ANZCTR search results

This is a randomized, double-blind, placebo-controlled, single ascending dose study of BW-00112 when administered subcutaneously to subjects. Approximately 32 male and female subjects with elevated Low-density lipoprotein cholesterol , aged 18 to 65 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose) after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Day 85. There will be 4 separate and sequential dose cohorts. The population in Cohorts 1 to 4 (50mg, 150mg, 300mg and 600mg) will include subjects with fasting Low-density lipoprotein cholesterol levels > = 100 mg/dL and 100 mg/dL < = Triglycerides (fasting) < 500 mg/dL who are not on a lipid-lowering therapy.

Hyperbaric oxygen is the provision of oxygen in a compression chamber.The aim of this trial is to test the hypothesis that hyperbaric oxygen treatment (HBOT) may improve symptoms in people with Long-COVID . We will compare symptoms of those allocated to the HBOT to participants allocated to no HBOT.

QUENDA is part of a broader research program aimed at using mobile devices and digital technology to better assess children’s pain. Digital mobile technology (e.g. mobile phones, tablets) can enable pain assessment tools that are interactive and respond to children’s inputs. The broader program seeks to embrace the potential of digital-enabled interactive tools and create new approaches to the assessment of pain that are better for kids, allow more engagement, and therefore give clinicians better insight into children’s pain, and enable better care. QUENDA is the first step in the program and is designed to better understand how children perceive and communicate their pain.

This study plans to determine if splinting in a neutral (straight) position of more effective than buddy loops in preventing reduced extension (straightening) at the proximal interphalangeal joint (middle joint of the finger). Specific hypotheses will address; splinting the PIPJ in a neutral position produces a) a lower average extension contracture of FFD than splinting in buddy loops; b) lower mean pain scores than buddy loops; c) lower mean oedema measure than buddy loops; and d) splinting the PIPJ in a neutral position results in changed Participants will be randomly assigned to one group and both will commence active exercises within the splint or buddy loop. Both interventions will be worn full-time for 3 weeks and then discharged at 5 weeks. Each participant will be treated and assessed by experienced hand therapists (occupational therapists or physiotherapists) and the assessing therapist will be blinded to the treatment group of there participants. Assessment will be undertaken at their initial presentation, weeks' 3, 5 and 8.

This double-blind randomised controlled trial will investigate the the feasibility, acceptability, and efficacy of digital support to improve pain and well-being of people with chronic pain who are reducing prescription opioids. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid tapering (dose reduction). 74 participants who meet the selection criteria will be randomized to receive either an educational video followed by text messages for 12 weeks (group 1) or an educational video (group 2) in addition to their usual care. The digital support intends to increase the self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the efficacy of the intervention in improving pain and well-being as the primary objective.

This is an Investigator led trial to assess the safety and efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an advantageous of Median Sternotomy Closure. Wire cerclage has long been the gold standard and lone method of median sternotomy closure, yet this method has substantial and obvious limitations that can cause patients considerable complications post-procedure. The use of the Waston Sternal Claw Plate has been proposed as an advantageous method of sternal closure compared to all previous closure methods due to the structure of the device, however there has only been one study evaluating the effectiveness of the Waston Sternal Claw as a method of sternotomy closure against wire cerclage. As such, the purpose of this research is to justify the use of the sternal claw system as an improved method for median sternotomy closure and provide additional evidence of its benefit to patient outcomes post-sternotomy. Participants planned for Cardiac Surgery involving a Median Sternotomy method of heart access will be recruited into the study. Participants will be evaluated for their appropriateness to partake in the study and will be randomised into 1 of 3 arms of sternal closure post cardiac surgery. Participants will have their sternum closed according to the method they were randomised to and will be assessed for 6 weeks post-intervention to assess the safety and efficacy of their sternal closure method. Assessments will be conducted to assess the effectiveness of sternal closure and sternal union, participant safety and quality of life post-intervention.

The study aims to evaluate the effectiveness of the TA intervention in young people who present to the ED for DSH or suicidal ideation with past DSH behaviour. The results of this project will be used to determine whether TA is effective in adherence to aftercare services and repeat presentations to the ED for DSH. The objectives are to: 1) To examine the effectiveness of the TA intervention on adherence to aftercare services at 6-months and 12-months post-presentation to the ED for DSH, including young people who present with suicidal ideation with a history of DSH. 2) To examine the effectiveness of the TA intervention on reducing rates of re-presentations to the ED for DSH or suicidal ideation at 6-months and 12-months post-presentation. 3) To identify key modifiable factors associated with access and availability of aftercare services for young people post presentation to ED for DSH or suicidal ideation with a history of DSH, in metropolitan and regional settings.

This is an 18 to 54-week open-label study to evaluate the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of paediatric acute-onset neuropsychiatric syndrome (PANS) in children. The purpose of this study is to determine how effective NTI164 is in patients with PANS when treated for 18 to 54 weeks. Participants will commence treatment with a daily dose of 5mg/kg of NTI164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-four (54) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the emotions and behaviour of patients with PANS. Whole blood RNA sequencing will validate the immune dysfunction signature.

There is considerable evidence that harsh managerial styles influence workplace efficiency and worker wellbeing. In contrast, supportive managerial styles that are characterized by empathy and non-judgmental attitudes to workers are associated with more positive workplaces and productivity. This issue is particularly influential in organisations that are characterized by demanding work duties, where mental health issues are more prevalent and contribute to absenteeism. The goal of this research is to evaluate the extent to which training managers in NSW Police can result in more supportive behavior of managers, and promote better help seeking in officers with mental health problems. This project is being conducted in collaboration with NSW Police. Sergeants in 6 regional commands in NSW will be trained in how to (a) provide supportive managerial assistance to officers under their command, (b) identify officers who may experience mental health issues or be dissatisfied with their work environment, (c) engage in supportive discussions in a way that promotes a better sense of employee control and work satisfaction, and (d) offer them confidential referrals for assistance they may need with personal issues. These trainings will be conducted in face-to-face group sessions in the 6 commands (each one comprising 10-20 sergeants) in 1 x 2.5-hour session. The outcomes of the project will be compared with 6 matched commands in NSW (identified by NSW Police). The primary outcomes of the project will be sergeants' reports of frequency of referring an officer for mental health assistance. Secondary outcomes will be knowledge of appropriate strategies to provide to officers; this data will be obtained from sergeants when they complete a brief questionnaire that is emailed to them by NSW Police. The primary outcome timepoint will be 26 weeks after the program.

Every clinical guideline recommends that individuals with knee osteoarthritis (OA) undertake planned, structured, and repetitive physical exercise. Such programs are ideally provided by physiotherapists or exercise physiologists. However, referral for planned exercise programs for people with OA by their GP is low. This prevents many people with knee OA from having the opportunity to participate in a treatment that will improve their knee pain. This study will investigate the effectiveness of two strategies designed to improve access to exercise programs provided by physiotherapists or exercise physiologists. Strategy 1 is including an educational message that exercise is important in the report sent to the GP after the person with knee OA has undergone x-ray. Strategy 2 supplements the GP educational message with an infographic to the person with knee OA informing them about the benefits of exercise for pain and function. We will work with radiology clinics in NSW to compare the strategies with current practice (no information to people with OA or GPs). We expect both strategies will be more effective than current practice in increasing the number of people being referred and attending appointments with physiotherapists or exercise physiologists.