ANZCTR search results

This study is testing whether a two-step, online support program can help adults reduce binge eating. Everyone will begin with a brief, self-guided online session about binge eating. Two weeks later, those who still need support will be randomly offered one of three options: a digital program based on cognitive behaviour therapy (CBT), a program based on dialectical behaviour therapy (DBT), or no additional support for now. We want to find out if these follow-up programs help reduce binge eating more than doing nothing further, and whether CBT or DBT works better. The study also aims to identify who benefits most from each step. Hypothesis: non early responders randomized to online CBT or DBT will experience greater reduction in primary outcome symptom measures than non-early responders randomized to waitlist and will not differ significantly to early strong responders.

Muscle-strengthening activities (MSA) are associated with a range of physical and psychosocial health benefits for youth. However, most school-based MSA interventions have been delivered by external providers or research staff, limiting scalability. This study aimed to assess the feasibility and preliminary efficacy of Muscle Movers, a teacher-delivered MSA intervention for primary school children.

Using a randomised controlled trial study design, 270 pregnant and 90 non-pregnant women will complete cycling trials in a climate chamber with increasing humidity at three fixed ambient temperatures (30°C, 35°C, and 40°C). Core temperature, local sweat rate, cardiovascular responses, and fetal heart rate (for pregnant participants) will be continuously monitored to determine the thresholds for heat strain. We will hence seek to quantify critical environmental limits (of temperature and humidity) in pregnant women compared to non-pregnant women during light physical activity. Lay hypothesis: Our study hypothesis is that the critical humidity before core temperature rises, will be lower for women in later stages of pregnancy regardless of ambient temperature.

We aim to determine feasibility of a single insertion prototype combined glucose-ketone continuous glucose sensor. Twenty participants (10 without diabetes and 10 with diabetes) will continuously wear the device over 72 hours with standardized meal and ketone drink tests performed on Day 1 (the day of sensor insertion) and Day 4 (the final day of study). Finger-prick blood glucose measurements will be performed a minimum of 8 times per day, for the duration of the study, while finger-prick blood ketone measurements will be recorded a minimum of 3 times per day in addition to those performed as clinically indicated. Blood ketone measurements will be performed on a capillary sample obtained by finger-prick using a hand-held Abbot meter using ketone strips during the at-home phase of the study. During the in-hospital meal and ketone drink tests blood will be collected for laboratory ketone level measurements. Comparison of investigational sensor outputs will be compared with the study blood glucose meter (Day 1 to Day 4), and glucose and ketone values collected for meal tests on Day 1 and Day 4.

In this study we will look at how the MCT supplement can be used in older adults to support brain function, mild cognitive impairment and Alzheimer’s disease. MCT oil is a supplement used to support nutritional ketosis, which is an alternative nutrient to glucose for providing energy to the brain and body. The primary aim of this research study is to assess the safe and optimal dosing of MCT oil to identify any change in participant cognition. This research will provide valuable information for aged care residents currently experiencing, or at risk of cognitive decline, to understand the most appropriate dose relative to weight to provide optimal cognitive support.

In recent years, there has been a notable increase in the prevalence of Postural Orthostatic Tachycardia Syndrome (POTS), a common form of dysautonomia. POTS is a debilitating condition resulting in exercise intolerance, a diminished ability to complete activities of daily living and profoundly impacts quality of life. Access to health care and services, including rehabilitation tailored for individuals with POTS is limited across Australia. Tailoring traditional cardiac rehabilitation services to better accommodate for individuals with POTS could be key to bridging the gaps in access to care for this cohort. This project aims to evaluate the feasibility, effectiveness and acceptability of the integration of a tailored rehabilitation pathway, reviewed by people with lived experience with POTS, into an existing cardiac rehabilitation service. This pathway will provide patients with 12 weeks of supervised exercise rehabilitation (phase one) before transitioning patients to a further 12 weeks of unsupervised exercise (phase two). At three timepoints, assessments will be completed to evaluate the impact of rehabilitation on exercise tolerance, symptom severity and quality of life. Patients will be followed up via phone across phase two to evaluate the maintenance of exercise after the completion of the supervised rehabilitation program. This research has potential to redirect the future of POTS rehabilitation in the public health system, bridging the existing gaps to care whilst importantly supporting improvements in exercise tolerance, health-related quality of life and activities of daily living for people with POTS.

Lung cancer in Australia often requires treatment with chemotherapy or targeted therapy when surgery is not possible. This study aims to find out if the addition of an antibiotic called doxycycline to targeted therapy for treatment of lung cancer can improve survival of lung cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with metastatic lung cancer and you are already undergoing targeted therapy (with or without chemotherapy) to treat your cancer. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be asked to take an antibiotic tablet each day for 28 days while undergoing their targeted lung cancer treatment. Participants allocated to the second group will be asked to take a placebo (sugar) tablet each day for 28 days while undergoing their targeted lung cancer treatment. Participants in both groups will then be asked to continue their scheduled lung cancer treatment and attend follow up appointments and scans as outlined by their doctor. It is hoped this research will provide more information to determine whether adding an antibiotic to chemotherapy or targeted therapy for lung cancer is able to improve survival of lung cancer patients.

This study is investigating ways to improve treatment of ventricular tachycardia, a potentially malignant heart rhythm disorder, in patients with structural heart disease. Radiofrequency catheter ablation is a recommended approach to treating patients with ventricular tachycardia and structural heart disease, wherein specially engineered wires are passed into the heart where therapeutic lesions can be delivered with heating electrical current. Irrigation fluids, typically 0.9% NaCl saline solution, keeps the catheter cools and reduces risks of blood clots or charring, but also absorbs some of the electrical current that can reduce the the amount of heart tissue treated. An alternative is 0.45% NaCl "half-normal" saline solution, which has been shown to absorb less current, and deliver larger therapeutic lesions. This is a double-blinded, randomised trial to investigate whether using half-normal saline results in better outcomes for patients suffering from ventricular tachycardia.

This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #3: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths.

RB201 is being developed by Rarefied Biosciences for the treatment of autoimmune diseases. We hypothesize that this new drug, which is being tested for the first time in healthy volunteers, may adjust the body’s immune system in a way that could help reduce the inflammation of autoimmune diseases. This study (RB201-001) is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating single and multiple doses of RB201 in healthy volunteers. This study will be conducted in 2 parts: Single ascending dose and Multiple ascending doses. Up to 88 healthy volunteer subjects total will be entered into the study. RB201 or matching placebo will be administered orally in an observed, inpatient setting to help us learn how the drug behaves in the body, how safe it is, and whether it has any side effects.