ANZCTR search results

The primary purpose of this study is to evaluate the clinical efficacy and safety of topical lidocaine spray in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo spray.

MYB is a randomised controlled trial of multiple online interventions designed to target modifiable risk factors for Alzheimer’s disease and dementia. Risk factors to be addressed are physical inactivity, cognitive inactivity, depression/anxiety, overweight and obesity, and poor diet. Up to four intervention modules (physical activity, nutrition, brain training and peace of mind) will be administered based on individual risk profiles. Each module will be initially delivered using MYB eHealth platform over 10 weeks. In this part of the intervention, participants complete their assigned modules back-to-back, noting that the total number of modules is variable depending on individual’s risk factors. In practice this will translate to a minimum of two modules and a maximum of four modules, over a maximum of 12 months. Booster sessions (specific to each module) and ongoing monitoring will then continue for three years. Follow-up assessments measuring these risk factors and cognition will be completed annually for three years. The control group (“information” group) will receive basic psychoeducation online about dementia risk factors via a website with set activities organised by corresponding module eligibility (i.e., information activities themed around peace of mind, brain training, nutrition and/or physical activity). They will otherwise undertake the same enrolment, baseline and annual follow-up assessments.

Hypothesis: We propose in patients with the dual phenotypes of severe allergic and eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, we will also go on and identify key clinical biomarkers that will clarify which patients will respond best to each of these interventions. This study will be the first direct clinical comparison of these agents and will apply expert clinical characterization, along with cutting edge biotechnology to better inform treatment choices for severe asthma. This is an important and urgent management problem facing the Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced clinical effectiveness as well as substantial and sustained costs.

This is an open-label, multi-center, dose-escalation phase I study. The primary purpose of this trial is to evaluate the safety and tolerability as well as the preliminary efficacy of KN046 in participants with advanced solid tumors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor with no standard therapy is available. Study details All participants enrolled in this trial will receive KN046 intravenously every two weeks for 6 months or until excessive toxicity, disease progression, patient consent withdral, physician's judgment (whichever occurs first), up to 2 years. The dose received by each participant depends on the time of their enrolment. KN046 is a biological drug for treatment of advanced solid tumor. As a part of the clinical research study patients will have regular blood tests, physical examinations, Tumor imaging examinations by either CT or MRI. It is hoped this study will contribute important safety and efficacy information as well as to determined the optimal dose of KN046 to administer for treatment.

Chronic constipation and faecal incontinence carry significant health and economic burdens on individuals as well as the health system. Initial treatment remains conservative including medications and dietary modifications. However should these be ineffective, guidelines recommend investigating for physiological abnormalities by anorectal physiology testing including ARM and BET. The results of these are subsequently used to guide prescription of second line management including biofeedback therapy, neuromodulation and surgical interventions which when used appropriately demonstrated positive outcomes. Given the central role of anorectal physiological testing, there remains a lack of standardisation when conducting these procedures and subsequently, we remain uncertain whether the results produced are comparable. This applies to the study protocol itself, the equipment used during testing and analysis of results. Literature has even suggested that in cases of faecal incontinence, it may be beneficial for individual units to have their own range of values for defining abnormalities. The sensory component of defaecation, namely alterations in visceral perception and rectal compliance has also become increasing studied and tested. Determining type and degree of dysfunction in these have implications on provision of treatment. Barostat methodology is now widely used to assess sensory components of defaecation but different protocols exist, mainly with varying duration and equipment for the procedure. As a result, normal cut-offs remain unclear.

The aim of this RCT is to assess whether interventions addressing the thoracic spine are effective in reducing shoulder impingement pain. Participants with shoulder impingement pain will be randomised to receive one of: sham treatment, manual therapy to the thoracic spine, or manual therapy to the thoracic spine and shoulder treatments. All treatments will be delivered by a registered osteopath using pragmatic standard osteopathic manual therapy techniques. Outcome measures will be shoulder pain and disability questionnaires, visual analogue scales ,global rating of change diagram, patient-specific function scale diagram, and thoracic posture measure and thoracic range of motion measured with an inclinometer.

This project aims to improve care for adults with heart disease by building the evidence for meditation as an adjunct non-pharmacological self-management strategy to improve health-related outcomes for adults after an acute cardiac event. This meditation intervention aims to provide an avenue for optimising self-management of depression and anxiety symptoms, known to be high after an acute cardiac event or hospitalisation, which may enhance the capacity for adults to adhere to conventional exercise-based CR, self-manage their symptoms and reduce re-hospitalisation rates. The proposed study design is an open-label parallel group pilot RCT with post-intervention follow up. The researchers hypothesise that a meditation intervention will improve self-reported depression and anxiety at 6 weeks, which will be sustained at 3-month follow-up. Post-intervention follow-up will be undertaken to better understand consumer perspectives of meditation as an adjunct strategy for the alleviation of depression and anxiety symptoms. Findings from this study will inform a phase III randomised controlled trial (RCT) that will be used to inform future policy and guideline development.

Exposure and Response Prevention (ERP), delivered individually, is the gold-standard treatment for Obsessive-Compulsive Disorder (OCD). However, there are significant barriers to accessing this form of treatment such as a limited number of specialists skilled in the provision of the treatment and long wait-lists. As such,attention has been given to exploring alternative modes of delivery of ERP. These alternatives include provision of ERP via the Internet and provision of ERP in a group format. A recent meta-analysis (Schwartz et al., 2016) found that ERP provided in a group format has equivalent effect sizes to individually administered ERP. The 12 studies in the meta-analysis were controlled trials comparing group ERP to wait-list and to individual ERP. The results of this meta-analysis lend support for the provision of ERP in group formats in clinical practice. However, most studies to date have been conducted in highly controlled settings (e.g. university clinics) and so little is known about how effective group ERP is in typical clinical settings. The aim of this study is to evaluate the effectiveness of group ERP in a ‘real-world’ clinical setting.

Maternal sleep disturbance is a significant and widespread complaint during the postpartum period. Though some aspects of sleep eventually improve over time, some mothers continue to experience poor sleep with persistent difficulties in initiating and reinitiating sleep. These postnatal sleep complaints have been associated with a range of deleterious outcomes, including fatigue, sleepiness, and symptoms of depression/anxiety. Despite the prevalence and associated negative outcomes of postnatal sleep disturbance, research investigating potential interventions to promote maternal sleep is scarce, representing a significant gap in the current literature. We plan to examine the efficacy of non-pharmacological interventions to improve sleep and wellbeing in sleep-disturbed mothers: (1) Cognitive Behavioural Therapy (CBT) and (2) Light and Dark Therapy (LDT). The CBT arm will involve strategies to target healthy sleep habits and management of daytime symptoms (including fatigue), delivered via emails with therapist assistance. The LDT arm will involve participants wearing light glasses each morning and adhering to recommendations for appropriate light exposure at night. Interventions will be personalised in an orientation call with a researcher in which specific recommendations will be made based on the participants’ individual needs. There will be four conditions: (1) a CBT-only group; (2) a LDT-only group; (3) a combined CBT-LDT group; and (4) a waitlist control that will receive CBT emails following trial completion. The active intervention phase will be six weeks, with four assessment time-points: (1) baseline; (2) mid-point – Week 3; (3) post-intervention – Week 6; and (4) follow-up – Week 10. This aims of this study are to: 1) Investigate the efficacy of CBT, LDT, and the combinations of LDT and CBT in the reduction of maternal sleep complaints as the primary outcome, and maternal fatigue, sleepiness, and mood as secondary outcomes. 2) Explore predictors and mediators of treatment effects. 3) Evaluate whether the combination of CBT and LDT supersede the effects of either intervention delivered alone.

BACKGROUND: The ‘artificial pancreas’ or hybrid closed-loop (HCL) insulin pump has been shown to be effective in improving glucose control in individuals with type 1 diabetes. The HCL system has been further modified from previous prototypes resulting in the advanced-HCL (A-HCL) system. The A-HCL system aims to increase time-in-target glucose range and improve user acceptability. The impact of the modifications implemented in A-HCL systems have yet to be evaluated. AIMS: The study aims to generate preliminary data regarding glucose control using A-HCL systems, and challenged by meal interventions, exercise and sensor miscalibrations. METHODS: The study is a prospective, three-stage study, incorporating ‘in-hotel’, ‘in-hospital’ and ‘free-living’ stages over a 5 week duration. Pump-experienced adults with type 1 diabetes will be recruited. All participants will be assigned the A-HCL system. Interventions in the supervised ‘in-hotel’ and ‘in-hospital’ stage aim to challenge glucose control and A-HCL system performance. Thereafter, participants will return home in the ‘free-living’ stage for 3 weeks using the A-HCL system. OUTCOME MEASURES: Glucose control including CGM time-in-target glucose range, and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance.