ANZCTR search results

The primary purpose of this study is to analyse the differences in language used by clinicians and melanoma patients of different socioeconomic statuses (SES) and between male and female patients. Who is it for? You may be eligible to take part in this trial if you are aged 18 or over and have been diagnosed with melanoma for which you are scheduled to attend your first consultation at one of the study sites. All participants enrolled in this study will have a single consultation with their clinician (surgeon/oncologist/nurse, etc.) audio recorded. This audio recording will then be analysed for different types of language used, including phrasing of questions, the control of 'turn taking' and expression of degrees of probability. Researchers will then look for patterns between patients of low and high SES, and between males and females. It is hoped that the findings from this study will provide information on the communication used by clinicians with melanoma patients, and how this communication differs between people with different SES statuses, and between men and women.

Advance Care Planning (ACP) is a process of reflection, discussion and communication that enables a person to plan for their future medical treatment and other care, for a time when they are not competent to make, or communicate, decisions for themselves. ACP could significantly improve the quality of care provided to patients with advanced illnesses. ACP allows patients to have a voice, to receive patient-centred care, in the setting of their choice, and avoid unwanted hospitalisations and inappropriate treatments. The importance of ACP in patient care has been widely recognised. The Australian Government National Health and Hospitals Reform Commission (2009) recommended the implementation of a national program of ACP in Australia. ACP has been widely endorsed by a large number of professional groups, specialist colleges, peak bodies and patient advocate groups. The NSW Health’s policy on ACP is outlined in the 2013 document ‘Advance Planning for Quality Care at End of Life: Action Plan 2013-18’. Among others, it shows that NSW Health’s priority is to: (i) incorporate ACP into routine care; (ii) educate health professionals in both conducting and responding to ACP; and (iii) improve collaboration between NSW clinical services and community and primary care health professionals. The policy also noted deficiencies that currently exist in NSW Health clinical services in identifying and recognising patients who might be at risk of dying in the near future. The intervention is informed by the Diffusion of Innovation Theory. This theory states that for innovation to be taken up, five conditions need to be met - relative advantage, compatibility, complexity (how difficult the innovation appears), trialability and observability (whether positive outcomes of the innovation can be observed). This means that didactic education sessions alone are unlikely to be sufficient to lead to significant increase in ACP undertaken by health professionals. This intervention will allow clinical services to ‘see’ a few, ‘do’ a few, and ‘teach’ a few, thereby embedding ACP firmly into routine care of patients. GPs of participating patients will be exposed to ACP documents and information material; the chance of them engaging with the educational material is significantly increased because they relate to their own patients. This research aims to trial and evaluate on patients attending NSW hospital clinics with advanced illnesses identified as potentially having supportive and palliative care needs, a model of ACP that seeks to: (i) increase the uptake of ACP by patients; and (ii) encourage NSW Health clinical services and GPs and other health professionals providing care for the patients to incorporate ACP into routine care. This study seeks to determine if this model of ACP will reduce acute health resources utilisation; improve the quality of care for patients and caregivers/family; and result in improved understanding and uptake of ACP by health professionals.

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for men. The study aims to evaluate a comprehensive online training program for managers in male-dominated industries to determine its effectiveness in modifying manager's behaviour, improving mental health literacy, reducing stigma and enhancing managers’ confidence in discussing mental health matters with their staff. Managers have a key role in the well-being of their staff. They often become involved when a staff member is having difficulties and should always have a role once someone is away on sickness absence. However, managers often report feeling unsure what to do when a staff member is ill, particularly if they are suffering from a mental illness. These problems are amplified in male-dominated industries, where there is culture that makes discussing emotions difficult or impossible. Together with our collaborators, we have recently developed two new types of face-to-face manager training for male-dominate industries; one focused on how depression may present in a male dominated workforce and helps managers develop the skills and confidence to have conversations about emotions with their staff, while the other focuses more on primary prevention via teaching managers how they can modify work-based mental health risk factors, such a job demands, job control and perceived support and promote the positive aspects of work. We propose that a combination of these two approaches would provide a comprehensive manager mental health training that would simultaneously address mental health literacy, stigma reduction and promote primary, secondary and tertiary prevention approaches to mental health in the workplace. This comprehensive online training program for managers will be delivered via a mobile responsive website and has 3 topics each with a set of 10-minute modules to work through. Completion of the program can occur in one go or spread out over a few days or a few weeks. This freedom and flexibility has been incorporated in the design so learning pace is matched to individual styles. Evaluation will be conducted through a randomised controlled trial within industry partner organisations. Waitlist control participants will be offered the training 6 months from the commencement of the study once follow up data is collected from the intervention group.

to determine whether in normal healthy volunteers without recent antibiotic exposure, one month of daily erythromycin treatment will induce lower rates of macrolide resistance in commensal oropharyngeal flora than one month of daily azithromycin

The trial will consider the clinical effectiveness of electrical stimulation therapy compared to or in combination with compression therapy. People with a lower leg ulcers will be recruited into the study. Participates will be randomised to either (1) continue their current compression therapy (control). (2) to use electronic stimulation therapy (intervention) or (3) use both compression therapy and electric stimulation. Participants in the study group involving electrical stimulation therapy will use a portable stimulation device that can be self administered in the home setting 4 times a day daily for 20 minutes per session. The number of wounds that heal and the percentage of wound size change will be monitored for 14 weeks in total. Fortnightly for the first follow up visit and then monthly. The clinical effectiveness of the treatments will be considered as will cost effectiveness.

Design: this is a randomised, double-blinded, placebo-controlled trial in patients with whiplash injury. it aims at testing whether a medicine we are trialling may reduce long term pain after a whiplash injury. Each group will include 20 participants, who will be recruited after presenting to the emergency department at JHC. Detailed information sheet will be supplied to all participants prior to asking them to consent for the trail. Participants will voluntarily enter the trial, have their rights of declining participation and terminating their participation explained to them in the first interview and provided to them in writing. All their data will be secured on a computer, not shared with anyone outside this research group. All their personal details will be destroyed once data analysis and journal submission is complete. You will be entering one of the groups by the order of chance using opaque sealed envelops. The investigators will have no prior knowledge which group you will fall into and no knowledge of which group you belong to during the phases of this study. If you are randomly selected into the treatment group, you will receive the active medicine, called low dose naltrexone. it is given as one tablet at bed time. If you are randomly selected into the 'placebo' group, you will be give a' sham' tablet to take daily at bed time. The study will run an observation period of 2 weeks, followed by a treatment period of 8 weeks, and a follow up visit at 6 months from the time you were randomised into a group. Observation phase: all participants will have daily numerical pain scale reported (0-100), zero equals no pain at all and a 100 means the worst imaginable pain, highest neck disability index (NDI) will be measured based on a validated questionnaire, Sensory testing (called QST) of your sensitivity to graded cold on specific sites of the body will be tested,. An assessment of your stress, anxiety and depression will be conducted using a specific questionnaire (DASS21), This will be done at same time points as the measures of neck disability and skin testing. A baseline blood test for inflammatory markers will obtained once from each participant. Treatment phase: placebo group will receive sham tablets at bed time for 8 weeks, treatment group will receive LDN at bed time for 8 weeks. All participants will record their NPS at the same time of taking the tablet. NDI, QST and DASS21 will be conducted at end of treatment period, and CRP will be tested once at end of the 8 weeks treatment period. Follow-up: at 6 months from entering a study group; we are planning to measure NPS, NDI, conduct QSTs, DASS21 and repeat the CRP test once per visit.

Alzheimer's disease (AD) has a long preclinical phase as characteristic brain changes accumulate before obvious symptoms and signs appear. The availability of a simple test to detect AD during this stage would have considerable value. Current tests or 'biomarkers' under evaluation for early AD detection are expensive (PIB PET imaging), invasive (CSF amyloid), or require a high level of skill and technology (MRI volumetric analyses). An inexpensive, ‘low tech’, minimally invasive, easily administered test for preclinical AD would therefore be especially valuable. We hypothesize that a small dose of an anticholinergic drug (atropine) given by 'nasal squirt' would reach the olfactory bulb (smell centre) and reduce -smell performance more in individuals with Alzheimer’s disease (AD), including those with early AD in whom poorer smell performance can also be expected, than in those without AD.

This is a project analysing three surgical approaches for the same orthopaedic procedure, total hip arthroplasty (THA). This study will be conducted as a pragmatic randomised controlled trial comparing three approaches to the hip joint for this procedure – anterior, posterior and direct lateral (Hardinge) approaches. The null hypothesis is there will be no difference in outcomes between three approaches in terms of patient satisfaction with the procedure. We will measure this via validated scores: patient reported outcome measures (PROMs).

Each year over 10 000 children attend Princess Margaret Hospital for Children (PMH) to have surgery under general anaesthesia, with many more children attending other hospitals at a state and national level. Respiratory complications are the most frequent problem under general anaesthesia, particularly in young children. Over one quarter of children visiting PMH for surgery have asthma or related breathing difficulties. These complications may have an impact on surgical outcomes, may lead to delays and cancelled surgeries as well as unplanned admissions to specialised wards. These respiratory complications can be minimised if children at risk are correctly identified preoperatively. Currently, anaesthetists rely on clinical histories to assess this risk. Symptoms such as asthma, wheezing, hay fever and a family history of allergies and asthma amongst others are all associated with a higher risk of respiratory complications under general anaesthesia. Over a series of studies, we have observed that children with active respiratory symptoms such as current asthma, wheeze or persistent dry nocturnal cough experience significantly more respiratory complications compared to children with other known risk factors (such as family history of asthma) or no risk factors. Our data suggests that these children have increased airway inflammation and lower lung function; in a previous study, we observed that 7 out of 10 children with active respiratory symptoms who had airway inflammation experienced respiratory complications during surgery. The use of new screening techniques that allow assessment of the risk for respiratory complications by measuring airway inflammation and changes in lung function would help anaesthetists to better assess this risk. This would then allow the anaesthetist to tailor a personalised anaesthesia management to minimise the risk for these complications. This pilot study aims to assess the feasibility of an innovative personalised approach, easily applicable to young children to significantly improve the prediction of respiratory complications prior to surgery. Males and females aged 4 to 10 years of age will be recruited after voluntary informed consent and will complete two tests prior to their surgery. Tests include measuring airway inflammation using the exhaled nitric oxide test and measuring lung mechanics using the forced oscillation technique. Strong evidence of successful use of these screening techniques will pave the way to dramatically change surgical and anaesthetic risk management prior to surgery and lead to improved health outcomes for children, their families and the broader health-care system.

This proposed study aims to investigate the association between a mixture of herb and how it could affect both body weight and depression in people who are on prescribed antidepressants. The mixture of herbs include red chili powder, black pepper, ginger, and turmeric . With the aid of DEXA scanning and SCID “a test to evaluate depression” this study will aim to examine if consuming the herbs mixture affects body weight or depression. It became a fact that people who are on prescribed antidepressants tend to gain weight. There are some studies in the past that attempted to create a remedy for the problem. None of them have proposed that herbs can be used together with antidepressants to reduce weight gain. Flyers and posters will be distributed to announce and recruit volunteers between 18 and 54 years old. Pages on on Facebook can be created to announce the trial. Clinical Trials Connect Database will be used as well to recruit with an in-built screening system. Women who are pregnant, people who are highly dependent on medical care, have a cognitive impairment, or intellectual disability will not be included in this study. However, our main target is people who are on antidepressants and suffering from depression. The duration of the study will be three months. During this time, the participants will be asked to use a mixture of four herb. The four herbs are Black pepper, Red chilli powder, Ginger, and Turmeric. The ability of these herbs to help with weight problems will be examined by using three groups of people. The first is the control group, which comprises of overweight but non-depressed subjects who take only the herb mixture. The second group comprises the depressed subjects who take only antidepressants with placebo. The third group "the main group" comprises of subjects who take the antidepressants together with the herb. Changes in body (weight/body-fat) and depression will be assessed using three main tests that will be repeated monthly; DEXA scanning to see changes in body fat, the Scale to test body weight, SCID to test depression, and Blood samples to see if there is an improvement in the blood inflammatory markers (C-reactive protein CRP).