ANZCTR search results

This is a double-blind, randomised, clinical study with a 14-day treatment duration with 2 arms (with 2 active ingredient groups and 2 placebo groups). The aim of this study is to assess the effectiveness of PEA and curcumin on reducing joint pain in otherwise healthy adults aged 25-70 years, compared to a placebo. A placebo is a substance with no therapeutic effect, in this case maltodextrin. Participants will be asked to attend our clinic to complete their enrolment with a Trial Coordinator. During this visit, they will also complete an initial assessment including, letting the trial coordinator know about their joint pain and general health by completing questionnaires; height and weight measurements; and a blood test. At the conclusion of the visit, participants will be randomly allocated to either the PEA, curcumin or placebo treatment group. Once enrolled in the study, participants will be asked to complete 3 days of pain recording (once morning and once at night) online. Following the completion of the 3 days of pain recording, trial coordinators will confirm supplementation commencement. Capsules should be consumed as described on the label. Once supplementation has started, participants will be required to record their pain level every morning upon waking, and every night prior to going to bed for 2 weeks. At the completion of the 2 weeks, participants will be required to attend the clinic for a final appointment where they will complete identical assessments to the initial visit.

This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 2. Part 2 is an open label, 2-period cross-over, randomised, pilot food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of ZY-19489 to healthy male and female subjects aged between 18-55 years old. Part 2 will consist of a single cohort of 8 subjects. For safety, the cohort will be split into 2 groups of 4 subjects each (Cohorts 1A and 1B). Adverse events and concomitant medications will be followed throughout the study. The study will be overseen by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.

This trial reports the unforeseen consequence of a novel design of a unicompartmental knee arthroplasty (UKA) that resulted in a specific mechanical and tribiological mode of failure. Convex polyethylene bearings were developed to decrease bearing dislocation and used in 32 patients with disabling medial compartment osteoarthritis of the knee. This study reports the clinical outcomes (PROMS) and revisions for failed implants,

HYHD is an evidenced-based 8-week program aiming to improve the healthy lifestyle behaviours of fathers and their pre-school aged children. HYHD provides fathers with the knowledge, motivation and parenting strategies to engage with their children and become role models to improve physical activity levels, dietary behaviours and weight status of both themselves and their children. This program has been successfully tested in a feasibility trial and RCT at the University of Newcastle. The aim of this community trial is to test the effectiveness of the HYHD program in a community setting.

This project aims to evaluate the effectiveness of the “Sleep Ninja” mobile phone app in reducing sleep disturbance in adolescents, and secondary depressive symptoms. The Sleep Ninja mobile app uses CBT principles to directly monitor and address poor sleep. It is predicted that 6-weeks of access to the Sleep Ninja app will reduce symptoms of insomnia and depression compared to an active control group that do not access the app.

The study explores the idea whether subclinical AF (SCAF) is associated with risk of dementia and is a longitudinal prospective study conducted over 3 years in patients with Cardiac Implantable Electronic Devices (CIED's) inserted. The study group will consist of 200 patients with SCAF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. The control group will consist of 200 patients with documented absence of AF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. All participants will undergo neurocognitive testing and quality of life questionnaires and optional brain Magnetic Resonance Imaging to assess for cerebral changes at study completion.

This study will explore whether intraoperative NIPE values correlate to the level of post-operative pain and the amount of analgesia required after elective surgery in children. This has not yet been explored, and could ultimately result in less pain and distress to children and their carers.

The proposed study aims to evaluate the relationships between changes in sleep-wake and circadian parameters and changes in depressive symptoms following adjunctive brexpiprazole treatment in young adults with Major Depressive Disorder and sleep-wake disturbance, who have failed to respond to at least 1 antidepressant treatment for the current episode. More specifically, this study wants to investigate whether a reduction in depressive symptoms following adjunctive brexpiprazole treatment is associated with sleep-wake and circadian rhythm (i.e. body clock) changes. The study will be conducted at Brain and Mind Centre, University of Sydney, and Woolcock Centre for Medical Research. Investigators expect to enroll 50 subjects in the trial.

The primary aim of the study is to examine the efficacy of TSI with steroid and TSI without steroid versus sham injection among individuals with Achilles tendinopathy at 12 months. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months. Study hypothesis: TSI with steroid and TSI without steroid will lead to superior VISA-A outcome compared to sham at 12 months.

To use a child-friendly smartphone application (App), called NAG, the Non-Adherence Gadget which incorporates tailored reminders, rewards and cognitive behaviour therapy (CBT) to overcome psychosocial barriers to following treatment advice for patients with chronic health conditions (specifically kidney or bladder conditions). The research is a pilot study to determine whether the App is useful in improving treatment adherence and is acceptable to children, parents and doctors.