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.
  • COMPARE - An evaluation of two different treatments compared to usual speech pathology in people with problems communicating after stroke.

    The study will compare different treatments for people with aphasia. Participants will randomly assigned to one of three treatment groups CIAT, M-MAT or Usual Care. Participants will attend baseline assessments, a two week treatment period, assessment immediately after treatment and further follow up assessment 12 weeks after completing the treatment. Participants randomised to the Usual Care group will be offered additional treatment at the end of the 12 week follow up period as part of an optional sub-study. In this sub-study participants will be re-randomised to receive either CIAT or M-MAT. They will attend treatment visits over five weeks with follow up assessments immediately after the treatment period and again at 12 weeks after completing the treatment. Study Hypothesis: Compared to usual care, both the study treatments (CIAT and M-MAT) will result in reduced aphasia severity .

  • Intensive rehabilitation after botulinum toxin-A injections in stroke.

    Impaired arm and hand function is a common and often devastating problem for stroke survivors. Regaining lost movement in the arm/hand is more difficult to achieve than walking, with only 5% of people with hemiplegia regaining functional use of their hand. This devastating outcome could potentially be addressed, however we do not yet know how to best increase movement in the arm and hand after stroke for patients with spasticity. There is a lack of randomized controlled trials of botulinum toxin A (BoNT-A) with a group who does not receive therapy in some dose, and so whether gains were achieved through BoNT-A or a combination of the BoNT-A and therapy cannot be determined from the studies to date.The research project is testing whether intense therapy given after botulinum toxin injections into the arm is more helpful than just the injections alone.

  • Postoperative Recovery After Abdominal Hysterectomy: A Randomised Clinical Trial of Methadone Compared to Morphine

    The aim of this study is to compare the use of intravenous methadone to morphine in improving quality of recovery, acute pain and reducing the risk of chronic pain after abdominal hysterectomy.

  • A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers

    This will be a single-center, two-period, open-label study to investigate the single-dose pharmacokinetics of PRN1008 when administered as a liquid formulation compared to a capsule formulation under fasted conditions. Participants will be screened for participation in this study within 28 days before dosing. Participants will be admitted to the study unit the day before dosing (Day -1), then dosed in the mornings of Days 1 and 3, and will remain in the clinic up to Day 4, after collection of the final PK sample. Participants enrolled will be randomized to one of the two possible orders in which the following treatments will be completed. Doses will be approximately 48 hours apart.

  • 12 weeks of exercise training and its effect on immune function and glucose regulation.

    40 participants will be recruited to complete a 12-week exercise training intervention which consists of either high-intensity intermittent exercise or continuous moderate-intensity exercise on a cycle ergometer. This study aims to determine the effect of exercise training on the changes in insulin sensitivity and the immune system as a result of a training adaptation over the 12-week period. This will be a parallel randomised group design which will include male participants between the age of 18-44 years old who are overweight (BMI greater than or equal to 25 kg/m2) but otherwise healthy (no previous history of type 2 diabetes or other immune-related diseases).

  • 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.

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