ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33073 results sorted by trial registration date.
  • Study of SBP-101 safety and tolerability in patients with previously treated pancreatic cancer

    The main goal of this study is to assess the safety and tolerability of the drug SBP-101 in patients with pancreatic cancer. 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 chemotherapy. Study details: Participants in the first part of this study (Phase 1a) will be administered SBP-101 in a dose-escalation scheme with cohorts at each dose level (0.05, 0.10, 0.2, 0.40, 0.80, 1.2, 1.6 and 2.0 mg/kg). All cohorts will receive injections of SBP-101 once daily Monday through Friday, for 3 weeks, followed by a 5-week rest period (3 weeks on and 5 weeks off = 1 cycle) for up to 5 cycles depending on response. Participants in the second part of this study (Phase 1b) will be administered SBP-101 at the maximum tolerated dose identified in Phase 1a for up to 5 cycles. SBP-101 is a small molecule which is similar to a compound, spermine, found naturally in human cells and important in cell survival / growth. Laboratory and animal studies suggest that SBP-101inhibits cell growth by substituting for spermine, suggesting that SBP-101 is a promising candidate for further development as a treatment for pancreatic cancer. 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 SBP-101 in the blood and urine over time and test whether SBP-101 can slow the growth of, or shrink tumours.

  • Assessment of shoulder proprioception using the Microsoft Kinect sensor

    The aim of this study is to design a system, using the Microsoft Kinect sensor, to assess proprioception at the shoulder. Proprioception is the ability to tell where your arm is in space and what it is doing without looking at it. Several different methods to assess proprioception have been outlined in the literature. These largely require expensive, specialised equipment, trained operators, and a large time commitment. We plan to make the Kinect System for Proprioception of the Shoulder (KSPS) portable, easy to use, accessible, and able to assess proprioception in the shoulder in a matter of minutes. Being able to accurately, easily, and quickly measure shoulder proprioception in a wide range of healthcare settings will help assess the treatment and rehabilitation of patients with injuries, assist with pre- and post-operative patient assessment, and evaluate the effectiveness of new shoulder treatments (surgical and non-surgical). The KSPS will be compared to 2 different, non-invasive assessment methods.

  • A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers

    The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of multiple doses of oral AD-6626 in normal healthy volunteers

  • Effects of testosterone and exercise (TEX) on fitness, physical activity and vascular health in men.

    This will be a 12 week, 2x2 factorial randomised controlled trial of the effect of testosterone treatment, with and without exercise training, on cardiorespiratory fitness, physical activity levels and vascular health and physiology (validated markers of cardiovascular risk) in men aged 50-70 years who have waist circumference 95 cm or more. The hypothesis is that 12 weeks of testosterone plus exercise training will produce additive beneficial effects on fitness, physical activity and measures of vascular physiology, compared to either intervention alone, or placebo. These results would inform the debate over the risks and benefits of testosterone therapy in men.

  • SMART CF - A smartphone application for reporting symptoms in adults with cystic fibrosis

    Cystic fibrosis (CF) is the most common Caucasian genetic disease and has a reduced life expectancy of approximately 40 years of age. The decline in lung function in CF is accelerated by exacerbations. Severe exacerbations require treatment with intravenous antibiotics (IVABs), but of concern many do not regain the lung function they have lost following treatment. One of the major factors in this failure to regain lung function is the delay in time it takes for the individual with CF to present to the CF centre to report symptoms and commence treatment. In collaboration with Curtin University and the Burke Rehabilitation and Research Institute in New York, USA, we have developed a smartphone application that can be used by participants to report their symptoms to the CF team at Sir Charles Gairdner Hospital on a weekly basis or sooner if they feel they need to. We will now aim to complete a 12 month randomised controlled trial in 60 participants, investigating the impact of using this smartphone application on the number of exacerbations requiring IVABs per participant, as well as other health outcomes and measures of healthcare utilisation.

  • The effectiveness of negative pressure wound therapy - PICO™ in the reduction of seroma formation following unilateral mastectomy, a case control study.

    Background Postoperative delayed wound healing impacts on patient wellbeing and return to normal life and can result in intrinsic and extrinsic complications. Unilateral mastectomy impacts on patient healing as well as body image perspective and is further complicated by the diagnosis of cancer. Aim of the study The purpose of the study is to determine the effectiveness of negative pressure wound therapy on seroma formation following unilateral mastectomy. Who is it for? The study is for females about to undergo an elective unilateral mastectomy that consent to be in the study. Study participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a negative pressure dressing applied to their wound for 7 days, whilst participants in the other group will receive a standard surgical dressing. Patients will be followed-up for up to 30 days postoperatively to determine seroma formation during the post operative period.

  • A trial of a novel attention bias modification paradigm on pain outcomes

    Attention modification training refers to training participants to attend away from emotionally relevant information. In the pain literature, ABM has been shown to improve pain outcomes. However, all research has used the dot-probe paradigm, the reliability of which has been questioned. This project aims to trial a novel ABM procedure using painful faces.

  • The effect of implicit versus explicit instruction on a cognitive bias modification task in relation to pain

    This study will investigate the effect of modifying interpretations of ambiguous faces on performance of a painful task. Specifically, we will compare how effective training participants to interpret an ambiguous facial expression as happy compared to painful. We are interested to know whether this training is more effective when instructions are explicit versus implicit.

  • Can a workplace-based exercise program reduce the risk of neck/shoulder symptoms for dental health students? A pilot study.

    With the tight work schedules of the dental workers, we propose that small daily doses of neck/shoulder specific exercise is an optimal approach to minimise the risk of neck/shoulder pain for these workers. This project will test the feasibility and benefits of a 10-week workplace-based exercise intervention in a population of dental health students in their clinical environment.

  • The effects of micro-osteoperforations on orthodontic root resorption and tooth movement - A pilot study

    A primary objective of orthodontic treatment is to achieve a functional and aesthetic outcome efficiently and with minimum root resorption. Preliminary research has shown promising results with micro-osteoperforations and accelerated orthodontic tooth movement. Being a relatively recent adjunct to orthodontic treatment, further research is required to gain insight into the effects of micro-osteoperforation on tooth movement as well as on root resorption. The aim of the proposed investigation is twofold. The first part consists of applying buccally directed orthodontic forces to the upper 1st premolars to compare the amount of root resorption that occurs with normal orthodontic tooth movement, with that which occurs with orthodontic tooth movement in areas treated with micro-osteoperforations. The micro-osteoperforations will be applied using a disposable appliance designed for this purpose by Propel Orthodontics. The Propel device is a TGA approved, FDA registered medical device specifically designed to create micro-osteoperforations. The second part consists of quantitatively measuring the rate of bodily canine retraction with normal orthodontic tooth movement, and orthodontic tooth movement associated with micro-osteoperforations. The hypothesis of this research project is that micro-osteoperforations will minimise orthodontic root resorption while allowing accelerated rates of orthodontic tooth movement. The proposed investigation will be a Prospective Cohort study involving 12-14 subjects. The first part of the project involves placing orthodontic braces only on the upper posterior teeth. Using a split-mouth design, one side will be randomly made control, while the other will be the experimental side in which micro-osteoperforations will be placed. Three perforations in a vertical alignment will be placed on both the mesial and distal aspects of the upper first premolar. Orthodontic force will be applied to the first premolars bilaterally for 4 weeks, after which the teeth will be extracted as part of the patient’s ongoing orthodontic treatment. These extracted teeth will then be scanned with a MicroCT scanner and the extent of resorption measured. Patients will also be asked to record their level of discomfort on the experimental and control side following the placement of braces and micro-osteoperforations. The second part of the study involves placing full braces on the subjects with 24 weeks of aligning and levelling teeth. After this period, another three perforations in a vertical alignment will be placed distal to the upper canine on the experimental side and the rate of canine retraction will be compared to the control side. Patients will be assessed and tooth movement measured off study models every 2-4 weeks, over an 8-week period. Conclusion: Root resorption is a significant consequence of orthodontic treatment. As micro-osteoperforations is a new adjunctive treatment to orthodontics, further research is needed to assess its effect on root resorption and to confirm its association with accelerated orthodontic tooth movement.

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