ANZCTR search results

This research study in BV patients is testing the safety, tolerability, preliminary evidence of efficacy and pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a bilayer tablet formulation of a drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) when it is given Intravaginally (into the vagina) after patients’ completion of primary treatment with antibiotics. Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of recurrent Bacterial Vaginosis (BV). The overall goal of this study is to optimize the duration of Low Iron MTbLF treatment post antibiotics for the prevention of recurrence of BV and the evaluation of different diagnostics to follow recurrence during the treatment period. BV patients will receive antibiotic treatment (metronidazole 0.75% intravaginal daily for 5 days at bedtime) for symptomatic BV. Then, they will self-administer daily doses of study medication for 12 weeks. They will self-collect three vaginal swabs weekly at home for the duration of the 12-week treatment and then the 12-week follow up period. A series of vaginal swabs and blood samples will be collected by a healthcare practitioner during 4 in-clinic visits that will take place in the 12-week treatment period and at the end of the study on week 24. Patients will use a patient diary to record symptoms, dosing of study medication and other study-related information daily during treatment (weeks 1 to 12) and twice a week during weeks 13-24.

The purpose of this study is to evaluate the effectiveness of the combination of zanubrutinib and tislelizumab in patients with brain or spinal cord cancer (CNS lymphoma). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have CNS lymphoma that has re-occured, or stopped responding to treatment, or you are deemed unfit for chemotherapy treatment. Study details All participants will be treated with Zanubrutinib 320mg once daily continuously, as an oral capsule together with Tislelizumab 200mg intravenously every 3-weeks (starting after week 9 of Zanubrutinib). Blood tests and questionnaires will be performed at baseline and every 3 weeks during treatment for up to 2 years. Magnetic Resonance Imaging (MRI) scan will be performed at baseline, after 8 and 17 weeks of treatment and then every 12 weeks for up to 2 years. The purpose of the MRI scan is to assess your response to the treatment. It is hoped that this research will find out if the combination of zanubrutinib and tislelizumab is able to treat CNS lymphoma, and improve patient outcomes.

Middle ear infections, known as otitis media (OM), are the leading cause of hearing loss in children and are estimated to affect over 90% of children at least once before their second birthday. Persistent otitis media with effusion (OME) and its associated hearing loss can have long-term impacts on a child’s language, communication, behavioural skills, literacy and educational experience, that will affect their relationships with others, educational outcomes and later employment prospects. Whilst the prevalence of OME is high, we know that some children will experience spontaneous resolution of OME (i.e. return to having an intact and well-functioning eardrum), and therefore will not require Ventilation Tube Insertion surgery (more commonly known as grommets). Currently, we do not know how many children could be expected to experience spontaneous resolution of OME. Some simple, low-cost, family-led health promotion programs have been developed to help improve resolution of OME without surgical intervention. This project aims to determine whether the implementation of these health promotion programs within an innovative telehealth service model will increase the non-surgical resolution of OME.

This is a single blind, placebo-controlled clinical trial to determine the safety and tolerability and to gather additional data to define the recommended phase II dose (RP2D) of MTx-COVAB36 after single administration in a dose escalation, dose limiting toxicity (DLT)-driven approach in healthy volunteers. MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus neutralising activity. It is indicated for the treatment of patients with mild to moderate COVID-19 disease and with high risk for progression to severe disease. The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration.

Almost half of all Australians experience a mental health disorder in their lifetime. Comorbidity is the norm and is associated with poorer functioning and lower quality of life. The COVID-19 pandemic has increased psychological distress and reduced access to gold standard mental health treatment like cognitive behavioural therapy (CBT). A paradigm shift is needed to increase the evidence-base and availability of mental health interventions. A “transdiagnostic” treatment approach where an intervention targets shared processes underlying comorbidity (e.g., sleep, emotion regulation) rather than disorder-specific symptoms is an innovative way to improve comorbid mental health. Individuals with better sleep and emotion regulation have less intense and persistent negative emotions in response to environmental stressors (e.g., pandemics, bushfires, floods), thus protecting against poor mental health. Yoga, a combination of mindfulness meditation, breathwork, and physical postures, is a compelling novel transdiagnostic solution. Yoga is efficacious for prevalent and comorbid mental health disorders among Australians: anxiety, major depressive, posttraumatic stress, and alcohol use disorders. Yet no study has assessed yoga efficacy for comorbid mental health. Yoga is popular and has several advantages over first-line CBT like lower associated stigma and wait times and increased cost-effectiveness. Yoga is proposed to exert positive effects via improved sleep and emotion regulation. This innovative research aims to establish yoga efficacy for comorbid mental health and to assess if sleep and/or emotion regulation are moderators and/or mediators of mental health outcome. It will use a non-inferiority randomised controlled trial design with CBT as the active control and both subjective (questionnaires, ecological momentary assessment) and objective (actigraphy, heart rate variability) measures of sleep and emotion regulation. This research will bring about a paradigm shift in mental health care and advance precision medicine.

This research has direct translational value for people with MS, critical given the impact of depression on people with MS. Outcomes are aimed at supporting clinicians to improve detection and management of depression in people with MS through neurology services. It will provide recommendations and supports to improve detection and treatment and will enable submission of funding proposals to facilitate the next translational phase (years 4-5) through iterative feasibility and acceptability implementation across neurology settings, ensuring suitability for rollout. Results will: 1) fill a knowledge gap about barriers and required supports to improve assessment and treatment in Australian neurology practices, 2) provide Australian validation data to screen for depression in routine clinical practice; 3) characterise the depressive symptom profile in MS to identify whether it differs in presentation from depression in people without MS requiring specific patient and clinician education; 4) utilise this research, literature review and advisory committee expertise to develop recommendations and supports that improve detection, treatment and monitoring of depression in people with MS. It will result in high-quality peer review journal outputs and conference presentation outputs reporting each sub- study, as well as a report detailing overall program results that will be submitted to relevant MS healthcare, consumer, advocacy and research organisations. This research has potential to positively impact people with MS who experience depression, and their families, as well as to provide economic gains by reducing direct and indirect costs of the impact of depression on MS.

The aim of this study is to investigate the use of pseudoephedrine in patients experiencing retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago, and have confirmed retrograde ejaculation following the procedure. Study details All participants will complete a one-off series of questionnaires assessing quality of life, and will then receive pseudoephedrine (60mg every 6 hours the day prior to semen collection, followed by an additional 60mg of pseudoephedrine at 0600hrs and 30-60 minutes prior to semen collection) as an oral tablet over a period of 1 day. After 1 day of treatment, participants will undergo semen and post-ejaculatory urine analysis to explore the efficacy of the treatment and any side effects experienced. It is hoped that this study may demonstrate that a short course of pseudoephedrine is effective and safe for the treatment of retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer.

As we age, the quality and strength of muscles and bone diminishes. Furthermore, changes in posture and musculoskeletal dysfunction, such as rotator cuff pathologies, can accelerate this deconditioning. Resistance training is recommended in older adults to try to slow the rate of decline and maintain strength and function, however the minimum National Physical Activity Guidelines are only being met by approximately 1 in 4 Australian older adults, with no indication that the resistance guidelines are being met. This project aims to investigate the most effective upper limb resistance exercise equipment to use for maximal range of motion and muscle activation of the targeted muscle(s) in older adults. Participants will be asked to attend a single testing session, where they will perform six upper limb exercises without resistance and then using elastic banding (Theraband), milk bottles and resistance machines. Total range of motion and muscle activity will be measured for each exercise, using each piece of resistance equipment, on the major muscles in the arms and chest. The order of exercise completion and the item of equipment used will be randomized between each participant. The results of this study will provide further insight for exercise professionals to prescribe home-based upper limb resistance exercises in older adults, taking into consideration the type of resistance equipment, that will allow for the greatest activation of the targeted muscle(s).

There is limited research on the medium-term recovery and outcomes of patients three months following major upper abdominal surgery. The aim of this study was to explore the functional outcomes and lived experiences in adults three months after major upper abdominal surgery at Royal Perth Hospital in Perth, Western Australia. Data collected from the participants prior to their surgery was compared with data collected from them three months after the procedure.. The measures included clinical frailty and functional independence. At three months post-surgery, information regarding abdominal pain, post-surgical fatigue, and cognition were also gathered in order to explore the association between these variables and the participants level of functional recovery three months following the surgery. Qualitative interviews were also conducted at this time to explore the participants lived experiences and those of their primary carer.

This trial is exploring if an online shared care plan and telehealth improve the frequency and quality of primary and preventive care for people with a lived experience of severe mental illness. It aims to improve the health of people living with mental illness by facilitating their engagement with primary care. It also aims identify more effective and time efficient shared care processes, which are essential given the multiple competing demands on primary care and mental health clinicians. The online shared care plan outlines the preventive care tasks that GPs and SLHD Mental Health Care Coordinators will share. This includes, for example, physical health checks, metabolic blood tests, lifestyle assessment and advice, preventive screening, medication management and referrals to allied health. This pragmatic trial will invite clients of the Sydney Local Health District Community Mental Health Teams and their usual GPs to participate. Participants will be followed for 12 months.