ANZCTR search results

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. Who is it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial. The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. Depending on the domain you are participating in, you may be assigned to a study treatment by chance (randomly). Following randomisation (if applicable), you will be asked to complete your Day 1 assessments. If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (immunoglobulins, antibiotics or none). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know which treatment to prescribe to try to prevent serious infections.

Multi-centre pilot randomised controlled trial to assess the efficacy of oral Azithromycin in eliminating Amniotic fluid sludge as a surrogate outcome for preterm birth. We hope that the results from this study will help up develop a bigger trial which will directly assess the impact of azithromycin in reducing the risk of preterm birth.

This is a randomised, blinded, placebo-controlled pilot study examining the effect of Urolithin A (UA) supplementation on 18 - 30 year old elite academy soccer players preseason training adapations through a six week preseason. UA (as Mitopure) will be given once per day on each training occasion throughout the six week preseason and training adaptations will be assessed through changes in aerobic capacity (YoYo IRT2), strength and power, and maximal sprint speed. Urine and saliva will be analysed for changes in oxidative stress across the six weeks, and perceived stress will be captured weekly throughout the six week preseason period. It is hypothesised that UA will assist players in developing training adaptations such as strength, power, and aerobic fitness throughout the preseason period.

The prevalence of diabetes is increasing in Australia. Lifestyle behaviours and patient self-management are crucial for improving diabetes control but are difficult to achieve in primary care. While an integrated digital care may be effective, there is limited research. Primary aim: The study will examine the effectiveness and cost-effectiveness of the multi-component Wear-IT intervention in achieving clinically significant reductions in HbA1c among general practice patients. A cluster randomised controlled design will be used with general practice clinics randomly assigned to either intervention (n=15) or usual care (n=15). Twenty patients will be recruited from each clinic. Patients will be eligible to participate if they were aged 18-75 years; had poorly controlled diabetes (i.e., most recent HbA1c greater than 7.5%); and were able to access the online application via an iOS or Android smart device. Those attending the usual care practices will receive standard care. A new model of care consisting of patient self-management digital support (i.e., wearable device, education, and glucose monitoring) approach and clinician management digital support (delivered by the practice nurse with review and endorsement of goals by the patient's GP) will be provided to the intervention group. Outcomes at baseline, 6- and-12-months follow- up include HbA1c (primary outcome), macro vascular risk (LDL-C less than 2.0mmol/L and a blood pressure reading of =140/90 mmHg), quality of life (36-item short form version 2)) and cost-effectiveness (quality-adjusted life years derived from SF-36). Healthcare utilization will be examined via PenCS medical report. Participants will complete a survey at 6- and 12-months, including sociodemographic characteristics, health risk behaviours, patient knowledge, skill and confidence for diabetes self-management (process measures). Intervention participants will also complete a 6-and-12 month survey about the ease of use, relevance, and quality of the intervention (feasibility and acceptability). GP and practice nurses views about their experience with utilising and delivering the intervention will be assessed by a brief survey and qualitative interviews. The primary analysis population will be the intention to treat, defined as all randomised participants. The secondary outcome variables will be compared between treatment arms using separate linear mixed effects regression models. Inductive thematic analysis will be used to analysis qualitative data. This study has the potential to improve self-management of diabetes among those with poorly controlled type 2 diabetes. This novel integrated process will empower patients with self-care knowledge and management of diabetes.

In Australia, gestational diabetes (GDM) affects around 10% of pregnancies with up to 30% of GDM pregnancies in a high-risk population. GDM carries a small but potentially important risk of adverse perinatal outcomes and a longer-term risk of metabolic abnormalities in mother and her offspring. Several factors such as patient’s age and family history and raised body mass index (BMI) are associated with future higher risk for GDM. Women who experienced repeated miscarriages were reported to have a higher prevalence of insulin resistance, which increases their risk for gestational diabetes. ;Although up to 20 % of pregnancies end up in an unintended termination of pregnancy there is a paucity of data examining impact of women reproductive history on their future risk of GDM. A recent metanalysis of 10 studies has revealed a 1.62-fold risk of gestational diabetes (95% CI: 1.32–1.98) compared to those never experiencing a miscarriage. In this metanalysis the majority of collected data were ascertained from patients’ questionnaires without effect measure being adjusted for GDM predisposing risk factors. We are planning to conduct a case control study which will compare the previous exposures to miscarriage/termination of pregnancies in women with and without diagnosis of GDM. We will be aiming to analyse data on 500 GDM women and these data will be matched with data on 500 women of similar age and BMI and ethnicity however without GDM. We have already collected data on 150 women with GDM with the miscarriage prevalence of 33%. The proposed study design will have power of 0.80 and of 0.05 to detect a difference of 70% in GDM incidence in women with and without history of pregnancy loss. Considering the large number of miscarriages, evaluating the link between previous pregnancy loss and hyperglycaemia may allow for an additional monitoring and earlier intervention in women at high risk for GDM.

This study aims to improve acceptability and usability, as well as further determine the efficacy of a single-session intervention for reducing eating disorder risk factors. To test this, participants will be recruited from Prolific. Participants will be screened for eating disorder risk using the Weight Concern Scale. Those considered to have elevated weight and shape concerns (and hence be at-risk of eating disorder development) will complete other baseline measures of perfectionism, cognitive flexibility, mood and an additional measure of weight and shape concern. Participants will be randomly allocated to complete the intervention or be in a waitlist control condition. Following this, participants will complete the same measures at 1-week post-intervention, 1- month follow-up, and 3-month follow-up.

The CUTE Project seeks to determine whether prenatal opioid exposure increases inflammation in neonates. The CUTE Project also seeks to determine whether umbilical cord milking (UCM) reduces inflammation in infants with prenatal opioid exposure, and whether it improves their postnatal developmental outcomes. UCM involves supplying the baby with the blood from their umbilical cord. 48 pregnant women will be recruited: 32 with histories of opioid use during pregnancy, and 16 without. At birth, half the opioid-exposed babies will be randomly assigned to receive UCM. Placenta, blood and saliva samples from all babies, and blood samples from all mothers, will be collected to assess immune functioning. Maternal and infant stool samples will also be collected to assess gut health. Urine from mothers and infants, and meconium, will be collected for toxicology analyses. Brain development will be measured through MRI scans of exposed babies, and behavioural testing of all babies. Compared to non-drug exposed controls, we hypothesise prenatal opioid exposure (POE) will be associated with systemic inflammation evident as increased proinflammatory markers in mother and infant blood and saliva. We hypothesise that both mother and infant with show evidence of gut dysbiosis. We hypothesise that infants with POE will have reduced brain volume and white matter density, and poorer cognitive, emotion and motor development at 3 months of age. Finally, we hypothesise that these measures will be inter-related, where infants with greater evidence of inflammation will have poorer outcomes on the MRI and 3-month follow-up. We hypothesise that UCM will reduce evidence of inflammation in the days following birth and that this will be related to improved outcomes at 3-month follow-up.

This is an open-label, single-centre observational study looking at the photographic resolution of atopic dermatitis in patients receiving Dupilumab per standard regimen. Patients will be photographed fortnightly from baseline to week 16, and then monthly from week 16 to week 52. 15 patients with moderate-to-severe chronic Atopic Dermatitis will be recruited. The decision to prescribe Dupilumab is made by the treating physician, prior to offering participation in this trial. Affected areas will be photographically mapped with whole body 3-D photography using Canfield Vectra WB360. Patients will take part for a maximum of 52 weeks in this study. The initial screening period is up to 4 weeks followed by scheduled visits at Week 0 (Baseline) and fortnightly visits up to Week 52. It is hypothesized that treatment with Dupilumab will lead to a statistically significant improvement in atopic dermatitis severity, as measured by the Eczema Area and Severity Index (EASI), and will correlate positively with improvements in quality of life, as assessed by the Dermatology Life Quality Index (DLQI), over the course of 52 weeks

In patients who are unable to be safely taken off a mechanical ventilator a tracheostomy is often placed to help protect their airway gradually reduce the mechanical ventilator support. One-way valves can be used within a ventilator circuit to direct air through the upper airway during expiration, allowing speech and communication.  Research suggests the use of speaking valves during mechanical ventilation is safe, improves communication, may reduce time to weaning off ventilation and removal of tracheostomy. This project aims to evaluate whether the early use of a speaking valve within the ventilator circuit in suitable patients results in earlier weaning from mechanical ventilation and earlier communication.   The primary outcome will be feasibility and safety with the ability to pivot to a primary outcome of duration of mechanical ventilation post tracheostomy utilising the pilot results.  Secondary outcomes include mechanical ventilation duration, ease of communication, patient and family, satisfaction and length of stay.

This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress. It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.