ANZCTR search results

This is a Phase 1/2, open label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and clinical activity of escalating doses of BOS-342 monotherapy in patients with Hepatocellular Carcinoma (HCC) or other Glypican 3 (GPC3)-expressing tumors. Who is it for? You may be eligible for this study if you are aged 18 years or older, have histologically confirmed diagnosis of locally advanced, unresectable or metastatic HCC for which no standard curative therapy is available or other Glypican 3 (GPC3)-expressing tumors. Study details There are 2 Phases in this study. In Phase 1, all participants will be enrolled into small groups. Each group will receive a dose of BOS-342 administered intravenously (IV) every 2 weeks until radiologically documented progressive disease (PD), unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the study treatment. There will be up to six different dose levels tested to identify the highest tolerated dose of BOS-342. In Phase 2, participants will receive a dose level and schedule that is deemed safe and tolerable as determined in discussion among the Sponsor, Medical Monitor, and Safety Review Team (SRT) in Phase 1. Observations related to safety including TEAEs occurring within and beyond the DLT window, tolerability, compliance, PK, pharmacodynamic, ADA and preliminary efficacy will be included in the rationale supporting the selection of the Recommended Phase 2 dose (RP2D). Safety, tolerability, PK and clinical activity evaluations will be assessed in both phases. After completion of the Safety Follow-up visit, patients will be contacted every 3 months for survival status following the last dose of study drug. It is hoped that the information obtained from this study may help treat and improve the survival of future patients with HCC and other tumors

Research question: Is it effective, feasible, and acceptable to deliver FEP (CRAFT) online? The primary aims of this study are to a.) evaluate the effectiveness of an online delivery of FEP to family members with a loved one experiencing substance problems and mental health conditions; and b.) Feasibility - extent of exposure to FEP by participants (number& length of sessions attended). The secondary aims are to identify the factors associated with successful implementation as perceived by a.) participants, b.) clinicians & c.) referral agents; and 2. whether the person with substance dependence a.) engaged with health or substance dependence services in the period during which FEP was delivered and b.) reduced their substance use as reported by a participating family member.

This proposal targets retention of the aged care workforce by implementing a mindfulness program to increase staff resilience and work engagement, while decreasing stress and burnout. The intervention is the Mindfulness In Motion (MIM) program. This is an eight week online evidence-based mindfulness and yoga intervention. The program has been delivered to a range of health care staff across a variety of settings in the US. This project will be the first Australian study to deliver and evaluate the MIM program and the first in a residential aged care setting. We will work with a Tasmanian Aged Care provider to codesign a bespoke implementation strategy that will support the translation of the MIM program into five residential aged care facilities. We will use a type 2 hybrid implementation design to assess the effectiveness of a) the MIM program on staff outcomes (burnout, stress, work engagement, resilience and turnover) and b) the codesigned implementation strategy. This project aims to assess the potential for translating the successful MIM program into residential aged care services as a feasible and acceptable intervention to reduce staff burnout and enhance staff retention.

The aim of our study is to measure the effect of trunk inclination on partition respiratory mechanics and gas exchange in a cohort of obese and non-obese mechanically ventilated ARDS patients.

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.

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.

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.

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).

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

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.