ANZCTR search results

Behavioural and psychological symptoms of dementia (BPSD) can be extremely stressful for the individual, carers and staff and are a contributing factor for people admitted to Residential Aged Care Facilities (RACFs). This research will involve a RCT across multiple sites aimed at assessing the effectiveness and implementation of a clinical pathway (‘the pathway’) to reduce antipsychotic treatment and adverse events. This study aims to determine the effectiveness of the pathway for best-practice management of BPSD. A secondary aim is to better understand the feasibility of implementing the pathway in multiple RACFs. Research questions: • Does the pathway improve clinical outcomes for individuals with BPSD in RACFs? • What are the barriers and facilitators of successful implementation of the pathway across RACFs? This study will provide evidence to improve quality of care and quality of life for people living with dementia in RACFs. The primary hypothesis is that the number of antipsychotic prescriptions specific to BPSD will be lower for the RACFs that implement the pathway compared to control RACFs. Secondary hypotheses are: (1) the quality of life of participants will be higher for the sites that implement the pathway compared to controls; and (2) the incidence of adverse events, call outs for Dementia Support Australia/specialist referral, and hospitalisations will be lower for the sites that implement the pathway than controls. A process-evaluation will collect exploratory data on the implementation of the pathway in multiple sites.

The primary aim is to establish baseline and change quality of life (QoL) levels for up to one year in older adults who present to Eastern Health with a fragility hip fracture (HF). Secondary aims are: 1) to validate ACS NSQIP risk calculator in older Australians after hip fracture surgery; 2) assess the correlation of MMSE score to post-operative outcomes and HRQoL 3) evaluate the relevance of intraoperative/postoperative data relating to renal function, intraoperative hypotension, and postoperative S. troponin This study will be a prospective observational cohort study. Patients will be identified after presenting with a hip fracture and be assessed for eligibility by one of the team members. Patient recruitment will occur at Box Hill Hospital or Maroondah Hospital, depending on where the patient presents or is transferred to at the time of review. Eligibility criteria includes patients aged 65 years or older who present to Eastern Health for low-trauma hip fracture, including both operative and non-operative patients. Potential participants will be evaluated within 72 hours after admission and prior to surgery. The exclusion criteria include high-energy trauma, pathological fracture, patients receiving palliative care, a history of previous hip fracture on the same side, periprosthetic fractures, patients having not decided on participation prior to surgery or after 72 hours from the time of admission, patients and proxy respondents being unable or unwilling to give valid consent, including visual, hearing, mental incompetence and non- English speaking patients or proxy respondents. Patients who die or sustain a second fracture during the follow-up period will also need to be excluded from HRQoL and functional capacity analysis. Quality of life will be assessed using the EQ-5D-5L questionnaire. Functional capacity will be evaluated using the Barthel Index. Preinjury HRQoL and disability will be assessed at time of recruitment. Participants will then be followed up at 4 and 12 months by telephone.

Taurolidine-citrate solution has been used effectively as a catheter-lock device to reduce infection and blockage in central venous catheters and tunnelled peritoneal catheters and has been used intra-pleurally. This study aims to assess the safety of Taurolidine-citrate (TauroLock) in indwelling pleural catheters (IPCs).

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.

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.

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.

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).

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).

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.

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.