ANZCTR search results

A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902. The single ascending dose phase will encompass a single bridging cohort across tablet strengths, and a food effect cohort.

Anxiety is under-examined in Parkinson's disease (PD) patients, yet it is a major contributor to a poor quality of life in this population. Our previous study aimed at improving diagnosis and treatment of anxiety in PD was the first to pilot Cognitive Behavioural Therapy (CBT) for anxiety in PD using a tailored, manualised and dyadic protocol involving both PD and carers. This project develops and tests CBT incorporating Virtual Reality (VR) proposed to augment anxiety treatment in PD. VR environments (in virtuo experiences) have the potential to improve the efficacy of CBT treatment with the following unique benefits: • Patients are not required to mentally reproduce the stimulus as in imaginal exposure and relaxation. This is an issue in persons with PD, as executive function and memory retrieval are often impaired even at early stages of the disease. • Multi-sensory engagement provides a tangible and ‘real’ experience, improving patient engagement in the therapy. • The environment can be tailored by the clinician based on the subcategory of anxiety. • Relaxation immersive VR (eg: Virtual Meditative Walk) assists patients to focus attention inward which is advantageous in a population of patients with compromised attention. • Current smart-phone technology is capable of running VR software to allow for home based remote delivery of VR therapy. A randomised waitlist controlled feasibility trial will be conducted comparing the new CBT-VR to treatment as usual in reducing anxiety in PD (primary outcome). Secondary outcome measures will be depression, sleep, quality of life, and outcomes for carers. The manualised CBT-VR package will comprise of eight weekly sessions of 90 minutes each conducted at the University of Queensland. Additionally, patients will be given a mobile device with headsets for VR view at home with relaxation VR applications and a smart watch for monitoring of anxiety via heartrate. Basline, post and 3 month follow-up data will be collected.

This clinical phase 2 proof-0f-concept study will test the safety and efficacy of NRP2945 in a placebo-controlled fashion within 5 patients diagnosed with drug-resistant absence epilepsy. It is hypothesized that NRP2945 will diminish in quick succession the frequency of drug-resistant absence seizures in patients through the stimulation of inhibitory neural networks in the brain. The formation of inhibitory neural networks are the prerequisite for re-establishing normal neural activity networks in said patients. This potential outcome will be measured through EEG analysis and a potential improvement of quality of life measures will be assessed by questionnaire during the follow-up visit.

Touchscreen tablet technology (including iPads), provide diverse opportunities for people with dementia to engage in personally meaningful activity. However, a ‘one size fits all’ approach, which focuses on applications designed for a particular population, cannot adequately address barriers to engagement in meaningful activity for people with dementia. The aim of this study is to test the hypothesis that personalized iPads will be more efficacious than treatment as usual for 1) slowing the pace of decline in dementia, 2) maintaining functional performance, 3) decreasing the occurrence of behavioral and psychological symptoms of dementia; and 4) improving quality of life. 1) maintaining dementia severity; 2) maintaining functional performances; 3) decreasing the occurrence of neuropsychiatric symptoms; and 4) improving quality of life, for people with dementia living in residential care. This study will use a feasibility pilot randomized controlled trial design, where the unit of randomization will be individual residents. The findings of this study will make a significant contribution to inform efforts by all residential care staff to support the health, wellbeing and quality of life of residents with dementia.

Hidradenitis suppurativa (HS) is a long-term, inflammatory skin condition of unknown cause affecting the sweat/scent glands in the skin, predominantly located in the groin, axillae and under the breasts. Patients can experience painful boil-like nodules in addition to discharging wound tracts which are difficult to heal. Consequently, this HS can cause severe long-term pain in addition to serious psychological effects such as depression, anxiety and social withdrawal. HS severity is graded according to the Hurley system which calculates a grade based on the numbers of inflammatory nodules, in addition to the presence of sinus tracts and abscesses. To manage their symptoms, many patients require immunosuppressant medications and extensive surgery to remove the affected tissue. In such cases, application of topical medications as well as effective dressings can be a challenge. To date, specialised nurse-led education programs have not been trialled in cases of HS, despite their proven benefit in other dermatological conditions. This pilot study aims to evaluate the efficacy of a personalised dermatology-led education program for patients with hidradenitis suppurativa. Participants will be allocated randomly using a randomisation sequence generated by Microsoft Excel using random block sizes of two (2). Randomisation and allocation of participants will be performed by the dermatology nurse who will be administering the education sessions. Allocations will be concealed from the researchers who will be analysing the collected data. Participants allocated to the intervention group will be provided with the education session whilst participants allocated to the control session will not receive any additional education. At the 8-week mark of the project, the groups will switch so that the participants initially allocated to the control group will then be provided with the education session. Nil further education sessions will be provided to the (original) intervention group. Intervention: The intervention employed in this project is a nurse-led education session provided by a highly experienced dermatology clinical nurse, to take place in the dermatology outpatient department at Princess Alexandra Hospital. The sessions will be individualised to each participant but, in general, will provide education about: • The nature of the condition • Effective application of topical medications and dressings (with demonstration) • Modification of lifestyle factors known to contribute to hidradenitis suppurativa severity (eg weight loss and smoking cessation) • Pain management Each session will take an estimated 45-60 minutes and participants will be offered the opportunity to contact the dermatology nurse 4-6 weeks later to address any questions or concerns that have arisen. The sessions will not be recorded.

HL161BKN is an experimental treatment. This means that it is not an approved treatment for auto-immune diseases in Australia by the Therapeutic Goods Administration (TGA). Auto-immune diseases occur when a person’s own immune system mistakenly attacks their own body, and are particularly hard to treat because there is no cure currently available, only medications that can manage the symptoms. There are over 80 different types of auto-immune diseases that range in severity (from mild to disabling), depending on which system (nervous, vascular, respiratory, muscular etc.) is under attack and to what degree. T lymphocytes (T cells) are immune cells that use special receptors on their surfaces to identify micro-organisms such as bacteria and viruses that may enter our bodies. Usually, the T cells are destroyed by the thymus, an organ of the immune system. Occasionally, they are not destroyed, and these rogue T cells may instruct another type of cell, B lymphocytes (B cells), to make antibodies against the body’s own tissues, organs or systems. Such antibodies are called 'autoantibodies'. HL161BKN acts as a “block” of special receptors in the tissues, organs or systems, so that autoantibodies cannot bind to them and cause an auto-immune reaction that causes damage.

This pilot study seeks to explore the feasibility of a novel treatment format for panic disorder: online cognitive behavioural therapy delivered in an intensive format across just one week. Outcomes will be compared from pre- to post-treatment. Uncontrolled data will also be examined at two months follow-up.

This randomised controlled trial seeks to compare the efficacy of two versions of internet-delivered cognitive behavioural therapy program for the treatment of panic disorder in adults. A multi-component program will be compared to an exposure-based program. Outcomes will be compared at mid-treatment, immediately following treatment and at 3-month and 6-month follow-ups.

The primary aim of this study is to assess the effect that three combinations of drugs (known as AD098, AD153, AD639) have on sleep apnoea severity (i.e. apnoea/hypopnoea index) compared to placebo. Additional measures of sleep apnoea severity, cardiovascular and sleepiness outcomes will also be assessed as secondary outcomes.

The SHINE randomised controlled trial aims to compare the incidence of successful endotracheal intubation on the first attempt without physiological instability, between neonates receiving nasal high flow during intubation, and those receiving standard care. The primary outcome is the incidence of successful endotracheal intubation on the first attempt, without physiological instability, defined as absolute decrease in peripheral oxygen saturation >20% from baseline or heart rate <100 beats per minute during the first intubation attempt. We think that the use of high flow during intubation may increase the likelihood of the breathing tube being placed correctly on the first attempt, without the baby developing low blood oxygen levels or a low heart rate.