ANZCTR search results

This is a study evaluating the safety, tolerability and efficacy of CS1003, an new antibody therepy, in participants with advanced, relapsed or refractory solid tumours. Who is it for? You may be eligible for this study if you are aged at least 18 years old and have a confirmed advanced or metastatic tumour, for which treatment is not available, not tolerated or refused. Study details All participants in the study will receive intravenous treatment with the study drug CS1003. The dose may vary depending on when the participant joins the study. A number of tests will be performed, including physical examinations, electrocardiograms, blood and urine tests, CT and/or MRI. It is hoped this study will contribute important safety and efficacy information for this new treatment.

Sleep problems are estimated to effect between 20-30% of children internationally, with immediate and longer-term impacts on physical health, learning, behavior and family functioning. Current evidence identifies early childhood as a critical period for intervention strategies to avert sleep problems and establish positive lifetime health trajectories. Childcare is an integral part of most children’s early life experience, and provides a point for promotion of sleep health and early interventions for sleep problems. The benefit of early intervention in childcare to improve sleep health and address specific sleep problems has not been tested. The aims of this study are to establishing the fidelity of conducting a gold standard RCT of an educator focused professional development sleep intervention program (Choosing Rest) in childcare settings and estimate the effects of an educator focused professional development program (Choosing Rest) in reducing the severity and/or incidence of sleep problems in young childhood. We hypothesis that children in the intervention group will demonstrate a larger mean reduction in the severity and/or incidence of objectively measured sleep problems from pre- to post- intervention when compared to those in the control (treatment as usual) group. This study will integrate objective measurement of sleep patterns and sleep problems via actigraphy to a concurrent randomized control pilot trial testing the fidelity of a of a professional development program aimed at improving sleep practices in childcare settings. Pre- and post- intervention actigraphy (N=150 children aged 1-5 years) will be used to measure 24-hr sleep-wake patterns continuously across a 1-week period. If successful, this trial will lead to the application of a gold standard RCT study to provide evidence to support implementation into Australian childcare practice.

This experiment is designed to assess cortical and neuromuscular mechanisms involved in control of leg muscles and how these are modulated by standing on a vibration platform. The study will help us to understand the effect of whole body vibration on the contribution of cortical function and reflex pathways to maintaining balance during quiet standing. This may have implications with regard to prescription of whole body vibration for enhancing exercise prescription that leads to improved function of lower leg muscles for young and older individuals. This may have important implications for optimisation of exercise for strength, endurance and balance. Volunteers will attend the lab on two occasions. During one visit they will undergo transcranial magnetic stimulation in a standing position with feedback about their muscle activation level, and without the feedback. They will then stand on the vibration platform for 5 minutes with breaks after each minute and repeat the brain stimulation tests. On the second occasion they will lay on a massage table while the tibial nerve is stimulated with an electrical pulse to measure H reflex. They will again stand on the vibration platform for 5 minutes with breaks after each minute and repeat the H reflex test.

The aim of our study is to examine the efficacy and safety of auto-titrating continuous positive airway pressure devices (CPAP) when compared to standard of care fixed-pressure CPAP in patients with obesity hypoventilation syndrome with concurrent severe obstructive sleep apnoea who are suitable for CPAP therapy. We hypothesis that auto-titrating CPAP is not inferior to CPAP with respect to improvements in ventilatory failure (measured by arterial CO2 tension), sleep quality, quality of life as well as a number of cardiovascular biomarkers.

While invasive coronary angiography (ICA) remains one of the most commonly performed procedures in Australia, currently exceeding >100,000 admissions per annum, we have demonstrated >7-fold geographic variation in its use, and only ~27% of these procedures are performed in the context of its core indication of type 1 myocardial infarction (T1MI). Compared with other similar OECD countries, ICA use in Australia is high despite comparable rates of ACS, suggesting that the “appropriateness” of ICA use is sub-optimal in Australian clinical practice. Appropriateness of care depends on three “sufficient” conditions: 1. The patient needs to be at sufficient risk of specific clinical events to warrant the treatment; 2. The treatment must be of sufficient efficacy in reducing relevant events; and 3. The treatment strategy must be of sufficient value to the patient (i.e. absolute benefits versus side-effects, complications and economic costs) Anatomical investigation of the coronary arteries is of proven benefit in directing care and improving outcome in T1MI, but the appropriateness of such investigations in type 2 myocardial infarction (T2MI) and myocardial injury, where there is high risk of cardiac mortality and high competing risk of death from other causes, is unknown. As such, clinical equipoise remains. To date, few studies formally integrating risk assessment into the strategy of coronary investigation and management have been undertaken. A randomised trial of routine early angiography versus conservative management that carefully evaluates baseline patient risks and competing risks, is critical to the development of robust recommendations for these common high morbidity and mortality patients. This study will comprehensively evaluate the clinical impact, and economic value of early anatomic coronary investigation in T2MI and myocardial injury within a pragmatic multi-centre randomised clinical trial.

Healthy eating can assist people with Type 2 Diabetes Mellitus (T2DM) to achieve and maintain glycaemic control, thereby lowering their risk of developing diabetes-related complications. A dietary pattern rich in whole-grains, fruits, vegetables, legumes, and nuts; moderate in alcohol; and low in refined grains, red or processed meats, and sugar-sweetened beverages has been shown to improve glycaemic control in people with T2DM. Consequently, a key feature of international T2DM management recommendations is to eat healthy foods that provide a high-quality diet. People with T2DM have been identified to have low-quality diets, despite recommendations to eat healthy foods. However, it is currently unclear whether people newly diagnosed with T2DM change their diet quality after diagnosis, nor if they maintain positive changes over time. No research has quantitatively explored changes in diet quality after diagnosis, and the factors (demographic, physical and psychosocial) that predict sustained improvements. Therefore, there is no evidence as to whether diet quality remains fixed once an individual is diagnosed with T2DM, or whether there are periods of marked dietary change. There is a clear need to investigate how diet changes over time so targeted strategies can be developed to facilitate improved glycaemic control. Therefore, the aims of the proposed study are to; (i) Describe diet quality changes in the 12 months following T2DM diagnosis. (ii) Identify the demographic, physical and psychosocial predictors of sustained improvements in diet quality defined as an increase in Dietary Approaches to Stop Hypertension (DASH) score of 3 points.

Admissions to intensive care units (ICUs) are increasing due to an aging population. With advances in medical care, patients are surviving an initial stay in critical care; however they are presenting with ongoing health and mental ability limitations following their stay in intensive care. Recent research has focused on the introduction of early rehabilitation within the ICU in an attempt to reduce the long-term complications regarding physical recovery and cognition. To date the exact scope and type of therapeutic care that occupational therapists can provide, as part of the multidisciplinary team, requires further investigation. This research project will investigate how useful and effective certain occupational therapy interventions can be in influencing longer term outcomes relating to physical strength and ability to complete simple daily activities such as self-care and grooming, following an early rehabilitation program within an intensive care unit. It will also interview patients who participated in the early rehabilitation program to understand how they felt about participating and whether there are changes that can be made to make their experience more beneficial. The results of this study will help to redefine how we provide occupational therapy in the intensive care unit and may help to support a clearer and more active role for occupational therapists in future critical care settings.

The purpose of this study is to evaluate the impact of treating concurrent, previously unrecognised obstructive sleep apnoea in patients with treatment resistant epilepsy. The primary outcome is the impact of treatment on seizure control, with secondary outcomes including quality of life and sleep measures, cognitive outcomes, psychiatric outcomes, and biomarkers of neurological injury

This study has been designed to compare relook laparoscopy versus standard follow up for early detection and treatment of patients at high risk for metastases after resection of colorectal cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, have been diagnosed with primary colorectal cancer for which you have undergone colorectal resection, and are at high risk of the cancer spreading within the abdomen (peritoneal metastases). Study details Participants will be randomly allocated (by chance) to undergo either a relook laparoscopy 9-12 months after initial colorectal cancer surgery in addition to standard follow-up or continue with standard follow-up only. Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. Standard follow up tests include regular blood tests for levels of tumour markers (every three months) and regular CT scans (yearly). Participants will then be followed up over three years to assess disease status (i.e. remission or relapse) and to complete a series of questionnaires to determine quality of life. It is hoped that this research will help determine whether a relook laparoscopy is a valid and effective way of increasing survival rates in patients with high risk colorectal cancer.

Circadian rhythms are vital to normal fetal development but the fetus is dependent on maternal circadian rhythms until near-term. Preterm infants spend the first months of postnatal life in the disruptive setting of constant environmental light and noise, without maternal circadian inputs. In animals, disturbed circadian rhythms are associated with impaired brain development. Cognitive impairment remains the primary morbidity associated with extremely preterm birth and increases health care costs. Therefore, we aim to establish if individual diurnal cycling of environmental light and noise levels improves cognitive outcomes of very preterm infants compared to more constant background lighting and noise. We are undertaking a multicentre, prospective, randomised, open, blinded end-point (PROBE) parallel controlled trial that assesses the effect of non-invasive application of eye masks and ear muffs for 10 hours per night via measurements of neurodevelopmental, social, psychological, physiological, and economic outcomes. We hypothesise that diurnal cycling of light and noise commenced from birth and continued until discharge home will improve the cognitive score (Bayley Scales of Infant Development (BSID) 4th edition), in infants born at < 32 w gestation. Primary outcome will be a mean difference of 4 points in the cognitive score on BSID-4 at 2 years corrected postnatal age. Sample size to achieve 90 % power and alpha 0.05 is 954 infants, assuming a standard deviation of 15 points, a 10 % loss to follow-up and a 30 % adjustment for multiple births. Secondary outcomes will target survival, anthropometry and growth, key neonatal morbidities (BPD/NEC/ROP/Sepsis/IVH), length of hospital stay, survival, Bayley 4 subscores, infant behaviour, sleep, hormonal and clock gene circadian profiles, health service utilisation, core health economic analyses and primary carer mental health and sleep, .