ANZCTR search results

The aim of this study is to assess the efficacy of delivering chemotherapy treatment through the arteries directly to the liver, bypassing the main blood supply throughout the body. Who is it for? You may be eligible for this study if you are aged over 18 years, have hepatic metastases from histologically proven adenocarcinoma of the colon/rectum, and have had some systemic chemotherapy. Study details Once enrolled, patients will have baseline scans and will have the AVAS device implanted. The patient will be admitted to hospital up to twice a week to be treated with the liver directed therapy until they have received 5-7 treatments of oxaliplatin, after which the device will be explanted. Oxaliplatin is approved in Australia as chemotherapy treatment for liver metastases from colorectal cancer (via IV infusion), but has not previously been approved when delivered to through the arteries to the liver using the AVAS study device. All patients will also receive Capecitabine from enrolment to 4 weeks after the AVAS explantation as a form of systemic disease management. The patient’s tumour will be scanned 4 weeks after explant of the device, and the patient will be followed up for two years. An additional CT scan will take place 8 weeks after the AVAS explantation which will be used to determine progression free survival for each patient cohort. The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.

The aim of this study will be to examine the efficacy of a targeted pre- and post-operative exercise program on treatment related side effects after radical prostatectomy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above and are scheduled for radical prostatectomy by one of the four selected surgeons. Study details Participants in this study will be randomly allocated (by chance) to one of two groups: 1) Exercise; or 2) Usual Care. The exercise group will participate in a structured exercise program 1-2 months before surgery and for 3 months after their surgery. The intervention involves individualized exercise prescription supervised by exercise physiologists during 3 group-based sessions weekly in an exercise clinic. The usual care group will receive standard medical care. Both the Exercise and Usual care will receive best-practice pelvic floor physiotherapy treatment before and after surgery. Assessments will be conducted at the following time points: baseline (-1-2 months), pre-operation (0 months), post-operation (1 month), post-intervention (4 months), and follow-up (12 months). We hypothesize that a structured exercise intervention tailored to men with prostate cancer delivered prior to and continuing after surgery will improve patient's rehabilitation outcomes after surgery, in particular attenuate the severity of sexual dysfunction and urinary incontinence.

The aim of this randomised control trial is to evaluate whether students, in particular girls, are more active during the school day if they are wearing their sports uniform as opposed to their normal formal uniform. Sixty primary schools in the Hunter Region and Mid North Coast will be randomly allocated to an intervention or control group.

The aim of this randomised control trial is to assist teachers to increase the amount of scheduled physical activity time they provide across a school week. Schools will be provided professional development, resources, time and access to a support officer to make these changes. Sixty primary schools in HNE and Mid north coast LHD’s will be randomly allocated to either an intervention group or a control group. The final trial endpoint is 18 months.

A three-group, randomised, placebo-controlled trial will be performed. Forty five participants with type 2 diabetes will be assigned to either 1) ECP30: ECP therapy for 30 mins/session or 2) ECP45: ECP therapy for 45 mins/session or 3) placebo (sham). Each participant will have 3 ECP/sham sessions/week for 7 weeks. To assess the effectiveness of the ECP therapy before and after the 7-week intervention participants will undergo tests of cardiorespiratory fitness, exercise capacity, blood markers (HOMA values and basal disposition index using fasting glucose and insulin), HbA1c, nitrate, nitrite, F2-isoprostanes, protein carbonyls, C reactive protein, IL-6, IL-10, IL-ra and thrombospondin-2) and vascular structure and function.

Atrial fibrillation (AF) is the most common complication after cardiac surgery, with an incidence ranging from 20 to 50%. It represents a potential cause of thromboembolic events, hemodynamic instability and prolonged Intensive Care Unit (ICU) stay. Maintaining a normal blood magnesium concentration may help prevent the onset of atrial fibrillation after cardiac surgery. Previously we performed an assessment of the pharmacokinetics of magnesium administration after cardiothoracic surgery from August, 2016 to April, 2017: “Assessment of Blood and Urine Magnesium Levels in Patients Admitted to the Intensive Care Unit” (HREC: LNR/15/Austin/306). We included 60 patients: 30 patients in the before period who received a bolus of 20 mmol of magnesium sulphate over 1 hour; and 30 patients in the after period who received a bolus of 10 mmol of magnesium sulphate followed by a continuous infusion at 3 mmol/h over 12 hours. In the before period, we found that the loading dose of 20 mmol increased both serum and urinary magnesium concentrations, however the serum concentration returned to pre-intervention levels within 12 hours of observation and the urinary excretion remained elevated. In the after period, the intervention of a loading dose of 10 mmol of magnesium sulphate followed by a continuous infusion was associated with an increase of both the serum and urinary concentrations of magnesium over time. The after-period protocol allowed us to achieve a sustained, safe, and moderately elevated serum magnesium concentration at twice to three times the lowest total magnesium concentration in our laboratory (1.4 to 2.0 mmol/L), which might be expected to deliver a greater chance of AF prevention. As such the management practices associated with magnesium administration in our intensive care unit has changed. The purpose of this project is to evaluate the effect of the new protocol on the incidence of atrial fibrillation in patients who undergo cardiac surgery and are admitted to the intensive care unit. Using a medical record audit design we will evaluate patients treated with the new magnesium protocol with that of a historical control.

A multifaceted program (the Reducing the Use of Sedatives; RedUSe project) was implemented across 150 Australian residential aged care facilities (RACFs). The RedUSe project consisted of educational sessions supported by auditing and benchmarking of sedative prescribing. There was also a sedative review component where pharmacists, nurses and doctors work together in consultation with the resident and/or relatives to review regularly used sedative medications (predominantly antipsychotics and benzodiazepines). We aimed to review the clinical outcomes of the residents and nursing home staff, and economic outcomes for the health care system resulting from this intervention. We hypothesised that reduced use of antipsychotics and/or benzodiazepines, as a result of this project, will: - Not negatively affect behavioural and psychological symptoms - Improve resident quality of life - Decrease the rate of resident falls - Increase activities of daily living - Decrease general practitioner visits - Decrease hospitalisations - Decrease caregiver burden - Increase the job satisfaction of nursing staff - Be associated with lower costs to the health care system than 'usual' practice. Nursing staff were interviewed with validated questionnaires to assess behavioural and psychological symptoms, social engagement, activities of daily living, and caregiver burden at the start and four months of RedUSe. Additionally, nursing staff were required to record the number of falls, challenging episodes, hospitalisations, and general practitioner consultations the residents had each month for the same four month period (a minor addendum to their existing recording activities). To asses job satisfaction, an anonymous survey was made available at the start and four months of RedUSe.

Six participants aged 18-60 years will be recruited for this study. Inclusion criteria includes: grade II whiplash of at least 3 months duration; living in a community setting; a neck disability index score >32% [1]; deemed medically safe to participate in moderate intensity PA; and currently insufficiently physically active for good health. Exclusion criteria includes: known or suspected serious spinal pathology; confirmed fracture or dislocation at time of injury – WAD Grade IV; nerve root compromise; and spinal surgery in the past 12 months. This study will utilise Multiple Baseline Single Subject Experimental Design with three phases: a 5, 8 or 11 week baseline period; a 16-week intervention comprised of 12 one hour sessions; and a 5-week no intervention withdraw. Primary outcome measures will be collected weekly during the baseline data collection period, fortnightly during the intervention period, and weekly during the follow-up period. Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period. Data collection will be completed by a researcher independent of the intervention delivery. 1. Vernon & Moir. The neck disability index: a study of reliability and validity. J Manip Physiol Ther, 1991. 14(7), 409-415.

We are studying ways to improve the health of people after their liver transplant. We want to develop better ways to improve the cardio-metabolic health after liver transplant so that patients can avoid developing common conditions like obesity, diabetes and heart problems. The aim of this study is to find out if using telehealth technology (web-based appointments and educational videos) is useful to support patients in healthy eating and exercising in a way that can improve overall cardio-metabolic health after liver transplant. The information gathered from this study will be used to improve liver transplant services, and assist in developing better long term access to services that can be made available through technology.

The aim of this project is to investigate if a novel tracer called 64Cu­-SARTATE can be used to help accurately image neuroblastoma on PET/CT in pediatric patients. Who is it for? Paediatric patients aged 16 years or less diagnosed with high-risk neuroblastoma and life expectancy of 12 weeks or more are eligible for this study. Study details Eligible patients will be administered a single dose of 64Cu­-SARTATE and undergo whole body PET scans at 4hrs & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & the visit 3 (day 8). Three blinded assessors will compare the new scans to the standard of care imaging to determine if they are superior. We hope that by testing this investigational product in paediatric patients, we can confirm that the biodistribution of 64Cu­-SARTATE will facilitate specific and more sensitive identification of malignant tissues using PET/CT scanning. It is hoped that this method can then be translated into everyday clinical care.