ANZCTR search results

The aim of this project is examine non drug methods of relieving breathlessness. We will also examine the effects of the non drug interventions on anxiety, depression and quality of life in this patient population with severe chronic obstructive lung disease. We will ask all patients attending the breathlessness clinic to participate. They will be randomly assigned to either start the interventions for breathlessness immediately or delayed start in 8 weeks. All patients will receive current standard of care. They will be asked to complete questionnaires, wear a pedometer (step counter), and to undergo breathing and walking tests. We hope that we can prove non drug management of breathlessness is possible in this patient population.

This study is designed to investigate the pharmacology of MTC896 Gel in otherwise healthy female participants with oily skin. In this study, MTC896 Gel will be applied at 1 concentration, twice daily (bid) for 4 weeks to the postauricular region (behind the ear) a region known to be rich in sebaceous glands. Participants will be required to administer study drug at home, other than when applications coincide with study outpatient visits. All participants will be required to attend a screening visit, at which skin oilyness will be measured with a Sebumeter (a non-invasive skin probe), If participants are deemed eligible for the study, a small biopsy will be collected from the post auricular region. Study participants will be shown how to administer study drug, and will be discharged with study medication for home dosing. Participants will be asked to record their doses and any symptoms in a diary during the 28 day follow up period. Participants will be asked to return for an outpatient visit after 14 days, then a final follow up visit at 28 days. At the final follow up visit a second biopsy sample will be collected from the post-auricular region, and sebum (oil) levels will be evaluated with a sebumeter. It is hoped that the results of this study will provide evidence that MCL16001 is able to reduce skin oiliness, and may therefore be useful in the prevention and treatment of acne.

Smartphone apps are an effective way to provide health services to the community. The current study will investigate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts. Participants will install and set up their safety plan using the BeyondNow app with a telephone support service counsellor. The app will remain installed on participants' phones for the subsequent 6-weeks. Opinions on the integration of the BeyondNow app into the telephone support service will be collected. How the participants use their apps, as well as measures related to suicide (suicide coping, hopelessness, perceived burdensomeness, and emotional and physical pain) will also be collected over the 6-week trial.

In Australia, between 60-80% of all residents in aged care facilities (RACF) have dementia. Rates of behavioural and psychological symptoms of dementia (BPSD) amongst people living in RACF are high with over 90% of Australian RACF residents exhibiting clinically significant BPSD. Physical aggression, agitation, wandering and disinhibition, especially when severe, are difficult to manage and can put residents, carers and other residents at risk. Likewise apathy and depression cause considerable discomfort to residents and require a skilled approach to manage effectively. Management of BPSD has recently become a focus of attention for the Australian Government, especially in relation to inappropriate overprescribing of antipsychotics. International good practice guidelines recommend the use of non-pharmacological interventions as the first-line of treatment for BPSD, while pharmacological interventions are considered second-line treatments. Despite little evidence of effectiveness and high rates of adverse effects, including increased morbidity and mortality, pharmacological methods are still commonly used to manage BPSD. The discrepancy between international and national recommendations and the continued over-prescription of medication to manage BPSD must be addressed. This project will evaluate the efficacy of BPSDplus, a person-centred intervention program developed to reduce the prevalence of BPSD and medication use in Australian RACF. This program will equip Australian staff working within RACF with the specialised training and skills needed to provide care proactively for all residents with BPSD and improve quality of life for residents, carers and relatives. The BPSDplus program offers a proactive, rather than, as at present, reactive response to BPSD. The unique contribution of this research is the evaluation of the impact of the BPSDplus program on RACF staff, their attitudes towards dementia care and quality of interactions with residents.

As Prolonged grief disorder (PGD) is known to persist without appropriate treatment, it is imperative to identify those at risk of PGD and to develop effective treatments. Treatments for PGD thus far are largely based on the cognitive behavioural model and there is a mounting research demonstrating its effectiveness; however, these CBT-based interventions have several components and little is known about which components are essential to alleviate PGD symptomatology (Jordan and Litz, 2014). There is a need to clarify which bereaved individuals are likely to benefit from which types of interventions. Furthermore, given that rumination, avoidance, and disengagement are key maintaining mechanisms of PGD, studying the effects of BA will provide a clearer understanding about the possible underlying maintaining mechanisms underlying post-loss psychopathology. Additionally, many CBT-based grief treatments have required long treatment protocols and while longer protocols of BA have demonstrated preliminary evidence of reducing PGD symptomatology, few studies have investigated whether the same benefits are possible with a briefer BA protocol. As such, the current study seeks to examine the feasibility of a 6-week intervention of BATD-R among two bereaved individuals with PGD and explore patterns of symptomatic and functional change based upon weekly measures to monitor symptoms and track the hypothesised mechanisms of change. It was hypothesised that: (a) BATD-R will result in pre-post decreases in post-loss psychopathology including PGD, Post-traumatic stress disorder (PTSD), and Major Depressive Disorder (MDD) symptomatology, and (b) activation will be the mechanism of change underlying reductions in rumination, disengagement, and avoidance. If the current 6-week intervention is effective in reducing PGD symptomatology, this may provide a platform for advancing the development and implementation of brief behavioural activation interventions for PGD.

There is currently no literature on the use of far cortical locking screws when compared to standard locking screw constructs in human patients, we know of one RCT currently in progress with Canadian Orthopaedic Trauma Society (COTS). The COTS study will look at the treatment of distal femoral fractures using Zimmer MotionLoc screws versus standard locking screws in all age groups and include high impact trauma cases. This study proposes to look more specifically at callus formation and fracture healing in older patients treated with FCL versus standard locking plate fixation, with the inclusion of peri-prosthetic distal femoral fractures. Fixation in these fractures is generally more challenging and therefore it is of interest to establish whether FCL is a valuable option also for these cases. Fracture healing by secondary healing with bridging callus formation will be the principal measurable outcome to demonstrate the potential differences in fixation between FCL and standard locking screws.

Up to 50% of OSA patients are unable to tolerate CPAP therapy leaving many OSA patients without treatment. Mandibular Advancement Devices are a suitable alternative for many patients however, as individual responses to MAD vary, combination therapies including CPAP-MAD are increasingly considered as an alternative therapeutic option and may result in lower pressure requirement and improve tolerance. The present study aims to: 1. evaluate MAD response as a function of nasal resistance and 2. evaluate the impact of combination therapy on pressures required to stabilise the upper airway, in participants who are non-responders to MAD treatment alone.

This study will investigate the effectiveness of Quittr, a smoking cessation app. Who is it for? You may be eligible to join this study if you are a current smoker interested in starting a quit attempt. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have access to full features Quittr, which include health and financial statistics, educational/behavioural support content, an achievement system, and novel game features. Participants in the other group will have access to the same features except the game. After 28-days the study will end, but participants will continue to have access to the full featured version of the app indefinitely. Participants will be prompted to indicate how many cigarettes they smoke each day, and usage data will be automatically recorded to a web service. Smoking activity, engagement and retention of users will be determined after the 28 day trial window closes. Participants who indicate they have successfully quit smoking at the end of the trial will optionally be able to demonstrate this using a self-administered cotinine urine analysis test strip. Volunteers will be posted an simple test kit, asked to photograph the result strip, and return the photograph by email. In return, the volunteer will be granted a $40 gift card as remuneration.

This study will help to better understand the effect of empagliflozin on the sympathetic nervous system in people who have pre­existing cardiovascular disease. The sympathetic nervous system regulates heart rate, controls blood pressure, regulates sweating and release of glucose from the liver. The primary aim is to answer this question: *What effect does empagliflozin have overall on the sympathetic nervous system? The secondary aims are to answer these questions: *What effects does empagliflozin have on the sympathetic nervous system activity in the heart, kidney, muscle and sweat gland? *What effects does empagliflozin have on pressure in the heart and on heart muscle contraction and relaxation? *What effects does empagliflozin have on glucose and metabolite levels? The study is a randomised trial with 18 people per arm: *Group 1 ­ empagliflozin *Group 2 ­ placebo Total length of study participation will be approximately 19 weeks, i.e. a screening period and baseline assessment period that will last up to 3 weeks, a treatment period lasting 12 weeks, and a safety follow­up period lasting 4 weeks. There will be up to 9 study visits. During this study, there will be medical history and medication reviews, physical examination, assessment of blood pressure, heart rate and weight, collection of blood and urine. To answer the primary aim, there will be baseline and end of treatment kidney and heart noradrenaline spillover studies and arteriovenous metabolite gradient sampling. This involves sampling from a vein in the back of the hand or arm, from a small tube in the artery in the arm, and from a catheter placed via a vein in the arm, to sample the blood in the heart vein, kidney vein and liver vein. To assess accurately the rate of noradrenaline release from the heart and the kidneys into the bloodstream, a small amount of a radioactive substance will be infused continuously at a low rate through the tube in the arm vein. In the same tube, there will be infused a chemical called para aminohippuric acid (PAH) to measure the kidney blood flow. To answer the secondary aims, there will be baseline and end of treatment tests of electrocardiogram, echocardiogram (heart ultrasound), questionnaires on general health, anxiety and depression, Sudoscan (nerve activity related to sweating), ankle brachial index (which assesses the blood pressure in all 4 limbs), nerve activity testing in the calf muscle, and a maximum exercise capacity test on a stationary bicycle.

Endometriosis is the leading cause for pelvic pain in women and is also associated with infertility. Twenty percent of patients with endometriosis suffer from Deep Infiltrating Endometriosis (DIE), defined as solid endometriotic masses situated deep in the peritoneum. Laparoscopic surgery is a very common treatment for DIE, however, its implications on future pelvic organ function are not yet clear. The overall aim of our research is to investigate the influence of laparoscopic surgery for DIE on bowel, bladder and sexual function. We further aim to compare the effect of different surgical approaches on bowel and bladder function after bowel surgery for DIE. Our hypothesis is that extensive and radical surgery for DIE (such as bowel resection) will be found to be associated with long-term adverse bladder and bowel function and that less radical surgical approaches (such as bowel shaving) would be associated with lower rates of bladder and bowel dysfunction. The Royal Women’s Hospital is one of the largest women’s health institutes in Australia and is a major referral center for patients with pelvic pain and endometriosis. Patients will be recruited in the outpatients clinic and through the private rooms of the investigators in Frances Perry House and Epworth Richmond. Questionnaires will be filled before and at three points of time after surgery (6 weeks, 6 months, 1 year). Up to date, there is very scarce data regarding long term function after laparoscopic surgery for DIE and some of it is contradicting. This study intends to recruit a significant amount of patients in order to shed light on this question. The data collected in this study will allow us to better council patients before undergoing major surgery for DIE.