ANZCTR search results

ECHOES-AF Pilot is a Phase II preparatory to Phase III, Patient Reported Outcomes Burdens and Experiences (PROBE) clinical trial to assess the safety of the trial medications (oral anticoagulants (OAC)) with a lower dose use in patients with cardioembolic stroke, non-valvular atrial fibrillation (AF) and cerebral micro bleed (CMB) taking routine post-stroke secondary prevention medications. We aim to recruit 200 participants with a 1:1 randomization ratio. They will either receive adjusted (lower dose) OAC treatment or follow regular guideline-recommended OAC treatment dosage. Participants will be followed for 12 months after group allocation. The primary outcome will be all-cause death. This study will be conducted in multiple hospitals and clinic-based centres across Australia. The study is funded by NSW Health and The George Institute for Global Health, with Dr. Zien Zhou as Chief Investigator. Findings from this trial will help ascertain whether a very large clinical trial to identify optimal anticoagulation strategies for stroke patients with AF and CMBs will be possible.

This project is evaluating the safety, tolerability (if any side effects occur), and immunogenicity (the ability of a molecule or substance to provoke an immune response) of two vaccinations with the study drug TVAX-006, a vaccine which is being developed with the aim to help prevent shingles. To evaluate the study drug, it will be tested in different groups who will receive different comparators. Grand Theravac Life Sciences (Nanjing) Co., Ltd is developing the study vaccine, a recombinant zoster vaccine, as a potential new way to prevent shingles for adults aged between 30-70 years. These long-term complications are the primary reason why vaccination is needed. Vaccination protects individuals from herpes zoster and postherpetic neuralgia and reduces associated medical and psychosocial outcomes and costs for the patient. The current treatments available once someone has herpes zoster and postherpetic neuralgia have limited success, so it is much better to prevent it from occurring at all. This makes vaccination a particularly important strategy for Australians to prevent this debilitating disease, especially in the elderly.

Cognitive changes are common in prostate cancer survivors after starting hormonal treatments. This study aims to investigate the feasibility and effectiveness of an online group cognitive rehabilitation program for these survivors. Who is it for? You may be eligible for the cognitive online group intervention if you are male, aged 18 years or over, and are currently receiving hormone therapy for prostate cancer. Study details This study will be conducted in two parts. Participants who choose to enrol in the first part will be presented with an outline of the proposed cognitive rehabilitation program. Participants in part 1 will be asked to discuss the proposed program in an online focus group of up to 6 participants (and 2 research team members) . Participants will be asked to spend no more than 1 hour reading through program material to familiarise themselves with the content and then attend a 2-hour online focus group. Feedback provided by the participants in part 1 will be used to refine the proposed cognitive rehabilitation program. In the second part, participants who choose to enrol will be given access to the final online cognitive rehabilitation program. The program will be run weekly over a 4 week period. Topics to be covered in the program include how to manage fatigue and difficulties with memory, attention and other cognitive abilities. There will be pre- and post-program assessments as well as questionnaires to compare prior, throughout and after the program. It is hoped this research will determine whether a new online cognitive rehabilitation program has a positive impact on the cognitive function of prostate cancer survivors who are undergoing hormonal treatments. If this study shows promise, the rehabilitation program may be expanded so that a larger number of prostate cancer survivors may take part.

The perinatal period, encompassing pregnancy and the first year postpartum, is a time of immense change where women are faced with new challenges, stress, and high emotions (Chlebowski, 2013; Newman et al., 2007). Previous coping strategies may prove inadequate when faced with sleep deprivation, a crying infant, physical pain, role transformation, and relationship stress (Geerling et al., 2019; Sved Williams & Apter, 2017; Wilson & Donachie, 2018). Women with personality vulnerability may become emotionally unstable (Sved Williams et al., 2018; Yelland et al., 2015), and existing symptoms of borderline personality disorder (BPD) may be exacerbated (Dunn et al., 2020). The National Health and Medical Research Council (2012) guidelines recommend that women with BPD who are pregnant, have infants or young children “should be provided with interventions designed to support parenting skills and attachment relationships”. As dysregulation (Apter at al., 2017) and neurobiological disturbances (Newman et al., 2011) can occur in infants of mothers with BPD by three months of age, early intervention is imperative. We will evaluate the impact of the provision of psychoeducation material in pregnant women with BPD/BPD traits compared to general information about parenting and mental health. It is hypothesised that emotional regulation, obstetric/birth outcomes, postnatal maternal behaviours will be less compromised for women who have completed psychoeducation compared to women who have completed general information about parenting and mental health.

The proposed clinical trial will evaluate the bioavailability of Satipharm CBD capsules compared to a CBD oil at a dose of 100mg. The trial will also determine if there is bioequivalence between the Swiss manufactured Satipharm CBD capsules and Australian manufactured CBD capsules. 12 healthy male participants will receive one single oral dose of 100 mg cannabidiol (1mL of the reference drug or two tablets of the test drug) after an overnight fast in each of the 3 periods according to a sequence determined by randomisation. In each study period, participants will take different products (either one dose of the 2 Test Drugs or one dose of Reference Drug) with a minimum 13 day wash-out between each study period. The study hypothesis is that the Australian manufactured CBD capsules will show an equivalent bioavailability at the specified time points to that of the Swiss manufactured CBC capsules.

Psychological distress is widespread among university students in Australia, and rapid changes to higher education brought on by the pandemic have exacerbated this problem. There is a need for university-wide mental health prevention and early intervention programs that harness existing resources within the university setting. The Sharper Minds package is a mental health package that includes a website, a weekly progress tracker and a range of short group interventions that target behaviours related to students’ mental health (i.e., physical activity, diet, sleep, music listening for study, mood regulation, and social connection). This open trial of Sharper Minds examined engagement, retention, and effectiveness of the package in undergraduate students at the University of Queensland. We predict that students who use the weekly progress tracker and complete a short course will report better mental health and academic outcomes at the end of semester compared to students who only use one component or who don't use any package components.

The XII-01 Study is a prospective, non-randomised, multi-centre technical feasibility study that is designed to evaluate initial safety and feasibility of the investigational device. This clinical investigation is the first critical step utilizing the investigational device in a series of planned studies. The main objective of this study is temporary placement of the investigational device to confirm its ability to achieve nerve stimulation. Researchers hypothesize that this system will achieve nerve stimulation representative of stimulation that is used to treat patients with OSA.

Over the last few years, evidence has emerged that Dapagliflozin, a blood sugar lowering drug that can be administered as a tablet, does not just return blood sugar levels toward normal with minimal or no side effects but also protects the kidney form injury. This drug has also been shown to slow the progression of heart and kidney related complications of diabetes and heart failure patients. This makes treatment with Dapagliflozin potentially desirable in patients at risk of acute kidney injury who are admitted to the intensive care unit. However, the effect of Dapagliflozin in such patients, although logical, has not yet been studied. For this reason, we are planning to perform a clinical research project, known as a randomised controlled trial. We aim to evaluate whether giving oral Dapagliflozin (10mg daily for up to 28-days while in ICU) compared to placebo (a dummy tablet) in ICU patients at risk of acute kidney injury (AKI) decreases the severity and risk of injury and maintains blood sugar levels while decreasing the use of insulin. We plan to study 40 patients at high risk of developing AKI. If our findings demonstrate safety and potential benefit, they will allow this treatment to be studied in larger groups and, perhaps become a new effective treatment for these patients.

The project will evaluate education and facilitation to build the capacity of general practices to identify and appropriately treat patients with chronic conditions, frailty, pre-frailty, or early dementia, and to be supported in primary care to live well. Primary care has an important role to play to support healthy ageing for early intervention of chronic disease. However, implementation of healthy ageing interventions into routine primary care has been limited, The program involves early identification, and provision of evidence-based support to improve quality of life and promote Healthy Ageing for people between the age of 40-70 years. This project will include a mixed methods approach, guided by the application of the Consolidated Framework for Implementation Research (CFIR) and RE-AIM frameworks.

This study will investigate the effect of adding CT imaging to guide the standard endobrachial ultrasound (EBUS) method of collecting lung tissue for the diagnosis of potential lung cancers. Who is it for? You may be eligible for this study if you are an adult ages 18 years or older, you live in South Australia and you have been referred to the Royal Adelaide Hospital lung cancer clinic with a pulmonary lesion (suspected lung cancer) that requires a biopsy to be taken. Only participants who are eligible to undergo a radial EBUS procedure will be invited to participate in this study. Study details All participants who choose to enrol in this study will undergo a general anaesthetic in order to have the EBUS procedure. The EBUS procedure will be undertaken per the standard method, which involves introducing a flexible camera (bronchoscope) into the participants airway via their throat. An ultrasound probe will also be used to identify the lesion to be biopsied. As part of this study, additional CT imaging will also take place prior to the lesion being biopsied. This imaging will not involve any additional injections and is anticipated to add 15 minutes to the overall procedure and anaesthesia time. It is hoped this research will determine whether adding CT imaging during the lung biopsy procedure is able to improve the ability of surgeons and physicians to collect the tissue sample accurately and with fewer attempts. If this imaging is found to have a positive impact on the accuracy and duration of the biopsy procedure it may be trialled in a larger number of potential lung cancer patients in a future clinical trial.