ANZCTR search results

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

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33058 results sorted by trial registration date.
  • What does open eye lens centration tell us about the treatment zone centration after overnight wear of orthokeratology (OK) lenses?

    Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short- sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed myopia control. Currently, research is underway to understand centration of OK lenses and the optical effects as a result of centration which may promote myopia control. Although optometrists will typically assess the centration of the lens in the open eye, it is not clear how much this influences treatment zone centration after overnight wear in the closed eye, and this warrants investigation. The aim of this project is to compare open eye lens centration with treatment zone centration after 3 nights of overnight wear of OK lenses. We will investigate open eye lens centration with and without eyelid interactions, as well as lens centration immediately after eye opening following short-term eye closure. Our intent is to determine how these measurements can be used clinically to predict treatment zone centration after overnight OK lens wear.

  • Can general anaesthesia provide similar results in the population in terms of pain after a total knee replacement surgery when compared to spinal anaesthesia?

    This study will look at different methods for administering anaesthesia for total knee replacements. The technical options we use nowadays are mostly spinal anaesthesia and general anaesthesia. In the past, spinal anaesthesia was the preferred option amongst anaesthetists. Today, the evidence shows that both techniques are similar in terms of complications. However, we still don't know which technique provides better pain relief. In this study, we will look into the pain levels of fifty patients who are having knee replacement surgery by checking the amount of morphine they have used during the research. Patients will be divided in 2 groups, general anaesthesia group and the spinal anaesthesia group. Patients won't be able to choose the group they are participating since this process will be done by an online tool. We hypothesise that the pain will be similar in both groups independent of the anaesthetic technique used. We will also look for patient satisfaction regarding the type of anaesthesia, nausea and vomiting and the anaesthesia efficiency. Results will help both patients and anaesthetists to have more information and more freedom to choose their preferred technique for this procedure.

  • Best Start Trial: early intervention physiotherapy to improve motor outcomes in infants at high risk of cerebral palsy or motor delay

    The Best Start Trial aims to determine whether targeted physiotherapy interventions initiated up to 4-5 months earlier than typically commenced (3 months corrected age), will improve motor outcomes at the 16 week time point in infants at risk of cerebral palsy or motor delay. Parents or caregivers will be closely coached by physiotherapists in the provision of targeted motor interventions to their infant, commencing as early as 34 weeks gestational age until their infant is 16 weeks old. The motor outcomes of infants receiving the parent administered physiotherapy or motor therapy will be compared to current "usual care" to determine if either of these approaches is more beneficial than the other. It is hypothesised that the parent-administered approach will be more beneficial than "usual care" because of it's targeted physiotherapy content and improved continuity of physiotherapy delivery from the NICU to home.

  • The effect of cardiorespiratory fitness and acute aerobic exercise on liver metastases blood flow

    The main purpose of this study is to assess if there is an association between cardiorespiratory fitness and acute aerobic exercise on tumour blood flow in patients with cancer that has spread to the liver. A secondary aim of the study is to determine the most effective exercise intensity for increasing tumour blood flow. Who is it for? You may be eligible for this study if you are aged over 18 and diagnosed with stage IV cancer with a liver metastases. Study details All participants in this study will be required to attend a single visit. Participants will perform an aerobic fitness test (YMCA). After a rest period, participants will ride on an exercise bike for 5 minutes, or take part in the sub-study which participants will complete 3 cycling tasks of varying difficulty. Each will last for 5 minutes and there will be a rest period in between each one. Physiological measurements will be taken before, during and after the intervention, including blood pressure, heart rate and oxygen saturation, as well as oxygen consumption and ultrasound measures. The study will extend the work of a current pilot study, investigating the safety and feasibility of intra-infusion aerobic exercise and help progress towards clinical application. The results will not provide a full picture into the mechanism or relationship of tumour blood flow and chemotherapy delivery but rather provide a platform for further research.

  • Investigating health effects of fibre consumption in healthy humans

    Acetate is a type of short-chain fatty acid that is normally present in the blood. In animal studies, increasing the level of acetate in the blood is associated with reduction of inflammatory processes in the body. The purpose this research project is twofold. 1. We wish to investigate how to increase acetate levels in the blood by comparing diets that have different levels of fibre. Fibre taken in the diet as dietary fibre is converted to small metabolites that include acetate by bacteria found in the lower part of the gut (colon) and this acetate finds its way into the blood stream. 2. We wish to determine if increasing the acetate levels in the blood does change immune cells and key enzyme activities in the blood that may reduce inflammation, just as it does in experimental animals. This study will help us to understand if dietary fibre can be used to reduce inflammation in conditions such as asthma or allergy in the future. In order to investigate this, we are asking for healthy volunteers to participate in a dietary intervention study that will involve consuming a diet with varying fibre level and having blood taken at the end of each diet (Morning of Day 5).. This research has been initiated by Dr. Jane Muir, a dietitian and Head of Translational Research at the Department of Gastroenterology. The results of this project will be used by Mr. Paul Gill as part of his Bachelor of Biomedical science honours degree.

  • Proof of concept trial alternating lorlatinib with crizotinib in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer

    The primary purpose of this trial is to evaluate the efficacy, safety and feasibility of alternating lorlatinib and crizotinib for the treatment of ALK-rearranged advanced non-small cell lung cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been diagnosed with ALK-rearranged advanced non-small cell lung cancer, refractory to prior therapy(ies). Study details All participants enrolled in this trial will begin with Induction therapy which involves taking lorlatinib tablets every day for 12 weeks. Participants will then move onto the Alternating phase. During the Alternating phase participants will take crizotinib for 4 weeks, then lorlatinib for 8 weeks, then crizotinib for another 4 weeks, and lorlatinib for 8 weeks until disease progression or unacceptable side effects. Following progression, some participants may be eligible to continue with alternating treatment or switch to continuous lorlatinib treatment until further progression, depending on whether your doctor believes that this would be of benefit to you. All patients will be reviewed up to every four weeks clinically, with bloods tests, CT scan and MRI (brain) and side effect assessments. It is hoped that the findings from this trial will provide information on whether alternating treatment with crizotinib and lorlatinib is feasible, safe and effective for the treatment of ALK-rearranged advanced non-small cell lung cancer with the potential to delay the emergence of drug resistance as compared to continuous lorlatinib therapy alone.

  • An evaluation of the effects of a topical traditional Chinese medicine formulation on muscle soreness associated with athletic training

    The primary purpose of this study is to use a scientific framework for evaluating whether an ancient Traditional Chinese medicine oil with a long history of use for muscle pain is effective in well-trained Australian males. Cheong Kun Oil is a topical preparation which has been marketed in Macau since the 1960’s for its beneficial effects on muscle pain due to exercise, strains and injuries. This study will scientifically investigate the efficacy of Cheong Kun Oil for reducing DOMS in the thigh muscles after eccentric exercise (exercise where the muscle is lengthened) in healthy, young, well trained males. The traditional Chinese medicine (TCM) Cheong Kun Oil is a topical preparation marketed in Macau since 1960’s and is popular for its beneficial effects on muscle pain due to exercise, strains and injuries. According to Chinese Medicine theory, the constituent herbs in the preparation help promote circulation, reduce inflammation and alleviate pain. Despite the long history of use, to date, clinical studies evaluating the efficacy of Cheong Kun oil in the management of DOMS have not been conducted. Therefore, the objective of this study is to evaluate the efficacy of Cheong Kun oil as a topical treatment for the management of DOMS and associated muscle performance in young healthy well-trained males.

  • A pilot study comparing the zero-heat-flux temperature monitoring device to oesophageal temperature monitoring in orthopaedic surgery.

    The overall aim of this study is to improve methods of temperature monitoring for patients undergoing surgery. There are concerns about how accurate the most commonly used, non- invasive methods of temperature monitoring are. The most accurate methods of measuring core temperature are very invasive, and therefore not routinely used for all patients undergoing surgery. Accurate and consistent measurement of temperature is important when patients are undergoing surgery to detect abnormal temperatures including fever, and perioperative hypothermia – that is, a very low temperature related to undergoing surgery and anaesthesia. Perioperative hypothermia is linked with range of adverse side effects. Therefore, it is very important that health care staff monitor temperature using the most effective, yet practical and safe mode of measurement. This study specifically seeks to test the zero-heat-flux temperature monitoring device (Bair HuggerTM). The device will be tested in comparison to oesophageal temperature monitoring, which involves the insertion of a temperature monitoring probe into the oesophagus. This is often undertaken as part of routine care, as this method is considered an accurate method of core temperature measurement. The zero-heat- flux device is completely non-invasive, yet existing research suggests that it may offer greater accuracy in monitoring core temperature than other non-invasive devices in use. This study will assess the accuracy of the device, ability to detect hypothermia, as well as assessing the feasibility of a larger trial of the clinical application of the device. This device will be compared with the standard of care (oesophageal) device and all participants will receive both forms of monitoring.

  • Effects of exercise in childhood brain cancer survivors

    This randomised control trial will evaluate the immediate and long terms impacts of a 12 week exercise program in pediatric survivors of childhood posterior fossa brain tumours (PFBTs) Who is it for? The study is for children aged between 5 to 17 years with a diagnosis of a PFBT that required surgery at least 12 months earlier. Study details Participants will be randomly assigned to either the intervention or the control group. All participants in the intervention group will be required to attend a research facility once a week for a 30-60 minute individualized, goal-directed exercise session for 12 weeks. The study will also involve a parent-led, home exercise program to be completed for 30 minutes, 3 times per week. The control will receive standard care. Participants will be assessed on immediate (at 12 weeks) and long-term (at 6 month and 12 month follow-up) effects on their cardiorespiratory fitness, goal attainment, muscular strength, habitual physical activity, and quality of life. If found to be effective, the therapeutic exercise program may improve the quality of survivorship, and will have strong potential for translation to clinical practice and paediatric rehabilitation services.

  • MINDtick app psychiatric care study-Digital signal indicators to enhance capacity of psychiatric services to predict distress in advance and intervene early.

    This project will aim to determine the feasibility of using smart phone based applications in a clinical population with severe mental illness, and to determine whether the information gathered from mobile devices can detect and predict deteriorating mental health. Two groups of participants will be recruited from mental health services across South Australia; primary healthcare professionals, and patients. Primary healthcare professionals (clinicians) will be recruited for the purposes of overseeing patient recruitment, and determining eligibility. Patients will be asked to download a smartphone app called Mindtick, and will be asked to use the app for the duration of the study. Through the app, they will be prompted (via push notification) a number of times in a week to answer 8 questions relating to a number of variables; (mood, sleep, cravings, level of functioning, and disruptions to life events). Additionally, the app will collect sensor data (GPS, call/text logs, etc.) from sensors already built into the smartphone. In addition to the mobile application, an online clinician dashboard has been developed for the purposes of clinician review to monitor and improve engagement with the intervention. The dashboard summarises patient app data, and presents this information in a graphical format for monitoring mental health patient’s symptoms and functioning. We will investigate whether fortnightly responses and statistics in mobile sensor data can predict early the change in the routinely collected traditional assessment measures observed at baseline, 3, and 6 months.

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