ANZCTR search results

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

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30916 results sorted by trial registration date.
  • Chest x-ray versus low dose high resolution computed tomography in screening Queensland workers for occupational dust lung disease.

    This study is a comparative study investigating how ILO chest x-ray compares to low dose high resolution computed tomography (LD HRCT) for early diagnosis of occupational lung disease. As part of this study participants will be asked to undergo a LD HRCT scan, which is new technology using very low levels of radiation. HRCT scans are better at diagnosing early stage of occupational lung diseases than chest radiography. This study will answer the question about whether the low radiation dose HRCT scan used in this study picks up more early stage lung diseases such as black lung, emphysema and silicosis. No Australian evidence has been collected to demonstrate the use the use of LD HRCT in the screening of occupational lung diseases.

  • The MAGPIE Study: Multi-cancer genomic risk assessment to target screening in general practice

    The MAGPIE Study: What is the purpose of this research? This research aims to transform early detection of Australia’s four most common cancers (colorectal, breast, prostate, melanoma) by identifying those at risk more accurately and encouraging all Australians to do the right cancer screening tests for their personal risk. We can do this by offering in general practices a new genomic test that predicts future risk of cancer. This risk information will be used to tailor screening recommendations, then to have a discussion to encourage the right decisions about screening for each patient. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 59 years who have not previously been diagnosed with bowel, breast, prostate cancer or malignant melanoma. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of multi-cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self-collected saliva swab. After 2-3 weeks the participant will meet with the researcher at the GP practice or by method of telehealth appointment to discuss the DNA test results. They will be given a report summarising their multi-cancer risk and screening recommendations to be discussed with their GP. Follow up questionnaires will be sent to all participants at 1, 2 and 6 months after recruitment. It is hoped that this study will determine whether providing participants with their personalised cancer risk factors has a positive impact upon their willingness to undergo cancer screening procedures. If this study does show a positive effect, it will facilitate provision of DNA testing for cancer risk in general practice and therefore personalised population cancer screening for all Australians.

  • Preparing, Planning and Prehab for Stem Cell Transplant: A Multidisciplinary Approach

    This study aims to develop and test a multidisciplinary prehabilitation (prehab) program for patients with acute myeloid leukaemia and myelodysplastic syndromes who are being offered an allogeneic haematopoietic cell transplantation (allo-HSCT) at the Royal Adelaide Hospital (RAH). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), you are being treated at the RAH and you have been offered a stem cell transplant (allo-HSCT) procedure as a treatment. Study details All participants who choose to enrol in this study will be given access to the specially designed prehab program. The program will commence immediately after completion of chemotherapy and prior to the scheduled stem cell transplantation procedure. The program will involve multiple areas, including diet and nutrition guidance, a supervised twice-weekly exercise program, advice from a social worker, an educational and occupational therapy needs assessment session, and a session with a psychologist. These sessions will be delivered over an 8-week period and participants will continue to receive their treatment as usual from allied health staff both before, during and after consenting to partake in this project. Participants may be referred to social work, physiotherapy, occupational therapy, exercise physiology, cancer psychology or other available allied health services at any point following their cancer diagnosis depending on their needs. It is hoped this research will demonstrate that the prehabilitation program is feasible and has a positive effect on participants physical and mental wellbeing. If the program is feasible, this study will provide key findings to inform a future large scale randomised controlled trial, and provide information required to underpin ongoing prehab for allo-HSCT patients. This innovative model of multi-disciplinary prehab has strong potential to be adapted for other patient populations across the cancer program at the RAH.

  • Verifying if aerobic training protocols benefit the heart in subacute stroke

    The benefits of aerobic exercise for people with stroke are well established, and worldwide clinical practice guidelines recommend aerobic exercise training across all phases of stroke recovery. But aerobic exercise is not routinely prescribed by therapists, and when it is prescribed, it is often at sub-optimal levels that does little to improve the fitness of people with stroke. For many, it is their aerobic deconditioning that limits their walking ability and engagement in physical activity more so than their neuromotor impairment. This is a significant problem. Walking is not only fundamental for physical independence but is so important for health that it has been called the 6th vital sign. Aerobic exercise at sufficient intensity to challenge the neuromotor and cardiopulmonary systems can improve walking endurance and enhance cardiovascular health post-stroke. Most randomized controlled trials (RCTs) of aerobic exercise post-stroke have employed moderate intensity continuous training (MICT, i.e., 40-60% heart rate reserve [HRR]) to good effect. This is why MICT is recommended in national and international guidelines. There is, however, emerging evidence that more vigorous aerobic exercise training (i.e., >60% HRR) can improve walking and enhance stroke recovery, but sustaining such higher intensities of exercise can be difficult. High intensity interval training (HIIT), which involves short bursts of vigorous aerobic exercise (i.e., >60% HRR) alternated with active or passive recovery periods, may be a feasible approach to eliciting the benefits of vigorous aerobic exercise training in a manner acceptable to patients and providers. Since females are less likely to achieve independence after rehabilitation and are less likely to be discharged home, there could also be sex and gender differences when testing such an approach. In this pilot RCT to be administered at Epworth HealthCare, we will: 1) Examine data on safety, feasibility, and acceptability to plan for an international trial. 2) Evaluate the effects of 10 weeks of HIIT or MICT on walking speed, cardiorespiratory fitness and quality of life during the subacute phase of stroke recovery. 3) Evaluate sex differences on stroke outcomes.

  • Effects of quinine, alone and combined with dietary nutrients, on gut function and blood glucose in healthy volunteers

    The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter agonist, quinine on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions in healthy individuals, We have found in one of our recent studies that quinine, given as a bolus in doses of 300 or 600 mg (in 10 ml water), potently slowed gastric emptying and lowered postprandial blood glucose. Moreover, we observed more potent blood glucose lowering effects when quinine was administered intraduodenally than intragastrically, suggesting that interaction of quinine with small intestinal receptors is required for potent effects. Therefore, based on these findings, this study aims to characterise the dose-related effects of intraduodenal quinine at these doses, on energy intake.

  • A multicenter randomized study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock

    Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP targets during vasopressor therapy for shock in ICU are individualized based on patients’ own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings. Hypothesis We hypothesize that targeting a patient’s pre-illness MAP during management of shock can minimize the degree of MAP-deficit (measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU. Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality. Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care. This is an opportunity for the clinicians to support a clinical trial that aims to compare the effects of a simple intervention of individualized blood pressure targets over standard care for patients with shock in ICU.

  • Telehealth-delivered well-being plan group program for adults living with bipolar disorder: Phase 1

    The present study aims to assess the acceptability and feasibility of a recovery-orientated well-being group therapy program for people living with bipolar disorder that was developed to be specifically designed to be delivered via telehealth (Zoom platform) by clinicians using a randomised-controlled pilot design. It was hypothesised that by assessing weekly attendance, drop-out rates, homework compliance and qualitative interview data that the zoom-delivered program would be found to feasible and acceptable program for participants living with BD and that the telehealth platform would be viable as a form of delivery.

  • Shoes for adolescent kneecap pain: the SHAPE randomised clinical trial

    We are conducting a clinical trial to compare two different classes of footwear for managing adolescent kneecap pain. The participants will wear their allocated study shoes during all planned sport and exercise based activities over a 3 month period. The two different treatment groups in this study are: 1. Flat flexible shoes 2. Stable supportive shoes We will evaluate the effectiveness of the different footwear classes on pain and physical function at 3 months. Primary and secondary outcomes will be collected via online survey at baseline and 3 months. Our hypothesis is that flat flexible shoes, which have been shown to reduce kneecap loading in adolescents, will result in a greater improvement in kneecap pain for adolescents.

  • A comparison of ongoing symptoms and functional impacts of people testing PCR-positive to either COVID-19 or influenza, and people testing PCR-negative to these illnesses.

    This project will use a short survey via text message to understand ongoing symptoms and functional impacts arising after COVID-19, influenza and a PCR negative control group. It aims to increase understanding of post-viral recovery amongst those who have had either COVID-19, influenza and other acute respiratory infections (ARIs), and provide Queensland Health with information on any difference between the burden of "long COVID" and a long recovery from influenza and other ARIs. The survey will be sent out to individuals who obtained test results across a four week period from late May to June 2022, which must be 12 weeks or more prior to the issuing of the initial survey, and 12 months prior to the second survey. The survey is based on a validated tool called the Post-COVID Functional Scale (PCFS). The results of the two groups are to be compared to ascertain the severity of long COVID when compared with the influenza-positive control group and those negative to these two illnesses (ie the group has "another ARI"). The findings may assist Queensland Health in any appropriate response to support those experiencing a prolonged recovery from COVID-19 and/or influenza. The Project Team is part of Queensland Health's COVID-19 System Response unit, which accesses the Notifiable Conditions System. The system houses information on COVID-19 and influenza positive PCRs, and people with a negative PCR for COVID-19.

  • Using facial patterns from artificial intelligence facial recognition to guide and optimise treatment with opioid medications following painful surgery

    This is a study that aims to identify patients that might be susceptible to prolonged requirement for opioids after painful surgery. It will do this by using facial recognition technology before surgery to see whether participants respond to a specialised pharmacologic intervention to minimise unnecessary opioid use. It will do so by comparing this intervention with usual care to see whether there is an overall reduction of days where opioid therapy is needed following surgery between two groups. One group will use information from Artificial Intelligence prior to surgery to identify facial characteristics predicting prolonged opioid requirement following surgery, Those with predicted prolonged opioid requirement will have postoperative pain managed in close conjunction with a pharmacist. They will be involved in a detailed program where they are reviewed regularly and, if circumstances are appropriate, have their opioid dose reduced proactively. This is known as pharmacy-led opioid de-escalation. It comprises management by an accredited clinical pharmacist providing an individualised plan aiming for detailed patient education together with opioid reduction of approximately 25-50% every (1-3) days. The plan will take pain intensity scores into consideration. Increasing pain intensity scores will result in no de-escalation, whilst unchanged and decreasing pain scores will result in reduction of opioid of approximately 25-50% every (1-3) days. The clinical pharmacist will also continue to closely follow progress of patients assigned to opioid de-escalation after discharge from hospital to continue the de-escalation pathway until cessation of all opioid analgesics, often working in conjunction with a family doctor. The other group will be randomly allocated to receive usual care for their postoperative pain. This comprises filming the participant but not acting on the results of the AI facial recognition analysis. All participants in this group will be subject to current practice whereby surgical residents (young doctors working with the surgical team) manage opioids after the acute recovery period using their existing knowledge with involvement of pharmacists who help with dispensing and provide basic education. Following discharge from hospital the family physician continues to provide follow-up. The main measure of the study will be the time in days of opioid requirement compared between the two groups.

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