ANZCTR search results

A randomized, placebo-controlled Phase 2a study to test the efficacy and safety of cilnidipine alone and in combination with tadalafil in participants at least 18 years of age diagnosed with severe secondary Raynaud’s disease (Raynaud’s Condition Score [RCS] greater than o r equal 40 and at least a 2-phase colour change in fingers of pallor, cyanosis, and/or reactive hypermedia in response to cold exposure or emotion) mostly resulting from SSc and exhibiting regular and frequent RP attacks (averaging at least one attack per day) during the Screening period. Double-blind, Placebo-controlled, Parallel-group, Dose Selection to assess the safety and efficacy of two doses of cilnidipine (10 mg and 20 mg), alone and in combination with tadalafil. Participants will be randomized to one of six prespecified treatment arms. During the study 36 participants will receive treatments in a blinded fashion. Placebo tablets (matching cilnidipine) and placebo capsules (matching tadalafil), for oral administration, will be provided to the site as well as the investigational treatments (cilnidipine and tadalafil). Medications will be dispensed during the preceding in-clinic study visit for self-administration by the participant. Each Dosing Period will last for 12 days (allowing for a variance window of -2 days [d10] or +2 days [d14] ) in which participants will take daily doses of assigned treatment in the morning. For each day of dosing, participants will take one capsule and one tablet to blind the active therapy being received. Dropouts will not be replaced. Primary Efficacy Endpoint: Percentage change from baseline in frequency of weekly RP attacks. Safety Endpoints: Incidence of adverse events (AEs) and serious adverse events (SAEs), including clinically significant vital signs from the time of randomization until 7 days following the last protocol dose.

It is currently estimated that approximately 35% of all dementias can be attributed to risk factors that are highly modifiable, including low mood, poor sleep, poor heart health and low cognitive/social engagement. The BetterBrains trial will test whether remotely delivered (via online, telephone and smartphone application) person-centred education and lifestyle behaviour change strategies, targeted at modifying these four risk factor clusters, can prevent cognitive decline in middle-aged adults aged between 40 – 70 years. The trial will recruit 1510 people living in the community throughout Australia. Of these people, 755 participants will be randomised to the intervention group and will receive the personalised BetterBrains program, while the other 755 participants will receive health education materials about dementia risk reduction. We hypothesise that a higher proportion of participants randomised to the BetterBrains program will show a favourable cognitive outcome at 24-months than those randomised to the control group.

This study builds on pilot work testing 2- and 3-session perfectionism programmes with early adolescents which found improvements in emotional problems, self-imposed perfectionistic standards (sustained at 4-week follow-up), and well-being, sustained at 3-month follow-up (Fairweather-Schmidt and Wade, 2015; Vekas & Wade, 2017). The modified programme for the current research expands the pilot programme to a 5-lesson perfectionism intervention led by teachers which include an emphasis on the difference in pursuing excellence and pursuing perfection to Year 8 and Year 9 students universally. To date no research has examined whether perfectionism interventions can increase intrinsic motivation and there have been no perfectionism interventions led by teachers. Research objectives 1. To examine the impact of the LIFE curriculum on primary (perfectionism) and secondary (anxiety, depression, wellbeing, self-compassion, academic motivation) outcomes. 2. To test whether improvements in certain outcome factors (anxiety, depression, well-being, academic motivation, self-compassion) are moderated by the following outcome factors: level of perfectionism, self-compassion and sex. We hypothesize that the intervention group will experience significantly greater decreases in perfectionism, anxiety, and depression, and significantly greater increases in wellbeing, self-compassion and academic motivation at follow-up. We also hypothesize that decreases in perfectionism and increases in self-compassion between baseline and end of treatment will moderate the association between group and follow-up changes in anxiety, depression, well-being and academic motivation.

Antipsychotics are commonly prescribed for behavioural and psychological symptoms of dementia (BPSD) and delirium despite serious short and long term risks. Australian guidelines recommend limiting use in these situations to 12 weeks due to evidence of increase risk of stroke and sudden death with prolonged prescribing; however the prevalence of use beyond this time frame is high. A Macquarie University study cited at the 2020 Australian Royal Commission into Aged Care Quality and Safety, showed 65% (n=5825) of aged care facility residents prescribed antipsychotics for BPSD, remained on treatment for an average of 30 weeks. Pervasive and inappropriate use of antipsychotics (among other ‘restrictive practices’) was a key finding of the Royal Commission’s Interim Report, negatively impacting patient outcomes, quality and dignity of life. Reducing antipsychotic use requires multifactorial approaches including systems to support non-pharmacological interventions. Whilst not all of these are addressed in this study, increasing patient/carer understanding of evidence base and best practice use of antipsychotics addresses a key element, centered on patient/carer empowerment. This project aims to evaluate the impact of changes to hospital standard care, including increased GP and specific patient/carer engagement on the use of antipsychotics after hospital discharge. We predict it will have an impact of reducing antipsychotics prescribed (either dose or complete deprescribing) at 12 weeks after hospital discharge.

Chronic Low Back Pain (CLBP) is a major health issue worldwide. Pain-related fear and activity avoidance are the most recognised barriers to recovery. Virtual Reality-based Cognitive Behavioural Therapy (VR-CBT) is an emerging exercise and education approach designed to better target fear and activity avoidance through graded exposure to movement by simulating an engaging environment, and reinforcing positive pain beliefs through education and augmented video feedback on performance. This project aims to evaluate the outcomes of VR-CBT on 1: fear-avoidance beliefs, reported pain; and 2: trunk movement; and 3: physical activity, in individuals with CLBP. The participants will be a single cohort of 37 individuals (18-65 years) with CLBP and at least moderate fear avoidance beliefs, quality of life and pain severity. These participants will be recruited through the RBWH Physiotherapy Department. This will be a repeated measures single-arm study. The expected outcomes are: the addition of VR-CBT to standardized PNE alone will reduce reported pain and fear-avoidance beliefs, increase trunk movement and walking speed, and increase physical activity levels during daily life among individuals with CLBP and pain-related fear of movement.

This study attempts to harness advances in machine learning and artificial intelligence to faciliate monitoring of symptom fluctuations in Parkinson's disease. Participants will be asked to draw a spiral while wearing a smart watch with accelerometer function in both 'on' and 'off' state, based on clinical assessment. These samples will be used to train the algorithm, and an independent set of samples used for validation of the algorithm.

Utilising group singing intervention via Telehealth, conducted by as Speech Pathologist and a Music Therapist, we aim to improve vocal intensity (as defined by dB SPL) in patients with Parkinson's Disease

Low Phospholipid Associated Cholelithiasis (LPAC) is a cause of post-operative pain and recurrent gallstones after gallbladder removal (cholecystectomy). This is a randomised control trial of a medication called ursodeoxycholic acid in patients with LPAC to prevent pain post gallbladder surgery, improve quality of life, reduce hospital presentations and patient use of strong narcotic painkillers. This trial is a crossover trial where participants will be randomised to undergo a 1 year experimental (ursodeoxycholic acid) or control arm (placebo). The experimental or control arm will be prescribed a daily dose of 10mg/kg of ursodeoxycholic acid or placebo. Participants will then undergo a 2 week washout period before crossing over to the opposite arm to complete the study. The dose will be prescribed at 10mg/kg daily and can be titrated to a maximum of 20mg/kg daily at the discretion of the treating clinician. The primary study outcome is number of episodes of biliary pain. Secondary outcomes include quality of life, hospitalisations, liver ultrasound findings.

Vitamin B12 is a water-soluble vitamin found in fish, eggs, meat and milk. An adequate level of B12 blood concentration is necessary to prevent anaemia, cognitive impairment and neuropathy. B12 deficiency in older people is common. Symptoms include changes in mood and dizziness. It is important therefore that B12 deficiency is promptly treated, particularly in residents of aged care facilities who fall at a greater rate than the general population. Detection is complicated in cases of functional deficiency where B12 is within normal levels. Negative conditions of B12 deficiency can potentially be reversed by administering vitamin B supplements. Due to potential issues with the ageing gastrointestinal tract of the older adult, there is a requirement for an intervention using B12 supplements that bypass the gut. This study will investigate the effect of B12 supplementation in the form of skin patches on falls risk and mood in residents living in aged care facilities. As nurses are the primary clinicians involved in the reduction of falls in residents, demonstrating that falls risk in older people is impacted by the application of a non-prescription vitamin B12 patch could have major implications for nursing practice and public health policy.

This study aims to investigate the feasibility of implementing a whole-of-lifestyle intervention, the Younger Women’s Wellness after Cancer Program (YWWACP), to promote health-related quality of life. Who is it for? You may be eligible for this study if you are a woman aged 18-50 years inclusive, have completed any intensive treatment (surgery, chemotherapy, radiotherapy) for breast cancer in the previous 24 months and have no metastatic disease. Study details Participants will be randomly allocated to either a control arm who will receive standard care, or an intervention arm who will receive materials for a 12-week program designed to help them self-manage their chronic disease risk. They will also have three 30-60 minute individual, video consultations at weeks 1, 6 and 12 with a registered nurse. Participants will be asked to complete a variety of questionnaires throughout the program. Data from this study will go towards assisting the design of future programs to decrease the likelihood of treatment-related chronic disease for women with breast cancer.