ANZCTR search results

This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. Part C will evaluate the effect of food (FE) on the PK profile of SGR-1505 (provisionally at 200 mg, although the dose of SGR-1505 will be determined based on emerging PK data). Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma. Study details Part C will consist of 3 phases: a Screening phase (within 28 days of the first dose of SGR;1505), a Treatment phase, and a Follow-up phase. The Follow-up visit will evaluate safety prior to initiating the subsequent cohorts and will occur on Day 34 (± 2 days). It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma

Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disease. It is a common occurrence after laparoscopic sleeve gastrectomy (LSG) with prevalence of de novo reflux ranging between 9.8 – 30%. GERD after LSG should be considered a serious adverse outcome due to worsening quality of life and increased incidence of Barrett’s esophagus after surgery. Surgical intervention with fundoplication is the usual treatment in those with GERD. However, it is not technically feasible in those who have undergone LSG. Other endoscopic treatments and devices exist however they are technically challenging and difficult to use. Recently, Anti-reflux therapy (ARAT) using Hybrid APC is an efficient and simple way to treat reflux. The first application of Hybrid APC as an anti-reflux procedure in endoscopy was reported in a retrospective study by showing cessation of PPI use of 78.6% at 36 months in a non-bariatric population. Therefore, the aim of this study is to assess the safety, feasibility, and efficacy of ARAT by measuring the reduction in PPI use in patients after LSG.

Aplastic Anaemia (AA) and Bone Marrow Failure Syndromes (BMFS) are rare diseases with significant morbidity and mortality. Currently there is little Australian data on the incidence of both acquired AA and BMFS, the therapies utilised or clinical outcomes. The relative rarity of this disease makes both the accrual of data and material to support scientific studies, and the establishment of high quality randomised prospective trials challenging. Furthermore, the existing literature concerning clinical outcomes of patients with AA may be biased by preferential reporting and publication of only good outcomes and/or serious or unusual events. The national registry for all Australian patients with AA and BMFS provides an important community resource to address these issues.

The proposed study will evaluate whether 45 minutes of lower limb heating at 40°C upregulates the thermal response (i.e., core temperature, skin temperature, skin blood flow), vascular function (lower an upper limb) and skeletal muscle tissue oxygenation in HF patients with reduced ejection fraction. A secondary aim is to compare the effect of water height (ankle vs knee) on thermal and vascular function and skeletal muscle of oxygenation. The study will 5 separate visits to Griffith University (approximately 5 hours in total). These will entail an initial baseline assessment (approximately 30 mins), followed by another 4 visits (approximately 60 mins) of lower limb immersion with measurements of core temperature and blood flow. For research visits 2-5, The lower limb immersion will be undertaken at thermoneutral (water temperature 30°C) or hot (water temperature 40°C) lower limb immersion with water up to ankle or knee height.

Persistent pelvic pain is pain in the area of the pelvis that has been present for at least three months, it is a common condition that can cause a lot of disruption to regular activities. Long wait times have been identified as delaying treatment for persistent pelvic pain, with wait between referral and initial appointment presently standing at 12 months at the Mercy Hospital for Women. Whilst patients await their initial appointment there is currently no care provided to them. We propose to apply a new system to manage patients referred to our gynaecology clinic while they are on the waitlist through communicating with their general practitioner. We will provide the general practitioner with materials that include management pathways to start treatment of persistent pelvic pain while the patient awaits their appointment and communicate with them until patients are seen at the gynaecology clinic. This research project aims to look at how useful actively managing patients while they wait for their first visit at a gynaecology specialist clinic is in terms reduction of pelvic pain while waiting. This waitlist active management could not only prevent up to 12 months of further suffering but also potentially reduce the number of patients requiring a specialist appointment at all.

Hypothesis: In patients with coronary artery disease who are treated with guideline recommended therapies, ongoing progression and destabilisation of atherosclerotic plaques will be associated with previously unrecognised clinical, biological and mechanical factors that this prospective, natural history study seeks to identify. Brief overview: This is a prospective, observational clinical study that will recruit participants undergoing clinically indicated coronary angiograms for stable or unstable symptoms at the Royal Adelaide and Queen Elizabeth Hospitals. All subjects will undergo guideline-recommended treatment of their coronary artery disease (CAD) at the direction of their treating clinicians. Eligible subjects will be those who have at least one major coronary artery system that will be left with residual coronary plaque. Following informed consent and within 30 days of their index angiogram, subjects will undergo further evaluation of their coronary plaque(s) by non-invasive computer tomography coronary angiography (CTCA), along with collection of clinical data and collection and storage of blood and faeces specimens (Baseline). They will return after 12±1 months for repeat CTCA imaging and collection of clinical information, blood and faeces (Follow-up). We will assess for changes in coronary plaque burden and composition between baseline and follow-up CTCA scans, and examine for their associations with a range of established and exploratory clinical, biological and mechanical factors. An additional study visit will be conducted at 6 months to collect clinical information and conduct questionnaires related to quality-of-life, mental well-being and pain scores. Aims/Objectives: To determine: (1) Changes in noncalcified plaque volume between baseline and follow-up CTCA scans in patients with CAD. (2) Changes in other CTCA-derived measures of coronary plaque burden and composition, between baseline and follow-up CTCA scans including: (i) total atheroma volume, (ii), calcified plaque volume, (iii) low attenuated plaque volume, (iv) percent atheroma volume, (v) maximum lumen stenosis, (vi) Leaman score, (vii) epicardial fat attenuation index and other (viii) novel plaque characteristics between baseline and 12-month follow-up. (3) Changes in blood, urinary and faecal biomarkers of interest that may associate with the development and progression of atherosclerotic CAD, as well as associations with quality of life, mental well-being and the presence of cardiac and non-cardiac pain syndrome data.

Infants and children requiring surgery often experience significant blood loss. Blood consists of several components that are required to maintain normal physiological processes. Included within our blood are red blood cells, white blood cells, platelets and proteins. One of the main roles of blood is to maintain haemostasis, a balance to ensure blood clots appropriately when tissue trauma occurs. When large volumes of blood loss occur, components of blood responsible for forming a clot are lost and require replacement to ensure cessation of blood loss and tissue healing. During surgery for craniosynostosis, due to the nature of the surgery, a large volume of blood is lost. Anaesthetists are very experienced in observing the blood loss and replacing blood products to ensure appropriate amount of red blood cells are present and that blood haemostasis is maintained, keeping the child safe. At the Queensland Children’s Hospital, we found that up to 33% of patients received blood products to assist with maintaining haemostasis. Typically, anaesthetists will use blood tests that are sent to the laboratory to determine appropriate clotting function. Typically, a child’s blood loss occurs quicker than the return of accurate results, therefore blood products used to assist clotting, including fresh frozen plasma, cryoprecipitate, platelets will be replaced based on perceived total volume of blood lost. Recently point of care viscoelastic haemostatic assay utilising a ‘thromboelastogram, (TEG)’ has been incorporated into clinical practice to guide transfusion of blood products responsible for haemostasis. In an audit of our clinical practice for craniosynostosis 43% of cases utilised TEG to guide haemostatic therapy. As such we have varied clinical practice of clinicians within our department. The evidence regarding the benefit of viscoelastic haemostatic assays in the elective paediatric surgical population is limited. To date there have been no high-quality studies comparing an anaesthetic physician guided, utilising standard coagulation tests, to a viscoelastic haemostatic assay guided transfusion strategy. We aim to compare the two techniques using a randomised controlled trial in infants having surgery for craniosynostosis. Initially our study at Queensland Children’s Hospital will be a feasibility study. If it can be conducted well, we plan to incorporate other paediatric hospitals within Australia to increase patient recruitment.

This study will aim to assess the impact of a progressive, structured exercise program in patients with symptomatic AF in a randomised controlled trial. The study intervention will be assessed by the maintenance of sinus rhythm post-ablation, when compared with standard medical care. The primary endpoint of this study is the recurrence of any atrial arrhythmia, off anti-arrhythmic drugs (AADs) in the 18-months post-ablation. We hypothesise that exercise training will reduce arrhythmia recurrence following ablation, compared to standard medical care alone. The key secondary endpoints will include atrial structural remodelling, peak oxygen consumption and AF symptom severity.

Banana pseudo stem tender core contains nutritional compounds that are crucial for health. This project aims to assess the feasibility and tolerability of a dietary supplement derived from banana pseudo stem tender core, which is high in fibre, polyphenols and minerals, and its effect on clinical measures, gut microbiome, and urine markers. To this end, a randomised controlled trial with 46 (23 in each arm) participants will be conducted. Participants will be randomly allocated to receive either the banana pseudo stem powder (intervention) or maltodextrin (placebo) over a period of 4-weeks. Participants, investigators, assessors, and study statistician will be blinded to group allocation.

This study addresses the question of whether an augmented version of a psychological intervention (Cognitive Behaviour Therapy combined with augmentation strategies; CBT/A) to reduce severity of Prolonged Grief Disorder (PGD) more than standard CBT. CBT/A is a novel extension of the gold standard treatment of Prolonged Grief by providing training in emotion tolerance skills and positive affect awareness. The key question of the study is the extent to which this modification to CBT can promote better outcomes relative to standard CBT. This study hypothesises that CBT/A will result in greater reductions in Prolonged Grief than CBT at 6 months following treatment. Participants with PGD will be randomized to 11 sessions of standard CBT or Augmented CBT.