ANZCTR search results

This study will explore the hypothesis that the advanced HCL (AHCL) system will reduce the glycaemic variability and thereby improve the glycaemic outcomes of children and improve the wellbeing of parents/caregivers. This proposed study is a 3-month multicentre randomised controlled study in children aged 2 to 7 years with Type 1 Diabetes (T1D) on insulin pump therapy. The participants will be randomly assigned to two groups: control group on standard therapy and the intervention group on AHCL system in the Medtronic 780G pumps. The primary objective is to compare the proportion of time in target range (sensor glucose 3.9-10mmol/l) in young children with T1D while using AHCL or standard insulin pump therapy. The secondary aims are to determine the effect of AHCL on hypoglycaemia and hyperglycaemia and to determine the psychological and social well-being of caregivers compared to standard care. The age of the participants means that this is placed in a category more than low risk although the level of parental supervision at this age and the use of a system that allows 24/7 glucose monitoring in reality more than mitigates this theoretical consideration. There are no potential ethical issues in the proposed study.

Infants and children with a symptom or abnormality involving the upper gastro-intestinal system often require a gastroscopy procedure. During anaesthesia for this procedure both the proceduralist and the anaesthetist share the child’s upper airway for delivery of oxygen and for the placement of a small flexible pipe with a fibre-optic camera (endoscope) to directly view the anatomy within the oesophagus, stomach, and upper small intestine. The choice of airway for this procedure is usually at the discretion of the anaesthetist of which various options are currently available. We aim to compare the newer technique of Nasal High Flow (NHF) with conventional ventilation using a laryngeal mask airway (LMA), through a randomised controlled trial in infants and children during upper gastro-intestinal endoscopy. If we can determine that NHF is not inferior to the use of an LMA, this has the potential to both reduce the number of interruptions, improve the access of the scope, and limit the anaesthetic exposure required to successfully complete these procedures in children.

In this trial, we will investigate the effectiveness of a campaign about low back pain compared to no intervention at improving an essential domain of pain-related self-efficacy. We will also conduct qualitative testing, including evaluating engagement to maximise the impact of delivering a reassuring message about low back pain using social media.

Pleural effusions (excess fluid accumulation between the lung and chest wall) affect 60,000 Australians every year and can arise from a wide range of causes including cancer, heart and liver failure. Pleural effusions often cause disabling breathlessness. Drainage of the fluid (usually requires inserting tubes between the ribs) can relieve symptoms, but the benefits vary among patients. The mechanism by which pleural effusion causes breathlessness remains unclear. A reliable method of identifying the patients likely to respond to drainage may help reduce unnecessary, painful procedures and their associated complications and healthcare costs. The PLeural Effusion And Symptom Evaluation project aims address this knowledge gap. Bendopnoea (breathlessness on bending forward) is a common clinical complaint in patients with pleural effusion but has not been previously studied. Our pilot data found that bendopnoea was significantly associated with the presence of pleural effusion. The PLEASE-3 study will aim to evaluate the value of bendopnoea as a screening test for effusion-related breathlessness, its predictive value of symptomatic benefits from fluid drainage and explore the physiological mechanisms underlying bendopnoea. Participation on this study involves completing questionnaires, performing a bendopnoea test, breathing test via spirometry and a 6-Minute walk test. If there is fluid needed to be drained first, the tests will be performed once before and once after the fluid is drained (within 36 hours of removal of the fluid). The results of these 2 sets will be compared to each other to find out the difference, if any, of removing the fluid.

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of CBD capsules in adults with sleep disturbance. Adults will be screened for study eligibility by attending the clinic between Day -28 and Day -4. Study eligibility will be confirmed at the clinic on Day -3 and baseline measures will be conducted at home between Days -3 to Day 1 with Day 1 being the first day of study drug administration. Participants will be required to attend the study clinic at screening, on Day 31, and Day 37 (EOS) or ETV. There will be no clinical confinement period in this study and all clinical assessments will be performed as outpatient visits or telehealth consultations. The study will evaluate 3 dose levels of the investigational product, Satipharm CBD capsules or placebo in 4 parallel treatment arms of 53 participants per arm. Participants will be enrolled across 4 parallel treatment arms to receive daily doses of Satipharm CBD or placebo for a period of 30 days. Treatment Arm 1 : 0mg (placebo), Treatment Arm 2: 25 mg, treatment arm 3: 50 mg, treatment arm 4:100 mg. A single daily dose of Satipharm CBD capsules or placebo (2 capsules/dose) will be administered from Day 1 to Day 30 whereby each participant will receive a total of 30 doses with an evening meal. Study drug will be self-administered on a daily basis from Day 1 through to Day 30. Outpatient clinic visits are scheduled for Days 31 (the day following the last dose of study drug), and again on Day 37 which is the end of study (EOS) visit.

This is a single centre, single arm, study primarily examining the safety and feasibility of psychotherapy combined with a single dose of 25mg psilocybin. Study Hypothesis: That psilocybin psychotherapy for methamphetamine dependence can be safely and feasibly delivered from a public addiction outpatient clinic.

We are conducting a clinical trial to evaluate the effectiveness of a telehealth-delivered clinician-supported program (Better Hip) which will comprise education, strengthening exercise, physical activity, self management strategies and if needed, dietary intervention for weight loss, for people with hip osteoarthritis. We will evaluate the effectiveness of the Better Hip program on pain and physical function at 6 and 12 months. The two different treatment groups in this study are: 1. Website (information) group: access to a website with information about hip osteoarthritis and how to manage the condition; or 2. Better Hip group: 6 video consultations with a physiotherapist for information and prescription of an exercise program. Additionally, for those with a BMI > 27 kg/m2 who are aged under 80 years: 6 video consultations with a dietitian for prescription of a dietary weight loss program over 6 months, comprising a ketogenic very low energy diet followed by guidance to transition to healthy eating for weight maintenance. Primary and secondary outcomes will be collected via online survey at baseline, 6 and 12 months. A further online survey for follow-up of primary and secondary outcomes will be also conducted at 2 years post randomisation. These results will be reported separately to the main trial results and will occur after analysis of the main trial data.

Otsuka Pharmaceutical Development & Commercialization, Inc (OPDC) is studying an investigational drug called OPC-224333. This drug is not available for sale in any country. OPC-224333 is being studied as a possible treatment for epileptic diseases including drug-resistant and rare epilepsies such as Dravet, Lennox-Gastaut, West, and Doose syndrome. Epilepsy is a condition that causes people to have repeated seizures. Seizures are caused by abnormal electrical activity in the brain. Seizures can make you have convulsions, pass out, shaking movements in just one arm or in a part of your face, suddenly stop responding and stare for a few seconds, or behave strangely. Epilepsy can start at any age. You are invited to take part in this research study. The reason for this study is to find out potential benefits and safety of OPC-224333. About 72 participants will be in the study and the study is being done at one research site, CMAX Clinical Research Pty Ltd, in Australia. We are looking for a total of 72 healthy male or non-childbearing potential female participants between the ages of 18 and 55 years (inclusive) who have a body mass index between 19-32 kg/m2 (inclusive). The study will involve: • A screening visit (2 – 3 hours), within 28 days of the study starting • 8 night in-house stay (Day -1 to Day 8) • Follow-up phone call 30 days after your last dose (approximately 15 minutes) Expected study duration for Arm 1 is up to approximately 59 days.

In Vitro Fertilisation (IVF) as a treatment for infertility, includes in part transferring an embryo (usually 5 days age) into the uterine cavity. Even with chromosomally normal embryos the resulting clinical pregnancy rate is 40-60%, indicating that approximately half of the embryos do not implant (implantation failure) The purpose of this study is to assess whether instilling 0.5-1.0 ml of autologous platelet rich plasma (PRP) into the uterine cavity 2-3 days prior to embryo transfer will lead to an improved clinical pregnancy rate. It is hypothesized that the PRP acts on the endometrium to improve receptivity for implantation.

Bangladesh is a developing country that produces a large proportion of the world’s Ready-Made Garments (RMG), employing millions of workers from the country’s low-socioeconomic demographic. These workers are faced with tough working conditions, high workloads and low wages. Monitoring the internal conditions of Bangladeshi RMG factories has shown that these workers are subjected to very high ambient temperatures (~40°C) with high relative humidity (~40%) These conditions render workers vulnerable to dangerous levels of heat-stress and the development of heat-related illness. Therefore, we aim to examine the efficacy of sustainable, low-cost cooling strategies that may be implemented in RMG factories to help improve the internal thermal conditions and reduce the heat-strain experienced by workers.