ANZCTR search results

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

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33041 results sorted by trial registration date.
  • New technology for new parents: Using technology to help parents bond with and care for their new baby

    The study is testing the effectiveness of a new web-based intervention for mothers and their partners. The intervention is designed to provide parents with accurate and up-to-date information about their unborn child’s development during pregnancy and how to help manage problems with infant sleeping or crying, and how to best cope when parents are feeling stressed by the demands of caring for young infants. Parents who are allocated to the intervention group will meet online with our research psychologist at approximately 25 weeks of pregnancy to learn how their baby is growing and how to better get to know their baby during pregnancy. They will also have 4D ultrasounds at 28 and 34 weeks of pregnancy when they can view their baby in real time, and together with our psychologist observe what their baby is doing. After their baby is born, they will meet online with our psychologist when their baby is 2 weeks and 6 weeks old for support about how to care for themselves and their baby during stressful times, like when babies are having difficulty sleeping or settling. We hypothesise that parents undertaking the intervention will form a stronger attachment to their child, be able to better undertake health-promoting behaviors during pregnancy, and will be better equipped to manage personal distress, infant crying and sleep problems,

  • A comparison of the efficacy of three methods of relocating the dislocated shoulder: Chair, FARES (FAst, REliable and Safe), and Cunningham's

    This study will compare three methods of relocating a dislocated shoulder. The three different methods being compared will use different positioning of the patient and their shoulder joint to relocate the shoulder. These methods are called the chair method, FARES method and Cunningham's method. The main purpose of the study is to determine which method is most effective at relocating the shoulder on first attempt.

  • Colorectal Anastomosis and Bacterial Eradication (CABE) Trial: The effect of pre-operative oral antibiotics on Anastomotic Leaks in Colorectal Surgery

    There is convincing evidence that OAB reduces iSSI in elective colorectal surgery. However, although there is a trend in AL many of these papers have mixed results. A recent network meta-analysis Woodfield et al had elaborated the need for future high-powered studies for assessing AL in elective colorectal surgery. Currently, there are no local studies looking into the effect of pre-operative oral antibiotics as part of mechanical bowel preparation in the Australian and New Zealand context. We aim to conduct a multi-centred randomised controlled trial on the efficacy of OAB in elective colorectal resection with anastomosis and the risk of post-operative AL and iSSI. Our hypothesis is that the addition of oral antibiotics to standard care for patients undergoing elective colorectal resection will reduce anastomotic leak and incisional surgical site infections.

  • A Phase 1/Part A study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract).

    This is a phase 1 study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract) in healthy volunteers.

  • The effect of Compassion Focused Therapy on psychological well­being in women with Lipoedema

    Chronic disease, such as lipoedema, has a negative impact on mental health and is associated with increased psychological distress, depression and anxiety. This project uses a randomised-controlled design (with an active intervention and waitlist control condition) to investigate the impact of an online, group based psychological intervention using compassion focused therapy (CFT) to improve the mental well­being of women with Lipoedema. Using a 10-week intervention design and follow-up at 8-weeks and 24-weeks post intervention completion, participants will engage in an online delivered group intervention, Participants will complete measures at baseline, post intervention and follow-­up. In addition, a subset of participants will contribute to an understanding of the biological mechanisms underpinning psychological change through gut-­brain related changes in microbiome. This project aims to improve the mental health of participants and provide critical, integrated bio­psychological and therapeutic focused research to promote well­being in lipoedema.

  • A randomized controlled trial to examine the effects of an online mindfulness intervention.

    People who complete mindfulness programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a popular four-week online mindfulness program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. While this program has been rated very positively by individuals who have completed it in the past, further research is required to evaluate its effectiveness.

  • Motor Improvement in Neurological Conditions (MINC): Feasibility of using a virtual dolphin to influence arm function and cognition in multiple sclerosis.

    The advent of technology that can enable immersive and engaging, high-dose practice, has led to new opportunities for restoring function in neurological patients. ECU’s Neurorehabilitation and Robotics (Edwards) Lab has acquired the Mindpod motion capture and gaming system, that enables fun exploration and practice using whole arm-hand in large movements to guide a dolphin to swim in a gaming environment. We test if this immersive digital gaming system in patients with MS, can safely and feasibly be conducted and can have positive effects on cognition, motor function, fatigue and quality of life.

  • Use of the Nutromics Sensor Device for the determination of Vancomycin concentrations and to evaluate biosensor safety.

    The Nutromics Sensor Device is a wearable device that is minimally invasive and can be placed on the skin peripherally or centrally. The device will provide vancomycin measurements once cleared and in clinical setting to be used in the diagnosis and treatment of vancomycin overdose and in monitoring of levels of vancomycin in order to help ensure appropriate therapy.

  • Postoperative pulmonary complications in the ENIGMA 2 Trial

    The ENIGMA (Evaluation of Nitrous oxide In the Gas Mixture in Anaesthesia) Trial was a large (n = 2,050) pragmatic multicentre randomised trial in patients undergoing major surgery. The incidence of clinically significant postoperative pulmonary complications (PPCs) measured by routine chest radiography and postoperative full blood and microbiology testing, as well a septic complications, were found to be increased with N2O. The larger ENIGMA 2 Trial (n = 7,000) did not confirm the findings of ENIGMA that N2O increased rates of wound infection or sepsis. Unfortunately, ENIGMA 2 did not prospectively collect data on pulmonary complications. Given the pragmatic nature of the protocol for measurement of PPC incidence used in ENIGMA, it was seen as feasible to replicate it post hoc in the ENIGMA 2 trial sample, using data collected as part of routine postoperative clinical management in these patients. This was done in the cohort of patients recruited to the ENIGMA 2 Trial within Australia, which consisted of over 2,500 patients or approximately 35% of total trial recruitment.

  • Developing and implementing an online nutrition education program for people with multiple sclerosis

    Evidence suggests that making healthier food choices is beneficial for people with multiple sclerosis (MS), and making dietary changes can give people with MS a sense of control over their disease. People with MS often turn to the internet for information about diet, and are faced with conflicting information from the “special diets” promoted for MS. People with MS want clear information on what dietary changes to make, and how to make healthy food choices. To meet this need, we will develop and run an online nutrition education program for people with MS, using a variety of ways to present the information. The free six-week program will be co-designed with people with MS and MS health professionals, and will provide information on diet and MS, including: how diet might affect MS symptoms; gut health; foods to eat and avoid; meal-planning; dietary supplements; understanding scientific research; current and emerging research in diet and MS; and “special diets” promoted or sold for MS. We expect that completing the program will help people with MS make healthier food choices and improve their nutrition knowledge and skills. We will assess the suitability of the content, format, and duration of the program.

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