ANZCTR search results

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

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30938 results sorted by trial registration date.
  • Investigating Metabolic Acidosis in Gastroenterology Induced by Colonoscopy preparation and Sodium glucose transporter 2 inhibitors: The MAGICS Study

    Diabetic ketoacidosis is a metabolic emergency of increased acidity of the blood resulting from a lack of insulin and an accumulation of ketones within the bloodstream. In this study, we will review a cohort of Type 2 Diabetes Mellitus (T2DM) patients regularly taking sodium-glucose co-transporter 2 inhibitors (SGLT2i) who prepare for colonoscopy with SGLT2i cessation, bowel preparation, and starvation across a 12-month period. From this cohort, we will measure pre-procedural serum SGLT2i levels in patients both presenting with ketosis, and without ketosis and to compare residual SGLT2i drug level between patients who are acidotic versus those who are not. We hypothesise that severe ketoacidosis will be due to insufficient clearance of SGLT2i prior to the procedure. Importantly, should we demonstrate a link between residual plasma SGLT2i levels and ketosis, it may suggest longer pre-procedural cessation periods are warranted and ultimately, will decrease morbidity and mortality associated with the admission of patients with diabetes, and the inconvenience of day-of-procedure delays or cancellations, and improved utilisation of healthcare resources.

  • FIBRE-PD: prospective randomised feasibility trial investigating bulk forming laxative adherence and effectiveness in peritoneal dialysis patients.

    FIBRE-PD is a prospective parallel-arm open-label randomised controlled study which aims to explore recruitment, adherence, efficacy and safety of implementing psyllium husk to patients receiving PD with constipation compared to standard care. Sixty prevalent PD patients will be recruited from the PD unit at the Princess Alexandra Hospital Participants will be randomly assigned in a 1:1 ratio to receive either Psyllium husk or continue Movicol®. Key objectives to be assessed in this feasibility randomised controlled trial include, whether: 1. Eligible PD patients can be recruited to take psyllium husk 2. PD patients will adhere to psyllium husk administered to maintain gut motility 3. PD patients will withdraw from a randomised controlled trial when Psyllium husk is administered to reduce gastrointestinal symptom burden and to help maintain gut motility 4. Psyllium husks help maintain gut motility, reduce gastrointestinal symptom burden and improve quality of life in PD patients Hypotheses include: 1. The FIBRE-PD study will be able to successfully recruit 60 patients within twelve months. 2. PD patients allocated to receive psyllium husk will adhere to treatment during the study (defined as >80% of treatment administered). 3. PD patients will not withdraw (10% or less withdrawal) from the study examining the safety and efficacy of psyllium husk as a gut health intervention strategy in PD. 4. Psyllium husk in PD patients will result in improved quality of life during the 4-week study period. 5. Psyllium husk supplementation in PD patients will maintain gut motility and reduce the burden of gastrointestinal symptom measured using Bristol stool score, frequency and Gastrointestinal Symptom Rating Scale.

  • Assessing the Feasibility and Acceptability of an Early Psychiatric Assessment after discharge from the Intensive Care Unit.

    Mental illness is unfortunately common after intensive care. A recent large cohort study of 4,943 ICU survivors in the UK found the prevalence of anxiety, depression, and PTSD to be 46%, 40% and 22% respectively, with 18% meeting criteria for all three conditions. At present, while many hospitals operate a post-ICU clinic, there is no agreement in literature as to the best model of care, and to-date the inclusion of a psychiatric assessment has not been evaluated. This study seeks to assess the feasibility and acceptability of including a psychiatric review in addition to standard cares, as well as estimate the effect size this review might have on symptom burden and quality of life to support power calculations for a fully powered RCT if the intervention is deemed both feasible and acceptable.

  • Evaluation of a paediatric inter-facility transfer initiative for acutely unwell children in regional Queensland: Standardised Workflow for Inter-Facility Transfer of Kids [SWIFTKids]

    Unwell children have a high chance of deteriorating if the right care, in the right place, is delayed. If the right care is at another facility, how and when children are transferred is paramount to protecting the child’s safety. Most paediatric inter-facility transfers within Australia are of unwell children who do not qualify for patient transport via specialist paediatric retrieval services but require transfer to access specialised paediatric care not offered at their current healthcare facility. Patient safety reports of these transfers highlighted children experienced harm due to lack of clear procedures and communication break-down. A strategy aimed to improve the safe transfer of unwell children to a facility where specialist paediatric care is available: Standardised Workflow for Inter-Facility Transfer of Kids [SWIFTKids], has been designed and implemented within the Sunshine Coast district. Findings will inform ongoing revision of paediatric inter-facility transfer processes within the local hospital and health service; and, if found to be economically feasible while improving positive patient outcomes it would be recommended the SWIFTKids strategy be considered state-wide. Hypothesis: A standardised workflow for inter-facility transfer of non-critical but moderately unwell children will improve the safety and efficiency of transfer for children and their families. Methods: Evaluation of the SWIFTKids strategy will be conceptually guided by the Donabedian framework. Factors within the domains of Structure, Process and Outcomes will be explored and measured.

  • Chronic Low Back Pain Survey in Australia

    This is a prospective, single-encounter, observational online survey of male and female adults who have chronic low back pain. The main objective is to evaluate the different types of pain experienced using a validated pain questionnaire, and also, respondent satisfaction with different types of pain management experienced by participants who have low back pain.

  • The SAUNA Study: a blood- and stool-based investigation of markers correlating with hallmarks of dementia

    Autophagy is a cellular process that cleanses our cells and is particularly important as we age. Importantly, autophagy can be increased and is therefore a potential therapy for age related disease. Numerous studies have shown that this process could be important for delaying the onset of dementia. Despite this progress, all our knowledge mostly comes from work done in the laboratory and in rodents, not humans. To answer questions about whether a change in autophagy correlates with the presence or absence of hallmarks of dementia (such as amyloid plaques in your brain) in humans scientifically, our research group has developed a first-ever test to measure autophagy in human blood. In addition, alterations to the gut microbiome (natural bacteria residing in our gut) have been linked to ageing-associated conditions, including Alzheimer’s disease, and to a range of modifiable dementia risks that have been shown to contribute to the development of dementia. We have shown that features of natural intestinal bacteria are associated with dementia, however, the role of these bacteria in development of amyloid plaques in Alzheimer’s disease, and a connection with autophagy, is unknown. This project aims to measure autophagy in blood from people who do, and people who do not have amyloid plaques (measured using Aß PET during the ADNet TRC study). This project also aims to determine if the natural bacteria composition, measured in stool samples, is altered in people who have amyloid plaques. This will provide information about whether autophagy is different in humans with Alzheimer’s disease hallmarks, and if there is a connection between gut health, autophagy, and dementia.

  • Hybrid Closed Loop in Advanced Renal Disease

    This proposal consists of a two-stage randomized crossover study comparing automated subcutaneous insulin delivery also known as Hybrid Closed Loop (HCL) therapy with usual care and CGM in people with type 1 and type 2 diabetes complicated by advanced renal disease and managed with insulin. Participants will be recruited from three groups: (A) advanced renal disease not on dialysis; (B) those managed with peritoneal dialysis; (C) those managed with haemodialysis in ratios of 2:1:1 respectively. All consented participants will enter a 6-week run-in period where baseline demographic data will be collected, diabetes education and carbohydrate count education provided. During the final three weeks of run-in continuous glucose monitoring (CGM) data will be collected following which HbA1c, and questionnaires assessing psychosocial function will be administered. Participants completing run-in-will receive in random order the Medtronic 780G CL system or usual care with CGM. Each of the two stages will last 8 weeks. For the last 3 weeks of each stage CGM data will be collected. Following each stage blood will be collected for electrolytes and an HbA1c, Questionnaires will be administered. Data will be collected post-randomisation in real-time on HCL technical performance and time spent by the participants on changing insulin-sets and glucose sensors.

  • Use of Smartphone Application to Detect Atrial Fibrillation After Ablation Procedure

    This research project seeks to investigate the use of a simple smartphone application (FibriCheck) in detecting atrial fibrillation (AF) recurrence after an AF ablation procedure. Early detection of AF recurrence is crucial to ensure proper and timely treatment. The study will compare FibriCheck with current monitoring strategy (Holter monitor) in identifying AF episodes. As short period of monitoring with Holter potentially miss episodes in between recording, FibriCheck could be a more superior and better tolerated alternative.

  • Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer

    Standard treatment of vulvar cancer includes surgery to remove the primary tumour, and if required, removal of groin lymph nodes. Groin Lymph Node Dissection (LND) can be delivered through a full inguinofemoral node dissection (removing as many nodes as possible) or through sentinel node biopsy (SNB -removing only one or two targeted groin lymph nodes). While the gold standard is often curative, groin LND is associated with debilitating long-term outcomes for virtually all women. The aim of this study is to assess the feasibility and accuracy of using high-resolution groin ultrasound as a non-invasive alternative method of identifying lymph node involvement in these patients. Who is it for? You may be eligible for this study if you are aged 18 years and over, have been diagnosed with vulvar cancer (i.e. without evidence of regional or distant metastatic disease), and are scheduled to undergo surgery to the vulva and groin(s) within the next 30 days. Study details Up to 30 days prior to their planned surgery, all participants will undergo a bilateral (i.e. on both sides) groin ultrasound. This will involve a radiologist placing a small probe on the groin to take measurements of any identified lymph nodes, and will take between 30 and 45 minutes to complete. After their planned surgery, any removed lymph nodes will be assessed by a pathologist for detection of spread of vulvar cancer cells. This will then be compared to the ultrasound measurements to determine whether groin ultrasound can be used to predict nodal involvement. It is hoped that this study may show that non-invasive groin ultrasound is a feasible and accurate method of predicting nodal involvement in vulvar cancer patients. If so, the ability to predict the absence of nodal involvement may spare future vulvar cancer patients unnecessary LND procedures to reduce complications, improve recovery time, and facilitate their return to normal daily activities.

  • The Effects of 12 Weeks of Upper Body Ergometry and Resistance Exercise in People with Diabetes-Related Foot Ulcers: The DFUEx Study

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