ANZCTR search results

The study will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of RLS103 in healthy adult volunteers. Safety oversight will be provided by a Safety Review Committee comprised of the Principal Investigator (PI), Sponsor’s medical representative, and an Independent Medical Monitor. The study consist of 3 cohorts and each cohort includes 4 treatment period with a washout period of 7 days between each treatment in each cohort. The total duration of study participation will be up to 38 days.

The study aims to investigate the potential therapeutic benefits of cannabidiol (CBD) as a treatment for brain changes and depression in individuals living with early-stage dementia. Accumulating evidence suggests that CBD is a novel, well tolerated medicine with beneficial neurorepair, hormone and symptom regulating effects and it may therefore be a promising candidate to address multiple facets of dementia. However, no trial to date has investigated the effects of pure CBD in people with early-stage dementia. The trial design includes 60 participants randomised to one of two treatment arms (30 CBD, 30 placebo), who will take a daily 300mg dose of their respective capsules for 12 weeks. A comprehensive range of outcome measures will be assessed at baseline, mid- point and post-treatment. It is anticipated that treatment with CBD will lead to improvements in neural structure, cognitive function, psychological symptoms and hormone profiles.

There is international evidence supporting the effect of intensive family preservation and reunification services in preventing out-of-home care (OOHC) placement among vulnerable families. However, such evidence in Australia is scant. This paper describes the protocol for a hybrid effectiveness-implementation evaluation of the Victorian Family Preservation and Reunification (FPR) Response implemented by MacKillop Family Services. Participants will include families who engage in the FPR and MacKillop Family Services staff involved in program delivery. A pre-post study design will be used to assess the effectiveness of the FPR in facilitating changes in family outcomes from intake to closure, including: i) parenting capability; (ii) family safety and home environment; (iii) child development; and (iv) prevention of children from entering or re-entering OOHC. Interviews will be conducted with staff to evaluate the program’s implementation (i.e., fidelity, reach, feasibility, acceptability, enablers and barriers to implementation). Quantitative data will be analysed using descriptive statistics and a series of paired-samples t-tests to examine changes in outcomes over time; thematic analysis will be used for qualitative data. If the FPR is well-implemented and yields significant improvements in families’ outcomes, this would provide strong support for its scale-up across Australia, to improve outcomes for vulnerable families.

Health service often requires healthcare workers (typically doctors and nurses) to place a thin plastic tube into patients' veins called an intravenous cannula (IVC). Placing an IVC is one the most commonly performed medical procedures. It is estimated that every year 2 billion IVCs are sold around the world and over 7 million Australians have an IVC placed. Despite the huge numbers of IVCs placed each year, inexperienced clinicians often take many attempts to successfully place one. This causes pain for patients and, in an emergency, failure to rapidly place an IVC can cause serious patient harm including death. There are some recent realisations about how the shape of the IVC tip influences the proper approach to placing the IVC. If these realisations are effective at improving IVC success rates then this will impact on millions of people. This study will test this by randomly allocating students to watch different videos. Each video will contain helpful tips for the students to place IVCs but only some students will be shown novel details about the recent realisations. A subset of students will also learn a novel method of practicing a critical step of placing the IVC. Students will then report back the outcome of their first 20 IVC attempts. This will enable us to test if the realisations and the novel practice method lead to less failed IVC placement attempts. The research team will monitor the results using predefined stopping rules. We hypothesise that teaching the theory of lifting of needle tip will increase cannulation success rates. We further hypothesise that the using the hands-on alcohol wipe teaching model will have an additional benefit beyond purely theoretical instruction.

The purpose of this study is to determine whether the combination of Selinexor and Dexamethasone combined improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, you have been diagnosed with either central nervous system (CNS) diffuse large B cell lymphoma (DLBCL) or myeloma. Study Details Eligible participants will receive Selinexor and Dexamethasone. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of this combination for patients with central nervous system (CNS) diffuse large B cell lymphoma (DLBCL) and myeloma.

This study is part of an evaluation of the emergED eating disorder services being delivered through Sonder/headspace. This project will investigate the cost-effectiveness of this program, so that further funding for the expansion of emergED services can be sought. This project is a collaboration between Sonder/headspace and the Flinders University, College of Education Psychology & Social Work. To establish cost-effectiveness of this program, we are asking for participants receiving emergED services from July 2020 through to September 2022 to consent to the release of their health information, such as doctors visits, and its costs (Medicare Benefit Scheme data) as well as what prescription medications you had filled out at pharmacies (Pharmaceutical Benefit Scheme Data). We are requesting this data to be released for all participants from July 2019 to March 2022, in order to cover health related costs 12 months prior to engaged with emergED services, and 6 months after engagement with emergED services

Background: Oral health and the inability to manage this independently is a known predictor of aspiration pneumonia in vulnerable populations such as the elderly and chronically ill, with the link between poor oral health with systemic disease, morbidity and mortality demonstrated extensively throughout allied health, nursing, and dental literature. If oral health is reduced, people are not only at greater risk of aspiration pneumonia, but they may have pain or poorer dentition which impacts on mastication and swallowing, and reduced oral intake, with potential for malnutrition, poorer health outcomes and reduced quality of life. There are currently limited oral care protocols with measurable outcomes that are used in hospitals and care facilities in Australia. This is of concern to speech pathologists due to the link between poor oral care and the potential for aspiration in vulnerable populations such as the elderly. However, a recent literature review by Shortland and colleagues (2021) reported improvements in oral hygiene, oral behaviours and swallowing, along with breathing and speech have been found to be associated with the use of myofunctional devices. Methods/Design: This project is an acceptability and feasibility pilot study for a new five-week intervention for oral hygiene and dysphagia for residents 65> years old in an aged care setting. Feasibility will be measured by way of consent and trial completion rates, and treatment adherence. Acceptability will be measured through verbal surveys of aged care residents and a questionnaire of care staff assisting with the intervention. Secondary outcome measures will be taken pre and post treatment for oral hygiene and dysphagia. Discussion: The results of this trial will provide important information regarding the use of a an oral device to improve oral hygiene and swallowing elderly patients in a residential aged care facility.

Psilocybin-assisted psychotherapy has demonstrated excellent safety and efficacy in the treatment of depression, substance use disorders, and mental ill-health related to terminal illness. Many patients in these trials have reported rapid, large, and persistent decreases in symptoms of anxiety, suggesting utility in treating anxiety disorders with psilocybin-assisted psychotherapy. However, the impact of this treatment for people with GAD is unknown. In this study, we will complete a randomised controlled trial to test a 7 week (2 dose) psilocybin-assisted psychotherapy for the treatment of GAD. 72 individuals will be randomly assigned to receive two doses either psilocybin (25mg or 30mg, oral) or placebo (diphenhydramine, 75mg or 100mg, oral) with three weeks between doses. All participants will receive psychotherapy before, during, and after dosing sessions. A variety of measures will test for safety and efficacy of the treatment. The primary outcome measure investigates change in clinician-rated symptoms of anxiety. A range of secondary and exploratory measures probe changes in disability, quality of life, comorbid psychiatric and addictive symptoms, baseline and acute predictors, as well as participant-rated acceptability, appropriateness and feasibility of the treatment.

This is a multi-centre, open label, 2 cohort study to determine the ocular exposure levels of oral OCX063 in participants requiring retinal repair surgery. Following an OCX063 loading dose on the day of surgery, samples of aqueous and vitreous humour will be collected during the surgical procedure. Post-surgery, patients will take a once daily dose for the following 7 days. On Day 8, an aqueous humour sample will be collected via an aqueous tap.

Babies who are born early (premature babies) often require help with their breathing. Some premature babies will require a breathing tube (intubation) and help from a breathing machine (ventilator). A ventilator helps babies to stay alive but may damage their lungs. To minimise this damage, we try to take the breathing tube out (extubate) as soon as possible. Unfortunately, some babies will not succeed and require the breathing tube to be put back in (reintubation). These babies are likely to be sicker in the long term than those who are successfully extubated. There are few tools available to help predict which babies will fail extubation. Ultrasound is a form of imaging that uses reflected sound to create an image of different parts of the body. It is safe, painless and does not use radiation. Ultrasound can be used to image the lungs of babies. We are exploring whether a lung ultrasound performed before a baby is extubated will help us predict extubation failure. We are also exploring if repeated lung ultrasound will give us more information on how a baby’s lungs behave after being extubated. Additionally, we are exploring two new types of ultrasound, one of a baby’s diaphragm (the main muscle of breathing) and one of their vocal cords. In this study, we will perform and ultrasound of a baby’s lungs and diaphragm before and after extubation and then daily for the next three days. We will also perform one vocal cord ultrasound 24 hours after extubation. We will use this information to see if we can predict which babies will require reintubation.