ANZCTR search results

To investigate the effectiveness of the adjunctive role of DHA omega-3 in outpatients with chronic anxiety and depression.

The primary purpose of the study is to assess left ventricular hypertrophy prevention at 1 year after heart transplantation with everolimus in combination with low-dose calcineurin inhibitors compared to full-dose calcineurin inhibitors.

Of the one in four young people who are diagnosed with mental disorders, only 35% seek professional help. There are many barriers preventing young people from seeking help such as: lack of recognition of mental health problems, lack of awareness about appropriate mental health services, readiness to seek help, and the stigma associated with mental illness and seeking professional health. Technological solutions have been identified as one of the key areas that should be utilised to improve treatments and access to care. Young people often seek information about health online and often prefer anonymous sources of help to traditional services. Nevertheless, despite the broad interest and vast amount of online services available to assist young people with mental health problems, evaluation is rarely conducted to determine the impact of online services on help-seeking. Focusing particularly on young adults aged 18 to 25 years, we aim to investigate the effects of a dedicated online tool to facilitate help-seeking in young adults compared to usual search strategies. All surveys and recruitment will be conducted online. Young adults will be asked to complete three surveys at baseline, one week, and one month. This project is of international relevance as one of the first dedicated online tool to facilitate help-seeking for young adults and one of the few to evaluate access to care as an outcome. It will also help inform policy and practice with evidence on whether technical solutions can increase help-seeking for young adults using a stepped-care approach.

This study aims to examine the moderating impact of baseline attentional bias on the relative efficacy of two brief interventions: mindfulness vs distraction. Participants will have their attention biases towards painful stimuli assessed and will then be randomized to receive either distraction or mindfulness before completing two experimental pain tasks.

To assess the effectiveness of butyrylated high amylose maize starch (HAMSB) in reducing gastrointestinal symptoms in volunteers suffering a functional bowel disorder. Aim 1: The primary aim is to determine if ingestion of HAMSB reduces symptoms in subjects that suffer a functional bowel disorder HAMSB. Aim 2: The secondary aim is to determine the effect of HAMSB on blood inflammatory markers and faecal microbiota in subjects suffering a functional bowel disorder.

AF is a major health and economic burden. Post-operative AF is thought to be mainly transient and reversible, however, there is very limited information about how often it may recur. Some research suggests it affects up to 8% of patients in the two years following surgery, but this is likely an under-estimate of the actual rate, as AF is often asymptomatic and there is no routine surveillance. The rationale for this study is to determine if a brief intervention increases knowledge about AF symptoms and whether a simple iPhone based handheld ECG device could be utilised to identify AF when recordings are obtained by post-operative cardiothoracic surgical patients.

This is a multi-centre (RDH and ASH), phase IV, double-blind, randomised, placebo-controlled trial of oral NTZ for the treatment of acute gastroenteritis requiring admission to hospital. Up to 300 children aged between three months and less than five years of age will be enrolled. Study participation would be from the point of enrolment until 60 days after enrolment. Enrolment will occur within 48 hours of admission to hospital. Enrolled participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo. Other treatment and management will be as per the standard of care described in the admitting hospital’s guidelines and will be ultimately the decision and responsibility of the named medical consultant. Stool samples will be collected at the point of admission. Solicitation of symptoms will be by review of routinely collected medical data recorded in the participant’s medical record, and will be supplemented by completion of study specific diary cards until discharge. All participants will be followed up at day 7 after enrolment (by telephone if already discharged) to ascertain symptoms occurring in the intervening period. At days 30 and 60 after enrolment a clinical record review will be conducted for all participants to ascertain health care attendances following discharge.

Paediatric split skin grafts leave a donor site, requiring a dressing. The optimum dressing for this site is the subject of much discussion and debate amongst burns clinicians. In our unit there are currently three dressings in regular use. We therefore have equipoise to undertake a randomised controlled trial in an effort to determine which is the best of the three. Outcome measures we will be examining relate to both patients and staff. These outcomes include pain and itch while the dressing is on ease of application, care, and removal time to reepithelialisation cost cosmetic appearance of the donor site There are a number of such trials in the literature. None of them have directly compared our three dressings (algisite, cuticerin, sorbact). Few of the trials in the literature have looked at children, so the answer is not already in the literature. By using real world controls we hope to find the optimum dressing in our environment. This will become our new preferred dressing, and will naturally then become the new control against which we will measure the performance of newer products that will inevitably come onto the market in subsequent years. Patients will be randomised to one or more of the three arms of the study, without them or the assessing staff being aware of the contact dressing. We will then measure outcomes with the above aims in mind; using previously validated scoring systems examining the responses of parents, patients and staff members. We will use both qualitative and quantitative assessment methods.

The study is evaluating the efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL). Who is it for? You may be eligible to join this study if you are aged 65 years and older, have documented CD20+ B-cell CLL according to NCI/IWCLL criteria, previously untreated CLL requiring treatment according to NCI/IWCLL criteria, CIRS score >= 6, an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at screening, able to comply with study protocol procedures and a minimum of 14 months of follow-up, and a life expectancy of at least 6 months. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive obinutuzumab (GA101) combined with fludarabine and cyclophosphamide (G-FC3). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Fludarabine will be administered orally, 24mg/m2 day 1-3 cycles 1-6. Cyclophosphamide will be administered orally, 150mg/m2 days 1-3 cycle 1-6. Participants in the second study group will receive GA101 with chlorambucil (G-Clb). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Chlorambucil will be administered orally, 150mg/m2 days 1-3 cycle 1-6. A treatment cycle is 28 days in length. A maximum of 6 cycles of therapy will be administered to each patient.

Glaucoma is a progressive disease of the optic nerve, which if undiagnosed, can lead to blindness. Surgery is often reserved for very severe cases and as such, surgical success is imperative. Our project will address this by performing a randomised double blinded assessment of the adjunctive use of intraoperative intravitreal bevacizumab (Avastin), a currently available and widely used anti-VEGF drug, on post-operative glaucoma surgery success. If this intervention is successful, the outcomes could undoubtedly influence future surgical management.