ANZCTR search results

We will conduct a pilot (using a randomised controlled trial approach) to evaluate the feasibility, acceptability, and effectiveness of a new behaviour program, called Hello Change, to ensure it meets the needs of Hello Sunday Morning members. Validated screening tools will be used to measure alcohol use (AUDIT-C) and psychological wellbeing (K6). We will also examine the demographic and characteristics of Hello Change users to gain a better understanding of who is utilising the program (satisfaction survey). The hypothesis of this study is that the Hello Change program will (1) have high uptake, (2) attract high satisfaction and recommendation ratings, and (3) reduce alcohol consumption and improve psychological wellbeing in those seeking to reduce their intake.

OLX75016 is being developed by OliX Pharmaceuticals as a treatment for patients with treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. This study will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016 in patients with non-alcoholicfatty liver disease (NAFLD). This study will be conducted in 2 parts : Part A (Single ascending dose) and PartB (Multiple ascending dose). Up 20 patients with NAFLD are expected to be engaged with the study for up to 87 days in Part A or up to 172 days in Part B of the study. OLX75016 and matching placebo will be administered as SC injections in the abdominal region in this study. Part A- Following confirmation of eligibility, patients with NAFLD will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1. All patients with NAFLD will be confined to the clinic until the completion of all safety/tolerability and PK assessmentson Day 3. Participants will be required to return to the clinic for additional outpatient safety/tolerability assessments on Day 4, 7, 14, 28, 42, 84, 112, 140, 168, 196 and 224. Participants will be discharged from each visit following completion of all safety and PK assessments, the end of study (EoS) visit will be on Day 224. Part B - Following confirmation of eligibility, patients with NAFLD will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1 and Day85. All patients with NAFLD will be confined to the clinic from day prior to dosing until the completion of all safety/tolerability and PK assessments 3 days post-dose and will be discharged following completion of all safety and PK assessments on Day 3. Patients with NAFLD will be required to attend the clinic on Days 4, 7, 14, 28 and 56 for safety and tolerability assessments. Patients with NAFLD will return to the clinic for a second confinement period from Day 84 to Day 87, with the second dose of OLX75016 or placebo administered on Day 85. NAFLD patients will be required to attend the clinic on Days 88, 91, 98, 112, 140, 169 for safety and tolerability assessments before the EoS visit on Day 253. It is hoped that the information learned from this study will help the sponsor learn more about how best to treat patients suffering from NASH and liver fibrosis in future. This research may also give rise to new or improved improvements.

This research aims to evaluate the feasibility, acceptability and preliminary efficacy of a mental health training program for managers in the aged care industry. This skills-based mental health training program has been shown to be effective in other occupational groups and has been tailored, alongside representatives from the aged care workforce, to suit the needs of those working in the aged care sector. The efficacy of the program will be evaluated through a pre-post intervention pilot trial design which aims to address the following research questions: 1. Is the delivery and content an adapted version of a previously evaluated manager training program tailored to managers working in Aged Care meeting the needs for this group? 2. Does training managers through a tailored workplace mental health program increase a) their knowledge in how to best support the mental health needs of the staff they supervise, b) their confidence to support the mental health needs of the staff they supervise and c) their application of responsive and preventive strategies to minimise psychosocial hazards in the workplace for the staff they supervise?

Despite continuous advancement in surgical technique and pain management, many patients remain dissatisfied following their total knee arthroscopy (TKA). From a patient-centred perspective, a TKA is only successful if the patient is satisfied with the outcome. In recent years, many studies have described the significance of patient expectations, level of function, post-operative pain levels, surgical techniques, and comorbidities to patient satisfaction. While current literature often mentions a correlation between patient satisfaction and rehabilitation, there is minimal comprehensive research on the topic. This study aims to identify the surgical and physiotherapy predictors of patient satisfaction during the rehabilitation process. These findings may play a role in implementing changes to clinical practice and thus, improving patient satisfaction in Gold Coast Health facilities with the potential for broader impact across QLD Health.

Partnered pharmacist medication charting (PPMC) is a safe and effective model of care which significantly reduces medication errors and length of stay in hospital, ultimately improving patient flow. This study aims to assess whether virtual delivery of this model (VPPMC) in rural/remote NSW can reduce length of stay, among other measures of effectiveness and feasibility, including an economic analysis using incremental cost-effectiveness ratios. Hospitals within Western NSW Local Health District will be approached for recruitment, then randomised to either the intervention (VPPMC) or control (best usual care). Eligible patients must be aged 18 years or over, admitted to a recruited hospital and, for those admitted to intervention sites, clinically reviewed by a pharmacist prior to partnered charting of regular medications and venous thromboembolism prophylaxis. Data generated from this project would provide evidence to support the VPPMC model as a new standard of care, enabling the expansion of clinical pharmacy services to geographically isolated patients. Therefore, the research team is uniquely placed to be the first to examine and evaluate the unique challenges associated with a VPPMC model.

Penicillin allergies are highly prevalent in the healthcare setting and are associated with second-line inferior antibiotics being prescribed. An incorrect penicillin allergy label leads to increased risk of resistant organisms, side effects from second-line antibiotics as well as increased medical costs. The gold standard for penicillin allergy testing is an oral challenge – either direct or following skin testing. What remains unknown is if a single dose is sufficient to determine if the patient has a delayed or unknown timing immune mediated penicillin allergy or if a prolonged oral challenge (5 days or more) is required. The PROSPECTOR pilot trial demonstrated the feasibility and safety of a placebo-controlled trial of single dose penicillin challenge versus prolonged challenge (5-day). PROSPECTOR2 continues from the PROSECTOR pilot trial (ACTRN12623001242617) to assess the superiority of prolonged oral challenge versus single dose challenge for identifying immune-mediated penicillin allergy. The current Drug Allergy Practice Parameters recommend “against the routine use of multiple-day challenges in the evaluation of penicillin allergy”, providing a “strong recommendation” but with “low certainty of evidence”. The European guidelines reviewed the literature of over 6484 patients, demonstrating a 2.3% positive rate following the initial challenge and 5.5% during the varied prolonged challenges. They concluded there is no consensus on a preferred procedure and could not provide a recommendation for or against prolonged challenge. In Europe, a mixture of observational and retrospective studies has suggested that extended challenges ranging from 3 to 10 days may be superior to single dose challenges at excluding delayed immune reactions, however the reported prevalence of delayed reactions is highly variable (5-12% of patients) and many were reliant on patient self-reporting. In a recent retrospective single centre Danish experience of 3,179 low-risk patients, 2.6% were positive on day 1 of challenge and 7.2% on days 3-10. This is in contrast to the North American experience, where delayed prolonged challenges have been associated with low rates of delayed reactions (0-1.8%). Whilst a study of children demonstrated that delayed reactions may occur less than 7 days following a single challenge. Therefore, whilst oral challenge is the well-defined gold standard for penicillin allergo-immunological investigation, limited controlled evidence is available regarding the efficacy of single dose versus prolonged oral challenge.

This study is investigating if low-dose localised radiotherapy (involved-site radiation therapy or “ISRT”) can sometimes activate the immune system to cause shrinkage or even disappearance of disease in other parts of the body, outside of the treated region, in patients with advanced Follicular lymphoma (FL) Patients in this study will receive very low dose radiotherapy to some, but not all, of their known lymphoma disease sites. This trial will systematically explore the potential of low dose ISRT as a single modality to engage anti-tumour immunity in advanced FL through investigating both the frequency and the biology of abscopal regression in FL. It will utilise serial imaging and correlative analyses with serial blood (+/- tissue) samples, to explore the underlying mechanisms that may be responsible for this important phenomenon. Who is it for? This study is open both to patients who have had recurrence of disease after previous treatments, and patients who have slow growing or stable lymphoma that would be otherwise be managed by close observation without any current active therapy. You must be aged 40 and over. Study details All participants will undergo a Positron Emission Tomography (PET)/Computed Tomography (CT) with fluoro-deoxyglucose (FDG) which is a standard type of scan to detect FL. PET scanning is performed by injecting a small amount of radioactive material (called a tracer) into your bloodstream followed by imaging your body by passing you through a PET/CT scanner. As well as standard FDG-PET scans, this study will involve the use of two new PET scan tracers that allow us to see different aspects of the immune system. These tracers are called 89Zr- IAB22M2C and 89Zr-durvalumab respectively. They need 1- 5 days to be taken up in the tumour after injection and therefore PET imaging scans are performed 1-5 days after the tracer is given. PET scanning with 89Zr-IAB22M2C allows CD8+ T lymphocytes to be tracked in the body. CD8 T cells can be involved in killing tumour cells in patients with cancer and there is evidence from laboratory studies that CD8 T cells accumulate in tumours before abscopal regression occurs. The other new tracer, 89Zr-durvalumab, enables a molecule called PD-L1 to be imaged in patients. PD-L1 is a target for Immune Checkpoint Immunotherapy and can be found on some tumour cells and on cells of the immune system. Using these novel PET tracers we hope to increase our understanding of the effects of radiation on immunity in general and on the abscopal effect in particular.

The HSCT-BIOME study aims to promote gut microbiota health prior to conditioning chemotherapy and promote its stability/recovery after HSCT using encapsuled, lyophilised faecal microbiota transplantation (FMT). Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have been diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT. Study details Participants in this study will be randomised to receive either encapsulated faecal microbiota transplantation (FMT) or placebo; each given as 2 courses of 36 capsules. The first course starts before chemotherapy, aiming to boost gut microbiota health. You will be given the second course after HSCT, once your immune system has recovered. Participants' bowel function and symptom burden will be assessed daily for 3 weeks after HSCT. Other clinical data, including how long you stay in hospital and the use of other medications to control side effects, will also be collected. Any adverse event will be constantly monitored during intervention until 30 days post FMT. It is hoped that findings from this study will show FMT is safe and effective at reducing HSCT complications.

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy, this is not currently available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.

Both dietary fibre and unsaturated fats are known for their health benefits on cardiovascular health, however, there are a lack of studies evaluating the effects of dietary fibre from whole foods on endothelial function. The purpose of the study is to assess the impact of a high fibre diet compared to a lower carbohydrate, high unsaturated fat diet on endothelial function, as an early indicator of cardiovascular disease risk. Males over 45 years old and females post menopause with a low dietary fibre intake of less than 15 g/day will be randomised to one of two groups: high fibre diet (40 g/day from whole foods - wholegrains, legumes, fruits, vegetables, nuts and seeds), or high unsaturated fat diet (approx. 40% energy intake from fat from whole foods). Participants will be provided with dietetic counselling to adhere to their allocated diet during the first 3 months of the study, with a follow up at 6 months from commencement. A subset of participants will be assessed in the postprandial phase (as a more sensitive marker or metabolic health), where they will be provided with a high fat, high sugar meal and have their endothelial function tested every 2 hours for up to 6 hours at baseline and 3 months. This study may help with the development of clinical practice guidelines for dietitians to provide dietary advice to patients for vascular health. We hypothesise that both diets will improve endothelial function.