ANZCTR search results

This study will evaluate the safety and tolerability of ACT001 in combination with standard of care whole brain radiation therapy for patients with metastatic brain cancer (cancer that has spread to the brain from another body part). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with secondary brain metastases (cancer lesions that have spread to the brain) from solid tumours including non-small cell lung cancer, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers, and you are eligible to undergo whole brain radiation therapy. Study details Participants will be asked to take 4 oral capsules of the study drug-ACT001 twice a day for up to 18 weeks. Standard care whole brain radiation therapy sessions will be scheduled to start 2 weeks after the first dose of ACT001, participants will continue to self-administer the daily doses of ACT001 until the end of the 18 week study period. During the study participants will be asked to attend a study clinic to report any unexpected side effects they experience during the study, and to complete quality of life questionnaires. Additional doses of ACT001 will be given to participants during these visits so that they can continue to self-administer the drug at home. All participants who are enrolled in this study will be asked to undergo a pre-treatment MRI, followed by two post-treatment MRIs at week 10 and week 18. It is hoped this research will demonstrate that ACT001 is safe and effective in treating patients with metastatic brain cancer, and is able to protect healthy cells during whole brain radiation therapy.

The SCRIPT Trial: A study of DNA testing to tailor bowel cancer screening in primary care. What is the purpose of this research? In Australia anyone aged 50-74 should have some sort of bowel cancer screening. People at increased rick of bowel cancer should start screening earlier. Screening is a highly effective way to diagnose bowel cancer earlier and save your life. There are two main ways you can be screened for bowel cancer, by FOBT (or poo test) or colonoscopy. Depending on your risk of getting bowel cancer, the age when you start and the type of bowel cancer screening will vary. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 70 years who have not previously been diagnosed with bowel cancer. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of bowel cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self collected mouth swab. After this the participant is placed at random into one of two groups. Randomisation means that you are put into a group by chance, like the toss of a coin. Neither the participant or their doctors can chose which group. If in the intervention group, after 2-3 weeks the participant will meet with the researcher at the GP practice or by phone to discuss the DNA test results. They will be given a report summarising their bowel cancer risk and screening recommendations to be discussed with their GP. For the control group, they will have a consultation with the researcher to discuss cancer risk, lifestyle factors and bowel cancer screening options. They will be given the option to receive their bowel cancer risk results after 12 months from recruitment. Follow up questionnaires will be sent to all participants at 1, 6 and 12 months after recruitment.

A multi-centre pragmatic randomised controlled trial will be undertaken to compare 10 weeks of early and intensive motor training with usual care for people with recent SCI. The primary endpoint will be Total Motor Score (/100 points) at 10 weeks to reflect neurological recovery. Secondary endpoints will be other measures of neurological status, the Spinal Cord Independence Measure (SCIM), ability to walk, psychological status, time to discharge, improvement on self-selected goals and participants' impressions of therapeutic benefit/change at 10 weeks and 6 months.

Team leading the resuscitation of a seriously injured or critical unwell patient can be stressful and this stress may affect the clinician’s ability to perform optimally, potentially adversely affecting patient care. Our recent systematic review of the literature revealed a paucity of studies looking at strategies for mitigating the effects of stress on clinician performance and this randomised controlled study will look at whether the deleterious effects of stress on clinician performance can be mitigated by a novel stress mitigation method. Our plain language research question: During a simulated stressful resuscitation can a novel stress mitigation method ameliorate the effects of stress on: 1. Objective physiological stress measures 2. Subjective stress assessment 3. Decision-making performance The primary outcome will be the ability of the intervention to ameliorate the change in physiological stress measures (based on real-time assessment of participants heart rate variability (HRV) during the simulated scenario as compared to their baseline). Secondary outcomes will be subjective measures of stress as well as an assessment of the effect of the intervention on the decision-making performance related to the scenario.

The study investigates the efficacy and cost-effectiveness of remote monitoring in patients with Implantable Loop Recorders, It is an observational study that collects data on time to detection of abnormal heart rhythms and clinical decision making in patients with and without remote monitoring attached to their devices. The utilization of health care resources (in-office visits) and cost-effectiveness of remote monitoring will be assessed.

Central arterial stiffness elevates one’s risk of developing hypertension and subsequent cardiovascular disease (CVD). There is also evidence to suggest that metabolic syndrome (MetS) may exacerbate central arterial stiffness (CAS). Alarmingly, MetS and arterial stiffness are both independent risk factors of cardiovascular events (CVEs) such as heart attack and stroke. Exercise-induced increase in cardiorespiratory fitness (CRF) has long been established as an effective antidote against both MetS and CAS, with its effect enhanced by higher exercise intensities. A more feasible modified version of the popular interval training known as reduced exertion high intensity interval training (REHIT), characterized by limited sprint durations and repetitions (2 x 20s sprints), has received much attention due to its health benefits yet time-efficient nature. Reports also show that BFR combined with lower exercise intensities can have favorable acute and chronic cardiometabolic adaptations. The aim of this study is to investigate the acute and chronic effects of REHIT compared to BFR moderate-intensity exercise on central arterial stiffness, metabolic severity, and other novel CVD risk factors in adults with MetS.

Many chiropractors believe that X-rays are needed to detect findings that will either contraindicate or change the application of spinal manipulative therapy. Without X-rays, these chiropractors believe that they may perform sub-optimal and potentially unsafe care. Although this belief is in contrast to recommendations in clinical practice guidelines, current evidence is unavailable to confirm or refute this belief. The limited research available indicates that X-rays do not improve outcomes in patients with acute low back pain when managed with usual medical care. No studies have assessed the effect of X-rays on patient outcomes when patient management includes spinal manipulative therapy. The effect of X-ray use on areas other than the low back, or on adverse events after spinal manipulative therapy have also not been examined. A large-scale fully powered effectiveness trial will provide important information to inform chiropractic clinical practice regarding the appropriate use of X-rays for spinal pain, to maximise patient outcomes and limit potential risks. This proposed pilot randomised controlled trial aims to provide critical feasibility data prior to performing a large-scale effectiveness trial. This study will inform the ability to recruit patients and chiropractors, the willingness of chiropractors to treat patients without X-ray, and the amount of patient loss to follow-up or cross-over rates.

Spinal cord injury results in a devastating change in a person’s life quality due to a loss in function to not only voluntary motor control but also to regulatory systems that control bodily processes. Over 200,000 new cases of spinal cord injuries occur each year, with more than half of these injuries occur at the level of the cervical spine and upper thoracic spine (C1-T5). Injuries to these levels result in alteration to the sympathetic nervous system which causes dysregulation to blood pressure control. A treatment that may increase blood pressure is electrical muscle stimulation. Stimulation is applied to the muscles through surface electrodes and transfer a current that activates muscles fibres and nerves. This study will investigate whether electrical stimulation of the abdominal muscles can improve blood pressure control for people with a spinal cord injury.

Women aged 50 years of age or older and men aged 70 years of age or older who require admission to an Intensive Care Unit (ICU) lose bone at a significantly higher rate compared to adults who do not become critically ill. Zoledronic acid and denosumab are medications that prevent bone breakdown but are not commonly used in the ICU population. This trial aims to study the effects of these medications, compared to placebo, on bone density in 450 critically ill women aged 50 years of age or older and men aged 70 years or older. Participants will be allocated to receive one of the medications listed or a placebo. Participants will have a bone density scan after trial drug is administered and again at 12 months and have information such as falls, fractures hospital readmissions and quality of life collected at 6 and 12 months. A smaller group of participants, with prior consent will be enrolled to have some additional blood tests to measure markers of bone breakdown in the blood.

The aim of this research is to evaluate the impact of a preoperative dietitian-led VLCD intervention to determine whether the intervention reduces incidence of unfavourable surgical outcomes arising from elective, non-bariatric surgery in adults with obesity. It is hypothesised that obese adult patients who receive preoperative dietitian-led VLCD-based treatment will have shorter operating time and fewer unfavourable surgical outcomes than controls. This study will be a parallel group, two-arm, superiority randomised controlled trial with 1:1 allocation ratio. The study population will be obese adult patients on elective surgery waiting lists at Logan Hospital for a range of general, colorectal, gynaecological, and orthopaedic procedures. In absence of appropriate literature, this intervention is not being widely adopted despite likely improved surgical outcomes and cost-benefits. This research will significantly contribute to the small body of literature and likely highlight the need and allow for more widely accepted implementation of this intervention across a variety of surgery types.