ANZCTR search results

This is a single-centre, randomised, open-label, two-way crossover, single dose study with three treatment periods conducted in healthy participants. The study is designed to compare the PK profiles of a single oral dose of an immediate and extended release formulation of propagermanium, and to identify if there is a food-effect on the extended release formulation. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. In addition to PK assessments, safety and tolerability data will be collected during the course of the study. Approximately 14 participants will be enrolled into two cohorts (Cohort A and Cohort B). Participants in Cohort A will receive the immediate release (IR) formulation while fasting at Dose 1, the extended release (ER) formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants in Cohort B will receive the ER formulation while fasting at Dose 1, the IR formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. No participant will be a member of more than one cohort. Participants will be screened from -14 days prior to dose administration. Participants will be admitted to the unit on Day -1 and will remain confined to the unit for 24 hours post-dose. On Day 1, participants will receive Dose 1 and will complete procedures as detailed in Table 3. On Days 7 and 14 participants will return to the unit and will receive Doses 2 and 3 on Days 8 and 15, respectively and will complete procedures as detailed in Table 3. Participants will return to the clinic on Day 24 for follow-up visits.

This study aims to assess whether sulindac therapy (100mg TWICE daily orally for 14 days) prolongs gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.

Our literature search failed to reveal any strength and conditioning program for chiropractic students to prevent injury whilst learning manipulative techniques or in the first years of practice. The concept of a strength and conditioning plan with the aim of reducing the likelihood of injury is worth considering as the implementation of such a program early in a practitioner’s career could reduce the prevalence and progression of injuries. The purpose of this large-scale study to examine the effectiveness of a strength and conditioning program to prevent injuries related to manual therapy training and practice. All participants will undergo a series of baseline measures over seven days. This will include demographic information, history of musculoskeletal injury, and maximal strength of muscle groups, which will be estimated using the multiple repetition test procedure (5-10 submaximal strength test) instead of traditional one repetition maximum test (1RM). 1RM will be calculated for each of strict shoulder press (SP), bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge. Participants will be instructed on correct usage of equipment prior to the testing session and given time to familiarize themselves with the equipment. A warm-up will be completed prior to testing. Thereafter, 3-5 separate single attempts will be performed. Subjects will lift a weight initially 40%-60% of the perceived 1-RM. The increments of weight are dependent upon the effort required for the lift. The weight added will become smaller as the effort to lift the weight increases. If subjects are able to perform more lifts than designated by the testing protocol, subjects are allowed a minimum of four min rest and then reassessed. Participants will be instructed to perform each exercise to acute muscular exhaustion or form fatigue. Any repetitions that are not performed with a full range of motion will be discarded. When the subject can only lift the weight five to ten times, that weight and the number of repetitions are considered to estimate the 1-RM. Grip strength dynamometry will be performed during the strength testing procedure. After completion of all baseline measures, each participant will be randomly assigned to either the intervention (n=106) or comparison (n=106) group using a random number generator. Intervention group participants will undergo a 12-week strength and conditioning program, whilst the control group will perform 30 minutes of moderate intensity walking 3 days per week. After the 12-week period, all participants will undergo the same assessments completed at the baseline.

The project has several aims: (1) To examine the effectiveness of the 'Get Up & Go' peer-support walking program compared to a waitlist control condition in contributing to decreased levels of interpersonal suicide risk, depression symptoms and psychological distress, and increased levels of social support, school membership, wellbeing, and resilience in participating students at the Australian National University (ANU). (2) To explore engagement, adherence, use, and satisfaction of the 'Get Up & Go' peer-support walking program, both quantitatively and qualitatively in the treatment group. Based on previous research, it is hypothesised that participation in the 'Get Up & Go' peer-support walking program will contribute to improvements in students levels of social connectedness and wellbeing. These may be influenced by the following variables: - Participants baseline levels of social support and connectedness to the ANU, mental health (i.e., psychological distress, depression, anxiety) and interpersonal suicide risk factors (i.e., thwarted belongingness and perceived burdensomeness). - Dosage effects, such as frequency and duration of walking, and frequency and duration of social contact with partner - Satisfaction effects, such as perceived quality of social contact with partner and connection to the ANU community induced by the program

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.