ANZCTR search results

The EarlyNuts study will recruit a population-based sample of 2.000 12-month-old infants in Melbourne, Australia, to: 1) Measure the current prevalence of challenge-proven peanut, cashew, egg and cow's milk allergy; 2) Measure current practices around introduction of allergenic foods (peanut, egg, tree nuts and cow’s milk) to infants in the population; and 3) Measure the association between age at introduction of allergenic foods and the development of allergy to these foods.

This study is designed to assess the safety and tolerability, pharmacokinetics (how the drug is absorbed by the body) and pharmacodynamics (the effect the drug has on the body) of CT-868 when administered as single and multiple ascending doses in overweight/obese (otherwise healthy) participants and as multiple doses in patient with type 2 diabetes mellitus. The study will start with a low single dose and safety information will be reviewed by a safety review committee to confirm if higher doses can be given to sequential cohorts before giving multiple doses.

The purpose of the research is to investigate young and adult people’s acceptability and satisfaction with a self-management program that aims to help make it easier for people to take their oral cancer tablets and is delivered via smartphone text messages. Who is it for? You may be eligible for this study if you are between 16-75 years old, own a smartphone, and are in either active or maintenance treatment with oral chemotherapy. Study details All participants in this study will receive daily text messages, information on their chemotherapy and information on symptom management, over a 10-week period. Participants will also be asked to complete surveys at the beginning and the end of the 10 week period. This study will help us plan a follow-up study and could help future young and adult cancer patients to more accurately follow their oral cancer treatment, as prescribed by their doctors.

Community leaders in ten local government areas in Victoria’s north-east will take part in an innovative program to reduce the region’s childhood obesity rates, in partnership with Deakin University’s Global Obesity Centre. The initiative – called RESPOND – will work with each of the communities in driving positive and practical changes from the ground up, to make them world leaders in promoting healthy weight among children. Over the next five years, RESPOND will engage with 14 of the region’s health services and 116 schools, reaching more than 30,000 children aged up to 12 years.

This study will evaluate the feasibility of a multidimensional support program for transitioning breast cancer survivors back to work Who is it for? You may be eligible to join this study if you are a female breast cancer survivor aged 18-65 and unable to return to work in your regular capacity prior to diagnosis and treatment for breast cancer for at least 3 months. Study details Participants in this study will all receive a psychosocial assessment to identify potential barriers to work. This is followed by individually-tailored return-to-work and general rehabilitation support which may include individualised planning and monitoring, health coaching, as well as employer advice and education as required. There will be a weekly face-to-face coaching session for up to 8 weeks with a specially trained occupational rehabilitation consultant. The tailored services are designed to give those who have experienced breast cancer the skills and confidence to better manage their move back into the workplace. The program also encourages women to seek advice and support from relevant treatment providers about work and health issues when required. This landmark study will provide the basis for a national roll-out of the return to work program, helping to improve the quality of life of those who have been directly affected by breast cancer.

The aim of this study is to examine the effectiveness of perampanel in the prevention of post-stroke seizures. Patients will be randomised to receive perampanel or placebo for 16 weeks. Doses will be escalated over the first four weeks before patients enter an assessment phase for the remainder of the trial. Patients will be followed up for 52 weeks. The primary outcome is the proportion of patients seizure free at the conclusion of the 52 week period. Secondary endpoints include measures of drug safety, tolerability and quality of life. In a subset of participants glutamate concentrations in the brain will be measured by MRI to assess whether they can be used to predict development of post-stroke seizures. This will be the third randomised trial examining the prevention of seizures after stroke. A positive study would support a larger randomised phase III trial of perampanel for prevention of post-stroke seizures. The novel use of 7T MRI to quantify glutamate offers the opportunity to assess if a non-invasive biomarker can help stratify seizure risk so that at-risk patients can be targeted for preventative treatment.

Mobility limitation is a particularly common and serious form of physical disability due to neurological, musculoskeletal health conditions, ageing and/or physical inactivity. Physical activity prescription in people with mobility limitations is complex so we hypothesise that tailored advice from physiotherapists will enhance activity levels. This pragmatic trial (n=600) aims to establish the effects on measured physical activity among adults with self-reported mobility limitations of: i). an enhanced intervention package (one face-to-face or video conference assessment, tailored physical activity plan, physical activity phone coaching supported with activity monitors and on-line website resources) compared with a less intensive intervention package (single session of tailored phone advice with website on-line resources and text messages); ii). an enhanced intervention package compared with no intervention; iii). a less intensive intervention package compared with no intervention.

Adolescence is an active phase of relationship development. Up to 25% adolescents reported a recent psychological distress because of a family or interpersonal issue, constituting a risk factor for depression and anxiety. Researchers at the Black Dog Institute have developed a mobile phone application called WeClick to help young people cope with the emotional impact of relationship conflicts. This pilot randomised controlled trial aims to evaluate the effectiveness of the WeClick mobile app for improving depression symptoms (primary outcome), as well as for improving anxiety symptoms, psychological distress, wellbeing, belongingness, social self-efficacy and help-seeking behaviour (secondary outcomes) among teens, in comparison to a waitlist control group. The current study is important in providing initial evidence of targeting relationships as a way to improve adolescents’ social and emotional wellbeing and increase their social self-efficacy and intentions to seek help for mental health problems from their social connections. Meanwhile, the findings of this study will also shed light on if mobile phone apps are able to deliver engaging, accessible, and personalised health interventions in adolescents.

Type 2 Diabetes Mellitus (T2DM) is a major risk factor for heart failure (HF), with particularly poor prognosis and a 5 year survival rate of <25% in major studies. A central aim of DM management is optimal glycaemic control, however the impact of this on the development and progress of the heart failure syndrome is unknown. Prior to recent trials involving different SGLT-2 inhibitors, evidence that any glucose lowering therapy reduces the rates of cardiovascular events (in particular HF readmission) and death was not convincingly shown (ACCORD, ADVANCE, UKPDS, VADT) The exact mechanisms of the benefits seen with the SGLT-2 Inhibitors, although postulated, are unclear. It is proposed that SGLT-2 inhibitors could demonstrate short term improvements in functional capacity, congestion parameters, biochemical, electrocardiographic and ,echocardiographic structural and functional parameters in participants with clinical HF and T2DM.

GT-1, the study drug being researched in this project, is an experimental antibiotic being developed by Geom Therapeutics, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. GT-1 is a novel siderophore cephalosporin antibiotic that is intended to treat serious infections. The primary objectives of this study are to assess the safety and pharmacokinetic (PK) characteristics of the GT-1 antibiotic compared to placebo controls when administered by intravenous infusion to healthy adults.