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Care navigation for adults with depression or anxiety: A propensity matched comparison
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Regenerating human jaw bone using custom 3D printed scaffolds – a preliminary clinical study
The use of pre-fabricated, customized and bioresorbable medical grade scaffolds is a significant development in this field of tissue engineering. Medical grade polycaprolactone (PCL) is a highly biocompatible and completely bioresorbable polymer. These scaffolds have been shown to be dimensionally accurate and stable, adaptable to a range of defects and conducive for bone regeneration. These scaffolds, are yet to be clinically assessed clinically. The objective of this proof of principle study is to report on the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects.
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Comparison of adaptive ventilation mode with low tidal volume mode in patients with acute respiratory distress syndrome (ARDS)- a pilot randomized cross-over study
AIM The primary aim of this study is to determine whether use of adaptive ventilation mode (AVM2) which uses an automated mechanical power algorithm leads to a decrease in driving pressure in patients with moderate to severe ARDS. HYPOTHESIS We hypothesized that, when compared to “traditional” Lung protective mechanical ventilation based on low tidal volume ventilation, ventilator settings selected by AVM2 will have a lower driving pressure DESIGN A single centre feasibility / physiological / proof of concept study in 20 ARDS patients within 24 hours of intubation (moderate to severe ARDS). Study design will be a prospective randomized cross-over study in 20 critically ill patients on controlled mechanical ventilation- with randomized 6 hours of LTV and 6 hours of AVM2. Study period 2 years Setting Single Centre study conducted in the Intensive care unit (ICU) at Flinders Medical Centre, Australia Population Inclusion: who are 'greater than and equal to' 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 <= 200 mmHg, PEEP >= 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload) Exclusion: patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies. Intervention AVM2 which uses an automated mechanical power algorithm. Comparator Usual care, with a tidal volume-based approach as per the ARDSnet protocol Sample size 20 patient – feasibility study STUDY ENDPOINTS Outcomes The Primary outcome is driving pressure. Other secondary outcomes will include delivered tidal volume, mechanical power, PaO2/FiO2 ratio, PaCO2, pH, lung dead space and patients hemodynamic (hemodynamic data on MAP and HR were averaged during the last 5 min of each hour of the 6-h period)
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Mind Your Nose Trial: The Impact of smell-based memory training (OMT) in older adults
Participation in the Mind Your Nose Trial may be associated with gains in aspects of visual and olfactory based memory. Gains in other outcomes such as mood and psychological wellbeing are also possible. It is hypothesised that olfactory based memory training may lead to gains in both olfactory memory and visual memory. This study will contribute to the current understandings of how we might prevent and treat olfactory and cognitive difficulties in older adults. Findings may have implications for improving functional abilities of older adults, enabling them to lead fulfilling and independent lives. In a very small number of cases, it is possible that participation in the current study will identify a need to refer a participant for more a detailed neuropsychological assessment which may reveal signs of cognitive decline which could turn out to be due to a neurodegenerative condition. It is therefore possible that through participation in this study, earlier detection of cognitive changes will lead to an earlier diagnosis of relevant conditions associated with older age.
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Rebate for an Adolescent Health Assessment Trial (RAd Health Trial)
Adolescence and young adulthood (‘young people’) is a time when health-compromising (‘risk’) behaviours such as substance use emerge and sexual activity commences – 1 in 4 will have a mental health condition. The Royal Australian College of General Practitioners Guidelines recommend evidence-based health checks for young people to detect risk behaviours such as substance use, unsafe sexual practices, assess weight and diet, and identify mental health conditions early enough to reduce morbidity and prevent escalation of behaviours. GPs can intervene by counselling, STI screening, referring to dieticians, prescribing contraception and initiating mental health plans. Yet, general practice is failing young people: only 15% have an annual chlamydia test; only 6% are prescribed the most effective contraception, and; only one third of the those with a mental health condition have a mental health plan initiated. Consultation time is the key obstacle. To address this, there are calls for a Medicare rebate to fund a longer consult so that the assessment can done. However, without RCT evidence that such a rebate would be ‘value for the patient’ and ‘value for the health system’, a rebate is unlikely to be recommended. We will conduct a cluster RCT to determine whether a rebated health assessment for patients aged 14 to 24 years in general practice is cost-effective. A total of 42 clinics will participate and be randomised to receive a rebate payment the same as is available for the 45-49 year check. The primary outcome is detection of risks and health conditions because this is the first step required to get GPs to initiate an action to improve patient outcomes whether this be testing (e.g. STI screening), prescribing (e.g. contraception), managing (e.g. common mental condition), referral (e.g. mental health, dietetics) or education/counselling (e.g. alcohol).We will recruit a cohort of 1,000 16 to 24 year old patients from the clinics to collect information about the impact of the health assessment on their quality of life. This information will inform our economic modelling which will investigate the impact of rebates on downstream health outcomes.
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Internet Delivered Skills Training for Chronic Pain
In a recent pilot study (ACTRN: 12620000604909) evidence was promising for the feasibility, acceptability and efficacy of an online skills training for people in chronic pain (internet-delivered dialectical behavioural therapy skills training; iDBT-Pain). We now aim to further investigate the effectiveness of iDBT-Pain in a Randomised Control Trial (RCT). iDBT-Pain is an online training to teach skills for more effective emotion regulation. iDBT-Pain utilises evidence-based protocols for DBT skills training and will be administered according to the DBT Skills Training manual (Linehan, 2015). The intervention includes eight group-based sessions delivered to participants via Zoom, and access to a web app. It is hypothesised that the iDBT-Pain intervention will significantly reduce emotion dysregulation in people with chronic pain. It is further hypothesised that there may be changes in secondary outcomes related to chronic pain, including, pain intensity, pain interference, trauma, depression, anxiety, stress, sleep quality, harm avoidance, coping behaviours, and satisfaction with life.
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Safety, feasibility and acceptability of a wearable electroencephalography (EEG) device
Clinical safety study to assess the safety, feasibility and acceptability of a long-term, continuous monitoring, wearable electroencephalography (EEG) device in ischemic stroke patients. The device will be worn for 9 hours by 20 patients with acute ischemic stroke. Eligible participants will have already received treatment and will be in the stroke ward being monitored for at least 9 hours. Participants will be asked to complete a questionnaire at 1, 3, 6 and 9 hours to assess device comfort, acceptability and user experience. Safety will be assessed by the number of adverse events. Feasibility will be assessed as the number of hours of viable data as a percentage of the total recording time. The device will not interfere with standard care.
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Online clinical trial on a novel topical gel for hand osteoarthritis pain
This study will be conducted as an online trial. All treatment packages will be shipped to the participant's postage address. Recruitment, and treatment application will be conducted in the participant's residence. This trial will evaluate the effectiveness and safety of new gel (Soodox Active) to reduce pain in hand osteoarthritis. It will be compared to another gel (Voltaren) that is widely used in current practice for a range of pain types and is considered the gold-standard commercial product. The effects on pain will then be measured in both using a 0-100mm Visual Analogue Scale, 100 being the worst pain and 0 being no pain. The participant's quality of life and hand function will also be measured using standardised questionnaires.
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Medical Cannabis and Its Effects on Driving
The aim of this study is to determine whether treatment with prescribed medicinal cannabis (containing delta 9-THC) for long-term symptom control impacts driving and cognitive/psychomotor performance. This will be assessed after 4, 8 and 12 weeks of treatment and examined relative to pre-treatment performance in a group of chronic non-cancer pain patients.
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Injectable antiretroviral therapy feasibility study: JABS
This is a single-arm, open-label study to evaluate the feasibility and effectiveness of long acting antiretroviral therapy in a "real world" setting, with inclusion of patients with complex social and medical needs and who have been under-represented in randomised clinical trials. Standard assessments of virological suppression and tolerability will be carried out however the study will primarily assess adherence to injections, qualitative aspects of the patient experience and satisfaction with injections as long-term therapy by both patients and providers, compared with patients' previously prescribed oral regimens. The study will also aim to describe the operational changes in clinical service required to deliver LA therapy and the patient and health-service characteristics associated with best outcomes.