ANZCTR search results

This trial is for patients with primary mediastinal B-cell lymphoma (PMBL) and is evaluating if combining pembrolizumab with R-CHOP (Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) will improve patient outcomes. All patients will receive the following treatment regimen: Cycle 1-2: R-pembro ‘window’ (21-day cycle) * rituximab 375mg/m2 Intravenous Infusion on Day 1 * pembrolizumab 200mg Intravenous Infusion on Day 1 Cycle 3-8: ‘Induction’ (21-day cycle) * rituximab 375mg/m2 Intravenous Infusion on Day 1 * cyclophosphamide 750mg/m2 Intravenous Infusion on Day 1 *doxorubicin 50mg/m2 Intravenous Infusion on Day 1 *vincristine 1.4mg/m2 Intravenous Infusion on Day 1 capped at 2mg *prednisolone 100mg oral tablet on Days 1-5 pembrolizumab 200mg Intravenous Infusion on D1 Cycle 9-17: Pembrolizumab ‘Consolidation’ (21-day cycle) * pembrolizumab 200mg Intravenous Infusion on Day1 Patients will have a PET/CT Scan at the following timepoints 1. After Registration 2. After the "Pembro" phase 3. After the "Induction" phase 4. Patients may have another PET/CT scan at the discretion of their treating physician. Patients will also have blood samples taken every three weeks whilst receiving treatment. It is hoped that this study may demonstrate that addition of pembrolizumab to R-CHOP may improve survival in patients with PMBL.

Following treatment of urinary tract stones, ureteric stents are typically left in for one to two weeks post-operatively. Removal of these stents can be performed in multiple ways - either by the patient themselves, by a nurse or via a subsequent procedure. This study investigates these methods of ureteric stent removal to see which is better tolerated by patients. We hypothesise that self-removal of ureteric stents will be preferable. This is because of convenience, reducing risk of potential exposure to COVID-19 and reducing hospital costs.

This is a 12-week double-blinded randomized control trial designed to assess the safety, feasibility and tolerability of a specialised dietary fibre supplement targeting the gut microbiota in children with type 1 diabetes (T1D); and to explore what impact it has on glycaemic control. Previous research has shown this dietary fibre supplement, which is a tapioca-based type-4 resistant starch that can be added to a normal diet, modifies the gut microbiota and promotes release of large amounts of the short chain fatty acids (SCFAs) after fermentation in the colon. In mice, the increase in SCFAs acetate and butyrate stopped pancreatic beta-cell damage providing near-complete protection from T1D. Studies in healthy human adults have shown this tapioca-based type 4 resistant starch supplement was well tolerated and improved glycaemic profiles through a reduction in post-prandial glucose and insulin excursions. In this study, children aged 5 – 14 years with T1D for at least 3 months, an HbA1c <9%, and BMI between 15th and 85th centile will be randomized to the intervention (tapioca-based type 4 resistant starch) or control (maize-based type 2 resistant starch) group. They will take this dietary fibre supplement daily for six weeks as part of their usual diet then return to their usual diet (without the dietary fibre supplement) for the final six weeks. They will be monitored throughout the study via in-person and phone reviews, with various measures including blood and stool samples, quality of life (QoL) questionnaires, supplement tolerability surveys, food diaries, continuous glucose monitoring (CGM), insulin dose reviews and growth parameters. The hypothesis is that inclusion of this tapioca-based type 4 resistant starch dietary fibre supplement into the normal diet of children with T1D will be safe, feasible and well tolerated; and it will also have a positive impact on their glycaemic control. It is hoped this study will provide important preliminary data for a Phase II study looking at efficacy of this supplement for preservation of beta-cell function and improving glucose homeostasis in children with newly diagnosed T1D.

A standardised treatment and monitoring protocol for Australian adult and paediatric patients requiring bacteriophage therapy is proposed, with no comparator arm. Patients included are those who have exhausted other therapeutic options for control of their infection and are being treated with phage products according to the special access scheme (SAS) as determined by the Australian Therapeutic Goods Administration (TGA) – so-called “compassionate access”. Patients who are assessed to be suitable for phage therapy will receive this as an adjunct to routine clinical care. The purpose of the study is to standardise therapeutic management and data collection in this setting and to assess overall safety and tolerability of phage therapy, as well as the feasibility of such a standardised national protocol.

Patellofemoral pain is experienced by one in four adolescents. This pain is debilitating, leads to reduced quality of life and decreased participation in physical activity. Adolescent patellofemoral pain persists into adulthood, with up to 78% continuing to experience pain up to 20 years later. A longer duration of patellofemoral pain is the most consistent predictor of poor prognosis, highlighting the need to intervene early. We know very little about how to effectively manage patellofemoral pain in adolescents. Evidence-based treatments that are effective in adults, such as exercise therapy, are not as effective in adolescent populations. Adolescents spend up to nine hours per weekday in stiff, raised heel school shoes whilst performing a significant amount of their daily physical activity. Stiff, raised heel shoes are known to elevate patellofemoral joint loads. Flat, flexible footwear have been shown to reduce patellofemoral joint loads. This is a simple, low-cost treatment option that directly targets repetitive patellofemoral joint loading known to contribute to pain in adolescents. This trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating flat, flexible school shoes for adolescents with patellofemoral pain. Findings will inform future large-scale clinical trials and guide clinical practice guidelines for management of adolescent patellofemoral pain.

The overarching primary research question for the QoVax SET Mixed Dose 1 and 2 study is; In the Queensland community, do heterologous COVID-19 vaccine doses 1 and 2 compared with homologous doses 1 and 2, offer higher recall levels of spike IgG, spike IgA, neutralizing IgG, and cell mediated immunity at 4 months post dose 2. The QoVAX Mixed Dose 1 and 2 study will address these specific research questions; 1. What are the host intrinsic (HLA type, genetic traits, immunological T and B cell receptor repertoires) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with variation in immune outcomes following vaccination? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect response variation of primary immune outcome measures? Further research objectives are to investigate medium-term health outcomes of vaccinated research participants at 12 months following recruitment, to identify factors associated with i) safety outcomes, and ii) vaccine efficacy outcomes in the study cohort.

Our study's primary aim is to inform the feasibility and recruitability of a larger scale RCT to investigate maternal and foetal outcomes after diagnosis and treatment of moderate-severe OSA in pregnancy. We aim to test women with body mass index greater than or equal to 35 for sleep apnoea, and determine if treating moderate to severe disease will in pregnancy will impact maternal or neonatal outcomes. Additionally we will investigate if the intervention is acceptable to women, and if it has any impact on their quality of life, or any impact on placental histology after the birth of their baby. Additionally we will assess the predictive utility of questionnaires, BMI, neck circumference in OSA in pregnancy.

This pilot project aims to investigate whether the quality of optical coherence tomography angiography (OCTA) scans, performed on patients with macular disease, can be improved using an in-office Isometric Hand Grip Test. The primary research question this study seeks to address is: *Does the signal quality of OCTA scans improve after performing the isometric hand grip test in individuals with macular disease? The secondary research question is: *Do parameters of OCTA images such as vessel density, vessel perfusion and foveal avascular zone area alter after performing the isometric hand grip test in individuals with macular disease?

Introduction Currently there is no consistent and widely accepted approach to the diagnosis of vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO). Harmonised diagnostic methods are vital to enable facilitate optimal diagnosis, advance management and enable research. Aim To obtain consensus on how expert clinicians diagnose VCD/ILO. Methods and analysis Two-round modified Delphi. Ethics and dissemination Ethics will be obtained from the Monash Health Human Research Ethics Committee. The dissemination plan is for presentation and publication.

Anaemia affects nearly a quarter of the world and is common in surgical patients. A third of patients present with preoperative anaemia and three quarters of patients are discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g/L for men and < 120 g/L for women. Perioperative anaemia is associated with delayed patient recovery and increased postoperative complications, leading to increased post-operative morbidity and mortality. In recent years, there has been a significant increase in the in the use of intravenous iron therapy for preoperative anaemia in line with major international guidelines. This is common practice in Australia and New Zealand. However, the recent PREVENTT study has questioned the value of preoperative iron transfusion in anaemic patients. Management of anaemia in the perioperative setting is variable and compliance to recommended practices such as measurement of haemoglobin levels, use of tranexamic acid, and avoidance of oral iron remains unknown. The POSTVenTT (POST-operative Variations in anaemia treatmenT and Transfusions) audit aims to determine the variability in adherence to anaemia management guidelines in the perioperative setting and to assess its impact on clinical outcomes following major abdominal surgery.