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PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial
Administration of antenatal corticosteroids to women prior to preterm birth has been one of the greatest success stories of modern pregnancy and newborn care. Multiple studies have demonstrated a reduction in the rate of breathing problems in newborn babies after this treatment. More recently, several studies have reported benefits when antenatal corticosteroids are given to women who give birth by elective caesarean section after 35 weeks. Elective CS, as opposed to vaginal birth (or even CS in labour) is associated with greater risks of breathing problems in newborn infants and this results in longer hospital stays and separation from the mother. Women with diabetes were specifically excluded from the studies that have demonstrated improvements in the rate of newborn breathing problems, hence, whether these benefits are the same for infants born to women with diabetes is uncertain. Further research in the subgroup of women with diabetes during pregnancy is urgently needed.
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The effects of antioxidants on health and exercise ability in individuals with peripheral artery disease.
Peripheral artery disease (PAD) can result in extensive functional alterations including vascular dysfunction, reduced capacity to exercise, and reduced quality of life. The progression and cause of PAD is thought to be associated with increased oxidative stress and tissue injury related to increased production of reactive oxygen species (ROS) and a decrease in antioxidant defenses. Oxidative stress and inflammation are major features in the development of atherosclerosis and are therefore extremely relevant in the development of PAD. Several important enzymatic antioxidant defenses have been shown to be deficient in the muscle of PAD individuals compared to controls. Endogenous antioxidants function as defenses to remove or regulate ROS production. Therefore, antioxidant deficiencies can lead to a state of excess oxidative stress which contributes to vascular dysfunction, decreased exercise capacity, and the development of PAD, cardiovascular disease, and cerebrovascular disease. However, few studies have adequately explored antioxidant treatment in PAD patients, and none have explored antioxidant treatment and the effects on the extensive vascular network during exercise. The aims of this developmental work are to directly test whether antioxidant treatment (via the intravenous infusion of an antioxidant) can acutely improve vascular function and exercise capacity in patients with PAD.
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Teletriage study to streamline access to specialist care and clinical trials for melanoma and other skin cancers in regional areas
The aim of this study is to determine the feasibility of implementing a telehealth dermatology service (‘teledermatology’) for melanoma and skin cancer care in Regional Australia, by first piloting in a single general practice (Bendigo Primary Care Centre). Who is it for? You may be eligible to join this study if you are aged 18 years or older, are presenting to Bendigo Primary Care Centre for assessment of a skin lesion of concern, and are willing to undergo clinical photography of the skin lesion of concern. Study details All consenting participants presenting to Bendigo Primary Care Centre during a 6-month period will have their skin cancer referral process managed through the teledermatology platform. GPs will submit an electronic referral containing basic information from participant medical records. and photographs of any skin lesions of concern to the Regional Care Navigator (RCN), a nurse at Bendigo Health. The RCN will assess the quality of photos, and if deemed sufficient, forward them to a reporting dermatologist. The dermatologist will complete a remote assessment and provide a report of preferred diagnosis and recommended management within 48 hours back to the RCN and referring GP. It is hoped that this study will show that teledermatology is a feasible and acceptable method of providing melanoma and skin cancer care in regional Australia. If so, this may provide evidence to facilitate implementation of teledermatology services in other regional general practices in Australia.
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A double-blinded randomised control human clinical trial evaluating the safety and effectiveness of colloidal silver sinonasal rinse versus standard of care on post-operative symptomatic outcomes in the treatment of Chronic Rhinosinusitis in adults.
Chronic sinusitis is a debilitating and costly disease. Consistent inflammation and infection of the sinuses causes headaches, facial pain, blockage of the nose and discharge from the nose. The cause of this condition is not fully understood, and it is difficult to treat with surgery being the recommended treatment for some patients. But even after surgery, many patient’s symptoms return, and they may need repeat surgeries in the future. We currently recommend sinus rinses after surgery as a way of keeping sinuses clean and clear and to assist with healing and reducing inflammation and infection. We have previously found that proper care post-operatively can reduce the chances of requiring further surgeries and part of our research has been assessing the different rinses. Our laboratory studies have shown that colloidal silver reduces infection load significantly. In the laboratory, we have improved this product’s manufacturing process by using extracts from gum tree fresh leaves which are abundant in Australia. The safety of colloidal silver was tested in the lab and according to the results it is safe to the sinuses. This clinical trial is aimed at assessing 1. The safety of colloidal silver administration by sino-nasal rinse by documenting any adverse effects and 2. The effect of sinonasal rinse of colloidal silver combined with topical antibiotics on infection load in chronic sinusitis, compared to standard-of-care oral antibiotic tablets. This will be assessed by endoscopic assessment of the sino-nasal tract by a doctor, measuring bacterial load in the laboratory and completion of symptom questionnaires by participants.
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Integrating Palliative Care in Liver Cancer Care Pathways
This study aims to evaluate the effectiveness of a symptom assessment supported by a clinical care pathway for adult patients with liver cancer who are attending ambulatory liver cancer clinics. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an active liver cancer and you are attending one of the participating liver cancer and palliative care centres as an outpatient (Royal Prince Alfred Hospital, Westmead Hospital, Liverpool Hospital and St George Hospital). Unpaid carers for eligible patients will also be invited to participate. Study details Depending upon the hospital/clinical care centre that participants would normally attend they will either continue to be treated per the current care guidelines or they will be invited to participate in the intervention model of care. Participants who attend either of the usual care or intervention centres will be asked to complete two questionnaires about their symptoms and quality of life at each of their scheduled visits, and will be provided with instructions that they can raise any symptom concerns with their treating clinician at their appointment. Completion of the questionnaires is anticipated to take 10-15 minutes. Carers of participants who attend one of the intervention centres will also be asked to complete a questionnaire about their support needs. For participants and carers who attend one of the intervention centres, the questionnaire responses will be assessed against a set of criteria. If the participant is experiencing a decrease in their quality of life, an increase in their symptoms and/or severity of symptoms, or the carer has identified that their support needs are not being met this will trigger a referral to be sent to palliative care services. Participants who receive this referral will also be reviewed by a Palliative Medicine Specialist for further clinical review so that they may be provided with personalised symptom management, other supportive management and interdisciplinary referral as required. It is hoped this research will determine whether implementation of a symptom and needs-based assessment framework for additional palliative care services is feasible and whether this framework has a positive impact on the quality of care of patients with liver cancer. If the assessment framework model of care is seen to have a positive impact, it may be expanded to include a greater number of clinic care centres which would allow further patients with liver cancer to receive more personalised care.
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Australian Epilepsy Project
The Australian Epilepsy Project (AEP) is a large scale project with a planned 4000 participants using a package of both established and experimental testing in epilepsy to improve our ability to both provide accurate prognosis and diagnose surgically-curable disease. The package will include advanced MRI, neuropsychological assessment and genetic testing.
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Efficacy of a digital pain management intervention on pain and reliance on opioids in patients with rib fractures
Patients who engage with behavioural pain management strategies (e.g., relaxation, thought management) have better pain relief and use less opioids. However, delivering these strategies in hospital settings can be costly and often is not feasible during acute pain service rounds. Emerging research indicates that behavioural pain management education can effectively be delivered using low-cost digital technology. The aim of this study is to test the hypothesis that patients who receive an mHealth intervention (educational video + supportive daily text messages) will utilise lower doses of opioids across the first week of hospitalisation and one week after discharge compared to those who receive the education video only.
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Acceptability, feasibility, and effectiveness of a choir for enhancing quality of life in people diagnosed with dementia and their caregivers
People with dementia and their caregivers often experience loneliness and depression, which can impact their quality of life and caregiver burden. One promising social intervention is choir singing - an accessible and enjoyable activity that benefits memory and thinking, social connectedness, and mental wellbeing of older adults. Previous studies have reported varying results about the extent to which choirs improve quality of life, mood, and wellbeing for people with dementia and their carers. We are partnering with Bulimba community centre to evaluate the Sing Sing Sing choir program for people with dementia and their caregivers living in the community. We will survey people in the early days of joining the choir (0-3 months post starting intervention) and follow them up once 6-8 months after their first survey to determine whether choir participation improves the quality of life, wellbeing, mood and loneliness of people with dementia and their carers; and whether it reduces burden for carers of people with dementia. We will also interview the participants to ask them about what they have experienced as the most significant change for them since taking part in the choir. By building on the growing body of research into choirs for people living with dementia, we will develop an evidence base to understand how to make these interventions most effective.
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A Phase II pilot study to determine protocol feasibility, and potential efficacy for disease modification of combined Doxycycline and Ambroxol in Dementia with Lewy Bodies
The purpose of this study is to determine the feasibility of the research protocol, as well as assess the potential effectiveness of the study medication (combination of doxycyline and ambroxol) in slowing the progression of Dementia with Lewy Bodies. Treatment effectiveness will be evaluated by means of clinical disease rating scales and questionnaires that evaluate participants’ DLB-related symptoms, quality of life and general health. The results of this study may help identify future disease modifying strategies for DLB, as well as provide the clinical trial framework with which to further investigate their effects on the disease. Participants will be assigned to either the active treatment group, or a placebo group. To try to ensure the groups are allocated fairly, each participant is put into a group by chance (randomisation).
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Phase II trial to evaluate the safety, feasibility and efficacy of using therapeutic weighted blankets for agitation in patients with dementia in acute care settings.
The rate of hospitalisations for persons living with dementia has increased in recent years, and the average length of stay is 13 days (five times the average hospitalisation) (AIHW, 2021). Persons with dementia can often experience behavioural and psychological symptoms of dementia (BPSD) including agitation while in hospital. Agitation experienced by patients with dementia is associated with poor health outcomes, long-term hospitalisation, overuse of medication, and increased health care costs (Cerejeira et al, 2012). Medical-grade therapeutic weighted blankets may be safe, and feasible to reduce agitation experienced by patients with dementia during hospitalisation. This research aims to evaluate the feasibility, safety and efficacy of using therapeutic weighted blankets to reduce agitation in patients with dementia in acute care settings. Objectives: To report the safety of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the feasibility of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the efficacy of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings.