ANZCTR search results

This is a Phase 1 ,Single arm open label clinical trial. The objective of this clinical trial is to test an alternative treatment to antibiotics in a small group of Chronic Rhinosinusitis (CRS) patients to evaluate safety, efficacy of a 4 strain lactobacilli probiotic nasal rinse. The study population will consist of up to 40 patients with a diagnosis of CRS. Patients will be invited to participate in a 14-16-week program from screening to End of Study. At the screening visit the patient will be reviewed and perform assessments to ensure the suitability of the patient to partake in the trial. The suitability will be checked using inclusion /exclusion criteria. Before any assessments take place the patient will asked to sign a patient information and consent form. This form will have been sent to patient to review prior to screening day. The subject if suitable for enrolment will attend a baseline visit 2-4 weeks after screening. At the Baseline visit the patient will have inclusion/exclusion criteria rechecked before being enrolled and commenced on the intervention ( Probiotic powder administered via nasal rinse) . Each patient will be trained under supervision in the clinic on how to self-administer the probiotic nasal rinse. The patient will then administer the probiotic rinse once daily at home for 4 weeks when they will attend an end of treatment visit at the ENT clinic. The patients will then be followed up for a further 8 weeks then will attend an End of study visit. The overall aim of this study is to improve quality of life by reducing the pathogen load and increasing beneficial bacteria in the nasal microbiome of Chronic Rhinosinusitis sufferers.

This is a dual centre, randomised, double blinded trial of two pulmonary vein isolation systems for paroxysmal AF. Participants will be screened from all participants referred for pulmonary vein isolation aged between 17 and 80 years. Randomisation will occur after consent is obtained and on enrolment into the study. Participants will be randomised to pulmonary vein isolation with the Arctic Front Advance™ Cryoballoon or the POLARx™ Cryoablation System. It is planned that 110 participants will be randomised in a 1:1 ratio to one of two treatment arms: • 55 will undergo pulmonary vein isolation via the Arctic Front Advance™ Cryoballoon. • 55 will undergo pulmonary vein isolation via the POLARx™ Cryoablation System. Primary non-inferiority endpoints • Total procedure time • Total ablation time Secondary safety and tolerability endpoints • Complications of Pulmonary Vein Isolation. • Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure). Secondary efficacy endpoints: • Burden of recurrent symptomatic documented AF episodes. • Burden of recurrent documented AF episodes. • Time to recurrence of AF. • Any symptomatic AF recurrence. • Hospitalisation.

The purpose of this study is to determine the feasibility and acceptability of telehealth cognitive behaviour therapy for sleep disturbance in women with breast cancer receiving chemotherapy. Who is it for? You may be eligible for this study if you are a women aged 18 years and over, stage I-III breast cancer and scheduled to receive chemotherapy Study details Participants will receive telehealth cognitive behaviour therapy for sleep whilst receiving chemotherapy. The cognitive behaviour therapy program consists of four sessions, delivered every two weeks over eight weeks. Participants decide if they would like to receive the sessions on the phone or online video conference. Each session takes 45 to 75 minutes to complete. Participants will complete questionnaires and complete a sleep diary during the trial. It is hoped this research will demonstrate if it is practical and useful for women to complete the program whilst receiving chemotherapy for breast cancer.

The aim of this study is to compare the use of robotic surgery with laparoscopic surgery for the surgical treatment of right sided colon cancer. Robotic and laparoscopic operations are called minimally invasive surgery, that is, they use instruments fitted in through small incisions or cuts in the abdomen. The removal of the colon cancer tumour called a hemicolectomy and in this study for right-sided colon cancer it is called a right hemicolectomy. Who is it for? You may be eligible to join this study if you are an adult aged 18 years and older, have adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon that requires surgery. Disease must be confirmed by histological, radiological, endoscopic diagnosis Study Details Participants in this study will be randomly allocated (by chance) to either robotic or laparoscopic surgery. You will have a two to one chance of be allocated robotic surgery. The purpose of the study is to evaluate the surgery and it’s short and longer term outcomes, quality of life, cost effectiveness and surgeons’ experience with the robotic surgery approach. All participants will be monitored for up to 12 months for recovery from surgery, adverse events, quality of life and return to usual activities or work.

There has been recent interest in understanding the costs associated with post-operative complications of patients undergoing oesophagectomy (removal of the food pipe, also known as the oesophagus). Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo oesophagectomy. Who is it for? You may be eligible for this study if you are an adult who underwent a oesophagectomy for for any indication including but not limited to oesophageal cancer, Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a oesophagectomy at the Austin Hospital during the above 10-year period. It is hoped that this research will help to provide a better understanding of the costs associated with major surgery.

There has been recent interest in understanding the costs associated with post operative complications undergoing gastric resection (removal of the stomach). Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are and implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo gastric resection. Who is it for? You may be eligible for this study if you are an adult who underwent gastric resection for any indication including (i.e. cancer and non-cancer causes) ,at the Austin Hospital between 1 Jan 2020 and 31 Dec 2019. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a gastrectomy during the above 10-year period. at the Austin Hospital . It is hoped that this research will help to provide a better understanding of the costs associated with major surgery.

The use of smart watch technology to improve the management of patients presenting with fast irregular heart rates (AF) in the Emergency department (ED). Participants will be given a Alivecor single lead ECG device to monitor their heart rhythm every 6 hours for the next 48 hours. If after 48 hours the heart rhythm has reverted to normal no further visits to ED are required. If they remain in AF they will return to the ED for an elective cardioversion to restore a normal heart rhythm. The aim of the study to the improve the management of these patients in ED and reduce the number of visits to ED.

Creatine monohydrate (CrM) is widely available as a nutritional supplement in Australia that mainly used as an ergogenic aid for sportsmen and women. Pre-clinical studies suggest dietary creatine supplementation during pregnancy may protect the fetus from acute in utero hypoxic events. While there is evidence to support the safety of creatine use in non-pregnant women of reproductive age, there is limited evidence on the pharmacokinetics (PK) of CrM in women of reproductive age and no information on the PK of CrM in pregnancy. To address these knowledge gaps safely, we have designed an open-label parallel-arm pharmacokinetic trial that will occur in three stages; where the first two stages will trial different CrM doses, starting with the lowest anticipated therapeutic dose. The third stage will trial the optimum dose (to be confirmed) over a multi-day period in the third trimester of pregnancy. Overall, This study will inform the optimum dosing of creatine monohydrate in late pregnancy (3rd trimester). This dosing regimen could be used in subsequent studies assessing the efficacy of maternal dietary creatine supplementation to improve pregnancy outcomes.

Our study will evaluate the feasibility of active Virtual Reality gaming (AVRG) in increasing engagement and adherence to physical activity (PA) in young men with mild to moderate depression. This randomised controlled trial is an important first step before undertaking larger trials to better understand factors affecting recruitment, engagement and adherence, retention and safety, as well as effects on depressive symptoms and lifestyle behaviour. The scalability of VR gaming in the community, means potential for increased access and reach, particularly during The COVID-19 pandemic has increased in social isolation and decreased access to fitness facilities, highlighting the need for accessible and acceptable options for physical activity participation. The scalability and popularity of AVRG among young males is a strength of potentially using this as a depression treatment for this hard-to-reach population with the lowest help-seeking rates but the highest incidence for mental illnesses.

Starpharma is developing a nasal spray intended to inactivate severe acute respiratory virus 2 (SARS-CoV-2), the virus that causes coronavirus disease of 2019 (COVID-19). The nasal spray contains 1% w/w SPL7013, a molecule with broad spectrum antiviral and virucidal activity. SPL7013 is able to physically block SARS-CoV-2 attachment to cells and therefore inhibit infection. The primary objective of this clinical investigation is to assess the safety and tolerability of 1% SPL7013 Nasal Spray applied to the nasal mucosa of healthy volunteers 4 times a day for 14 days.