ANZCTR search results

To investigate the acute effect of the UnderCool 2.0 cooling vest during high-intensity exercise in a heat sensitive MS population on; i) body temperatures and sweating, ii) feelings of exertion and hotness, iii) MS symptoms that are aggravated by heat, and iv) Concealability, comfort and functionality. With a controlled, cross-over design, 20 participants diagnosed with MS will complete four high-intensity interval cycling sessions on separate days including familiarisation and three experimental trials with participants wearing either; i) an UnderCool 2.0 cooling vest, ii) a CryoVest Comfort cooling vest (current evidence-informed practice), or iii) no vest. The exercise sessions will be high-intensity interval cycling sessions of 45 minutes in controlled conditions (22°C, 40% relative humidity). Exercise intensities will be standardised across all trials. It is hypothesised that compared to control, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 1) Attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 2) Attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 3) Reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency It is further hypothesised that compared to the CryoVest Comfort, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 4) Improve perceptions of concealability, comfort, functionality and intention to use 5) Similarly attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 6) Similarly attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 7) Similarly reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of durvalumab plus chemotherapy in patients with with extra-pulmonary small cell carcinoma. Who is it for? You may be eligible to join the study if you are aged 18 years and older and have recently been diagnosed with extra-pulmonary small cell carcinoma. Study details Participants will receive durvalumab and chemotherapy. Durvalumab is given by infusion every three weeks, and chemotherapy will be given by infusion every three weeks for the first 4 doses. After the combination completes, you will receive durvalumab every 4 weeks, for as long as you are tolerating the treatment well and the cancer is under control. Participants will undergo clinical assessments at 3-4 weekly intervals from first treatment until end of treatment. Safety and tolerability of treatment will be assessed at 3-4 weekly intervals. Health related quality of life during treatment will be assessed at 3-4 weekly intervals while on treatment and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that durvalumab and chemotherapy will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Health literacy refers to a person's ability to find, understand and use health information. Many studies show that people with lower health literacy also have poorer health outcomes, yet this is relatively unexplored among people with heart disease. The aim of this research project is to see if health literacy affects people’s future hospital admissions, the cost of health care, and their quality of life following a heart attack. The study findings may help us identify how best to address health literacy barriers to lifestyle change following a heart attack.

The purpose of the study is to evaluate whether a specific AI technique (multi-arm contextual bandit combined with an adaptive group sequential study trial design) can be used to efficiently identify how well interventions work in a multi-arm randomised controlled trial in a mental health context. To test this idea, the study is comparing the effectiveness of three brief self-guided smartphone interventions based on mindfulness, physical activity and sleep hygiene, and an active control of mood monitoring (i.e. ecological momentary assessment), in reducing self-reported psychological distress in university students. Based on past research, we hypothesise that the mindfulness and physical activity conditions will be more effective than the sleep hygiene and active control conditions. We hypothesise that the novel method used in this study will be able to efficiently determine the effectiveness of the interventions.

Approximately 25% of all medicine is broken down by liver enzymes called CYP2D6 and CYP2C19. In many people these enzymes work more slowly than normal causing particular medicines to accumulate in the body at concentrations higher than intended. In some people these enzymes work too quickly, clearing some medicines before they can work. This type of testing is called precision medicine. Recommendations based on a genetic test may suggest an increase or decrease in medication or that a medicine not be used and that an alternative be prescribed. Numerous genetic studies have shown that a significant number of prescribed medicines are ineffective or cause negative side effects. This study aims to improve the genetic methods used to guide and inform medicine prescriptions. Precision prescriptions may reduce side-effects and increase symptom relief for many individuals. In the main research project, the randomised controlled trial (phase 2) of the Precision Medicine Pathway, we are testing whether genetic testing which determines how well the liver processes medication when given to the participant and their psychiatrist, actually influences any changes in prescribing and in so doing reduces psychiatric symptoms, improves the severity of the illness and quality of life. Understanding a person’s genes may be able to explain why some people respond to a treatment, while others do not, or why some people experience a side effect and others do not. In this second part of the research project we would like to talk to some of the participants, their carers and the research and clinical mental health staff involved in the project to learn whether the genetic information was beneficial or not, and whether there were any barriers or difficulties being involved in the process of the Precision Medicine Pathway including saliva collection, filling in questionnaires, and receiving the information from the genetic testing. We would also be interested in whether any improvements could be made in any of these processes.

This 12-month pilot trial at Southern Adelaide Local Health Network Emergency Departments (EDs) will build upon the successful ED-SAFE trial in the United States which reduced the number of people attempting suicide in the 12 months after discharge from 8 hospital EDs. The interventions included post ED phone counselling and involvement of a family member over a 12 -month period. The Southern Adelaide mental health team have implemented post ED Improving Access to Psychological Therapies (IAPT) phone delivered cognitive behaviour therapy (CBT) at the Flinders Medical Centre, which has resulted in a 59% recovery rate for anxiety and depression. IAPT was also used for the Beyond Blue New Access project with nearly 4000 participants achieving recovery from anxiety and depression of 68% with no suicides . Surprisingly few trials of suicide prevention have included a family member. In this pilot trial, the intervention (IAPT-M), provided over 6 months will consist of 3 evidence-based modifications to standard IAPT: a) 7 sessions of guided self-help CBT focussing on suicidal ideation and problem solving, b) 4 sessions involving a family member, and c) personalised text messaging and use of Mindtick app to monitor mood and activity In this 12-month study period, 10-15 people with suicide attempts presenting to an Emergency Department will be offered a 6 month intervention (IAPT-M) followed for a study period of 10 months with the primary outcome being suicidal ideation and suicide attempts. This phone delivered service can be scaled up to be provided to any Emergency Department in Australia.

The Daughters and Dads basketball Program is a sport-specific variant of the highly successful ‘Daughters And Dads Active and Empowered program’. Specifically, the program aims to engage fathers in positive lifestyle role modelling and effective parenting strategies to improve their daughters’ skill proficiency in basketball, basketball enjoyment and participation, and social-emotional wellbeing. The purpose of this pre-post trial is to expand the evidence-base for Daughters and Dads Basketball from intervention testing to intervention replication (i.e., the first phase of translation research) using a quasi-experimental research design. The present study will investigate whether: a) Recruitment targets are achieved and program fidelity, compliance, satisfaction, and attendance is maintained, b) The impact of Daughters & Dads Basketball on daughters’: - Sport-specific skill proficiency (e.g., Basketball skills) - Enjoyment in the sport (e.g., Basketball ) - Intention to continue playing the sport - Long-term engagement in the sport

Lyndra Therapeutics is currently developing LAO capsules for weekly administration across therapeutic areas with certain medications for which simplified logistics of dosing and/or consistent pharmacokinetics (PK) or enhanced adherence may translate to improved efficacy and possibly better safety. The LYN-163ER capsule is designed to provide steady, extended release of ivermectin into the stomach by gradually eluting the drug from a non-dissolving form that stays in the stomach for approximately 2weeks. Central to this goal is the need for a dosage form capable of safely remaining within the stomach for 2weeks. Equally important are the requirements of safe passage into the stomach after swallowing: opening of the capsule in the stomach to release the formulation (stellate), controlled drug release, and safe exit and passage out of the stomach and through the intestinal tract. This single ascending dose study will evaluate the safety, tolerability, pharmacokinetics (PK) of LYN-163in healthy individuals. The PK of ivermectin will be assessed. Data from this study will be a key indicator of feasibility of the product concept and will inform formulation optimization and dose selection for further development. This study will enroll individuals who are in good health. Healthy volunteers are most suitable for providing the initial characterization of the LYN-163safety and PK profile after a single dose. This is an open-label study that will enroll 3 cohorts, each with 5-10 participants. Cohort 0 had 5 participants and cohort 1 and 2 will have 10 participants in each cohort. Cohort 1 and 2 will include 2 participants in a sentinel group and 8 participants in a main group. In each cohort, safety data through Day 5 post dose for both participants in the sentinel group will be reviewed by the Investigator before enrollment of participants in the main group begins. Enrollment of sentinel participants in Cohort 2 will not begin until review of safety data through Day 5 post dose from both participants in the sentinel group in Cohort 1.

This pilot study aims to determine the feasibility of running a larger, multi-centre randomised controlled trial comparing the effectiveness of the UPLIFT program as a treatment for persistent back pain when compared to usual physiotherapy care. Primary outcomes: feasibility (recruitment, retention, intervention delivery) and acceptability (patient satisfaction and semi-structured interviews). Secondary outcomes: Clinical efficacy and cost effectiveness of the UPLIFT program compared to usual care physiotherapy. Participants will include patients aged over 18 years who have been referred to the Gold Coast University Hospital Neurosurgical Screening Clinic (NSC) service with low back pain of >6 months’ duration. 60 participants (30 per group). UPLIFT was developed in response to a need for alternative treatment modalities for people with persistent low back pain at Gold Coast University Hospital. A large cohort study indicated the UPLIFT program to be effective for managing this population. Another advantage is that it is delivered in a group-based format which increases cost effectiveness, by increasing the consumer to clinician ratio. The UPLIFT model of care could become the standard model of care for this cohort of patients state-wide in Queensland and even nationally. The UPLIFT program has been part of standard practice within the Gold Coast University Hospital Neurosurgical Screening Service for the past four years, with no adverse events occurring within this time. The proposed research project involves no changes to standard practice, except participants will be required to complete additional questionnaires imposing an additional but small imposition on their time. The requirement of completing additional questionnaires is also explained in the informed consent procedure. Given the trial involves people experiencing persistent pain, there is a possibility that participants will experience a transient increase in symptoms following exercise, however this possibility is no greater than what occurs with usual care. Experienced clinicians with expertise in managing this population group are leading this project and delivering the UPLIFT program (Experimental group) and physiotherapy care (Control group).

This is a Phase 1 study. This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EQ121 following oral single (Part 1) and multiple (Part 2) ascending dose administration in healthy subjects. Approximately 104 adult healthy volunteers.