ANZCTR search results

This study investigates the feasibility and safety of managing acute uncomplicated diverticulitis using remote virtual monitoring and treatments, as opposed to standard inpatient care. Acute diverticulitis is a common condition; in 2019, almost 5,000 bed days were recorded across the Sydney Local Health District for this condition alone. There is some evidence that certain cases (primarily those with uncomplicated diverticulitis) may be managed entirely in the community with oral antibiotics, but there is apprehension amongst surgeons to use this treatment approach because of challenges in patient monitoring and early detection of clinical deterioration. One strategy to circumvent these challenges is to use virtual healthcare which allows the remote monitoring and treatment of patients, whereby current standard care may be translocated to the patient's home. This study will investigate the safety and feasibility of this approach, on the belief that such a treatment strategy may also improve patient-reported outcomes and experiences.

This trial aims to determine the effect of exercise training and whey protein supplementation on body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer undergoing androgen-deprivation therapy. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with prostate cancer, and are undergoing androgen deprivation therapy. Study details All participants will receive 36 sessions of resistance training, and 36 doses of whey protein supplementation over a total duration of 12 weeks. The resistance training will involve whole-body exercise using resistance training machines that overload the lowering phase of the repetitions. Before, during, and after the exercise program, participants will undergo body composition scans, have blood samples taken, perform a number of tests of muscle strength, and complete a series of questionnaires. It is hoped that this study may demonstrate that the combination of exercise training and whey protein supplementation is effective in improving body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer receiving androgen deprivation therapy.

Botanix is developing BTX 1702 for the topical treatment of moderate to severe papulopustular rosacea. This is a randomised, double-blind, vehicle-controlled, parallel-group, Phase 1b study in adult patients, aged 18-65 with moderate or severe papulopustular rosacea. The objective of this study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel and BTX 1702 20% (w/w) Gel in patients with papulopustular rosacea. Eligible patients will be enrolled and randomised 1:1:1 to BID treatment with BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or Vehicle Gel for a planned 56 days. Approximately one hundred and twenty (120) patients (80 active: 40 vehicle) will be enrolled. The primary outcome for the study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or BTX 1702 Vehicle Gel following 56 days BID applications in patients with papulopustular rosacea. The safety and tolerability outcome measures will be assessed through the collection and review of AE's, laboratory parameters evaluated throughout the duration of the trial and via information recorded in participant diaries. Exploratory analysis will be conducted via change in inflammatory lesion counts, change in Investigator’s Global Assessment (IGA-PP), change in Clinician’s Erythema Assessment (CEA) scale and Patient Reported Outcomes (PRO).

The purpose of this study is to compare the addition of a low-dose antibiotic with properties that reduce inflammation to the therapy regimen after endoscopic surgery in chronic sinus disease, versus our current standard of care,

This study will investigate the feasibility and validity of Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer Who is it for? You may be eligible to join this study if you are female, aged between 18 and 75 years, have a confirmed diagnosis of primary breast cancer and are scheduled for a lumpectomy and a sentinel lymph node biopsy (SLNB) procedure as part of the surgical plan. Study details All participants in this study will receive single dose of FerroTrace and a single dose of radioisotope via intraparenchymal injections into the breast tissue the day prior to, or on the morning of, surgery. During surgery, a modified sentinel lymph node biopsy (SLNB) will be performed, using a magnetometer probe to locate the magnetic tracer in sentinel nodes, followed by the standard gamma probe. At least one follow-up MRI of the breast will be performed 30 days after surgery, to assess tracer clearance, with additional MRIs at 90 days and 180 days after surgery if there is not complete clearance on the earlier post-operative MRI. It is hoped that this research project will lead to further studies and eventually the technology will be widely available so that patients with can have breast cancer surgery without the use of radioactive isotopes and dye.

Modern navies are focused on trying to shrink the size of their crews to exploit the benefits of new achievements in automation of ships systems. While technological advances are enablers, the performance of these advanced systems is only as good as the crews who man them. The ability to remain vigilant for an automation failure is impacted more severely by fatigue than are other mental functions. From a fatigue management point of view, most navies have sub-optimal watch systems that unnecessarily fatigue naval crews which results in sub-optimal crew performance. An overlooked opportunity exists on Subsurface vessels in that the natural light dark cycles can be manipulated. Theoretically this would be advantageous for a 2 watch system, but this is never been attempted under laboratory conditions. We hypothesise that sleep, cognitive performance, and physiological measures will differ between the watches within both a two-watch routine, and a three-watch routine. The research question is whether a two-watch or three-watch routine lead to better sleep, cognitive performance, and physiological functioning.

Atrial fibrillation (AF) is common, and makes people often feel symptoms, or have complications such as stroke. Doctors have many options for AF treatment, but these all have drawbacks. Tablets for AF often have side effects, and AF ablation is the most effective option we have, but unfortunately comes with risks of major complications. Researchers have therefore been looking for other options. SGLT2 inhibitors are medications, which are used to treat diabetes. Unexpectedly, this drug class was shown in a trial of 17,160 patients with heart failure, to reduce the rates of AF. This class of medication was developed as a diabetes medication, working on the kidney to increase the amount of sugar that the body gets rid of into the urine, and therefore lowering the sugar levels in the body. These medications have also been shown to reduce cardiovascular death, reduce heart failure and reduce renal failure. Researchers and doctors don’t exactly understand all the different ways that these medications lead to benefits, in particular how they reduce AF. There may be many different pathways in the body that impact the way that cells work. This project is to try and examine if dapagliflozin (an SGLT2 inhibitor) changes the electrical properties of the heart, to try and explain the reduction in AF that has been shown in trials.

Post-operative atrial fibrillation is a heart rhythm disorder that is a major clinical problem, affecting 15-30% of patients undergoing cardiac surgery. It is associated with high rates of stroke, and increased mortality. Post-operative atrial fibrillation is thought to be caused by abnormalities in the physiological function of the atrium around the time of surgery. The current application is for a pilot open-label randomised controlled trial assessing the impact of sodium-glucose co-transporter 2 inhibitor pre-treatment on cardiac electrophysiology studies performed during cardiac surgery in 16 patients. The rationale for the study is that this medication has been shown in a very large randomised controlled trial (Wiviott SD et al. NEJM 2019 "DECLARE-TIMI 58" trial) to decrease incident atrial fibrillation by 19%. We therefore reason that these medications may potentially mediate this effect. The aim of the current study is to determine if pre-treatment will improve the electrical function of the atrium, or change the rates of postoperative atrial fibrillation.

The purpose of the research is to explore the educational, self-monitoring and self-management needs of patients living with indwelling urinary catheters in the community, from the perspective of the patients, carers and clinicians. Findings from this study will help to understand knowledge and attitudes towards indwelling catheters and how these shape behaviours and practices. Furthermore, understanding the needs of both patients and nurses will provide a foundation for the development of an acceptable, feasible and sustainable educational package for patients to self-monitor and self-manage their urinary catheters. The information will also assist clinicians to develop a patient-centred bundle of care aproach to meet patients needs and minimise anxiety and fear around catheters. Future educational interventions developed as a result of this project will improve clinicians’ confidence in providing catheter care to patients/carers and improve patients’ self- monitoring and self-management practices and thus minimise catheter associated complications and unnecessary hospital presentations.

Endometriosis is a common problem, affecting approximately ten percent of women of reproductive age. It has negative effects on quality of life through pelvic pain, dysmenorrhoea and infertility. Current clinical examination and ultrasound techniques are not effective in diagnosing superficial endometriosis. This leaves laparoscopy, an invasive surgical procedure, as the current gold standard for diagnosis of endometriosis. Recent studies have shown a correlation between shorter anogenital distance (AGD) and the presence of endometriosis. This study aims to further examine this correlation, in the hope that AGD may be used as a clinical tool to predict the presence or absence of endometriosis in women considering laparoscopy. This study will aim to define an average anogenital distance in a cohort of women undergoing gynaecological surgery. It will also aim to investigate the relationship between anogenital distance and gynaecological conditions of interest, particularly endometriosis, and other patient factors that might be associated with a shorter or longer than average AGD. We will invite premenopausal women aged 18-50 undergoing gynaecological procedures with a general anaesthetic at the RWH to participate. They will be recruited pre-operatively and asked to complete an online survey to determine relevant demographic and health information. Their AGD measurements will be taken by the treating gynaecological team during their procedure and recorded. If the patient is undergoing laparoscopy, the operation notes and any histopathology results will be reviewed to determine the presence or absence of endometriosis. This study is hoped to add evidence of the correlation between short AGD and endometriosis. It will also help determine what the average AGD is in the adult gynaecological patient population, and other factors such as age, obesity, ethnicity, etc that may be associated with differences in the AGD.