ANZCTR search results

Cardiovascular (CV) disease including coronary artery disease (CAD) is the leading global cause of morbidity and mortality, Early diagnosis of CAD can help to manage the disease. Invasive coronary angiography (ICA) is a common diagnostic test used to detect CAD, but ICA provides no direct assessment of plaque burden, is costly, and also exposes patients to potentially serious complications such as stroke, coronary dissection, and local access site complications. Recently, we showed that polarisation-sensitive optical coherence tomography (PS-OCT) can be used to non-invasively assess the structure of retinal blood vessel wall tissue in-vivo (https://opg.optica.org/boe/viewmedia.cfm?uri=boe-12-7-4340&html=true). Retinal blood vessels share structure and function with the heart, making them an interesting non-invasive proxy for coronary artery disease. The objective of the trial is to develop an accurate low-cost tool based on the assessment of retinal blood vessel wall tissue through PS-OCT measurements that can non-invasively screen for cardiovascular diseases, particularly for CAD.

This randomised controlled trial will investigate the effectiveness of a web-based peer support intervention for reducing levels of depression among community-dwelling older Australians. It will also determine whether older adults receiving access to the intervention experience: (a) reduced levels of anxiety, (b) reduced levels of loneliness, and (c) higher levels of quality of life. Eligible participants (aged 65 years or older; English speaking; with access to the internet) will be randomly allocated to one of two groups: (1) usual care, or (2) web-based peer support intervention. The web-based peer support intervention includes a secure study-specific online community dedicated to older people, where participants can meet and engage in asynchronous one-to-one and group-based communication with other study participants allocated to the intervention arm. The primary outcome (mean depression scores) will be collected at 6-months post study recruitment.

People who have been diagnosed with a blood cancer that has a risk of relapse, (e.g. Acute Myeloid Leukemia, Myeloid Dysplastic Syndrome, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma) may benefit from having a transplant of healthy stem cells into their bone marrow to encourage their body to produce healthy cells. This treatment has a high risk of transplant rejection and so patients often need to take immuno-suppressing drugs for a time before and after the transplant to ensure the transplant is not rejected. This study aims to assess 4 different immuno-suppressing treatment regimes (drugs and body irradiation/radiotherapy) to determine which treatment is best at suppressing the rejection response without compromising the overall health of the patient. Who is it for? You may be eligible for this study if you are aged 16 to 75 years of age, you have been diagnosed with a blood cancer that has a risk of relapse and your doctor has recommended that a stem cell transplant is indicated. You may also need to meet additional criteria (heart, lung and kidney health criteria) in order to be eligible for this study. Study details Participants in this study will take part in one of two separate sub-studies. The decision of which of the two sub-studies a participant will take part in is at the discretion of the study investigator. The two sub-studies are: 1. Reduced Intensity Conditioning (RIC) -Sub-study 1: contains two sequential treatment arms. The first treatment arms.will examine using will use standard of care radiation but at a higher dose with fludarabine. The second treatment arm will use of treosulfan instead of standard of care busulfan with fludarabine. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required ( may start weekly then monthly) 2 Myeloablative Conditioning (MAC) - Sub-study 2: contains 2 treatment arms running concurrently. One will use of treosulfan instead of standard of care busulfan with fludarabine and the other will use standard of care radiation but at a higher dose. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required ( may start weekly then monthly) It is hoped this research will demonstrate that one (or many) of the treatment regimes tested is safe for cancer patients and effective at keeping the transplant rejection response rate low. The best treatment regime may then be tested in a larger randomised trial that could benefit future patients with blood cancers.

Painful exercise or exercising into pain, is a form of therapeutic exercise that allows temporary aggravation of a person’s pain. In people with chronic pain, painful exercise offers small, short-term benefits in reducing pain compared to non-painful exercise. One potential mechanism for painful exercise is that they typically induce higher loads and dose of exercise and thus likely to evoke a greater analgesic response (reduction of pain following exercise). However, the literature regarding painful versus non-painful exercise is sparse (n=7 trials, n=385 participants) and includes only a small range of chronic pain conditions (e.g. back, shoulder and ankle pain). Moreover, the effect of painful exercise in people with knee osteoarthritis (OA), one of the most prevalent and disabling musculoskeletal conditions in Australia and globally, has not been studied. In addition, there is considerable variability in how painful exercise has been prescribed (e.g. pain allowed versus recommended, measurement of pain during exercise, and the timeframe after exercise for pain to subside), limiting its application in clinical practice. The current project will examine the feasibility of painful exercise compared to non-painful exercise in people with knee OA. This study is significant because, while guidelines recommend different types of exercise (e.g. aerobic and strength exercise for people with knee OA, they do not advise on exercising into pain (or not). Therefore, clinicians must rely on their learnings, prior experiences and patient preferences to prescribe exercise appropriately, but this currently varies considerably in clinical practice with respect to exercising into pain. This may be due to the lack of studies of painful versus non-painful exercise for people with knee OA. This study will provide insight into whether painful exercise under the guidance of AEPs using evidence-based best-practice exercise and education is a feasible intervention for people with knee OA. The outcomes may have implications for how exercise is prescribed in clinical practice in the management of knee OA, including strategies to improve the effectiveness of, and adherence to, exercise in people with knee OA in whom pain and maladaptive beliefs about pain and exercise are often a barrier to treatment engagement.

The aim of the clinical trial is to determine if the novel Moisturising Skin Support is as effective or more effective in managing chronic wounds than standard care (sorbolene cream) when used by wound care nurses within the pharmacy setting over a 3 year period. The hypothesis is that the novel moisturising skin support will be as more effective than standard treatment in managing chronic wounds,

Protein-rich animal foods (cooked meat, dairy) are highly digestible - our bodies are able to utilise nearly all of the protein consumed, whereas the protein digestibility of plant based food products can vary considerably. Given the growing interest in alternative non-animal based sources of protein, it is important to establish the protein digestibility of these new foods and protein concentrates which has important health implications especially for vulnerable groups who have difficulty in consuming enough dietary protein. The gold standard method for measuring protein digestibility is the human ileostomy model, as it enables protein digestion to be quantified independent of protein degradation in the large intestine. The use of animal models involving rats and pigs has been preferred for determining the digestibility of dietary proteins over using people with an ileostomy due to the availability of study participants. However, to minimise the use of animals in research, a standardised in vitro method, INFOGEST, has been developed to simulate the digestion process. This method has undergone considerable validation which has included direct comparisons with protein digestibility measurements in humans. A majority of this validation work has focused on highly digestible animal meat and dairy products and the European COST INFOGEST consortium have identified the important need to further validate the model using non-animal based protein foods. Aim: To use the ileostomy model to determine the protein digestibility of three plant proteins and to validate an in vitro model of protein digestion (INFOGEST). Primary objective is to compare plant protein digestibility data obtained from the ileostomy model with that obtained from the INFOGEST model. Secondary Objective is to determine the protein digestibility of wheat-based food containing alternative plant-based high protein flours. Hypotheses: H0: That plant protein digestibility as measured by the INFOGEST method does not correlate with protein digestibility data obtained from the ileostomy model. H1: That plant protein digestibility as measured by the INFOGEST method correlates with protein digestibility data obtained from the ileostomy model

This trial evaluates the efficacy of two herbal medicines and a B-vitamin complex for improving stress and anxiety in adults who experienced elevated stress post-flooding natural disaster in the Northern Rivers Area of Australia. A total of 100 participants will be randomly allocated to one of four arms, and three out of these will receive the intervention for a total of 6 weeks each. The primary outcome is feasibility of study procedures and interventions. Perceived stress will be measured at the beginning and each 2 weeks until the end of the 6 weeks, and other mental health/quality of life measures will be included at baseline and 6 weeks.

This will be a Phase 1 first-in-human (FIH) study in 2 parts to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNT-517 at various incremental doses administered as single and multiple doses in healthy volunteers. The study will begin with a single ascending dose portion (Part A) followed by the multiple ascending dose portion (Part B) in healthy volunteers in Australia to evaluate the safety, tolerability, PK, and PD of JNT-517 at various incremental doses.

Insomnia is a prevalent and debilitating disorder in Australia. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi. Insomnia and sleep apnoea frequently co-occur. There is evidence that CBTi improves symptoms of insomnia, daytime function and quality of life in people with co-morbid insomnia and sleep apnoea. However, access to therapist-administered CBTi for people with co-morbid insomnia and sleep apnoea is very limited. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia in people with both insomnia and sleep apnoea. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations. This randomised controlled trial aims to investigate the effectiveness of a digital brief cognitive behavioural therpay for insomnia program, versus waitlist education control, on reducing insomnia symptoms in people with co-morbid insomnia and sleep apnoea. It is hyopthesised that the group who receive the brief CBTi program will report a greater reduction in insomnia symptoms, compared to the group that receive education (waitlist control).

Our First trial (ACTRN12615000898550) examined the immune responses to pertussis and other vaccine antigens following a modified infant vaccination schedule for DTPa-IPV-Hep B-Hib (Infanrix Hexa®) vaccine when given at 6 weeks, 12 weeks and 11-12 months of age. The immune responses in this study following this modified vaccine schedule will be compared to immune responses in a separate historical comparison study where Infanrix Hexa® vaccine was given at 6 weeks, 4 months, and 6 months of age), Continued study of the cohort enrolled onto ACTRN12615000898550 is a unique opportunity to examine the longer-term safety and immunogenicity at 18 to 36 months and again at 4 years old of children who followed the modified vaccine schedule and to compare their results with a historical cohort of infants who received pertussis-containing vaccines given according to the standard immunisation schedule. The key questions of prolonged immune tolerance to pertussis antigens, negative interference on concomitantly administered antigens and increased reactogenicity to booster doses following altered timing of Pa vaccination are only able to be answered by the long term follow up of our cohort. These are essential data to inform national vaccine policy and will be of considerable interest internationally. Antibody responses in the blood of children originally enrolled on ACTRN12615000898550, which are believed to correlate with protection, will be measured at (1) 18 to 36 months of age, at (2) 4 years of age pre-booster dose of DTPa-IPV vaccine and (3) 1 month after receipt of 4 year old DTPa-IPV booster vaccine. In addition, differences in immune and safety responses in the study cohort after receipt of the 4 year old booster dose of DTPa-IPV compared to historical controls who have received the existing vaccine schedule (at 6 weeks, 4 months and 6 months of age).