ANZCTR search results

A medication called surfactant is commonly given to preterm newborn babies to help with their breathing. We are conducting a study using ultrasound to measure how quickly surfactant works to help babies who need help breathing. To do this, we will get ultrasound recordings of newborn baby’s lungs before and after surfactant is given. The purpose of this study is to use ultrasound to see how quickly surfactant works. We are using ultrasound of the lungs to monitor how the amount of air in the lungs changes after surfactant treatment. We hope to use the results from this study in the future to improve our care for babies that need surfactant. If you decide to participate, we will get ultrasound images of your baby’s lungs by gently placing an ultrasound probe on each side of your baby’s chest or back. The lung ultrasound assessments are brief, less than 1 minute. We will perform a total of four ultrasound assessments – one before your baby receives surfactant, and three in the two hours after surfactant is given. The assessments will not interfere with cuddles. If you don’t wish to take part, you don’t have to. Your baby will continue to receive the best possible care whether you take part or not. The decision to give surfactant, or the way that surfactant is being given, will be decided by the treating doctors and will not be changed by your participation in this study.

The purpose of this study is to compare the effects of 3 years vs. 5 years of imatinib in patients with gastrointestinal stromal tumor (GIST). Who is it for? You may be eligible for this study if you are at least 18 years old, have been diagnosed with GIST, and have been treated with adjuvant imatinib for 3 years after surgery. Study details Once participants have already been receiving their usual standard of care imatinib treatment for 3 years, they will be randomly allocated into two groups. One group will stop their treatment. The other group will receive 400mg oral imatinib once a day for 2 more years. Participants will be followed up and take part in CT/MRI scans, clinical assessments, and questionnaires every few months (ranging from 3-12 month intervals) for 10 years. It is hoped this research will reveal if 5 years of imatinib ensues in better outcomes for GIST patients compared to 3 years of imatinib, thus contributing to improving cancer treatment.

This is a study of safety and tolerability of a drug called SLS-005 in adults, aged 18 to 75 years with selected neurodegenerative diseases [up to 4 patients with amyotrophic lateral sclerosis (ALS), up to 10 participants with Huntington’s disease (HD), and up to 4 participants with spinocerebellar ataxia type-3 (SCA3)]. This study will also help to determine the treatment response of SLS-005 using a patient-reported outcome measure. The study comprises of a 2-week screening period, 24-week open-label treatment period of SLS-005 to be administered as a once weekly intravenous infusion, and a 2-week safety follow-up period. On the day of the infusion, the study participant is expected to remain at the study centre for up to 6-8 hours. All participants will be asked to undergo blood tests and answer questions regarding their health. It is hoped that information from this study informs researchers of how the body metabolises SLS-005 and thus how it may be used to treat neurogenerative diseases, such as ALS, HD and SCA3.

AIMS OF THIS STUDY To test model PCT-style regimen of hCG , framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. This randomized double-blind placebo-controlled clinical trial is designed to test the efficacy and safety of a pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of weekly hCG treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4 and 8 weeks after cessation of study drug treatment.

Finding the balance between the risks and benefits of sun exposure is extremely challenging. The Cancer Council Australia and other organisations now advise daily sunscreen use to reduce UV radiation-induced damage arising from incidental exposure. Sunscreen blocks vitamin D production in experimental settings but there are no data about the effect of frequent application of high SPF sunscreens in community settings. Despite this, there is a widely held perception that using sunscreen will increase the risk of vitamin D deficiency and this is undermining skin cancer prevention messages. We plan a two-arm open-label RCT with a one-year intervention phase. The primary aim is to determine whether participants randomised to provision of a broad-spectrum SPF 50+ sunscreen, and advice to apply it to all body parts uncovered by clothing on all days when the UVI is forecast to reach 3, have a lower mean 25 hydroxyvitamin D (25(OH)D) concentration at the end of either summer or winter than those randomised to usual discretionary sunscreen use. If daily sunscreen use reduces 25(OH)D concentration, we will model the impact on the prevalence of vitamin D deficiency in Australia to assess the public health significance of the change

AIMS OF THIS STUDY To test model PCT-style regimens comprising either hCG or an antiestrogen, framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. These randomized double-blind placebo-controlled clinical trials are designed to test the efficacy and safety of pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of hCG or letrozole, an aromatase inhibitor, treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4- and 8- weeks after cessation of study drug treatment.

The project is funded by the NHMRC Medical Research Future Fund to conduct a retrospective and prospective trial of patients with autoimmune encephalitis to gain a better understanding of disease mechanisms, clinical manifestations, identify improved biomarkers for accurate diagnosis, improve treatment options and ultimately enhance patient outcomes/quality of life. Dr Monif believes that the trial and the creation of the Australian Autoimmune Encephalitis Consortium will raise the profile of the disease so that anyone presenting with the symptoms of autoimmune encephalitis are triaged accordingly, and with timely investigations, the disease is diagnosed promptly. The findings from the national research study are hoped to lead to production of clinical guidelines to assist with early diagnosis and improved treatment options. The ultimate aim is to improve patient outcomes.

Gambling-related suicide has been underestimated and few systemic responses are in place to support those experiencing suicidality. The study aims to understand the relationship between gambling and suicide; and, contribute evidence to prevent gambling-related suicide to inform system-wide responses to these preventable deaths. The project will use a descriptive qualitative approach. Adult participants (18 years+) from three key groups located in Australia will be recruited to share their experiences and insights into this problem via a one-to-one semi-structured interview. Participants will be asked to describe their experiences with gambling, suicide or suicidality, their understanding of the relationship between gambling and suicide. Interviews will also seek to document how these participants perceive current gambling arrangements and how this may contribute to stigma and shame.

The distal ischaemic stroke thrombectomy against medical therapy trial is the last FRONTIER in stroke trial and builds on the success of Australian led thrombectomy trial, EXTEND IA. It is an Australian led trial in the Asia-Pacific region (FRONTIER-AP) which seeks to answer an important clinical conundrum on the optimal treatment approach for patients with clot in medium sized vessels (MVO) in the brain. Following the results of multiple randomized clinical trials some states in Australia have structured clinical pathways for treatment of patients with large vessel occlusion (LVO). Such knowledge does not exist for MVO. There is clinical equipoise to proceed with phase II clinical trials given the conflicting data from observations from multiple observational studies and small sample size of data from randomised clinical trial . Our primary hypothesis is that the clinical outcome of ischaemic stroke patients treated with endovascular therapy within 9 hours will be superior compared with that of standard medical therapy. This trial will require moderately large sample (n=240) and thus may not be achievable even in our large network of collaborators in Australia. We will leverage the opportunity provided by the International Clinical Trial Collaborations (ICTC) to recruit 50% of the patients for this trial by our international partners. If the trial shows superiority of thrombectomy for MVO then it may lead to significant restructuring of acute stroke care across multiple states as the current model of care is that hospitals that provide thrombolysis therapy can treat patients with MVO. In anticipation of this change we have built an implementation phase into this grant incorporating statistical analysis, health economics analysis, operational research and geospatial analysis. We will also seek support from Stroke Foundation and engage with their network of consumers to determine their perception of the impact on new model of care and other changes that they would like to see given their experiences These analyses will inform the scalability of our findings as well as design of phase III such that full implementation will be achievable. Within the first 12 months, we would have the trial registration, submit the trial to Australasian Stroke Trial Network, develop educational material for trialists and clinicians to recognise MVO, published protocol paper as well as recruitment of the initial group of patients .

This project examines the feasibility and effects of a 10-week online music therapy program involving songwriting for people with dementia and their family care partners. The project aims to address the following aims: To, 1) examine the feasibility and acceptability of online music therapy for people with dementia and their family care partners; 2) examine the sensitivity of outcomes measuring depression and quality of life with people with dementia and their family care partners who have participated in online music therapy; 3) explore how people with dementia and their family care partners experience an online music therapy program.