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The ROC study aims to compare the effectiveness of a new model of eye care (Residential Ocular Care) with the Usual care received in aged care homes on presenting and best corrected near and distance vision. It will also assess the effectiveness off ROC on various aspects of quality of life, depression, rate of falls and eye care utilisation.

A quasi-experimental study will investigate whether provision of pork, a rich source of dietary thiamin, as the main protein source in meals four times a week for 12 weeks will result in improved muscle mass, body strength and cognitive function in healthy community-living older adults.

This is a first in human study to evaluate the safety, tolerability and performance of a new vaccine delivery device. The sponsor is developing a novel approach for the administration of vaccines that does not require the use of needles. Small nanopatches patches designed to carry the vaccine are applied to the skin and kept in place for 2 minutes. This study will assess how safe and acceptable these nanopatches are.

Surgery provides the most efficient method of weight loss in severely obese patients, but also leads to malabsorption of micronutrients. Sleeve gastrectomy is a purely restrictive procedure and removes the greater curvature of the stomach leaving a small gastric sleeve. Advantages include rapid weight loss, comorbidity reduction, and avoidance of the complications seen in bypass procedures. Nutrient deficiency in this patient group is common, with Vitamin D deficiency reported in 21-80% of patients one year post-surgery. This may predispose these patients to poorer health outcomes, as inadequate Vitamin D levels have been associated with disruptions to calcium homeostasis, impaired bone metabolism and osteoporosis, cancer, insulin resistance, diabetes, cognitive dysfunction, depression and cardiovascular disease. However, there is also current debate around whether Vitamin D levels are a marker for, rather than a cause of chronic illness. It would be expected that stored Vitamin D in the extensive adipose tissue of these patients would help correct deficient levels as weight is lost, although there is no evidence to support this in the literature. It is possible that these patients have: (i) excess storage and potential dysfunctional metabolism and release of Vitamin D from adipose tissue; (ii) lower sun exposure and dietary intake due to lifestyle factors, or (iii) impaired synthesis and release from the skin. These mechanisms are unclear, and there are few published studies about treating Vitamin D deficiency post-surgery in this patient group and no consensus on recommendations for supplementation dosage and duration for gastric sleeve, or indeed any of the bariatric surgeries. This emphasises a significant gap in patient care recommendations. There is currently insufficient evidence to support the development of uniform supplementation guidelines post-surgery for patients undergoing bariatric surgery, and data for sleeve gastrectomy patients is most lacking, therefore protocols for supplementation are only consensus-driven. Further understanding the effect of supplementation in gastric sleeve patients is critical, as two recent studies have suggested Vitamin D supplementation may cause net harm in other groups and a recent systematic review confirmed little to no association between 25(OH)D levels and the course of a range of diseases/conditions shown to be associated with low 25(OH)D levels in epidemiological studies (e.g. cancer, insulin resistance, diabetes, cognitive dysfunction, cardiovascular disease). Current reasoning behind this null effect includes variations in baseline levels, body mass index and genetic variations in response to supplementation. There is significant individual variation in 25(OH)D levels pre-bariatric surgery, with most patients being deficient (<25nmol/L) or insufficient (<50nmol/L). There is also evidence for varied responses to set doses of Vitamin D3 post surgery however there is no data on this for patients undergoing sleeve gastrectomy. Genetic variation in the Vitamin D binding protein and the Vitamin D receptor in target tissues has been implicated in such variation in obese individuals. The current test for Vitamin D – serum 25(OH)D levels – does not account for this potential genetic variation, or for individual variation in Vitamin D metabolism (i.e. production of active metabolites) in tissues. Measuring the variation in genes for the Vitamin D binding protein and Vitamin D receptor alongside the response to Vitamin D supplementation would add clarity to the variations in responses to Vitamin D supplementation in order to determine evidence-based supplementation guidelines. The mechanistic work completed as part of this study will form the basis of future clinical trials to optimise supplementation strategies for these patients. In addition to the lack of understanding of the basis of 25(OH)D levels and supplementation response in sleeve gastrectomy patients, there is no evidence of the contribution of UV exposure and diet on Vitamin D status in these patients. As UV exposure plays an important part in endogenous production of Vitamin D, this is vital. In a group with already restricted intake and a higher risk of nutrient deficiencies, understanding the influences on Vitamin D intake and production are critical to optimising sun exposure, dietary intake and supplementation practices. Aims *To optimise patient outcomes post gastric sleeve surgery by achieving adequate and sustained 25(OH)D levels through individualised supplementation (usual care) *To establish the variation in 25(OH)D levels in patients undergoing gastric sleeve surgery before and 6, and 12-months after surgery to monitor the effect of usual care supplementation practices *To examine differences in 25(OH)D levels in patients before and 6 and 12-months after gastric sleeve surgery according to direct and indirect measures of sun exposure, detailed dietary intake data, genetic variation in the circulating Vitamin D binding protein and Vitamin D receptor, to provide pilot data on the variation of individualisation required in future supplementation practice

Traumatic Brain Injury (TBI) can lead to fundamental changes in a person’s ability to function day-to-day. The development of cognitive impairment is a particularly common and disabling consequence. As such, rehabilitation of cognition is an important part of post head injury treatment but current standard cognitive rehabilitation (consisting of either re-training / remediating impaired abilities) has generally resulted in only modest improvements in functioning. Our study will explore an innovative approach to repairing cognitive functioning following TBI that combines biological modulation of neural systems with behavioural remediation. We will combine transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training and examine the effectiveness of this combination using a Randomised Controlled Trial design. The ultimate aim of this research is the development of an effective targeted treatment for cognitive impairment following TBI to allow for a more complete recovery following injury.

The aim of this study is to recruit and educate participants with obsessive-compulsive disorder using a 5-lesson education program administered via the Internet. Participants in the Internet self-guided group begin the program immediately, and their results will be compared with a waitlist control condition. To understand who responds best to a self-guided education, participants will complete various measures assessing variables such as self-efficacy, reason for compulsion, type of obsession, level of disgust, readiness to change and emotion regulation deficits. Participants in Group 2 will receive access to the education program when Group 1 completes post-education assessments (Week 9). Both groups will be followed up at 3-,12-, and 24-months post-education.

This study aims to identify changes in the genes and proteins within the ovarian cancer tissues. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above presenting at Royal Women's Hospital or the Peter MacCallum Cancer Centre with recurrent epithelial ovarian cancer (including peritoneal and fallopian tube cancers), regardless of histological subtype. Study details: All participants in this study will be required to undergo a biopsy procedure on a single occasion to obtain a tumour tissue sample, or have archived formalin-fixed, paraffin-embedded tumour tissue retrieved from pathology laboratory archives. A blood sample will also be drawn. The samples will then be analysed using a next generation sequencing panel targeted to ovarian cancer. Initially, our work will focus on getting a better understanding of the specific types of changes in ovarian cancer. Over time we hope to use that information to design and implement better treatments for women with ovarian cancer. No treatments will be administered as part of this study. This study was designed to enable women with advanced ovarian cancer to be rapidly selected for clinical trials of targeted therapies.

BACKGROUND It is well established that emergency workers have increased rates of psychiatric morbidity, which is presumed to be related to their regular exposure to potentially traumatic events. However, to date there is very limited information regarding what strategies may enhance psychological resilience among emergency workers. The RAW program has been developed in close consultation with the emergency services, meaning the findings of the evaluation study are likely to have direct translational benefits. It is anticipated that an engaging and interactive online program will help address the issue of accessibility and delivery that NSW Fire and Rescue faces in terms of offering psychological training and support to their workers. This program differs markedly from the first generation of online therapy programs, which have typically involved the reproduction of cognitive therapy manuals into an online format. Rather than sifting through wordy paragraphs on a website, the RAW Mind program will involve the worker in a highly interactive process of learning by utilising a combination of video vignettes, interactive exercises, audio and animation. To ensure the training is memorable, it will be delivered in a series of six short, attention-grabbing segments, running no longer than 20 minutes. The program will provide firefighters with quick access to a range of adaptive skills, which could enhance their ability to manage stress and cope with trauma more effectively. These core skills are derived from the principles underpinning a number of evidence based cognitive therapies including Acceptance and Commitment Therapy (ACT) and mindfulness based Cognitive Therapy (mBCT) and Mindfulness based Stress Reduction (MBSR). Aims and Objectives The proposed study seeks to examine the effectiveness of a new online mindfulness-based resilience program for emergency workers. Specifically, it will examine whether a combined program of mindfulness training, evidence-based cognitive therapy skills and psychoeducation will increase overall psychological resilience and well-being of emergency workers. Hypotheses: The study will evaluate the effectiveness of the RAW Mindfulness Program to test the following hypotheses: 1. There will be no difference between the intervention and the control group at the point of baseline 2. At baseline, participants with greater mindfulness scores will have higher resilience and bounce-back resilience scores 3. Post training, the intervention group will report higher levels of resilience, bounce-back resilience, and well-being and lower levels of psychological symptoms and maladaptive coping strategies. 4. These differences will be maintained at 6 month follow up If all of the above hypotheses are confirm, this would provide substantial evidence that combined mindfulness training, cognitive therapy skills and psychoeducation is not only useful in terms of building psychological resilience but is also capable of changing firefighters ability to cope and manage stress in an effective and positive way. This project will represent the first ever published RCT of resilience training amongst emergency workers. This resilience program, has been developed in close consultation with the FRNSW, meaning the findings of the evaluation program are likely to have direct translational benefits in terms of informing future prevention programs for emergency services personnel.

This is a phase 1 proof of concept trial measuring the effect of a novel intranasal stent and tolerability of an expiratory positive pressure device on subjects with moderate obstructive sleep apnoea. Hypothesis: The combination fo dilation of the nasal cavity with an intranasal stent combined with a valve that increases pressure to the upper airway on expiration will favorably effect moderate sleep apnoea and snoring.

The primary purpose of this study is to determine whether Metformin and Atorvastatin (taken alone or together) improve outcomes for men with prostate cancer in terms of the aggressiveness and the biology of their cancer Who is it for? You may be eligible to join this study if you are aged 40 to 80 years, have a PI-RADSv2 (Prostate Imaging-Reporting and Data System) score of 4 or 5 and proceed to prostate biopsy with an intention of having a prostatectomy for confirmed high-risk prostate cancer. Study details Metformin is a medication commonly used in the treatment of Type 2 Diabetes to lower blood sugar levels and Atorvastatin is a common cholesterol lowering medication. Previous research has found that people who take these Metformin are less likely to have prostate cancer and those who take Atorvastatin are more likely to have less dangerous prostate cancers. Participants in this study will be randomly allocated (by chance) to one of four groups. The four groups will be divided as: 1) Placebo; 2) Metformin; 3) Atorvastatin; and 4) Metformin and Atorvastatin. You will have to take oral capsules three times a day for 6 weeks and all parties will be blinded regarding patient treatment allocation. Patient outcomes will then be assessed through blood, urine and tissue samples provided before the treatment starts and 6-8 weeks after as well as through medical imaging for some patients. It is hoped that the findings of this pilot trial will serve to help other men after they have had diagnostic prostatic biopsies showing prostate cancer, through providing evidence for a treatment that reduces the aggressiveness of their cancer, although this will need to be established in larger studies.