ANZCTR search results

The study will analyse the safety and biological efficacy of administering the investigational products (donor-derived T cells stimulated with WT1 or engineered to express a CD19 chimeric antigen receptor, together with donor derived T cells stimulated with viral and fungal antigens) for the prevention of relapse and viral/fungal illnesses in patients undergoing transplantation for acute leukaemia in first complete remission. Who is it for? You may be eligible for this study if you are 69 years or younger and are undergoing an allogeneic transplant for the treatment of either acute myeloid leukaemia or acute lymphoblastic leukaemia. Study details Participants will receive a bone marrow transplant. 21 days following the transplant, participants may receive an infusion of T cells made from their donor’s cells that is anticipated will help fight off infections. Following this, participants may be eligible to receive up to 4 Tcell infusions that is anticipated to help fight cancer. Patients will then be followed up for 12 months (for AML patients) or 15 years (for ALL patients). Over this time you will be asked to donate extra blood for clinical trial use which will mostly be collected at blood tests that are required for normal transplant follow up. It is hoped that this research will provide safer and more effective blood or marrow transplants for those suffering from leukaemia.

The aim of this study, is a 12 week intervention trial measuring the effects of a multicomponet strength based exercise program with and without a milk- based beverage and to investigate the independent and combined effects of these factors on on skeletal muscle mass, muscle strength and performance in active older adults. It is hypothesised that exercise combined with the milk beverage will result in a greater skeletal muscle response than either exercise or the milk beverage alone.

Cardiovascular diseases (CVD) are the leading causes of death in the world. Globally, over 30% of all deaths are attributable to CVD, with the majority of these attributable to either ischemic heart disease (heart attack) or cerebrovascular disease (stroke). In Australia ~29% of all deaths have an underlying cause of CVD. Suboptimal lifestyle behaviours are the leading causes of CVD globally, and most CVD-related events could be prevented or substantially delayed by improving diet, increasing physical activity and stopping smoking. There is a strong rationale to focus on primary prevention targeting lifestyle behaviour change. Early intervention can arrest chronic disease and prevent adverse outcomes. Intervention guided by new non-invasive measures of advanced structural vascular disease are revolutionising CVD risk management. Structural vascular disease measurements, assessed using vascular calcium scores substantially improve estimation of future CVD risk. The most commonly used measure clinically is coronary artery calcium (CAC) scoring. The main disadvantage of this test is that it is not recommended for routine, repeated assessment because of the radiation dose involved. Its cost also limits repeated measurement. We have developed a test to assess abdominal aortic calcification (AAC) that is rapid, inexpensive and ultra-low radiation, and thus can be used for population-based screening in almost any individual. It can also be repeated at regular intervals to follow disease progression. AAC is closely related to coronary artery calcium (CAC) and atherosclerosis at other vascular beds, and strongly predicts CVD events, CVD deaths and deaths from all-causes. We will conduct a 12week randomized controlled trial including men and women 60 to 80 years old. Participants will then be followed up out to 12 months in an observational study. Our overarching aim is to determine if providing individuals with knowledge of their structural vascular disease together with brief nutrition and lifestyle education might lead to short-term (12 weeks) and longer-term (2 years) benefits on diet and lifestyle, and other health-related measures. We expect that an individual’s knowledge of AAC will result in increased fruit and vegetable intake (primary outcome), improved diet and improvement in other measures related health status.

The primary purpose of this trial is to assess whether the addition of venetoclax to a velcade (bortezomib), cyclophosphamide and dexamethasone treatment regime will cause an improvement in disease progression free survival. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are a candidate for chemotherapy and autologous stem cell transplant. Study details Eligible participants will be treated with 4 35 day cycles of venetoclax, velcade, cyclophosphamide and dexamethasone (V-VCD) followed by a high-dose melphalan conditioned autologous stem cell transplant (ASCT) with residual disease evaluation at day 100 post-ASCT. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of venetoclax in combination with VCD for the treatment of multiple myeloma patients early in the course of their disease.

This study will investigate cyclosporin in AA. This randomised, double-blind, parallel group, study will enrol a maximum of 38 subjects. The study will be conducted at Sinclair Dermatology. Subjects who have moderate to severe AA (at least 50% hair loss of the scalp without evidence of hair regrowth within the previous 6 months; current episode of fixed hair loss up to 7 years) present at the screening and baseline visits will be included in the study. Subjects will be randomised to cyclosporin or matching placebo in a 1:1 ratio. Investigators and subjects will be blinded as to treatment group. Subjects will be screened within the 35 days prior to the first dose of study drug to confirm that they meet the subject selection criteria for the study. The 12-week treatment period is followed by a 4-week follow up period after the last dose of investigational product. Non-responders will be eligible to participate in the extension phase of this clinical trial, investigating open-label tofacitinib.

Research aims: The aims of this trial is to assess the efficacy and rationale for routine topical antibiotic (Ciprofloxacin) for the prevention of grommet obstruction and otorrhoea in grommet surgery (myringotomy and ventilation tube placement) Hypothesis: That a single intraoperative dose of topical ciprofloxacin is as effective as a 5-day postoperative course for prophylaxis of two post-operative complications of paediatric grommet surgery when compared against no prophylaxis. That factors such as age, indication for surgery, number of previous grommets and intraoperative middle ear status are correlated with developing post-operative complications. That there is a significant patient reported quality of life benefit in prophylaxis compared to no prophylaxis. Participants: 360 paediatric patients (17 and under), who are undergoing bilateral myringotomy and ventilation tube placement, with a diagnosis of otitis media with effusion for at least 3 months or recurrent acute otitis media. Methods: 360 participants will be randomised to three groups. (1) Control group, receiving no intervention. (2) Single dose group, receiving one intraoperative dose of topical ciprofloxacin and no post­operative doses. (3) Multi dose group, receiving one intraoperative dose of ciprofloxacin and a 5­day post­operative course of topical ciprofloxacin (2 doses daily) Measured outcomes: (1) Incidence of ventilation tube obstruction at 6 weeks diagnosed by otoscopy and tympanometry.    (2) Incidence of ventilation tube otorrhoea at 2 weeks and 6 weeks by otoscopy. (3) Difference in validated disease specific QOL(OMO­22) at date of surgery and 6 weeks.  (4) Difference in audiometry pre­op and 6 weeks post­op.

This is a pilot study looking at the treatment of obstructive sleep apnoea (OSA) in patients with atrial fibrillation (AF), using a mandibular advancement splint (MAS). MAS is an alternative treatment to CPAP (continuous positive airway pressure) therapy, which adheres to the top and bottom dental arches and brings the lower jaw forward, thus preventing upper airway collapse during sleep. There is evidence suggesting that treatment of OSA improves outcomes for patients suffering from AF. This may be particularly true for those patients who have had treatments for their AF such as Cardioversion or Pulmonary Vein isolation. There are no randomised control trials looking at MAS treatment for OSA in AF patients. This pilot study will collect data on patient acceptance, efficacy and compliance of MAS treatment in this patient group. Secondary outcomes include AF recurrence rates, changes in blood pressure, heart rate variability and quality of life questionnaires. Data from this important pilot study will inform a future randomised control trial.

This is a healthy volunteer study to evaluate the safety, tolerability, and pharmacokinetics of a new drug called RT234.

This study aims to determine if patients with cardiac failure and pacemakers are being adequately assessed prior to consideration of listing for cardiac transplant. We hypothesise that by using a treadmill instead of a stationary bike as their functional assessment (cardiopulmonary exercise test) we will generate a higher degree of cardiac function and appropriately delay their transplant listing.

This preliminary survey will determine the baseline characteristics and preferences for prehabilitation in patients schedule for colorectal cancer resection. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with colorectal cancer and scheduled for surgical resection. Study details “Surgical prehabilitation” is the process of making an individual as fit as they can be, before an operation so that they can better tolerate the stress of surgery. Surgical prehabilitation includes exercise, improving nutritional status and psychological counselling with an intention to increase your strength before surgery. Studies have shown that increasing fitness can reduce complications following bowel surgery. We are looking to design a prehabilitation programme for cancer patients at the Prince Charles Hospital. To do that, we would like to know the health condition and fitness levels of the patients. We also want to know your preferences for such a programme. We believe that if we have this information, at a later date, we could design a programme that could be easily followed by the future patients. This is only a preliminary survey