ANZCTR search results

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

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31108 results sorted by trial registration date.
  • Diabetic Retinopathy Screening at Point Of Care (DR SPOC)

    This study is attempting to address shortcomings with the current DR screening process by implementing novel portable devices at point of care for high-risk patients. Non mydriatic camera (NMC) fundus photography has been approved by the NHMRC as a screening tool for DR. Combined pupillometry/electroretinography (ERG) has been proven sensitive and specific for DR screening. We will build on these promising novel screening tools through implementation in new clinical settings: point of care in hospital. Opportunistic diabetes case-finding by HbA1c screening of patients presenting to Blacktown ED identified 66% of patients had diabetes or pre-diabetes. Synchronising our DR screening protocol with established successful systems for identification of high-risk patients, using the WSLHD Diabetes Detection and Management Strategy & Western Sydney Diabetes Initiative will amplify the clinical impact of these initiatives by reducing the burden of blindness. The goals of this study align with the WSLHD Better West Strategic Priorities which identified the priority for “Healthy people- Overcome diabetes through screening and early management”. Our aim is to investigate whether NMC and ERG screening at the point of care in patients with high risk for DR, results in improved detection of new and vision threatening DR compared to current screening practices. This study aims to establish: *The proportion of patients with undiagnosed and/or vision threatening DR in patients presenting to hospital emergency departments with raised blood sugar level (BSL) and/or HbA1c, or high-risk foot clinics. The rate of undiagnosed DR will be compared to population based estimates from the 2016 National Eye Health Survey and ophthalmology clinic populations. *The various methods (NMC, ERG, MC and computer-automated DR screening) will be compared with respect to: *Rate of successful administration eg. proportion of retinal images that are readable. *The relative diagnostic accuracy in this novel setting *Cost of the procedure from health care provider perspective (time, personnel, equipment). *The value of ERG in addition to NMC in screening this population. *The validity of portable NMC and ERG compared with dilated 2-field MC. *Fundus DR grading by an automated image screening program will be compared to human graders with a cost-benefit analysis. *The value of this screening protocol compared with community screening. In combination, these aims will provide an evidence base for clinically appropriate HbA1c and BSL screening criteria.

  • Electronic Patient Reported Outcome Measures (PROMs) in Blood Cancer Patients: A Pilot Study

    The purpose of this study is to test a new screening tool to see if this tool helps the hospital meet patient’s supportive care needs. Supportive care includes physical, financial, emotional, family and practical support. Who is it for? You may be eligible for this study if you are aged 16 or over, you have a diagnosis of blood cancer and are receiving treatment. You may also be eligible for a part of the study if you have received treatment for a blood cancer in the past. Study details Participants in this study will be divided into two groups, depending on whether they are currently having treatment (called the prospective group), or received treatment in the past (the retrospective group). Both groups will complete screening tools, which involve a questionnaire. The retrospective group will complete a paper questionnaire and return by mail. The prospective group will complete the questionnaire at each appointment in a 12-month period. In addition to the questionnaire(s), all participants will also complete a satisfaction survey. It is hoped this research will demonstrate the usefulness of this screening process, and enable the needs of patients to be responded to more effectively.

  • The Effect of Ginger on the Gut Bacteria of Healthy Adults

    Ginger has long been used in ancient medicine. Modern research has found ginger has many health benefits from relieving nausea and pain to lowering blood pressure. However, little is known about how and why. Studies on animals suggest that ginger may benefit health through its effect on the gut microbiota. Therefore, The GINGA GUT (GINGer And the GUT Microbiota) Study will be the first human trial to assess the effects of ginger supplementation on the gut microbiota and related health outcomes (bowel habits, depression, anxiety, stress, fatigue, quality of life and adverse events). Participants will be advised to follow a one-week run-in period to stablise diet and lifestyle factors (e.g. sleep, exercise, diet), followed by a 14-day supplementation period of either four ginger root or placebo supplements per day (two in the morning and two at night). Participants will take one stool swab sample prior to supplementation and one on the 13th or 14th day of supplementation. In addition, participants will answer numerous online surveys. It is hypothesised that ginger supplementation will be associated with increased quantities and diversity of gut bacteria species and strains.

  • Dietary interventions for weight loss in women with obesity

    The primary aim of this study is to investigate the possible differential effects of two VLEDs on gut microbiota composition and associated health in women with obesity. It is hypothesised that from baseline to endpoint, those allocated to the food-based VLED will have more diverse and abundant bacterial microbes compared to those in the supplement-based VLED. It is also hypothesised that those allocated to the food-based VLED will have more beneficial metabolic and mental health outcomes relative to the supplement-based VLED.

  • Awareness campaign to improve care for low back pain

    In 2015/16 there were 104 072 low back pain presentations to Emergency Departments in Australia. Many of these patients do not require an imaging test. However, 30 -40% of patients receive an imaging test. Imaging tests take time, cost money, and can cause unnecessary concern for patients. We aim to determine whether it is feasible to run a campaign to raise awareness of unnecessary imaging for low back pain among patients and physicians.

  • Randomized Control Trial comparing PENG (PEricapsular Nerve Group) block to femoral nerve block in patients with a neck of femur fracture

    The intervention is a relatively novel hip regional block, called the PENG block. This is an injection of local anaesthetic solution into a fascial plane close to the acetabulum bone. We hypothesise that this local anaesthetic technique is more effective in preventing and relieving pain than the most commonly used regional block for hip fracture surgery, which at the moment is the femoral nerve block.

  • The role of Aboriginal and Torres Strait Islander Liaison Officers in acute health care

    This project aims to improve the quality of acute health care services provided to Aboriginal and Torres Strait Islander peoples, in line with the Australian Safety and Quality Framework for Health Care (ASQFHC) and the Aboriginal and Torres Strait Islander Quality Improvement Framework (ATSIQIF). Based across three sites (Flinders Medical Centre SA, Alice Springs Hospital NT and Royal Prince Alfred Hospital NSW), this project will highlight the immensely important role of Aboriginal liaison officers, strengthen the capability of the Aboriginal health research workforce, privilege the voices of Aboriginal people in research and ultimately improve health for Aboriginal patients in the acute care setting by improving the effectiveness of the acute care provided

  • Supporting cooks to provide healthy meals in childcare

    In Australia, less than 4% of children aged four to five years old consume the recommended amount of vegetables. Liking and acceptance of vegetables are learnt in early childhood and habits track into adulthood, thus efforts to increase vegetable intake need to start in the early years of life. About half of Australian children aged 2-5 years attend formal early care and education. These settings, such as Long Day Care, can provide 40-60% of children’s daily food intake. Early care settings can play a pivotal role in shaping children’s dietary habits and care-based nutrition promotion has been successful in improving children’s food intake. In centres where food is provided onsite, the responsibility for menu planning and food preparation falls with the cooks. The purpose of this cluster randomised control trial is to support childcare cooks to provide healthy meals, with a focus on vegetable intake, through piloting the delivery of menu boxes direct to long day care centres. This study will evaluate the effects of menu box delivery on the provision and consumption of vegetables in long day care centres and evaluate the feasibility and acceptability of menu box delivery. Menu boxes will include recipes and ingredients tailored to the number of serves required by the centre, which meet long day care menu planning guidelines. This will be compared to an online cook’s training module supported by an online menu planning tool to increase vegetable provision in meals and snacks. South Australian Long Day Care Centres will be randomly allocated to either receive a menu box delivery (n=4-5 Centres) to provide recipes and ingredients for their menu cycle, or receive access to an online cooks training and menu planning tool (n=4-5 Centres). The intervention (menu box vs menu planning) will be conducted over 12-14 weeks (menu boxes will be delivered for 8-weeks). Evaluation data for dietary intake, menu food provision, acceptability and feasibility of the intervention will be collected at baseline and at the end of the intervention period. This project is being conducted as part of VegKIT (https://www.vegkit.com.au/), funded by Hort Innovation.

  • A Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-729 Administered by Subcutaneous Injection to Subjects with Chronic Hepatitis B Infection

    The study drug AB-729 is being developed as a potential new treatment for Chronic Hepatitis B (CHB). The main goal of the study is to determine whether AB-729 is safe and well tolerated when given at different doses. We will also measure the levels of the drug in the blood at different times. The study will be conducted in 3 parts. Study Part 1 (Healthy Subjects SAD) : Part 1 will enroll 24 healthy subjects using a SAD design consisting of 4 sequential dose groups Study Part 2 (Subjects with CHB Infection SAD): Once the safety and tolerability data from the first 2 doses of the SAD assessment in healthy subjects have been completed and it is considered safe to proceed by the SRC, Part 2 will commence in subjects with CHB infection. Study Part 3 (Subjects with CHB Infection MD): Part 3 will be an open-label, Non-Randomized, MD design and will be conducted in 35 subjects with CHB infection. Discontinuation of all HBV treatment is optional. If subjects stop all therapy, they will enter a more intensive follow-up period for 12 months and then have quarterly visits for up to 2 additional years for a total of up to 3 years of follow-up post-NA discontinuation

  • Randomised study regarding the site of temperature probe placement in very preterm infants at birth

    This study is testing a new way to monitor body temperature of premature infants (23-31 weeks' gestation) to prevent them being too hot or too cold on admission to the NICU. Specifically, it is looking at whether the left back or left armpit is a better place to keep a skin temperature probe to monitor and maintain the infants' temperature from the time they are born until they are admitted to the NICU.

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