ANZCTR search results

This is a single centre, single arm, study primarily examining the safety and feasibility of psychotherapy combined with a single dose of 25mg psilocybin. Study Hypothesis: That psilocybin psychotherapy for methamphetamine dependence can be safely and feasibly delivered from a public addiction outpatient clinic.

We are conducting a clinical trial to evaluate the effectiveness of a telehealth-delivered clinician-supported program (Better Hip) which will comprise education, strengthening exercise, physical activity, self management strategies and if needed, dietary intervention for weight loss, for people with hip osteoarthritis. We will evaluate the effectiveness of the Better Hip program on pain and physical function at 6 and 12 months. The two different treatment groups in this study are: 1. Website (information) group: access to a website with information about hip osteoarthritis and how to manage the condition; or 2. Better Hip group: 6 video consultations with a physiotherapist for information and prescription of an exercise program. Additionally, for those with a BMI > 27 kg/m2 who are aged under 80 years: 6 video consultations with a dietitian for prescription of a dietary weight loss program over 6 months, comprising a ketogenic very low energy diet followed by guidance to transition to healthy eating for weight maintenance. Primary and secondary outcomes will be collected via online survey at baseline, 6 and 12 months. A further online survey for follow-up of primary and secondary outcomes will be also conducted at 2 years post randomisation. These results will be reported separately to the main trial results and will occur after analysis of the main trial data.

Otsuka Pharmaceutical Development & Commercialization, Inc (OPDC) is studying an investigational drug called OPC-224333. This drug is not available for sale in any country. OPC-224333 is being studied as a possible treatment for epileptic diseases including drug-resistant and rare epilepsies such as Dravet, Lennox-Gastaut, West, and Doose syndrome. Epilepsy is a condition that causes people to have repeated seizures. Seizures are caused by abnormal electrical activity in the brain. Seizures can make you have convulsions, pass out, shaking movements in just one arm or in a part of your face, suddenly stop responding and stare for a few seconds, or behave strangely. Epilepsy can start at any age. You are invited to take part in this research study. The reason for this study is to find out potential benefits and safety of OPC-224333. About 72 participants will be in the study and the study is being done at one research site, CMAX Clinical Research Pty Ltd, in Australia. We are looking for a total of 72 healthy male or non-childbearing potential female participants between the ages of 18 and 55 years (inclusive) who have a body mass index between 19-32 kg/m2 (inclusive). The study will involve: • A screening visit (2 – 3 hours), within 28 days of the study starting • 8 night in-house stay (Day -1 to Day 8) • Follow-up phone call 30 days after your last dose (approximately 15 minutes) Expected study duration for Arm 1 is up to approximately 59 days.

In Vitro Fertilisation (IVF) as a treatment for infertility, includes in part transferring an embryo (usually 5 days age) into the uterine cavity. Even with chromosomally normal embryos the resulting clinical pregnancy rate is 40-60%, indicating that approximately half of the embryos do not implant (implantation failure) The purpose of this study is to assess whether instilling 0.5-1.0 ml of autologous platelet rich plasma (PRP) into the uterine cavity 2-3 days prior to embryo transfer will lead to an improved clinical pregnancy rate. It is hypothesized that the PRP acts on the endometrium to improve receptivity for implantation.

Bangladesh is a developing country that produces a large proportion of the world’s Ready-Made Garments (RMG), employing millions of workers from the country’s low-socioeconomic demographic. These workers are faced with tough working conditions, high workloads and low wages. Monitoring the internal conditions of Bangladeshi RMG factories has shown that these workers are subjected to very high ambient temperatures (~40°C) with high relative humidity (~40%) These conditions render workers vulnerable to dangerous levels of heat-stress and the development of heat-related illness. Therefore, we aim to examine the efficacy of sustainable, low-cost cooling strategies that may be implemented in RMG factories to help improve the internal thermal conditions and reduce the heat-strain experienced by workers.

This feasibility study is an 8-week, prospective, single-arm study, in free-living conditions in children aged 2 to 7 years with Type 1 Diabetes on insulin pump therapy. The participants will use the MiniMed 780G Advanced Hybrid Closed Loop system in Manual Mode for 2 weeks followed by 6 weeks in SmartGuard mode. It will establish the clinical parameters and settings of the device to test for the effectiveness of the device in this group. The primary aim of the 6-week feasibility phase is to increase the clinical experience with the device and to identify logistical barriers that may affect the optimal conduct of further studies. Secondary aims of the feasibility phase are: 1. To assess the likelihood of uptake and engagement with the device (MiniMed 780G Pump) 2. To gather further estimates of glycaemic control metrics in children with T1D

What is this study about? We are looking at the immune response to influenza vaccine and how this can be improved in patients during or after treatment for certain types of blood cancers. When you are vaccinated, your body makes antibodies against influenza virus, which protect you from influenza infection. We know that the body’s immune response to influenza vaccine is not as strong after treatment for blood cancer. Currently, having one dose is recommended to try to protect you against influenza. We would like to study if two adjuvant dose influenza vaccines or two standard vaccines will improve the immune response. An adjuvant vaccine is a vaccine that contains an ingredient which can stimulate a stronger immune response and is generally used in people 65 years and above. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been receiving treatment for blood cancer (myeloma, chronic lymphocytic leukaemia or non-Hodgkins lymphoma) or have received treatment for the listed blood cancers within the last 12 months, and have not yet received a flu vaccine for the current season of recruitment (i.e. 2022 influenza vaccine for 2022 recruitment, 2023 influenza vaccine for 2023 recruitment). Study details There will be two groups of participants and both groups will two doses of influenza vaccine, one month apart. One group (Group 1) will receive two doses of the adjuvant influenza vaccine 1 month apart and a second group (Group 2) standard dose influenza vaccine followed by the standard dose vaccine 1 month later. Blood samples will be collected at four time points: before the first vaccine, before the second vaccine, 21-28 days after the second vaccine, and 6 months after the first vaccine. Participants will also be asked to provide information on vaccination history, side effects and if an influenza-like illness (ILI) occurs. Participants will be contacted weekly to see if they have developed any influenza-like illness from first vaccination until 6 months later. If respiratory symptoms occur, the participant will be asked to give a nasal swab and get checked out by their regular treating or general practitioner. This study will help us understand if two doses of the adjuvant or standard dose vaccine should be used in patients.

This study aims to prospectively assess the impact of multidisciplinary multimodal supportive care intervention on cancer selected outcomes in people diagnosed with high grade glioma (HGG) brain cancer and their family and/or caregiver. Who is it for? Adults (18+ years) diagnosed with high-grade (III-IV) gliomas, and if applicable their family and/or caregiver. Study details: 30 participants will be randomly allocated into one of two groups. One group (n=15) will receive standard care currently available at their clinical site (oral/written information and the contact details of the specialist nurse for additional support, if required). The other group (n=15) will undergo (needs-based) multimodal supportive care, which involves informational materials, holistic needs assessment, self-management care plan and a tailored exercise programme. It is anticipated the results of this study will improve health outcomes for cancer patients in Canberra by driving changes in local health procedures and policy to ensure better integrated multimodal supportive care based on routine, holistic needs assessments. This project may also have implications that inform care models both domestically and internationally.

The SMuRFless CAD Registry is a study involving patients referred to an National Health & Medical Research Council (NHMRC) Centre for Research Excellence (CRE) for Coronary Artery Disease (CAD) clinic: a specialty clinic of patients with diagnosed or suspected atherosclerotic CAD. The SMuRFless CAD Registry seeks to measure and improve quality of care in SMuRFless CAD patients utilising traditional and applied data linkage methods for key longitudinal endpoints, to determine the clinical and cost effectiveness of the NHMRC CRE clinical pathway in identifying risk factors of CAD progression and to understand risk factors for outcomes and regional/centre differences.

Chronic kidney disease (CKD) is a complex health condition that has a profound impact on an individual’s general health and wellbeing and consumes enormous economic resources. The lifetime of living with CKD requires individuals to actively manage their own healthcare needs where possible. Health services in Australia have had limited success in encouraging self-management among people with CKD. To overcome these low levels of self-management, a new patient activation approach has been identified. Patient activation requires relevant healthcare knowledge, skills, and confidence in order to achieve optimal self-management. A growing body of research in chronic conditions has shown low activation is associated with higher symptom burden, higher hospital admissions rates and reduced health-related quality of life. However, a complete understanding of patient activation in the CKD population is limited, creating a challenge to develop the strategies required to address low patient activation and low self-management. This study aims to identify: (1) the current status of patient activation levels in people with advanced CKD (2) measure the association between patient activation and patient sociodemographic characteristics, clinical variables, treatment adherence and emergency visits/hospital admission rate. This study will result in a better understanding of patient activation and enable kidney care teams to target appropriate individuals and propose strategies to move towards a more active role for patients and their family in their own health care.