ANZCTR search results

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

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32103 results sorted by trial registration date.
  • Can isolated referencing of femoral and tibial bone anatomy yield comparable ligament-balanced total knee arthroplasty to a robotic implantation technique? A Comparison of Two Planning Techniques

    Osteoarthritis (OA) is the most common joint disease of the elderly, with knee OA more common than hip or ankle OA. Primary total knee arthroplasty (TKA) has been used successfully for decades to treat osteoarthritis. While a mechanical alignment (MA) of the prosthesis was initially pursued, this is increasingly being abandoned with the knowledge of the large variability of individual anatomy and knee biomechanics. New techniques involving patient-specific implantation techniques based on individual cutting guides and robotic-assisted implantation techniques have become more prevalent. While 3D-printed cutting guides are used to plan and perform osseous resections based on the individual bony anatomy, robotic-assisted techniques take into account the ligamentous stress ratios in flexion and extension. The purpose of this study is to determine whether planning based solely on the patient's bony anatomy achieves similar medial and lateral ligamentous tension ratios after total knee arthroplasty as a robotic-assisted technique that implements resections based on ligamentous tension ratios and bony anatomy.

  • A mobility booster program (HiWalk) in long-term community stroke rehabilitation

    This project will investigate a new, short-term mobility program known as the HiWalk program. HiWalk is a physiotherapy program provided at a time of need - meaning if the stroke survivor is experiencing challenges with their mobility or has a new mobility goal (even years after stroke), then this three-week program may assist their walking ability. Our preliminary research has demonstrated that HiWalk could be successfully implemented in the community after stroke and that the HiWalk program was enjoyed by people after stroke. The next, phase of research for the HiWalk program is a pilot trial of HiWalk allowing us to test the program in a clinical trial setting.

  • Teleorthodontics & Artificial Intelligence in Orthodontic Triaging

    This study evaluates teledentistry and artificial intelligence (AI) in the screening of new orthodontic referrals as well as during braces treatment in Australian adolescents and adults. Its goal is to improve access to public orthodontic services. 208 participants will submit photos using a smartphone-compatible platform called Dental Monitoring (DM). Based on these, patients will have their elgibility status assigned according to NSW Health Policy. Participants will also be assessed at a face-to-face appointment. The outcome of these two methods will be compared to determine the validity of teleorthodontics. Patient satisfaction, oral hygiene status, gingival health status, reduction in waiting lists and the cost-effectiveness will also be assessed.

  • Acceptability and Efficacy of Remote Treatment for Social Anxiety Disorder

    The primary objective of this program of research is to examine the acceptability and efficacy of videoconferencing delivered cognitive behavioural therapy (CBT) for social anxiety disorder. The secondary objective of this research project is to examine the efficacy of an imagery rescripting (ImR) enhanced cognitive behavioural therapy intervention for individuals with social anxiety disorder. It is anticipated that high-intensity videoconferencing delivered CBT will (1) be acceptable to individuals with SAD; (2) result in significant reductions in symptoms of social anxiety compared to waitlist control at post-treatment and follow up; (3) ImR enhanced CBT will result in similar reductions to standard CBT.

  • Does the use of knowledge of results feedback increase stroke survivors’ motivation to practise and intensity of practice?

    The intervention group will receive knowledge of results feedback during a physiotherapy session. Knowledge of results feedback is an objective measure of performance, for example, last session you were able to put 20kg through your leg for 15 out of 20 repetitions, this session you were able to put 20kg through your leg for 18 out of 20 repetitions. This information will be given to the participants immediately after each set of exercise repetitions within the treatment session and will be recorded on a recording sheet. The same type of knowledge of results feedback will be used for each exercise across sessions so that participants can see changes in their performance. The control group will receive usual therapy only which does not consist of the routine use of knowledge of results feedback. Change in motivation to practice and intensity or practice (,measured as exercise repetitions per minute) will be compared between the two groups to ascertain the effect of knowledge of results feedback. Hypothesis: The provision of knowledge of results feedback during therapy will increase stroke survivors’ motivation to practise and their intensity of practice.

  • Exteroceptive Reflexes in Neurological Conditions and Healthy Controls

    Stiff Person Syndrome (SPS) is a rare disorder that causes pain, stiffness and spasms in the back, trunk, arms legs. It can be a difficult condition for doctors to diagnose as the key symptoms are common with many potential causes, and there is no single test that proves a person has the condition. Blood tests can be helpful in some cases and abnormalities in a particular test called the exteroceptive reflex test has been described in the condition. It is not known, however, how accurate exteroceptive reflex testing is in the diagnosis of SPS. The purpose of this study is to get more information about whether the exteroceptive reflex test can help doctors diagnose stiff-person syndrome and distinguish this from other neurological problems which present with pain or stiffness in muscles, people who take medication which make other reflexes more prominent (selective serotonin reuptake inhibitors and selective serotonin and noradrenaline reuptake inhibitors), and from healthy individuals. Exteroceptive reflex testing involves a doctor or neurophysiology scientist recording signals from several muscles in the back and legs by placing small disposable recording electrodes on the skin. Muscle contraction is measured after nerves in the wrist and ankle are activated with low-level electrical current. The test takes approximately 15 minutes, and does not cause any harm to the nerves, muscles or other parts of the body.

  • A Study to Evaluate the Effectiveness of the Avelle™ Negative Pressure Wound Therapy System on Adults with Chronic Wounds

    The primary objective of the study is to demonstrate of whether Avelle® Negative Pressure Wound Therapy helps better management of chronic wound and exudate when used in accordance with the Instructions for Use. Exudate is the fluid that leaks out of a wound. The secondary objective is to measure ongoing safety of the Avelle® Negative Pressure Wound Therapy system. Medications, drugs and devices have to be approved for use by the Australian Federal Government. The Avelle® Negative Pressure Wound Therapy System is approved in Australia to treat low to moderately exuding (leaking fluid) wounds that would benefit from a Negative Pressure Wound Therapy device. It is indicated to treat different types of wounds, one which is chronic wounds like ulcers. This study will gather information about the device’s ability to manage wound fluid and progress made in the healing of the wound. The hypothesis is that the Avelle™ Negative Pressure Wound Therapy system will help the wound close and manage the fluid that leaks from the wound. The hypothesis is that the Avelle™ Negative Pressure Wound Therapy system will help the wound close and manage the fluid that leaks from the wound.

  • Cardiopulmonary outcomes of right heart dysfunction in the critically ill: a prospective observational trial

    Until recent years, right heart dysfunction (RHD) has been paid little attention due to a combination of it being challenging to assess, not having unified diagnostic criteria and the apparent robustness of the right ventricle. However more recent data combined with improved imaging techniques have changed this attitude. This project aims to create a longitudinal cardiopulmonary profile of patients who have suffered from right heart dysfunction to to determine if there is correlation between RHD and physical limitation/symptom burden following hospital discharge. It will use inpatient data (clinical and echocardiographic) as well as longitudinal outpatient data (qualitative and combined CPET-SE) to map the course of these patients. This longitudinal observational data will be hypothesis generating, a first step in considering how an acute phase intervention may change the natural history of this insult.

  • The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep

    This project will investigate the effects of theacrine, a supplement that is similar to caffeine. It is well shown in the literature that caffeine can improve cognitive performance, which refers to the ability of an individual to use their mental processes to perform tasks such as thinking, problem-solving, and decision making. With the similarities to caffeine, it is suggested that theacrine may be able to improve cognitive performance without some of the side effects associated with caffeine including sleep disturbance. However, as theacrine is a relatively new supplement, there is limited investigations to support these findings. Therefore, this project aims to investigate the effect of theacrine dose and timing combinations on cognitive performance across the day and subsequent night-time sleep. Using a placebo-controlled, double-blind, randomised crossover design, participants will complete seven conditions separated by a six-day washout period. Conditions will include a placebo (glucose) and a low (100 mg) and high dose (400 mg) of theacrine administered 12, eight, and four hours prior to bedtime. These timepoints reflect consumption in the morning, afternoon, and evening. With the repeated measures design, it is estimated that 21 participants will be required. Participants will be healthy males aged between 18 and 40 years with no reported medical or sleep condition and a daily habitual caffeine consumption between 2-5mg/kg/day.

  • Phase I study to evaluate Safety and Tolerability of RX108-A Tablets in Patients with advanced Cancer

    This study is investigating a new cancer treatment drug, RX108-A, to determine whether it is safe and effective for patients with locally advanced or metastatic solid tumors. Who is it for?: You may be eligible for this study if you are an adult aged 18 years or older and you have been diagnosed with locally advanced or metastatic solid tumors and you have failed at least one standard of care therapy, or you were intolerant to a standard of care therapy, or you have refused such treatment. Study details: This study will firstly enroll participants into a dose escalation study. Participants who choose to enroll in the escalation study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants will be asked to keep a diary of any side effects that they experience while taking the experimental treatment, and may be asked to stop taking the tablets if they experience any severe side effects. Participants will also be asked to provide blood samples at 4 different times during their 3-week treatment cycle. New groups of participants will be enrolled to test each higher dose of the experimental treatment until the best tolerated dose is identified. After the best tolerated dose has been identified, a new group of up to 9 participants will be enrolled for the dose expansion study. Participants who choose to enroll in the expansion study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants in this study will be asked to keep taking the tablets for 3-week cycles for up to 7 months, and will be asked to provide blood samples at different timepoints during their first three 3-week treatment cycles. It is hoped this research will determine the highest safe dose of RX108-A that reduces the growth of tumors in people with locally advanced or metastatic solid tumors. If this study finds that RX108-A is safe and effective, it may be expanded to a larger trial of people with locally advanced or metastatic solid tumors.

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