ANZCTR search results

This research study is examining whether patient education booklets and videos are a clear and informative way of communicating information about the safety, effectiveness, accessibility and affordability of experimental stem cell treatments (i.e. stem cell injections to the brain, spinal cord, vein, artery or stomach) offered by private clinics in China, India, Russia and South America.

Children diagnosed with mild obstructive sleep apnoea are enrolled and randomised to one of three treatment groups: 1) NS = with nasal steroids alone, 2) NS+AL = nasal steroids plus a leukotriene receptor antagonist, or 3) AD = to surgery with adenoidectomy alone. The aim was to determine whether treatment with surgery (adenoidectomy) or treatment with nasal steroids plus a leukotriene receptor antagonist has clear benefit compared to treatment with nasal steroids alone.. As steroids are routinely used as the first treatment in this disease, outcomes from the surgical and combined treatment (nasal steroid plus leukotriene receptor antagonist) groups will be compared against the group using nasal steroids alone (the comparison group).

AIM To assess whether Drug Eluting Angioplasty Balloons (DEB) prevent recurrent narrowing in Arterio-Venous Fistulas (AVF). The study is an investigator initiated, prospective, double blinded, randomised, multicentre, control trial conducted at 3 Australian institutions BACKGROUND When a patient’s kidneys fail, they will die unless some form of “renal replacement therapy” is provided. Haemodialysis is a mainstay treatment in renal failure to keep patients alive in the short and long term. Haemodialysis occurs when the patient’s blood is “washed” in a haemodialysis machine, which takes the place of the patient’s failed kidneys. The biggest problem with haemodialysis is “haemodialysis access” i.e. repeatedly (3 to 5 times per week) placing two large bore needles into the patient’s blood vessels to circulate their blood through the haemodialysis machine. The best form of haemodialysis access is the AVF - a swollen vein created surgically on the patient’s arm. The commonest problem with the AVF is the development of narrowings (stenoses) in the AVF. This prevents proper haemodialysis – an immediately life threatening situation - and can lead to destruction of the AVF. AVF stenoses are readily treated with angioplasty balloons – small balloons placed inside the narrowed part of the fistula – which “stretch” the narrowing and restore the AVF’s function. The problem with this angioplasty treatment is that the body will attempt to “heal” the “stretched” narrowing and the narrowing will recur (restenosis). As a result, many haemodialysis patients require repeated treatments. A new technology – DEB – has emerged to prevent this restenosis problem. DEBs are angioplasty balloons covered in a drug – Paclitaxel for our study – that blocks the restenosis process. The DEB is placed in the AVF immediately after a narrowing has been treated in the hope that it will prevent restenosis. In the last 6 years, a similar technology - Drug Eluting Stents - have decreased restenosis after coronary artery angioplasty from 20% to 5%. The use of Drug Elution in the AVF has not yet been investigated. METHODS We propose a multicentre, randomised control trial, comparing AVF stenoses treated with standard angioplasty techniques to AVF stenoses treated with standard techniques plus a DEB. All trial patients will have their AVF stenosis treated by our current standard angioplasty protocol. In addition, the STUDY GROUP and will receive a DEB to the treated stenosis and the CONTROL GROUP will receive a sham balloon. Patients will be followed up with ultrasound of their fistula for one year to see if there is a difference in the rate of re-narrowing (restenosis) between the two groups.

*The aim of this study is to examine whether an innovative mobile health (mHealth)-enabled care program (MH-COPD) will improve patient self-management and relevant health outcomes. *We expect that the MH-COPD program would increase the self-management of COPD patients and consequently improve health outcomes.

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.