ANZCTR search results

This study is investigating how different formats of information provision on breast density affect women’s screening intentions, psychological outcomes and knowledge of breast density. Who is it for? You may be eligible for this trial if you are female, aged 40-74 years, live outside Western Australia and have no prior history of breast cancer or ductal carcinoma in situ. Study details Participants in this study will complete an online questionnaire and during which will be presented with a hypothetical scenario of undergoing a routine screening mammogram and receiving the results. Participants will be randomised to receive control information (screening mammogram result without the breast density messaging) or one of two versions of the intervention with breast density information via notification messaging. Participants will then be asked to complete questions in response to the information they have received. It is hoped this study will inform researchers of how different formats of information on breast density impact women's screening intentions and psychological outcomes.

When intravenous (IV) catheters stop working the medication meant to be delivered into the bloodstream pools into the tissue; known as an extravasation injury (extra=out of; vas = vessel) - a serious cause of harm that can result in permanent scarring. They are especially common in paediatrics as children have small vessels, and can't always tell us when their IV starts to hurt. An effective way to reduce these injuries is to ensure that the right IV is inserted in the right place, at the beginning of treatment.There are new international guidelines on the selection and insertion of IVs in paediatrics; known as the Michigan Appropriateness Guide for Intravenous Catheters in paediatrics (miniMAGIC). They provide recommendations on IV catheter choices (e.g., smaller vs larger vessels), and where to insert them (e.g., foot vs forearm). Within this project our team will tailor and implement miniMAGIC in sequential blocks across the Queensland Children’s Hospital. We will create resources to ensure miniMAGIC is practical and easy to use in Australian healthcare, and then measure how well it performed to improve IV choice and reduce extravasations.

A multi-site prospective study to implement and evaluate the feasibility of a Pharmacogenetics Screening Program for 5-fluorouracil [5-FU], capecitabine and irinotecan chemotherapies for patients with cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer and will receive fluorouracil [5-FU], capecitabine and/or irinotecan chemotherapy for the first time. Study details All participants in this study will receive a genetic screening for DPYD gene test if commencing on 5-FU or capecitabine and/or screening for UGT1A1 gene if commencing on irinotecan anticancer treatment, 7 to 10 days before starting chemotherapy. It is the responsibility and choice of the treating clinician to implement/not implement dosing recommendations based on genetic tests and to manage all aspects of cancer treatment. The feasibility of operating a Pharmacogenetics Screening Program will be assessed using recruitment data from study databases and patient and clinician surveys. Participants will also be followed for up to 12 months to assess toxicities and 24 months to assess treatment response and status. This research will contribute to improve health outcomes for patients with cancer in terms of safety and survival in particular patients who carry altered/deficient genes; dose individualisation prior to administration to 5-FU or capecitabine and/or irinotecan will assist with better tolerance to treatment and hospitalisations (given better toxicity management).

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.