ANZCTR search results

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

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32114 results sorted by trial registration date.
  • COPING: COgnitive impairment in People with glioma and distress in the INformal care-Givers

    The study aims to assess the feasibility and acceptability of a cognitive assessment tool for brain cancer patients. The study will examine if the tool is acceptable to patients and health professionals and could be included in routine health care practices. The study will also look at the relationship between cognitive decline in patients, hospital use, and the impact on caregivers. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with Brain cancer (Glioma/Glioblastoma) Study details This study will involve a questionnaire about cognitive function. Participants will write down their responses to the verbal questions. The questionnaire will be administered two or three times during the study at regular clinic visits. Carers can also answer questions about their experiences caring for someone with brain cancer. It is hoped this study can provide greater insight to the cognitive challenges of people with brain cancer and the experiences of their carers. The information gathered in this study will help inform future studies regarding the acceptability of the screening tools. Hypotheses: Hypothesis 1: Patients will report the ARCS tool is acceptable (i.e. over 75% of patients will report willingness to complete a similar test in the future), and will record assessment completion rates over 90% at both time-points. Hypothesis 2: A high proportion of participants (>60%) will show cognitive decline over time as measured by changes in ARCS scores between at least two measurement time points. Hypothesis 3: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with decreased survival at 6-months. Hypothesis 4: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with increased logistic odds of hospitalisation at 6-months. Hypothesis 5: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with survival at 6-months. Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by the Zarit Burden Interview Short Version. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale. Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by using the Caregiver Reaction Assessment. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale.

  • Mental health and wellbeing on general population during the COVID-19 outbreak

    Since the first case reported in Wuhan city, China in December, 2019, COVID-19 has now become a pandemic issue and affected more than 1.5 million of people globally. On 23rd January, 2020, Chinese government implemented strict social isolation policy by locking down Wuhan city. Since then, COVID-19 outbreak has gradually been under control in China. However, a significant increase in incidence of COVID-19 occurred outside of China has made it a pandemic issue. More and more countries and cities adopted social isolation policy to ask their residents to stay at home for self-isolation and to maintain social distance in order to minimise disease transmission. On the other hand, this social isolation can also have psychological impacts such as anxiety and depression on the involved residents. The IMSOMNIA study will provide initial unique insights into the impact of social isolation on mental health and to identify the group of people requiring intervention.

  • Cord Blood Therapy to prevent progression of COVID-19 related pneumonia

  • The design of an updated iron lung ventilator which can be easily built and used by people with minimal training in situations such as COVID-19 where skilled doctors or normal ventilators are unavailable.

    We herein propose a simple, achievable and safe method of assisting ventilation using a high throughput device, which can be operated without specific skills in ventilator management. The device is a modernised version of the Both Respirator created in 1939. A Modern commercial version has been FDA approved in the United States by Hayek Medical, but currently lacks Australian distribution. As advertised by Hayek Medical, a cuirass ventilator does not require skilled medical professionals. Our simplified device has also been designed to not require a skilled medical professional. Moreso, this device is specifically designed with simplified parts so it can be built quickly and easily in regional areas.

  • Design of a Theory-based Mobile Health Coaching App for Surgery in Obese Patients: A Study Protocol

    Obesity is the leading public health challenge in Australia. Approximately 3,300 patients who undergo elective surgery in the Illawarra and Shoalhaven Local Health District each year are obese.. This area does not currently offer a comprehensive multi-disciplinary weight management clinic. The waiting time for many patients with obesity booked for common operations is three months or longer. Losing weight and increasing cardio-respiratory fitness can improve aerobic capacity and physiological reserve. The majority of people routinely carry a ‘smart’ mobile phone. We will design, build, pilot, and evaluate a mobile application to provide patient-centered interactive health coaching specifically designed for patients with obesity who are waiting for surgery. Our hypothesis is that mobile health coaching via an app utilising the time that patients with obesity spend on surgical waiting lists will improve their health, fitness, and motivation at the time of operation.

  • Comparative assessment of treatment efficiency and patient experience between Dental Monitoring and conventional monitoring of clear aligner therapy: A single-center randomized controlled trial

    Introduction: The aim of this 2-arm randomized controlled clinical trial (RCT) was to assess the effect of Dental Monitoring (DM) on the efficiency of clear aligner therapy (CAT) as well as the patient experience, compared to the conventional monitoring (CM) protocol of regularly scheduled clinical appointments. Methods: 56 patients with a full permanent dentition and treated with CAT participated in this RCT. They were recruited from a single private practice and treated by 1 experienced orthodontist. Randomization was performed with permutated blocks of 8 patients assigned to either a (CM) or DM group with allocations concealed in opaque, sealed envelopes. It was not feasible to blind the subjects or investigators. The primary treatment efficiency outcome assessed was the number of appointments. Secondary outcomes included time to reach first refinement, number of refinements, total number of aligners, and treatment duration. The patient experience was assessed using a visual analogue scale (VAS) questionnaire administered at the end of CAT. Results: No patients were lost to follow-up. There was no significant difference in the number of refinements (mean 0.1; 95% CI, -0.2, 0.5; p = 0.43) and number of total aligners (median 5; 95% CI, -1, 13; p = 0.09). There was a significant difference in the number of appointments, with the DM group requiring 1.5 fewer visits (95% CI, -3.3, -0.7; p = 0.02) as well as overall treatment duration, with the DM group taking 1.9 months longer (95% CI, 0.0, 3.6; p = 0.04). There was a difference between study groups regarding the importance of face-to-face appointments, with the DM group not perceiving face-to-face appointments as important (p = 0.030). Conclusions: The use of DM with CAT resulted in 1.5 fewer clinical appointments and a longer treatment duration by 1.9 months. There were no significant intergroup differences with the number of refinements or total aligners. Both CM & DM groups had similarly high levels of satisfaction with CAT. This research project aims to evaluate these claims by conducting a randomised controlled trial comparing a control group of patients undergoing Invisalign treatment only to an intervention group of patients undergoing Invisalign treatment with Dental Monitoring GoLive over 140 days. Participants will be from Newwave Orthodontics, a private orthodonitc practice in Caloundra. We expect DM will reduce the number of appointments by 1 over this time frame.

  • Airway Pressure Release Ventilation for mechanically ventilated patients with COVID-19 in Western Australian Intensive Care Units: an observational study

    Prior research has suggested that in adult patients requiring mechanical ventilation for hypoxic respiratory failure, that airway pressure release ventilation (APRV) is associated with a mortality benefit and improved oxygenation when compared to conventional ventilation strategies. The Western Australian Intensive Care clinical community has extensive experience with APRV, including during the H1N1 epidemic. The aim of this observational study is to record the outcomes for mechanically ventilated patients with COVID-19, with the expectation that a significant proportion of WA intensive care clinicians will choose APRV. Analysis will compare APRV with non-APRV ventilation modes.

  • Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85

    The Covid-19 pandemic causes mild illness in most but when it spreads to the lungs it may cause a severe illness with acute respiratory distress syndrome (ARDS), severe systemic inflammation, respiratory failure and death in some. Front line Healthcare Workers (HCW) are at particularly high risk of contracting Covid-19 and sadly many HCW have died in the worst affected areas. Personal protective equipment such as masks are in short supply and surgical masks are unlikely to protect HCW from contracting the disease. Therefore we propose to treat healthy HCW with a drug which simultaneously targets front-line innate anti-viral immune defences, together with the core mechanism that controls immune response intensity in the airways. Our hypothesis is that development of severe SARS-Cov-2 (COV)-associated ARDS in front-line health workers, even in those who have contracted this disease, can be prevented via a regimen of daily dosing with the bacterial-derived immunomodulatory agent OM85. We propose a clinical trial to demonstrate reduction in acute respiratory illnesses in HCW necessitating workforce removal. 1000 HCW will be recruited in Brisbane and treated for 3 months using a wait-list study design. If successful, this trial will produce a treatment to protect doctors, nurses, and other frontline healthcare workers from developing the most serious form of the disease.

  • Adapting the Decathlon Group Easybreathe® snorkelling face mask for the safer administration of oxygen and/or continuous positive airway pressure and in the intra/interhospital transportation of patients with proven or suspected COVID 19 infection.

    Covid 19 disease, caused by the SARS COV2 virus, is highly infectious. Patients presenting to hospital suspected or proven to have this condition may be at risk of spreading the virus to visitors and staff. The Decathlon BreatheEasy snorkel mask has been adapted to both cover your face and, if required administer O2 or air pressure. This mask has been tested in a laboratory setting at Monash University to demonstrate its safety and it demonstrates a very low level of leakage. We believe the use of this mask on patients with suspected or confirmed Covid 19 disease may reduce the likelihood of transmission of Covid 19 disease to hospital workers and other patients. Currently there is no medical grade device designed to perform these tasks and consequently a non-medical device has been adapted. We aim to test comfort, tolerability adherence to usage of this mask in the clinical setting to determine its feasibility for more widespread use. This will help us to determine if this mask or a subsequent purpose build version with similar specifications will be able to be deployed in hospital settings on a larger scale.

  • Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus.

    The primary purpose of this pilot study is to provide an indication that the in vitro disinfectant activity seen against the SARS-CoV-2 virus translates to disinfection of the nasal cavity in vivo of COVID-19 patients. Other objectives include collecting data to guide follow-on clinical studies and to provide insights as to mode of action. Overall, the study will provide important insights into the potential role for a PVP-I nasal spray in managing the risk of infection by the virus.

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