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Reducing the frequency of outpatient review in people with cystic fibrosis on high-efficacy modulator therapy – a non-inferiority, randomised controlled trial (REFORM).
Expand descriptionThe aims of this study are to investigate the safety and acceptability of reducing the frequency of outpatient clinic visits from 3 months (standard of care) to 6 months (intervention group) in people with cystic fibrosis (pwCF) on high-efficacy modulator (HEMT). We hypothesise that 6 monthly routine clinic visits will be non-inferior to 3 monthly visits (current standard of care).
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A clinical study to investigate the infusion of an amino acids solution to protect the kidneys during radiotheranostics for patients diagnosed with metastatic prostate cancer.
Expand descriptionThis study aims to mitigate nephrotoxicity and enhance the therapeutic benefits of Lutetium-177 PSMA-I&T treatment by introducing an amino acid infusion as a renal protective measure. Who is it for? You may be eligible for this study if you are an adult male with confirmed prostate cancer and considered for ongoing treatment with 177Lu–PSMA-617. Study details: Participants will receive an amino acid infusion before their 4th, 5th, or 6th treatment cycle. Renal dosimetry will be assessed using 3D SPECT/CT imaging after this cycle and compared to the renal dosimetry of the same patients at the preceding cycle without amino acid infusion. It is hoped that findings from this study will help establish a protocol to reduce renal toxicity in patients undergoing radiotheranostics, thereby improving patient outcomes and safety profiles.
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Evaluation of the MOVERS professional development program
Expand descriptionThe aim of this study was to investigate the potential efficacy of the MOVERS Professional Development Program on children's physical activity, fine and gross motor skills and numeracy and literacy skills and the quality of the movement environment. It was hypothesised that at the end of the 6 month professional development program, that children in the intervention group would have significant increased in physical activity, fine and gross motor skills and numeracy and literacy skills compared to those in the control group. Additionally it was hypothesied that the quality of the movement environment would increase in the intervention group compared to the control group.
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The FITTEST Study: Supporting older people to participate in frailty prevention programs
Expand descriptionThe purpose of the study is to understand whether a supervised or a self-directed frailty program can slow frailty in older adults. We know that building muscle strength, eating a balanced diet and checking medications is best for healthy aging. We also know that being social or connecting with others can help improve or maintain quality of life. Both the supervised and self-directed programs are based on current clinical guidelines and best practice and include help with things we know can help slow or reduce frailty - exercise, diet, checking medicines, and social support and engagement. The study will also look at how easy these programs would be to put into practice in the real world, and to assess the cost of doing so. This study will be conducted in most states of Australia with a total of 390 participants Australia-wide.
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Safety, tolerability and pharmacokinetics of 2g subcutaneous ceftriaxone as an alternative to intravenous administration
Expand descriptionThere is an increasing body of evidence demonstrating the safety and efficacy of subcutaneous (SC) administration of antibiotics. This is a prospective single arm cross over design study aims to extend our experience with subcutaneously administered antibiotics by determining the safety and tolerability of subcutaneous administration of 2g of ceftriaxone. Inpatients already receiving ceftriaxone 2g to treat an infection will have dry blood spots (DBS) collected immediately prior to an intravenous dose and at several time points subsequently over the dosing interval to measure the antibiotic concentrations in bloods. They will then have DBS collected at the same time points with a single dose of ceftriaxone 2g administered via subcutaneous infusion. Patients will be closely followed throughout the study with detailed safety and tolerability assessments completed. We hypothesise that the administration of 2g subcutaneous Ceftriaxone will be safe and well tolerated with equivalent bioavailability to intravenous administration of the same dose.
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A randomised control trial comparing NursE recording Accuracy and Time taken for blood glucose checks with different glucose meters (NEAT)
Expand descriptionAudit comparing amount of nursing time taken and accuracy of blood glucose levels recorded in the electronic medical record for the standard Nova Biomedical glucose meter currently used for clinical care compared with the AMSL wi-fi connectivity Statstrip glucose meter. Nova Biomedical manufactures a wi-fi connectivity glucose meter which can upload its glucose data directly to the patient electronic medical record (eMR). We anticipate that using the wi-fi connectivity glucose meters will substantially save nursing time and also contribute to an increase in the accuracy of glucose recording in the eMR. We plan to compare the time taken to check and record in the eMR a finger prick glucose level using each glucose meter type and to determine the proportion of glucose levels recorded accurately in the eMR by each technique (correct patient, correct time, correct glucose level and delay to glucose being documented in the eMR).
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Nut consumption patterns and 24-hour blood glucose regulation
Expand descriptionThis study aims to compare the effects of two nut ingestion patterns, vs. no nut intake, on the 24-hour blood glucose homeostasis of adults with type 2 diabetes (T2DM). We hypothesise that nuts, when evenly distributed across three main meals, will result in better blood glucose control over 24 hours than when consumed only with breakfast in individuals with T2DM. We further hypothesise that both nut ingestion patterns will be better than a diet without any nuts.
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A Sleep Intervention for Improving Sleep and Lifestyle (Diet, Physical Activity and Sedentary Behaviour) in Women with Polycystic Ovary Syndrome
Expand descriptionCognitive behavioural therapy (CBT) sleep interventions for non-clinical sleep symptoms have positive impacts on sleep quality and quantity and better participant engagement than other lifestyle interventions. This study is a pilot randomised controlled trial (RCT) that aims to test the feasibility of a sleep CBT intervention compared to a minimal intervention for improving sleep and lifestyle in women with PCOS. This would help inform a larger trial to test the hypothesis that women with PCOS are more likely to maintain improved lifestyle (diet, physical activity and sedentary behaviour) if they are obtaining adequate and good quality sleep.
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A multi-center study to investigate the utility of biosignals recorded during deep brain stimulation.
Expand descriptionDeep brain stimulation (DBS) is an established efficacious treatment to reduce symptoms associated with neurological conditions such as Parkinson's disease, essential tremor and dystonia. The success of DBS relies on accurate electrode lead implantation and targeted DBS stimulation. Biosignals, such as evoked resonant neural activity (ERNA), provides additional information to clinicians that may assist in optimising DBS treatment. This study aims to explore the reliability of biosignals collected during DBS implantation under multiple conditions and their utility in optimising DBS treatment.
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Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR): An Evaluation
Expand descriptionCBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). The purpose of this evaluation is to determine the feasibility, acceptability and effectiveness of this treatment. It is hypothesised that this treatment will be feasible and acceptable to clinicians, carers and patients and will be effective in reducing symptoms of ARFID for patients.