ANZCTR search results

Anorexia nervosa (AN) is a serious, debilitating psychiatric disorder, with numerous physical and psychological health impacts (Lock, 2012; Katzman, 2005). Typically diagnosed in young people, individuals with AN are 12 times more likely to die and 57 times more likely to commit suicide compared to same-age peers (Keel et al., 2003). Illness duration may extend to over 20 years for more than half of those afflicted (Fichter et al., 2017), highlighting marked chronicity. It is essential that evidence-based treatment for this disorder is delivered efficiently and effectively. Family-based treatment (FBT) is the most efficacious treatment currently available for young people with AN (Le Grange et al., 2016; Lock & Le Grange, 2019). FBT is an outpatient behavioural treatment which emphasises the parents as the primary resource in the recovery of young people with AN (Anderson et al., 2017). However, there is a concerning inequity in access and treatment outcomes for people with AN, particularly among those in regional and rural populations. Telehealth offers a viable, scalable solution to this critical issue, and preliminary research in the USA demonstrated equivalent outcomes for FBT delivered via telehealth compared to face-to-face therapy (Anderson et al., 2017). The proposed study sets out to build on this vital research, testing the efficacy, feasibility, acceptability and cost-effectiveness of delivering FBT via telehealth to 30 young people and their families living in regional and rural New South Wales. This pioneering study brings together a multidisciplinary team of national and international experts to address both the treatment needs of regional and rural families; and the needs of regional and rural health services. Further, it will inform future efforts designed to improve the health of all Australians impacted by this debilitating disorder.

This study aims to find out if receiving intravenous iron ferric carboxymaltose (FCM) will reduce the incidence of anaemia while patients are receiving chemotherapy before or after surgery for breast cancer, and whether this is associated with an improvement in quality of life (QoL) and exercise tolerance. Who is it for? This study may be suitable if you are 18 years or older and will be starting adjuvant or neoadjuvant chemotherapy to treat early or locally advanced resected breast cancer. Trial Details Participants will be randomly allocated to receive either: 1) Iron ferric carboxymaltose (FCM) intravenously at baseline and further FCM if functional iron deficiency criteria are met OR 2) Standard of care during chemotherapy according to local guidelines. All participants will be regularly monitored every 5-6 weeks (depending on the type of chemotherapy) throughout treatment to evaluate their health. There will be a final treatment visit 3 weeks after the last dose of chemotherapy. Follow-up visits will occur at 3 months, 6 months and 12 months after the last dose of chemotherapy. Further treatment will be at the discretion of the participant and their treating clinician. At each visit, all participants will: * Complete online functional assessments to assess cognitive function, daily function and quality of life, using the PROMIS Cognitive Function Short Form 8a (PROMIS-Cog 8a), Daily Cognition and Mood (DCAM) cognitive assessment, and FACT-An * Complete a 6 Minute Walk Test to evaluate exercise tolerance * Have blood samples collected for additional assessments of iron parameters in the blood. It is hoped that this research will improve the quality of life of women undergoing adjuvant or neoadjuvant chemotherapy for breast cancer.

The purpose of this study is to assess the safety and tolerability of REVx-99, as well as the Pharmacokinetics (PK- how your body uses the study drug) and pharmacodynamics (PD - how the study drug carries out its actions on the body). We are doing this study in healthy men and women to find out: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will compare REVTx-99 with placebo. A placebo has no active drug in it. One group of participants will receive REVTx-99 and another group will receive the placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. We will be testing a single dose of the study drug in up to 40 healthy volunteers who will be divided into 5 cohorts of 8 people each and testing multiple doses in a single cohort of 8 people. Each single dose cohort is planned to receive an increasing dose of REVTx-99.

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic – a designed set of diverse, human-commensal bacterial strains, administered as oral capsules. This study has a seamless design, as it is composed of two study parts, each with different objectives, with an operationally seamless transition in between. Participants will be enrolled into either Part 1 or Part 2. Part 2 is randomised, double-blind, placebo-controlled. Approximately 50 participants will be randomised 2:3 to receive either 10 weeks of once-daily placebo following 6 days of placebo (4 times daily) or 10 weeks of once-daily induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (4 times daily), respectively.

The Pasifika Preventing Diabetes Programme (PPDP) primarily aims to test whether a community activation and peer support delivered lifestyle programme across churches in the Greater Western Sydney and South Eastern Sydney Pacific communities can improve a blood marker called HbA1c, an indicator of glucose (sugar) level in the blood. The programme also aims to improve other clinical measures such as weight, waist circumference and blood pressure, through changes in lifestyle behaviours particularly healthy eating and physical activity. The aim is also to see if the programme can help the body weight of children in the church families. This programme is an expansion of a pilot study, Le Taeao Afua (LTA) where the same lifestyle and peer support programme was delivered through three Sydney Samoan Churches. The PPDP is a much larger trial testing the LTA intervention into atleast 48 Sydney Pacific churches over the next 51 months.

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, increased wear, dislocation and reduced functional movement, which lead to poorer patient outcomes. Medacta have recently developed a new acetabular cup device called the Mpact 3D Metal Monocer, designed for use in Total Hip Replacement (THA), the acetabular cup is one component of a THA. The Mpact 3D Metal Monocer device is a cementless hemispherical acetabular shell that comes pre-assembled with a ceramic bearing surface. Pre-assembly may show to have several advantages compared with traditional modular cups used for total hip replacement procedures, including allowing the use of a larger femoral head diameter which can reduce the risk of hip replacement dislocation and reduced wear rates. The Monocer cup is also manufactured with a 3D-Printed titanium alloy material on the back-side to enhance osseointegration and thereby improve implant stability in the bone. The newly designed Mpact 3D Metal Monocer cup device has recently obtained European CE Mark approval. CE Marking allows the Medacta to supply the Mpact 3D Metal MonoCer device in the European Union (EU). The Medacta Mpact 3D Metal MonoCer acetabular cup is not yet approved by the TGA. Thus, the purpose of this study is to investigate the Monocer cup efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available acetabular cups. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless cups currently in use in the Australian Market.

The study will evaluate the feasibility of a patient self-directed transfusion strategy, which it is expected will tailor the benefit to individual needs. People with anaemia on chronic transfusion regimens will be recruited. After a baseline assessment and education, they will have their regular transfusion as prescribed by their doctor and assessments repeated. They will then keep a symptom diary, and when they feel they need a transfusion, asked to contact the study team who will arrange daily red cell transfusions until the recipient feels that they have satisfactorily controlled their symptoms, or where they feel there has been no improvement with additional transfusions. The study will evaluate quality of life, exercise tolerance before and after transfusion, the haemoglobin at which patients choose to have transfusions and feel that they have reached their maximum benefit. There will also be patient interviews at the end of the study to assess acceptability of the self-directed approach.

This study is being undertaken to assess whether a test, known as the sit to stand test (STST) is a useful measure of fitness for people with heart failure (HF). Participants enrolled in a HF exercise programme, will perform two versions of the test (the STST-5 and STST-60s) as part of their baseline and completion assessments. Results will be compared to usual measures of fitness. The study will also determine whether the test is able and reliably performed by people with HF, not only at the health facility, but when also in the home environment when supervised remotely. Results of this study will be used to influence how HF exercise programmes are delivered in the home environment, potentially reducing the need for appointments at the health facility.

There is currently a crisis in drug discovery for neuropsychiatric disorders, with a profound, yet unexpected drought in new drug development across the spectrum. Increasing attention to biomarker-indicated targets is likely to be a promising avenue for new drug discovery. Candesartan, an AT1R agonist, may target key biological factors in the pathophysiology of major depressive disorder. Candesartan reduces stress reactivity, impacts the HPA axis, oxidative and inflammatory stress and enhances neurogenesis; all documented pathological markers of major depressive disorder. The CADET-UD study will test the efficacy of candesartan 16 mg/day as an adjunctive treatment for major depression. CADET-UD is a multi-site, double-blind, randomised, placebo-controlled 16-week trial of candesartan as an add-on to treatment as usual. We plan to recruit 240 participants aged 18 years and above with moderate to severe major depressive disorder.

Cancer survivors are susceptible to heart failure caused by heart muscle damage from chemotherapy. The purpose of this study is to determine if a test called cardiac strain can be used to predict whether an individual undergoing chemotherapy will develop heart failure. Who is it for? You may be eligible for this study if you are an adult who is currently undergoing chemotherapy. Study details: You will have a magnetic resonance scan (MRI) to measure cardiac function at baseline and after 12 months. You will have a standard heart ultrasound test (echocardiogram) to measure strain and ejection fraction every three months. There are three possible outcomes of this test; a) The ejection fraction and strain remain normal – you continue with 3 monthly echocardiograms, no treatment is required. b) The ejection fraction and strain become abnormal – you will be started on medications (ACE inhibitors and beta blockers) to protect the heart c) If only the strain becomes abnormal and the ejection fraction is normal - you will be randomly selected to continue testing with no treatment, or to take medications (ACE inhibitors and beta blockers) to protect the heart. If you don’t take treatment and the ejection fraction changes, then you will start treatment. This is the first randomized trial of cardioprotective treatment based on the use of strain measurement. The results of this trial will determine what tests will be done to track the heart’s response to chemotherapy, and to identify how best to respond to abnormal test results.