ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Review of manipulation under anaesthesia post total knee replacement with a view of redefining a lower threshold algorithm

    Stiffness post Total Knee Replacement (TKR) can cause quite significant disability in patients and is associated with persistent pain and inability to perform activities of daily living. Stiffness post TKR has been reported between 8 to 25 percent. The standard management for stiffness is aggressive physiotherapy followed by manipulation under anaesthesia (MUA) predominantly when patients' flexion range of movement (ROM) is restricted to less than or equal to 90degrees. MUA entails forced flexion and extension of the knee under anaesthesia to break the scar tissue causing stiffness, resulting in significant acute improvement usually around 5 to 6 weeks post primary total knee replacement. We propose decreasing that threshold of acceptable range of movement post total knee replacement in patients whom would otherwise deal with the restrictions and would not qualify for MUA under current guidelines. Patients will assessed 5-6 week post total knee replacement and those who have a flexion range less than or equal to "'pre-operative flexion' minus 20 degrees" will be included into the study. Patients selected for participation will be primary TKR patients that fall between 90 degrees and the "new range". Participants meeting selection criteria will be randomised into one of two groups; either 'intervention' or 'control' groups Results analysis will focus on range of movement and patient reported outcomes. We intend to follow up patients and record data for a period of 12 months. This will ensure capture of patients that require late manipulation for worsening function, depicted by manual assessment, patient outcome scores and other complications.

  • The RESOLVE Trial: Retraining the brain to reduce pain intensity of chronic low back pain

    The primary concern of people with chronic low back pain (CLBP) is pain relief, for which current treatments are not very effective. Our current understanding of pain and CLBP indicates that we should target the central nervous system in new treatment approaches. This project will test two new treatment approaches that target the central nervous system as part of the treatment of chronic low back pain. We predict that one of the new treatment approaches will result in a clinically meaningful reduction in pain intensity at six weeks post intervention

  • A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Left Ventricular Systolic Dysfunction following Myocardial Infarction.

    NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI). After someone has a MI, their heart ‘remodels’, which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI, so new drugs are needed. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling. It is hoped that NP202 will help to reduce the damage to the heart that is caused by a MI in humans.

  • 68Ga-PSMA PET-CT in biochemical relapse following primary treatment of Prostate Carcinoma (PCa)

    This study is investigating the sensitivity of Gallium 68 -Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) imaging in the detection of recurrent prostate carcinoma. Intention to treat analysis will be used to assess the impact of the 68Ga-PSMA PET on clinical management. Who is it for? You may be eligable for this study if you are over 40 years of age and have initial biochemical relapse, based on serum prostate specific antigen (PSA), following surgery or radiotherapy for prostate carcinoma, and have either no evidence of disease, or have oligometastatic disease (up to a maximum of four lesions) on current staging imaging. Study details: All participants in this study will undergo 2 68Ga-PSMA PET scans, 1 within a month of joining the trial and 1 six months later. These scans would not normally be part of routine care. The scans involve injection of a radioactive tracer. Participants will be followed up 3 months after the final scan to determine what treatment has been performed. This information will be used to evaluate the usefulness of the 68Ga-PSMA PET scans in detecting recurrent prostate carcinoma and determining how the scans affect clinical management. There are no additional appointments to attend outside your normal treatment visits except for the 2 PET scan visits, which should take approximately 2-3 hours. All followup data will be collected from your medical notes when you attend your routine treatment appointments.

  • Cabrini Scribe Trial - a pilot study of the relationship between emergency department scribes and emergency physician productivity using locally trained, Australian scribes

    There is a rising medical cost base in emergency medicine. There is a rising seniority of medical staff required to safely perform the role of physician in an emergency department. The currently accepted productivity of a FACEM is one patient per hour. Much of this time is spent writing and printing notes, faxing documents and contacting physicians. None of this work requires the skill set of an emergency physician and there is opportunity for work substitution, performed by a well-trained medical scribe or secretary. A pilot Cabrini ED study using an American trained and experienced scribe showed emergency physician productivity improvements of around 30%. A second larger Cabrini ED study, again using an American trained and experienced scribe showed variable improvements, overall an 18% productivity improvement (submitted for publication currently). There were no major safety/quality/risk issues with the use of these scribes. This offers emergency physicians the opportunity to increase productivity without compromising quality. The next step in using scribes is to establish whether it is possible to train local Australian scribes to perform the same role with the same level of competence as their USA counterparts and what the cost of this training will be.

  • 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.

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