ANZCTR search results

The primary aim of this pilot cross-over RCT is to estimate the immediate-effects of the knee brace. Together with a feasibility evaluation of a 6-week intervention with the knee brace (separate trial registration), this pilot study will inform a future full-scale RCT.

This study is evaluating the utility of an intracavernosal injection of botox for penile rehabilitation in men undergoing a nerve sparing radical prostatectomy, a procedure which causes erectile dysfunction in over two-thirds of patients. Who is it for? You may be eligible for this study if you are an adult male aged 40 to 75 years old who has been diagnosed with prostate cancer, and is undergoing unilateral/bilateral nerve sparing radical prostatectomy. Study details Participants will be randomly assigned to receive an intracavernosal injection of either botox or normal saline immediately at the end of their surgical procedure (radical prostatectomy). Participants will also be asked to complete questionnaires regarding their sexual function and quality of life at several timepoints during the 12 months following the prostatectomy. It is hoped that findings from this study will help determine the utility of botox in penile rehabilitation for men with prostate cancer undergoing radical prostatectomy.

This is a study to characterise the effects of a Moderate CYP3A4 and P-glycoprotein Inhibitor on the impact of Bomedemstat (IMG-7289) in healthy volunteers. IMG-7289 may be indicated for use in patients with cancer. A drug-drug interaction trial is needed to better understand how the body interacts with administered drugs throughout the entire duration of drug exposure. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details This trial will take place over 73 days, where participants will be screened for 28 days, receive oral medication over a 13-day period, and will then be followed up. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine whether Moderate CYP3A4 and P-glycoprotein Inhibitor have an effect on the reaction of volunteers to Bomedemstat (IMG-7289). Healthy participants in the current study will not receive any health benefit (beyond that of an assessment of their medical status) from participating in the study; however, data from this study will support the potential development of bomedemstat.

This study aims to determine the impact of coeliac plexus neurolysis on pain and quality of life in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years and older and have confirmed clinical diagnosis of pancreatic cancer and have cancer-related pain. Study details All participants in this study will undergo Endoscopic ultrasound (EUS) - coeliac plexus neurolysis (CPN) procedure performed by an interventional gastroenterologist. EUS-CPN is conducted as a day-only procedure under deep intravenous sedation. Participants will then be followed-up and assessed regularly for 6 months to determine the impact of EUS-CPN on pain and quality of life. Longer follow-up to 12 months post EUS-CPN procedure will be conducted to assess safety and survivorship. It is hoped that this research project will improve the quality of life of patients with pancreatic cancer through reducing pain and assisting with other activities of daily life that maybe affected by the cancer.

The purpose of this study is to explore the therapeutic benefits, tolerability and acceptability of psychedelic therapy using psilocybin and its potential to improve symptoms of treatment resistant depression (TRD), depression in people which has not resolved with a number of courses of standard treatment. Prior research has suggested that this type of treatment may have significant antidepressant effects, but we require further evidence to fully understand the therapeutic value, benefits, and risk of psilocybin in a treatment setting. The design includes an adaptive, dose finding, single phase 2b clinical trial exploring the efficacy and safety of psilocybin assisted psychotherapy (PAP) in the treatment of people diagnosed with treatment resistant major depressive disorder (TRD). If successful, this will lead to the conduct of a subsequent multi-site phase 3 trial to report findings of the therapeutic value, benefits and risks of psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the relevance to real-world use in Australia.

The aim of this study is to use a 3D-printed scaffold made specifically for the patient to help improve the visual appearance and symmetry of their nose. The current treatment to improve symmetry to the nostril base is to use either bone graft which is prone to resorb with time or to use an artificial material which doesn’t grow with the child. We hope to overcome these shortcomings by implanting a biodegradable scaffold under the base of the nose to improve nostril shape. The scaffold will be placed during the same surgery as the patient’s secondary alveolar bone grafting procedure or secondary rhinoplasty. The scaffold is made from a material (polycaprolactone-tricalciumphosphate (mPCL-TCP)) that degrades over time allowing for their own tissue to grow into it leaving them with just their own tissue once the scaffold has fully degraded. The scaffold will typically fully degrade in 24 months.

NUDG-ED is a randomised trial that will investigate behavioural strategies to reduce the use of low-value care for low back pain in emergency department (ED). We will recruit ED clinicians who manage back pain, and patients 18 years or over presenting to ED with back pain with a musculoskeletal condition. We will randomly allocate hospital sites to receive i) waiting room messaging for patients on best care for back pain, ii) computer prompts reminding clinicians of the indications for imaging and opioids, iii) both interventions, or iv) no intervention. The primary outcome will be the proportion of low back pain encounters where a person received low-value diagnostic imaging or an opioid prescription at discharge from ED.

This study aims to assess whether a digital conversational agent can be used to effectively deliver a low intensity emotion regulation intervention to people who have sustained a minor to moderate injury in a motor vehicle accident. This is a cohort of people who are often under stress. The intervention has been designed with input from clinical psychology and computer science. The intervention encourages people to reflect on the current way they manage negative emotions and provides information and examples of evidence based adaptive emotion regulation strategies that have been identified as being critical for effective coping. The emotion regulation strategies included in the program include positive refocusing, reappraisal, acceptance, planning and problem solving and putting things into perspective. It is anticipated that completing this intervention will assist participants to learn strategies to assist them to regulate emotions which will in turn increase their confidence that they can cope at this challenging time. It is also anticipated that the program will assist in reducing participant's reported levels of distress.

This study will evaluate the effects of a fasting mimicking diet or an exercise program on immune biomarkers in breast cancer patients receiving (neo)adjuvant chemotherapy compared to a group of patients undergoing (neo)adjuvant chemotherapy without following a diet or exercise program. Who is it for? You may be eligible for this study if you are an adult woman aged 18 years or older, you have been diagnosed with breast cancer and you are scheduled to undergo or already receiving chemotherapy. Study details Participants who choose to enrol in this study will be offered to join one of three groups. Participants who choose to join the first group will be given a prescribed diet that is designed to mimic a fasting diet. The diet will be low calorie and low protein, participants will be asked to follow the diet 2 days before their chemotherapy infusion and continue it for 2 days after their infusion. Participants will then return to their usual diet until 2 days prior to their next infusion. Participants who choose to join the second group will be asked to attend a gym 2 or 3 days per week to complete supervised exercise routines. During weeks where participants are undergoing chemotherapy they will attend 2 sessions/week for 50-60 min per session. During the weeks without chemotherapy treatment, patients will attend 3 sessions/week for 50-60 min per session. Participants who do not wish to participate in either the diet or exercise groups may also enrol in this study and complete blood tests and questionnaires prior to and after completing their chemotherapy. These participants will act as the comparator group to determine if either the diet or exercise program has any effect on the cancer cells compared to chemotherapy alone. It is hoped this research will provide preliminary evidence as to whether following a fasting mimicking diet or an exercise program while undergoing chemotherapy for breast cancer can promote beneficial effects on immune biomarkers. . If either the diet or exercise program is shown to have a beneficial effect on breast cancer patients, a larger randomised clinical trial of one or both of these treatments may be undertaken

People with advanced Peripheral Artery Disease (PAD) require costly, complex surgery, and often have heart attacks, strokes, and amputation. Preventative care is poorly provided, and many people with PAD miss out on medications that improves long-term health and avoid complications. We hypothesise that involving a range of expert doctors in team-based care will improve recognition and treatment of cardiovascular risks compared to current care practices. This project aims to improve prevention of adverse cardiovascular outcomes in people with peripheral artery disease by providing multidisciplinary team-based care that is targeted to an individual person’s health needs. To do so, we will compare the cardiovascular risks of people treated according multidisciplinary team recommendations (measured using the SMART-REACH model) to those who receive current standard care. We will also measure patient and clinician experiences, and costs associated with the new team-based model of care.