ANZCTR search results

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

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32105 results sorted by trial registration date.
  • Get A Grip: Spinal stimulation for upper limb and respiratory function in incomplete tetraplegia

    Fifty five percent of all spinal cord injuries result in tetraplegia with impaired motor and sensory function of arms, hands, legs and respiratory muscles. For people with tetraplegia, restoration of hand and arm function ranks highest of all functional recovery targets, closely followed by improved breathing and coughing. Exercise training is the main treatment for improving upper-limb and respiratory function after spinal cord injury. Emerging evidence from pre-clinical and clinical studies suggests transcutaneous spinal cord neuro-stimulation (TSS), increases spinal cord excitability through increased reflex input. The aim of this study is to explore the efficacy, safety, and acceptability of TSS combined with exercise training for chronic tetraplegia, targeting hand and respiratory function. The study will be a multi-centred community-based adaptive Bayesian Optimal Phase (BOP) II trial design across Australia. A BOP trial design allows for early analysis, identifying and ceasing trial arms that prove to be futile to continue. We hypothesise participants with incomplete tetraplegia will improve in their strength and breathing outcome measures, to reach the pre-determined signal of benefit.

  • Acceptability of a 12-week movement program (Motum) to address functional outcomes in people with chronic non-specific low back pain: a mixed methods pilot study

    The purpose of this study is to assess how acceptable those with NSLBP symtpoms find the Motum program to be as in intervention to improve their function and pain. After participating in the Motum program (a ground based exercise class, 12 x 1 hour classes, 1 per week), participants will complete the questionnaires listed previously and the YBT as outcome measures.

  • A Randomised, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Elderly Volunteers. (Multiple Ascending Dose (MAD), Part 2 Cohort 5).

    This will be a single-centre, randomised, double-blind, placebo-controlled, and sequential cohort study to evaluate the safety, tolerability, PK and PD of multiple ascending doses of SIR9900 after oral administrations in healthy elderly volunteers. One cohort of male and female healthy elderly volunteers aged greater than or equal to 65 years in Part 2 MAD, at the time of screening are eligible for recruitment. Part 2 MAD participants will have a screening period of up to 28 days and be required on-study for approximately 3 weeks post-dose. SIR9900 is a potent and selective allosteric RIPK1 inhibitor being developed for the potential treatment of inflammatory, autoimmune, and degenerative diseases, particularly in the central nervous system.

  • Evaluating the patient experience of orthodontic treatment using virtual monitoring and digital technology for rural and metropolitan public patients in NSW.

    The study aims to trial a remote care model which should give remote patients earlier and better access to orthodontic care using their local dentist and an application, supported by an orthodontist remotely. This is a Quasi-Experimental trial to investigate the efficacy of a virtual care model, using artificial intelligence (AI) to provide orthodontic treatment by dentists to public rural and metropolitan NSW patients, while under the remote supervision of orthodontists, in comparison to conventional face-to-face treatment provided by specialists. Participants: Up to 90 patients, aged 8-18 years, who are eligible to receive orthodontic treatment in the public system and meet the orthodontic treatment severity criteria will be selected. Treatment will be done using aligners with Dental Monitoring (DM Group) and compared to treatment using aligners without DM (Positive Control Group) and conventional braces treatment without DM (Negative Control Group).

  • A monocentric, retrospective and prospective, non-randomised, clinical survey to evaluate Mpact cup performance 5 years following Total hip arthroplasty

    Mpact cup is a modular hemispherical press-fit acetabular shell with an external Titanium porous coating called Ti-Growth (Medacta commercial name: MectaGrip). The primary objective of this study is to evaluate Mpact clinical and radiological performance through modified HHS and standard X-rays. The secondary objectives are to evaluate five-year survival rate of the Mpact cup and to quantify and document any associated complications

  • A First-in-human Study of APG777 in Healthy Participants

    The purpose of the study is to assess the safety, tolerability and pharmacokinetics of APG777 following single and multiple subcutaneous (SC) administration to healthy participants.

  • RESHAP-ED: comparing primary-contact physiotherapy with standard care for musculoskeletal conditions in emergency departments.

    Musculoskeletal conditions, including low back pain, are among the top 10 reasons for presentation to Australian emergency departments (EDs). Current evidence have shown that timely access to physiotherapy in EDs reduces wait-time, and overall ED length of stay. Primary-contact physiotherapists have been present in some Australian EDs for approximately 20 years, however the level of service provision varies across sites and access is inequitable. This may be because strong evidence of effectiveness is lacking, i.e. predominately observational studies or trials of low quality. The RESHAP-ED trial will determine the effectiveness, cost-effectiveness, and scalability of a primary-contact physiotherapy service when compared to usual care (doctors and nurses service) in managing musculoskeletal conditions in the ED. Our hypothesis is that a primary-contact physiotherapy pathway in the emergency department, to assess and manage patients who present with musculoskeletal conditions, will reduce time spent in emergency departments.

  • A trial to assess the visual performance of myopia management contact lenses in adults

    The purpose of this study is to assess the visual performance of prototype contact lenses with a tinted edge pattern compared to commercially available single vision contact lens and myopia management contact lens.

  • Effects of a self-directed online Tai Chi program in people with knee osteoarthritis: randomised controlled trial (The RETREAT Trial)

    The trial aims to determine the effectiveness of a self-directed 12-week online Tai Chi program plus online educational information supported by the “My Exercise Messages” app on the primary outcomes of knee pain during walking and physical function at 12 weeks when compared to an online educational information control for people with knee OA. Following baseline assessment, participants (people with knee osteoarthritis who meet eligibility criteria) will be randomly allocated to one of two groups i) intervention - 12-week self-directed online Tai Chi program “MyJoint Tai Chi program” plus online educational information and an exercise adherence support app (“My Exercise Messages” app), or ii) control - online educational information alone. The intervention group will have access to a self-directed online 12-week Tai Chi program guided by an instructor delivering the program in a pre-recorded video format. The study hypothesis is that the Tai Chi intervention plus online educational information group supported by “My Exercise Messages” app will have greater benefits in improving pain and function compared to the online educational information group for people with knee osteoarthritis.

  • “Courage Quest” - A Digital Exposure-Focused Intervention for Children with Anxiety: A Pilot Case Series Intervention Study

    The overarching goal of this research is to develop and evaluate a digital exposure-focused intervention (the Courage Quest intervention) for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Does the Courage Quest intervention reduce high levels of anxiety symptoms and result in greater remission of anxiety disorders for children aged 8 to 12 years? We aim to evaluate this through a pilot case series intervention study. The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. The intervention will be pilot tested using a case series intervention design, the outcomes from which will refine the intervention. The study hypothesis is that there will be clinically significant reductions in children’s anxiety symptoms and disorders (parent and child reported) after completion of the intervention.

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