ANZCTR search results

This study looks at how helpful a mindfulness app is in improving a woman’s mental health over the period of when she is pregnant and after birth. We will also see if this app can promote her quality of life and bond to her baby, as well as reduce the cost to the healthcare system. We will also interview women to receive feedback on this approach. The study hypothesis is that regular use of the intervention (mindfulness app) will be found to be a cost-effective intervention that will reduce measures of postnatal depression, and improve mother-baby bonding.

This is an international study that aims to determine if there is a decline in neurocognitive function in children having scoliosis surgery. The trajectory of the child’s neurocognitive function will be assessed using well validated psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively. The following aspects of neurocognition will be assessed: reaction time, attention, inhibition, and memory including working memory. The incidence and time course of post-operative delirium will be assessed in the first 48 hours or until discharge after surgery. Blood will be sampled for biomarkers during the immediate peri-operative period, for future analysis. We aim to enroll 50 children aged between 10 and 16 years. Currently we have no data on which to base recommendations for when children should return to school, what to expect in terms of functioning at school or when to sit exams after surgery. This study targets what could plausibly be a high risk group – major surgery. The findings from this study should have an immediate impact on what we tell parents as well as being an example for similar studies for other surgeries. The study will also provide data to understand aetiology, potential risk groups and possible targets for future interventions.

The sub-study MR-CASPER will incorporate MR Imaging and clinical assessments to examine the effect of long-term low-dose colchicine on cerebrovascular disease progression and cognitive decline using a Composite CerebroVascular Disease Burden (CCVDB) outcome measure. The aim of this study is to examine low-dose colchicine’s potential effect on the inflammatory vascular injury responsible for both recurrent stroke and post-stroke cognitive decline. Selected sites in the CASPER (ACTRN12621001408875) trial will participate in this MR-CASPER sub study, with an aim to recruit up to 200 participants who will undergo MRI for the MR-CASPER study, while concurrently participating in the CASPER trials (ACTRN12621001408875) study.

Adequate folic acid intake is a widely accepted preconception behaviour to improve fetal health and viability. Recent research has highlighted that women in preconception and pregnancy do not meet the required level of folate to support pregnancy from their diet alone and therefore to support a viable pregnancy they do need to take a prenatal multivitamin containing folate (Ledowsky et al., 2022). Prenatal multivitamins predominantly contain the synthetic form of folate, folic acid and contain upwards of 800mcg in each dose (Bailey et al., 2019; Masih et al., 2015; Murphy et al., 2021). The amount of folic acid therefore may exceed the upper tolerable limit as set by the Institute of medicine. The purpose of this study is to evaluate the feasibility of a larger trial to test a new form of folate (5-methyltetrahydrofolate (5-MTHF)) to reduce the incidence of miscarriage in those couples that have experienced recurrent miscarriage. The hypothesis is that unlike folic acid, 5-MTHF does not build up, does not mask a Vitamin B12 deficiency and can be better utilised by the body to support a healthy pregnancy, thereby reducing the risk of miscarriage.

This study will assess whether treatment with a biofactor-combination helps delay progression or worsening of symptoms of Mild Cognitive Impairment (MCI). This study will also assess whether treatment with the investigational product influences surrogate markers of cognitive impairment and vitamin and mineral blood levels.

The purpose of this prospective, randomized crossover trial is to understand how Precision 1 Toric contact lenses impact on functional vision with digital devices, in comparison to functional visual performance with spherical equivalent contact lenses (Precision 1 sphere) in healthy participants with low to moderate levels of astigmatism.

The primary aim of this acute study is to examine the acute effects of resistance exercise performed with ISR compared to TRAD on the maintenance of force, velocity, and power output, as well as differences between exercises targeting the upper and lower limbs in adults with CMT. Secondary aims include whether better affective responses and less physiological and psychological fatigue can be achieved following resistance exercise using ISR compared to TRAD sets. Hypotheses: 1. Resistance exercise performed with ISR will lead to higher mean force, velocity, and power output across the set compared to resistance exercise performed with TRAD. 2. Resistance exercise performed with ISR will lead to lower perceived effort and more positive and less negative affective responses compared to resistance exercise performed with TRAD. 3. Resistance exercise performed with ISR will lead to greater muscle oxygenation and blood flow compared to resistance exercise performed with TRAD. 4. Muscle oxygenation and blood flow will explain a significant portion of the variance in power output, velocity, perceived effort, and affective responses between groups. 5. Similar responses for upper versus lower limb resistance exercises will be observed following the ISR and TRAD conditions.

The primary aim of this acute study is to examine the acute effects of resistance exercise performed with ISR compared to TRAD on the maintenance of force, power output, and work, as well as differences between exercises targeting the upper and lower limbs. Secondary aims include whether better affective responses and less physiological and psychological fatigue can be achieved following resistance exercise using ISR compared to TRAD sets. Hypotheses: 1. Resistance exercise performed with ISR will lead to higher mean force, power output, and work across the sets compared to resistance exercise performed with TRAD. 2. Resistance exercise performed with ISR will lead to lower perceived effort and more positive and less negative affective responses compared to resistance exercise performed with TRAD. 3. Resistance exercise performed with ISR will lead to greater muscle oxygenation and blood flow compared to resistance exercise performed with TRAD. 4. Muscle oxygenation and blood flow will explain a significant portion of the variance in power output, velocity, perceived effort, and affective responses between groups. 5. Similar responses for upper versus lower limb resistance exercises will be observed following the ISR and TRAD conditions.

The study will include a Screening Period, a Treatment Period, and a Follow-up Period. Sequential groups of fasted participants will receive a single dose of inhalation administered APR002 at 6 increasing dose levels or placebo. Staggered dosing will be employed with approximately 24 hours between dosing cohorts. After all participants in a dose group have completed study procedures to Day 3 (48 hours after dosing), a decision on dose escalation and enrolment of the next dose group will be made based upon all available data, including the incidence and severity of reported AEs and safety laboratory test results collected after administration of APR002/placebo. Escalation to the next dose level will occur in the absence of dose-limiting toxicity or other significant safety findings after agreement between the Sponsor, an independent Medical Monitor, and the Investigator. Follow-up assessments will occur approximately 14 days after the dosing to inquire for any ongoing AEs or serious adverse events (SAEs), worsening of AEs or SAEs, or development of new AEs or SAEs, and concomitant medications taken since final dose. Follow-up will occur by telephone unless abnormal, clinically significant findings are observed upon discharge or at the Investigator’s discretion. Participants should then be brought back to the clinic for re-evaluation.

The purpose of this study is to determine the assess the safety, tolerability, pharmacodynamics and pharmacokinetics of EARLI-001, a product developed to asses with the detection of cancer. Who is it for? You may be eligible for this study if you are a healthy adult under the age of 55. Study details Participants will receive the study drug via an infusion in the vein and be required to stay at the testing clinic for 24 hours for observation. They will then be required to attend follow-up assessments on days 3,5,7, 14 and 28. As part of this study, we will be collecting blood samples for both safety and research purposes. During the study, the estimated total blood volume to be collected will be approximately 140 mL (approximately 0.6 cups or 7 tablespoons). As a reference, a standard blood donation is 470 mL in any 12-week period. At follow-up visits, participants will also undergo physical examinations, vital sign assessments (blood pressure, pulse rate, breathing rate and temperature) and electrocardiograms for the assessment of safety. It is hoped that this research will help determine if this product is safe for use, to then be used further in future studies to determine whether this product can be used to assist cancer detection.