ANZCTR search results

Q fever is a zoonotic disease caused by the highly infectious agent Coxiella Burnetti. This agent is transmitted via animal’s urine, faeces and bodily fluids in which they dry up and become contaminated dust in air. Humans contract this intracellular bacterium via the respiratory route, as they breathe the contaminated air. Literature provides some ideas on the exposure risks for developing Q fever such as; being a farmer, sheep and dairy workers, veterinarians, laboratory workers, and many more. However not much has been shown on specific animals transmitting Q fever, especially the comparison of the well-established risk of exposure to cattle verse the native mammals such as macropods. In addition acute Q fever can develop into chronic Q fever within some patients, thus creating an array of complications such as endocarditis, pneumonia, hepatitis, pregnancy related problems, and meningitis. These complications delineate the importance of identifying the exposure risks in order to develop possible preventative regimes against Q fever. In the setting of a regional and rural population consisting of approximately 160,000 people which is mainly known for its’ mining, farming, cane-farming industry as well as its’ diverse native fauna, it is interesting in analysing the different exposure risks for developing Q fever. This exposure ranges from contact with different animals (such as sheep, cattle, macropods), living in different climates (such as wet and dry season) and those within different professions (such as farming, cane-farming, meat workers, veterinarians, laboratory workers). In addition, the study will hopefully illustrate any underlying medical conditions which may predispose patients to contracting Q fever. Researching both of these outcomes will help create a risk profile for humans in developing Q fever.

This study will investigate the management impact of staging with a diagnostic scan known as 18-F Sodium Fluoride PET/CT compared to bone scintigraphy in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged at least 18 years with newly diagnosed, untreated, biopsy confirmed, intermediate to high risk prostate cancer. Study details: All participants in this study will undergo two different diagnostic tests. The first test is called 18-F Sodium Fluoride Positron Emission Tomography (PET)/Computed Tomography (CT), and this involves the injection of a small amount of radioactive tracer into your veins. You body is then scanned to look for areas of tracer-uptake which may suggest cancer in your bones. The second test is called bone scintigraphy, and this involves a different radioactive tracer. Surgeons will first view the bone scintigraphy and use this to record a management plan and treatment goals. They will then view the 18-F Sodium Fluoride PET/CT and record a separate management plan. It is suggested that 18-F Sodium Fluoride PET/CT can pick up prostate cancer that has spread to the bone better than Bone Scintigraphy (BS). We wish to assess whether having access to 18-F Sodium Fluoride PET/CT actually changes the surgeons intended management of men with intermediate to high risk prostate cancer, and whether the detection of bone metastases (cancer spread to bone) is different between tests.

This study will determine whether a smoking cessation program may improve radiotherapy outcomes in patients with head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, a smoker and have been diagnosed with head and neck cancer (including skin cancer), for which you are scheduled to undergo radiotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will participate in a multicomponent smoking cessation program which includes an initial three-month course of oral tablets (Varenicline), with the possibility of an additional three-month course to maintain abstinence, as well as 10 behaviour change sessions with a psychologist. Participants in the other group will receive standard NSW Health tobacco assessment and smoking cessation advice. Both groups will receive their standard radiotherapy treatment. Participants will be followed-up for up to 6 months, in order to determine compliance to and side effects of the smoking cessation program, behaviour change and tumour response to radiotherapy.

The use of the novel teat to feed expressed breastmilk when mother not available to breastfeed preterm baby resulted in a shorter length of stay in hospital (2.5 days corrected for gestational age at discharge (p=0.026) and weight (p=0.006). Infants in the novel teat group had less formula feeding a discharge (novel 35%, control 16%, p=0.036) but otherwise did not differ in respect to feeding.

This study aims to evaluate the effectiveness of fish oil for the prevention of skin cancer in lung transplant recipients. Who is it for? You may be eligible to join the study if you are over 18 years of age, and are a lung transplant recipient for at least 1 year. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 4 x 1000mg oral capsule of omega-3 fish oil supplement daily for 12 months. Participants in the other group will take 4 x 1000mg of placebo (olive oil) daily for 12 months. Participants will not know which treatment they are taking until the end of the study. All participants will be asked to complete questionnaires, blood tests and skin exams at baseline and at the end of the study at 12 months.

Severe burn injuries are associated with considerable psychological trauma and burns patients are at increased risk of developing Post Traumatic Stress Disorder (PTSD), depression and other mental health disorders. EMDR is an effective evidence-based treatment for psychological trauma, it has been well researched, however there have been very few studies on early EMDR intervention as a means of preventing PTSD. To date there is no research on EMDR and burns related trauma in a primary care setting. Hypothesis and Aims Effective early intervention may enhance patients’ outcome, resilience and coping. The aim of this research is to establish that early EMDR intervention is safe and effective in this acute and medically complex setting. It is hypothesised that early EMDR intervention integrates traumatic memories thus preventing the development of chronic pathology. This research then aims to explore the effects and efficacy of early EMDR interventions on burn patients’ mental health outcomes with a primary focus on posttraumatic symptoms and secondarily tracking mood and coping, which are often poorly addressed during rehabilitation. The opportunity to promptly intervene with simple and effective psychological treatment to avoid sequelae in those who were previously well warrants investigation and sits with clinical observation that even good psychological “first aid” with counselling and Consultation-Liaison Psychiatry support appears to be insufficient to support best recovery. The hypothesis that early EMDR intervention/treatment has a positive effect on burns patients’ mental health outcomes, in terms of reduction in PTSD and depression will be tested. This study aims to improve psychosocial care of burns patients. Knowledge gained from the proposed research can be utilized to inform and further develop more effective early trauma interventions. Early EMDR interventions may facilitate improved psychosocial recovery of burns patients and this study is aims to establish basic proof of concept that early EMDR intervention is safe, useful and valuable in this acute and medically complex setting. Research Plan Protocol Stages: Stage 1- Screening for posttraumatic symptoms. All patients admitted to the SBIU, RNSH will be screened within the first two-four weeks following injury (or the first 2 weeks following discharge from Intensive Care using the Impact of Event Scale –Revised (IES-R). Patients whose baseline scores on this scale indicate moderate-to-severe posttraumatic stress symptoms will be considered for recruitment (IES score =26).The remainder of the questionnaires are used to track depression, anxiety and coping style, pain and alcohol use. Information re burn depth, size and location will also be obtained (collected routinely in all burns patients).These measures will be repeated at Burns outpatient follow-up visits at 3 monthly intervals over the first year and then annually for five years. Stage 2_- Clinical assessment to identify exclusions and pre-treatment variables. The subgroup of patients with elevated IES scores from the screening study will be evaluated further via a full psychiatric assessment by the Consultation-Liaison Psychiatry team to determine clinical exclusions and Ms Kwiet will also perform a fuller psychosocial research assessment, including evaluation of dissociative symptoms via interview and the Dissociative Experiences Scale (DES). Past trauma history as well as other risk and resilience factors, such as past psychiatric illnesses, family history, medications, premorbid personality and functioning and levels of social support will also be assessed. This will be obtained via a semi-structured interview incorporating these clinical domains, the Adult Attachment Interview (Burns Modified with Social Support probes) and the CAPS (the gold standard interview measure of PTSD). Patients identified as having unresolved chronic complex trauma (including prior PTSD) and high levels of dissociation will not be considered for inclusion in the RCT, as they are likely to require a prolonged period of stabilization and treatment within a longer term therapeutic relationship. Other potentially relevant biopsychosocial variables were obtained by the screening study to which will be added the (PCL-C), and current medications and pain relief. Stage 3: Randomized treatment Patients with (uncomplicated) moderate to severe posttraumatic stress symptoms will be recruited and randomly allocated into two groups. One group will receive three hours of EMDR as per the Acute – Traumatic Incident Procedure (A-TIP) and the other group will receive three hours of supportive psychotherapy, which will include basic psychological stabilization and stress management, considered as psychological “first aid”, provided within a supportive psychotherapeutic relationship. At commencement and completion of each session of treatment the IES will be repeated to track any change in the interval between screening and treatment and any interval changes between sessions. Stage 4: Residual symptoms and crossover to EMDR. Those patients in the control group whose IES scores remain elevated at the end of 3 sessions will be offered the EMDR treatment after 3 months out of ethical concern. Stage 5: Outcome and Follow-up assessments The IES (24) will be administered to all patients following each treatment intervention and at 3 months follow-up the Clinician-Administered PTSD Scale (CAPS) the gold standard for PTSD symptoms will be administered to all participants from both groups. At the 12-18 month follow up Ms Kwiet will perform another Burns Modified Adult Attachment Interview to all participants from both groups. The COPE , DASS and DES will also be re-administered to each patient at each follow up. Outcomes of both groups will then be compared to evaluate the effectivness of EMDR in improving burns patients mental health outcomes (specifically reduced reate of PTSD, depression, anxiety and greater quality of life)

This project aims to evaluate the effectiveness of different commercially available moisturizer in managing xerosis, a common skin condition in general population. These moisturizes will include different concentrations of urea and will be tested in the general population. Through the use of validated measurement tools, which include the Xerosis Assessment Scale (XAS) and Specific Symptom Sum Score (SRRC) we will be able to measure the efficacy of each moisturizer. Other areas of further interest and secondary outcomes to the project include evaluating the associated side effects, cost, ease of use and the overall patient satisfaction with each moisturizer.

Eating Disorders are a very serious illness with severe and psychiatric and health consequences. Current treatment outcomes are less than optimal, with room for improvement. Research is required to find out ways in which these outcomes can be improved. Research has shown that the provision of patient progress feedback to clinicians can enhance therapy outcomes, although the body of literature into the provision of feedback within an eating disorder treatment setting is minimal. This study seeks to implement a symptom based clinical feedback tool into the course of eating disorder therapy, and compare it to an already established, more general, therapy process-based feedback tool.

Intravenous fluid therapy may influence outcomes in critically ill patients. Some of these outcomes have been linked to the contents of intravenous fluids, including colloid source and electrolyte compositions. The chloride content of intravenous fluids has recently emerged as an area of interest in terms of renal injury. For example, a double-blind randomized controlled trial in healthy volunteers showed significantly better renal cortical tissue perfusion following a 2L infusion of a low-chloride fluid (Plasma-Lyte-Registered Trade Mark) compared with a high-chloride fluid (0.9% saline) (Chowdhury et al 2012). Similar effects were seen with the administration of hydroxyethyl starch (HES) in a low chloride solution compared to HES in saline (Chowdhury et al 2014). These studies suggest that excess chloride administration may modulate renal perfusion in man. However, the clinical implications of reducing chloride administration remain poorly understood. We previously reported the findings of a before-and-after study of restrictive vs. liberal intravenous chloride administration in a tertiary intensive care unit (ICU). Although our study found a beneficial renal effect of restricting chloride administration, it was suggested that a Hawthorne effect induced by preparation and education for the before-and-after study may have accounted for the findings . Accordingly, to mitigate the impact of such a putative Hawthorne effect, we extended the control and the intervention periods of our study from 6 months to 1 year to include a longer control period and an intervention period when the most common prescribers (ICU residents and fellows) had not received any specific training and simply rotated through the ICU when only low chloride fluids were available. We hypothesize that extending the study period will not affect our earlier finding of decreased incidence of acute kidney injury with chloride-restrictive intravenous fluid strategy compared with chloride-liberal strategy.

This study will determine whether reducing the doses of anti-rejection drugs is effective in preventing squamous cell carcinoma of the skin in kidney transplant recipients. Who is it for? You may be eligible to join this study if you aged 18 years or above, are a kidney transplant recipient with a previous squamous cell carcinoma of the skin. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have monitored dose reduction in immunosuppression, whilst participants in the other group will remain on their current drug regimen. Participants will be follow-up for 60 months, in order to determine how many new squamous cell carcinomas develop and whether they are aggressive. There are several test of the immune system to make sure the risk of acute or chronic rejection is very low but your kidney function will be followed for up to 60 months to make sure the dose reduction is safe over the long term.