ANZCTR search results

This is a single centre, first in human, SAD, randomized, double-blind, placebo-controlled clinical trial of PLG0206, an engineered cationic antibiotic peptide (eCAP) or matching placebo, administered to healthy subjects. There will be a total of up to 56 subjects, divided into up to 7 sequential groups. Subjects who are eligible for enrolment after screening testing will return to the study centre on Day -2 for confinement at the study site. Subjects will be discharged on Day 3 (48 hours post dose), after recording vital signs and the 12-lead ECG and obtaining safety bloods (haematology and chemistries). Serial blood samples for PK evaluations will be obtained. For each subject, the total duration of the study will be 1 week after dosing. A Safety Review Committee (SRC) comprising of relevant site investigators, the medical monitor and sponsor representative will oversee safety, Cohort evaluation and dose-escalation for the study. A formal charter will be established to include the rules, meeting frequency and scope of responsibilities of the SRC for the conduct of the SRC.

The aim of this randomised control trial is to evaluate the efficacy of a lunchbox program on the nutritional content of student lunchboxes. The program will run for approximately 15 weeks. 36 primary schools in the Hunter New England region will be randomly allocated to one of two intervention arms, or a waitlist control group. The program aims to support parents/carers to swap what is packed in lunchboxes from sometimes to everyday food, through the use of weekly support messages delivered through a school communication app and resources for parents, with or without the development of school lunchbox guidelines.

Aging is associated with loss of muscle mass and this accelerates after 60 years of age, even in healthy individuals. This is undesirable, as loss of muscle mass is strongly associated with sarcopenia, increased morbidity and mortality and lower quality of life. Sarcopenia is the age related degenerative loss of skeletal muscle mass, quality, and strength. The cause of sarcopenia with aging is multifactorial, with declines in physical activity and poor nutrition, neuromuscular decline, hormonal changes, systemic inflammation and chronic illness, all being implicated. Interventions to enhance and maintain muscle mass are urgently needed. This study is a 16 week, randomised controlled trial for adults aged 65 years and over, who are at risk of sarcopenia due to a low protein intake and sedentary lifestyle. Participants complete a home based resistance exercise training programme as well as consume either a high or low dose protein based nutritional drink. The aim of this study is to determine the efficacy of the combined nutritional and exercise approach in improving: • Body composition • Bone mineral density • Muscle strength and function • Muscle protein synthesis markers • Systemic protein markers • Systemic inflammation • Systemic gene expression of inflammatory/ muscle protein synthesis pathways We hypothesise that In an older population at risk of sarcopenia, greater improvements in fat free mass, bone mineral content, muscle strength and function can be achieved when a resistance exercise programme is combined with a high dose versus low dose protein based nutritional supplement drink.

The purpose of this study is to determine the risk factors related to progression of myopia in children aged 4 - 15 years by evaluating hereditary and environmental factors. The possible role of these newly found and existing factors in predicting the onset and progression of myopia in non-myopic eyes will also be determined. To achieve this, participants will be followed up for 2 years with 6 months interval. There will be a total of 5 to 6 visits for each participant. The null hypotheses of this study are; (i) Annual rate of myopia progression is age dependent. (ii) Onset and progression of myopia is dependent on the magnitude and intensity of near and outdoor activities

We hypothesize that engagement in yoga and mindfulness will lead to significant improvements in quality of life and other important clinical outcomes including activity and psychological status in individuals diagnosed with severe asthma. A total of 54 adults (>=18yrs) that have stable severe asthma and will be recruited and randomly allocated to the NAMASTE yoga intervention group or control group. Participants randomised to the intervention group will participate in two supervised classes of yoga and mindfulness per week for 16 weeks. Participants randomised to the control group will receive written information about physical activity, mindfulness and goal-setting after their baseline assessment, in addition to usual care. All participants will also receive an activity tracker and be encouraged to increase their daily steps each day.

This study aims to identify the most appropriate cooling strategy for older adults with and without hypertension during a simulated hot and humid heatwave (38°C and 60% relative humidity) Research questions: The primary research question guiding this project is: 1. Are fans and/or skin-wetting effective in decreasing the physiological strain experienced by elderly during a simulated hot, humid heatwave (38°C and 60% relative humidity) The research hypotheses going into this study are: 1. All interventions will result in reductions in thermal and cardiovascular strain compared to no intervention (control) With fan and skin-wetting (FSW) being the most effective, then no fan and skin-wetting (NFSW), then fan (F), and finally, the control, no-fan (NF).

The aim of this research is to ascertain whether physiotherapy exercise programs provided via Telerehabilitation are as effective as current standard face to face outpatient physiotherapy exercise programs with respect to clinical outcomes for patients with burn injuries post hospital admission. Males or Females aged 18 years or greater who are admitted to the Professor Stuart Pegg Adult Burn Unit, RBWH with a total body surface area partial or full thickness burn injury (%TBSA) of < 25% are eligible for this study. Participants must have access to an internet-enabled computer, tablet or mobile device with web camera / video streaming capability within their own home Study Details - Baseline outcome measures will be collected at discharge from hospital and then the participant will then be randomised to either the Telerehabilitation Physiotherapy group or the Standard Care Outpatient Physiotherapy group. Each of the groups will receive a burn specific physiotherapy exercise program over a 6 week period but the Telerehabilitation group will receive this exercise training using the ehab telehealth system delivered via the internet into their own home and the standard care groups will receive their exercise programs via a face to face outpatient appointment. All groups will be expected to continue an independent home exercise program. Outcome measures will be collected at baseline, 6 weeks and 12 weeks post baseline. These measures will include health related quality of life, range of motion, muscle strength, pain, scar assessment and self efficacy for exercise. Information will also be collected on both participant and therapist satisfaction with the telerehabilitation service. It is hoped that telerehabilitation will prove a viable alternative method for the delivery of exercise programs after burn injury.

A clinical research study to evaluate focal balloon contouring to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.

The purpose of this study is to assess the feasibility of an education and exercise program called Co-PreP in the context of prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 or over are independently mobile and are receiving treatment for prostate cancer. Study details All participants in this study will attend a weekly outpatient group program prior to commencement of their treatment. The first session will include an hour of group exercise and an hour of education delivered by a nurse and physiotherapist. Subsequent sessions will include an hour of group exercise until commencement of treatment. Participants will complete a number of questionnaires before and after the program. It is hoped this research will demonstrate the feasibility of the Co-PreP program and contribute to improved physical function and decreased rates of anxiety and depression during and after commencement of cancer treatment.

Australia relies on volunteers to fulfil its blood donation requirements. The number of potential donors is constrained by strict donor eligibility criteria necessarily imposed to ensure the safety of the donor and of the blood supply. Not all volunteers who present to donate have veins which are easy to see and feel. Recent findings from the VALIANT Trial using independent assessment of donor vein suitability for successful phlebotomy found that only 50% of donors were assessed as having easily visible and palpable veins; the phlebotomy success rate in these donors was 98% (P. Mondy MD, et al unpublished data August 2018). However, 12% of donors were assessed as having veins which were difficult to see and to feel, and 25% of donors in this group experienced a failed phlebotomy. In donors with intermediate vein visibility and palpability scores, the phlebotomy success rate was 92% (P. Mondy MD, et al unpublished data August 2018). Recent knowledge exchanges with international blood operators have identified that significant improvement in phlebotomy success rates can be achieved with the use of a skin marking device to assist phlebotomists locate the position and direction of veins after the skin disinfection has occurred, when re-palpation is not possible. The use of permanent markers to identify the site of surgery / invasive procedures is standard practice in most clinical settings and forms part of the surgical safety procedures both locally and internationally. To date there is no published data on the use of surgical skin markers in a blood donation setting. The following study proposes to determine if a single use sterile skin marker used to indicate the location and direction of a preferred vein prior to venepuncture increases the rate of phlebotomy success. A single use sterile skin marker will be used for the trial in order to minimise any source of nosocomial infection transmission between donors.