ANZCTR search results

The aim of this study is to assess the efficacy of blood flow restriction exercise training during a 6-week community-based cardiac rehabilitation exercise program. Specifically, in individuals with coronary artery disease who are eligible for cardiac rehabilitation, this study will assess whether adding blood flow restriction (via inflating pneumatic cuffs on the proximal portion of the legs) during aerobic exercise portions of the rehabilitation program leads to greater improvements in exercise capacity, 6 minute walking distance and markers of vascular health, when compared with the routine aerobic exercise undertaken by cardiac rehabilitation participants (no cuffs). Participants will be randomised to either the blood flow restriction exercise group or the routine rehabilitation exercise group for the duration of the 6-week (12 session) program. Participants will also attend a total of 4 assessment visits; 2 baseline (week 0) measurement visits (the first of which includes screening to assess eligibility) and 2 visits post-program (week 7 post-baseline) to compare changes between groups and over time.

AXA-042 furnctions through a multi-cellular mechanism to re-engage the innate immune response. This first in human study is planned to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics (PD) of AXA-042 in combination with cemiplimab, an anti-PD-1 monoclonal antibody, in subjects with advanced solid tumours. Who is it for ? You may be eligible for this study if you are aged 18 years or over, have a diagnosis of a locally advanced or metastatic solid tumor, and are refractory or intolerant to standard of care therapies. Study details – Participants will receive AXA-042 followed by cemiplimab, both administered as intravenous infusions on Day 1 of a 21-day treatment cycle. AXA-042 will be given first; if no significant infusion-related reaction occurs within one hour, cemiplimab will follow. Treatment will continue until disease progression, withdrawal of consent, or toxicity that in the opinion of the investigator or Sponsor requires study treatment discontinuation, or up to study completion, whichever occurs first. Dose escalation will follow a 3+3 design, where 3 to 6 participants will be enrolled per cohort to evaluate safety and determine the maximum tolerated dose. The starting dose level of AXA-042 is 0.00001 mg/kg, and all doses of cemiplimab are fixed at 350 mg IV every 3 weeks. The dose of AXA-042 will be increased by up to 3-fold in each subsequent cohort, after review of safety data, to determine the maximum tolerated dose. Participants will be monitored for adverse events throughout treatment and for at least 30 days after their last dose. of study drug. Participants will also have blood samples taken throughout day 1 (and in subsequent cycles on certain days) of treatment after receiving AXA-042 to study the time course of drug absorption, distribution, metabolism and excretion. Preliminary efficacy and pharmacodynamics will be determined through objective response rate, progression-free survival, time to response and overall survival and pharmacodynamics data on cytokines and other immune response biomarkers in response to AXA-042 treatment (in combination with cemiplimab). It is hoped that this study may show that AXA-042, in combination with cemiplimab, is safe and effective for the treatment of advanced solid tumours, which may lead the way for larger efficacy trials in future.

INDUCE is a multicentre prospective randomised controlled trial to compare the efficacy and safety (using standardised clinical outcomes plus non-invasive monitoring of mucosal healing using gastrointestinal ultrasound of Upadacitinib vs Corticosteroid in patients with Ulcerative Colitis and Crohn's Disease flares. We hypothesize that upadacitinib is non-inferior in terms of efficacy to prednisolone for disease flares, with no difference in rate of adverse event.

This study aims to test whether inserting a ureteric stent — a small tube used to relieve kidney blockage caused by kidney stones — can be done safely and effectively using local anaesthesia in the emergency department, instead of general anaesthesia in the operating theatre. We are inviting adults who come to hospital with kidney stone pain requiring stent placement to take part. The procedure will be done using numbing gel and other local pain relief, with additional medications like Penthrox (green whistle) available if needed. We will assess whether the procedure can be successfully completed under local anaesthesia, how well patients tolerate it, and how satisfied both patients and doctors are with the experience. The study will also look at the impact on hospital workflow, resource use, and cost. We hope this approach could offer a quicker, simpler, and more efficient alternative to standard care, especially in busy emergency settings.

This study will use a two-stage, mixed-methods design. Stage 1 will involve co-designing a tailored sleep intervention for the Geriatric and Rehabilitation Unit (GARU) using the Double Diamond framework, followed by a 2-week Plan-Do-Study-Act (PDSA) cycle to refine the intervention. Stage 2 will comprise a 4-week feasibility and acceptability trial, with mixed-methods evaluation of protocol adherence, sleep outcomes, and stakeholder feedback.

Perinatal depression and anxiety affect 1 in 5 Australian mothers and costs the Australian health care system in excess of $877 million annually. Social support has been consistently shown to (a) assist women in meeting challenges in the postpartum period, (b) reduce postpartum depression, and (c) counteract both postpartum anxiety and stress. The aim of this pilot RCT is to evaluate the feasibility, acceptability, and preliminary effectiveness of an online social support intervention aimed at improving the mental health of first-time mothers.

The Sonas Programme is a structured, multisensory group intervention designed to enhance communication and well-being in people with dementia. It includes activities such as music, singing, touch, and sensory stimulation delivered in a supportive environment. This study aims to evaluate the feasibility and cultural relevance of a culturally adapted Sonas Programme in one or more multicultural aged care settings in Australia. We hypothesise that the adapted programme will improve residents’ engagement and quality of life.

Our project aims to enhance the prescription and delivery of exercise to people with type 2 diabetes and long-COVID symptoms (e.g., breathlessness, fatigue) to allow return to, or uptake of, regular exercise. Mirroring the structure of the current Medicare-subsidised type 2 diabetes group exercise scheme, we will examine the feasibility and preliminary efficacy of a long-COVID symptom-guided exercise program after eight weeks.

We aim to assess the effect of two types of individualised education and exercise programs to determine if they can improve neck disability in people with chronic neck pain. Both groups will receive between 2-8 one-on-one treatment sessions with an allied health clinician via telehealth. The study design will be a nation-wide randomised controlled trial. The primary outcome is neck disability at 12 weeks. Cost-effectiveness of the treatments will also be evaluated.

This study aims to evaluate whether the ElectroPulse PFA System (which delivers energy to scar areas of the heart tissue causing abnormal rhythms, so the heart beats normally again) is a safe and effective treatment for people with atrial fibrillation (AF), a common heart rhythm disorder. The results will help support global regulatory approval of the system.