ANZCTR search results

Adults who were born prematurely and mothers who give birth to a preterm baby are at increased risk of cardiovascular disease but neither are included in New Zealand’s risk assessment guidelines. As part of a wider project investigating the impact of premature birth on cardiovascular health we will invite the New Zealand Very Low Birth Weight cohort (born <1500g) and their mothers to have their cardiovascular disease risk assessed and compared to a control group. We will compare cardiovascular risk factors, cardiovascular events, general health and reproductive history in the premature-born NZ VLBW cohort and controls at age 35 years (2021). Cardiovascular events and risk factor trajectory will be compared to cardiovascular risk estimations using health data collected as part of risk factor data collected at 28 years of age using validated calculators (such as NZ PREDICT guidelines). We will also compare cardiovascular disease event rate and all-cause mortality in mothers of the NZ VLBW cohort compared to mothers of controls and calculate and compare five year cardiovascular risk estimates using the NZ PREDICT equations. This will be compared to actual cardiovascular disease events as part of a comprehensive evaluation of cardiovascular health planned in five years’ time. Evaluation for cardiovascular risk in participants will be based upon medical history, blood pressure and anthropometric measurements and blood testing for diabetes and dyslipidemia. This study and our wider research project will help to inform recommendations around cardiovascular risk screening after preterm birth/delivery.

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001. Part B will evaluate the combination treatment of ACT001 with pembrolizumab in patients with recurrent GBM (Glioblastoma Multiforme brain cancer) only. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with glioblastoma. Those who participated in Part A of the study (ACTRN12616000228482) may be eligible to also participate in this study, subject to principal investigator approval. Study details: Participants will receive oral ACT001 twice every day for 21 days, together with intravenous (IV) infusion of pembrolizumab on the first day. After 21 days, once the safety of this treatment is determined, all participants will be given the treatment in recurrent 21-day cycles until tumour progression or adverse event. Researchers will take a number of blood samples from the initial 3 participants in Day 1 of the first and second 21-day cycle, to examine the rate that the body processes the drug. MRI scans and assessments of treatment response will be taken before treatment and then every 9 weeks to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether the combination treatment of ACT001 with pembrolizumab can be safely given to cancer patients, and provide information on the rate of processing of ACT001 by the body when pembrolizumab is also given. Using this information, researchers hope to find if the combination of ACT001 and pembrolizumab is safe and effective.

Osteoporosis is a disease characterized by bone fragility resulting in bone fractures, which leads to increased morbidity and mortality. Following menopause, bone resorption exceeds bone formation, leading to net bone loss and bone fragility. There is an emerging body of evidence linking the gut microbiome and probiotic ingestion to skeletal, muscle, cognitive, and cardiometabolic function. The aim of this study is to investigate whether a taking a probiotic supplement .twice daily for 12 months positively impacts the rate of bone loss in recently psotmenopausal women The proposed study is a double-blind, placebo-controlled randomised trial, which will investigate whether consuming a probiotic supplement containing inulin (a prebiotic soluble fibre) twice daily for 12 months will improve bone health in early postmenopausal women, aged 40-65 years. In addition, secondary outcomes will measure the effect of the intervention on immune system modulation and cognition as well as musculoskeletal and metabolic function as potential mediators. It is hypothesised that the probiotic supplementation will improve markers of bone health, muscle health, and metabolic health in postmenopausal women.

We aim to identify complexities in the scale-up, spread and sustainability of interact-ABI-lity, an online intervention to provide scalable communication training to communication partners of people with acquired brain injury (ABI), including family, friends, partners, paid support workers, clinicians and the general public. We therefore seek to identify; 1. Who uses interact-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is interact-ABI-lity used? 3. Do users complete interact-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing interact-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing interact-ABI-lity? 6. How satisfied with interact-ABI-lity are the users? 7. What is the cost of delivering interact-ABI-lity? The direct evaluation of the implementation of interact-ABI-lity by end-users aims to ensure the course reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

This study aims to compare bronchoscopic biopsy to CT-guided biopsy for the purposes of evaluating peripheral lung nodules. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a lung lesion in the outer 1/3rd of the lung field measuring between 1-3cm clinically requiring a biopsy. Study details Participants will be randomised (i.e. allocated by chance) to receive either bronchoscopic sampling performed by a respiratory physician or CT-guided biopsy to be performed by an interventional radiologist. Bronchoscopic biopsy will involve the doctor planning the path based upon CT images you have already had, followed by insertion of a thin, flexible tube into the airway, confirmation of position with ultrasound and x-ray and sampling of the lesion using transbronchial needle aspiration as well as forceps and brush. CT-guided biopsy will involve having a needle passed through the chest wall to biopsy the lesion, with guidance of CT images taken immediately before and during the procedure. Diagnostic methods will be compared for accuracy, and all participants will be monitored for complications for 7 days post-procedure. Costs, human resource use, and timing of the procedure will also be evaluated. It is hoped that this research will show that bronchoscopic biopsy is safer, has a comparable diagnostic yield, and is cost-effective compared to CT-guided biopsy for the purposes of evaluating peripheral lung nodules.

While there is currently no cure for dementia, there is evidence that some health conditions and lifestyles may increase the risk of developing dementia. Some of these risk factors for dementia can exist in mid-life, well before a person may start to show signs or symptoms of dementia. HAPPI MIND is a multi-domain intervention that brings together the expertise of different health professional groups to help reduce dementia risk factors and subsequent development of dementia in at-risk middle-aged adults. This primary care based model involves dementia risk assessment led by the practice nurse and GP, motivational interviewing to drive behavioural change, multidisciplinary management of dementia risk factors and a smart-phone app supported self-management of dementia risk factors. The study aims to evaluate the effectiveness and cost-effectiveness of the HAPPI MIND program for assessing dementia risk and reducing dementia risk factors in middle-aged adults in the primary care setting. It is hypothesised that primary care-based dementia risk assessment will lead to increased awareness and detection of dementia risk factors, and the tailored interdisciplinary GP/nurse-coordinated health promotion program (HAPPI MIND) will lead to reduced dementia risk, compared usual care and dementia risk assessment alone (minimal intervention).

This study is aimed at evaluating the feasibility of an online program, Healthy Living after Cancer Online, aimed at supporting people who have completed cancer treatment in improving their quality of life. Who is it for? You may be eligible for this trial if you are aged 18 or over and have been diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type within the last five years, and have completed treatment for this (please note: people on hormonal treatment or Herceptin still eligible). Study details Participants will be asked to work through an online program for 12 weeks that addresses multiple areas of health, including physical activity, healthy eating, mental health, finding the new normal after cancer treatment, fatigue, and weight management. Questionnaires will be collected before and after the intervention. Information from this study will help inform post-cancer survivorship programs.

The hypothesis to be tested is that wearing thicker wet suits (7mm or double 7mm on torso) impairs the ventilatory mechanics of healthy divers. This has never been studied for colder water wetsuits that are often used in Tasmania. Divers wearing thinner wetsuits (median 3mm), have been studied in the past. The aim is to measure the effect that wearing thicker (7mm or greater thickness) wetsuits has on the respiratory function of healthy divers measured by lung function testing.. A series of volunteer healthy divers will be enrolled. Spirometry (lung function) measurements will be be undertaken firstly without a wetsuit, and when wearing 7mm one- piece Summer suit and/or 7mm dual layer Winter suits, These wetsuits are standard for Tasmania’s climate. Based on previous studies of divers in thinner wetsuits, we expect that there will be significant impairment in lung function when wearing a 7mm or greater thickness wetsuit. The information gained from the study could guide medical advice to older divers and also divers with pre-existing medical conditions. In addition it may provide some physiological information that helps to unlock why some older divers in colder water are prone to breathing problems associated with immersion.

Lipiodol, an oil soluble contrast medium (OSCM) has a clear fertility enhancing effect, but its mechanism of action is uncertain. This trial seeks to determine the feasibility, from both the clinical perspective and the laboratory perspective, of changes brought about by lipiodol within the endometrium, the fallopian tubes and the peritoneal lining. Establishing the variables within these tissues that demonstrate the trends of effect of largest magnitude when women who have had a lipiodol hysterosalpingogram (HSG) are compared to women who have had an HSG with a water soluble contrast medium (WSCM), and when women who have had a lipiodol HSG are compared to women who have had no intervention, is likely to point towards candidate mechanisms. This pilot randomised controlled trial (RCT) will then inform the feasibility of testing such variables in a definitive RCT of women with infertility that could, in the future, assess whether such changes are associated with a successful fertility outcome. Future RCTs examining the fertility efficacy of lipiodol could then endeavour to link fertility efficacy to the candidate mechanism as part of the entire RCT or within a cohort of women who form part of the overall RCT group, but in whom the mechanisms of lipiodol are also sought.

This is a parallel arm, 1:1 allocated randomised controlled trial comparing anterior cruciate ligament (ACL) reconstruction with suture tape augmentation of the graft to standard ACL reconstructive technique. Whilst many ACL reconstruction patients return to sport, a significant minority suffer complications of graft rupture, particularly during the early return to sport and rehabilitative period. Inherent weakness of the graft in withstanding the loads applied during these periods has been attributed to graft failure risk, as well as residual laxity (looseness) of the knee. Recently, the use of suture-tape to run alongside the graft (or augment) has emerged to increase the strength of the new ACL, however, there is little comparative evidence available regarding this technique, particularly in its capacity to reduce residual knee laxity, or improve patient outcomes after ACLR. We aim to investigate the use of this technique by randomly allocating ACL reconstructive patient to receive it, or standard technique (the same surgery without the additional suture). We will compare the outcomes following this by testing the looseness of the knee at standard time points (3 months, 12 months and 2 years) compared with the patients other 'normal' knee. We will also compare patient reported outcomes (via patient delivered surveys), findings on examination of the knee, return to sport times and rates and complications such as the need for return to surgery, and failure of the ACL reconstruction. We will perform this study with an aim to improve our understandings about the potential benefit or harms associated with tape augmentation, with the hope that it will inform the use of this technique in future patients needing to undergo ACL reconstruction to return to sport. We hypothesise that patients whose knees are reconstructed with suture-tape augmented grafts will have a smaller difference between operative and non operative sides at two years after surgery, compared with patients who undergo standard ACL reconstruction. Secondly, we hypothesise that patients with tape augmented ACL grafts will return to sport sooner, and have improved patient reported outcome measures during the follow up period (2 years).