ANZCTR search results

This is a clinical study of 20-30 participants who will receive and wear Ankle Foot Orthosis (AFO) manufactured through a digital process using the three-dimensional scanning technology along with the computer-aided design and additive manufacturing technologies. The results collected from these patients will be compared against the pre-existing data of the same patient wearing AFOs made using the traditional method.

Cardiovascular comorbidity is common in patients with COPD. They share cigarette smoking as an important risk factor. However, beta blockers, which are commonly used to treat cardiac diseases, are traditionally avoided in patients with COPD due to the theoretical risk of respiratory adverse events. The aims of this study are: 1. To assess the safety of commencing beta blockers during an acute exacerbation of COPD in individuals with coexistent cardiovascular disease. 2. To assess the impact of commencement of beta blockers on lung function as measure by post bronchodilator spirometry in patients admitted for exacerbation of COPD. This is a prospective interventional study of individuals admitted with exacerbations of COPD conducted in two metropolitan hospitals in Melbourne. Individuals who are admitted to the Northern and Austin Hospital with acute exacerbations of COPD who have a history of COPD (GOLD Class II – III) and of cardiovascular disease will be invited to participate in the study. When they are considered stable and suitable for participation, the treating team will notify the study coordinator who will consent and enroll the individual in the study. After signing of the informed consent form, participants who are identified to be ready for discharge the following day will perform spirometry. An initial dose of a cardio-selective beta blocker will be administered and spirometry will be repeated. Unless an adverse event has occurred, beta blocker administration will continue on the day of discharge, with spirometry repeated. Participants will be reviewed at 21-days post discharge with repeat spirometry. This will be carried out in the Respiratory Outpatient Clinic as is standard practice.

Optical coherence tomography angiography is a new imaging technique for retinal and choroidal vasculature.Diabetic retinopathy and retinal vein occlusion are the most common retinal vascular diseases which lead to significant vision loss due to retinal ischemia and macular edema. Coats disease is an idiopathic retinal vascular disease characterised by telangiectasia and exudative retinopathy. In this study we do retrospective and prospective analysis of OCTA images of patients with retinal vascular diseases and a group of healthy volunteer who have undergone OCTA at Lions eye institute from 2015 to 2018 .These patients are identified through database search of all patients . Patients who have given consent for their retinal images to be used for research are eligible. The aim of the study to measure the vascular density and foveal avascular zone in patients with retinal vascular diseases and healthy volunteers. In addition, to compare the vascular density between the diseased subjects and healthy controls.

SYNOPSIS Study Title: An adaptive trial of topical anti-inflammatory agents on pain in patients with chronic venous leg ulcers: A Sequential Multiple Assignment Randomised Trial - Pilot study Development Phase: IV, Pilot Study Purpose: The primary purpose of this study is to evaluate the effectiveness of an anti-inflammatory wound dressing, containing ibuprofen, on pain levels of patients with chronic venous leg ulcers. The primary hypothesis is that this ibuprofen-impregnated wound dressing will result in reduced levels of pain, in comparison to a non-medicated dressing. Indication: Pain score of 3 or more on the Numerical Rating Scale (0-10) in patients with venous leg ulcers Study Therapy: Group 1- Ibuprofen impregnated foam dressing, compared to a non-medicated foam dressing. Group 2 – Activated Carbon dressing. A pragmatic adaptive multiple allocation trial design will evaluate an antimicrobial and anti-inflammatory activated carbon dressing for participants who fail to respond, i.e. whose pain scores do note reduce by 3 or more on a 0-10 rating scale; to the ibuprofen dressing. Study Population: Male and female adults with chronic venous leg ulcers (present for 4 weeks or more) and who fit with the study inclusion/exclusion criteria will be recruited into the study. For this pilot study, 30 study participants will be recruited. No. Centres: Queensland University of Technology; Royal Brisbane & Women’s Hospital; Holy Spirit Northside Private Hospital Study Design: The study has a Sequential Multiple Assignment Randomised Trial design. Study Duration: Total of 4 weeks Objectives of the Study: This pilot study aims to obtain preliminary evidence on the effectiveness of two anti-inflammatory wound dressings on pain in patients with chronic venous leg ulcers. A sequential, multiple allocation randomised controlled trial of an ibuprofen-impregnated foam dressing, or an activated carbon dressing for non-responders, will be compared with a non-medicated foam dressing. Study Endpoints: (Primary and Secondary) The primary outcomes of this pilot Sequential Multiple Assignment Randomised Trial is to obtain preliminary evidence on the effectiveness of two anti-inflammatory wound dressings on pain in patients with chronic venous leg ulcers. Secondary outcomes include obtaining evidence on the feasibility of the study and variation in outcome measures, to guide future applications for a fully powered trial. The primary safety endpoints will be incidence of treatment emergent adverse events with study participants assessed prior to commencing the trial and then again following every week for adverse effects.

For the 15 million new people each year globally suffering stroke, 85% have difficulty moving their arm and hand, and 60% still have non-functional arms 6 months after stroke. Evidence for more effective treatments is needed. This project is a multicentre randomised controlled study, with 300 participants, to test the hypothesis that task-specific training is more effective in improving upper limb function compared to usual care. Participants will be recruited from the community, at 3 months after stroke. They will receive 6 weeks treatment, at home, of either task-specific training or usual care. Task-specific training will be delivered according to a detailed exercise manual. Participants receive 14 x 1 hour visits from a therapist and will perform in addition 1 hour/day of self-practice. The primary outcome measure is the Action Research Arm Test performed immediately after the 6 weeks of treatment, and repeated at 6 months.

One in four Australian adolescents is overweight or obese. While short-term weight loss is possible, keeping the weight off long term is difficult. Intermittent Energy Restriction (IER) has shown success in adults. IER includes 3 days per week of energy restriction and 4 days of an unrestricted, healthy diet. This may be more sustainable and lead to greater weight loss than daily energy restriction. The Fast Track study tests whether IER is more effective at producing weight loss compared to a standard reduced calorie diet. We will also evaluate the safety and effectiveness of IER to adolescents. The study will involve 13 - 17 year old adolescents with obesity. They will be randomly allocated to either an IER or reduced calorie diet and followed for 52 weeks with regular dietitian reviews. Outcome measures will include weight, height, body composition, heart and diabetes risk factors from blood samples and psychological well-being and dietary intake information. The primary aim of the study is to find out if intermittent energy restriction results in significant weight loss (via BMI z-score) after 52 weeks compared to a standard care reduced calorie intervention.

This is a randomized, double-blind, parallel-group, placebo-controlled study in patients with painful wounds, designed to evaluate the analgesic effect of VPX638 applied topically to the wound. Each participant will receive VPX638 or placebo topically, twice on a single study occasion. Analgesic efficacy, tolerability, and safety of VPX638 will be assessed.

This study was to compare the effectiveness of a combination of Tai Chi plus Thera-bands on both mental health and physical futbess with Tai Chi exercise only in older sedentary office workers; and to examine the feasibility of, and to support refinement of, the protocol, methods, and procedure. The study hypothesis that Tai Chi plus thera-bands exercise could effectively improve levels of stress, depression, anxiety, and pain, as well as physical fitness.

There has been a surge in popularity of so-called "kinematic" alignment in total knee arthroplasty, with a relative lack of evidence to support the claimed benefits. At the same time, knee ligament balance does appear to be a major surgical factor for an optimised patient outcome. For this reason, a study comparing the balance achieved with methods that restore the native coronal plane alignment of the knee compared to mechanical alignment is required to provide further research in this are. The aim of this study is to determine whether ligament balance is more readily achieved by restoring the native coronal plane alignment versus traditional methods. The results of this trial will aim to inform future clinical practice internationally with regard to soft tissue balance and kinematic alignment in total arthroplasty surgery. The hypothesis of this trial is that knees aligned to restore a patient's original anatomy will be more balanced compared to those aligned with a neutral mechanical axis and horizontal joint line.

The project is a double blind, between subject, randomised controlled study. Specifically the study will assess the impact of OT on the number of heavy drinking days and alcohol craving. The study will also investigate the potential neuroprotective benefits of OT, by assessing learning and memory, executive functions and changes in neurometabolites measured through neuropsychological assessments and MRI. Participants will be recruited through the drug and alcohol centre at Royal Prince Alfred Hospital, as well as community recruitment through media and Facebook. They will be required to attend a screening and eligibility assessment and if eligible be randomised to receive placebo or OT nasal spray, which will need to be self-administered twice a day, for 12 weeks. Participants will be asked to return at 6 weeks (mid-treatment), 12 weeks (end of treatment), 1 month post follow-up, and 6 months post end of treatment for further follow-up. During the study, participants will be asked to complete a number of self-report questionnaires, undergo physiological, neuropsychological and neuroimaging assessments, as well as provide urine and blood sample.