ANZCTR search results

This study looks at treatment with a targeted biological therapy (Anti-Human Epidermal Growth Factor Receptor (Vectibix sequence) Targeted, Doxorubicin Loaded EnGeneIC Delivery Vehicles [VEDVsDox]) in people with recurrent Glioblastoma Multiforme (GBM). Who is it for? Patients may be able to join this study if they have recurrent WHO Grade IV advanced malignant GBM which expresses EGFR. Trial details The study will be conducted in two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion. Part 1 of the study is aimed at determining the maximum tolerated dose (MTD). It will commence dosing at 2x10^9 VEDVsDox and escalate to 5x10^9 VEDVsDox evaluating the safety and tolerability of VEDVsDox. The dose expansion phase (Part 2) will begin upon completion of the dose exploration (Part 1) and up to 46 subjects with recurrent GBM will be treated at the Recommended Phase Two Dose (RPTD) The treatment phase of both parts of the trial is divided into cycles. Each cycle is 8 weeks long and will require that the patient come to the hospital to receive the study treatment every week for 8 weeks. This will involve an intravenous injection (injection into a vein) of a 20mL of EDVs over a period of 20 minutes. The time spent at each hospital visit will vary and may be between 1 and 5 hours. During the treatment phase at various times the patient will have the following procedures performed: * An MRI scan every 8 weeks; * A physical examination, weight and a neurological examination; * Blood sample collection of 40ml (2 tablespoons) and urine sample collection and testing to assess overall health; *Electrocardiogram (ECG) to assess the health of the patients heart; *Vital signs including resting pulse, respiration, blood pressure, temperature will be measured; * Patients will be asked questions about quality of life and any side effects; * Blood sample collection of 9ml (1/2 tablespoon) for pharmacokinetic analysis in the first cycle only. The Patient may continue to receive cycles of study treatment for as long as the cancer remains stable or continues to reduce in size, and they are tolerating the treatment. When the patient has stopped treatment they will be asked to return to the hospital for a safety follow-up visit approximately 1 month after the last study treatment. This visit will be similar to the treatment visits.

The aim of this project is to assess the feasibility and effectiveness of an intervention, recently shown to have promise in the US, in Australia. The intervention targets depression by increasing nursing home residents’ involvement in simple, enjoyable activities. The pilot project will be conducted in two Brisbane Residential Aged Care (RAC) facilities and will involve working with residents and staff to increase resident involvement in enjoyable activities. The intervention is inexpensive and relatively simple to implement and will be assessed for effectiveness, feasibility and acceptability.

Given the range of observed (randomised controlled trials) and purported (anecdotal and epidemiological evidence) effects of both multivitamin and Omega-3 supplementation has upon mood and behaviour the general aim of the study is to investigate the combined effects of Omega-3 and multivitamin supplementation. The study will focus on the effects on mood, workplace stress and cardiovascular health in a workplace sample. More specifically, a three month supplementation with Healthy Body Vitamin Pack is expected to improve the experience of workplace stress, workplace variables, cardiovascular risk parameters and mood in conjunction with an improvement in biological measures such as antioxidant status and triglycerides.

The general aim of this study is to investigate the effect of Executive B Stress Formula supplementation on mood and workplace stress in a healthy workplace sample. More specifically, a six month supplementation is expected to improve participants' experience of workplace stress, workplace variables, and mood in conjunction with biological measures. The participant group will be 165 full time employees, who report feeling stressed in the workplace. These participants will be aged between 30-55 years, who are able to commit to two visits to Swinburne University to provide blood samples and complete computerised cognitive assessments. They will also be asked to complete online questionnaires on a monthly basis. Participants will be randomly assigned to take either Exectutive B tablets or placebo daily for 24 weeks.

PINBALL Synopsis Background CABG surgery remains the treatment of choice for many patients with severe ischaemic heart disease, the leading cause of death in Australia and worldwide. Patients undergoing CABG surgery are increasingly older, have greater comorbidities and are at high-risk of serious adverse postoperative outcomes. Prophylactic IABC may reduce postoperative mortality and morbidity in high-risk patients however current evidence is inconclusive and use remains low. Aim To describe the incidence and outcomes of high-risk patients undergoing CABG surgery. Objectives 1. Assess the crude and adjusted odds ratio for the association between prophylactic IABC and six-month postoperative mortality 2. Determine the combination of preoperative characteristics identifying a group of patients in whom prophylactic IABC may be of greatest benefit 3. Describe current perioperative management strategies of high-risk patients undergoing CABG surgery 4. Determine the quality of life at six months of high-risk patients who have undergone CABG surgery 5. Obtain information critical to the design of a RCT of prophylactic IABC in high-risk patients undergoing CABG including the calculation of sample size, determination of recruitment rates and treatment protocols for the intervention and control arms Methods We will conduct a prospective multi-centre inception cohort study of high-risk patients undergoing CABG surgery. All patients booked for CABG surgery with at least two of four high-risk characteristics, (left ventricular fraction less than 30%, redo cardiac surgery, left main coronary artery stenosis greater than 50% and unstable angina), will be included in the study. A telephone follow-up will be conducted at six months post surgery to measure vital status and quality of life. Outcomes Primary outcome: -Six month all-cause mortality Secondary outcomes: - Incidence of high-risk surgery - In-hospital and 30-day mortality - Composite of in-hospital mortality, CVA, AKI, AMI - Duration of MV, ICU and hospital LOS - Adverse events directly attributable to IABC - Six month quality of life

To determine the interactions between lung disease, nocturnal sleep disordered breathing and daytime functioning in patients with cystic fibrosis. Overnight polysomnography will be compared with cough recordings and Sonomat recordings to evaluate sleep disruptions including cough, grunting, snores, shallow breathing and respiratory related arousals in cystic fibrosis patients. In addition, the study will evaluate if the sleep abnormalities, measured non-invasively, can predict the onset of a pulmonary exacerbation in a cystic fibrosis patient.

The purpose of this study is to evaluate hunger, energy intake, antropyloroduodenal motility, and plasma concentrations of the gut hormones, ghrelin, cholecystokinin (CCK), peptide YY3-36 (PYY3-36), and glucagon-like peptide-1 (GLP-1), in response to exercise of two intensities, 35% and 70% of peak oxygen consumption (VO2), and a no-exercise control condition, in healthy, lean young men. Each subject will be studied on three occasions. Each visit will be either sedentary or involve exercise at one of two intensities (35 and 70% VO2max) for 60 minutes, with the three interventions administered in a counter-balanced order. On each occasion antropyloroduodenal motility, plasma CCK, ghrelin, GLP-1, and PYY3-36 concentrations, appetite perceptions, energy intake and energy expenditure will be measured. Peak aerobic capacity of each subject will be determined within a week before the start of the study using a screening treadmill test. During this screening test, as well as at intervals during the study, subjects will breathe through a mouthpiece equipped with a two-way valve. VO2max will be measured from expired gases that are continuously sampled by a metabolic cart.

Vitamin D deficiency is common in Australia. But Australia has high skin cancer incidence. While advice is given on safe sun exposure to avoid the risks of skin cancer, it is not clear how much sun exposure is required, at different locations in Australia, to maintain sufficient vitamin D levels throughout the year. This study thus addresses the following public health questions: 1). Can safe patterns and doses of sunlight exposure achieve and maintain vitamin D adequacy with no vitamin D supplementation? and 2). How does sun exposure advice calibrate against 2 different doses of vitamin D3 supplementation to manage mild vitamin D deficiency? We will recruit 228 Australian adults aged 18-64 years who have been diagnosed with mild vitamin D deficiency on routine testing (25(OH)D of 40-60nmol/L) in each of four regions in Australia - Canberra, Melbourne, Brisbane, Perth. Participants will be randomly allocated to one of four groups receiving different types of sun exposure advice and supplementation. Outcomes will be the proportion of participants who are vitamin D sufficient at 12 months, and at the end of winter, the time when vitamin D levels are usually lowest.

The study is evaluating the efficacy of substituting the drug, alemtuzumab, for another drug known as ATGAM, as part of combination therapy for steroid-refractory acute graft versus host disease in post haematopoietic progenitor cell transplantation patients. Who is it for? You may be eligible to join this study if you are a male or female aged between 18-69 years who has been diagnosed with grade II or higher steroid-refractory acute graft versus host disease (SR-GVHD) following haematopoietic progenitor cell transplantation (HPCT). Trial details All participants in this trial will be given the drug alemtuzumab for 5 consecutive days. Alemtuzumab will be administered intravenously (into the vein) over a period of 2 hours each day. All patients will also receive standard premedication (including paracetamol, phenergan and hydrocortisone) 30 minutes prior to alemtuzumab. Participants will be assessed at 6 months in order to evaluate response to treatment and survival.

The aim of this project is to demonstrate the feasibility of using visual feedback to increase minimum toe clearance during walking in people with stroke. This intervention has the potential to improve walking safety and reduce falls. Ten participants will be required to attend 10 sessions. The training sessions will occur over a 3-4 week period, with at least one rest day between sessions. At all sessions, participants will be required to walk on a treadmill for 5-10 minutes. They will wear exercise shorts and also a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. They will also wear insoles in their shoes (FScan), which will record pressure under their feet. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, participants will be asked to modify their walking pattern to match a “target” minimum toe clearance.