ANZCTR search results

This study aims to compare a new form of image processing for endoscopy, called Texture and Colour Enhancement Imaging (TXI), with the existing image processing, white light endoscopy (WLE) and Narrow-Band Imaging (NBI) to determine if TXI is better able to detect early cancerous changes in the oesophagus of patients with Barrett's Oesophagus. Who is it for? You may be eligible for this study if you are between 18 and 80 years of age and you are undergoing a scheduled endoscopy for Barrett's oesophagus monitoring or you have been referred for further assessment of dysplasia/early cancer because of long term Barrett's oesophagus. Study details All participants who choose to enrol in this study will be randomly assigned by chance (similar to flipping a coin) to undergo either TXI followed by WLE and NBI imaging during their endoscopy, or to undergo WLE and NBI followed by TXI during their endoscopy. All participants will undergo both imaging processes, only the order will be randomly assigned. During the endoscopy, tissue biopsies will also be taken to check for cancerous or pre-cancerous cells within the oesophageal tissue. The endoscopy procedure is expected to take up to 15 minutes. It is hoped this research will determine whether the new TXI image process is able to detect more pre-cancerous cells than previous forms of endoscopic imaging. This new form of imaging may then be used to improve health outcomes of future patients with Barrett's oesophagus, by detecting potential cancers earlier so that treatment can be most effective.

This study will be a randomised controlled trial aiming to compare traditional Plaster of Paris (POP) cast versus synthetic cast for management of patients with simple wrist fractures who present to Monash Health emergency departments (ED). We hypothesize that if synthetic casts are applied in the ED in the first instance, although this material is more expensive than POP, this would eliminate the need for further cast changes at the Fracture Clinic review (usually 2/52 post injury). Therefore this intervention would reduce cost and time for the organisation overall. The primary outcome measure will be total number of cast changes until immobilisation by cast is no longer required. Secondary outcomes will include cost effectiveness and patient satisfaction. 110 participants will be recruited to the study between July 2021 to January 2022. Evidence gained from this study will contribute to future treatment of wrist fractures in the ED. It would reduce the cost to the healthcare system and demand on Fracture Clinic and also improve patient satisfaction and comfort. This practice may be translated into other health care networks in Australia and worldwide.

Background Artificial intelligence (AI) has become increasingly capable over the last decade. AI technologies are approaching or surpassing human abilities at complex tasks. Specifically, in healthcare, AI is approaching or surpassing human clinician ability in multiple narrow domains. Research on AI in medicine has been increasing worldwide and across almost all specialties. General public opinion has seen to be positive in several surveys, with the public expressing high hopes that AI could be used to improve healthcare. Interaction with AI technologies is likely to become an increasingly common aspect of healthcare for both patients and physicians. Despite these trends, there is no data regarding health consumers’ attitudes, and opinions towards the use of AI in emergency medicine and healthcare. Aim Assess health consumers’ attitudes towards the use of AI in emergency medicine and healthcare. Plan We will conduct voluntary semi-structured interviews with a representative sample of health consumers until thematic saturation is achieved. Health consumers will be recruited from consumer advocacy groups such as the Consumer and Community Involvement Program, and we will conduct the interview either in person or over the phone (at a time of their convenience). We will continue interviews as required until we achieve appropriate representation and theme saturation. We will undertake qualitative analysis on transcribed interviews to uncover attitudes and themes.

This study will investigate the feasibility, acceptability and effect of electroacupuncture on erectile dysfunction after robotic assisted radical prostatectomy in prostate cancer patients Who is it for? You may be eligible to join this study if you are over 18 and have undergone robotic assisted radical prostatectomy > 6 weeks ago and <=24 months ago and experience erectile dysfunction as a result of the surgery. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants group A will receive an electroacupuncture intervention for 10 visits over 8 weeks. Participants group B will continue with their usual care which may include medications and use of devices. Feasibility and acceptability of the intervention will be assessed by recording key trial parameters of screening, eligibility, consent, recruitment rate, intervention adherence and adverse events. Erectile function will be assessed using questionnaires. It is hoped that this research project will provide more information on whether electroacupuncture could be another treatment option for erectile dysfunction after radical prostatectomy which would improve the lives of many men.

Periodontal inflammation is ultimately responsible for the bone loss and tooth loss in periodontal disease. Previous studies have indicated an association between vitamin D deficiency and both chronic and aggressive periodontitis. We hypothesize that topical application of vitamin D via toothpaste application can lead to an overall therapeutic effect on the etiology and development of periodontal disease. Hence, this clinical research study is to investigate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.

The purpose of this trial is to investigate the impact of a school-based physical activity program (known as Burn 2 Learn adapted [B2La]), incorporating High Intensity Interval Training (HIIT), on the functional capacity of senior school students with disability. We hypothesise that students participating in the B2La intervention will experience improved functional capacity (primary outcome), moderate-to-vigorous physical activity levels, muscular fitness, cognitive function, quality of life and physical literacy (secondary outcomes), and time-on-task’ in the classroom (secondary outcome), compared with a control group of students participating in usual practice (i.e., normal curricular lessons).

We aim to determine if our UI/ LUTS practice-change package is feasible and effective for delivering optimal UI/ LUTS care in the inpatient setting. Our package includes an intervention (SCAMP) synthesized from the best-available evidence on UI/ LUTS care, and a theoretically-informed implementation strategy targeting identified barriers and enablers. The package is targeted at clinicians working on the participating wards.

This is a Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have been previously vaccinated with licensed vaccine against SARS-CoV-2 The study will also investigate whether an adjuvant is required in the formulation to enhance immune responses to IVX-411. The selected adjuvant, MF59®, is an oil-in-water emulsion that has shown to increase immunogenicity and is associated with a good safety and tolerability profile. The stopping rules and safety will be monitored by an internal safety review committee (iSRC) and a Safety Monitoring Committee.

This study will be investigating the safety and tolerability of an implantable device to administer chemotherapy directly to the tumour site for people with confirmed borderline resectable or locally advanced pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have biopsy proven pancreatic ductal adenocarcinoma with borderline resectable or locally advanced disease that has not spread to other organs, and you have not had any prior treatment for your cancer. Up to 12 participants who meet the inclusion criteria will be recruited for this study. All participants will undergo a standard diagnostic surgery at which time the trained surgeon will insert the intervention device directly onto the pancreas. The device will then slowly release a chemotherapy drug (paclitaxel) before being biodegraded. There is no need for a second surgery to remove the device. After the device has been inserted, all participants will undergo standard IV chemotherapy as prescribed by a doctor. Participants will be asked to provide weekly blood samples during the first 28 days and will undergo standard of care imaging (CT) to assess for device placement and response to therapy. Participants will be followed weekly for 1 month, at 3 months (for primary endpoints). It is hoped that this research will determine whether an implantable biodegradable device intended to deliver chemotherapy directly to the pancreas is safe and tolerable in patients with pancreatic cancer. If the device is deemed to be safe, this may provide a new method of treatment for future pancreatic cancer patients.

The purpose of this study is to determine if a physiotherapist supervised pelvic floor muscle training intervention delivered online is feasible for participants with incontinence who have previously had a surgery for a gynaecological cancer. Who is it for? You may be eligible for this study if you are an adult female who has previously had a surgery for a gynaecological cancer. Study details All participants who choose to enrol in this study will receive a femfit® device that provides live data on the person's ability to correctly contract their pelvic floor muscles. All participants will be offered 7 sessions with the research physiotherapist via videoconference (e.g. Zoom platform or similar) over a 12 week period. Each session will be 30 minutes. Using the femfit® device, the research physiotherapist will then teach the pelvic floor muscle training program. As a home exercise program, the participant will complete the pelvic floor muscle training program using the femfit® app and record their progress on an exercise diary within the femfit® app. Participants who require conservative therapy will also receive additional education regarding incontinence alongside the intervention. All participants complete questionnaires at the end of 12 weeks, and 3 months after the intervention finishes, to assess their pelvic floor symptoms. Three months after the intervention, all participants will complete a short telephone survey, and may be invited to participate in in-depth interviews, about whether they found the intervention to be acceptable. It is hoped this research will demonstrate that a physiotherapy program delivered via telehealth is a feasible method of providing pelvic floor muscle rehabilitation and improving quality of life for those who have received surgery for a gynaecological cancer.