ANZCTR search results

Macular oedema that is secondary to central retinal vein occlusion (CRVO) has conventionally been treated with laser photocoagulation. The outcomes of this treatment show a slight improvement in visual acuity. Recently various therapeutic agents such as Triamcinolone, Pegaptanib, Bevacizumab and Ranibizumab have been injected intravitreally into the eye. Bevacizumab and Ranibizumab in particular have been shown to reduce macular oedema in the short term, however, repeated injections are required. The Central Vein Bypass Study, where a high intensity laser is used to create an anastomosis between the a retinal and a choroidal vein as a means of bypassing the obstruction to venous flow (L-CRA), is the only study to date that has addressed the causal pathology of macula oedema secondary to CRVO, rather than simply addressing the sequelae of the retinal venous obstruction. Patients who received the L-CRA had significantly improved visual acuity compared to the sham L-CRA treatment group. In this study patients will either be treated with the L-CRA or sham L-CRA. Both groups will receive monthly injections of Ranibizumab for 6 months. Patients will be assessed for a further 18 months, and may/may not receive further injections depending on whether the retreatment criteria have been met. The primary aim of the study is to show that L-CRA treated patients will require fewer Ranibizumab injections in the 12-24 month phase of the study compared to sham L-CRA treated patients. The use of Ranibizumab in the short term and the long term treatment effects of the L-CRA may prove to be an effective treatment for macular oedema that is secondary to CRVO. A recent study showed that 56% of patients had persistent macular oedema requiring an average of 5.9 injections in the 4th year. The study protocol has been amended to follow the two treatment groups bimonthly or once every four months for a further 24 months. Patients will be assessed according to the retreatment criteria for further injections. The extension study will provide long-term follow up data.

The majority of individuals with spinal cord injury (SCI) have neurogenic bowel dysfunction. Severity of the condition is dependent upon the completeness and the level of lesion. Constipation and faecal incontinence are common problems experienced by individuals with SCI and have significant impact on their physical, social and psychological lives. People with SCI rate bowel care as one of the most disabling aspects of SCI and of more importance to them than the inability to walk. It is therefore appropriate that research attention be directed at improving bowel care. People with SCI claim that regular standing improves bowel regularity and bowel function. However, there is no high quality evidence to substantiate these claims. A recent Cochrane review noted that there is still limited research on the management of neurogenic bowel dysfunction and it is not possible to draw any recommendation from the trials included in the review. It is important to determine whether regular standing is therapeutic because it is a costly and time consuming activity. Hence the primary aim of this study is to determine the benefits of regular standing on bowel function in people with spinal cord injury or lesion. The null hypothesis is that regular standing will have no effect on bowel function in people with spinal cord injury or lesion.

Acute renal failure is a common and serious postoperative complication of orthotopic liver transplantation. The reported incidence ranges from 17% to 95% and severe renal failure requiring renal replacement therapy occurs in 5% - 35% of patients after transplantation. Renal failure requiring haemodialysis post liver transplant, irrespective of pre-transplant dialysis status, is a profound risk factor for death. Identifying the risk factors for renal dysfunction after liver transplantation and developing therapeutic approaches to prevent, halt, or ameliorate de novo renal dysfunction or retard the progression of preexisting renal dysfunction should be fundamental goals in managing these patients. Sodium bicarbonate is a drug in common use for the prevention of contrast nephropathy and has been shown to be effective in preventing acute kidney injury in patients undergoing cardiac surgery. It is used to effectively treat severe metabolic acidosis in critically ill patients. It is possible that sodium bicarbonate might reduce the oxidative stress which occurs during liver transplantation and so decrease or prevent acute kidney injury in these patients. This is an investigator initiated, pilot, double-blind, randomized controlled trial. The purpose of this study is to determine whether administration of sodium bicarbonate reduces the risk of kidney injury, and also reduces some of the cellular changes and oxidative stress known to cause kidney injury after orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplanation will be randomized to receive either sodium bicarbonate or placebo for the duration surgery. Primary outcome: a rise in the serum creatinine to > 1.5 times the baseline value or decreased GFR > 25% (RIFLE class ‘R’) measured 72 hours postoperatively. Secondary outcomes: To examine changes in peak serum and urinary NGAL and peak serum cystatin C (sensitive biomarkers of acute renal injury) compared to baseline, peak changes in delta creatinine, acid– base status. Other outcomes collected will include duration of ICU stay, duration of hospital stay, all adverse events including institution of renal replacement therapy and hospital mortality. Recruiting hospitals: Austin Hospital Number of participants planned: 60

This pilot study aims to assess the effects of a daily moderate amount of resveratrol-enhanced red wine on cognitive performance in older adults. This is a preliminary study to determine if a 100mg dose of resveratrol in wine has clinically significant effects on cognition.

Currently there is no treatment for the common liver condition NASH. Vitamin D has effects which can act against inflammation and scarring in the liver, which are important in the development of NASH. This study will assess high-dose vitamin D as a treatment for NASH.

This study is aimed at looking at the physiology of sleep in patients with lung fibrosis. Investigators are particularly interested in those people whose oxygen levels fall during sleep, and the role of giving supplemental oxygen in such cases. The hypothesis is that supplemental oxygen during sleep improves a number of health domains, including quality of life, sleep quality, blood flow in the lungs and strain on the heart. Subjects will receive oxygen (or air) during sleep via nasal prongs for 4 weeks. They will then undergo an overnight sleep study. After a two-week "washout" period, they will then receive air (or oxygen) through nasal prongs for 4 weeks, followed by another sleep study.

This is a study looking at exercise physiology in people with lung fibrosis. In particular, investigators are interested in the role of oxygen in exercise endurance, maximal exercise levels, and in its effect on reducing strain on the heart. Participants will perform endurance exercise tests and maximal exercise testing on both air and oxygen. The hypothesis is that oxygen will improve endurance and reduce strain on the heart. This study will form the basis for future trials that examine the benefits of supplemental oxygen over longer periods.

A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being ‘at risk’. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity), and all such risks combined, will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken prior to and following the intervention with randomly selected samples of clinicians from each facility group to assess the reported provision of preventive care, and the acceptability of the practice change intervention and implementation.

This study aims to prospectively explore the anatomical and biological characteristics of non-small cell lung cancers (NSCLC) in patients receiving combined radiation therapy (RT)-chemotherapy treatment with a curative intent. Patients will undergo PET/CT scans during the course of their treatment using two different PET tracers. The first tracer, 18F-FDG, is a proven tracer in current clinical use used to detect glucose metabolism. The second, 18F-FLT, is a novel tracer that can visualize cellular division rates in tumour compared to normal tissue.

Over the last 15 years mindfulness and acceptance therapies have taken hold in psychology as a new era of treatment. Acceptance-mindfulness therapies differ from traditional cognitive behavioural therapies (CBT) in that rather than attempting to change the content, frequency and form of thoughts and feelings, acceptance or mindfulness-based therapies seek to change the functions of thoughts, feelings and physical sensations so as to minimise their impact. While there is growing empirical support for the utility of acceptance-mindfulness treatments for adults with anxiety and other psychological problems, very little research has been conducted on children evaluating its effectiveness despite the growing use in children and adolescents. This study aims to conduct a controlled clinical trial evaluating the efficacy of acceptance-mindfulness therapy for children with anxiety disorders. Children aged 7-17 years will be randomly allocated to one of 3 groups: acceptance-mindfulness integrated with cognitive behavioural therapy, cognitive behavioural therapy only, and a waiting list control group. Repeated measures of psychological outcomes will be taken pre, immediate post and 3 months post-treatment. Parents will also undertake group therapy sessions while the children are undergoing therapy to assist children transfer the skills to everyday life.