ANZCTR search results

The purpose of this prospective, randomized crossover trial is to understand how Precision 1 Toric contact lenses impact on functional vision with digital devices, in comparison to functional visual performance with spherical equivalent contact lenses (Precision 1 sphere) in healthy participants with low to moderate levels of astigmatism.

The primary aim of this acute study is to examine the acute effects of resistance exercise performed with ISR compared to TRAD on the maintenance of force, velocity, and power output, as well as differences between exercises targeting the upper and lower limbs in adults with CMT. Secondary aims include whether better affective responses and less physiological and psychological fatigue can be achieved following resistance exercise using ISR compared to TRAD sets. Hypotheses: 1. Resistance exercise performed with ISR will lead to higher mean force, velocity, and power output across the set compared to resistance exercise performed with TRAD. 2. Resistance exercise performed with ISR will lead to lower perceived effort and more positive and less negative affective responses compared to resistance exercise performed with TRAD. 3. Resistance exercise performed with ISR will lead to greater muscle oxygenation and blood flow compared to resistance exercise performed with TRAD. 4. Muscle oxygenation and blood flow will explain a significant portion of the variance in power output, velocity, perceived effort, and affective responses between groups. 5. Similar responses for upper versus lower limb resistance exercises will be observed following the ISR and TRAD conditions.

The primary aim of this acute study is to examine the acute effects of resistance exercise performed with ISR compared to TRAD on the maintenance of force, power output, and work, as well as differences between exercises targeting the upper and lower limbs. Secondary aims include whether better affective responses and less physiological and psychological fatigue can be achieved following resistance exercise using ISR compared to TRAD sets. Hypotheses: 1. Resistance exercise performed with ISR will lead to higher mean force, power output, and work across the sets compared to resistance exercise performed with TRAD. 2. Resistance exercise performed with ISR will lead to lower perceived effort and more positive and less negative affective responses compared to resistance exercise performed with TRAD. 3. Resistance exercise performed with ISR will lead to greater muscle oxygenation and blood flow compared to resistance exercise performed with TRAD. 4. Muscle oxygenation and blood flow will explain a significant portion of the variance in power output, velocity, perceived effort, and affective responses between groups. 5. Similar responses for upper versus lower limb resistance exercises will be observed following the ISR and TRAD conditions.

The study will include a Screening Period, a Treatment Period, and a Follow-up Period. Sequential groups of fasted participants will receive a single dose of inhalation administered APR002 at 6 increasing dose levels or placebo. Staggered dosing will be employed with approximately 24 hours between dosing cohorts. After all participants in a dose group have completed study procedures to Day 3 (48 hours after dosing), a decision on dose escalation and enrolment of the next dose group will be made based upon all available data, including the incidence and severity of reported AEs and safety laboratory test results collected after administration of APR002/placebo. Escalation to the next dose level will occur in the absence of dose-limiting toxicity or other significant safety findings after agreement between the Sponsor, an independent Medical Monitor, and the Investigator. Follow-up assessments will occur approximately 14 days after the dosing to inquire for any ongoing AEs or serious adverse events (SAEs), worsening of AEs or SAEs, or development of new AEs or SAEs, and concomitant medications taken since final dose. Follow-up will occur by telephone unless abnormal, clinically significant findings are observed upon discharge or at the Investigator’s discretion. Participants should then be brought back to the clinic for re-evaluation.

The purpose of this study is to determine the assess the safety, tolerability, pharmacodynamics and pharmacokinetics of EARLI-001, a product developed to asses with the detection of cancer. Who is it for? You may be eligible for this study if you are a healthy adult under the age of 55. Study details Participants will receive the study drug via an infusion in the vein and be required to stay at the testing clinic for 24 hours for observation. They will then be required to attend follow-up assessments on days 3,5,7, 14 and 28. As part of this study, we will be collecting blood samples for both safety and research purposes. During the study, the estimated total blood volume to be collected will be approximately 140 mL (approximately 0.6 cups or 7 tablespoons). As a reference, a standard blood donation is 470 mL in any 12-week period. At follow-up visits, participants will also undergo physical examinations, vital sign assessments (blood pressure, pulse rate, breathing rate and temperature) and electrocardiograms for the assessment of safety. It is hoped that this research will help determine if this product is safe for use, to then be used further in future studies to determine whether this product can be used to assist cancer detection.

The purpose of this study is to identify whether spinal analgesia with intrathecal morphine alone is superior to spinal analgesia with intrathecal morphine combined with intrathecal clonidine and bupivacaine for patients undergoing major abdominal surgery. Who is it for? The study will include adult patients undergoing liver and pancreatic resection surgery. This is a retrospective study to test the hypothesis that the intrathecal morphine combined with clonidine and bupivacaine results in reduced postoperative opioid use and enhanced postoperative analgesia and recovery in patients undergoing major liver and pancreatic resections using a standardized enhanced recovery after surgery (ERAS) protocol. Study details The aim of this study is to quantify the cumulative oral morphine equivalent daily dose in milligrams (oMEDD) in the postoperative period and evaluate maximum pain scores at rest and on movement after surgery. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of intrathecal morphine in patients undergoing major liver and pancreatic surgery.

Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. Supervised exercise therapy is an effective treatment for impaired walking due to peripheral artery disease. However, availability and uptake of supervised exercise therapy is limited, perhaps due to the requirement to attend a central facility. The TEAL trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 236 eligible participants with peripheral artery disease will be recruited and consented to the study. In this randomised controlled trial (RCT) the effectiveness and acceptability of TEAL is compared to usual care. Participants will be randomly allocated to one of these groups for 6 months: TEAL, a supervised home base exercise program delievered using telehealth. AEPs will supervised patients and use worn accelerometer to monitor exercise behaviour. The usual group will receive monthly telehealth contact which are unrelated to exercise The primary outcome is maximium distance walked during a six minute walk test. Secondary outcomes include health-related quality of life (HRQOL), cardiovascular risk factors, engagement with the program, and participant satisfaction assessed by a survey and, in a sub-set of participants, through interviews.

Diabetes-related foot disease (DFD), such as ulcers, infection or gangrene, causes ~30,000 hospital admissions and ~4,500 amputations (the highest global amputation rate) at a cost of ~$2 billion a year in Australia. The key risk factors leading to DFD are driven by hyperglycemia, high blood pressure and dyslipidemia. Tele-DFD is a one-year prospective, randomised, multi-centre trial aimed to improve modifiable risk factor control measured based on improvement in DFD-score following Tele-DFD intervention. 142 participants with moderate or high risk of diabetic foot disease will be consented and recruited to this trial. In this RCT, usual care is compared to Tele-DFD with participants randomly allocated to one of the following groups: Usual care, where participants will receive standard care by participants' general practitioners for regular clinical monitoring, endocrinologists for risk factor control, and face-to-face consulting in the outpatient clinics for support and ongoing monitoring of patient’s health and prognosis. Tele-DFD will use an integrated multi-disciplinary approach via a technology-facilitated prevention program consisting of remote medical management, remote footwear management and foot health monitoring, education and behaviour change support to optimise DFD risk factors. The primary outcome will be a change in DFD score with secondary outcomes looking at quality of life, participant engagement and satisfaction, cardiovascular event and DFD complications

With improving developments in technology rehabilitation, use of technology devices and modalities are becoming more integrated into clinical practice. While there is good evidence for robotics and virtual reality in rehabilitation for improvement of sensorimotor outcomes (e.g. strength, range of motion) of the arm, evidence gaps persist for translation to functional outcomes which continue to be poor. Further, majority of research to date has focused on single-technology modality use (e.g. stand-alone robotics or virtual reality focus only) with little comparative research on sensor-based therapy as an emerging technology enabler for upper limb rehabilitation. This randomized controlled trial will test efficacy of a combination of robotics, virtual reality and sensor-based therapy used for upper limb rehabilitation for inpatients with neurological deficits compared to usual care and will explore feasibility in a hospital setting. It is hypothesized that hybrid technology-enabled upper limb rehabilitation is feasible within a hospital setting, will lead to better therapy intensity and functional outcomes for the upper limb compared to usual care and that participants will show satisfaction for this novel therapy.

This study is an open-label, Phase I safety and feasibility trial, named 'hrtDCS-Attention'. We aim to evaluate whether 10 weekdays of home-based, remotely supervised transcranial direct current stimulation (tDCS) for 20 minutes during attention training is feasible and tolerable in children aged 8-18 years with acquired brain injury. tDCS will be applied once daily on the scalp, over the left and right prefrontal cortex. Participants will be randomised to one of two trial arms, to receive either (1) 1 mA of tDCS or (2) 2 mA of tDCS. Participants will be blinded to which dose they have been assigned to. 15 participants will be assigned to each group, for a total of 30 participants in hrtDCS-Attention. The first hrtDCS-Attention session will take place in the clinic to ensure initial tolerability, provide information about the home sessions and training to conduct them, and answer any questions from participants. HD-EEG and other baseline neurocognitive outcomes will be recorded. After the first session, participants will conduct hrtDCS-Attention sessions at home using remote supervision (i.e. through video call) to ensure correct use of the device, adherence to the protocol, safety and support. As well as receiving prior training by tDCS personnel, participants will be given an information guide to use tDCS from home. hrtDCS-Attention will occur from Monday to Friday for two consecutive weeks for a total of 10 sessions. Participants will return to the clinic on tDCS Day 10, where the final (10th) session will take place in clinic, together with an EEG and neurocognitive outcomes. Follow up assessment at 1- and 4-weeks post-tDCS will be conducted remotely. The primary outcome is feasibility and tolerability, measured by sensations recorded during tDCS sessions, compliance to tDCS sessions, and the participant/family's views or comments about the sessions. We will also assess preliminary efficacy, according to changes in reaction time across the 10 days of tDCS and change in functional brain connectivity between baseline and day 10 of tDCS.