ANZCTR search results

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

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32902 results sorted by trial registration date.
  • The PLEUral Effusion Rapid Analysis using DIPsticks (PLEURADIP) Study: Evaluation of Automatic Urine Dipstick Analysis as a Point of Care Test

    Pleural effusion is the abnormal accumulation of fluid in the space within the chest wall but outside the lung. In Australia, approximately 60,000 patients are found to have pleural effusions each year, of which there are multiple aetiologies. Pleural fluid biochemical and cellular analysis remains the gold standard for diagnosis, including the classification into transudative and exudative effusions using Light’s Criteria, which compares serum to pleural fluid protein and LDH levels. However, pleural fluid laboratory testing can take several hours to return and results cannot therefore be determined during the same procedure. Commerical urine reagent strips are cheap, readily available in the hospital setting and can provide rapid results within 1-2 minutes. The purspose of this study is to test the utility of urine reagent strips as a point of care test for pleural effusions to differentiate between different pleural effusion types.

  • BioSpine 2.0: A multimodal non-invasive neurorehabilitation program for people with chronic spinal cord injury

    Spinal cord injury (SCI) causes partial or complete loss of movement and sensation below the level of injury, significantly affecting quality of life. Even when SCI appears clinically complete, most injuries leave some nerve pathways intact, creating an opportunity for recovery through targeted rehabilitation. BioSpine 2.0 is a multimodal rehabilitation program developed at Griffith University for people with chronic traumatic SCI. The program combines several non-invasive technologies: a brain-computer interface that reads the participant's intention to move, electrical stimulation of leg muscles and the spinal cord, a motorised arm and leg cycling ergometer, and an immersive virtual reality environment. When a participant thinks about cycling, the system detects this intention and activates the muscles and spinal cord with precisely timed electrical stimulation while the ergometer assists the movement. We hypothesise that repeated, coordinated activation of dormant nerve circuits, combined in some participants with a daily oral dose of buspirone hydrochloride (a medication that enhances spinal cord excitability), will promote the formation of new nerve connections around the injury site and lead to partial recovery of voluntary movement and sensation. The study consists of four consecutive 6-month programs, with participants attending 2 to 3 sessions per week. Primary outcomes are recovery of motor and sensory function, measured using standardised clinical assessments at the start and end of each program

  • New physiotherapy treatment for older people with lumbar spinal stenosis that causing leg symtpms

    Lumbar spinal stenosis (LSS) with neurogenic claudication is common in older adults, characterised by leg pain, heaviness and weakness when standing and walking. LSS-related neurogenic claudication is caused by a narrowed spinal canal that compromises the spinal nerves. While many people undergo surgery for this, most manage their symptoms through non-surgical care. Interestingly, medical imaging often shows spinal narrowing even in people without symptoms. Research suggests factors including spinal movements, psychological distress, and cardiovasular health play an important role. Importantly, these factors can be modified with target conservative treatments. We have developed a personalised multimodal physiotherapy intervention, including patient education, lifestyle modification, specific exercises, manual therapy and cardiovascular exercises. This pilot study will explore potential effect of this approach in three patients with LSS-related neurogenic claudication. People who are interested in the study will complete an online eligibility survey. Potential participants will be invited to attend an initial physioptherapy assessment to confirm their eligibility and eligible participants will be enrolled in the study. Initially, participants will complete online pain questionnaire daily for one to two weeks to establish baseline. They will then attend seven weekly physiotherapy sessions delivered a trained physiotherapist and perform guided home exercises. Participants will record daily online pain questionnaires after completing the treatments for up to 6 weeks. Patients and physiotherapist will be interviewed to understand how the intervention is received and delivered. This study will provide pilot data for a future large study to conduct a full investigation of this new intervention.

  • Public health physiotherapy pathways for anterior cruciate ligament injury

    This study aims to determine whether it is feasible to conduct a larger trial evaluating a physiotherapist-led education and supervised exercise-based treatment pathway for people with an anterior cruciate ligament (ACL) injury. The study will compare three approaches: usual care alone, physiotherapist-led education plus usual care, and physiotherapist-led education with supervised exercise plus usual care. The main focus is to assess whether participants can be successfully recruited and retained, whether they adhere to the program, and whether the interventions are acceptable to patients and clinicians. The study will also collect preliminary data on outcomes such as ACL reconstruction surgery rates and patient-reported outcomes to inform the design of a future trial. Ultimately, this research aims to evaluate whether adding education and exercise-based rehabilitation to usual care can reduce the number of people undergoing surgery without negatively affecting patient outcomes.

  • Feasibility of a physiotherapy-led outpatient model of managing sleep apnoea in people with spinal cord injury

    Over 80% of people living with spinal cord injury (SCI) have sleep apnoea. This study will investigate the feasibility of a novel physiotherapy-led outpatient model for identifying and managing sleep apnoea in SCI. People attending outpatient clinics of two state-wide SCI services (Victoria and Queensland) will be screened for risk of sleep apnoea. Those at risk will be referred to a highly trained neuro-respiratory physiotherapist, located within the health service and supported by a respiratory specialist, for ambulatory investigations and management. A thorough process evaluation will assess the feasibility of this alternative care model and estimate the impact on important clinical outcomes.

  • Tranexamic acid bladder instillation for blood in the urine requiring bladder irrigation: a randomized controlled trial

    This is a triple-blind, randomised, placebo-controlled trial investigating whether a single intravesical dose of tranexamic acid (TXA) reduces the duration of continuous bladder irrigation (CBI) in adults presenting to the Emergency Department with macroscopic haematuria. Macroscopic haematuria (blood visible in urine) can cause clots in the bladder, leading to urinary obstruction that requires a bladder catheter and CBI. TXA is a medicine that helps stop bleeding by preventing clot breakdown. Adults aged 18 or over with macroscopic haematuria requiring CBI will be randomly assigned to receive either 1000mg TXA in 100ml saline or a placebo (100ml saline alone), instilled into the bladder via urinary catheter and clamped for 15 minutes before CBI starts. Neither participants nor treating staff will know which treatment is given. The main outcome is how long CBI is needed. Secondary outcomes include hospital admission rates, emergency department re-presentations, catheter duration, and safety outcomes including venous thromboembolism. 80 participants will be recruited across four Emergency Departments in the Illawarra Shoalhaven Local Health District, NSW, over 12 months.

  • Investigating the use of humidified high flow therapy (supplemental oxygen optional) in the home setting for patients with existing lung disease (Chronic Obstructive Pulmonary Disease (COPD) or Bronchiectasis). The DOMINO Study

    This randomised controlled feasibility trial will evaluate domiciliary Humidified High Flow Therapy (HHFT) in patients with COPD/Bronchiectasis. The primary aim is to determine the feasibility of a larger adequately powered trial and explore potential effects on exacerbation frequency, patient comfort, quality of life, and hospital admissions. Sixty participants will be recruited from respiratory inpatients/outpatients across two sites and randomised (1:1) to HHFT plus standard care or standard care alone. Intervention participants will use HHFT overnight where possible, or for a minimum of four hours per twenty-four hour period. Participants, once recruited will be discharged home or transferred to Hospital in the Home (HiTH) and will be followed at weeks 1-3 by telephone, week 4 face-to-face and month 2and 3 (study completion) by telephone. Adverse events and device performance will be monitored throughout the study period.

  • CLEAR-TKR: Chronic biofilm Local Eradication with Anti-biofilm Regime in Total Knee Replacement

    evaluating the safety, tolerability, and proof-of-concept efficacy of the investigational production BromAc® administered intra-articular in addition to standard-of-care suppressive antibiotic therapy. Participants will be followed for 90 days with clinical, laboratory, and patient-reported outcome assessments. It is hypothesized that BromAc will be safe and tolerable, with potential improvement in symptoms

  • Artificial Intelligence-Driven Hearing Aids for Auditory Neural Disorders for individuals 12 years and above

    This study explores how advanced hearing aids using artificial intelligence (AI) can help individuals with auditory neuropathy to better understand speech in noisy environments. The research will compare these advanced devices to traditional hearing aids by testing how well individuals hear and identify the location of sounds in a laboratory setting and during a eight-week trial. The goal is to determine whether AI-hearing aids provide better speech clarity and listening comfort in complex situations. The findings will help improve recommendations for individuals with auditory neuropathy and determine whether advanced hearing technology is more capable at enhancing communication than traditional technology. Individuals participating in the study will contribute valuable insights into the daily challenges of listening in noisy environments.

  • Shaping Dietary Treatment Expectations and Response in irritable bowel syndrome in participants undergoing a Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide and Polyol Diet.

    This research seeks to explore whether it is possible to modify treatment credibility and expectancy in patients undertaking a low FODMAP diet and assess if potential increases in treatment expectancy impact the diet's efficacy. It is expected that the use of optimistic realism and positive expectations as part of the dietary counselling will enhance dietary adherence, symptom response, quality-of-life response, and treatment satisfaction.

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