ANZCTR search results

This study is to assess whether photobiomodulation is beneficial in treating Retinitis Pigmentosa (RP). Photobiomodulation is a low level laser therapy that is used to treat varying conditions by stimulating cell functioning. Lasers are routinely used and are approved in Australia for treating differing eye conditions. These lasers are called Thermal Lasers and are usually green in colour. They are applied to the retina through a special type of microscope and many laser spots are individually placed over the affected area. In all cases, these lasers work by burning small areas of the retina in order to trigger the required healing response for the affected cells. We are trying to assess the effectiveness of a new type of Near Infrared (NIR) laser that is about 100 times lower in power density than a Thermal Laser. The NIR laser causes no burn; however, it appears to stimulate a healing response to injured cells, including blood vessels and neurons in the retina, resulting in a protective effect on cone cells. This treatment is not yet approved for use in Australia, although it has been tested in research studies overseas. The purpose of the trial is to determine if NIR laser has an acceptable safety profile to treat patients with RP. The study will last for approximately 6 months with up to 11 study visits. Each visit will take up to 1 hour depending on the assessments involved. There will be a total of 2 laser treatments within a 1 week period for 4 weeks. After the completion of the laser treatment there will be a visit 4 weeks later to repeat the same checks as the baseline visit, and again at 6 months. This is a research study, and NIR Laser therapy is not registered for use in patients with RP in Australia at the present time and may never be registered. If this treatment becomes registered, then it may not be subsidised by the Medicare Benefit Scheme (PMBS) in Australia. The Investigators cannot commit at this stage to provide this as ongoing treatment after the study is over.

The study is a phase 1, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacokinetics of multiple-ascending doses of PRAX-114 in healthy subjects. In addition, potential metabolites of PRAX-114 will also be evaluated.

The aim of this study is to identify and categorize barriers and facilitators to the use of guidelines in the management of bronchiectasis and to clarify current bronchiectasis care. Objectives: 1.To examine sample populations of health professionals and patients working or living with bronchiectasis to determine their attitudes to bronchiectasis management and the use of guidelines. 2.To examine opinions to bronchiectasis guideline specific areas of patient management including action plan/ emergency pack use, vaccination, sputum clearance, use of antibiotics, impact of co-morbid disease, clinical assessment and documentation of review. 3.To explore patterns and common themes in attitudes to bronchiectasis management and use of guidelines Study design: Questionnaires and semi moderated guided interviews will be conducted to obtain quantitative, semi quantitative, and qualitative data from participants. Participants will be health professionals (Respiratory physicians, respiratory nurses and respiratory physiotherapists) and bronchiectasis patients. It is expected recruitment will be between 12-18 people from each of these 2 groups. If data saturation is not reached more participants will be recruited. Study procedure At interview participants will bring consent form and sign, answer the questionnaire and then take part in the semi structured interview. Bronchiectasis patients will complete an additional Quality of life assessment using the quality of life bronchiectasis questionnaire. A eFACED severity score will also be calculated for patients to allow grouping of patients responses with like disease severity/ impact. Data Analysis Transcribed interviews will be coded by 2 researchers using deductive thematic analysis to categorise the responses into the 18 Domains of the Theoretical Domains Framework. Date will be analyses using IBM Statistical Package for Social Science (SPSS) Statistics Version 24.0. for quantitative data and coded responses will be entered and analysed in NViVo software version 11.0. Data collected will be safely and securely managed. Audio recordings will be kept for 15 yrs, data will be de-identified through use of a study code. All data will be stored securely with password protection on secure network or locked filling cabinet accessible by trial researchers only.

The purpose of this study is to evaluate the effectiveness of paraesthesia-free (sub-perception) waveform patterns for patients with chronic neuropathic low back pain.

The purpose of the study is to determine the effectiveness of personally-tailored, web-based physical activity intervention, with and without Fitbit syncing, targeted to inactive older adults (65+ years of age) in a 6-month randomised controlled trial . It is hypothesised that increases in objectively measured physical activity will be greater in both intervention groups compared to the control group and greater in the Fitbit and tailored advice group compared to the tailored advice only group at 12 weeks.

This randomised, double-blind, placebo-controlled, phase 4 trial will compare the incidence of surgical site infection, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to cefazolin plus placebo. The study will be initially undertaken in patients undergoing elective or expedited joint replacement surgery. Dependent on timelines and funding, the study may be expanded to include patients undergoing cardiac surgery.

The overall aim of this project is to identify perceived and actual barriers and facilitators to the provision of guideline-concordant care for people with chronic obstructive pulmonary disease in the hospital setting and the community setting, There is a particular interest to understand the experience and perceptions of people with chronic obstructive pulmonary disease and the health professionals that help them manage their condition, with relation to best practice guidelines and technology and outreach nursing services. The information gathered through these interviews will help identify potential strategies to improve motivation to access and use guidelines in practice. This project is a qualitative investigation using semi-structured interviews. The responses gathered from the interviews will be triangulated with quantitative data through use of questionnaires. Once the data is collected it will be analysed to identify themes and patterns which will help to understand the problem and identify potential solutions.

We have developed a smartphone application, MunchIO, to help users reduce their consumption of unhealthy snack foods. Users are asked to track their snack food consumption while being provided support to understand and plan against their snacking habits. The novel distinguishing factor of this app is the use of behaviour change techniques known as cue monitoring and implementation intentions. Cue monitoring refers to tracking snacks alongside user affect and context data that can influence individuals to consume snacks. For example, a snacking cue might involve being stressed. Implementation intentions then refer to creating if-then plans that when repeated form a new replacement habit for snacking. For example, if I am stressed, I will go for a walk. This research project will collect data from two phases: Phase I includes data from the smartphone application (see above for outline of the app). Phase II includes data collected from a series of focus group interviews. Overall, the aim of this project is to determine if these apps features have any impact on participant snacking, engagement and retention. Results will further inform the design and deployment of future interventions.

Autism Spectrum Disorder (ASD) affects learning, social participation and daily function across the lifespan. Approximately 35,000 school-aged Australian children live with ASD; 95% of these experience educational restrictions. Available treatments are only moderately successful and are not effective for all children with ASD. Knowledge about what (intervention) is likely to work for whom is missing from the field. Individuals with ASD and their families frequently attribute the significant functional difficulties experienced to sensory symptoms. Sensory symptoms are reflected in behaviours such as hyper-reactivity (e.g. extreme distress in response to an unexpected sound), hypo-reactivity (e.g. failure to respond to a painful stimulus) and unusual sensory interests (e.g. excessive smelling of objects). Sensory symptoms are so common in ASD that they now form one subset of the diagnostic criteria for ASD. Therapies to remediate sensory symptoms are in high demand. In fact, occupational therapy, which is the lead profession providing sensory-directed therapies, is the second most frequently utilised therapy by families of children with ASD. The few controlled studies that examine the efficacy of sensory-directed therapies, however, report inconclusive results. A critical issue limiting previous research in this area is that sensory symptoms have been broadly defined and imprecisely characterised. Our group has developed a method of classifying children with ASD into clinically meaningful subtypes based on their parent-reported sensory symptoms. We observe that children with ASD can be classified into sensory subtypes that vary on the dimensions of sensory reactivity (regulating the intensity of a response to a given stimulus) and multisensory integration (MSI; simultaneous processing of concurrent sensory modalities). Each sensory subtype has been found to display a distinct pattern of behaviour thus providing a novel basis on which to customize treatments. The primary objective of our study is to assess the relative effectiveness of a sensory regulatory intervention - Alert Program for Self-Regulation (AP) - for children with ASD and their caregivers. The hypothesis for the study is that for all participants, engagement in the AP will result in: 1) achievement of caregiver defined goals in self-regulation, 2) reduced physiological sensory reactivity (EEG & ANS cardiac), 3) reduced clinical sensory reactivity, 3) reduced parent stress and caregiving effort and 4) improved adaptive behaviour and anxiety following participation in the AP. We further hypothesise that participants with a sensory subtype indicating more difficulties with sensory reactivity will demonstrate significantly greater improvements on all measures than matched ASD participants whose sensory subtype indicates difficulties in MSI.

Athletes commonly reduce body weight or body fat prior to contest seeking various competitive advantages. Intermittent energy restriction is known to effectively reduce body fat in non-athletes, however evidence in athletic populations is lacking. We thus aim to provide an evidence-based intermittent energy restriction protocol for athletes, by investigating this dietary model in a cohort of resistance trained athletes, using a macronutrient profile thought to maximise retention of fat free mass and performance during energy restriction. We will compare changes in fat mass, fat free mass and performance between a continuous and intermittent dieting approach. Measures of body composition, resting energy expenditure, hunger and satiety, blood hormone levels, and muscle strength and endurance will be taken at a number of time points throughout the study.