ANZCTR search results

This research study is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug) of ABI-1968 Topical cream delivered to the cervix by intra-vaginal application. In this study, a total of 40 participants will be enrolled over 5 dosing groups/cohorts with each cohort consisting of 8 people – 6 will receive the active drug, and 2 will get placebo. Participants will be randomly assigned to receive either the active drug or placebo (a ‘dummy’ topical cream that looks identical, but contains no active drug). Participants will have a 75% chance of receiving study drug and 25% chance of receiving placebo. The study drug (or placebo) will be administered as a topical cream to the cervix by intra-vaginal application by the Gynecologist. No participant will be a member of more than one cohort. This study is a dose escalation study meaning that the first cohort will receive the lowest dose of study drug. The dose of study drug will increase with each subsequent cohort. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with testing in the next cohort. The next cohort will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. The five different dose strengths planned for this study are 0.01, 0.03, 0.1, 0.3 and 1.0 % by weight, applied as a topical cream via a single-use graduated applicator which delivers an approximate 2g dose. During this study, it is possible that the strengths may be reduced, repeated or increased; however, 1.0 % is the highest dose that will be given. Participants will not have a choice as to which cohort or dose level they are assigned (randomised) to, with each cohort enrolled on a first eligible basis. The participant and the study staff will not know if the they are assigned to receive the active study drug or the placebo, although in an emergency the study staff can find out. The first cohort will have 2 ‘sentinel’ volunteers; one will receive the active drug, the other the placebo. These individuals will receive the study drug (or placebo) approximately 24 hours before the rest of the cohort. Participants will be told if they are assigned to the sentinel cohort.

Cognitive impairment, as experienced in people with Alzheimer’s Disease, a common cause of dementia, is an important factor leading to driving cessation. Making decisions regarding fitness-to-drive based on a diagnosis of dementia or dementia severity alone in the absence of rigorous assessment can lead to premature driving cessation or continuation of unsafe driving. Many people who are suspected of having, or have a new diagnosis of Alzheimer’s Disease, are referred for an occupational therapy driver assessment. While a portion of drivers with early Alzheimer's Disease will need to relinquish driving, there is also a need to support those who can drive safely to continue to do so for as long as possible. Since driving is an over-learned skill, it may be possible for some individuals with Alzheimer’s Disease to continue to drive safely for some time after a diagnosis and undergo periodic re-assessment to ensure the continued safety of the individual and the community. A driving assessment involves both off-road and on-road components. The purpose of the off-road component is to identify strengths and weaknesses that may impact on driving and to screen out clients who are unsuitable to progress to an on-road assessment. During the on-road assessment, an occupational therapy driver assessor observes driver behaviour and performance. The outcome for the purpose of this research is classified as pass or fail. While some people with Alzheimer’s Disease may perform poorly on the unfamiliar (open/standard) test route, performance may be significantly improved if tested in their local area leading to a recommendation for local-area-only licence. Drivers who do not pass an open area assessment may therefore undergo a local-area-only licence. There is little research evidence concerning the performance of drivers with Alzheimer's Disease on initial versus subsequent testing and if improved performance is related to the area the assessment is undertaken in, or related to a practice effect. Additionally, it’s not clear if performance in both these testing locations is affected by whether the client has navigational problems. Clients tested in their local area need to self-navigate. However, clients tested in an open area are generally directed by the driving instructor. This study determined the effect of: (1) location of assessment and ordering of the tests (local area test first or second); (2) opportunity to undertake a second test, and; (3) navigational difficulties on the performance of people with Alzheimer’s Disease on an on-road driver assessment.

The insertion of peripheral intravenous catheters (PIVC) or cannulas for intravenous treatment and venepuncture for blood sampling are common in modern health care. However, difficulty in obtaining successful access is common and patients may undergo repeated attempts. This difficulty results in high costs for health care organisations and distress for patients (Sharp et al. 2014; Robinson Reilly 2015). Successful attempts may be influenced by both the size and the depth of the vein (Witting 2010; Kimori 2016). Clinicians often apply heat to the area and encourage fluid intake to increase vein diameter and make veins more superficial so as to improve venepuncture success (Fink 2009). However, these interventions are based on limited evidence. Existing research about the effect of hydration on the size of veins used for venepuncture and PIVC insertion is scant. No existing research could be identified that has investigated the effect of heat or hydration on the distance of the vein from skin surface. Hypotheses: - Heat and hydration will increase vein diameter - Heat and hydration will decrease vein depth

What is the study purpose? The purpose of this study is to investigate whether a specially-designed hip brace is effective for treating hip impingement. We hypothesise that the hip brace will help alleviate hip pain for people with hip impingement. What does the study involve? Participation in this study goes for six weeks. This type of study is known as a ‘randomised trial’. Since we don’t yet know whether the hip brace is effective in treating hip impingement, we need to compare it to the usual treatment people receive. To do this, study participants are put into two groups: one group using the hip brace as well as the normal treatment their doctor would recommend, and the other group just having the normal treatment their doctor would recommend for hip impingement. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, like the flip of a coin. Participants will fill out questionnaires about their hip symptoms before beginning the study, and then also fill out the questionnaires after six weeks, allowing the researchers to compare results between the two groups to see which treatment is better. Here is some further information about each of the two treatments : 1. Treatment with the hip brace The hip brace is a new device that has been designed by Ossur, a company that develops and manufactures non-invasive orthopaedic equipment. The brace has been made for people with hip impingement, with the purpose of reducing their hip symptoms. There has not been any previous study on the effectiveness of this hip brace for hip impingement, so we don’t yet know if it is effective or not. People allocated to receive treatment with the hip brace can still continue with the normal treatment for their hip recommended by their doctor. However they cannot have surgery during the six weeks of the study and cannot start any other new treatments that their doctor has not recommended. Participants allocated to the hip brace gorup will receive the hip brace at no cost to them, and will be free to keep the hip brace after the study is over. 2. Normal treatment Participants allocated to receive normal treatment will be asked to simply proceed with the normal treatment that your doctor recommends for your hip impingement (apart from surgery). Participants allocated to normal treatment will not be given a hip brace to use. All people participating in this study will go for an EOS scan (a special type of low radiation dose X-ray). This will help the researchers to measure the extent of each participant's hip impingement.

This study aims to contribute to the improvement of the general health of young people affected by schizophrenia, bipolar disease and/or major depression. This model of nutrition and health education is likely to influence the high risk of comorbidities that are known to be related to treatment with the newest psychotropic medications in severe mental illness. Obesity is the key risk factor predisposing to the development of metabolic syndrome, exacerbated by the lack of physical activity seen with these patients. The prevention of the development of obesity among these young people is paramount in order to enhance their physical and mental well being. Educating in isolation is not sufficient to alter outcomes in these patients who require additional support. Family or carers, hence, are key players in the education of their young relatives or clients. This study aims to establish firm strategies for motivating young people to change their lifestyle by empowering them with knowledge and realistic skills to put into practice for the benefit of their physical and mental health. It is hoped that this can be achieved via the development of health literacy and nutrition education programs which are not only low cost but highly effective.

Aim: To determine the minimum dose of exercise required to elicit a positive clinically meaningful improvement in cardiorespiratory fitness in stroke survivors. Eligible participants are independently- ambulant, community dwelling stroke survivors who have met the screening criteria. Fitness will be assessed pre, during and after an 8-week exercise intervention. Habitual activity (over a 7-day period) will also be assessed at these time points. Baseline measures include demographics (age, gender, living arrangements), stroke-specific variables (stroke type and severity, time since stroke, side affected, level of disability, anthropometric measures (height, weight, girths), cognitive function and exercise preference. Intervention Participants will participate an 8-week 3 day/week home-based individually prescribed exercise program and will be monitored remotely via tele-rehabilitation.. Exercise sessions will consist of 5 minute intervals at alternating higher/lower intensities (55-85% HR max), progressing from 30s/30s to 2min/2min by week 8 as tolerated. Programs will take into account initial fitness level, degree of disability and participant preference. The starting dose duration will be 30 min/week, progressing 15min/week per dose. The primary outcome will be the smallest dose of exercise required to increase cardiorespiratory fitness by 2ml.kg-1.min-1 in 8 weeks where dose is defined as the total number of minutes of exercise prescribed per week at a moderate to vigorous intensity (55 to 85% HR max). Secondary measures include blood pressure, weight, girths, cycle GXT peak power output, peak HR, lactate, walking ability, mood (anxiety and depression), physical activity level and health-related quality of life factors (HRQoL).

Reducing the prevalence of obesity remains a major public health challenge, demanding effective, broad-scale interventions to support weight management and health behaviour change. The intensive approach seen within academic lifestyle intervention programs is effective, but requires considerable resources, including time, money and the availability of multiple health professionals with expertise in the behavioural treatment of obesity. It may therefore be considered too burdensome and expensive to be sustainable in a community environment. In order to translate the success of academic lifestyle interventions into community settings, we must explore innovative ways to adapt these approaches, while still maintaining the key features that led to their success. Offering patient-provider support via mobile technology offers a potential way to reduce face-to-face contact, thereby lowering the cost, time and burden of obesity management programs. Emerging evidence supports the efficacy of providing technology-delivered extended contact interventions to support weight maintenance after the completion of a lifestyle intervention program. However to the best of our knowledge this is the first study to explore the use of technology as an adjunctive tool to support a community-based obesity management program. This 12-month randomised controlled trial is designed to determine if the addition of telephone and text message support to a community based obesity management program improves lifestyle intervention adherence and clinical outcomes when compared to standard care. Participants within the intervention group will receive monthly telephone calls and individualised text message support for a period of six months in addition to standard care within a community based obesity management program. The additional support will be grounded in behaviour change theory, with a range of behavioural treatment strategies targeted, including: goal setting, self-monitoring, motivational interviewing, problem solving, relapse prevention, stimulus control, cognitive restructuring and self-reinforcement. Outcome measures include diet and physical activity adherence, program attendance/attrition, weight loss, diet and physical activity self-efficacy and motivational readiness.

This research project is being conducted to look at the safety, tolerability, pharmacokinetics (PK, how the human body processes a substance) and pharmacodynamics (PD, the measure of what a substance does to the human body), of different dosages of IONIS-TMPRSS6-Lrx when given to healthy participants as either a single subcutaneous (SC, an injection just under the skin) dose, or as multiple SC doses over a course of 6 weeks.

Background: Lifespan is the systems approach to suicide prevention developed by Black Dog Institute (BDI) and the NHMRC Centre for Research Excellence in Suicide Prevention. BDI is undertaking an evaluation of the LifeSpan approach in four sites across NSW, funded by the Paul Ramsay Foundation and with the support of the NSW Government and the NSW Mental Health Commission. LifeSpan includes nine evidence-based interventions implemented simultaneously within a localised region. Recognising that multiple strategies implemented at the same time are likely to generate bigger effects than just the sum of its parts (i.e., due to synergistic effects), LifeSpan offers a data driven, evidence-based approach, setting it apart from current practise and raising the bar in suicide prevention. Based on the most up-to-date evidence available and drawing from positive results of similar suicide prevention programs overseas, this integrated systems approach is expected to prevent 20% of suicide deaths, and 30% of suicide attempts. Design: LifeSpan involves a stepped-wedge, randomised design whereby the intervention will be sequentially rolled-out in each of the four sites at three month intervals. This design will avoid the effect of the intervention being confounded with any underlying temporal trend. Once rolled-out, the intervention will be active in each site for two years. Methods: LifeSpan will involve implementing nine intervention strategies. The individual-based strategies include: aftercare and crisis care, psychosocial and pharmacotherapy treatments, GP capacity building and support, frontline staff training, and gatekeeper training. The universal strategies include: school programs, community campaigns, media guidelines and means restriction. Furthermore, the project will include a community, professionals, and key stakeholder self-report measures. The project will incorporate and be measured against an Implementation Science framework, to ensure maximum engagement and fidelity to the model.

The primary purpose of the study was to evaluate whether a bundle of line management measures focused on reducing the risk of contamination of Parenteral Nutrition (PN) lines would reduce the incidence of Late Onset Sepsis (LOS) in Very Low Birth Weight babies. The hypothesis was that the study intervention; comprised of a strict sterile technique for line changes and minimising the administration of other medications or fluids through PN lines would reduce catheter contamination and by minimising breaches would reduce the incidence of LOS when compared to the standard technique routinely used in the Neonatal Intensive Care Unit.