ANZCTR search results

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

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32727 results sorted by trial registration date.
  • A music intervention for consumer and staff wellbeing in an advanced dementia unit.

    MATCH is an eHealth solution, “Music Attuned Technology Care via eHealth,” developed to support carers of people living with dementia to use music intentionally to support care. It is a scalable solution for the growing number of people living with dementia. We developed the ‘MATCH Music Training Program’ as part of this package, which we will trial in a hospital setting in this study.

  • A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial)

    The REBUILD-SM trial will evaluate the efficacy of a combined self-management package and smartphone application for people with interstitial lung disease (ILD). This intervention will be supported by phone calls from health professionals. Participants will be allocated to either the intervention or control group and take part in the 12-week intervention, with follow-up at 6 and 12 months. It is hoped that the intervention will improve health-related quality of life for people with ILD by helping them better manage their chronic condition.

  • ENRICH ME STUDY- Examining the impact of an Early Intervention on incidence of poor cardiovascular health outcomes in women with pre-eclampsia and gestational hypertension.

    A diagnosis of pre-eclampsia or gestational hypertension have long-term implications for women's health, with an associated increase in lifetime risk of ischaemic heart disease, stroke, and heart failure. Research suggests earlier cardiovascular risk assessment for women with a history of hypertensive pregnancy disorders would likely benefit from establishing care with a cardiologist before the age of 45 to optimise modifiable risk factors and initiate primary prevention strategies to reduce cardiovascular disease. Behavioural science studies have also shown that positive behavioural changes are more likely when individuals are already undergoing significant life changes. This study aims to review if early intervention of diet and lifestyle counselling and cardiovascular assessment. help improve cardiovascular outcomes in women post delivery of their baby. Through two post natal cardiovascular follow up visits one at 3 months and one at 9 months post delivery and if necessary a review with a cardiologist.

  • Evaluating the Effect of Endocrine Therapy on Gut Bacteria in Estrogen Receptor-Positive Breast Cancer

    This study aims to identify gut bacteria that are associated with vasomotor symptoms, such as hot flushes, that affect quality of life for women with breast cancer. Who is it for? You may be eligible for this study if you are a female who has either been diagnosed with estrogen-receptor positive breast cancer postmenopausally and are due to receive endocrine therapy, or are a carer for a breast cancer patient. Study details While breast cancer patients undergo the standard 5 to 10-year regimen of endocrine therapy, participants will be requested to provide blood and stool samples, along with completing questionnaires before and during the treatment (at week 4-5 and week 12). Healthy caregivers in the control group will not undergo any treatment, however, they will be requested to provide samples and complete questionnaires at a single time point before the individual under their care undergoes endocrine therapy. It is hoped that findings from this novel study will help to identify key gut bacteria associated with vasomotor symptoms to improve the quality of life and increase the survival of breast cancer survivors.

  • Un-Necessary Tests in Emergency Departments (UNTIE), a Stepped-wedge Cluster Randomised Trial

    Hypothesis: We hypothesise that audit feedback will be more effective than observation in improving appropriate pathology test ordering practices in Emergency Departments   Population: All/consecutive visits at the four western Sydney local health district's (WSLHD) emergency departments (ED) and Nepean Hospital over each 10 weeks time period, where the patient presentation maps to one of the 35 presenting problems covered in the guideline. Intervention: Automated generation of UNTIE U and UNTIE N scores for each presentation generated by reviewing initial pathology testing ordered. After site randomisation to intervention, data will then be presented to clinical staff in the form of an audit feedback process involving multimodal investigations. UNTIE scores will continue to be collected and department performance reviewed in response to the audit feedback process Comparison: Usual practice- there will be no contact between the research team and an ED that is not in an intervention phase. Outcome: The primary outcome is UNTIE-U, secondary outcome UNTIE-N. Both will be generated blinded to an ED’s intervention/comparator status.

  • Effects of Sports-Hydration Drink on Infantry Soldiers

    A novel hydration strategy will be investigated as an aid for the maintenance of hydration status in austere environments. The novel hydration strategy (beverage) employs resistant starch (in the form of high amylose maize) as well as glucose and electrolytes. Previous research has shown that resistant starch may increase water absorption in the large intestine, capable of absorbing upwards of 6L/day. This study aims to assess: -Whether a hydration drink containing resistant starch improves the hydration of personnel immediately before training and during recovery -Whether a hydration drink can improve gut health It is hypothesised that the resistant startch hydratation drink will improve the hydration status of military personnel undertaking high levels of physical activity in a hot tropical environment.

  • PROMPT: PROcedural sedation vs Methoxyflurane a Prospective cohorT Study.

    Procedures performed in interventional radiology are often quick and minimally invasive, however some procedures traditionally require increased pain relief and sedation than local anaesthetic alone. For these procedures, we have previously used intravenous medications (midazolam and fentanyl) for sedation and pain relief; however, dosing of these medications is controlled by your nurse or doctor which can lead to under or over dosing of medications, or delayed pain relief due to delays in administration of medication. We believe that letting the patient control how much medication and how often can be effective.

  • T cells and pembrolizumab for recurrent and newly diagnosed glioblastoma

    This study aims to assess the safety and potential effectiveness of a new treatment combining two different cancer treatments, a T cell-based immunotherapy and pembrolizumab (a drug that is used to prevent cancer cells from hiding from T cells), for glioblastoma multiforme (GBM) or astrocytoma grade 4. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with GBM or astrocytoma Grade 4 brain cancer and you have been exposed to a common virus called cytomegalovirus (CMV) at some point in your life, this exposure will be determined by a blood test. Study details In this trial, based on the patient tissue type, the best-matching T cell therapy available will be selected and given to patients over four infusions, followed by 18 doses of pembrolizumab (at an interval 6 weeks between each treatment). The main aims of this clinical trial are to see whether this CMV-specific T cell therapy combined with pembrolizumab is safe for people with GBM/astrocytoma grade 4, and it if can show effectiveness against this type of tumour. The trial is being conducted in two parts. Phase I of this trial aims to work out the highest dose of T cells that does not have serious side effects. Participants will be enrolled firstly into the lowest T-cell dose group, if there are no serious side effects noted then enrolment into the higher T-cell dosing groups will occur. Once the maximum tolerated dose is determined, the second part (Phase II) will begin enrolling participants. Phase II of the trial is used to gather additional safety data and determine the efficacy of four infusions of the maximum tolerated dose (determined in phase I) of allogeneic CMV-specific T cells in combination with pembrolizumab. Participants enrolled in either Phase I or Phase II will be asked to undergo routine blood tests and MRI scans to determine any impact the combined treatments may be having on their cancer. Overall participation is not expected to exceed approximately 26 months. It is hoped this research will determine the maximum safest dose of T-cell therapy that can be administered to brain cancer patients together with pembrolizumab. Once a safe dose has been determined, a larger trial enrolling more cancer patients may be undertaken to further assess the efficacy of the combined treatments.

  • safe@home: effectiveness and cost effectiveness of telemonitoring and virtual care supported by primary care for people living with chronic disease in low socioeconomic neighbourhoods on ambulance ramping, readmission and GP clinic bloc

    Our healthcare system urgently needs a major boost in efficiency to manage hospital bed shortages and lengthening waiting-lists for primary and secondary care consultations. Once a winter issue, the unrelenting pressure on our healthcare system by our ageing, multi-morbid population now persists across all seasons and is exacerbated by the recent pandemic and its aftermath. The safe@home project is a potential solution. Safe@home aims to reduce emergency department (ED) presentations (ambulance ramping), readmission and length of stay (hospital avoidance), out-of-hospital mortality and improve access to primary care (clinic block) and self-care. With a focus on chronic conditions with high healthcare utilisation (diabetes, COPD, heart failure and hypertension), Safe@home will use the Model for Large Scale Knowledge Translation combined with co-design methods and a prospective, non-blinded pragmatic randomised Usual Care led trial (RCT) and economic evaluation to test and implement a daily home telemonitoring model of care supported by health professionals, for people living with chronic disease in low socio-economic neighbourhoods. We will evaluate the intervention’s effectiveness and cost-effectiveness. It is the clinical decisions and actions taken based on information obtained by monitoring that will alter patient wellbeing and outcomes, rather than the monitoring itself.

  • NSW Government-Sponsored Clinical Trial: Extended supply of Oral Contraceptive Pills (OCPs) by Community Pharmacists

    The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in NSW and 5 pharmacies in ACT, e-supplying specific oral contraceptive pills for a specific patient cohort over a 12-month study period. Women must be aged between 18 to 35 years (inclusive), taking the pill for contraception purposes only, and has seen their GP/nurse practitioner for a review of their low-risk oral contraceptive pill in the last two years. Specific objectives are to: 1. Assess the accessibility and acceptability for patients managed and/or treated by community pharmacists. 2. Assess implementation uptake of the intervention including the reach, fidelity and adoption of the intervention in community pharmacies, participant characteristics, and variation in uptake by geographic region. 3. Assess the clinical and experience outcomes for patients managed and/or treated by community pharmacists. 4. Assess the safety of the intervention and identify any risks that need to be addressed for future implementation. 5. Qualitatively assess the acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service. 6. Identify contextual enablers and constraints to access, adoption, fidelity delivery, impact, sustainability, and generalisability of the intervention. 7. Conduct a health economic evaluation to determine the economic benefits from the intervention. The study will use a cohort study design to assess the clinical and economic and implementation of the intervention in NSW and ACT over a 12-month study period. The intervention is multicomponent including Pharmacist training and support and a Pharmacy consultation, using an IT program, applying a clinical management protocol. Pharmacies and pharmacists must meet the criteria of an 'approved pharmacy' and an 'approved pharmacist' outlined in the NSW Health Authority to participate. Primary outcomes will be accessibility and acceptability of the service (based on self-report at 7-day follow up).

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