ANZCTR search results

Myocardial infarction with non-obstructive coronary arteries" (MINOCA) occurs in 5-10% of all patients with acute myocardial infarction (AMI). There are neither any randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI, nor any treatment guidelines. The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether Angiotensin Converting Enzyme Inhibitors (ACEI/ Angiotensin Receptor Blockers (ARB) compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with MINOCA and with no clinical signs of heart failure and with left ventricular (LV) systolic ejection fraction above or equal to 40%.

Gluteal tendinopathy is a degenerative condition of the hip. A recent randomized control trial showed that a single injection of platelet-rich plasma was associated with improvement of gluteal tendinopathy. This study will aim to assess whether imaging changes can be identified in the study population. The aim is to assess whether single LR-PRP or corticosteroid injection for gluteal tendinopathy results in improvement in gluteal tendon appearance on MRI at 2 years post intervention. The primary outcome measure will be statistically significant improvement in tendon imaging abnormalities on 2 year follow up MRI compared to pre-treatment MRI. MRIs will be reviewed and graded by an experienced radiologist. Gluteal tendon changes will be graded based upon a previously published gluteal tendinopathy MRI grading score. A secondary outcome measure will be statistically significant correlation with clinical improvement as described in the original randomised control trial by Fitzpatrick et al . This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial. The subjects will be all subjects from the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI. An experienced radiologist will assess pre and post LR-PRP RCT MRI using a validated grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. They will also be compared to the clinical changes seen in the randomised control trial to assess any statistical correlation in the two measures.

The purpose of this study is to determine whether a structured peer support program can improve exercise adherence and health-outcomes in breast, prostate and colorectal cancer survivors. Who is it for? You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer. Study details All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an accredited exercise physiologist or equivalent. Following the supervised phase, participants will enter a 1-year maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. Participants will be randomly assigned to either receive peer support or no peer support during the maintenance phase. It is hoped that this research will help determine if a peer support program is effective in enhancing exercise adherence and long-term health outcomes in cancer survivors.

People who have hip pain frequently report pain with walking and climbing stairs or hills. We want to know if using shoe inserts (orthotics) can change the level of discomfort that people with hip pain report. Using the Gait Laboratory at the University of Canberra, we will evaluate if real or sham shoe inserts changes the way people walk. Further, we’ll give people a shoe insert to use for four weeks to see if this helps with their hip pain and their walking, and reassess them after this time. Our hypothesis is that the use of shoe inserts will reduce hip pain with walking.

This is a single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants comparing 98% cannabidiol oil (CBD) with placebo in reducing Severe Behavioural Problems (SBP) in children aged 8 – 16 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo. The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, tolerability of the study medication, study duration, study procedures and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized clinical trial of CBD to reduce SBP in children with ID. The secondary objectives of this study are to assess the safety of the administration of oral CBD in children aged 8 -16 years with ID and SBP.

Protagonist Therapeutics, Inc. is developing PN-10943A as a potential oral therapy for patients with ulcerative colitis (UC). This study will be conducted in upto 80 normal healthy male subjects who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the safety and tolerability of PN-10943A to normal healthy volunteers. This includes vital signs, safety labs, ECGs, and physical examinations The drug will be given in single ascending then multiple ascending doses. The study will also evaluate the PK and PD of the drug after dose administration. Participants will be entered into standard study cohorts.

This study will evaluate the effect of MH-PR on a range of biomarkers and cognitive tests associated with age-related decline. Additionally, this study aims to evaluate additional health benefit through measuring change in QOL and blood pressure.

The study is a multi-site, comparator, retrospective, observational study to evaluate the safety of repeated dosing of methoxyflurane for the treatment of acute pain. The study will collect clinical laboratory and observational data to characterise the safety of methoxyflurane. A comparator group of non-methoxyflurane treated patients with burns or wound injuries will be included to further determine adverse events that may be associated with methoxyflurane administration. All relevant data will be collected from patients admitted to study hospitals for the treatment and management of burns or other wound injuries that will require interventions that may cause pain and/or discomfort and require analgesia for the management of acute pain. Patients included in the methoxyflurane group will have been administered no less than 4 doses of methoxyflurane, including a minimum of 2 doses in the first 7 days. The comparator group will have received analgesia (such as nitrous oxide) for treatment of acute pain. Particular emphasis will be directed toward those patients who have received a larger number of doses for a longer time period, as these patients may be considered at higher risk of an adverse event occurring.

We are aiming to assess the potential differences in immune cell proportions between healthy and diabetic individuals. We hope to identify these differences in order to decipher the gap in knowledge regarding the immune system, diabetes and heart failure.

In Australia, approximately 1 in 6 women has experienced domestic violence over her lifetime. Often the first professional an abused woman sees is her healthcare provider offering a unique opportunity for support. South Asian women are over-represented in domestic violence crisis service data but under-identified in general practice. HARMONY is a cluster randomised controlled trial testing the effectiveness of an intervention in primary care for doctors to sensitively identify, appropriately support and refer women, especially South Asian migrant and refugee women experiencing family/domestic violence. This study is adapted from a successful UK model and is being trialed in 28 general practices in high migrant regions in Melbourne. The intervention combines: (i) family violence training for all clinicians provided jointly by a GP trainer and bilingual family violence advocate; safety and confidentiality training for all reception staff, (ii) secondary consultation and feedback for clinicians by the bilingual family violence advocate, and (iii) family violence advocate support for victims referred from intervention practices. All practices will have innovative software tailored specifically to improve routine recording of family violence and migrant/refugee status in GP electronic data.