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An Interventional Trial for Persisting Post-Concussive Symptoms after Mild Traumatic Brain Injury
This purpose of this study is to examine whether new brain training regimes (active interventions) can influence brain function and reduce persistent post-concussion symptoms. This study will compare two different types of brain training to the “standard treatment”, which for mTBI is no treatment other than symptom management (control with no intervention). This will aid in determining whether people in the brain training groups have less symptoms because of brain training, or whether they would have had a reduction in symptoms anyway during that time.
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A trial of iCamperdown - an online treatment for adults who stutter.
Researchers at the Australian Stuttering Research Centre have developed an online speech treatment program—iCamperdown—for adults who stutter. iCamperdown is an online version of the Camperdown Program, an evidence-based treatment for adults who stutter. iCamperdown is designed to teach adults who stutter a way to learn to control their stuttering without seeing a speech pathologist. The purpose of this study is to assess the safety of the iCamperdown Program, to evaluate compliance and preliminary treatment outcomes.
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The effects of neuromodulation on sleep and cognition in healthy older adults: A proof-of-concept study
Ageing is associated with poor sleep which can contribute to cognitive decline. Non-invasive low current brain stimulation has been used as a method to enhance deep sleep in healthy adults and in some cases improve memory performance. However, intervention outcomes on sleep and memory were inconclusive across the different studies. This proof-of-concept study uses a new technique of brain stimulation which can target more specific brain areas compared to previous methods. This proof-of-concept study aims to evaluate the feasibility of applying high-definition slow oscillatory transcranial direct current stimulation (so-tDCS) in two brain regions – frontal and parietal, and assess the effects on slow oscillation activity during sleep in a middle to late aged healthy population. Participants will attend three in-person visits at the Woolcock Institute of Medical Research where they will receive low current brain stimulation during a nap. Participants will also complete cognitive tasks before and after the nap.
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An evaluation of early intervention using compression garments following neck dissection surgery for head and neck cancer and the impact on lymphoedema
Head and neck lymphoedema (HNL) is a chronic swelling (‘oedema’) that often forms following cancer treatment of the head and neck. People with HNL often experience difficulty breathing, speaking and swallowing along with impaired movement and increased psychological distress and reduced quality of life. Treatment for HNL is inconsistent due to a low level of evidence, no recommended standard of care guidelines and poor assessment protocols leading to the condition being under-diagnosed and under-treated. This parallel, pilot-randomised control trial will evaluate the safety, feasibility and indication of effectiveness of adding early compression garment wear to standard care through random assignment of compression garments to participants 1-2 weeks following hospital discharge from neck dissection surgery. Who is it for? You may be eligible for this study if you are aged 18 years and over, planned to undergo cancer-related neck dissection surgery at Fiona Stanley Hospital (FSH), with no history or presence of external HNL at baseline (assessed at time of recruitment), have not previously had neck dissection surgery, have not previously received radiation therapy to the head or neck, are not receiving treatment for another cancer or have no known cognitive impairment. Study details Participants will be randomised to either the experimental group or the control group. Participants in the control group will receive standard treatment and telephone consultation, while participants in the experimental groups will receive 2 head and neck compression garments, standard treatment and video consultations. Safety outcomes include incidence of adverse events. Feasibility outcomes include recruitment data, participant perception of acceptability of the use of compression garments and adherence data. Participants are asked to keep an e-diary to record how frequently they wear the compression garment and complete standard home care. Indication of effectiveness will be evaluated using lymphoedema incidence and severity, symptom severity, quality of life, anatomical changes and range of motion outcomes. It is hoped that the findings from this study will develop an understanding on the safety, feasibility and effectiveness of adding early compression garment wear to standard care to inform future research.
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The Youth Pain Course: A feasibility trial of an Internet-delivered psychological pain management program for adolescents with chronic pain
The primary objective is to evaluate the feasibility of an Internet-delivered psychology pain self-management program, the Youth Pain Course (YPC), for Australian adolescents with chronic pain. This will be achieved through the following aims: 1. Assessing the acceptability of the YPC, via levels of treatment engagement, adherence, and adolescent- and carer-reported treatment satisfaction. 2. Determining the potential efficacy of the YPC on improving disability, pain severity and emotional functioning, post-treatment and at 6-months follow-up. 3. Exploring the demographic and clinical moderators (predictors) of treatment feasibility, including acceptability, efficacy, and costs. 4. Completing a preliminary cost-consequence analysis examining the costs of the treatment to providers, adolescents, and their carers, in relation to a range of potential economic outcomes.
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Move to Improve: A single-arm, pragmatic feasibility trial of an individualised physical activity program for children with chronic conditions
This research aims to: (1) assess key implementation and sustainability indices of implementing an individualised physical activity program for children with chronic health conditions, (2) test preliminary effects of the individualised physical activity program on physical activity, health, and psychosocial outcomes, (3) determine the cost of delivering the program. Who is it for? You may be eligible for this study if you are a pediatric patient aged between 5 and 18 years with one of four chronic health conditions: type 1 diabetes, cancer, post-burn injuries, or cerebral palsy Study details The Move to Improve team will work with the child and family to develop an individualised physical activity program aligned with the participants’ goals. Participants will be encouraged to follow the program over the 8-week duration of the intervention. To support participation in the individualised program and address specific barriers to physical activity, the Move to Improve team will provide additional resources (e.g., information sheets) as required. Participants will receive weekly support as required and additional support from psychologist and dietitian if needed. The child's physical activity, quality of life, goal attainment, as well as other mental and physical changes, will be assessed at 6 and 12 months follow-up. It is hoped that findings from this study will support children with chronic health condition to be more physically active.
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Evaluating a co-designed shared care model of care on the quality of life of patients accessing gender affirming hormone therapy
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Effectiveness of a custom anaesthetic solution on postoperative pain in hand surgery: a pilot study.
This will be a pilot study to determine efficacy of combination clonidine, adrenaline, ropivacaine, lidocaine, dexamethasone combination in reducing pain, time to first opioid analgesia, and total opioid analgesia consumption postoperatively compared with combination lidocaine and ropivacaine. We hypothesise that the combination of the above medication will contribute to a longer lasting postoperative anaesthetic effect, such that patients will be more comfortable in the 24-48 hours post surgery, requiring less usage of opiate analgesia, and a quicker return to premorbid activity and function.
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A Phase 1, Single Centre, Open Label, Single Dose, Food Effect, Cross Over Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
The proposed clinical study will investigate taking the investigational product under fasted or fed conditions. The investigational product is a potential treatment for Coronavirus disease 2019 (COVID-19) patients with mild to moderate disease. It is anticipated that the proposed combination therapy will minimize disease progression and thereby lessen the risk of hospitalization and death.
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A Phase 1, Single Centre, Open Label, Multiple Dose Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
The proposed clinical study will investigate the safety of multiple doses of the IP over 10 days. This IP is being trialed as a potential treatment for Coronavirus disease 2019 (COVID-19) patients with mild to moderate disease. It is anticipated that the proposed combination therapy will minimize disease progression and thereby lessen the risk of hospitalization and death.