ANZCTR search results

This experimental study aims to investigate the effects of presenting diagnostic accuracy information from real-world studies, and of using health literacy sensitive text for RAT instructions, on people’s decisions to self-isolate and take other preventative measures. Australian adults aged 18 years and over will be sampled. They will be presented with 5 different hypothetical scenarios and asked a number of survey questions investigating knowledge, understanding, decision making, risk perception and behaviour to prevent onward spread. RAT instructions that are easier to understand and include real-world estimates of accuracy may help users to interpret RAT results and to take appropriate actions.

When conservative treatment fails for constipation or faecal incontinence, biofeedback and pelvic floor health therapy are two different management options. These two modalities are often thought to be similar by some physicians due to both employing components of pelvic exercise. However, these two modalities have very distinct programmes and are usually delivered by different health care professionals (nurses versus physiotherapists). Despite this, no randomised controlled trial has been performed to date to compare them for both indications. This study aims to investigate any difference in outcome between the two modalities.

Older drivers have relatively high crash rates and are increasing in number. We aim to evaluate the relative effectiveness and cost-efficiency of interventions for older drivers over a 12 month period. A randomised control trial comparing driving lessons, personalised feedback on driving skill, and a road-rules refresher workshop will be conducted. If effective, interventions will improve driving safety, reduce costs associated with crashes, and maintain social participation.

The aim of this study is to assess the feasibility, safety, and efficacy of autologous GD2-specific chimeric antigen receptor-expressing peripheral T cells (GD2-CAR T cells, a blood transfusion derived from the patient’s own cells) in patients with recurrent GD2-positive glioblastoma multiforme. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have histologically confirmed glioblastoma that is recurrent, and your tumour stains positively for the marker GD2 on biopsy. Study details All participants will undergo collection of peripheral T cells by apheresis (i.e. removing whole blood from a vein) to manufacture the GD-2 CAR T cells. If manufacture of the therapy is successful, the participant will receive a single treatment of GD2-iCAR-PBT intravenously at an initial dose of 1 x 10^8 cells/m^2. For 8 weeks following the GD2-CAR T cell infusion, participants will be assessed for any toxicities from the treatment, and at 8 weeks post-injection their initial tumour response will be assessed using brain MRI. If determined to be safe and effective, subsequent participants enrolled into the study may receive a higher starting dose of GD2-iCAR-PBT, to determine the maximum safe dose of administration. All participants will be monitored for up to 1 year post-enrolment for efficacy of the treatment using brain MRI. It is hoped that this study may help us find the dose of administration of GD2-CAR T cell therapy that produces the greatest tumour response with the least toxicities for the treatment of glioblastoma multiforme. This may help to direct treatment of other patients with this tumour in future.

So far, very little research has looked at the ways we can help young people with traumatic brain injury (TBI) overcome their anxiety. This study will evaluate an online delivered intervention program based on the acceptance and commitment therapy (ACT) for managing anxiety in adolescents with TBI. We will compare two groups: (1) intervention and (2) usual care control. Following completion of the intervention, we expect participants in the intervention group will demonstrate reduced anxiety and improvement in other areas of psychological well-being. The results of the study will contribute to the evidence base for the clinical management of anxiety for young people with TBI.

In this randomised, double-blind, placebo-controlled study, 116 recreationally active adults will be randomly assigned to receive capsules containing either a fenugreek extract (IDM01) (500 mg once daily) or a placebo for 8 weeks. We will assess changes in self-perceived fatigue. Moreover, participants will complete an exhaustive aerobic exercise task at baseline, week 4 and week 8, and we will examine group differences in self-reported exhaustion, motivational states to exercise, and mood before and after the exercise task. Will we also examine changes in attention, vigilance and concentration after this exercise procedure using computer-based cognitive tasks.

The aim of this study is to assess the immune response to the SARS-CoV-2 vaccines and the prevalence of antibodies (anti-PF4) associated with development of a rare complication of SARS-CoV-2 vaccination, thrombotic thrombocytopaenia syndrome, in patients with blood cancers compared to an elderly control population from primary care. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a haematological disorder (including chronic lymphocytic leukaemia, lymphoma, other B cell lymphoproliferative disorders, myeloma, monoclonal gammopathy of undetermined significance, and myeloproliferative disorders) or are immunosuppressed, and are eligible to receive or have received at least 3 doses of an intramuscular SARS-CoV-2 vaccine (including Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax) or the subcutaneous vaccine (Evusheld) as per current Australian Government Vaccine Guidelines. You may also be eligible for this study if you are aged 18 years or older, presenting to primary care without haematological disorders and have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines. Study details All participants will undergo SARS-CoV-2 vaccination in accordance with Australian Government Vaccine Guidelines. For those receiving intramuscular vaccination, a single blood sample for the assessment of immune response and antibody formation will be collected between Days 30 to 120 post 3rd or 4th vaccination, 6 months post 3rd or 4th vaccination (or immediately prior to additional booster vaccination), and between Days 30 to 120 post 4th or 5th vaccination. For those receiving subcutaneous vaccination, a single blood sample will be collected up to 7 days prior to vaccination and at Days 20 and 30 post-vaccination. At these timepoints, clinical reviews will also be undertaken to determine haematological malignancy diagnosis, baseline characteristics of independent variables (e.g., previous treatments) and blood parameters (e.g., full blood count). It is hoped that this study may help to determine the immune response to the SARS-CoV-2 vaccination in this vulnerable group of patients, and will inform formulation of guidelines and treatment protocols for SARS-CoV-2 infection in the general population and immunosuppressed haematology patients.

Type 1 diabetes (T1D) requires intensive insulin management to maintain blood glucose levels in the normal range. Access to specialist care is vital for optimal management. Without optimal management, serious complications develop including blindness, kidney failure, heart attack, strokes, nerve damage and early death. HbA1c is a blood test that reflects blood glucose levels over a 3 month period and is a good indicator of risk of diabetes related complications. Many young people with T1D in rural New South Wales have limited access to specialist care. The John Hunter Children's Hospital (JHCH) in Newcastle, NSW have developed a diabetes management program (Success with Intensive Insulin Management (SWIIM)) and achieve among the best diabetes related outcomes in Australia. In this research we will implement the SWIIM program in two centres in rural New South Wales and assess its impact on diabetes related outcomes and treatment satisfaction.

This is a randomized, double-blind, placebo-controlled dose-escalation study to evaluate the safety, tolerability and PK of ACT004 after administration of single (Part A) and multiple (Part B) oral doses in healthy adult subjects. Approximately five sequential dose cohorts (single oral doses of 100, 200, 400, 600 and 800 mg ACT004) will be evaluated as single ascending doses (SAD) in Part A. Select appropriate dose cohort(s) (seven consecutive days for respectively daily oral) based on the Part A and safety review committee (SRC), which will be evaluated as multiple ascending doses (MAD) in Part B. For each dose cohort in this study, ten healthy subjects will be randomized in an 8:2 ratio to receive either ACT004 or placebo in SAD and MAD. Based on the safety, tolerability, and PK data of the previous dose cohort, the SRC will make decisions on whether to proceed with dose escalations, dosage adjustments, use of sentinel subjects or termination of the study, etc. Higher dose cohort(s) may be attempted additionally if judged necessary by the SRC. Safety data up to Day 7 in SAD study and up to Day 14 in MAD study will be reviewed prior to dose escalation by the SRC. Dosing will be escalated in a sequential fashion if approved by the SRC. Dose escalations will be terminated when there are 1/2 or more subjects with grade 2 adverse events (AEs), or 1/3 or more subjects with grade 3 AEs, or 1 or more subjects with serious adverse events (SAEs) related to the study drug in the current dose cohort. Each subject will receive only one dosing regimen in this study. The proposed doses/dosing frequency of ACT004 may be adjusted over the course of the whole study, and cohorts may be added or removed depending on the exposure of ACT004 in humans. For the safety of subjects, two sentinel subjects will be randomly dosed (ACT004: placebo=1:1) at least 24 hours prior to the remaining subjects in each cohort. Once safety is confirmed, the remaining 8 subjects will be dosed in 7:1 to receive ACT004 or placebo.

Gastric emptying (GE), which exhibits a wide inter-individual variation, determines the rate of exposure of nutrients (including carbohydrates) to the small intestine, where they are absorbed into the circulation. Insulin-induced hypoglycaemia (~2.5 mmol/L) accelerates gastric emptying substantially in both health and diabetes. The major mechanism for lowering of postprandial glycaemia by GLP-1 receptor agonists is by slowing gastric emptying. Although GLP-1RAs themselves are associated with minimal risk of hypoglycaemia (since their insulinotropic effects are glucose-dependent), the risk of hypoglycaemia is increased substantially when GLP-1RAs, especially short-acting, are combined with exogenous insulin or insulin secretagogues. Our aim is to determine whether treatment with short-acting GLP-1RAs, attenuates the acceleration of gastric emptying during insulin-induced hypoglycaemia in patients with type 2 diabetes.