ANZCTR search results

This double-blinded, randomised controlled trial aims to determine the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS) and oral ketamine (OK) as a combination treatment for PTSD. Given the complexity and broad range of symptom presentations in patients diagnosed with PTSD, this study seeks to capture changes in sleep quality, perceived stress, suicidality, depression, anhedonia, chronic pain, and social/occupational functioning. Findings from this study will help to identify the brain circuitry involved with and neural processes associated with these glutamatergic and GABAergic-based interventions.

This study will investigate the efficacy of an eHealth nutrition intervention on lifestyle-related colorectal cancer risk in patients undergoing colonoscopy Who is it for? You may be eligible to join this study if you are aged 18 and above, scheduled to have a colonoscopy done by participating surgeons at the Open Access Colonoscopy service at the Newcastle Endoscopy Clinic and the Direct Access Colonoscopy service at John Hunter Hospital and Belmont Hospital and have access to a computer, tablet or smartphone with internet access. Study details Participants in this study are randomly allocated (by chance) to one of three groups. Participants in group one will receive an enhanced nutrition intervention consisting of a 30 minute online consultation via Zoom with a Dietitian, and a personal nutrition report. Participants in group two will receive, via email, a personal nutrition report. While participants in group three will not receive any intervention materials or education during the active intervention period. After completing the 3 month assessment, participants in group three will receive their personal nutrition report. Colorectal cancer risk will be assessed using the 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score. Feasibility and acceptability of the intervention will be assessed using a number of different surveys. It is hoped that this research project will provide new knowledge about the efficacy of an eHealth nutrition intervention at reducing lifestyle-related colorectal cancer risk in adults.

Every day, more than one million people globally are diagnosed with the four most common non-viral sexually transmitted infections (STIs) and gonorrhoea and chlamydia are the two most common bacterial STIs. In Australia, rates are at increasing rapidly with their highest levels in recent years. Infections in women can cause infertility, and in both sexes, increase HIV acquisition and transmission. Treatment failure is an increasing issue and may be due to factors related to the bacteria (e.g. antibiotic resistance), the individual (e.g. immune response, vomiting/diarrhoea) or how the body processes the drug (its ‘pharmacokinetics’, or PK). Antibiotic resistance for STIs has developed so rapidly that in 2017, the World Health Organization (WHO) declared resistant gonorrhoea as an urgent global threat with the real danger that it may soon be untreatable. We now know that treatment failures occur more often at non-genital (‘extra-genital’) sites such as the mouth or rectum, with current treatment cure for chlamydia or gonorrhoea being up to 20% lower than at the genital site. We also know the mouth/oropharynx drives STI transmission through oral sex, kissing and use of saliva during sex so effective treatments for non-genital infections are critical to stop ongoing transmission. Rectal infections in women can result in persisting vaginal infection from cross contamination between the two sites. There are only a few new drugs in development to treat STIs, but they are many years away and may not be sufficiently effective, especially not for the mouth/oropharynx. Therefore, clinicians must optimise what drugs we have now, but without clinical trial evidence, they must rely on pharmacokinetic (PK) data to guide this decision making. However, there are few PK data available for the mouth or rectum. This project will develop innovative techniques to generate the first comprehensive data in the mouth and rectum for four commonly used antibiotics used to treat STIs – cefixime, ceftriaxone, ciprofloxacin, azithromycin and doxycycline. After this we will apply these methods to emerging drugs currently being tested in trials that have not been marketed yet. This is to ensure new drugs in the pipeline will be effective against STIs. These data will address the urgent global call for data to inform STI treatment guidelines.

Background: Reception of injured patients form key areas of practice in emergency medicine. In this hectic environment there is significant potential for medication errors. Pharmacists have traditionally had no involvement during the initial management of injured patients in the ED. However, Emergency Medicine (EM) clinical pharmacy is a rapidly growing area of practice. There is increasing evidence for improved patient outcomes associated with EM pharmacists practising in the ED. Aim: To determine the effectiveness of early EM pharmacist involvement in trauma presentations on time to analgesia in an Australian Emergency and Trauma Centre (E&TC). Method: A randomised trial comparing early EM pharmacist involvement in trauma presentations versus standard care (either no EM pharmacist involvement or delayed involvement). We will aim to recruit 40 patients in each arm of the study. The primary outcome is time to analgesia in trauma patient presentations. We hypothesise that early involvement of the EM pharmacist will improve time to analgesia in trauma presentations to the Emergency and Trauma Centre.

The purpose of this study is to observe patients for one year who present with diabetes or reduced blood flow to their legs, and are also are experiencing ulceration, pain or other issues with in their legs. There are no medications or interventions given as part of this study, we will instead record observations such as whether ulcers heal or surgery is required. We hypothesise that patients presenting with more severe disease will take longer to heal their wounds, and experience a greater number of amputations, compared to patients with less severe disease.

Manuka honey has a positive effect on enhancing the body’s natural immune responses due to its anti-inflammatory and antioxidant properties. Its antibacterial property is useful for wound healing and the prevention of inflammation. Other than the antibacterial property, manuka honey also showed to have antioxidant and anti-cancer properties. Multiple clinical trials have concluded its effectiveness against various ocular conditions: blepharitis, contact lens related dry eyes, and Meibomian Gland Dysfunction. The Optimel Manuka+ Dry Eye Drops packaging claimed: “For use as an adjunctive therapy in addition to good eyelid hygiene”.("Optimel Manuka+ Dry Eye Drops", 2020) However, the effectiveness of the Optimel Manuka+ Dry Eye Drops with the addition of eyelid hygiene therapies has not previously been investigated. Therefore, it is worthwhile to conduct a thorough investigation on this potential adjunctive treatment by measuring both the subjective and objective parameters associated with dry eye disease. Thus, this study will be a randomized clinical trial comparing the effectiveness of conventional adjunctive treatment (warm compresses) in combination with Optimel Manuka+ Dry Eye Drops on dry eye disease compared to the eye drops alone. This study will include at least 40 participants who experience dry eye, where they are randomly assigned into two groups receiving the combination therapy of warm compresses plus Optimel Manuka+ Dry Eye Drops or Optimel Manuka+ Dry Eye Drops only, where eye drops will be applied two times daily (Albietz & Schmid, 2017) in both eyes for one month. Optimel Manuka+ Dry Eye Drops are commercially available in Australia, therefore the results of this study will provide an evidenced based dry eye therapy option for society to consider.

This study aims to improve care in the Emergency Department (ED) for older patients with cognitive impairment. We will collect baseline data including a patient audit of adverse events, staff survey of practice in the ED and an environmental audit. Working with a team of ED staff we will meet on three occasions to discuss the baseline findings, identify areas where care improvements could be made and develop an intervention and action plan to improve the care environment. We will evaluate the intervention through repeated audits of patient files post intervention along with interviews with staff and older patients (and/or their family carers) attending the ED during or immediately post the intervention period.

How a woman feels about her birth experience influences the rest of her life, her family’s life and how many children she may have. The rest and posture that the Labour Support Chair provides may improve women’s sense of personal power during labour. It may also, shorten the time labour takes before the woman is ready to give birth to her baby. To give birth vaginally a woman’s cervix needs to be fully open letting her baby move out of her uterus and into her vagina. Her baby’s head also needs to be inside her pelvic bones. The Labour Support Chair is designed to promote in the woman, the best posture for encouraging these two vital requirements. The labour experiences of 40 women, will be assessed. These women will be randomly placed into two groups, one group will use the chair and one group will not use the chair. The comparison will look for any evidence of an effect of the use of the Labour Support Chair.

Estimation of true burden of sepsis remains is largely unknown and relies on the use of discharge diagnosis administrative codes. We aim to develop reliable estimate of true sepsis burden in Australia by measuring the accuracy of a new administrative coding methodology by comparing with the gold standard of the clinical diagnosis.

The overall objective of the study is to develop and implement a practical pathway (NAFLD-RRR pathway) for optimal care of NAFLD in “high-risk” patients with T2D. The most important predictor of mortality in NAFLD is the extent of liver fibrosis as these patients are at risk of developing cirrhosis and its complications, including hepatocellular carcinoma (HCC). People with T2D have a high prevalence of NAFLD (40–70%), and are more likely to develop advanced fibrosis/cirrhosis and HCC. This study will use transient elastography with FibroScan as a screening and risk stratification tool for NAFLD in people attending diabetes clinics. The test allows measurement of the controlled attenuation parameter (CAP), which assesses the presence and level of hepatic steatosis, at the same time as evaluating liver stiffness to determine the presence or absence of advanced fibrosis. A referral pathway will be developed to facilitate patient access to required services. Individuals at low risk of advanced fibrosis will be managed in primary care, with a focus on healthy lifestyle and weight reduction and minimizing cardiovascular risk. In contrast, patients at risk of advanced fibrosis will be referred to secondary care for investigation of liver disease and management of advanced fibrosis with surveillance for HCC and liver decompensation. It is expected that more patients will be diagnosed with “high-risk” NAFLD than in usual diabetes care, and that a higher proportion of NAFLD referrals to Hepatology clinics will have clinically significant fibrosis. We anticipate that the study will produce new evidence about the economic benefits of a NAFLD detection/risk stratification pathway in patients with type 2 diabetes. We anticipate that patients with NAFLD will have a high rate of unmet needs related to lifestyle changes and practical and physical needs, and that identifying these needs will permit us to tailor strategies to promote patient-centred care and facilitate timely interventions or referral to appropriate support services.