ANZCTR search results

The aim of this pilot research project is to perform a case control study with a cross-over design to explore the potential clinical benefits of 2 times 12 weeks (twice daily) supplementation of TENDOFORTE [Trademark] P (containing 2.5g of highly bioactive collagen peptides) or PLACEBO in chronic midportion Achilles tendinopathy patients as an add-on therapy to 24 weeks of eccentric exercise therapy. To improve our understanding of the in vivo working mechanism of this nutraceutical, we aim to investigate the ultrastructural and microvascular changes of the Achilles tendon using contrast enhanced ultrasonography, ultrasonographic tissue characterization as well as bicomponent analysis of Achilles tendon volumes ultrashort echo spin (UTE) on a 3T MRI.

The aim of this proposal is to conduct the first study of the impact of subcutaneous injection of PT-141 on key mechanisms involved in social communication in healthy adults. We hypothesize that PT-141 will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.

Childcare centres represent a promising setting for interventions to improve the dietary behaviours of children as they provide broad reach to a large number of children and opportunities to be exposed to a range of nutrition promoting practices. While nutrition guidelines recommend that childcare centres provides food consistent with dietary guidelines, the impact of improving childcare food service environment on children’s diet in care has not been previously quantified. Previous childcare-based interventions have largely examined the modification of food environments in conjunction with other components which limits the ability to assess the isolated impact of improving food environment and availability on child behaviour. This study aims to assess the effect of an intervention to improve childcare service menus to comply with National nutrition guidelines. The intervention will target childcare service managers and cooks. We hypothesise the intervention will positively impact on service menus and child food intake.

The primary purpose of this study is to determine whether Stereotactic Body Radiotherapy (SBRT) given prior to surgery is technically feasible and clinically safe for the treatment of patients with localised spine metastases. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, have any non-haematological cancer type, and have been diagnosed with spinal metastases in the past 4 weeks for which spinal surgery has been prescribed. Study details: SBRT is a type of radiation therapy in which a few, very high, doses of radiation are very accurately delivered to a small, well-defined target area. It is normally delivered after surgery in the treatment of spinal metastases however this approach has a number of drawbacks. In this study, all participants will receive radiation treatment at least 7 days before surgery, with doses ranging between 16 – 24 Gy over 1-2 days. Patients will be assessed for signs of toxicity and pain at 1 then 3 monthly intervals for 2 years following the SBRT treatment. It is hoped that the findings of this trial will aid understanding of whether it is technically possible, and safe, to deliver SBRT prior to surgery for spinal metastases, in place of the current standard care in which SBRT is delivered following surgery.

The purpose of this study is to analyze the reliability and validity of the Mshorts (a wearable EMG) in individuals with patellofemoral pain syndrome and those with no knee pain. We hypothesized that the Mshorts is reliable and accurate tool to assess muscle activation in individuals with and without patellofemoral pain syndrome.

Aim to evaluate the effect of exenatide on postprandial glycaemia in patients with cystic fibrosis related diabetes (CFRD) and impaired glucose tolerance (IGT). CFRD has a detrimental impact on pulmonary function, mortality and prognosis after lung transplant, that is currently treated by intensive insulin regimen. GLP-1 is released in response to food ingestion and is known to stimulate insulin secretion, suppress glucagon secretion and slow gastric emptying. Exenatide is a GLP-1 (glucagon-like peptide 1) agonist that can be administered daily without significant risk of hypoglycaemia. It is anticipated that exenatide will normalise postprandial glycaemia. This is a double blinded crossover trial where participants will have 2 study days. On the first day they will receive the intervention or placebo, receiving the opposite on the second day. Once the intervention or placebo has been given, the participant will consume a pancake followed by assessment of glycaemia, incretin response and gastric emptying.

What is this study about? The purpose of this study is to investigate how safe and tolerable a single dose of ZYN002 transdermal gel is in healthy participants and patients with epilepsy. The study will look at how the body absorbs, distributes, breaks down and then removes the study drug from your body. This will be done by analysing the levels of ZYN002 in your blood and urine at various times following drug administration. Your skin at the application site will be checked to see if there is any irritation or reactions present after ZYN002 application. The study will also investigate the effect that ZYN002 has on your visual attention and ability to complete a simple task. The task requires you to ‘connect-the-dots’ of 25 consecutive dots as fast as possible. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are either in general good health or have epilepsy with partial onset seizures that is stable. Study details: This study will investigate various doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit, which could be up to 28 days before your study treatment; One confinement period starting on the evening before dosing and lasting until 48 hours after the study treatment i.e. a total of about 62 hours (2.5 days). This will require three (3) nights in the clinic. There are also two out-patient clinic visits following the confinement period on Days 4 and 5. These visits will be at 72 and 96 hours after the application of the study treatment. Additional out-patient visits may be required if there is any skin irritation present at the study treatment application site. Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, neuropsychological tests) and will have several blood and urine samples collected for laboratory analysis.

This study aims to compare Skype-based intervention with in-person intervention involving a conversation skills training program for people with traumatic brain injury and their family, friends or carers. We will determine whether there is any difference in outcomes between Skype-based and in-person conversation skills training.

Winter is a surprisingly dangerous time in Australia with greatly increased rates of death and hospitalisation. Winter death rates are 47% higher for heart failure and 32% higher for hypertensive disease compared with summer. Warm countries like Australia have a far greater winter increase in morbidity and mortality than cold countries like Sweden. This is because many Australian homes are inadequately insulated or heated, with indoor temperatures in winter often below 18 degrees C. This cold exposure increases blood pressure and inflammatory factors, which increases the risk of an acute cardiovascular event. Home insulation and heating have both been proven to improve cardiovascular health and wellbeing during winter. This study will test if personal insulation also improves cardiovascular health. Heart failure patients will be randomised to receive no intervention or a pack containing thermal tops, hats and socks, indoor temperature monitors, and advice on when to wear the thermals. Our primary hypothesis is that winter hospital admissions will be reduced, and we will also examine improvements in blood pressure, inflammatory factors, quality of life, sleep and personal insulation. This will be the world’s largest study of the health benefits of personal insulation, and will build on our work with heart failure patients at The Prince Charles Hospital. Thermal clothes are a cheap and simple intervention that could greatly reduce winter morbidity and mortality across Australia.

To determine if: Patients who obtain and participate in a home exercise program received via 2 home visits, in addition to group exercise will experience greater improvements in balance than participants who participate in the group program and are given a home exercise program at the hospital (normal care).