, including PK data (if available), does not highlight safety concerns after consultation with the Safety Review Committee (SRC). Following the starting dose of SGB-3403, decisions regarding dose escalation will be based on safety and tolerability assessments, PK data (if available), and reviewed SRC. Safety assessments will include monitoring of Adverse Events (AEs), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination.

Physical activity, healthy eating, and weight management are important to help prevent cardiovascular disease. Advancing on the success of pilot studies of the Australian Fans in Training (Aussie-FIT) program (ACTRN12617000515392 and ACTRN12620001260910), this study will establish if Aussie-FIT can help men with or at risk of cardiovascular disease to improve and sustain improvements to their physical activity levels, diet, physical and psychological health, compared to men that have not undertaken the program. This study will also explore the potential for the Aussie-FIT program to continue to be delivered after this study finishes on a wider scale, to help more men to improve their cardiovascular health across Australia. 320 men aged 35-75 years old with or at-risk of cardiovascular disease will be recruited to take part in Aussie-FIT. Half of the men will commence the program immediately after their enrolment appointment and the other half will commence the program 6 months after their enrolment appointment. All participants will undertake measurement assessments at 3-months and 6-months. Participants starting the program immediately will also undertake a measurement assessment at 12 months. Aussie-FIT involves 12, weekly, face-to-face sessions including coach-led interactive education workshops and physical activity delivered in sports club settings (Australian Football in Perth and Darwin, and Rugby League in Brisbane). Findings from this study will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings.

Diabetes-related foot ulcers (DFU) are a common and burdensome condition. Established interventions to promote DFU healing include local wound care, debridement, pressure offloading, management of infection and revascularisation. Despite this, the condition still accounts for significant morbidity and mortality in the community and further improvements in ulcer healing and overall outcomes in patients is essential. Recent studies have suggested that patients with type 2 diabetes mellitus are at risk of nutritional deficiencies due to high calorie yet low quality diets, poor food choices and/or restrictive eating (2). Nutrients such as Vitamin C (VitC), Vitamin A (VitA) and zinc are essential in wound healing by stimulating epithelialisation and cellular proliferation. Deficiencies in these micronutrients are common amongst people with diabetes and DFU but data regarding the effect of supplementation is limited. Our team is currently recruiting to a double-blinded randomised controlled trial of multivitamins in patients with chronic foot ulcers (VITAFOOT). However following minor amputations, patients are ineligible for recruitment for VITAFOOT, yet presumably are also at similar risk of micronutrient deficiencies. To complement VITAFOOT, in this pilot randomised controlled trial, we aim to recruit 100 adult patients at Fiona Stanley, Royal Perth, Sir Charles Gairdner or Albany Hospital with a DFU within 7 days of a minor amputation or debridement. Subjects can be either hospitalised or attending the outpatient high risk foot clinic. We will then compare 28 days of oral supplementation of VitC and zinc with placebo in a pilot randomised controlled trial. Subjects will be followed up at 4 and 12 weeks to assess wound healing, as measured using ARANZ Medical Silhouette™ wound measurement camera. Our primary outcome is to prove that micronutrient supplementation with VitC and zinc will result in greater reduction in wound area from baseline to 12 weeks (ie percentage change in wound area measured by Silhouette wound camera at 12 weeks). Secondary outcomes include: i) the percentage of completely healed DFUs at 12 weeks (ie percentage of patients with completely healed DFU at 12 weeks in intervention vs control group) ii) minor or major lower limb amputation or death at 12 weeks and iii) wound healing trajectory over 12 weeks (measured using total % area change from baseline). The following are not prespecified secondary outcomes but will also be reported i) baseline prevalence of VitC and zinc deficiencies in people with DFU, ii) adverse effects associated with micronutrient supplementation and placebo iv) baseline prevalence of anaemia, absolute iron deficiency and functional iron deficiency.

This project will implement a model of care using the Namaste Care Program for people living with advanced dementia in Residential Aged Care Services (RACS). Namaste Care is a non-pharmacological, psychosocial intervention focused on enhancing quality of life in the end stages of dementia and can be provided until the end of life. The program provides structured, personalised, multi-sensory care in a dedicated, peaceful and comfort-orientated space. Namaste care is provided by RACS staff in partnership with family caregivers and volunteers. The project will establish the Namaste Care program in 3 RACS in Tasmania supported by a Namaste Care Community of Care. The project will be the first Australian study to evaluate Namaste Care on eligible residents’ quality of life, aged care workforce satisfaction with care provision and experiences of delivering the program and family carers experiences of care. Evaluation of the project will assess for effectiveness of the intervention and implementation effectiveness. The project aims to show the Namaste Care program intervention is a feasible and acceptable intervention for residents living with advanced dementia, aged care staff and volunteers in RACS, and family carers.

We don’t yet understand why some people who experience suicidal thoughts attempt suicide while others recover. The aim of this project is to investigate the risk and protective factors in the transitions between suicidal thoughts and suicide attempts or recovery. To identify these factors, we will ask people who have recently experienced suicidal thoughts to complete several online surveys about their suicidal thoughts, suicide attempts, self-harm, mental health, alcohol and drug use, and other topics over a period of three years. We intend to use this information to identify new targets for interventions to prevent and reduce suicide attempts and suicide deaths.

Our project aims to co-design, develop and test feasibility of a digital, personalised self-management intervention for reducing pain-related disability in each individual patient with chronic pain. StudyU (https://play.google.com/store/apps/details?id=health.studyu.me) is an innovative online self-management treatment platform—it allows patients to rigorously compare different pain management interventions using gold-standard N-of-1 trials (personalised single patient behavioural experiments), empowering them to adopt strategies that help the most. In previous work, CI Konigorski and his team developed StudyU, a general-use platform and mobile App for researchers and physicians to design N-of-1 trials for chronic conditions and patients to carry out these personalised experiments. We will tailor StudyU specifically to patients with chronic pain, and with improved features that allow patients to create and run their own personalised experiments to determine which non-pharmacological management strategies improve their daily functioning.

This study is investigating a new cancer treatment drug, ELVN-002, that may be used for patients with lung cancer. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old. Please note that this study will not be enrolling patients with lung cancer. Study details This registration is for Part B of a 3-part study investigating ELVN-002. Participants in this study will receive two doses of ELVN-002 on separate days. ELVN-002 will be given to you in capsule form. During the first dosing period, participants will be asked to fast for 10 hours prior to receiving a single dose of ELVN-002. Participants will then be asked to continue to fast for another 4 hours after dosing. Nine days after this first dose, participants will then be asked to consume a high fat breakfast before being given a single dose of ELVN-002. Total participation will last up to 13 ± 1 to the clinic for physical examination and vitals assessments and to collect blood and urine samples. It is hoped that this research will help determine the dose that ELVN-002 can be safely given to patients with lung cancer.

This study will investigate whether in subjects (people with idiopathic pulmonary fibrosis (IPF) and aged matched controls without lung or gastroesophageal disease) who are found to have pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC), simple postural measures and common acid suppression medication can reduce the level of pepsin in the EBC

Patients with glioblastoma have particular needs that distinguish them from other patients with cancer, as they also have neurological issues that can affect them physically, cognitively and psychologically. This in turn produces significant burdens on their carers. The aim of this study is to assess the effect of having brain tumour nurses visit patients at home. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a glioblastoma, and you are well enough to undergo combined radiotherapy and chemotherapy treatment. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants who are allocated to the first group will have brain tumour nurses visit them at home every 2-4 weeks. This may increase over time as the needs of participants and their carers change. During the at home visits, nurses will assess the participant and carers needs and act as a point of contact to address any issues that may arise. Occupational therapists will assist in assessing the needs of these patients and providing the necessary equipment to enable them to remain safely at home. Participants who are allocated to the second group will continue to receive their usual care from their oncologist but will not receive at home visits from a brain tumour nurse or occupational therapist. These participants will be able to request additional assistance and equipment from the hospital if needed, but they will not have any at home visits as part of their involvement in the study. Participants in both groups will be asked to fill in forms to assess their symptoms. Participants who have the nurses visit them at home will be asked to attend one-on-one interviews with a member of the research team to provide their feedback on the care they have received. It is hoped this research will show whether providing at home care options to patients with glioblastoma has a positive impact upon their quality of life and reduces the need for hospital admission compared to usual care practices. If this study does show a positive impact of the at home visits, a larger trial involving a greater number of glioblastoma patients may be undertaken to further investigate this method of care.