ANZCTR search results

The goal is to understand clinical factors in euthanasia requests. We hypothesise that a proportion of euthanasia requests are driven by potentially reversible factors such as depression, decline in physical mobility or social isolation. By understanding the factors that affect euthanasia attitudes we can treat the possible reversible causes. This will mean that when a person requests euthanasia informally or formally, clinicians will be able to assess a number of reversible causes in order to provide treatment for the patient. Examples of this may include but is not limited to: improving mobility, improving social isolation or treating mental illness.

Globally, a child dies from sepsis every 30 seconds. In Australia, one child dies every week, and many surviving children experience long term disability. We hypothesise that treatment of septic children with vitamin C and hydrocortisone will result in earlier shock resolution. We will perform a worldwide randomised controlled trial in paediatric sepsis which will test the use of Vitamin C (100 mg/kg 6 h) and Hydrocortisone (1 mg/kg 6 h) which has shown some promise in improving patient-centred outcomes in adults. The study will assess functional outcomes and quality of life, consumer engagement, and sepsis related costs. The wide dissemination of findings will increase awareness of sepsis and could save lives. In addition, we aim to establish a biobank of patient samples enrolled in the trial for sepsis biomarker studies.

This study will evaluate the safety and efficacy of AZD5153 for Acute Myeloid Leukemia in the maintenance setting. Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard care which is generally observation. Participants in the other group will receive the drug AZD5153 daily for a total of upto 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 21 days) as well as an ECG to monitor heart function. AZD5153 is known to have adverse effects on the heart therefore, participants will also have a MUGA (Multiple Gated Acquisition scan) at screening. We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available ,become accessible to the general population at faster than the normal process.

The treatment of multiple sclerosis (MS) with immunomodulatory drugs play an important role for many people with MS (PwMS) in modifying disease progression. However, many come with significant side-effects. It has long been understood that lifestyle factors can impact the progression and outcome of MS, with programs targeting lifestyle components in PwMS describing improved quality-of-life (QoL) outcomes, disability, fatigue and mental health outcomes. The effectiveness of the Overcoming MS (OMS) lifestyle modification program is established from multiple studies describing better patient-reported outcomes compared to PwMS that do not attend the residential lifestyle intervention. With the success of the program in a modest, representative sample of the population of PwMS, transition of the program from a face-to-face, fee for service intervention into a freely available online course is the next step to maximise reach. Web-based interventions have shown great efficacy at promoting positive lifestyle changes in a range of populations for a variety of conditions, including MS. To date, no evidence-based lifestyle modification program for PwMS has been translated into a web-based intervention and tested in a randomised control trial (RCT). An online course would have a reach essentially unimpeded by geography; overcoming distance is crucial as approximately one-third of PwMS in Australia live in regional, rural or remote areas. Furthermore, mobility issues impact many PwMS and travelling to the sites where face-to-face interventions take place can pose a significant burden. Compared to other populations, PwMS are a highly-motivated population that show modest levels of engagement and retention in lifestyle management programs, and previous online self-assessments show good levels of engagement and retention in the short- and long-term. The purpose of this study is to establish the feasibility of the online Overcoming MS program.. In the context of this web-based study, feasibility be will considered to mean: 1) significant numbers of participants engaging and completing this study, in both arms; and data collection procedures are well-designed and appropriate length; 2) participants consider the project enjoyable and accessible. This will involve: 1) evaluation of participant responses to data collection procedures, including long-form baseline and follow-up surveys; 2) qualitative and quantitative evaluation of participant responses to intervention content and platform; 3) quantitative evaluation of participant’s para/metadata on participant, engagement and retention/attrition of the course. Assessing the accessibility, learnability and desirability of the intervention content and platform, delivery is a crucial component of this and will be explored via post-intervention surveys and qualitative, semi-structured telephone interview. A primary consideration for the development of this online program is accessibility for PwMS.

This pilot study aims to reveal the profiles of histone deacetylase (HDAC) in healthy, gingivitis, periodontitis and periodontitis treatment follow-up (3, 6 and 12 months)..There are three aims for this project: Aim 1: Diagnosis Compare the differences in Class I and II HDAC gene expression between health, gingivitis and periodontitis Aim 2: Prognosis Evaluate any correlations between changes in HDAC expression and response to periodontal treatment over a 1-year observation period. Aim 3: Non-responding sites To evaluate the HDAC activity in non-responding sites (identified at the first review) and follow changes in these sites over the remaining 9 months. It is hypothesised that HDACs are differentially expressed in periodontitis patients compared with healthy and gingivitis patients, and correlates with the severity of periodontitis. Furthermore, it is hypothesised that HDAC levels will be positively correlated with improvements in clinical parameters after periodontal treatment. After conducting a scoping review of the existing literature, the vast majority of studies assess epigenetic profiles of periodontitis vs healthy tissues based on a cross-sectional snapshot. As periodontitis is a dynamic inflammatory disease fueled by dysbiosis, with widely varying periods of remission and exacerbation, cross-sectional epigenetic studies provide limited insight into disease onset and progressive over time from the host perspective (Goodson et al 1982). Most of the existing human studies governing this topic have collected gingival biopsies from periodontitis patients, however this may deter patient acceptance and invalidate sample reproducibility, particularly for repeated sample collections over a follow-up period (Alminana-Pastor et al 2019). Other less invasive and easily accessible DNA sources such as gingival crevicular fluid and saliva could be considered as a clinically feasible diagnostic tool for targeted epigenetic analysis (Nishitani et al 2018). Another noticeable gap in the literature is the lack of human studies conducted on histone modification changes in the periodontal tissues, with current research focused on animal and in-vitro studies. Thus, to our knowledge, this is the first prospective longitudinal study to assess epigenetic histone modifications in human periodontitis and in response to periodontal therapy. Overall, the results of this study hope to identify which HDACs could be differentially expressed in periodontitis patients, and if changes in the epigenome correlate with treatment response. This could provide preliminary data for epigenetic marks as a diagnostic biomarker to detect non-responders, and also epi-drug HDAC inhibitor targets for treating periodontitis.

Case reports and case series have documented efficacy of either sublingual or oral ketamine. They have not been compared with each other in past. The study aims to compare the efficacy between the two routes and their side effects profile in hope of guiding future practice.

This trial is investigating the efficacy of providing neuropsychological feedback in addressing self-reported cognitive impairment in breast cancer survivors. Who is it for? You may be eligible for this trial if you are a female over the age of 18 who has completed adjuvant chemotherapy for breast cancer within past 36 months and have self-reported cognitive dysfunction attributed to cancer and/or cancer treatment. Study details Participants will be randomly allocated to either the intervention arm or the control arm. Intervention: Participants will undertake a screening interview, online cognitive assessment and complete questionnaires related to cognitive performance and health. They will then receive feedback on their results and discuss implications with a psychologist over the phone. Control: Participants will undertake a screening interview, online cognitive assessment and complete questionnaires related to cognitive performance and health. Information from this study will be used to plan future intervention studies about the impact of feedback on perceived cognitive impairment.

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.