ANZCTR search results

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.

Certain Transcutaneous Electric Nerve Stimulation (TENS) machines are approved to be used in Australia to treat incontinence, however, it is not known if it is useful for people who have just had a stroke. In this study, the investigators aim to see if it is feasible and acceptable to use TENS in addition to standard treatments for incontinence after a stroke. Participation will involve trying two TENS treatment protocols and one sham TENS protocol. Participants are to learn one protocol on one day and then given a chance to perform the protocol while being observed by the investigator on the following day. The investigators hypothesise that adults can learn and safely perform TENS protocols for post-stroke incontinence.

Metformin is the first-line oral glucose-lowering medicine in almost all clinical guidelines on the management of type 2 diabetes (T2D). Standard advice has been to ingest metformin with meals to minimise any gastrointestinal adverse effects. It was long thought that metformin’s main action relates to suppression of glucose output from the liver. However, newer evidence suggests that the gastrointestinal tract is a key site of metformin action, and that administration of metformin at an interval before the meal may be more effective than ingestion with the meal, for lowering postprandial blood glucose levels. We have recently shown that the lowering of postprandial glucose by metformin in patients with T2D is associated with stimulation of the incretin hormone, glucagon-like peptide-1 (GLP-1), and inhibition of intestinal glucose absorption. We now propose to evaluate whether the timing of metformin administration affects glucose absorption, GLP-1 secretion, and the glycaemic response to intraduodenal glucose infusion in metformin-treated patients with T2D.

Bile acids (BAs) are now recognised as pivotal signalling molecules that orchestrate metabolic homeostasis through interacting with specific intestinal regions to induce the secretion of gastrointestinal (GI) hormones. Indeed, BAs trigger the release of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) from enteroendocrine L-cells (which are abundant in the distal small and large intestine), to slow gastric emptying, suppress energy intake, stimulate insulin, and inhibit glucagon in both health and type 2 diabetes (T2D) 1. The proposed project will determine whether reducing intestinal exposure to BAs (using BA sequestrants) enhances subsequent GI sensitivity to BAs subsequently to augment GI hormone secretion and thereby diminish the magnitude of postprandial glycaemic excursion in T2D. Specifically, we will evaluate the hypothesis that depletion of intestinal BAs by two weeks treatment with colesevelam increases GI sensitivity to BAs, thereby enhancing the GLP-1 response to intrajejunal BA infusion and diminishing the glycaemic in response to an intrajejunal glucose infusion in patients with T2D.