ANZCTR search results

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

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31611 results sorted by trial registration date.
  • Time to analgesia with early involvement of the Emergency Medicine pharmacist in trauma callouts: a randomised trial (Study Protocol)

    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 treatment of foot problems in patients with diabetes or reduced blood flow to the legs

    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.

  • The effect of Optimel Manuka+ Dry Eye Drops with adjunctive treatment on signs and symptoms of dry eye

    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.

  • Promoting DEmentia Friendly EmergeNcy DepartmentS: The effect of a hospital audit-directed action plan on adverse events in older people with cognitive impairment presenting to ED

    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.

  • Pregnant woman's experience of using the Labour Support Chair.

    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.

  • Accuracy of discharge diagnosis codes in estimating true sepsis burden in NSW, Australia

    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.

  • Identifying non-alcoholic fatty liver disease fibrosis risk in type 2 diabetes patients: implementing the right care, in the right place, at the right time (NAFLD-RRR study)

    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.

  • Does Confocal Laser Endomicroscopy enable identification of positive and negative surgical margin during breast cancer surgery.

    The purpose of this study is to determine if an imaging method called confocal endomicroscopy can accurately identify the margins of breast cancer during surgery. Who is it for? You may be eligible for this study if you are an adult who has breast cancer and is undergoing primary wide local excision with cavity shave. Study details Participants in this study will undergo their usual treatment, meaning their primary wide local excision procedure. During this procedure the surgeon will take some cancerous tissue and perform the imaging test and then send the tissue for standard pathology tests. There will be no additional involvement from participants. If it is determined that confocal endomicroscopy can accurately determine the margins of breast cancer then it would lead to a larger study. It is hoped that the larger study will determine whether using confocal endomicroscopy during surgery can better define the surgical margin at the time of the operation and significantly reduce the likelihood of a second operation.

  • Ketamine for Cancer Pain

    The purpose of this study is to determine the use of sublingual ketamine drug to help with relieving pain for patients with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have significant pain associated with advanced cancer, your body weight is more than 40 kg and are willing to comply with the study requirements. Study details Participants in this study will receive three cycles of two treatment drugs in random orders: 1. sublingual ketamine wafer (flat tablet placing under tongue) for 7 days 2. non-active (sham) wafer for 7 days The first 2 days of each period will be considered analytical washout days and hence will not be analysed for efficacy regardless of whether study medication is taken. Participants will be expected to complete a daily and weekly questionnaires and also have interviews with study staff through either video-conferencing or visit to hospital after each 7-day study period. It is hoped that this research will determine if a larger trial can be completed on evaluating the effect of sublingual ketamine drug as pain relief for management of moderate to severe pain in patients with advanced cancer.

  • Dose finding clinical trial of sodium benzoate in people with treatment refractory schizophrenia

    The study will be a randomised, placebo-controlled double-blind parallel-group trial; over a 6 week period. The primary objective in this study is to determine the dose of sodium benzoate which maximises the clinical benefits in patients with treatment refractory schizophrenia. Specifically, it is hypothesised those participants allocated to the active arms (1000mg daily or 2000mg daily or 4000mg daily) of Sodium Benzoate treatment will have significant reductions in PANSS total score at week 6 compared to individuals taking placebo.

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