ANZCTR search results

Each year more than 10,000 Australian stroke survivors are admitted to rehabilitation to improve independence. Occupational therapy assessments conducted before discharge aim to enable a safe independent transition from hospital to home, however there is no evidence that home visits improve outcomes for stroke survivors. The HOME trial will address this evidence gap with the aim of determining the effectiveness, and cost effectiveness of an occupational therapy discharge planning intervention consisting of three occupational therapy sessions primarily conducted in the home. This multicentre, randomised controlled trial will recruit 360 patients with a confirmed diagnosis of stroke admitted for inpatient rehabilitation. Patients will receive either the HOME intervention, or an inhospital predischarge planning package. The primary hypothesis is that the HOME intervention will improve functional participation levels at 4 weeks, 6 and 12 months, compared to predischarge planning package. Secondary hypotheses are that the HOME intervention will result in fewer hospital readmissions at 6 months postdischarge, and will be less costly than an occupational therapy predischarge home visit package.

Implantable loop recorders (ILR) are used to detect and define heart rhythm problems (cardiac arrhythmias) where symptoms are too infrequent to be captured on non­implantable cardiac rhythm monitoring devices. Currently, the main accepted indication for implantation is recurrent syncope, with a recent addition of cryptogenic stroke as an indication also. Remote monitoring of other implanted cardiac devices (pacemakers and defibrillators) has become the standard of care, based on several randomised trials showing benefits extending across morbidity, mortality, cost effectiveness, and patient satisfaction. The benefits of remote monitoring of ILRs have not been clearly established. The purpose of this study is to assess the effect of remote monitoring. A comparison between usual office-visit follow-up and remote monitoring only with an initial period of phone-contact will be made. Remote monitoring should lead to action on ILR findings in a shorter time-frame than waiting for the next office visit.

Approximately 150 male participants aged between 18-40 years of age will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=50) or one of two active intervention groups (n=50 per group). Height, weight, body composition, cardiovascular function, and treadmill exercise testing and questionnaires regarding gastrointestinal tolerance, score of fatigue, and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to undertake the training program consisting of aerobic training. Participants will complete 4 training sessions per week and undertake further assessment at weeks 4 and 8. At the mid-point (week 4) participants will complete treadmill exercise testing, as well as having weight and waist circumference assessment. At the completion of the study (week 8), an assessment identical to what was undertaken at baseline will be carried out. At both time points (week 4 and 8) and as part of the assessment, participants will be interviewed and asked to provide details regarding any lifestyle changes (diet, exercise, medication) in addition to subjective changes in exercise, performance and any adverse effects (including change in libido and mood).

This project seeks to determine the feasibility and effectiveness of postmeal walking exercise to control blood glucose in gestational diabetes. Postmeal walking involves 10 min of physical activity (preferably walking) after breakfast, lunch and dinner. Women with gestational diabetes will be randomised to standard-care alone, or with postmeal walking. It is hypothesised that postmeal walking will improves aspects of blood glucose control more than standard-care alone.

The aim of this research is to translate the low-cost ‘Integrative Medicine for Labour & Birth Program’ (My Birth Course) into end-user benefit and to inform health service delivery. The study will be conducted as a randomised controlled trial (RCT). Randomisation will occur between 24-36 weeks’ gestation. Women will be enrolled into the My Birth Course (antenatal education program), in addition to standard care, or receive standard care alone. This RCT will contribute to a prospective meta-analysis design to assess clinical effectiveness and quantify resource use that will affect translation into practice and sustainability. This study extends the finding of the original RCT conducted in Sydney, Australia which demonstrated significant reductions in caesarean section and medical interventions. The unique contribution of this proposal is to extend the generalisability of the findings by recruiting women from a more diverse group of women at a different hospital to determine the real-world effectiveness of an antenatal education intervention when it is delivered through a range of maternity units in Australia and internationally.

Who is it for? You may be eligible for this study if you are aged over 18, have cancer, are attending the Royal Brisbane and Women's Hospital medical oncology outpatient clinics and have been identified as being at risk of malnutrition. Caregivers of these patients may also be eligible. Study details Participants will be randomised (by chance) into two groups. One group will see a hospital research dietitian for three counselling sessions, two weeks apart (i.e. over four to five weeks). The other group will continue to receive their usual care. Before and after the program, participants will answer a number of questionnaires relating to their quality of life, nutritional status and level of distress. It is hoped this research demonstrates improved quality of life for people with cancer and their caregivers (where available). Additionally, this research hopes to demonstrate the feasibility of the program, and facilitate the implementation of a definitive randomised controlled trial (RCT) in the future.

The purpose of this study is to determine the effects of oral Vismodegib as an adjuvant treatment in periocular basal cell carcinoma. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with periocular basal cell carcinoma. Study details All participants in this study will receive the treatment of Vismodegib once daily. This medication will be subsidised by PBS for participants. Prior to commencing treatment, female participants will require a pregnancy test and a punch biopsy of the tumour will be taken in all cases. You may require additional blood tests prior to commencing the treatment medication, no additional scans or investigations will be required outside of standard practice for this trial. It is hoped that this research will demonstrated a reduction in the surface area of skin removed by wide surgical excision following neo-adjuvant use of Vismodegib for periocular basal cell carcinoma and improved surgical outcomes for patients.

Visual evoked potentials (VEP) are a measurable brain signal as a response to a visual stimulus. VEPs assess the integrity of the visual pathway of the brain. Conventionally, these systems are not portable, relying on bulky cathode-ray tube displays and electroencephalography (EEG) systems. This investigational device is a portable implementation of a VEP system, allowing for use in non-clinical environments. The study intends to verify and validate the SSVEPs of twenty healthy participants using two systems: the investigational device, and a reference EEG system. It is hypothesised that the VEPs may be obtained from both “standard” and portable systems with similar sensitivity and specificity.

The purpose of this project is to measure the uptake of a new type of Positron Emission Tomography (PET) scan (using Ga68-PSMA) in relapsed glioblastoma. We would also like to examine if standard and new x-ray techniques such as PET can be used to predict the behaviour of the cancer. This will allow us to understand if this type of scan gives a clearer image of the tumour when compared to standard scanning. Who is it for? You may be eligible for this study if you have histologically confirmed glioblastoma Study details All participants will attend on two days for PET scans. The scans will take approximately 90 minutes. Participants most recent MRI scan will also be used to identify the blood brain barrier breakdown. A blood sample will be collected - approximately 30mls at baseline. This study will help ensure the optimal targeting of anti-cancer treatment and imaging in the future. It is hoped this study will help ensure the optimal targeting of anti-cancer treatment and imaging in the future.

Do you have Type 1 Diabetes and want to know how different types of protein affect your blood glucose levels? The ‘iBolus: Protein’ Study is exploring how different types of protein impact blood glucose levels in adults with type 1 diabetes and using an insulin pump. You’ll be asked to have a blood test and attend 5 sessions at the University of Sydney to eat 5 different types of protein (beef, chicken, salmon, egg and protein shake) served with carbohydrate, take an insulin bolus and monitor your BGL for 5.5hr.