ANZCTR search results

This study is aiming to determine whether one of two needles (that are approved by the Therapeutics and Goods Administration) is better than the other for taking samples from mediastinal (chest) lymph nodes for the diagnosis of lung cancers. Who is it for? You may be eligible for this study if you are aged 18 or older and you have been referred by your doctor to undergo a chest lymph node biopsy procedure known as Transbronchial Node Aspiration by Endoscopic Ultrasound. Participants may have a known cancer diagnosis or will be undergoing this procedure to determine a final diagnosis such as, but not limited to, lung cancer, sarcoidosis or tuberculosis. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin), to undergo a biopsy by one needle (Acquire), or the other (ViziShot). The biopsy procedure will involve giving anaesthetics then examining airways using a camera passed via vocal cords. Both procedures will be the same, the only difference will be which needle is used. 7- 10 days after the procedure, a member of the research team will phone all participants to check if they have experienced any side effects potentially related to the procedure, including going to the emergency department. It is hoped this research will determine whether one needle is superior to the other, and this may then improve current practice by reducing the number of biopsies needed.

Suicide is the leading cause of death for young people in Australia and hospital treated self-harm is the strongest risk factor for subsequent suicide. Brief contact interventions (BCI) after patients have been discharged have been shown to reduce repeat self-harm. RAFT is an SMS-based BCI that links patients with self-guided therapeutic content. This study will recruit individuals who have recently attended a hospital or emergency department for self-harm. Participants will be assigned to an intervention arm or a treatment-as-usual (TAU) control group. Participants assigned to the intervention arm will receive supportive text messages over 12 months. Adopting a 2x2 factorial design, half the participants assigned to the intervention arm will receive access to the self-guided therapeutic content. Additionally, half the participants assigned to the intervention arm will have the option to nominate a support person to receive information about self-harm and suicide. RAFT is aimed at reducing suicidal ideation and self-harm. This trial will assess whether RAFT is effective compared to treatment as usual, with exploration of the most effective combination of RAFT features. It is hypothesised that participants in the intervention arm will demonstrate greater reductions in suicidal ideation and the event rate of repeat self-harm relative to the control group. Self-report data will be collected remotely via online questionnaires at baseline, 5 weeks, 6 months and 12 months.

Post-Traumatic Stress Disorder (PTSD) is a debilitating and costly condition. Conventional treatments are insufficient and fail to adequately address comorbid conditions such as coronary heart disease and diabetes. Dietary intervention is a well-established approach in the treatment of physical conditions whereas building evidence suggests improving diet quality may address factors that are maintaining and exacerbating PTSD. However, current research in dietary improvement programs for those at risk of PTSD is limited in quantity and quality. We aim to develop and assess the acceptability, engagement and feasibility of a codesigned digital dietary improvement program for those at risk of current PTSD. We will use data collected from a previous study that adapted the My Food and Mood app for adults at risk of PTSD, This information will be used to inform an initial prototype for the Healthy Eating Lifestyle Program (HELP) app. We will pilot HELP with 300 adults at risk of current PTSD. HELP prototypes will be iteratively co-developed with cohorts of 100 participants, based on data analytics and consumer follow up surveys. Changes to PTSD symptoms and diet quality will be also be assessed. This study targets the co-development and optimisation of a digital program targeting diet quality improvement for those at risk of PTSD. Given the relatively high prevalence of PTSD and its enormous individual and societal costs, the online self-help approach could provide a pragmatic and effective adjunct treatment strategy. Outcomes of the project will inform funding applications for a large online RCT to establish the comparative efficacy of dietary interventions for PTSD populations.

The primary objective of this project is to evaluate the effectiveness of the "Tell Your Story" (TYS) intervention for male and female Arabic-speaking refugees by conducting a randomized controlled trial (RCT). It is hypothesized that participants in the TYS condition will show reduced self-stigma and increased help-seeking relative to a waitlist control group. The secondary aim of this project is to investigate the psychological mechanisms underpinning changes in self-stigma and help-seeking. It is hypothesized that TYS increases help-seeking by decreasing negative stigma related beliefs about help-seeking and by reducing self-stigma via psychological mechanisms (future self-efficacy, self-esteem and help-seeking beliefs).

Gout has effective, safe and readily available therapies. Yet it continues to be sub-optimally managed in the community. This is due to poor adherence to medication taking. We want to examine the relationship between self-monitoring of urate and urate-lowering medication taking behaviour. We hypothesise that self-monitoring of urate concentrations enhances adherence to urate-lowering medicines. That is, patient measuring their urate and seeing the results will encourage them to take medications as prescribed. We are conducting a proof-of-concept study with 30 people with gout. They are provided with the point-of-care uric acid monitoring meter, the HumaSens2.0plus, for self-monitoring throughout the year. Adherence to medication (MEMS), gout flare occurrence, and urate will monitor throughout the year.

Supervised Injectable Opioid Treatment (SIOT) is an evidence-based treatment for dependent opioid injectors who have not responded to conventional, oral treatment. This project will implement SIOT as an adjunct to oral methadone and explore whether benefits observed during injectable treatment are sustained after transfer to standard methadone treatment. The 2-year, open-label non-controlled study will be located in a methadone clinic. We will recruit 20-30 long-term injectors of street opioids, prescribe a combination of parenteral hydromorphone and oral methadone, then around 18 months gradually transfer to oral methadone only. The project will provide data to assess the acceptability (to staff and participants), safety, outcomes, and direct costs of SIOT. We will monitor non-prescribed drug use, health, psychological state and quality of life before, during, and after ceasing injectable treatment by performing qualitative interviews with participants, staff and policy makers.

The purpose of this study is to determine whether it is feasible and safe to use Technetium99m-labelled PSMA as a tracer during prostate removal surgery (or a 'radical prostatectomy') for men with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with prostate cancer and is scheduled to receive a radical prostatectomy. Study details All participants will be asked to come into the hospital around 3-4pm the day before the surgery to receive an injection of the tracer and a scan. Once they have received the tracer, they will be observed for a while before going home. All participants will then proceed with the surgery as planned the next day. It is hoped that this study will be able to determine whether using Technetium99m-labelled PSMA as a tracer during radical prostatectomy is safe and results in better detection of any cancer that may have spread. Follow-up visits To determine the outcome of treatment, the participant will be asked to complete the self-reporting Expanded Prostate Cancer Index Composite (EPIC) survey. The EPIC survey has been extensively used to report on the physical, emotional and psychological outcomes of prostate cancer. The questionnaires will be completed at baseline (prior to surgery), at 6 weeks, 3 months, 6 months, 1 year and then yearly for a minimum of 3-5 years

A study to determine the safety and efficacy of treatment with AM-301 in subjects who suffer from seasonal AR. In this study, a saline nasal spray, ie, a drug free standard-of-care product commercially available in Australia will be used as a comparator After Screening, subjects will undergo a 7 day Run-in Period to establish Baseline, followed by a 2-week Treatment Period. The AM-301 medical nasal spray device is being developed as a nasal spray intended to treat Allergic Rhinitis by limiting exposure to airborne allergens and promoting alleviation of allergic symptoms triggered by the inhalation of airborne allergens. It is hoped that the AM-301 nasal spray device will be better than the standard of care saline spray nasal spray device (comparator) to help in improvement of Allergic Rhinitis symptoms.

Chronic analgesic use is widespread amongst active individuals and athletes. However, the most common over the counter analgesic options interfere with training adaptations and may therefore impact negatively on performance outcomes. This research project will investigate the effects of daily oral supplementation of palmitoylethanolamide (PEA - a nutraceutical analgesic) on improving muscle mass, power, strength, wellbeing and sleep in 18-35 year-old recreationally active adults while they undergo an 8-week program of whole-body, progressive resistance training. The project has been designed to test the hypothesis that supplementation with the nutraceutical compound palmitoylethanolamide (PEA) will improve muscle mass and strength/power when combined with resistance training, and that wellbeing, post exercise muscle soreness, menstrual pains and sleep quality will be improved during the study in participants taking PEA vs placebo.

This is a single centre, investigator-led study of the regional origins of biomarkers in patients with heart failure (heart failure with reduced ejection fraction: HFrEF, and heart failure with preserved ejection fraction: HFpEF) and in healthy control subjects, and of the relationship between biomarkers in cardiovascular function. The past studies have demonstrated the association between many biomarkers in the peripheral blood only and the regional blood is somewhat lack of information. This study is hypothesized to investigate the biomarkers at regional blood sampling to better understand the pathophysiology of heart failure