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Assessing Safety and Treatment Efficacy of Running On Intervertebral Discs (ASTEROID)
The study will be a 12-week parallel randomised controlled trial. Participants with chronic low back pain will be randomised to either a digitally delivered progressive cardiovascular exercise training or waitlist control. Participants randomised to the progressive cardiovascular exercise training will receive three individually tailored 30 minute community based sessions a week over the 12 weeks. Individuals in the waitlist control will undergo no formal intervention and will be asked to manage their low back pain as usual. All participants will be assessed at baseline, six and 12 weeks. The primary outcomes of this study are intervertebral disc health, low back pain intensity and disability. It is hypothesised that the intervention will improve each of the primary outcomes when compared to control.
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NHL37 - A phase I/II study to assess safety of combining Glofitamab and Pirtobrutinib (LOXo-305) for treatment in patients with Mantle Cell Lymphoma (MCL) and prior therapy with a BTK inhibitor.
The purpose of this study is to evaluate the safety and efficacy of combination pirtobrutinib and glofitmab in patients with relapsed/refractory MCL and prior BTK inhibitor exposure. Who is this study for? You may be eligible to join this study if you are aged 18 or over and have been diagnosed with relapsed/refractory MCL. Study details: This study design involves phases for treatment ramp-up, fixed course combination and maintenance. Treatment Ramp Up 1. Pre-Phase (7 days): Pirtobrutinib 200mg oral daily. 1000mg of Obinutuzumab administered intravenously (IV) on D-7 and a second dose administered between Day 6 and Day 1 2. Cycle 1: Pirtobrutinib 200mg oral daily. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive dose-limiting toxicity is observed, including cytokine release syndrome (CRS), a lower initial dose of 1.25mg of glofitamab will be evaluated at "dose level -1". Dose level 1 (14 days): *Pirtobrutinib 200mg oral daily *2.5mg Glofitamab by IV on Day 1 *10mg Glofitamab by IV on Day 8 Dose level -1 (21 days): *Pirtobrutinib 200mg oral daily *1.25mg Glofitamab by IV on Day 2 *2.5mg Glofitamab by IV on Day 8 *10mg Glofitamab by IV on Day 15 3. Cycle 2 (21 days): 30mg Glofitamab by IV on Day 1 Fixed course combination phase Cycles 3-12 (21 days per cycle): Pirtobrutinib 200mg oral daily, 30mg of Glofitamab by IV on day 1. Maintenance phase Cycles 13+ (28 days per cycle): Pirtobrutinib 200mg oral daily. Glofitamab discontinued. Other testing that will be performed includes physical examination, neurological examination, ECG and monitoring of adverse events. It is hoped that this study will provide evidence for the safety of pirtobrutinib and glofitmab used in combination for relapsed/refractory MCL patients.
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Vitamin blood levels and severity of foot ulceration
We are aiming to assess whether there are any correlations between serum levels of vitamin C, vitamin D or zinc in relation to foot ulceration. Patients will be recruited from Blacktown high risk foot service and blood tests are completed as part of routine care. Ulcer sizes are measured at each visit which is anywhere between 1-4 weeks apart. The ulcer size is measured using a Silhouette Star camera (ARANZ medical) and will be correlated to their serum blood levels.
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Optimizing the clinical effectiveness of dual site Theta Burst Stimulation (TBS) treatment for individuals with depression (OPTI-TBS; Study 2)
Transcranial magnetic stimulation (rTMS) has been established as a safe, effective and well-tolerated treatment for depression in patients who do not get better with other therapies. Although rTMS is an effective treatment, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to both enhance and accelerate treatment response including helping to develop the use of a novel form of rTMS, intermittent theta burst stimulation (iTBS), which can be applied in a far more efficient manner. The overall objective of this research is to try to maximize the number of patients who respond to treatment and to ensure that these benefits are achieved as quickly and as efficiently as possible. This project aims to optimise the application of TBS therapy by exploring whether enhanced outcomes are achieved with a dual site stimulation protocol (as opposed to the standard TBS treatment protocol which targets one site of the brain only).
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BioSpine: multimodal rehabilitation for individuals with complete chronic spinal cord injury
Approximately 20,800 Australians are living with a spinal cord injury (SCI) and 350-400 people sustain a new spinal cord injury each year. Of these injuries ~80% are due to traumatic injury and just under half are from motor vehicle accidents. Most therapies offered for people with spinal cord injury involve passive movement of the limbs, but these approaches result in only small benefits. A robust rehabilitation alternative is available, and it includes combining the effect of multiple rehabilitation technologies. Current evidence suggests that electrical stimulation of muscle, brain-computer interfaces, virtual reality, exercise, and anti-anxiety drugs could partially restore movement and sensation in people with spinal cord injury. This research involves assessing the long-term effects of this new type of rehabilitation on motor and sensory function of people with complete spinal cord injury. We hypothesise that the proposed intervention will result in clinically measurable improvements in participants' motor and sensory function, as assessed by the American Spinal Injury Association (ASIA) impairment scale (AIS).
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First in human clinical study of a novel drug JNT-517 to assess its safety and tolerability, effects of food intake and to compare JNT-517 levels when taken as an oral suspension and tablet formulation.
This will be a phase 1, first-in-human, open-label, 3-period, 3-treatment crossover design study to evaluate the food effects and relative bioavailability of 2 formulations of JNT-517 in 12 healthy participants.
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Optimising Adherence Pilot Program: Investigating the impact of a novel intervention on the incidence of trismus during radiotherapy for head and neck cancer patients
This study aims to explore how we can improve adherence to trismus exercises during radiotherapy for head and neck cancer Who is it for? You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you will be treated using radiotherapy. Study details Control: participants will receive standard care, which involves attending their usual weekly/fortnightly sessions with a speech pathologist where they will be encouraged to complete stretching exercises. Intervention: participants will attend a pre-radiotherapy education and training session which teaches them the importance, relevance and skills to assess their mouth opening and complete their exercises. Daily reminders will be sent to help remind them to complete their exercises during their radiotherapy and weekly face to face sessions with speech pathology will review progress and modify exercises within individualised program. Data on changes in jaw opening distance and quality of life will be collected over a 12 month period. It is hoped that this study will demonstrate that providing information and support improves adherences to mouth opening exercises, which could lead to an improvement in quality of life for these patients.
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Effect of multifocal spectacle lenses on eye length and other ocular parameters in human.
Myopia or nearsightedness is characterized by elongation of an eye length that is greater than normal. The prevalence of the condition is high (>90% of young adult Taiwanese are myopic) in many parts of the world and rising elsewhere. Higher levels of myopia lead to several sight threating complications such as retinal detachment, glaucoma and cataract. Myopia is associated with a significant economic and health burden. There exist treatment strategies that can slow the progression of myopia in children. Evidence suggests that ocular growth and refractive development is sensitive to visual signals including optical defocus. Imposing hyperopic defocus (i.e., have the image plane fall behind retina) can lead to ocular elongation whereas myopic defocus was found to slow ocular elongation in chicks, guinea pigs, and monkeys. Spectacle and contact lens designs incorporating segments or sections of the lens devoted to myopic defocus were seen to significantly reduce myopia progression in children. Interestingly, observations indicate that wearing range of multifocal lens designs may slow myopia progression compared to wear of full field negative lenses. Thus, there is a need to better understand the response of a human eye to multifocal lenses to determine if there are differences in responses to different types of multifocal lenses. PRIMARY AIM: To investigate changes if any in axial length (central and peripheral) of myopic eyes to short term (60 mins) wear of multifocal spectacle lenses. Secondary Aims: To investigate changes if any in, - refractive error (central and peripheral) - choroidal thickness - contrast sensitivity function Potential significance of study: The findings of the study will help understand the ocular response to different types of optical blur and may play a role in development and/or refinement of optical strategies to slow myopia.
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A randomised controlled trial of a wellbeing and resilience program for emergency service personnel/first responders, their significant others and their supervisors
First responders and emergency service personnel are exposed to significant stress and potential trauma in their roles and are at risk of significant mental health issues such as PTSD, depression and problematic alcohol use. Through three interconnected programs, the project aims to promote wellbeing and further strengthen resilience in first responders with a key goal of reducing the risk of mental health problems. The first program is an online wellbeing and resilience program for police and fire service members in their first five years of service, supported by a wellbeing ‘coach’ who checks in regularly during the program. This is supported by a parallel program tailored for members’ significant others, the 'Be Well' program, while the third program provides supervisors with training and skills to promote good mental health and identify and work with members who may have mental health challenges. The project will evaluate key indicators of wellbeing and mental health, index cost-effectiveness of the programs, and conduct substantial follow-up of participants.
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Multi-centre Study to evaluate the Medacta GMK SpheriKA Total Knee survivorship (efficacy) following primary Total Knee Arthroplasty
The GMK® SpheriKA is a total knee replacement device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking. The purpose of the study is to assess the clinical effectiveness and survivorship of the GMK SpheriKA device. This will be achieved by; evaluating patient reported outcome measures (PROMs), clinical outcomes, radiological outcomes and survivorship. Medacta may use the results of this project in their application to the Prosthesis List Advisory Committee (PLAC) for assessment. The GMK SpheriKA is not yet listed on “the Prosthesis List”. A patient reported outcome measure (PROM) is defined as any report of a patient’s health status that comes directly from the patient without the interpretation by others. Incorporating PROMs not only enables the inclusion of this unique and critically important perspective of the patient’s opinion, but also broadens the range of outcomes that can be evaluated. With specific regard to joint replacement, PROMS can provide meaningful information on the extend of pain and disability prior to surgery, as well as the extent and timing of recovery and the presence of complications. The successful collection, knowledgeable interpretation and integration of PROMs with other outcomes can improve the benefit and cost effectiveness of health care delivery. The hypothesis is that the 2-year survivorship for the GMK SpheriKA knee system is not inferior to the survivorship rate of the other medial pivot knee designs.