ANZCTR search results

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.

Patients who sustain a minimal trauma fracture benefit from co-ordinated secondary fracture prevention clinics - Osteoporosis Re-fracture Prevention (ORP) services. There is cumulative evidence that these services increase rates of identification, investigation and initiation of appropriate treatment as well as reduce the rate of re-fracture and mortality. Multiple models of ORPs exist, with increasing numbers being implemented worldwide. However, existing ORPs may vary considerably in quality and the contribution of these services in truly reducing the care gap and treatment burden must be critically evaluated. Successful implementation of ORPs into practice needs to be informed by implementation research, with trials of sustainable implementation strategies to support more rapid and effective translation of effective models of care into practice. The Implementing the Osteoporosis Re-fracture Prevention Model of Care effectiveness-implementation hybrid trial (IORP trial) will assess the effect of a facilitated implementation strategy using existing local implementation resources and supports on multiple implementation, effectiveness outcomes. This project is designed to improve the implementation of ideal ORP services into three different hospital settings across three local health districts in New South Wales, Australia. The IORP trial will use available implementation training and resources as well as improvement cycles and implementation stages. It is a type 3 hybrid study, with emphasis on testing the implementation strategy, whilst also gathering information on effectiveness. Each site will have pre-implementation formative assessments, two implementation cycles (initial implementation, full implementation) and post implementation summative assessments. The study will use a stepped wedge design, commencing at the three sites in a sequential fashion. The trial will report implementation and effectiveness outcomes including reporting of 3 monthly key performance indicators, capture the fracture assessments, linked re-fracture and mortality data and qualitative analysis, and will compare effectiveness outcomes to those of a fourth comparator site, currently operating as a model site.

This trial is designed to evaluate safety, tolerability, PK and PD of BI 730357 in male and female patients with psoriatic arthritis using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 730357. Although effective treatments for psoriatic arthritis are approved, the unmet medical need remains for safer oral therapy that works well, improves joint and skin inflammation, prevents structural damage and maintains the efficacy over time. This trial is a randomised, double-blind, placebo-controlled trial in which three dose regiments of BI 730357 will be compared to placebo over a 12-week treatment period. Only approximately 40 patients out of total 160 patients will be randomized to receive placebo treatment. A placebo-control design is required for evaluation of evaluation of BI 730357 efficacy and safety. In addition, a placebo arm is needed in order to avoid potential confounding factors, such as placebo effect, potential investigator bias in safety and efficacy assessment or regression to the mean in endpoint scoring. In addition, as a risk mitigation strategy, if the patient experiences an intolerable increase in diseases activity of psoriatic arthritis during the course of the trial treatment, the patient will be discontinued from the trial treatment and will receive a standard of care treatment as deemed appropriate by the investigator.

This research study will conduct a pilot evaluation of the Salvio digital platform to ascertain a preliminary understanding of the potential benefits to participants and their experiences of use. The research team has developed a platform that brings together various behaviour change programs into a common portal for self-management of heart disease. The platform enables users to customise their experience using a suite programs and tools. Participants will be able to choose from the technology and type of support that suits them to best self-manage their condition. Participation in this research study will require adults (>18 years) living with cardiovascular disease to trial the Salvio digital platform for a 6-week period and actively provide feedback to inform future development. During this time, participants can remotely access the platform alongside their usual care. They will create a profile and use an online decision support tool to guide them to the digital intervention that is best suited to their particular needs and preferences. Participants can choose to enrol in one or more of the interventions presented and will be able to view their progress on a personalised Salvio dashboard.