ANZCTR search results

COVID-19 is associated with a high rate of lung infection (pneumonia), and it is uncertain for how long the inflammatory changes of pneumonia remain in the lungs once people have recovered from their symptoms and whether this is associated with adverse long-term outcomes. This study aims to determine if there are persistent areas of inflammation in the lungs in people who have recovered clinically from COVID-19 pneumonia, and also to assess whether there is evidence of increased blood vessel inflammatory activity in these people. As inflammation has an important role in the development and progression of cardiovascular disease, the persistence of inflammation may be a predictor of increased risk for future heart disease. 18FDG-PET/CT is an imaging test which is very sensitive to detection of inflammation.

The purpose of this study is to determine what dose of ReoCure, a virus that targets and kills cancer cells, is safe to use in humans. Who is it for? You may be eligible for this study if you are an adult who has a confirmed advanced/late stage solid tumour. Study details: Dose Escalation: Part A will test ReoCure at 3 different dose levels, Participants will receive 1 injection every 3 weeks in 3 Cohorts. Part B will test 2 dose levels of ReoCure in combination with a fixed dose of Pembrolizumab (200mg every 3 weeks) in 2 cohorts. Dose Expansion: ReoCure in combination with a fixed dose of pembrolizumab (200 mg once in every 3 weeks) treated with the recommended dose selected from Dose Escalation part. Blood, sputum, urine and faeces samples will be obtained for PK assessment before and after administration of study drug. Blood and urine will also be collected for clinical laboratory tests (haematology, clinical chemistry, blood coagulation and urinalysis), tumour marker evaluation and immunological response evaluation. It is hoped that this study will determine the safest and most effective dose of ReoCure for those with advanced or late stage cancer, and help provide more insight in the effect of ReoCure.

Critically ill patients receive inadequate nutrition, potentially contributing to muscle wasting and reduced physical function in the long term. Increased protein delivery is recommended during critical illness with the intent of maintaining muscle mass, but there is little understanding on how the body handles protein during critical illness. This study is aimed at understanding whether the ability of critically ill patients to use dietary protein to build muscle is dependent on the amount of amino acids provided. Critically ill patients will be recruited from the Intensive Care Unit at the Royal Adelaide Hospital and randomised to receive either 20g or 40g of protein. The amount of muscle protein synthesis that occurs following these protein doses will be measured.

BACKGROUND / RATIONALE: After recent disaster Incidents such as the Bourke & Flinders Street events, The Alfred Emergency & Trauma Centre staff have reported feeling under prepared and having a lack of awareness, confidence & knowledge to respond to such situations. OBJECTIVES: This study aims to evaluate that a practical face to face disaster response training program, in comparison to the standard annual on-line emergency preparedness training, will improve Emergency Department staff’s confidence and knowledge regarding disaster response preparedness. METHODOLOGY: A prospective approach will be adopted for this study. The intervention group will be exposed to the enhanced practical face-to-face training program; the comparator group will undergo the standard electronic hospital training program. The evaluation of post-training knowledge and confidence will be compared across the two groups. STUDY PERIOD: 3-month study period. EXPECTED OUTCOMES: At the conclusion of this study it is anticipated that staff involved in the study group will report a greater degree of confidence & demonstrate a greater degree of knowledge in responding to disaster situations, in comparison to the control group who only participated in the mandatory on -line training.

This research study investigates an online healthy lifestyle behavioural modification intervention and the associated changes in cardiometabolic risk parameters and mental health symptoms in young people seeking treatment for mental health related issues. All participants will engage in an online 12-week self-paced healthy lifestyle behavioural modification intervention program. This will involve structured nutrition, physical activity, sleep-wake and healthy lifestyle advice delivered fortnightly over 6 online workshops (week 1, 3, 5, 7, 9, and 11). During this time, participants will be asked to wear an actigraphy watch to detect body movement on the non-dominant wrist intermittently throughout the study. Two-week actigraphy recordings will be collected during weeks 1-2, 6-7 and 10-12. Blood tests, anthropometric assessments (blood pressure, height, weight and waist circumference), self-report questionnaires and clinician administered assessments will be conducted in weeks 1 and 12.

Among strokes resulting from blood vessel blockage leading to sudden damage to the brain (known as ischaemic strokes), just under one third have no underlying cause found despite extensive investigations and most of these are known as embolic stroke of undetermined source (ESUS). To prevent recurrence of these strokes, we hypothesise that intervention to modify risk factors (including being overweight, smoking, diabetes, high blood pressure, high cholesterol, alcohol use, and sleep apnoea) could lead to reduced recurrent strokes and reduced onset of atrial fibrillation (an irregular heart rhythm also known to lead to stroke) in stroke survivors. This risk factor modification, delivered via visits to a specialised risk factor modification clinic, already proven to improve outcomes in atrial fibrillation, will be compared in this study with usual post-stroke medical care. If validated in a separate group of participants without stroke, a special surface ECG’ mapping’ vest will be applied to assess and re-assess the upper heart chamber health of participants with stroke at the beginning and end of this study.

In this randomised, double-blind, placebo-controlled study, 100 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive capsules containing either a bacopa monieri extract (300mg a day) or placebo for 28 days. We will assess change in sleep quality, quality of life, and mood via several validated self-report measures (to be completed at various time points throughout the study). We will also examine changes in salivary hormones (cortisol, DHEAs, secretary IgA, melatonin, c-reactive protein, and salivary a-amylase) and in the salivary fatigue index.

Chest pain is the second most common presenting complaint to emergency departments and Acute Coronary Syndromes (ACS) are a high risk differential diagnosis in this group. As per the NHF guidelines the standard work up of ACS is a risk stratification process which aims to separate patients into low, high or intermediate risk categories. The diagnostic process for determining risk is resource-intensive, currently inefficient and of extremely low yield. 25% of patients assessed for suspected ACS in the emergency department (ED) are categorised as“intermediate risk” , i.e they neither “rule in” or “rule out” for ACS at their index visit in ED and require further testing to determine if they are high- or low- risk. Locally the Royal Adelaide Hospital (RAH) currently investigates this intermediate cohort with cardiology review in ED to arrange for further testing either as a cardiology inpatient or for follow up in specialised OPD clinic as the necessary tests are not available from ED. This multistep process is complicated, associated with delays to diagnosis, is resource intensive and low yield in confirming ACS. On August 3, 2020, SA Health will launch high sensitivity reporting which will increase the number of patients who fall into this intermediate category with potential significant stress to the system. A method to more accurately determine which patients can be managed without cardiology input has the potential to significantly decrease the resource burden of this process, whilst also improving patient convenience and satisfaction. The primary hypothesis is that ED-initiated CTCA will decrease resource utilisation, in terms of ED length of stay and cardiac testing, compared to current standard of care in ED patients with suspected ACS with indeterminate high sensitivity troponin results.

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 combination of tucatinib and trastuzumab in a population of participants with advanced tumours harbouring HER2 amplification or mutations. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to harbour HER2 amplification or mutations. Study details: Participants will receive 2 drugs, trastuzumab and tucatinib. Trastuzumab will given to participants by injection at 600mg every 3 weeks and tucatinib will be taken orally by participants at a dose of 300 mg twice daily. Both trastuzumab and tucatinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 9 weekly intervals from first treatment until progression. For participants with brain metastases, MRI scan will be every 6 weeks up to 18 weeks, followed by every 9 weeks. Safety and tolerability of treatment will be assessed at 3 weekly intervals. Health related quality of life during treatment will be assessed at 3 weekly intervals and then every 9 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 trastuzumab and tucatinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Stargazer Pharmaceuticals. is developing STG-001 a potential oral therapy for patients with Stargardt's disease. This study will be conducted in 10 healthy volunteers who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the safety and tolerability of STG-001 in normal healthy volunteers. This includes vital signs, safety labs, ECGs, and ocular and non-ocular examinations. The drug will be given in single dose of unmilled STG001 capsules in part 1 and after a washout period a single dose of milled capsules in part 2. The study will also evaluate the PK and PD of the drug after dose administration. Participants will be entered into standard study cohorts