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The link between oral health and cardivascular disease has been proven. Currently, there is no oral health education within cardiac rehabilitation facilities within Western Sydney Local Health District. Patients living with cardiovasuclar disease and gum disease are at an increased risk of a future cardiac event. Introducing oral health education into this vunerable poopulation may reduce their gum disease and with it their future cardiac event risk.

Single centre, adaptive design, open-label, two period crossover, study to evaluate the safety, pharmacokinetics and ex vivo antibacterial effects of RECCE®327 in healthy male and female volunteers. This study consists up to 4 cohorts with 4 participants at each dose level. The first cohort will involve two infusion rates 45 minutes (Period A) and 30 minutes (Period B) of RECCE®327 at a concentration of 4 mg/ml. Each participant will begin with a single dose with RECCE®327 intravenously over 45 minutes, followed by 48 hours safety surveillance and PK data collection. Safety assessments will be performed by the investigational site study staff and reviewed (sign off) by the PI or designee before the second dose of RECCE®327 infusion over 30 minutes with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose. For the subsequent cohort, a non-DSMB committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and / or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well. the aim of this study is to investigate possible safety dose of RECCE®327 in various dose levels and infusion duration.

What is the project about? This research project aims to evaluate the outcomes of two social media psychoeducation videos. We are inviting people who have had an Instagram account for at least 1-week by the time of study participation, are over the age of 16 years, and are fluent in English. Participants are also required to have access to a smart phone, from which they are able to access their Instagram account. During the intervention, you will be requested to complete a survey to collect demographic and well-being information, before watching one of two (10 minutes or 13 minutes long) online social media psychoeducation videos and then engaging in 10 minutes of Instagram use (using your personal account). You will then be invited to complete another survey immediately following and again 3 days later. How much time will my involvement in the project take? The initial experiment and surveys will take approximately 40 minutes. The follow-up survey is expected to take 5 minutes.

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.