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Factors affecting insulin dose requirements for treatment of prednisolone induced hyperglycaemia.
Prednisolone is an oral glucocorticoid used in the acute treatment of many inflammatory diseases. Glucocorticoid excess leads to hyperglycaemia. There is wide variability in the degree of hyperglycaemia associated with oral prednisolone use. We aim to define how clinical features and different times of day are associated with insulin requirement in hyperglycaemic hospitalised patients taking prednisolone. We will recruit 50 consecutive participants who are admitted to general medical or medical sub-specialty inpatient teams at Flinders Medical Centre or Lyell McEwin Hospital who meet eligibility criteria. This is an open interventional study. Eligible, consenting participants will receive 24 hours of intravenous insulin infusion. Flash glucose monitoring will be used to measure hourly blood glucose concentration. Use of intravenous insulin infusion will follow Flinders Medical Centre infusion protocol. We expect to be able to characterise how clinical features and time periods throughout the day predict for insulin requirements in hyperglycaemic hospitalised patients taking prednisolone.
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A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted with a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. In SAD, participants will receive one dose of BT-11 or placebo. In MAD, participants will receive multiple doses of BT-11 or placebo for 7 consecutive days. In both parts, sequential cohorts will be exposed to increasing doses of BT-11. In SAD, five doses will be evaluated, in MAD 3 dose levels will be evaluated.
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feasibility of Innovative photography technology (The VISIA facial imaging system) to monitor the effect of 5-flurouracil treatment for people with solar/actinic damage to their face.
Patients already under the care of specialist dermatologists or referred to a dermatologist at The Princess Alexandra Hospital will be recruited during attendance for their full skin examination. Should a patient require topical field therapy and the clinician deems 5-fluroruracil the treatment of choice – the patient’s usual doctor or nurse will introduce the study to their patient and gauge their interest in participating. A member of the study team will be available to answer any questions or concerns a patient may have regarding the trial, before ensuring informed consent is granted. The member of the study team will also record information on demographic, and relevant medical history from the patient, as listed below. Baseline clinical photographs will be taken using the specialised facial photography machine (VISIA®, Canfield Scientific). Once enrolled, patients will be flagged by the study team and followed at their subsequent reviews. As part of standard care, patients are requested to present for review at 2weeks after commencing treatment and again at the conclusion of treatment (4 or 6 weeks depending on indication). Patients are also requested to present 12weeks after the commencement of treatment for final evaluation. At any stage, but particularly at 12weeks after commencement of treatment – careful examination is performed to determine of any field-treatment failures so that subsequent management may be initiated (e.g. formal excision). At the conclusion of their usual clinical follow-up appointment, the participant will be ushered into the adjunct research room for repeat/progress specialised facial photography as described above (VISIA®, Canfield Scientific).
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Introducing Best Practice Oxygen therapy for Infants with Bronchiolitis
This study aims to determine the benefit, effectiveness, and sustainability of a facilitated and structured educational support program versus no facilitation or educational support program in the uptake and adherence to NHF therapy guidelines for infants less than 12 months old admitted with bronchiolitis. The key stakeholders (nursing and medical workforce) have been familiarised with the use of NHF therapy within the boundaries of the completed NHMRC PARIS I trial, 2013-2016. Our study group has developed a comprehensive education program, which includes visual education, paper and signage resources, face to face teaching and online video postings.
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A study investigating safety, dosing and effectiveness of medicinal cannabis for symptom relief for patients with advanced cancer
Recently there has been a growing interest in the use of cannabis to try and relieve symptoms of pain, nausea, shortness of breath, anxiety, and depression, in patients with advanced cancer. The purpose of this study is to determine an appropriate dosing regimen, safety and efficacy for THC and CBD (both components of cannabis) for symptom relief in patients with advanced cancer. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with advanced cancer. Study details Participants will be allocated into 1 of 2 treatment arms. Group 1 will be receiving CBD (cannabidoil) and Group 2 will be receiving THC (Delta-9-Tetrahydrocannabinol). Determination of the treatment given to the participant will be based on the participant, the treating doctor, and the supply of the medication. Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. Participants will be required to have a blood test and if any females are of child bearing potential a urine test to determine eligibility. It is hoped that this research will be effective in determining a safe and effective dose for symptom relief in patients with advanced cancer.
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A model of culturally-informed integration of diabetic retinopathy screening and diabetes education assessment in Indigenous primary care settings.
Diabetic retinopathy is a major public health problem in Australia, particularly among Indigenous Australians. For this reason, national guidelines in Australia were first developed for diabetic retinopathy. Despite efforts over two decades aimed at timely detection and early treatment of diabetic retinopathy, about half the Indigenous population with diabetes in Australia is not screened in accordance with the guidelines. Novel approaches to screening for diabetic retinopathy are needed, particularly in Australia's remote, under-resourced and Indigenous communities.The aim of this project is to implement an imaging-based telehealth diabetic retinopathy screening program managed by a diabetes educator in Indigenous primary care clinics. Objectives 1) To develop a model of integrated DE and DRS assessment in regional Indigenous primary care services. 2) To develop culturally-informed DE and DRS programs with input from Indigenous stakeholders. 3) To improve DRS coverage in Indigenous primary health care services. 4) Use DRS images and vision status to reinforce importance of diabetes self-management for reducing risk of all diabetes complications. 5) Facilitate timely referral pathways to ophthalmic services and diabetes specialist services. Research Design Proof of concept trial using a qualitative and quantitative approach. Up to three rural/regional trial-sites and approximately 250 T2DM participants aged older than 18 years of age Pre-post trial design: diabetic retinopathy screening, assessing health literacy, clinical and lifestyle risk factors, social/emotional well-being, satisfaction with diabetes education, perceived barriers/motivators to access and follow-up services. Baseline visit: Diabetic retinopathy screening, Smoking, Nutrition, Alcohol, Physical (activity) and Emotional (well-being) [SNAPE] and Vision Impairment Questionnaires to will be administered. HbA1c, lipids and blood pressure will also be measured to gauge patient’s baseline diabetes self-management. Surveys will assess a patient’s diabetes knowledge and health literacy, Final visit: Diabetic retinopathy screening repeated to assess adherence to annual screening recommendation, administration of the Diabetes Knowledge Questionnaire to gauge if patient’s diabetes knowledge has increased and self-care has improved over the intervention period, repeat measurement of patient’s HbA1c, lipids and blood pressure to see if diabetes risk factor control has improved. Patients will also have administered the Diabetes Treatment Satisfaction Questionnaire that will gauge patient’s satisfaction with the intervention over time. With integration of diabetes education and diabetic retinopathy screening, it is expected that engagement with self-management [risk factor control and adherence to retinopathy screening recommendations] will improve.
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Using a new genetic blood test in disease monitoring for lung cancer.
The purpose of this study is to determine the practicality of a new blood test called droplet digital PCR (ddPCR) to detect circulating tumour DNA in early stage lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has suspected or proven non-small cell lung cancer. Study details Participants will provide blood samples and a sample of lung tumour at time of surgery. Participants will be reviewed one month post-surgery and then every 6 months for 3 years, with a clinical review, CT scan and blood test completed at each follow up. Participants will be reviewed at 4 and 5 years with a clinical review and CT scan. It is hoped this research will enable doctors in the future to use this new blood test to better predict outcomes of cancer surgery in order to determine the best post-operative treatment required for each individual participant.
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An evaluation of two contact lenses to correct presbyopia
The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings) in presbyopes between two different contact lens designs. To achieve this, participants will each wear both lens types for a minimum of 1 month. Outcome measures will comprise visual acuity and subjective ratings. Our hypotheses are there will be no differences between lens type for either visual acuity or subjective ratings.
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Cognitive behavioural therapy for sleep disturbances in children with brain injury
Traumatic brain injury (TBI) has been recognised as a major public health issue by the World Health Organisation. Children are particularly susceptible. Children with TBI are at risk of life-long residual cognitive and behavioural deficits. Therefore, development of treatments that promote recovery and improve outcomes is of critical importance. Our initial outcome study showed that 62% of children who sustain moderate to severe TBI experienced sleep disturbance. This is an important finding as sleep is vital for brain development, cognitive, and emotional health. At present, however, sleep disturbances remain largely undiagnosed and untreated after childhood TBI. Development and implementation of effective treatments for sleep disturbances is important, as improved sleep will promote recovery, brain development, cognitive and emotional health, and the wellbeing of children and families. Aims: This study aims to (i) determine the feasibility of CBT for insomnia (CBT-I) following child traumatic brain injury and (ii) determine the efficacy of CBT-I on sleep and secondary functional gains in fatigue, pain, behaviour/mood, and cognition. Participants: Seven children (age 11-16 years) who meet the following criteria will be recruited: (i) receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program, Sydney Children's Hospital Randwick; (ii) subclinical to clinical symptoms of insomnia (i.e., T-score >55) on the Sleep Disturbance Scale for Children or evidence of reduced sleep quality on actigraphy. In addition, a structured clinical interview will be conducted to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition; and (iii) participant and family fluent in English. Baseline assessment: Participants will be randomised to 7- or 14-day baseline assessment of sleep (i.e., wear an actigraphy watch and complete a daily sleep diary) and questionnaires about sleep, fatigue, pain, behaviour/mood, and cognition. Intervention: All participants will then complete 4 x 75min weekly sessions of individual manualised CBT-I treatment during which time they will continue to wear an actigraphy watch and complete the daily sleep diary for the duration of the 4 weeks. Therapists delivering the intervention will rate participants' treatment engagement using a questionnaire after each treatment session. Post-intervention assessment: Following treatment, all participants will complete 7-day assessment of sleep (actigraphy and sleep diary) and questionnaires. They will also be asked to rate whether they found the intervention to be satisfactory and acceptable by completing an additional questionnaire on completion on treatment.
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Does choice enhance the placebo effect for sleep?
Choice has been found to facilitate placebo effects in acute conditions where standard placebo treatment without choice has failed to elicit a placebo effect. However, it is unknown whether choice can enhance the placebo effect for longer-term treatments where placebo effects are readily established without choice. This study tested whether either a single or daily choice between two treatments enhanced the placebo effect for sleep difficulty relative to no choice and no treatment over a one-week period.