ANZCTR search results

This study is looking to find an optimal insulin-dosing strategy that effectively and safely controls blood glucose levels after meals in people with T1D on closed loop insulin pump therapy. The study involves 8 study days over the course of two weeks while the participant is using the currently available closed loop insulin pump system. The study will be split over two weeks with one week using the closed loop function and one week without. During this time the participant will test different insulin dosing strategies over two different meal types (4 meals will be high in carbohydrate, 4 meals will be high in fat and protein). Blood glucose will be measure through the cgm linked to the pump and this will be used to measure blood glucose levels and time in target after each meal. This will be used to determine the most effective insulin dosing strategy.

This study is a feasibility study looking at personalised medicine for asthma. A planned full randomised controlled trial would test whether tailoring a patients treatment according to an algorithm based on their asthma symptoms, level of airway inflammation and airway narrowing gives better results than usual care. Before we can run that full RCT we need to test 5 specific feasibility questions around recruitment, acceptability, and the proportion of participants with co-morbidities which may change how we run it. This open-label single group cohort feasibility study will provide the answers to these five specific questions which may change how we run the full RCT: 1)How quickly can we recruit? 2)Do participants find the intervention acceptable? 3)In theory would participants be willing to take part in a randomised controlled trial testing this approach? 4)What proportion of patients still have not-well controlled asthma at the end of the study, or have had an exacerbation during the study? 5)How common are the additional conditions (e.g. sinus disease) that are looked for at the final visit? Fifty participants will be recruited, 25 in New Zealand and 25 in Australia. Each participant will attend for 3 visits over 10 weeks and will have their medications adjusted according to the treatment algorithm specified in the protocol. All participants will receive inhaled steroid and long-acting bronchodilator medications in line with national and international guidelines. The difference is that the dose of inhaled steroid and whether or not participants are prescribed oral steroids (prednisone) will be adjusted according to the protocol algorithm rather than individual clinician's judgement.

Quinidine is the only drug shown to reduce the risk of dangerous irregular heart rhythms in Brugada Syndrome. While studies have shown invasive electrophysiology studies can be useful in assessing response to quinidine in Brugada Syndrome, currently, there is no definitive way to monitor drug effect in an individual. The QUIET BrS Study will investigate the effect of quinidine on a variety of clinical parameters in patients with Brugada syndrome. We seek to identify non-invasive markers of quinidine effect in patients with Brugada Syndrome which could be used to develop a non-invasive strategy for monitoring medical therapy in these patients and reduce the need for invasive procedures.

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and is associated with significant morbidity and impairment to quality of life. Adalimumab is approved and marketed in Australia, US and EU for treatment of UC. Its efficacy is suboptimal when given subcutaneously. This Phase 1 study will assess the PK/PD parameters following dosing with adalimumab administered rectally as an enema in subjects with active UC. Rectal administration will bring the drug into closer proximity with the inflamed tissues at much higher local concentrations compared to subcutaneous administration. As the Sponsor is developing an ingestible drug/device capsule intended to deliver the drug payload (adalimumab) into the cecum, the rectal administration via an enema was chosen as an initial step to assess the absorption of adalimumab across the mucosal/epithelial interface of the cecum. Data obtained from this study will assist in determining the starting dose/dose regimen for the Progenity PGN 001 program by providing further understanding of absorption, bioavailability, and the early safety data of adalimumab following local administration in subjects with UC in local tissues as well as systemically.

Doctors currently examine the human gastrointestinal tract using a device called an endoscope, which contains a camera that enables the doctor to view and treat diseases from within the gastrointestinal tract. Most endoscopic procedures are done under sedation, what means that people are put asleep during such procedures by an Anaesthetist. During the examination, it is costumery that the patients' breathing capabilities become mildly impaired. For this reason, the Anaesthetists utilise supplementary oxygen to avoid the oxygen levels in your blood getting too low. Although we know that using some supplementary oxygen is better than using none, it is still under debate what is the ideal amount (or flow) of oxygen that should be used to avoid the loss of oxygenation. The purpose of this study is to determine whether two devices that deliver two different flows of oxygen (standard nasal cannula - 2 L/min or high-flow nasal cannula - 60L/min) are similar or different in preventing the loss of oxygenation while under sedation for long endoscopic procedures.

Doctors currently examine the human gastrointestinal tract using a device called an endoscope, which contains a camera that enables the doctor to view and treat diseases from within the gastrointestinal tract. Most endoscopic procedures are done under sedation, what means that people are put asleep during such procedures by an Anaesthetist. During the examination, it is costumery that the patients' breathing capabilities become mildly impaired. For this reason, the Anaesthetists utilise supplementary oxygen to avoid the oxygen levels in your blood getting too low. Although we know that using some supplementary oxygen is better than using none, it is still under debate what is the ideal amount (or flow) of oxygen that should be used to avoid the loss of oxygenation. The purpose of this study is to determine whether two devices that deliver two different flows of oxygen (standard nasal cannula - 2 L/min or high-flow mouthguard - 20L/min) are similar or different in preventing the loss of oxygenation while under sedation for short endoscopic procedures.

The upper heart chambers (atria), particularly the left-atrium, can deteriorate with unhealthy changes in the heart muscle over time leading to abnormal electrical, structural and functional features, collectively termed 'atrial cardiomyopathy'. This process can progress to a significant extent without any direct symptoms, can thus go undetected, and contributes to increased risk of atrial fibrillation and stroke. Changes in the atria can be detected via measuring altered voltage in the heart muscle and changes in size and function on cardiac imaging. This study will assess a new body-surface electrical signal ‘mapping’ strategy with a vest containing 252 surface electrodes, and a cardiac CT scan to assess electrical signals in the atria. This will be compared to the established procedure of mapping with catheters inside the heart in participants who are already undergoing heart mapping as part of a planned procedure. The hypothesis is that surface ECG mapping could be a useful, non-invasive method for detecting atrial cardiomyopathy without the need for invasive mapping.

Mental health problems affect one in five Australians every year. Psychological distress may be a risk factor for more serious mental health conditions. Recent research on the microbiome of the gastrointestinal tract suggests a complex interaction between this community of bacteria and the health and mental well-being of the host. Lack of balance in the microbiome is often indicated by mild digestive discomfort. This study investigates a combination of nutrients that have been found to benefit the gastrointestinal tract (glutamine), the microbiome (probiotics) and support healthy mood balance (fish oil) in 10 individuals who suffer mild digestive symptoms and psychological distress. This study aims to investigate the effects of this combination of nutrients on perceptions of psychological distress in these 10 specific individuals. The data from the placebo phase and the ‘active treatment’ phase will be compared for each individual participant and will also be combined to explore some preliminary more general findings that will help with the design of future studies in this area.

This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two hamstring autograft constructs: 1) a graft constructed by folding a single hamstring tendon (harvested from the semitendinosus) four times (ST, 4 strand), or 2) a graft constructed by folding two hamstring tendons (harvested from the semitendinosus and gracilis tendons) two or three times (STG, 4/6 strand) (dependent on achieving the required minimum graft diameter). Patient outcomes will be collected and compared between the two surgical autograft cohorts over a 24 month post-operative period. This will include hamstring donor site morbidity (primary outcome variable), a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength, and single limb hop capacity, and radiological assessment of ACL graft integrity and hamstring graft site regeneration.

This study seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (current standard, control arm) versus scaffold augmentation (using the REGENETEN scaffold, experimental arm) for symptomatic partial thickness rotator cuff tears in the shoulder. Patient outcomes will be collected over a 24-month post-operative period and will include a range of subjective and functional outcomes, radiological measures and patient satisfaction. It is hypothesized that using the REGENETEN scaffold to augment/cover the symptomatic partial thickness rotator cuff tear will lead to improved early post-operative functional recovery, compared to the current standard surgical repair.