ANZCTR search results

The proposed study in an open-label, Phase IIa, multi-centre, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adolescent and adult male patients with Tourette Syndrome (TS).

Children with cerebral palsy (CP) who have difficulty walking or cannot walk have low physical activity levels and very high sedentary behaviour. When they become adults they have at least a 3-fold increased risk of dying from cardiovascular disease compared to people without CP. There are few high quality clinical trials of interventions to improve physical activity in this population, and none that specially target risk factors for cardiovascular disease. We propose an adequately powered randomized waitlist controlled clinical trial of 12 weeks training in a brand new sport called RaceRunning in342 in 105 children with CP aged 8-21 years who have difficulty walking or cannot walk. RaceRunning is a para-athletic event using a specially designed supportive frame. We will measure the effect of the training on cardiovascular health including cardiovascular fitness, body composition, bone density, lung function, and physical activity. We will also see if it improves community participation, functional strength, mental health, quality of life, sleep and gross motor ability. There will be sites in Brisbane (n=2510), Cairns (n=158), Sunshine Coast (n=170) and Sydney (n=156), Gold Coast (n=18) and Perth (n=15), all involving local experienced clinicians and consumer representatives. If effective, this training could improve future health outcomes for children with CP and be quickly translated into clinical practice and community sport.

Background: The Needs in Recovery Assessment (NiRA) is a newly developed needs assessment tool, designed to identify the needs of people recovering from mental illness. This tool has been evaluated outside of the clinical context for validity and reliability. The aim of this study is to introduce the NiRA into clinical practice and to evaluate the value of the NiRA as an adjunct to service delivery from the perspectives of stakeholders and to evaluate the barriers and facilitators of embedding the NiRA in a mental health service. Methods: The implementation of the NiRA in a tertiary mental health unit over a six-month period will be evaluated using a mixed methods approach. Quantitative data will be collected using The Recovery Self-Assessment (RSA) administered to service users and clinicians pre- and post- administration of the NiRA. Face-to-face interviews with service users and clinicians will be conducted following initial completion of the NiRA, with a follow up interview for service users on discharge from the service. Regular informal follow-up with clinicians throughout the study will support the introduction of the NiRA. Descriptive statistics will be used to analyse quantitative data, and descriptive qualitative methods will be used to analyse data from interviews. Discussion: Aligning mental health services with recovery-oriented frameworks of care is imperative. The NiRA is a tool that has been designed in accordance with recovery principles and may assist services to be more recovery-oriented. If the NiRA is able to achieve the aims and objectives of this project, a larger implementation study will be conducted.

Bronchiectasis is a commonly seen chronic lung disease in our inpatient and outpatient services. The unmet needs of people with bronchiectasis are huge, with relatively few randomised controlled trials (RCTs) and evidence-based interventions. This RCT aims to improve the outcomes of children and young adults with bronchiectasis. It will examine the benefits (or otherwise) of a novel medication, erdosteine. Erdosteine’s effects include (a) mucolytic action, modulation of mucus production and increasing muco-ciliary transport; with (b) antioxidant; (c) airway anti-inflammatory and; (d) bacterial anti-adhesion properties. This RCT will answer: In children and adults aged <49 years with bronchiectasis, does 12 months treatment with erdosteine, compared to placebo, (i) reduce acute respiratory exacerbations and/or (ii) improve quality of life (QoL). The RCT will also determine the cost-effectiveness of the treatment.

Haemorrhage is a significant cause of preventable death in combat settings. Clinical practice guidelines advocate for the rapid delivery of intravenous fluid bolus challenges for the hypovolemic trauma patient in the tactical environment. However, peripheral intravenous catheter (PIVC) insertion is challenging in the austere setting and failure is common. The aim of this study is to investigate dressing and securement methods that prevent catheter dislodgement and explore participants’ experiences with these devices within an Australian Defence Force tactical care of the casualty (TCCC) training course. A two phase mixed-method design will be used to compare the Ruggedised Field (Ranger) IV method to the S-Wrap technique to reduce PIVC dislodgement rates during TCCC simulations. The study will be undertaken at the Australian Army School of Health in Victoria, Australia. Observational data from this study will reveal securement techniques that optimise practice in high threat/disaster settings and enhance patient safety and quality.

People often spend time recovering in a rehabilitation hospital after an injury, illness or surgery. During their rehabilitation stay, most patients experience improvement in their ability to move and think. However, patients sometimes don’t get enough time with their occupational therapist (OT) or physiotherapist (PT) to practice their tasks and exercises, and maximise the benefits of rehabilitation. Although it would be good to hire more staff, this may not be an option due to financial pressures within the hospital. An alternative is to help patients become more independent with their rehabilitation so that they can continue to practice their occupational therapy tasks or physiotherapy exercises outside of supervised sessions. The ‘My Therapy’ program does this by motivating patients to be pro-active in their approach to rehabilitation through education and empowerment, so that the patient continues to safely and independently practice their tasks and exercises outside of supervised sessions. This is in addition to the usual supervised therapy sessions. In this project the ‘My Therapy’ program will be tested in four Victorian rehabilitation hospitals to see if patients can be more confident in managing their own health, and make even more gains in their ability to move and think. This project will also see if My Therapy can reduce the cost of a rehabilitation stay in hospital.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of alectinib in a population of participants with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or patients with advanced cancers harbouring ALK gene alterations identified using comprehensive genomic profiling (CGP). Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic NSCLC or solid tumour of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to harbour ALK gene alterations identified using CGP. Study details: Participants will receive alectinib treatment. The alectinib is to be taken orally, at 600mg twice daily (days 1 to 28 in a 28-day treatment cycle). Alectinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals from first treatment until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Alectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Major Depressive Disorder is a leading cause of death and disability worldwide. Although the uptake of treatment varies between nations and amongst socio-demographic groups, overall there is a considerable unmet need for treatment. Many reasons exist for this, including lack of education, social stigma, limited treatment options and unaffordability. There is increasing interest in repurposing and repositioning of extant compounds in the management of mental illnesses, partly due to the retreat of pharmaceutical companies in neurosciences potentially as a result of lengthy approval processes for new discoveries, poor or delayed returns on investment relative to the investment risks, and logistical barriers. The investigational agents, Naltrexone and Flumazenil, both have existing uses in medicine and psychiatry around the world, but both may offer unique mechanisms of action in the treatment of depression contingent upon the doses utilised. Both have short elimination half-lives in the human body and have either a low oral bioavailability and/or short duration of action. Subcutaneous infusions allow for pulsatile, sustained and predictable delivery of the investigational agents in an ambulatory setting. The investigational agents will be combined into a 4 day infusion, and each infusion will have a total volume of 30mls. In total, each participant will receive 4 infusions with a break between the 2nd and 3rd infusions. There is no proposal for ongoing treatment.

The study aims to assess whether a novel type of mandibular advancement device (MAD) design that does not require retention on the teeth is effective in the treatment of obstructive sleep apnoea (OSA). Specifically, the study will compare two settings (active vs sham) of the MAD. Participants that meet the selection criteria undergo a 4 week sham treatment and 4 week active treatment phase with the order being determined randomly. There is a washout period of 1 week after the initial 4 weeks of treatment. The participants will be informed of the nature of each phase at the study conclusion, i.e., the end of 9 weeks period.

We will conduct a 12-week feasibility and pilot randomised controlled trial of a personalised exercise and dietary intervention delivered via VIPAs in adults aged 50 to 75 years with oral hypoglycaemic agent-controlled type 2 diabetes mellitus (T2DM). Primary Aim: Our primary aim is to assess study processes including recruitment and retention rates, adherence to the exercise and nutrition intervention, acceptability and adverse events. Secondary Aim: Secondary aims are to compare changes in scores for the Diabetes Self-Management Questionnaire (DSMQ), objectively-assessed physical activity, self-reported fruit and vegetable intakes, health-related quality of life (EQ-5D-5L) and productivity, compared to a control group receiving general advice on physical activity and healthy eating via email. Hypotheses: Our primary hypothesis is that a 12-week home-based personalised exercise and dietary intervention delivered by VIPA will be feasible and acceptable, as evidenced by greater than or equal to 70% retention in the study, completion of greater than or equal to 66% of prescribed exercise and dietary advice, recruitment greater than or equal to 20% of eligible participants and overall themes of acceptability expressed. We also hypothesise that the VIPA group will demonstrate improvements in diabetes self-management, objectively-determined physical activity, health-related quality of life, self-reported fruit and vegetable intakes and direct and indirect productivity. We anticipate that these preliminary data will support the need for future studies to explore cost-effectiveness of this telehealth approach in Type 1 or 2 insulin dependent diabetes mellitus and gestational diabetes. This innovative model of service delivery has the potential to markedly reduce health care practitioner workloads and telehealth costs in type 2 diabetes management, while increasing empowerment and accessibility to evidence-based programs for patients most at need