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A multisite clinical trial of repetitive transcranial magnetic stimulation (rTMS) for social communication in autism spectrum disorder (ASD).
Expand descriptionThere are no validated biomedical interventions for core social symptoms in autism spectrum disorder (ASD). Repetitive transcranial magnetic stimulation (rTMS) has been established as a safe, effective, and targeted technique for a range of brain-based disorders, including depression, migraine, and obsessive-compulsive disorder. While it has been trialled with some success in ASD, this work has been limited by small sample sizes, the heterogeneity of ASD, and less rigorous study designs. Young adults with ASD (aged 14-40, n = 150) will undergo four weeks (20 sessions) of either active or sham (i.e., placebo) rTMS to the right temporoparietal junction (rTPJ). The rTPJ is a key node of the "social brain," and it is underactive and underconnected in people with ASD. Participants will initially undergo a structural magnetic resonance imaging (sMRI) brain scan to allow accurate targeting of the rTMS coil. There will be five sites (Brisbane, Sydney, Melbourne, Adelaide, Perth), with each enrolling 30 participants (15 active, 15 sham). Assessments will be conducted at various points before and up to 6 months after treatment. Both participants and those conducting assessments will be blind to treatment condition. Mixed model analyses will be used to compare active and sham conditions across the assessment timepoints. If successful, this work will establish a first biomedical intervention for ASD, which will result in improved quality of life, participation, and mental health for the estimate 1 in 59 people affected.
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Comparison of a discharge system and usual care, for supporting people after completing conservative treatment for chronic low back pain: a randomised controlled trial
Expand descriptionMany people improve following discharge from conservative hospital treatment for low back pain (LBP), however some experience worsening LBP and seek additional care. The lack of support for patients after treatment discharge has been identified as a key driver for this clinical pattern. Introducing a discharge support system, incorporating referral to the NSW Health Get Healthy Service®, which delivers telephone and telehealth-based health coaching programs, has strong potential to bridge this clinical gap. Health coaching can improve physical activity levels in people with LBP. We will conduct a randomised controlled trial investigating the effectiveness and cost-effectiveness of a discharge support system (incorporating referral to the Get Healthy Service®) for improving pain, disability, and physical activity levels, in people recently discharged from hospital outpatient physiotherapy treatment, or from public or private physiotherapy, chiropractic or general practitioner care for chronic LBP. In-depth interviews will be conducted to identify factors contributing to intervention success, which will be used to inform the development of an implementation plan for upscaling the discharge support system across NSW LHDs.
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Total Cardiac Care: a smartphone-based remote monitoring system for Heart Failure Patients
Expand descriptionThe primary purpose of the study is to evaluate the implementation of a smartphone-app based model of care. Participants with heart failure will be provided with a smartphone app as well as equipment including a blood pressure machine, weighing scale and pulse oximeter. Participants will use the app to send their results daily to a monitoring team who will check for abnormal readings. Abnormal readings will be discussed with a doctor or nurse who is familiar with the participant, and treatment may be provided if necessary.
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Does the use of the Canadian CT Head rule (CCHR) definition of minor head injury in a regional NSW emergency department safely lead to lower utilisation of computer tomography (CT) imaging in patients over 65 when compared to the NSW Closed Head Injury guidelines definition?
Expand descriptionMild head injury (MHI) in the elderly population is a very common presenting complaint to the emergency department. After assessment, the main decision health providers need to make is whether or not the patient requires a CT Brain to assess for significant intra-cranial injury such as intracranial haemorrhage. Current NSW Health Head Injury guidelines define a minor head injury as “a patient with an initial Glasgow Coma Score (GCS) of 14-15 on arrival at hospital following acute blunt head trauma with or without a definite history of loss of consciousness or post traumatic amnesia”. As a result of this broad definition, almost all patients in NSW who present to the emergency department after blunt head trauma undergo a CT scan. In comparison, the “Canadian CT Head Rule (CCHR)”, which is the most commonly used and validated clinical decision rule around head injury, defines MHI as a patient with a GCS of 13-15 and who has one of the following; sustains a period of loss of consciousness, post- traumatic amnesia or disorientation post head impact. Using this inclusion criteria, the CCHR definition and rule was shown to be 100% sensitive and 69% specific for the need for detecting need for neuro-surgical interventions post head injury. It was also 98% sensitive and 50% specific for detecting clinically significant brain injury. Our study will aim to assess whether the use of this more restrictive imaging strategy can safely reduce the number of CT Brains ordered post MHI in a regional NSW emergency department.
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Total Ankle Arthroplasty Outcomes Study (TAAOS): Assessment of patient-reported measures and clinical outcomes following total ankle arthroplasty
Expand descriptionThe aim of this study is to investigate clinical and patient reported outcomes following total ankle arthroplasty (TAA). The study will comprise a consecutive observational cohort with retrospective and prospective study design. Recruitment will include patients who have presented with ankle pathology to the principal investigators, Dr Andrew Wines and Dr Michael Symes, and elected to undergo TAA procedure. Patients will be presented with a Participant Information Sheet to inform them of the nature of the study and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-in approach. The data collection process will involve retrospective chart review and collection of patient demographic, treatment and clinical data as well as patient reported outcome scores collected routinely as part of the standard clinical pathway at the baseline presentation. Consenting patients will also be requested to complete a set of questionnaires (FAOS, satisfaction) to enable evaluation of patient reported outcomes as part of the post- treatment follow up. Aggregated pooled results will be deidentified, analysed and reported in the form of a manuscript for publication in a peer-review journal.
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Variations in the level of blood ketones in patients commenced on a very low-calorie diet before and after having weight loss reduction (bariatric) surgery
Expand descriptionThis study aims to assess the change in blood ketones seen in patients prescribed a very low carbohydrate diet (VLCD)before bariatric surgery. Patients on a VLCD have an increase in the blood levels of a chemical know as a"ketone' The level of measured ketones is different in each patient. Some diabetic medications can result in excessive levels of ketones in patients on VLCD. This study will help understand changes in blood ketones in patients undergoing bariatric surgery who are on VLCD who may or may not be on diabetic medications
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Optimisation and validation of a nutritional intervention to enhance sleep quality and quantity
Expand descriptionThe aim of this study was to investigate whether a nutritional intervention could enhance sleep by determining the effects on sleep quantity and quality as well as balance and cognitive function in healthy adults. Three trials were performed where different combinations of ingredients were provided and compared to a placebo in 18 healthy male participants.
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Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy for Insomnia in Older Adults
Expand descriptionThe current study used a randomized controlled trial to investigate the effects of a brief, group-based CBT-I program in a large sample of older adults with chronic primary insomnia not currently taking hypnotic/sleep aid medications.
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An observational study of discharge analgesia and analgesic outcomes after discharge following surgery in Southern Adelaide Local Health Network: A prospective pilot study
Expand descriptionMany patients experience pain after surgery, but this can vary significantly between individuals. With patients being discharged from hospital following surgery earlier than in previous generations, managing pain after discharge has become an important part caring for surgical patients. Frequently, this includes the prescription of opioid medications on discharge. While opioid medications are widely used to treat pain after surgery, there is now a large amount of evidence demonstrating that when prescribed on discharge opioids can contribute to a range of adverse outcomes for patients and the community more broadly. This presents a challenge to clinicians, who need to balance these risks while meeting the pain relief needs of patients. The purpose of this study is to capture accurate data on the nature of opioid prescribing and usage on discharge within Southern Adelaide Local Health Network, data which has previously never been captured or reported. We are aiming to assess if; 1. Opioid analgesia prescribed on discharge following surgery undertaken in SALHN is undertaken in accordance with current clinical guidelines. 2. Opioid analgesia prescribed on discharge following surgery undertaken in Southern Adelaide Local Health Network (SALHN) is adequate for patient analgesia requirements. 3. Opioid analgesia prescribed on discharge following surgery undertaken in SALHN results in unused prescription opioid in the community. 4. The volume of opioid prescribed on discharge could be reduced without increasing rates of patients needing to return to hospital as a consequence of pain OR patients experiencing pain limiting function when they are unable to access care.
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NODE Study - Randomised Trial of Extended Pelvic Lymph Node Dissection In Patients Undergoing Robotic-Assisted Radical Prostatectomy For High-Risk Prostate Cancer
Expand descriptionThe purpose of this pilot study is to determine whether it is possible to recruit sufficient participants in a trial investigating the role of extended pelvic lymph node dissection in addition to the removal of the prostate gland for the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult with prostate cancer who has already been scheduled for robotic assisted radical prostatectomy. Study details Participants in this study will receive one of two treatments: 1. Removal of the prostate gland, or 2. Removal of the prostate gland plus removal of pelvic lymph nodes Both surgeries will be completed using robotic assistance, as is the standard of care. The treatment the participant will receive will be decided randomly. All participants will be followed up for 12 months for recurrences of cancer, side effects and overall survival. Following the procedure, you would be required to undergo regular blood tests, and possibly radiological scans to monitor for cancer recurrence. It is hoped that this research will determine if a larger trial can be completed on extended lymph node dissection, and that the larger trial will help determine if extended lymph node dissection is beneficial over a radical prostatectomy.