ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32114 results sorted by trial registration date.
  • I-PRP-FET Trial: Intrauterine Platelet-Rich-Plasma Infusion Prior to Frozen Embryo Transfer in Women Undergoing In Vitro Fertilisation (IVF)

    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.

  • Sustainable cooling strategies for use in garment factories in low- and middle-income countries

    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.

  • Assessment of closed loop technology in young children with Type 1 Diabetes Aged 2-7 - A feasibility study

    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

  • Influenza vaccination strategies in haematological cancers

    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.

  • Multidisciplinary brain cancer rehabilitation, holistic assessment, and multimodal interventions to address survivorship needs: Brain Trial

    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 Coronary Artery Disease (CAD) Registry: An observational study of the quality of care and risk factors in patients with CAD but without Standard Modifiable cardiovascular Risk Factors (SMuRFs)

    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.

  • Patient activation in chronic kidney disease

    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.

  • Yoga for BP2 (Blood Pressure Postpartum)

    Women with a history of a hypertensive disorder of pregnancy (HDP) have significantly higher blood pressure in the early years of postpartum and in later life compared to normotensive women. As well as this increased risk of chronic hypertension, these women have also been shown to have an increased risk of recurrent HDP in futures pregnancies, premature cardiovascular disease (CVD) and death beginning within 10 years of the HDP pregnancy and continuing lifelong. The majority of women in the postpartum period do not remain hypertensive, and although they may remain at risk of HDP in a future pregnancy, pharmacological management such as Angiotensin-converting enzyme (ACE) inhibitors are contraindicated. However, prevention to reduce the risk of early onset CVD trajectory is lacking. This represents a need for evidence-based non-pharmacological therapies, including lifestyle interventions. The aim of this study is to explore the feasibility of conducting a yoga-based mind body intervention to reduce blood pressure for women 6 months postpartum. This will be achieved through a mixed methods model involving: (i) a non-randomised open label pre and post-test design to assess the feasibility of a yoga-based mind body intervention to manage blood pressure postpartum and improve quality of life; and (ii) in-depth interviews with women to examine their experience and views of acceptability of the intervention. Twenty women will be recruited to the study.

  • Treating adult Crohn's disease with exclusive enteral nutrition using a protocolised approach

    Exclusive enteral nutrition (EEN) is a nutrition-based treatment for Crohn’s Disease (CD) with numerous advantages compared to current conventional therapies. While its efficacy has been demonstrated in adult CD patients, EEN remains an underutilised therapy due to a number of factors including uncertainties around the optimal regimen, monitoring and treatment targets. While frameworks have been established to aid decision-making and prescription, evidence to support these recommendations is limited. This multi-centre single arm pilot clinical study aims to meet this clinical need through prospectively evaluating the efficacy and feasibility of a protocolised approach to delivering exclusive enteral nutrition in adult patients with active Crohn's Disease. Participants who meet inclusion criteria and provide consent will receive a 6 week course of exclusive enteral nutrition under the guidance of an experienced dietitian with regular follow up. This study's primary outcome is the clinical response or remission and/or objective response or remission as demonstrated by normalisation of inflammatory biomarkers or resolution of intestinal inflammation on gastrointestinal ultrasound. Our study will also assess the impact of EEN on disease activity utilising clinical, biochemical, radiological, patient reported outcome measures. Adherence to the therapy and protocol as well as tolerability to EEN will also be assessed. Protocol feasbility and fidelity will be analysed along with health economic data to evaluate the cost-effectiveness of the protocol. Changes in colonic microbial composition, diversity and function post EEN therapy.

  • A study on patients in cardiac arrest to determine the effect of equipping GoodSAM responders with an ultraportable defibrillator on 30-day survival

    For every minute that passes without defibrillation, survival from cardiac arrest falls by approximately 10%. Defibrillation by bystanders and GoodSAM responders using an automated external defibrillator (AED) halves the time to first defibrillation and can help double or triple rates of survival. Although the GoodSAM app aims to increase the visibility and access to AEDs in the community, the proportion of GoodSAM responders providing defibrillation remains low. This multicentre cluster randomised controlled trial will examine whether equipping high-frequency smartphone-activated (GoodSAM) first responders with an ultraportable defibrillator (CellAED®) can increase survival to 30 days in OHCA compared with the current strategy of retrieving the closest available AED.

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