ANZCTR search results

Recent development of non-invasive brain stimulation techniques has provided further insight into human nervous system function. Transcranial direct current stimulation (tDCS) is one such technique, which involves delivering mild electrical current to the brain via surface electrodes. Further research, however, is required to evaluate the effects of consecutive daily application of tDCS on human sensory function. Consequently, the aim of this research project is to investigate whether five consecutive daily sessions (1 session / treatment day) of tDCS can improve sensory function in a healthy human population. The results of this study will lead to a better understanding of human sensory function modulation.

The aim of this study is to assess the deliverability and efficacy of high dose lenalidomide for the treatment of adult patients with acute lymphoblastic leukaemia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with relapsed or refractory acute lymphoblastic leukaemia, which is unsuitable for further intensive chemotherapy. Study details All participants in this study will receive a drug called lenalidomide (Revlimid), which is administered as oral capsule. Treatment will be delivered in 28 days cycles until disease progression or unacceptable toxicity. The dose of lenalidomide administered will potentially be twice or thrice the dose that it is approved in Australia for the treatment of other blood cancers. Lenalidomide works against the cancer via multiple mechanisms. It damages the genetic code (DNA) of cancer cells (there is no evidence to suggest that normal cells are affected the same way), dampens the pro-survival genes in cancer cells and boosts the body’s natural immune response against the cancer cells. Lenalidomide has been found to be effective in cancers such as multiple myeloma, chronic lymphatic leukaemia, non Hodgkin’s lymphoma and acute myeloid leukaemia. However, it’s effectiveness is not examined exclusively in subjects with ALL. Participants will be regularly assessed throughout the duration of the trial in order to evaluate safety and efficacy of treatment.

The main goal of this study is to assess the safety and tolerability of the drug, SUN-101, in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic or locally advanced ductal adenocarcinoma of the pancreas, which has been previously treated with first line chemotherapy. Study details: Participants in the first part of this study (Phase 1a) will be administered SUN-101 in a dose-escalation scheme with cohorts of three patients at each dose level (1.0, 1.5 and 2.0 mg/kg). All cohorts will receive injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks for up to 5 full cycles (up to 50 injections) depending on response. Participants in the second part of this study (Phase 1b) will be administered SUN-101 at the maximum tolerated dose identified in Phase 1a for up to 5 cycles. SUN-101 is a small molecule which is similar to a compound found naturally in human cells. Laboratory and animal studies suggest that SUN-101 targets and destroys the ductal cells in the pancreas where the tumour grows. Participants will be regularly assessed during treatment in order to assess safety and tolerability. Other goals of this study are to measure the levels of SUN-101 in the blood and urine over time and test whether SUN-101 can slow the growth of, or shrink tumours.

This is a parallel group, prospective randomised trial comparing two methods of monitoring asthma control. Participants will be recruited from the Pulmonary Function Laboratory who have been referred for testing using inhaled mannitol to assess BHR in persons who are suspected of having asthma. Following the identification of a positive test, the provision of written consent and once there is confirmation the clinician has prescribed ICS, the subject will be contacted by phone and asked to return to the Laboratory at 6, 12 and 18 weeks to have either a mannitol challenge with spirometry performed or spirometry performed alone. The subject will be provided with feedback at each visit as to the benefit of ICS on the test outcomes and encouraged to seek the goal of achieving a reduction in their airway response to mannitol or improvement in lung function into the normal range. The referring clinician will also be provided with the results at each visit. Subjects will also perform an Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) at each visit and both patient and clinician will be informed of these improvements. Prior to both spirometry and a mannitol challenge, participants will have two rapid non-invasive tests performed that measure the size of the small airways as well as the degree of inflammation by measuring a gas when expired known as nitric oxide.

The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.

Our aim is to study the efficacy of pterygium excision and conjunctival autograft with autologous blood and compare with the gold standards of sutured autograft and autograft with fibrin glue. Conjunctival autografts with autologous blood have been reported to be effective in the literature. Only a small number of prospective studies with small numbers of patients have studied conjunctival autografts with autologous blood. Comparing this method to that with sutures and with fibrin glue will provide meaningful comparative data on efficacy of method, rates of recurrence, cost and patient comfort. We hypothesize that patients will experience less discomfort and will have similar rates of graft stability and recurrence.

During Knee replacement surgery there are different techniques that the doctor can use to anaesthetise the patient during their surgery and differing options for managing pain relief immediately following surgery. The aim of this study is to compare 3 ways of doing this and to work out which way is best by looking at the pain relief needed by the patients in the different groups after their surgery. The 3 different ways are: 1. Locally Administered Anaesthesia 2. Spinal Anaesthesia 3. Femoral Nerve Block

This study involves participants who have undergone solid organ transplantation and are either experiencing human cytomegalovirus (CMV) disease or are at risk of developing it. The study is assessing the feasibility of generating T cells (a type of white blood cell) that target CMV, and the effect of these cells when infused into participants. Eligible participants will donate 250-300mL of blood to expand CMV-specific T cells which will form their treatment. Participants will receive 2-6 intravenous infusions of T cells. The effects of the treatment will be studied by monitoring signs and symptoms and by blood tests. Total length of involvement in the study will be no longer than 10 months.

Dental decay (caries) is a highly prevalent disease in Australia and Early Childhood Caries (ECC) is one of the most common chronic diseases of childhood. ECC is the presence of any decayed, missing (due to decay) or filled surface in primary (deciduous) teeth in children 6 years or less. ECC has wide-ranging health and developmental consequences and is often associated with pain, infection and abscesses which can lead to delayed growth, reduced general health, sleep problems and disrupted social and academic development due to school absences. In Australia the epidemiological and service data on prevalence and morbidity for child oral health is patchy; with only 2002 national data available. In 2002 Australian children 0-4 years in the National Child Oral Health survey had a mean of 1.55 decayed, missing or filled teeth (dmft) and 80% of this was active, untreated decay. Of those children with decay (44%), the mean dmft per child was 4.23. In 2006, the Victorian Child Health and Wellbeing Survey found that 21% of 0-3 year olds had experienced toothache and Victorian data available from DHSV shows that of children aged 0-6 years attending public dental clinics in 2009 (n=14,911), 47% had tooth decay (n=7,072), with an average dmft of 2.2. Dental treatment was the 3rd most common cause of hospitalisation for 0-14 year olds in Australia in 2009-10 and the average cost per admission for extractions and restorations was AUD$2508 per child. Importantly the severity of the disease in young children may be increasing as there was a 53% increase in dental Ambulatory Care Sensitive Conditions (ACSC) admissions from 1997/8 to 2004/5 for 0–9 year-olds, with an average annual increase of 7.6%. However, caries rates are higher among the more socially disadvantaged, particularly in childhood, and amongst those living in rural and regional areas. This is also reflected in the ACSC data and rural children have dental related hospital admission rates that are 4 times higher than metropolitan children. After tooth extraction, the potential impacts on child social, emotional, nutritional and developmental experiences are considerable. The significance of this project is to test the effectiveness of a simplified method, reported in the literature, for managing carious primary molar teeth in preschool children without any tooth preparation or local analgesia and therefore making treatment more acceptable to preschool children in a primary care setting. If the approach were shown to be effective, the expected long term outcome would be a reduction in hospital admissions for the management of dental caries in this age group.

Many recent studies have shown that overweight and mildly obese individuals have marginally better outcomes compared to individuals with normal weight following surgery or even nonsurgical situations such as heart related problems. However, body mass index (BMI) is not an accurate measure of body fat composition. We therefore need a measure that can be used at the bedside as well as one that can accurately predict the body fat composition and hence the risk associated with surgery. This pilot study is a miniature version of a future multicentre prospective cohort study to assess if waist circumference is a predictor of postoperative major adverse outcomes after elective non-cardiac surgeries. If that is so, we would like to know if it is better predictor than the currently popular predictor, BMI. We are also testing if other measures like waist to hip ratio, neck circumference are equally useful predictors or not.