ANZCTR search results

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

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32107 results sorted by trial registration date.
  • 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

  • Brain Activity Effects of Psychedelic Medicines

    The objective of this project is to investigate changes in neural activity associated with a single session of psychedelic drug exposure, in particular with psilocybin or 3,4- methylenedioxymethamphetamine (MDMA). Specifically, the study aims to use electroencephalography (EEG) to measure neural activity both before and two weeks after psychedelic exposure. EEG activity during a latent inhibition task will be measured, as decreased latent inhibition has been associated with the personality trait of openness to experience, a trait which previous research has shown is increased by exposure to psychedelics. Similarly, EEG activity during an auditory oddball task will be measured, as previous research has shown that exposure to psychedelics reduces neural adaptation to familiar stimuli. Neural activity associated with processing of facial emotions will also be assessed, as this activity has been suggested to be modified by MDMA and could be a potential explanation for therapeutic effects. Additionally, resting EEG measures will be used to test whether psychedelic exposure is associated with changes to the excitation/inhibition balances that underpinning healthy neural activity. We hypothesize that the measures of neural activity listed above will differ from pre to post psychedelic exposure. Since both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to both improve our understanding of the potential mechanisms of action of these drugs. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs as they transition towards broad scale implementation as therapies for psychiatric conditions.

  • Highly Personalised and Measurement-Based Care implementation trial for mental health treatment seeking young people (EMPOWERED Trial)

    This study aims to assess in 1500 mental health treatment seeking young people whether more personalised health care packages, linked with continuous digital feedback, deliver better functional improvements at 12 months (and follow-up for a further 12 months after cessation of active care) than digitally-supported assessment linked to standard care packages. We hypothesise that the highly personalised & measurement based care (HP&MBC) treatment packages are superior to standard care packages, by implementing continuous monitoring and care coordination through the use of digital technologies, and providing extensive feedback to the clinical service, the treating clinician and the young person and their family or carer. The continuous feedback will detect unmet care, increase the likelihood of identifying persons that do not respond to treatment and facilitate the process to optimise care and increase the engagement of young people in their own care.

  • Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-VLC)

    SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.

  • comparing the effect of a Dextrose solution on the length of labour in women undergoing an induction of labour

    Women normally receive Hartmann's solution in labour we wish to provide them with more energy using a dextrose solution given slowly in labour to see if we can shorten their length of labour and possibly reduce caesarean section rate

  • 'Adventure & Veg' - the effectiveness of a parental text message and social media program on primary-school aged children's physical activity and vegetable eating behaviours; a randomised, controlled trial (pilot study).

    Mobile (M)-health programs hold promise as health promotion interventions: they require minimal resourcing, can be delivered at scale and have the potential to engage a wide audience, including hard-to-reach families and rural and remote populations. Text messages and social media posts have been shown to be an effective and convenient way to help people adopt healthy habits. The “Adventure & Veg” research study aims to assess the effectiveness of a text message and social media program for parents on their primary school-aged children’s physical activity and vegetable eating behaviours. Eligible participants will be asked to do a brief online survey at the beginning of the study and then at 2 months. This survey will ask questions about the participant's and participant's primary school-aged child's physical activity and vegetable eating behaviours. After completing survey 1, participants will be randomly allocated into either an intervention or control group. The intervention group will receive 8 weeks of text messages (5 messages each week) on tips for healthy lifestyle habits (e.g. physical activity, nutrition) and have access to a closed Facebook group with weekly local outdoor activity ideas. The control group will be invited to join the program in 2023, should the research study prove successful. At the completion of the study participants will be offered a $50 gift voucher as a thank you for their time.

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