ANZCTR search results

This study aims to determine the efficacy and safety of low-dose cannabidiol for anxiety. Cannabidiol or CBD is a major component originally derived from the Cannabis plant and works on cannabinoid receptors. There are two types of cannabinoid receptors, CB1 mainly in the brain and CB2 mainly in the immune system. These two receptors help regulate things like sleep, mood, pain and more. This study will be investigating if low-dose CBD will improve anxiety when compared to a placebo or inactive drug. CBD has been used for a number of conditions but there are limited clinical studies for individual products and conditions. There is evidence that low-dose CBD is safe to use and the Therapeutic Goods Administration (TGA) has scheduled low-dose CBD (maximum of 150mg per day) as Schedule 3 or pharmacist only due to the acceptable safety and tolerability profile. There is evidence to suggest CBD is effective for anxiety but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for anxiety compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for anxiety then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.

This study aims to determine the efficacy and safety of low-dose cannabidiol for sleep disturbances. Cannabidiol or CBD is a major component originally derived from the Cannabis plant and works on cannabinoid receptors. There are two types of cannabinoid receptors, CB1 mainly in the brain and CB2 mainly in the immune system. These two receptors help regulate things like sleep, mood, pain and more. This study will be investigating if low-dose CBD will improve sleep disturbances when compared to a placebo or inactive drug. CBD has been used for a number of conditions but there are limited clinical studies for individual products and conditions. There is evidence that low-dose CBD is safe to use and the Therapeutic Goods Administration (TGA) has scheduled low-dose CBD (maximum of 150mg per day) as Schedule 3 or pharmacist only due to the acceptable safety and tolerability profile. There is evidence to suggest CBD is effective for sleep disturbances but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for sleep disturbances compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for sleep disturbances then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.

Resistance training safely improves a range of outcomes in older adults, with high-velocity resistance training (HVRT) the most effective at improving power and function in this group. Improving power generation with training such as HVRT is critical for older adults because muscle power is more important than muscle strength for physical function, dynamic balance and reacting to a loss of balance to prevent a fall. While HVRT is effective, the benefit of such training is partly dependent on maximising movement velocity. Providing augmented feedback during resistance training is effective at improving movement velocity, motivation, and functional performance in young adults, but the use of feedback during resistance training in older adults has not been studied. Feedback is an integral component of a physiotherapist’s tool kit to optimise interventions (e.g., providing verbal feedback during task practice) but evidence to support the efficacy of feedback during HVRT in older adults does not yet exist. The proposed study will be the first to identify whether providing augmented feedback during resistance training enhances movement velocity in older adults. Based on the established benefits of adding targeted instruction or feedback to other physiotherapy interventions, and the identified benefits of velocity-based feedback in young adults, it is hypothesised that augmented feedback will improve movement velocity during training. Improved movement velocity should translate to greater power adaptations and functional improvements. If feedback is effective at improving within session performance in older adults, the benefits may be transferrable to other physiotherapy settings such as rehabilitation where improving muscle power and function is a priority for most patients. Importantly, if feedback influences perceived exertion/motivation, this has positive implications for exercise adherence. The objectives of this study are to identify whether: a. providing augmented feedback during a resistance training session increases barbell velocity in older adults b. different types of augmented feedback (e.g., visual) optimise barbell velocity c. provision of feedback influences motivation and perceived exertion in older adults

This research project is testing the effectiveness of using pressurised fluid during flexible cystoscopy insertion in reducing pain. We know that the most significant pain is experienced during camera insertion. There is some evidence that a ‘bag squeeze’, which temporarily generates an increase in fluid pressure that can reduce a participant’s pain, it is unclear how much pressure during the ‘squeeze’ is ideal and it is not easily reproducible. Hence, we also will use pressurised fluid bags with a standardised pressure level to make this more reproducible for participants. Whilst fluid-pressure bags are commonly utilised other areas of Urology such as ureteroscopy, it would represent an experimental intervention for pain-reduction in Flexible Cystoscopy.

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.