ANZCTR search results

The aim of this study is to investigate the effects different terminology for depression on hypothetical help-seeking intentions and psychosocial outcomes by presenting workplace stress and mental illness scenarios. We will also examine the impact of the different terminologies on self-stigma, perceived stigma from others, perceived severity and cognitive illness perceptions. Additionally, we will examine the impact of different terms used to describe therapist providing psychological support (clinical psychologist vs mind coach) on help-seeking intentions and psychosocial outcomes.

During pregnancy, one modality of ensuring the well-being of the fetus is by measuring the heart rate. At present, the mainstay of such fetal surveillance is carried out by utilising cardiotocography (CTG). The CTG utilises Doppler ultrasound to approximate the FHR by detecting the movement of cardiac structures, which requires signal modulation and auto correlation to provide accurate quality recordings of FHR (Smith et al. 2018). Some of the main limitations with CTG are its inability to support mobile, ambulatory and accurate FHR monitoring. This is particularly worse in women with obesity, where there is the need for clinician oversight during its placement so as to ensure that the maternal heart rate (MHR) is not wrongly monitored over the FHR and that an interpretable trace is obtained. The limitations of CTG use prompted a Singapore based medical technology company, Biorithm, to investigate new methods of fetal monitoring using fetal ECG. This subsequently led to the prototyping of a new device, Femom, which can obtain and analyse fetal heart rate patterns in an outpatient setting. The output from the device will mirror available CTG technology and will therefore be interpreted in line with pre-existing available CTG guidelines. Femom utilises trans-abdominal electrocardiogram (ECG) to measure the fetal and maternal heart rates. Routine data collection at the National University Hospital in Singapore and Monash Medical Centre in Melbourne supports the ability of Femom to collect FHR patterns and contractions. No adverse effects were reported. This study will pilot a clinical trial aiming to examine the efficacy of Femom. Similar technology has also been previously used to monitor the fetus of women in clinical populations with no documented adverse effects (Reinhard et al., 2012). The device presently comprises of 5 electrodes which will be attached to the woman’s abdomen. Our primary research focus encompasses pilot testing the efficacy of Femom in comparison to traditional CTG monitoring to evaluate the quality of tracing obtained. The aims of the project are: 1. to assess the similarity between fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA) measured by Femom vs CTG, and 2. to assess whether there are any differences in fetal heart short term variation (STV) measured by Femom versus CTG 3. to pilot and inform the design of a future confirmatory study

A double-blind randomised controlled study to evaluate the effectiveness of a fermented red ginseng extract supplement (FermenGIN) compared to placebo on blood circulation parameters in an adult population. The aim of this study is to assess the effectiveness of FRG for improving peripheral blood circulation compared to a placebo.

This project is testing the safety, pharmacokinetics (PK, the amount of study drug in your blood), and pharmacodynamics of single intravenous doses of a new drug called EARLI-001. EARLI-001 is a method for the detection of cancers. Who is it for? You may be eligible for this study if you are an adult man or woman over the age of 18 who has been newly diagnosed with locally advanced or metastatic lung cancer. Study details Participants will receive a single dose of EARLI-001 at one of 4 different dose levels. EARLI-001 will be given to you intravenously. Total participation will last up to 60 days which includes 8 visits to the clinic for assessments and to collect blood and urine samples. It is hoped that this research will help determine the safety of EARLI-001 when given to patients with lung cancer.

The purpose of the study is to determine what dose of Tdap-1018, a vaccine intended for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 to 22 years of age is optimum for use. The study will enroll healthy adolescent and adult volunteers aged between 10 and 22 years. The total duration of the study will be approximately 16 weeks. Study details: The study will be conducted in 2 parts: • Part 1 will enroll approximately 90 healthy adult participants 18 to 22 years of age, inclusive. Part 1 has two groups evaluating two dose levels of Tdap-1018. • Part 2 will enroll approximately 48 healthy adolescent participants 10 to 17 years of age, inclusive. Part 2 will also have two groups for evaluating two dose levels of Dtap-1018. All participants will receive 1 dose of their assigned treatment (Tdap 1018 Dose 1, Tdap-1018 Dose 2, or Boostrix). All participants will undergo assessments of safety and immunogenicity. Participants will be followed for safety for 12 weeks after the study injection. All participants will have a pre-vaccination blood draw and receive the assigned treatment vaccine at Day 1. Blood draws for measuring post-vaccination antibody levels and exploratory evaluations will be done at Week 4. Safety assessments will be done at Weeks 4 and 12. It is perhaps intended that this study will determine the dose of Tdap-1018 vaccine intended for active booster immunization against tetanus, diphtheria, and pertussis.

Fast and irregular heart rhythms coming from the bottom chambers of the heart are called ventricular tachycardia (VT). VT is caused by electrical short circuits in the heart, usually as a result of a previous heart attack. 'VT storm' is a medical emergency which occurs when multiple episodes of VT occur within a short period of time. This can be life-threatening because it can stop your heart from pumping enough blood around the body, which may lead to dizziness, fainting or even death. VT can be treated with either anti-arrhythmic drugs (AADs) or catheter ablation. Catheter ablation involves navigating soft wires from the groin into the heart, to find and deliver controlled burns to the short circuits causing the VT, in an attempt to eliminate the VT. We hypothesise that in patients with VT storm, catheter ablation, compared to the current standard of care with AADs, will reduce VT recurrence, mortality, rates of hospitalisation and adverse events.

Transcatheter aortic valve implantation (TAVI) is a less-invasive, non-surgical approach for the treatment of severe aortic stenosis. With each successive generation of the transcatheter heart valve, combined with increasing experience of the proceduralists/heart teams, the outcomes have been more successful, and the risk of complications have been decreasing. One of the commonest complications of the TAVI procedure is the associated conduction abnormality (atrioventricular and intraventricular conduction blocks) which may require insertion of a Permanent Pacemaker (PPM). This is often performed post TAVI procedure, however certain patients undergo prophylactic insertion of PPM pre-TAVI. We will compare the follow up outcomes for each of these groups to assess differences in their heart rhythm following TAVI and associated requirement for PPM.

Depression is common following stroke, affecting one in three stroke survivors (Hackett et al., 2009), and it is considered one of the strongest predictors of reduced quality of life (Kim et al., 1999; King, 1996). Studies investigating treatments for post-stroke depression have mainly examined pharmacological treatments (Hackett et al., 2009), and only a small number of studies have examined psychological treatments. In a series of case studies, Rasquin et al. (2009) found that four of five stroke patients who completed cognitive-behavioural therapy (CBT) reported reduced depressive symptoms. Aphasia refers to a communication impairment caused by damage to the language centres of the brain and can include difficulties with expressive language (e.g., speaking/writing), receptive language (i.e., comprehension of what is said or what is read) or both. Stroke survivors with aphasia are at a further increased risk of experiencing depression (De Ryck et al., 2013; Hilari, 2011; Kauhanen et al., 2000). Furthermore, it is unclear whether CBT, which is predominantly a talking-based psychological therapy, can be successfully modified and tailored for feasible and effective delivery to stroke patients with depression and aphasia. In consideration of this evidence, this study aims to investigate the feasibility and efficacy of a CBT intervention in reducing depressive symptoms in individuals with aphasia secondary to stroke. A series of nine case studies will be conducted to evaluate the efficacy of a modified and individually tailored CBT program. This study will help inform future research and clinical practice, and will contribute to best practice standards in stroke rehabilitation and care.

Older adults admitted to acute care hospitals often experience frailty and pain which can impact patient outcomes. Our study will implement interventions comprising volunteer support and pain assessment to minimise the progression of frailty. The aim is to evaluate the effectiveness of using volunteer support interventions and a technology driven pain assessment (PainChek Universal®) compared with standard care, on changes in frailty and specific clinical outcomes of older adults during hospitalisation, at discharge and at 30 days after discharge, utilising a cluster randomized control trial design. Data collected will include demographic data, clinical data, measures of frailty, pain and other assessments, in patients aged 65 years and over with an anticipated length of stay 48 hours or longer. Findings will provide insight into care delivery for older adults with frailty and pain admitted to acute care hospital settings.

This study is an open label single arm trial coordinated by the Investigators at the Princess Alexandra Hospital (PAH) in Woolloongabba (Queensland, Australia), the Australian Centre for Complex Integrated Surgical Solutions at the Translational Research Institute (Queensland, Australia) and the Centre for Regenerative Medicine at the Institute of Health and Biomedical Innovation in Kelvin Grove (Queensland, Australia). The primary purpose of this study is to assess the feasibility of surgical placement of a new protein scaffold in conjunction with free tissue transfer for bone reconstruction in patients who have an acquired skull defect secondary to trauma, malignancy or infection. Experimental data suggests augmented bone regeneration of this new protein scaffold when combined with autologous vascularised free tissue from the subject. It is hypothesised that this method of reconstruction will result in superior regeneration of skull bone with improved cosmesis at a reduced cost to hospital and patient. This will be assessed through pre-and post-operative CT imaging to quantify bone regeneration. This will be compared to previous types of skull reconstruction in terms of functionality (i.e. cosmesis and patient satisfaction) and financial implications (i.e. costs associated with operation(s) and complications). Patients will be followed up at 4weeks, 3, 6, 12 and 24 months to assess to adequate bony union (through CT and clinical exam) as well as completed surveys of their experience and physical, mental, emotional and social outcomes.