ANZCTR search results

This is a randomized, placebo-controlled, sequential, participant- and Investigator-masked Phase 1 study to assess the safety, tolerability, PK, and PD of ascending single and multiple doses of SAR446422 in female and male healthy participants 18 to 55 years of age. Number of participants: Up to 120 participants will be randomized to study intervention at a single study site. Part1-SAD17875: approximately 9 dose level cohorts with 8 participants per cohort (6 active and 2 placebo). The last cohort will be optional. Part2-MAD17876: approximately 4 dose level cohorts with 12 participants per cohort (9 active and 3 placebo). The last cohort will be optional.

Researchers at the Centre for Eye Research Australia (CERA) in collaboration with industry partner Eyetelligence Pty Ltd have developed a system integrating retinal photography and artificial intelligence (AI) to predict the risk of heart diseases. The retina is located at the back of the eye and has the important ability to sense vision. When the retina is photographed, it shows small vessels that can indicate the health of your heart. The cardiovascular disease (CVD) risk score refers to the probability of developing CVD events in the future. This project aims to assess the real-world impact, accuracy, and feasibility of the rpCVD screening system in primary care settings in Australia.

Older adults with cognitive concerns are at greater risk of loneliness, depression, and dementia. Often their cognitive difficulties are related not only to memory problems, but also to problems interacting and engaging socially with others. These problems include misreading body language, missing social cues, and having difficulty keeping conversations going. Existing treatments focus on improving memory or language, but there is no treatment that helps people enhance or maintain their social skills and connections. We received a Dementia Australia pilot grant in 2020 to co-design a ‘Maintaining Social Engagement program’ with Dementia Australia advocates. We successfully piloted this program with 10 people and found improvements in social cognitive skills (understanding oneself, understanding others, communicating with others). A randomised controlled trial will test if the program helps older adults with cognitive concerns to stay socially connected, feel more confident in social situations, and contribute to activities that are meaningful for them and potentially improve their quality of life.

This study aims to determine the incidence of breast oedema following whole breast radiotherapy using an objective measure of TDC measurements, to determine the difference, if any, between a moderately hypofractionated radiation schedule and an accelerated ultra-hypofractionated schedule. Who is it for? You may be eligible for this study if you are a woman aged 50 years or older and have been diagnosed with breast cancer. Study details Participants will be randomised to one of two possible treatments: the current standard of care of "moderate hypofractionation" treatment, as 40.05 Gy in 15 fractions as daily treatment sessions for 15-19 consecutive days; or " ultra-hypofractionation" treatment, as 26 Gy in 5 fractions to the whole breast, delivered in 5 sessions over 5-9 days. A tumour bed boost is an optional component of both treatments. Participants will be followed for 60 months after the treatment to determine post-radiotherapy breast changes, such as swelling and oedema, quality of life and other patient reported outcomes. It is hoped that this research will help to improve the safety, patient experience, and efficacy of breast cancer treatment.

Delirium (confusion) is a common complication of cardiac surgery. Dexmedetomidine, a routinely used sedative, has been shown to reduce delirium in different populations. This study aims to test if dexmedetomidine can reduce delirium after surgery in patients undergoing cardiac surgery aged 65 years or older. The aim of the study is to see whether a medication called dexmedetomidine (a routinely used sedative) impacts delirium after surgery. We hypothesize that dexmedetomidine will reduce delirium after surgery.

Clinical, microbiological and histological studies have confirmed the safety and efficacy of air polishing devices with the use of glycine and erythritol powder for the removal of biofilm in prophylaxis and in the treatment of periodontitis and peri-implantitis (Petersilka, 2011). There appears to be minimal scientifically validated or published data in the current literature base pertaining to the novel Airflow® MAX handpiece. This study is intended to provide an initial investigation regarding the the efficacy, safety, patient reported outcomes and aerosol generation of an air polishing device used in dentistry in conjunction with a novel EMS Airflow® MAX handpiece as compared to the conventional EMS Airflow® handpiece. The hypothesis is that the EMS Airflow® MAX handpiece is as safe and efficacious as the conventional EMS Airflow® handpiece in professional prophylaxis (biofilm and stain removal).

This study is investigating a state-of-the-art exercise intervention for those undergoing chemotherapy for breast cancer in comparison to usual care. Who is it for? You may be eligible for this study if you are an adult with newly diagnosed, non-metastatic breast cancer, with planned treatment including neo-adjuvant or adjuvant chemotherapy and/or endocrine therapy. Study details Participants will be randomly allocated to receive either a tailored exercise program, or usual care pathways without individualized exercise prescription. The tailored program will involve supervision of exercise sessions and ongoing personal support. Participants will be asked to fill in questionnaires about their quality of life and absenteeism from work, and other health data including chemotherapy completion rates will also be collected. It is hoped that findings from this study will help evaluate the utility of a personalised exercise intervention during breast cancer treatment.

Procedures performed in interventional radiology are often quick and minimally invasive, such as portacath insertions, portacath removal and deep tissue biopsies. These procedures are most commonly performed under local anaesthetic alone, which may not always adequately control your levels of pain or anxiety, leading to suboptimal patient experiences. Occasionally, a procedure may have to be abandoned or rescheduled if it is not tolerated with local anaesthesia alone. Methoxyflurane (Penthrox) is a safe inhaled pain relief medication traditionally used in the community, ambulance and emergency department settings. It is administered via a hand-held “green whistle” that you can safely use as much as you want or need during the procedure. The device delivers the medication very quickly but limits the amount of medication inhaled to safe levels and adverse reactions are rare. In our experience so far, patients have reported reduced levels of pain and anxiety when using the “green whistle”, which has been supported by other research papers looking at various procedures. The purpose of this study is to determine whether use of Methoxyflurane (Penthrox) plus local anaesthesia for interventional radiology procedures provides better patient experience and procedural outcomes compared to local anaesthesia alone. This has already been shown in other procedures. We hope that showing the benefit of Methoxyflurane (Penthrox) will lead to improved outcomes and patient experiences in the future. Medications, drugs and devices have to be approved for use by the Australian Federal Government. Methoxyflurane (Penthrox) has been approved in Australia for over 30 years, and is specifically validated in Australia to treat: (1) pain in the emergency setting in stable conscious patients presenting after trauma, under the supervision of trained personnel (2) pain in monitored conscious patients who require pain relief (analgesia) for surgical procedures such as the change of dressings. This research is being conducted by the Liverpool Hospital Interventional Radiology Department.

Colorectal cancer is the third most common cancer worldwide with 5,000 patients in Australia being diagnosed with rectal cancer per year. Over half of those patients will undergo major resectional surgery. Low Anterior Resection Syndrome (LARS) is a consequence of this surgery and describes a constellation of bowel symptoms including urgency, faecal incontinence, stool clustering and incomplete evacuation. The purpose of this study is to determine: a) if sacral nerve modulation and/or transanal irrigation will reduce the severity of LARS symptoms in patients who underwent anterior resection surgery when compared to an optimised conservative treatment, and b) understand more about how LARS changes over time. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with rectal or sigmoid cancer and has received a low or high anterior resection in the last 10 years. Study details There are two parts to the POLARiS Study. In the first part of the study, all participants will complete surveys every three months over a two-year period regarding their quality of life and bowel symptoms. These surveys will take around 30 minutes to complete the full set of questionnaires at each timepoint. For participants who have major symptoms, they can progress to part 2 of the study, if they wish, where they will be randomly placed (by chance) into one of 3 treatment groups: - Sacral nerve stimulation, called neuromodulation, involving a minor surgical procedure under anaesthetic to insert a wire close to the sacral nerve, which is in the lower part of the back above the buttocks. - Self-administered bowel flushes, called transanal irrigation, completed at home every 1-2 days for 24 months. - Optimised Conservative Management with a clinician. Participants who progress to part 2 of the study will complete questionnaires designed to capture health-related quality of life at baseline and 3 monthly throughout the 24-month follow-up period. It is hoped that this study will see how well the treatment for LARS works and to determine if there is a ’best’ treatment overall. Note: this brief summary is intended for lay audience.

In running-based sports, hamstring strain injuries (HSIs) are one of the leading causes of time lost from competition for athletes. HSI also has a high reoccurrence rate, with the risk of sustaining a HSI only increasing with a history of previous HSIs. Training interventions that load the hamstrings while they lengthen, known as eccentric strengthening exercises, have demonstrated the ability to reduce HSI incidence by modifying the hamstring internal structure (known as muscle architecture) and strength of the hamstring muscle. Eccentric strengthening exercises are believed to be effective as they occur where the muscle is being stretched, mimicking the hamstring position where most HSI occur. As such, hamstring eccentric strengthening protocols have been recommended and attempted to be adopted by many professional sporting organisations. However, a common adverse side effect of eccentric strengthening exercise is muscle soreness, stiffness and tenderness, which often persists for 24-72 hours post-training. As a result, compliance with eccentric strengthening exercise programs can be poor. Isometric strengthening exercises, where the muscle is loaded but does not change in length, is associated with less muscle soreness and has been proposed as a possible alternative to eccentric strengthening exercise due to the ability to still train the hamstrings in a lengthened muscle positions. However, there is minimal evidence surrounding the impact of isometric strengthening exercises on hamstring muscle structure and strength. Thus, the effect of isometric strengthening exercises at lengthened muscle positions on markers of HSI risk is unknown. This proposed project will determine if an isometric strengthening exercise intervention can lead to favourable adaptations in the structure and function of the hamstrings.