ANZCTR search results

Individuals living with treatment resistant depression are faced with an especially challenging road to recovery. The factors that complicate treatment include, lack of a universal definition on what treatment resistant depression is, poor doctor-patient relationship, inadequate knowledge about treatment options, patient /caregiver fatigue, and high cost associated with co-morbidities. Due to the nature of treatment resistant depression, a need to emotionally self-regulate amidst stress commonly arises in adults. This stress may range from activities of daily living (like bathing, taking medication, grocery shopping) to medical management (attending doctor’s appointment, corresponding with insurance providers etc.) and/or social engagements. Continuous exposure to such stress keeps one’s sympathetic nervous system charged and activated often resulting in a heightened state of alarm which further exasperates depressive symptoms. In this way, repeated exposure to stress is part of the lived experience in adults with treatment resistant depression. This graduate researcher believes that moving towards stability begins with an increased understanding and awareness about one’s automatic stress responses. Such knowledge can help foster and create a path where individuals living with treatment resistant depression can comfortably identify manage their stress. Current tools in depression treatment do not document the experience of learning and practicing somatic based stress management techniques after participating in group dance therapy sessions. This tool may be potentially helpful for both, adults living with TRD and their health practitioners in tracking symptoms of TRD. Based on this background, this research project is designed as to help understand if group dance therapy sessions may be helpful in alleviating stress associated with a treatment resistant depression diagnosis by fostering somatic aptitude in participants and if dance therapy helps provide any symptomatic relief associated with treatment resistant depression.

To assess the efficacy of the NurofluxTM device to continuously monitor and detect significant neurological deterioration in patients with acute ischaemic stroke due to large-vessel occlusion (LVO) in anterior cerebral circulation against the gold standard of high-intensity nursing monitoring of vital signs and neurological function, and use of routine brain imaging. Study Design: This is an investigator-initiated and conducted, multicentre, open-label, single arm, clinical evaluation feasibility (proof-of-concept) trial. After an internal pilot phase (Phase 1; registered seperately) to rehearse the main study to identify key issues to consider in the next phase of the study, as well as to optimise the device parameters, this study phase (Phase 2) will be rolled out for full assessment of the sensitivity, specificity, and predictive value of monitoring of patients in acute phase across three major teaching hospitals in Sydney under the supervision of leading stroke clinician-scientists. Phase 2 – Main phase 260 consecutive patients with AIS with LVO in the anterior circulation will be recruited and monitored using the device and followed through the course of regular treatment and management. Device metrics (sensitivity, specificity, and positive/negative predictive values) will be determined against routine clinical and brain imaging (CT/MRI) to determine thresholds for detection of: AIS (severity and location), response to treatment (successful reperfusion) and neurological deterioration (from bleeding [haemorrhagic transformation], cerebral oedema [‘brain swelling’] and/or extension/recurrent stroke). Phase 2 Primary Outcome: 1. Performance of the device (sensitivity and specificity) on detection of neurological deterioration Secondary Outcomes: 1. Positive and negative predictive values of the device 2. Detection of acute ischaemic stroke (severity and location) 3. Correlation to initial and follow-up imaging parameters 4. Response to treatment (successful or unsuccessful reperfusion) 5. Detection of recurrent stroke 6. Detection of cerebral oedema, haemorrhagic transformation, and early seizure (after study enrolment) 7. Proportion of time spent wearing the device within the intended period

Aims: To assess the efficacy of the NurofluxTM device to continuously monitor and detect significant neurological deterioration in patients with acute ischaemic stroke due to large-vessel occlusion (LVO) in anterior cerebral circulation against the gold standard of high-intensity nursing monitoring of vital signs and neurological function, and use of routine brain imaging. Study Design: This is an investigator-initiated and conducted, open-label, single arm, clinical evaluation feasibility (proof-of-concept) trial. This stage is an internal pilot phase to rehearse the main study to identify key issues to consider in the next phase of the study, as well as to optimise the device parameters within the RPAH under the supervision of leading stroke clinician-scientists. Phase 1 – Threshold estimation RPA only. Recruit 50 patients to wear the device following confirmed AIS with LVO in the anterior circulation to estimate device threshold of critical neurological deteriorations. An assessment of device utility in routine clinical practice will also be undertaken. Outcome Measures: Phase 1 Primary Outcomes: 1. Device threshold estimation on detection of neurological deterioration 2. Safety and patient acceptability profile of the device when immediately deployed Secondary Outcomes: Device threshold estimation on: 1. Acute ischaemic stroke (severity and location) 2. Response to treatment (successful or unsuccessful reperfusion) 3. Recurrent stroke 4. Cerebral oedema, haemorrhagic transformation, and early seizure (after study enrolment) Phase 2 of this study will involve a larger sample size gathered from multiple sites for more detailed assessment of device accuracy. Phase 2 will be registered separately.

This study aims to assess the effect of an intervention to reduce problematic internet usage, to be run over 21 days. The intervention is based on the results of previous studies testing different aspects of a theory of self-regulation, which showed expected effects of inducing a Commitment or Progress framework on intentions for internet usage goals. The study intervention will test the effect of investigator feedback on participant internet usage in participants who report objectively problematic levels and patterns of internet use. It will test the following hypotheses: Hypothesis 1: When experiencing a goal setback on the previous day, individuals who frame their behviour in a Progress framework will subsequently perform better than individuals who frame their behaviour in terms of self-monitoring Hypothesis 2: When experiencing a goal achievement on the previous day, individuals who frame their behaviour in terms of a Commitment framework will subsequently perform better than individuals who frame their behaviour in terms of self-monitoring In terms of personal benefit, participants may reduce problematic internet usage and may learn new methods for regulating their behaviour towards their goals.

Labour and birth can be painful experiences. In Australia, 53% of labouring women use inhaled nitrous oxide. The widespread use of nitrous oxide is currently being reconsidered due to environmental concerns. Without nitrous oxide, there would not be a widely available self-administered, needle-free method of pharmacological labour analgesia. In this pharmacokinetic study, we will evaluate the use of nebulised fentanyl for labour analgesia, obtaining maternal and cord blood samples to measure concentrations in the mother and baby. This will be used to develop a proposed dosing schedule. We will also evaluate patient and midwife experiences. This preliminary research will lead to dosing recommendations and larger clinical evaluations, aiming to provide an additional needle-free option for labour analgesia across Australia.

Due to ongoing workforce deficits in the health sector, particularly in rural and remote regions, access to essential healthcare services including emergency care have been compromised. Challenges with attracting and retaining appropriately qualified medical and nursing staff in these areas has resulted in many health care facilities needing to deploy expensive contingency plans, including the commissioning of out-reach medical services. Emergency department nurse practitioners employed to manage patients presenting to emergency departments with non-life threatening conditions have been reported to be effective in providing timely, effective high quality care that is acceptable to patients and feasible for services to adopt. This study seeks to evaluate if a similar model implemented in four rural emergency departments in Hunter New England Local Health District is an effective, feasible, acceptable and cost-effective approach to maintaining emergency services within rural health jurisdictions.

This study aims to determine the incidence of respiratory depression in post-surgical patients who received intrathecal morphine, and whether those patients that develop respiratory depression have an increased risk of post-operative complications.

The millions of Australians seeking care in our emergency departments each year are routinely confronted by overcrowded waiting rooms, ambulance ramping, stressed clinicians and long wait times. EPIC START aims to help this situation. The Early nurse Protocol Initiated Care- Sydney Triage to Admission Risk Tool (EPIC-START) model of care will implement data analytic tools and evidence-based clinical pathways specifically designed to improve patient flow in the emergency department. The model focuses on the three D principles of patient flow: Earlier decision-making, delivery of care and detection of clinical deterioration.The EPIC-START will be tested accross 30 Emergency departments in metropolitan, regional and remote New South Wales

This study aims to compare if magnetic resonance imaging (MRI) is equivalent to a diagnostic laparoscopy as a tool for finding macroscopic (visible to the eye) ovarian cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or older with advanced ovarian, primary peritoneal or fallopian tube cancer. Study details All participants in this study will have MRI performed, which takes approximately one hour. This will be done either before chemotherapy, midway through chemotherapy, or both. At the time of your MRI, two radiologists (doctors who specialise in imaging) will calculate a score based on how much cancer is visible. You will then have your scheduled diagnostic laparoscopy (keyhole surgery) within two weeks of your MRI. If you are having laparoscopy only, then the surgery is likely to take approximately 30 minutes and you would be in hospital for a few hours. Based on the laparoscopy, the surgeon will calculate a cancer burden score. The MRI and laparoscopy scores will be compared for the purpose of this study. It is hoped this research will determine if MRI is able to replace laparoscopy in assessing cancer, which would allow risk and patient burden to be reduced.

This study aims to compare radiation therapy delivered directly to the prostate with or without radiotherapy to close lymph glands, to active surveillance in terms of cancer control, in a carefully selected group of men with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male aged 18 or older, who has previously been treated for prostate cancer, including removal of all or part of your prostate. In particular, people who still have active prostate cancer that has low risk features and negative Prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) imaging will be eligible. Study details Participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of the two study groups. Participants who are allocated to the first group will not undergo radiotherapy and will be seen in clinic at regular intervals by their doctor for routine check-ups and blood tests. The PSA blood test will be done every 6 months to allow surveillance of their cancer. Participants who are allocated to the second group will undergo specific radiotherapy to their prostate area with or without radiotherapy of their pelvic lymph nodes as decided by the treating clinician. Before starting the radiotherapy, participants will have a CT scan of the area where the prostate gland used to be (the prostate bed) and potentially the lymph glands related to the prostate in the pelvis to plan the radiotherapy. The radiotherapy is given over about 6 and half weeks. Participants will need to come in for treatment 5 times a week and will have a total of 32-35 treatments. Each radiotherapy treatment will take approximately 15 minutes each day. Following the radiotherapy, review appointments and investigations will be carried out every 6 months including PSA blood testing. All participants will be asked to complete a series of questionnaires to provide information on their health and wellbeing for up to 3 years after enrolment into the study. It is anticipated that completing these questionnaires will take about 20 minutes at each timepoint. It is hoped this research will determine whether additional radiotherapy directly to the prostate area after removal of the prostate is effective in controlling cancer recurrence in these low-risk patients. If the radiotherapy treatment is found to be better at controlling cancer recurrence for prostate cancer patients compared to the standard care surveillance, it may be introduced as a standard of care for all prostate cancer patients.