ANZCTR search results

Regular consumption of traditionally allergenic foods, like egg and peanut, in solid foods can reduce food allergies, however this is too late for some infants. This PrEggNut study will determine whether the risk of developing food allergies in infancy can be reduced by a maternal diet rich in eggs and peanuts during pregnancy and breastfeeding. The intervention period is from 22 weeks gestation in pregnancy until 4 months of breastfeeding. The infants are followed up until 12 months of age. The study design is a multi-site, randomised controlled trial. It is powered for infant egg and peanut food allergy outcomes with a sample size aim of 2136 women and their infants. The primary outcome for this study will be food challenge proven IgE-mediated egg and/or peanut allergy at 12 months of age. The key translatable message from this study will be to answer the question of whether higher maternal dietary intakes of eggs and peanuts during pregnancy and breastfeeding are needed to reduce the risk of food allergies developing in infants..

The purpose of this study is to assess the efficacy of the use of TraceIT for radiotherapy in prostate cancer when compared to SpaceOAR. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer and is scheduled for primary curative prostate cancer radiotherapy. Study details All participants who are undergoing radiation therapy with the insertion of TraceIT as part of standard care. Using an MRI scan, we will follow up on the reabsorption of the TraceIT hydrogel over the 12 month period. This is in addition to the standard of care treatment. Participants will also be asked to complete questionnaires to assess quality of life and overall experiences. This study will assess the efficacy of the TraceIT product and further support and validate its use in our clinical practice.

Pulmonary rehabilitation (PR) is an evidence-based intervention recommended for people with chronic obstructive pulmonary disease (COPD), the second leading cause of avoidable hospitalisation in Australia. PR improves quality of life and reduces health care utilisation. However, any benefit from completing Phase 2 (“initial”) PR diminishes in the months following. Currently, participants are invited to continue attending a weekly Phase 3 (“maintenance”) program for 10 weeks. With lack of robust evidence supporting the benefits of Phase 3 PR, program funding is constantly threatened. The 2017 Australia and New Zealand Pulmonary Rehabilitation Clinical Practice Guidelines calls for further research to clarify the benefits of Phase 3 PR. Our primary aim is to compare the health-related quality of life (HRQoL) in participants receiving the extended Phase 3 PR against those not receiving the extended program. We hypothesise that in the 6 months following completion of the extended Phase 3 PR program, participants who completed the extended program will have a better HRQoL than the control group. We will randomise participants who have completed a Phase 3 PR program to either a further 6 months of the maintenance program plus unsupervised home exercise (community program) or 6 months of unsupervised home exercise (home program).

To conduct a multisite pragmatic RCT pilot study of early vision-aware and parent-directed environmental enrichment program (VISIBLE: early Vision Intervention for Seeing Impaired Babies: Learning through Enrichment) which aims to: 1. Determine the feasibility and acceptability of the VISIBLE intervention program for infants with severe CVI and high risk of Cerebral Palsy. 2. Evaluate efficacy of the VISIBLE program to lead to greater improvements of (i) visual function, (ii) developmental outcomes (developmental, motor, fine motor) and (iii) parent infant emotional and relational development, as compared to standard of care (SoC). VISIBLE is an early intervention program based on the core principles of optimising infant’s visual experience during the first phases of development. The general principles are activity-dependent learning and environmental enrichment. Parents are essential to environmental enrichment for infant learning success. They provide the environmental cues for both social and physical infant exposure. Utilizing this principle, parents will provide vision-awareness environmental enrichment – adapting the social and physical environment to allow the infant the opportunities to learn by successfully experiencing their enhanced environment. Within the context of parent-child daily goal-oriented interactions, environmental enrichment, as it relates to vision-awareness modifications, will include light, spatial distances, salience, consistency and multimodality of infant’s environment. The major hypothesis to be tested is: H1Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior visual behaviour scores at 12-months of age, compared to those who receive standard care. The secondary hypotheses are: H2 Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior cognitive scores on the Bayley Scales of Infant Development and/or superior motor scores on Peabody Developmental Motor Scales at 12-months of age, compared to those who receive standard care. H3Parents will find the VISIBLE program intervention feasible and acceptable to implement.

The purpose of this study is to investigate the patterns of relapse for germ cell tumours of the testicle. Who is it for? You may be eligible for this study if you are a male over 18 and have a confirmed germ cell tumour (both seminomas and non-seminomas). Study details In this study, participants will be asked to complete treatment for their cancer as per normal while being monitored by researchers every 6 months while you are on active surveillance. This will involve taking some blood and tissue samples as well as answering a few questionnaires. Researchers will then look at the differences in the tissue and blood to see how these differences relate to how the participant responded to treatment. It is hoped that this research will help us understand why some germ cell tumours are more aggressive than others and why some treatments work better in some patients than others.

This study aims to compare the effectiveness of two scalable interventions (Exercise; Exercise plus Weight Management) to each other, and to an information-only control group, for overweight/obese people with clinically diagnosed knee osteoarthritis (OA) on the primary outcomes of knee pain and function at 6 months. The Exercise group will receive six consultations with a physiotherapist via videoconferencing over six months, including prescription of an exercise and physical activity plan, education and advice about common management strategies, and provision of educational material. The Exercise plus Weight Management group will receive six physiotherapist consultations in addition to six consultations with a dietitian via videoconferencing over six months, which will include a weight management program. We will recruit 415 Medibank Private members from around Australia who have clinical knee OA and are overweight/obese. The primary outcomes are self-reported pain and function. A range of secondary outcomes will also be assessed including weight, physical activity, health-related quality of life, global rating of change, mood, satisfaction with care, appointments with orthopaedic surgeons, knee surgery procedures and willingness to undergo surgery. Outcomes will be measured at baseline, 6 months and 12 months. A health economic analysis will be conducted alongside the trial.

The purpose of this study is to determine whether certain biomarkers have an impact on the effectiveness of treatment for kidney cancer. Who is it for? You may be eligible for this study if you are over the age of 18 and have been diagnosed with kidney cancer. Study details If there is left over tissue after planned medical procedures then a sample of this tissue will be kept. The tissue samples will then be tested to determine how the cells, genes and immune system interact with the cancer and whether these relate to treatment results. It is hoped that this research will help us to better understand why some kidney cancers are more aggressive than other and also why some treatments work better in some patients than others.

This study is examining a combination of hormone treatments that may be useful as pre-surgery treatment for breast cancer. Who is it for? You may be eligible for this study if you are female, post-menopausal and have histologically confirmed newly diagnosed hormone receptor positive breast cancer. Study details Participants in this study will be randomised (by chance) to one of three groups. One group will receive the medications letrozole and promethium, another group will receive the medications tamoxifen and promethium, and the other group will receive the medication letrozole alone. The assigned treatments will be taken daily for two weeks prior to surgery. Participants will provide blood samples and consent to their cancer tissue being used for analysis, in addition to medical examination. It is hoped this research will provide fundamental evidence of the efficacy and safety of these medications in patients with early stage breast cancer

The purpose of this study is to test the safety and tolerability of the MultiBiotic probiotic formulation before starting chemotherapy and until the end of treatment. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and have not yet commenced chemotherapy. Study details Patients who decide to take part in this trial will be given probiotic (friendly gut bacteria) capsules to be taken daily before and during the duration of the chemotherapy. The probiotic has been developed to support gastrointestinal health. It contains three species of Lactobacilli, three species of Bifidobacterium and one species of Streptococcus bacteria. Participants will be asked about their general wellbeing at the beginning and at the end of the study. They will also be asked to keep a record of intestinal symptoms. A stool and a blood test will be required at beginning and at the end of the study. Chemotherapy is associated with mucositis manifesting as pain, inflammation, diarrhoea, weight loss, and infection. It is hoped that this research will help improve the general wellbeing of patients during chemotherapy.

The aim of this study to assess the effectiveness of an online cognitive behavioural program (myCompass) versus a health education program for 6 weeks at reducing concerns about falling in community-dwelling older people. The primary outcome (concern about consequences of falling) and secondary outcomes (concerns about falls, balance confidence, activity avoidance, depression, anxiety, health literacy and physical activity) will be measured in the form of a randomised controlled trial.