ANZCTR search results

This study will investigate a new drug, sodium selenate, for the treatment of drug-resistant temporal lobe epilepsy (TLE). Up to 124 patients with TLE will be recruited in to the study. Half of the patients will receive 26 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The primary outcome will be the a consumer co-designed DOOR-epilepsy rank, combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment and placebo groups over the whole 52 week period. Secondary outcomes include measures of seizures, epileptiform activity, cognitive and, neuropsychiatric outcome measures, quality of life, and medication burden at the end of 26 and 52 weeks (compared to baseline). Other measures will include safety and tolerability and exploratory biomarkers of treatment response.

Clinical protocols to manage three common complications after stroke (Fever, hyperglycaemia (Sugar) and Swallowing problems [FeSS protocols]) was shown to reduce death and disability by 15.7% for patients in the Quality in Acute Stroke Care Trial. As a result of this trial, a ‘Strong Recommendation’ to support use of the FeSS Protocols was included in the 2017 Clinical Guidelines for Stroke Management. Before the new guideline recommendation there was a significant evidence to practice gap with only 41% of patients receiving care according to the FeSS Protocols in Australian hospitals. Outside of the FeSS Intervention trials, there has been no nationwide systematic implementation efforts to introduce FeSS protocols. The aim of this research is to determine adherence to the FeSS Protocols since their inclusion as recommended care in the 2017 National Acute Stroke Guidelines. Secondary aims of this research are to: i) determine if participation in any of the previous FeSS Intervention studies (QASC, QASCIP or T3 Trial) improved adherence with the FeSS Protocols when compared with hospitals who did not participate; ii) determine if admission to an acute stroke unit when compared with patients who are not admitted to an acute stroke unit improves adherence with the FeSS protocols; iii) determine if FeSS Protocol adherence is greater for hospitals that contributed data to the FeSS optional dataset in AuSCR when compared with hospitals that did not; iv) identify what strategies or interventions have been used to implement the FeSS protocols in individual stroke services; v) identify critical individual and organisational factors, including barriers and facilitators, perceived to influence uptake and adherence of the FeSS Protocols by stroke clinicians; vi) understand barriers and facilitator variability in hospitals with high, low and variable adherence rates to FeSS Protocols, and to compare these with those previously reported in FeSS Intervention studies; vii) explore sustainability of use of FeSS Protocols for hospitals exposed to any of the FeSS Intervention studies.

Introduction The Gastric AlimetryTM platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life, and psychological health. Methods This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry™ will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity (PAGI-SYM) index, and the Gastroparesis Cardinal Symptom Index (GCSI). Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7 (GAD-7), perceived stress using the Perceived Stress Scale 4 (PSS-4), and depression via the Patient Health Questionnaire 9 (PHQ-9). Clinical parameters including diagnoses, investigations, and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30-days, 90-days, 180-days, and 360-days thereafter. Analysis The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry™ testing; from which patients’ continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life, and psychometrics (anxiety, stress, and depression). Inferential causal analyses will be performed at the within patient-level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.

Following on from the meta-analysis findings that pregnant women who subjectively report going to sleep on their back are at higher risk of stillbirth, the purpose of this project is to objectively characterise overnight sleep position during pregnancy by using more precise measurement techniques over a longer period of time. This assessment of supine sleep during pregnancy will also help to collect data on the relationship between sleeping on the back during pregnancy and lower fetal birthweight as a risk factor for stillbirth, to inform future study designs and power calculations.

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.