ANZCTR search results

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

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31000 results sorted by trial registration date.
  • The Effects of an Intervention to Optimise Quality Use Of Medicines In Older People in Hospital

    Polypharmacy is the use of five or more regular medicines. In some patients taking polypharmacy, the current risk of some of their medicines may outweigh the benefits. This is called ‘inappropriate polypharmacy’. We have developed several tools, presented as a bundle, to reduce inappropriate polypharmacy for inpatients. Using a stepped wedge randomised control trial, we aim to use these tools, supported by a stewardship pharmacist, to optimise medicines use in the hospital and improve outcomes for older people across six hospitals in Northern Sydney and Central Coast NSW. By later obtaining linked data from the Centre for Health Record Linkage, we will investigate whether the bundle can reduce hospital readmissions, Emergency Department presentations and mortality within 28 days and 12 months of the patients' baseline hospital stay. Additionally, we will investigate whether the bundle improves the patients' experience of medication review in hospital and their quality of life after hospital discharge.

  • A trial of integrated arm and language rehabilitation in people living in the community with arm and communication impairments 3 to 24 months post stroke.

    A large proportion of stroke survivors experience loss of arm and communication functions at 3 months post-stroke. These effects are extremely debilitating and can result in long term disability. The aim of this study is to identify the most promising model of arm and communication rehabilitation for people 3 to 24 months after stroke who are living in the community. It is hypothesised that at least one promising UPLIFT model of rehabilitation combining upper limb and language rehabilitation can be identified and taken forward to further clinical trials and translation into the clinic. Participants shall complete some baseline assessments to determine their level of disability, then undertake a 4 week intervention program. The intervention will be intensive daily training (2 or 4 hours/day), either in person or via telerehabilitation, involving both arm training and communication training. Rehabilitation focuses on combining impairment and functional training for tasks such as reaching to pick up a cup of coffee, with contextual everyday communication such as asking for a cup of coffee, and integration of the two, i.e. reaching to pick up a cup of coffee and saying ‘thank you’ while doing it. Baseline assessments will be repeated at the conclusion of the 4 week intervention period. Participants shall be closely monitored for adverse events throughout the intervention program.

  • Replenishing a vital molecule in stiff heart failure patients and examining effect on heart stiffness, blood pressure, and exercise tolerance

    We recently discovered a deficiency of oxidized nicotinamide adenine dinucleotide in the hearts of patients with stiff heart failure. We have shown that replenishing heart levels of this molecule in a mouse model of stiff heart failure can completely rescue this disease. Now, we will deliver the same precursor of this molecule, as used in mice, to human patients with this disease, for three months. At the end of the three months, we will determine if they have had any benefits in heart stiffness, exercise tolerance, blood pressure, and glucose tolerance.

  • Personalised liver stereotactic body radiation therapy using magnetic resonance imaging for liver cancer

    The purpose of this study is to evaluate the "PRISM approach" where MRI imaging is used to improve radiation therapy treatment for liver cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with liver cancer (either hepatocellular carcinoma or liver metastases). Study details All participants will undergo liver stereotactic body radiation therapy and MRI scans as standard of care. There will also be an additional MRI scan during SBRT, and liver function blood tests at three times: before, during, and 3 months after SBRT. Each MRI scan will take no longer than 1 hour and each blood test for liver function will take no more than 40 minutes. The results from these tests will be used to make maps of liver function, to optimise the delivery of radiation to the liver. It is hoped that this research can determine if the PRISM approach is feasible, and thus improve the effectiveness of liver cancer radiotherapy.

  • The enrolment of Total Hip (THA), Total Knee (TKA) or Partial Knee Arthroplasty (PKA) patients performed using either Stryker Mako Robotic-Arm Assisted Technology (Mako) or non-Mako techniques into an outcomes data registry.

    The purpose of this registry is to compare the clinical outcomes of primary total hip, total knee and partial knee arthroplasty patients operated with Mako and non-Mako techniques. Outcome data entered by patients will be collected electronically via an app (called myrecovery) or websurvey link. The secondary purpose is to monitor the early use of this platform (in terms of questionnaire completion rates achievable with the app) that is expected to aid in the data collection process and ultimately achieve high dataset completion rates. Patients will be recruited (retrospectively and prospectively) across Australian sites and data will be collected pre-operatively, peri-operatively and at 6-weeks, 3-months, 6-months, 1-year and 2-years post-operatively with a minimum of 500 patients at 1-year and 250 patients at 2-years (across all procedures). Retrospective patients provided consent to the collection of their data in the same way as prospective patients via the myrecovery app, after being invited to use the app by their surgeon. This took place at the time of their pre-operative visit and patients had time to consider and ask questions. Thus, for the use of their Data in this registry a waiver of consent may be applied.

  • INTERgenerAtional Clinical Trial In at risk Older adults and pre-school childreN (INTERACTION Trial)

    Our ageing population alongside job-related migration has resulted in reduced interaction between grandparents and grandchildren. Increasing evidence suggests that structured intergenerational interaction can mutually benefit community-dwelling older adults and young children. Two community-based sites (St Nicolas’ Anglican Church and St Augustine’s Anglican Church) and associated preschools (St. Nics’ Christian Preschool) in Coogee and (Neutral Bay Preschool) in Neutral Bay are partnering with researchers to evaluate a co-designed intergenerational programme targeted at preschool children and local older adults. This programme will utilise the church hall and preschool facilities based in the local communities. This research is essential/significant because, despite growing public interest (as shown by our pilot work (Kenning et al., 2021), there is almost no empirical evidence to support the anticipated benefits of community-based intergenerational initiatives (Peters et al., 2o21). Our research takes important first steps in evaluating the impact of an intergenerational programme on preschool children and community-dwelling older adults. By doing so, we will be able to estimate the effect sizes needed to power a definitive follow on trial across multiple sites. We have recently completed a small pilot project that showed an appetite for such research in the community and provided initial data on acceptability, allowing us to refine our intervention and delivery of the intergenerational practice program.

  • Cool water foot immersion, skin wetting and fan use as low-cost, at home cooling strategies for older adults during heat waves

    Our laboratory has been conducting research in collaboration with the Montreal Heart Institute, Montreal, CA. examining the effect of fan use with and without skin wetting on thermal and cardiovascular strain in older adults with and without CAD during a 3-hour simulated heatwave. These data demonstrate that fan use during a hot and humid heatwave (38°C, 60% humidity) mitigates the rise in core temperature and heart rate compared to no fan use. During a hot and dry heatwave (45°C, 10% humidity), wetting the skin with 18°C water mitigates the rise in core temperature and heart rate compared to no cooling intervention. This study is is the second phase of identifying low-cost cooling strategies for older adults who are healthy and have heart disease to use in home during heat waves. In this study we aim to investigate whether there is an additional benefit of cold-water foot immersion when combined with fan use during a simulated hot and humid (38°C, 60% humidity) heat wave. A secondary aim of this study is to investigate whether there is an additional benefit of cold-water foot immersion when combined with skin wetting during a simulated hot and dry (45°C, 10% humidity) heatwave.

  • The efficacy of Larri® Oral Spray in the management of Laryngopharyngeal reflux disease.

    Hypothesis: Larri Oral spray will have symptomatic benefit as measured by the RSI questionnaire. Method: 80 patients will be recruited from our ENT clinics at a tertiary centre in Monash Health. Patients will need to be clinically diagnosed to have laryngopharyngeal reflux by their laryngologist and then test positive on a salivary pepsin test to be included. They will then be recruited and randomised into either receiving Larri Oral Spray or a Placebo spray for eight weeks. Prior to commencing their therapy, a baseline Symptom questionnaire will be taken, and then after eight weeks this will then be repeated. Patients already on anti-reflux medication will be allowed to continue their medication

  • Assessment of NSW Early Clinical Trials Alliance Network Assistance in Cancer Trials Access

    The NSW Early Clinical Trials Alliance (NECTA) is a network of cancer centres across NSW which collaborates to improve patient's enrolment in the most suitable early phase clinical trials that are available across the network. This study aims to understand the efficiency by which patients with advanced/refractory cancer are able to access phase 1 clinical trials in NSW within the NECTA network Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with any advanced solid tumour and you have have completed/failed standard treatment for your specific cancer type. Participants will also need to provide a blood sample to check whether their kidney/liver/overall health is strong enough for them to participate in a specific trial. Study details Participants who choose to enrol in this study may be asked to provide two blood samples for ctDNA (genetic) screening, depending upon their tumour type. All participants (regardless of tumour type) will have their treatment history reviewed by a study oncologist to determine trial eligibility. Participants' health information will also be shared with a tumour board who will review the data and ctDNA results (where applicable), and provide recommendations for trials of new treatments (first in humans) that the participant may be suitable for. Once a participant has been enrolled into a trial, they will be asked to complete a questionnaire regarding their experiences and feelings on ctDNA testing and NECTA's recommendations. Participants may also be asked to attend follow-up visits or be contacted by phone to provide feedback on their experience in the clinical trial. It is hoped this research will determine whether collaborative networks such as NECTA can utilise genetic screening of cancer patients for enrolment into clinical trials of new treatments in an efficient and satisfactory manner for those involved. If this process is found to be efficient it may be utilised to enrol future cancer patients into suitable clinical trials much faster, which could provide further benefits.

  • Longitudinal Study of Teenagers with Endometriosis, Period and Pelvic Pain in Australia (LongSTEPPP)

    LongSTEPPP tracks young people’s development and trajectories of period and pelvic pain, and endometriosis with current gynaecological care. The study investigates multiple individual and family characteristics for each participant. By tracking participants over time, we will be able to determine factors associated with pain, quality of life (QoL), mental health, and health utilisation. The study aims to establish a comprehensive national cohort of young people seeing a health care provider, for the management of period or pelvic pain or endometriosis, establishing baseline characteristics and exploring longer term outcomes. The health care provider may be a general practitioner (GP), a federally funded Endometriosis and Pelvic Pain GP Clinic (EPPC), a gynaecologist or paediatrician. This reflects the evolving landscape of service provision for these conditions. LongSTEPPP will commence in 2022 with a single cohort of young people aged 10 to 18-years. Participants will be invited from across Australia. Data will be collected annually. Study participants include the young person and the female parent/guardian. LongSTEPPP data will be linked to sources of administrative data including the Medical Benefits Schedule (MBS) and the Pharmaceutical Benefits Schedule (PBS).

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