ANZCTR search results

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.

This is a 6 month multi-centre randomized controlled trial assessing the effect of advanced hybrid closed loop (AHCL) in adolescents with poor glycaemic control and comparing this technology with their standard care. The purpose of this project is to utilize an automated insulin delivery system to improve glycaemic control which has been shown during in-home use by adolescents and adults with increased time in target, and reductions in HbA1c, hyperglycaemia and hypoglycaemia, compared to baseline. Hence, it would be valuable to test the effectiveness of AHCL in patients with poor glycaemic control. We hypothesize that AHCL system will circumvent the significant glycaemic excursion associated with conventional therapy in patients with poor glycaemic control. Reduced adherence to diabetes self-management tasks is often associated with poor glycaemic control and this trial will address, in effect, whether the challenge of managing AHCL is less than the challenge of routine treatment and will generate data that will inform approaches to enhance adherence.

Implantable cardioverter-defibrillators (ICDs) are common for prevention of sudden cardiac death in patients with heart muscle dysfunction. Traditionally, ICDs have been followed up via clinic visits every 3 to 6 months. Remote monitoring of ICDs has become more common, allowing for early detection and intervention following clinical or device related events. However, in practice many patients do not receive remote monitoring, and those that do have sub-optimal compliance, suggesting more intensive management of remote monitoring may be better. This project aims to evaluate the efficacy of an intensive remote monitory strategy to help improve treatment and outcomes for ICD patients.

CHI-936 is a standardized cannabis extract in an oil preparation that contains an approximate 20:1 ratio of CBD to THC (20 mg/mL CBD and < 1 mg/mL THC). At present, regulatory approvals, physician acceptance, and the utilization of CHI-936 in Phase 2/3 clinical trials for specific indications are hampered by the absence of critical Phase 1 data regarding its safety, tolerability, and pharmacokinetic (PK) profile. Therefore, the aim of this randomized, double-blinded, placebo-controlled, multiple-dose study is to evaluate the safety, tolerability, and PK of CHI-936 in healthy participants.

This study first aims to evaluate whether there are differences between patients requiring stenting who have stable blockages in their coronary arteries versus those who present with unstable heart attacks. We hope to examine whether are difference in blood clotting (platelets in particular), release of inflammation markers (neutrophil-derived in particular), resistance to blood flow in the tiny capillaries of the heart muscle (microvascular resistance), and finally in morphology and composition of the culprit blockage or plaque as assessed by a technique named optical coherence tomography (OCT). In the unstable heart attack group in particular, we will also assess whether patients treated pre-procedurally with colchicine will demonstrate changes in these parameters compared to untreated controls. The purpose of the study is to identify whether colchicine could serve as a potential therapeutic option in these high-risk patients and improve outcomes by limiting adverse events such as further heart attack at the time of stenting (peri-procedural myocardial infarction). We hypothesise that levels of inflammation will be higher in unstable heart attack patients compared to patients with stable blockages, and that colchicine will attenuate the release of inflammatory products. We also hypothesise that in the unstable heart attack patients, there will be greater dysfunction in the microvessels of the heart and that this will correlate with inflammatory release and blood platelet adhesiveness, as well as with high-risk features of the culprit blockage/plaque as assessed by OCT.