ANZCTR search results

This study will be investigating the safety and tolerability of NIDO-361 and the amount of NIDO-361 in the body when taken in single and multiple doses in healthy male participants so as to possibly be a treatment in the future for Spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease. This is a condition that only affects men and causes muscle weakness, tremor, and cramps among other neuromuscular and hormonal symptoms. Kennedy’s Disease is caused by a genetic mutation affecting the androgen receptor, which controls how hormones like testosterone work in the body. It is hoped that in patients with Kennedy’s Disease, NIDO-361 will correct the way the androgen receptor interprets signals from the testosterone re-establishing its normal function. This study will involve the recruitment of 64 healthy male participants between the ages of 18 and 55 years who weigh at least 45kg and have a body mass index between 18-32 kg/m2. There will be 5 cohorts of 8 participating in the single ascending dose part of the study involving a 3 night in house stay and follow-up visit on Day 8 and 3 cohorts of 8 participating in the multiple ascending dose part of the study involving 7 days of consecutive dosing, a 9 night in house stay and follow-up visit on Day 15.

The aim of this study is to investigate if testing for the DPYD gene in patients is practical and useful, for the purpose of providing personalised dosing of chemotherapy treatment Fluoropyrimidine (FP; 5FU, Capecitabine). Who is it for? You may be eligible to join this study if you are aged 18 years or older; and have or will be receiving Fluoropyrimidine chemotherapy treatment. Study details All patients will be asked to provide a blood sample, and the blood sample will be tested for the DPYD gene. The result will be shared with the patient's doctor, and whether this affects the patient's chemotherapy treatment or not will be decided by the patient's doctor. Additionally, patients and medical professionals will also be invited to do a questionnaire exploring the perceived knowledge and attitudes toward genetic testing for DPYD. It is hoped that this study will reveal if screening for the DPYD gene can be used to inform personalised chemotherapy dosing, and understand factors that affect this process, to be able to provide better care to cancer patients.

This pilot clinical trial aims to evaluate the safety and acceptability of relational peer work for young people (aged 12-25 years) with personality disorder. Peer workers are people who have lived experience of mental illness, and are trained to use that experience to provide support for other young people with mental ill health. Participants will be young people attending headspace, who will be offered up to 10 sessions of relational peer work over a 13-week period. In addition to testing safety and acceptability, this trial will also explore whether peer work is associated with improvements in young people’s sense of belonging, hope, and functioning, while reducing their severity of personality pathology, depressive symptomatology, anxiety, and substance use.

The aim of this study is to assess the pharmacokinetics, safety and tolerability of two CBD formulations and test for bioequivalence to an existing commercial CBD product HYPOTHESIS: CBD oil given as either a soft gel or oil solution will have a bioequivalent absorption to that of a commercial CBD oil (Epidylex). DESIGN: A randomised, cross-over trial with 3 interventions. Product will be allocated on a 1:1:1 ratio.

Extensive research has suggests that high levels of perfectionism are associated with various mental health issues and that many university students possess perfectionistic traits. A previous pilot study showed that the Intentional Imperfection Program (IIP) was feasible and resulted in reductions in different aspects of perfectionism as well as reductions in hostility, rejections sensitivity, depression and anxiety. This study expands the findings of the previous study to assess the efficacy of the IIP in comparison to a healthy lifestyle intervention. Both interventions will consist of one 2.5 hour session. Eligible participants are university students with high levels of perfectionism. Participants will be assessed at baseline and at 1 month and 3 months post-intervention. The primary outcome is psychological distress. Secondary outcomes include perfectionism, rejection sensitivity, interpersonal hostilitiy, social disconnection, self-compassion, distress tolerance, mindfulness and academic performance.

Alcohol is a major source of harm. More than 1200 deaths each year and 43,736 Disability Adjusted Life Years (DALYs) attributable to alcohol in Victoria alone. Risky alcohol use has ramifications for health and wellbeing, and effects families and the wider community through absenteeism, family violence, assaults, and motor vehicle collisions. People from low income groups are affected by alcohol related harms more, and at lower levels of alcohol intake than people from higher income groups. General practice plays an essential role in reducing alcohol-related harm in communities, as nearly 85% of Victorians see a GP at least annually. Brief interventions (BI’s) involve assessing the amount of alcohol a person is using, and offering individualised advice on how to reduce the associated health risks. These are effective in reducing the average amount of alcohol people consume in a week, and are recommended in the RACGP Preventive Care guidelines for all patients over the age of 15 years. Despite their effectiveness, and the support for this approach in evidence-based guidelines, clinicians do not routinely provide this intervention in daily practice. The REACH Project aims to better support clinicians to provide brief interventions for alcohol in general practice. Through a collaboration with patients and clinicians, we will develop a new approach to increase the use of brief interventions in General Practice across Victoria. The focus will ensure the approach is most acceptable, feasible and effective for low-income patients

This is an open-label, four-way crossover, fasted pharmacokinetic study in healthy volunteers. The screening visit will include a physical exam, vital signs collection, an electrocardiogram, safety laboratory sampling and urinalysis to determine suitability for inclusion into the study. Qualified study participants will be admitted the evening prior (Day -1) to scheduled dosing. Each participant will receive a single dose of study medication per dosing day. There will be a minimum washout of 44 hours between doses. Participants will remain inpatient for the entire dosing/washout period and will be discharged 24 hours after Treatment D.

Post-traumatic Amnesia (PTA) is a state of confusion after someone experiences a TBI. Speech Pathologists (SPs) currently undertake a range of practices for patients with PTA but what they do is under-reported and requires further investigation (Steel et al., 2013). It is common practice that when patients are in PTA, direct therapy is kept to a minimum in case activities lead to agitation. However recent studies have demonstrated that patients in PTA can participate in some therapies such as physiotherapy or occupational therapy. Cognitive-communication deficits are a common sequelae of Traumatic Brain Injury (TBI) with 80–100% experiencing this type of communication impairment (MacDonald & Wiseman-Hakes, 2010). Part of this cognitive-communication profile is the ability to structure verbal narration of an event or a series of events (i.e. narrative discourse). This research project aims to investigate the feasibility of conducting structured narrative discourse therapy with people in PTA in order to improve their cognitive-communication skills. It is hypothesised that patients will tolerate participating in this specialised novel therapy program without any adverse effects and we expect to see improvement in their narrative discourse skills. We also hypothesise that people in PTA will have impaired narrative discourses.

BEAT CF is a national, multi-site project which aims to learn and implement , which of the antibiotics commonly used to treat lung infections are best. There is no single standard of care for managing CF pulmonary exacerbations. Standard care comprises a range of interventions and varies across and within CF treatment centres and may evolve over the course of the PEx Treatment Platform. At the time of initiation of the PEx Treatment Platform Protocol, management of pulmonary exacerbations generally involves the use of one or more intravenous (IV) antibiotic therapies. The duration of IV antibiotic therapy is typically 14 days, and generally ranges from 10 days to 21 days. A recent RCT found evidence that 10 days was non-inferior to 14 days of IV antibiotics therapy in those with a rapid treatment response, and found no evidence that 21 days was superior to 14 days of IV antibiotics therapy in those without a rapid treatment response. Most Australian clinicians manage pulmonary exacerbations with an antipseudomonal beta-lactam or carbapenem, combined with a non-beta lactam antibiotic - most typically the aminoglycoside IV tobramycin. Some, but not all, clinicians reserve the use of IV aminoglycoside for patients known to be colonised with Pseudomonas aeruginosa. Some, but not all, clinicians use the results of microbiology and in vitro susceptibilities to guide antibiotic selection. Many centres provide additional antibiotic cover targeted to specific pathogens, but only if identified on sputum microbiology, e.g. for Stenotrophomonas maltophilia or Staphylococcus aureus. CF clinicians prescribe physiotherapy for airway clearance as a core part of the management of CF pulmonary exacerbations, though there is variation in the nature and frequency of this therapy. Some, but not all, CF clinicians all prescribe muco-active or anti-inflammatory therapies. As for the use of antibiotics, there is no evidence to support any of these modes of treatment as a single best standard of care. The primary objectives, outcomes and endpoints for the PEx Cohort were informed by a systematic review of the literature and involvement of key clinical and consumer stakeholders.

The current picture of young peoples’ health in Australia is alarming with escalating health risks such as poor diet, physical inactivity, increased screen time and poor mental health becoming widely prevalent. These health risks can lead to chronic health problems such as heart disease in adulthood. Australia’s 3.3 million teenagers have little support to manage these health risks and accessible, engaging programs that support a healthy lifestyle are urgently needed. This innovative Health4Me program will strive to solve this problem. We know that text message healthy lifestyle programs in adults have improved health outcomes and resulted in positive behaviour change. This project will develop and test an engaging healthy lifestyle program for teenagers using text messages, a method through which they communicate every day. We will work with teenagers to co-create theHealth4Me program using an established process, test how effective Health4Me is in a randomised clinical trial (390 teenagers) and evaluate if the program improves physical and mental health outcomes, whether it is acceptable and engaging and if the program can be embedded into the Australian healthcare system. We hypothesise that the Health4Me intervention (with optional health counselling) will improve physical activity or nutrition behaviours more effectively than usual care over 6-months. If it helps, it can be scaled up to deliver to teenagers throughout Australia to improve health outcomes.