ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32834 results sorted by trial registration date.
  • Evaluation of the effects of a resilience intervention to on burnout levels in general practice registrars

    This study seeks to evaluate the effect of a one-day resilience workshop on the burnout levels and occupational resilience in general practice registrars.

  • The Australian Inflammatory Bowel Disease Microbiome Study - The AIM Study

    IBD is a global disease challenge and common cause of chronic ill-health among young people in Australia, for which there is currently no cure. It affects approximately 1 in 250 Australians aged 5 – 40 years, with almost 75,000 Australians having CD or UC, with this number projected to rise to 100,000 within the next 5 years. Being able to identify people at risk of disease onset, prior to symptomatology, or by preventing symptom progression would yield significant global social impact and economic benefit and plays to the heart of IBD healthcare, namely to improve patient health. Two recently published studies have highlighted the strengths of utilising longitudinal assessment of the IBD gut microbiome. There is an existing knowledge gap in terms of defining microbiota changes in IBD in Australia. Different populations have differing genetic risk loci and disease prevalence rates in terms of IBD, they also harbour different gut microbes, in part due to varying environmental exposures and dietary habits. We believe it is timely to initiate such a study to contribute information on the natural history of gut microbiota changes in IBD in Australia. We will adopt state-of-the-art clinical data and sample collection in a large case-controlled cohort to elucidate microbial changes associated with onset of IBD symptomatology, the identification of an ‘at risk’ microbial signature to allow targeted intervention and the generation of novel predictive models of direct translational utility.

  • Can motor imagery training improve strength and walking in older adults following discharge from rehabilitation?

    Motor imagery is the imagining of an action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. Motor imagery has been shown to increase strength, improve mobility and promote motor learning in older adults. The primary aim of this research project is to identify whether the addition of six weeks of motor imagery training to standard physiotherapy care promotes improved outcomes compared to standard physiotherapy care alone in older adults following discharge form rehabilitation. Specifically, the project aims to determine whether the addition of motor imagery training promotes greater improvements in leg strength and mobility in older adults. Participants will undergo baseline testing two to three days prior to discharge from the facility, then again six weeks after discharge from the facility. Testing will involve assessments of leg strength, walking speed, imagined walking, and questionnaires relating to balance confidence and fear of falling. After baseline testing, participants will be randomly assigned to either standard care or standard care plus motor imagery. Upon discharge, participants in both groups will receive standard care as determined the community health care team (independent of research project). Those in the motor imagery group will also undertake 15 minutes of motor imagery training per day, 5 days per week for 6 weeks. The motor imagery training will be guided by audio tapes uploaded onto an electronic device (ie. phone, tablet). The motor imagery tracks guide participants to imagine doing lower limb strengthening activities and walking tasks.

  • A pilot clinical study of Vitamin C for the prevention of acute kidney injury in critically ill patients

    Acute kidney injury (AKI) is a medical term that defines a condition when kidneys fail to make enough urine output or dispose of waste products leading to increased level of toxins in blood. AKI effects close to one-third of patients admitted to the intensive care unit (ICU). AKI is problematic as it makes patient care more difficult and exposes such patients to extra risks. This is because patients cannot remove drugs and toxins effectively and cannot control fluids, potassium, and blood acidity in a normal way. AKI, therefore, increases risk of death, and prolongs ICU and hospital length of stay. Unfortunately, despite numerous efforts, no effective treatment to prevent AKI has been developed. One of the reasons for this is that it is difficult to find out which patients are going to develop AKI early enough to intervene. However, there has been recent progressed in this area. A new urine test has been developed called NephroCheck, which measures proteins in the urine that are released when the kidneys are under stress. If such protein levels are high, then these patients are very likely to develop AKI in the next 24 hours. This means that early treatments to can be applied. Recently, there has been much research regarding the possibility that, in ICU patients, high dose vitamin C, given into through a vein, can protect organs (including the kidney) from malfunctioning in the setting of stress, as occurs in critically ill ICU patients. Such treatment is very safe and has not been reported to cause any side effects so far. It is unknown whether intervening early, in response to the findings of positive NephroCheck test, can prevent the development of AKI. However, the consensus view of the Austin hospital ICU treating team is that, in light of the available evidence, the introduction of such vitamin C therapy is both safe and desirable in ICU and should be studied. In response, we plan to perform a study to test whether giving high dose vitamin C to patients who have a high risk of developing AKI as identified by positive NephroCheck test can decrease the occurrence and/or intensity of AKI.

  • Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

    The purpose of this study is to evaluate the safety, Tolerability Pharmacokinetics and Pharmacodynamics of AR882. There will be up to 4 cohorts with 10 subjects per cohort randomized to receive treatment with AR882 (8 subjects) or placebo (2 subjects). Dosing: Subjects will ingest IP after an overnight fast and will remain fasted until at least 4 hours post-dose. Subjects may ingest water ad libitum during the period of fasting before and after IP administration. Planned cohorts; Cohort 1: Subjects will be dosed (50mg) AR882 or placebo once daily for 10 days Cohort 2: Subjects will be dosed (75mg) AR882 or placebo once daily for 10 days Cohort 3: Subjects will be dosed (100mg) AR882 or placebo once daily for 10 days Cohort 4(Optional): Subjects will be dosed with a lower or intermediate dose (less than or equal to 100mg) of AR882 or placebo once daily for 10 days

  • Prophylactic anticoagulant use in weight loss surgical patients

    The hypothesis (based of the previous literature) of the study that obese patients should receive higher prophylactic anticoagulant doses. Therfore, the purpose of the study was to evaluate drug dosing practice of prophylactic anticoagulants in obese patients who underwent gastric band surgery and to look at the clinical outcomes (venous thromboembolism and major bleed). .

  • The effect of weight stigma and the polycystic ovary syndrome (PCOS) disease label and causal explanations on intention to eat healthier and perceived personal control over weight: A randomised online study in reproductive aged women

    It is unknown whether knowing a diagnosis of PCOS encourages women to engage in recommended preventative activities for associated long-term implications, such as a healthy diet and exercise, and if this is more effective than giving advice regarding weight gain on its own. If genetic explanations for PCOS reduce personal agency/self-control and induce doubt about the effectiveness of non-biomedical treatments (lifestyle), this could have significant negative consequences. It is vital the potential impact of a PCOS diagnosis on lifestyle behaviours is explored. The aim of this study are threefold: - What is the effect of the PCOS label on intention to eat healthier compared to a weight label? - How does the PCOS label influence perceived personal control of weight compared to a weight label? - Does this differ depending on whether an environmental or genetic explanation is given?

  • Validity of pulsatile flow assessment by carotid artery ultrasound

    Current cardiac arrest algorithms require assessment of the return of spontaneous circulation (ROSC) following rhythm checks by observation for patient movement or spontaneous respirations, both of which may be absent in sedated and paralysed patients. Healthcare professionals may also check for a pulse in the presence of an organized rhythm, however manual pulse checks have been demonstrated to be unreliable, even when performed by health professionals. There have been two papers published from St George Hospital (Sydney) related to the use of ultrasound (US) of central pulses and whether they may be an alternative to manual pulse checks. The first was a case report where US of the femoral artery demonstrated ROSC and guided subsequent resuscitation, following cardiac arrest in a patient where manual pulses were absent. The second was an investigation into the inter-rater reliability of carotid US in detecting the return of a pulse, using cardiac surgery patients coming off bypass (where they go from no-pulse to a pulse). This showed a high intraclass correlation (0.86) for two-dimension (2D) ultrasound when detecting the return of a pulse. This current study seeks to extend on these previous efforts by assessing the validity of carotid US in detecting the presence/absence of a pulse. We hope to use cardiac surgery patients as a human model for the presence and absence of a pulse by obtaining 2D US of the carotid arteries when not on bypass (when there is a pulse), and on bypass (when a pulse is not present). We will then present these videos to critical care physicians who are familiar with US and would be likely to perform an US in a cardiac arrest. We will assess the validity using diagnostic test criteria for subgroups of MAP, and the cohort as a whole. Our gold standard will be presence or absence of a pulsatile waveform on the participants radial artery pressure monitoring.

  • A Clinical Registry for Children presenting to Hospital with Respiratory Infections.

    The aim of PATRIC Clinical Registry is to develop improved evidence-based treatment of Acute Respiratory Infections (ARI), the most common reason that children attend the emergency department (ED) for care. The data collected by the PATRIC Clinical Registry will evaluate current treatments for ARI in a variety of patient groups and provide a platform the PATRIC Clinical Trial that will test various interventions in ARI treatment and management. The PATRIC Clinical Registry will recruit parents and children from the Emergency Department at Perth Children's Hospital (PCH) utilising an informative video and e-consent form. The informative video and e-consent are accessed via a study iPad. A baseline survey immediately follows completion of e-consent with a link sent to the parent's smartphone that can be completed later, if necessary. Following this, engagement with parents will continue with weekly follow-up e-surveys until Day 28, unless they report their child is no longer sick or choose to withdraw from the study.

  • Hyperbaric oxygen therapy for lower limb burns in diabetic patients

    This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing. Diabetic lower limb burns are very common - a recent audit performed in our service revealed 35 such injuries over the past 18 months, 75% of which required debridement and skin grafting. It also identified that these patient stay on average 2.5 times longer in hospital than our normal average length of stay. In addition a third require a second operation and due to poor healing 23% proceeded to some form of amputation. Hyperbaric oxygen therapy has been used increasingly to assist with healing of complex and chronic wounds, however robust evidence for its use, particularly in burns, is still lacking. At Fiona Stanley Hospital we have a HBOT unit and are the adult tertiary referral service for burn injuries. We therefore propose to perform a double blind randomised controlled trial looking at diabetic lower limb burns which required debridement and skin grafting. All diabetic patients with deep lower limb burns would be considered for the trial and would have debridement, skin grafting and VAC therapy within 72 hours of presentation to our service. Immediately post-operatively they would be randomised to receive either HBOT post-operatively OR sham HBOT. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds. At 4 weeks the wounds would be assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a camera to map the area of the healed/unhealed area of wound to form a ratio. At 3, 6 and 12 months the wounds would be assessed for healing, time in dressings, episodes of breakdown, requirements for secondary surgery and QoL

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