ANZCTR search results

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

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31194 results sorted by trial registration date.
  • The “NATURE” Trial: Nutritional Adjunctive Treatment Used for Recovery in Early psychosis

    To date, randomized clinical trials have only assessed the efficacy of single-nutrient supplementation in early psychosis. Research in other populations has indicated that combining various nutrients within multi-ingredient ‘nutraceuticals’ can result in greater benefits for mental health than single-nutrient supplementation, and is less likely to cause nutritional imbalances. This project will be the first internationally to assess the feasibility and efficacy of a multi-ingredient nutraceutical for treating young people with early psychosis. The novel formula contains a range of food-derived nutrients including vitamins, minerals, antioxidants and amino-acids. Each of these nutrients, in isolation, have already been indicated as potentially effective adjunct treatments for mental health conditions, perhaps through restoring nutritional deficiencies, and targeting abnormal brain processes implicated in the disorders. We hypothesize that combining these nutrients within a single nutraceutical, and administering this in early illness (when nutrients are most effective), may present a novel adjunctive treatment for improving outcomes of early psychosis. This pilot study will assess the feasibility and effectiveness of a multi-ingredient nutraceutical, designed to act as an adjunctive with standard antipsychotic treatment, in order to improve physical and mental health outcomes in people with early psychosis. Specifically, we will be performing a randomized controlled trial to test the hypothesis that adjunctive treatment with a nutrient-enriched fruit flavoured drink mix can reduce negative symptoms in young people with early psychosis.

  • Randomised Controlled Trial Addressing Wound Debridement Frequency and Healing Outcomes in Diabetic Foot Ulcers

    This study will examine the effect of wound debridement frequency on the healing of foot ulcers in people with diabetes. The study will take place in up to 2 different sites, the Diabetes Centre High Risk Foot Service at Royal Prince Alfred Hospital (RPAH) and the High Risk Foot Service at Concord General Repatriation Hospital (CGRH). Foot ulcers most often develop because diabetes can cause damage to the nerves and/or blood vessels of the feet. An important part of treatment is a procedure called debridement. This is when the Podiatrist or the Nurse removes hard skin from the edge of the ulcer and unhealthy tissue, called slough or necrotic tissue, from the base of the ulcer. This is done using a scalpel blade and/or curette and/or forceps; each are special instruments to help to remove unhealthy tissue. While debridement is considered best practice and is performed safely and with good effect on wound healing, and is part of the standard care patients recieve at this service, there is very limited evidence to tell us how often this should be done and whether the frequency with which it is done affects how the ulcer heals. The purpose of this study is therefore to look at whether debridement performed on a weekly basis versus every 2 weeks affects the healing of diabetes-related foot ulcers. As of April 2018, there are 5 participating treatment sites; Concord, Royal Prince Alfred Hospital, St George Hospital, John Hunter and Bankstown Hospitals. Northern Sydney Hospitals, Royal North Shore and Hornsby have submitted site specific approval to become additional sites for this study.

  • Psychological Coaching for Patients Undergoing Total Knee Replacements

    People may have different outcomes after having a knee replacement; some may experience fast and untroublesome recovery while others may experience pain, dissatisfaction and problematic outcomes in spite of successful surgical procedures. Many studies have shown that various psychological factors may have a large influence on recovery and the outcomes of knee replacement. To date, psychological coaching is not part of standard treatment in hospitals for managing outcomes post-surgery for knee replacements. This study will assess the effectiveness of a six session psychological coaching program specifically modified and designed for patients undergoing knee replacements. This program was designed based on interviews with previous patients who have undergone a knee replacement, and based on previous research literature. Participants will be randomised to either receive the 6 sessions of psychological coaching in addition to standard care, or to receive standard care only. The psychological coaching program will start 2 weeks before surgery, and conclude 4 weeks after surgery. All participants will fill out questionnaires asking about physical and psychological variables, 5 times over a period of 12 months. Participants will also measure their range of motion in their knees at these 5 points. The control group will complete questionnaires at the same times as the coaching group: 1) 2 weeks before surgery, 2) 4 weeks after surgery, 3) 3 months after surgery, 4) 6 months after surgery, 5) 12 months after surgery. Outcomes of patients who receive psychological coaching will be compared to the outcomes of patients who receive treatment as per usual in hospitals to assess the effectiveness of the program. We hypothesize that patients receiving psychological coaching will have better outcomes compared to patients who receive standard treatment.

  • A pilot randomised controlled trial comparing placebo to continuous erector spinae block for patients having surgery of the torso

    Surgery on chest, abdomen, pelvis and hip (torso) is commonly performed worldwide. Adequate pain relief is essential for smooth recovery and avoidance of complications after surgery. Commonly, strong painkillers containing morphine or morphine like drugs (opioids) are used to treat pain following surgery. Opioids have side-effects such as drowsiness, nausea and vomiting. Furthermore, opioids can impair respiratory function, resulting in reduced oxygen in the bloodstream. Opioids are also highly addictive, and it has become apparent that when patients use these drugs to treat pain following surgery, a proportion continue to take the drugs well beyond the period that they are required to do so because of pain. In other words, the use of opioids to treat acute pain following surgery is a potential pathway to persistent use of opioids and even addiction. In the United States, a leading cause of death is opioid overdose following a legal prescription. There are signs in Australia that similar events are occurring, for example our population are increasingly being prescribed stronger longer lasting opioids and there have also been an increase in opioid-related deaths. In this research, we will be examining whether a regional anaesthesia technique called erector spinae block is effective in both reducing pain and patients’ requirements for highly addictive opioids. Erector spinae block uses local anaesthetic to block the pain and therefore it should reduce the need for opioids, however, this is technique is new and therefore should be subject to rigorous scientific evaluation. The erector spinae block uses ultrasound to guide injection of local anaesthetic between the muscle layers of the back. The nerves that supply the chest, abdomen, pelvis and hip are located between these muscles. By numbing these nerves, this technique has the potential to reduce pain after surgery on the torso. This study is a placebo-controlled randomised controlled trial and involves patients being allocated into two groups. Each group has a different treatment, erector spinae block either with local anaesthetic (active treatment) or with saline (salt water mixture, placebo). A catheter (thin plastic tube) will be inserted into the plane and regular boluses will be given up to 24 hours after the operation, with solutions administered depending on the patient allocation group. To ensure the groups are similar, each patient is allocated to a group by chance (random) before surgery takes place. The patients have an equal chance of being allocated to either the treatment group or placebo group. We plan to recruit 80 patients into the study.The main outcomes to be measured are pain score, opioid use and other outcomes that are important to the patient. These include patient-rated quality of recovery and satisfaction 24 hours after the operation. We expect that patients who received erector spinae block will have reduced pain scores and improved quality of recovery.

  • Optimising exercise for cognitive function in older adults

    The positive influence of exercise on cognitive decline in older adults is established and previous research has demonstrated that exercise increases the hippocampus volume, a region of the brain that is responsible for creating and storing new memories. However, it is not known whether the intensity of exercise is important for improving cognitive function, and what mechanisms are involved in cognitive improvement with exercise. In mice, we have demonstrated that exercise acts directly on the brain to increase the growth of new brain cells (neurons) in this brain region, and as a result, learning and memory are improved. A compound known as growth hormone appears to be an important mediator for the growth of new neurons. In older adults, growth hormone levels are much lower than in younger adults, but exercise can increase growth hormone levels in the brain and the blood, and the greater the exercise intensity the greater the increase in growth hormone. Therefore, based on our results from mice, it is thought that growth hormone may be an important link between exercise, brain health and cognitive function. This project will investigate whether exercise can increase the production of important growth factors, leading to hippocampus volume increase and improved cognitive function in older adults. We are recruiting adults aged 65-85 years, who will be divided into three groups to complete either low-intensity (very easy), moderate-intensity (easy) exercise or aerobic-interval (hard) exercise three times per week for 6 months. All exercise will be supervised and monitored for participant safety using heart rate and perceived exertion. Cognitive function, fitness, blood hormones and hippocampus volume will be measured before beginning exercise, at mid-point (3 months) and following the conclusion of the exercise program (6 months), as well as following a 6-month follow-up period after the conclusion of the exercise. Results will be analysed to see whether the exercise changed cognitive function, and whether this changed is related to factors such as blood hormones and hippocampus volume. Our approach is the first systematic, multimodal approach to investigate the mechanistic and phenomenological effects of exercise on cognitive function, with the unique interchange between animal and human investigation. The overall aim of this project is to translate the beneficial effects of physical exercise observed within mice to older adults and develop robust biomarkers that can be used to evaluate the effectiveness of exercise interventions on cognitive function in humans. Exercise is a relatively cheap, safe, accessible and available treatment, which can be offered systematically to a large aging population. Therefore, the use of exercise as a prevention and treatment for cognitive decline will potentially benefit a large portion of the population and may provide a significant economic benefit, at both an individual and a societal level.

  • Analysing variation in the absorption and elimination of glucosamine among healthy individuals to investigate possible reasons for inconsistent clinical outcomes to glucosamine therapy

    Glucosamine is used for the management of osteoarthritis. It shows inconsistent clinical outcomes in patients. Therefore, we propose that one possible explanation for the observed inconsistent clinical outcomes is variable inter-patient bioavailability of oral glucosamine. To test our hypothesis, we will recruit 24 healthy adult individuals, who will take two brands (Blackmores and DONA) of glucosamine supplements individually for total six days to reach a steady-state plasma concentration of glucosamine. On the sixth (last) day of dosing of each brand, we will collect their blood samples just before ingestion and then at 1, 1.5, 2, 3, 4, 5, 6, 10 and 12 hours after the ingestion of the last scheduled dose to analyse pharmacokinetic parameters at steady-state, including minimum, maximum and average plasma concentration. We will compare the obtained pharmacokinetic parameters to estimate the variation in absorption of glucosamine among the participants and across the two brands.

  • Head positioning for Stroke blood flow Augmentation assisting Reperfusion Therapies

    The purpose of the study is to evaluate the effects of head-down positioning (15 degrees below horizontal) in acute stroke, using both clinical and radiographic outcome measures. Primary Aim: 1) To demonstrate definitively whether body positioning improves cerebral blood flow in acute ischaemic stroke, as measured by CT perfusion imaging Secondary Aims: 1) To demonstrate (in ‘responders’) whether altered body position acutely affects neurologic function 2) To determine (in ‘responders’) whether altered body positioning (15 degrees head down) lessens the likelihood of progression of ‘penumbra’ to infarction, as assessed by 24 hour magnetic resonance imaging.

  • Video versus written materials for research implementation

    Justification: Many healthcare practices do not align with current research evidence, prompting healthcare governance agencies to invest in efforts to increase translation of current knowledge into widespread practise. A common approach is the simple dissemination of text-based summaries. While this approach has demonstrated some success, other modes of transmission such as video may be more effective given that is how many of us increasingly consume information. Video-based approaches have emerged as a new way for journal publishers to communicate study results by providing video abstracts. A recent study reported increased knowledge as a result of a web-based video education series that aimed to build capacity for evidence-informed decision-making. However, further evaluative research is needed, due to the paucity of evidence supporting the effect of video mode dissemination for research findings. Aim: This study aims to evaluate the efficacy of video versus written research dissemination strategies for promoting knowledge translation in nursing and allied health using a novel helix crossover randomised design. Participants: Registered nurses and allied health professionals from all inpatient wards at the Kingston Centre will be sampled. Method: This single centre study will be evaluated using a 3-group helix crossover randomised study design, which enables each group to experience each condition, but in a different sequence. The 3 conditions are video-based evidence-summary (a), written-based evidence-summary (b), and usual care control condition (no intervention) (c). The material to be disseminated relates to the use of bedside pressure sensor alarms to prevent falls (S1), written falls prevention patient education (S2), and physical activity after diagnosis of deep vein thrombosis (S3). This study will be conducted as a 3 level helical crossover model as follows: S1a S2b S3c / S1b S2c S3a / S1c S2a S3b. The evaluation will be broadly based on the four levels of the Kirkpatrick Evaluation Model Hierarchy framework, designed to evaluate training programs: (1) reaction, (2) learning, and (3) behaviour, and (4) results Outcomes: Primary outcome: alignment between self reported rating of treatment benefit and current research evidence. Secondary outcomes: (1) self reported confidence of judgement of treatment benefit, (2) self reported perception of whether practice should be implemented or de-implemented, (3) self reported perception of the value of dissemination mode.

  • Single centred, interventional study on abdominal breathing to eliminate/reduce sleep apnoea.

    The study is interventional, employing devices, behavioural approaches and diagnostic procedures. The behavioural change aims to instil and continue abdominal breathing by the participants during sleep. Firstly this will be attempted by instructions, training, participant's abdominal muscle awareness during breathing, This will be assisted with Biofeedback. Secondly supporting activity via EMS and APAP devices may need to be utilised. Thirdly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The interventions will delivered by themselves and staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment. The mode of delivery will be face to face preferably in group sessions (individually if requested by participants), employing instructions, training and devices, as well as remote monitoring via telephone and internet.

  • Investigation of Nasal Deposition using a Medical Device (Nasal Mesh Nebuliser -NMN)

    This is an exploratory study using a new clinical NMN prototype to determine the regional depositions in the nasal cavity of aerosols using different pulse frequency modes in healthy volunteers. The main objective of the study is to determine the optimal frequency for the NMN that will provide the basis for future in vivo sinus targeting of drug delivery systems. The primary endpoint of this study is the total area of distribution (mm2) of radiolabelled saline immediately after administration by the NMN (T0) in the different regions of the sinus cavity.

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