ANZCTR search results

This study aims to determine if high volume HCLA SSNB injection leads to decreased pain and improved functional outcomes, when compared with low volume injection in patients with rotator cuff tears. This will be a landmark study for SSNB HCLA injection volumes in the literature. This research will help create a standardised process for the administration of HCLA SSNB injections. At present, there is no protocol or guidelines in place that guide SSNB volumes. Evidence based processes could be created with this research and will have the effect of reliable and reproducible treatment which increase the efficacy and safety of treatment for patients.

The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction (PCR) of pharyngeal swab or on a rapid antigen test (RAT) and be asymptomatic of: fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual. Participants will be randomized 1:1 to receive either Ivermectin 200ug/kg orally or Placebo on Day 1. The trial will recruit until 40 participants have converted to a positive PCR or TGA-approved RAT for SARS-CoV-2 within 14 days of their contact with an infectious SARS-CoV-2 index case. Amongst the 40 participants who convert to a positive PCR or positive TGA-approved RAT for SARS-CoV-2, the proportion who received Ivermectin. Specifically, the trial will test whether that proportion is less than half.

Biliary or pancreatic stents are used for management of ductal obstruction. Currently, biliary or pancreatic stents are made of either plastic or metal alloy. As a result, repeat endoscopic retrograde cholangio-pancreatography (ERCP) is necessary for stent removal. Our aim is to study the feasibility, safety and technical performance of the novel bio-degradable stent (ARCHIMEDES) in 3 patient groups: (1) Post liver transplant duct to duct anastomotic strictures; (2) hepaticojejunostomy anastomotic strictures and (3) patients requiring post ERCP pancreatitis prophylaxis with pancreatic stent placement.

This study is aimed at testing the effectiveness and cost-effectiveness of the RecoverEsupport digital health program in supporting colorectal cancer patients undergoing surgery. Who is it for? You may be eligible for this trial if you are aged 18 years or older, have been diagnosed with colorectal cancer, and are planning to undergo bowel resection with an expected inpatient stay of at least 3 days. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention or a usual care group. Participants allocated to the intervention will be asked to access the RecoverEsupport website to complete online activities, learn about pre- and post-surgery behaviours, and access behaviour change strategies to enhance their recovery. Participants and clinicians will also receive prompts (e.g. SMS or email) to support adherence to Enhanced Recovery After Surgery (ERAS) recommendations. This intervention will occur from 2 weeks before surgery, to 3 months after surgery. Those participants who are randomised into the control group will receive usual care. Questionnaires will be collected at baseline, post-surgery, 1 months and 3 months after surgery. It is hoped this intervention will facilitate improved implementation of ERAS, and improve patients' recovery from surgery.

Chronic hip pain is a highly prevalent condition that is largely due to osteoarthritis (OA). Hip OA affects around 40 million people globally and is a leading cause of years lived with disability. With an ageing population and rising rates of obesity, the condition is projected to increase by 58% in Australia over the next decade, leading to substantial societal and health care burden. As hip OA has no cure, advice on self-management of symptoms is recommended as a core treatment component for all patients with hip OA. Currently, footwear guidelines for people with hip OA are based solely on expert opinion, and no research has investigated which type of shoes are most effective at reducing symptoms in people with chronic hip pain. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on individual's self-reported hip pain. To do this, we will allocate people via a random process into two different groups. Participants in each group will be provided with 2 pairs of different shoes to wear daily for 6 months. To ensure that this is a fair and unbiased evaluation, we will not disclose the differences in the shoe classes between the two groups until the end of the study. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help determine which shoes are best for people with chronic hip pain and will guide clinicians in providing appropriate evidence-based footwear advice for their patients. The findings of this study will be published in medical journals and be presented at conferences.

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.