ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • Targeting wellBeing in AdoLescent and young Adult treated for CaNCEr (BALANCE)

    This study evaluates a lifestyle program that aims to improve quality of life in young people who are recovering from cancer treatment. Who is it for? You are eligible for this study if you are aged between 15-25 years of age and have either completed intensive treatment (surgery, chemotherapy and radiotherapy) or are on maintenance therapy for any cancer diagnosis. Study details Participants will receive access to online lifestyle modules to work through over eight weeks, as well as three individual one-hour consultations with Canteen staff (cancer nurses, psychologists and social workers) to discuss how to identify and meet their wellbeing needs. Participants will also be asked to complete questionnaires on their physical and mental health status. It is hoped that findings from this study will help develop programs to ensure young people who survive cancer have the same quality of life as young people who haven’t had cancer.

  • Nasal high-flow during deferred cord clamping in very preterm infants

    Deferred (delayed) cord clamping for at least 60 seconds improves survival in very preterm infants. However, some infants require positive pressure ventilation to establish breathing in the first minutes after birth. For these infants, the cord is often clamped early, therefore they miss out on the benefits of deferred cord clamping. Furthermore, positive pressure ventilation may injure the fragile preterm lung. Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. We hypothesise that the provision of nasal high-flow prior to cord clamping may support and stimulate breathing, therefore allowing deferred cord clamping to occur and limiting positive pressure ventilation, improving outcomes. In this single-centre pilot feasibility trial, preterm infants born 26-31+6 weeks’ gestation will receive nasal high-flow during deferred cord clamping. We aim to study the feasibility of providing nasal high-flow prior to cord clamping in 20 infants with respect to 1) acceptability to clinicians and 2) practical application. We will also study clinical and physiological outcomes in infants receiving nasal high-flow during deferred cord clamping. These pilot data will help establish feasibility for a larger randomised controlled trial, and inform the primary outcome and sample size for this definitive trial.

  • A randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple doses of SAR446422 in healthy, adult participants

    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.

  • Assessing cardiovascular disease risk from retinal images using artificial intelligence at primary care settings

    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.

  • Maintaining Social Engagement: A social cognitive skills intervention for older adults with cognitive concerns.

    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.

  • HYPO-BL: Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial – Ultra versus Moderate Breast Hypofractionation Radiation Treatment

    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.

  • DExmedetomidine in Cardiac surgical Intraoperative Drug Evaluation

    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.

  • A study comparing two different handpieces for dental plaque removal with an air polishing device

    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).

  • The effect of exercise intervention for adults undergoing treatment for breast cancer

    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.

  • MONITOR - MethOxyfluraNe in InTerventiOnal Radiology

    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.

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