ANZCTR search results

There is some concern that medications called opioids, which are used to treat pain, may delay the onset of blood thinning medications that are vital to improving patient outcomes after a heart attack. This study seeks to enrol patients suspected of having a heart attack to compare the safety and effectiveness of a different type of painkiller called lignocaine (which does not appear to interact with blood thinners) to fentanyl which is the current standard of care opioid used. We hypothesise that use of lignocaine will be safe and effective for pain related to a heart attack. Ambulance Victoria paramedics will randomise patients with suspected heart attacks to receive either intravenous lignocaine or intravenous fentanyl and assess its effectiveness as pain relief and also side effects (safety) in each group. We will also assess size of the heart attack based on blood testing as well as clinical outcomes during follow-up.

The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases. This study is a prospective, randomized, single-masked, crossover clinical trial with five scheduled visits. A total 40 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for three month) along with a multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 5 visits within 6 months (baseline, 1 month, 3 months, 4 month and 6 month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1, 3, 4 and 6 month visits. At each visit, participants will be requested to complete two questionnaires relating to their contact lens use. The contact lens storage cases and multi-purpose disinfecting solutions will be provided free of charge during the duration of the study. Participants will be provided with a $10 vouchers at the end of each study visit to compensate for their costs incurred in attending the study visits.

Mal de Debarquement Syndrome (MdDS) is a rare neurological condition that affects the vestibular system and currently has no cure. Symptoms of MdDS include a continuous swaying, rocking, or motion-like feeling that typically arises following a motion experience such as traveling on sea, which leaves patients with a feeling of chronic “sea legs” or “sea sickness” though they are on stable ground. The underlying cause is currently unknown, and thus treatments for this condition are often ineffective. This project seeks to investigate the efficacy of a combination of Theta Burst Stimulation (a form of Transcranial Magnetic Stimulation) and the Vestibular Ocular Reflex Protocol (a manual therapy) in reducing objective and subjective measures of the condition. It is hypothesized that MdDS patients will report an improvement of symptoms after the combined therapy, which will significantly affect their quality of life, compared to the sham treatment.

This pilot pragmatic open label randomized controlled Trial (RCT) compares the use of Nitric Oxide (NO) treatment blended into the oxygenator of the Extracorporeal Membrane Oxygenation (ECMO) circuit in comparison to standard care defined as no treatment with NO into the ECMO circuit. We hypothesize that in children treated with ECMO, a randomized trial investigating the use of NO during ECMO is feasible. We hypothesize that neonates and children on ECMO exposed to NO on ECMO have a reduced rate of clotting and bleeding complication and reduced inflammatory response measured by various clotting markers as well as serum cytokine levels in comparison to controls, leading to shorter ECMO run duration and reduced health care costs. The findings could have major potential to improve patient-centered outcomes and reduce health care costs.

Young disadvantaged mothers are at a higher likelihood of having their child/children removed from their care, which results in poor psychosocial outcomes for the mother and the infant. Therefore, a prospective cohort study will be conducted to evaluate the efficacy of the Cradle to Kinder program on psychosocial outcomes among young and vulnerable families. An anticipated sample of 50 young at-risk women and their families will receive the Cradle to Kinder program, commencing from pregnancy up until the child turns four years old, Cradle to Kinder is a targeted, intensive and long-term ante- and postnatal support service for vulnerable young mothers (aged less than 25 years with one or more risk factors) and their families. Cradle to Kinder practitioners will conduct weekly to fortnightly home visits and engage families in a range of different interventions to support and facilitate health outcomes. Assessments will be conducted by the practitioner at baseline and then every six months over the four years of the intervention. Maternal health outcomes (i.e., mental health, parenting capacity) will be measured using the North Carolina Family Assessment Scale, and infant outcomes (i.e., attachment style, social and emotional development) will be assessed by the Brigance. It is expected that families who engage in the program for its entire duration will demonstrate better psychosocial outcomes at the conclusion of the program compared to the beginning.

Our modern 24h society means that sleep and waking activities are changing. Ten million Australian workers sit at work, eleven million Australians are sleep restricted and 1.9 million Australians are shiftworkers. This is problematic, as prolonged sitting and sleep restriction have negative impacts on health and safety at work and contribute to a huge burden on public health. Although sleep restriction and prolonged sitting have been investigated separately, to date, no study has investigated how these factors jointly impact health and safety. To investigate the combined effects of prolonged sitting and sleep restriction in different shiftwork types, this study measures cardiometabolic outcomes and cognitive performance in healthy adults doing dayshifts or nightshifts under different levels of sleep restriction and in conditions of prolonged sitting and conditions of breaking up sitting. We propose that breaking up sitting will improve cardiometabolic health and cognitive performance compared to prolonged sitting, but this effect will be lessened under conditions of sleep restriction. These results inform the development of workplace policy and public health guidelines targeting prolonged sitting at work and the impacts on health and safety.

Previous research has showed a reduced lung function after cardiac surgery and this has been associated with increased mortality and morbidity. The aim of this prospective, observational study is to determine if a cheap and simple tool like HGS could be an indicator of lung function and health-related quality of life after cardiac surgery. It is hypothesized that HGS will be a simple and valid method to monitor lung function and health-related quality of life during post-hospital recovery in cardiac patients.

In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing digestive complaints will be randomly assigned to receive capsules containing either a herbal combination or placebo for 8 weeks. We will assess change in digestive symptoms, intestinal bacteria, vitamin D and B12 concentrations, and overall quality of life.

Rivastigmine (RIV) is an acetylcholine esterase inhibitor which prevents neurotransmitter breakdown. As such it is currently approved for the treatment of neurological disorders such as Alzheimer's and Parkinson's disease dementia. RIV is available in two forms, oral (capsule) and as a transdermal (through the skin) patch. The latter was developed as a consequence of the oral forms causing nausea, vomiting and diarrhoea predominantly caused by the low oral bioavailability of this drug. Although the transdermal patch overcomes a lot of these side effects, a high percentage of people suffer from skin irritation and possible sleeplessness. This study will investigate whether delivering RIV nasally (into the nose) provides RIV therapeutic levels in the blood plasma that are comparable to Exelon (Registered Trademark) oral capsule and whether nasal RIV results in lower side effects. Each intervention will be as a single dose with thorough blood sampling over 24 hours to assess drug levels; each intervention will be separated by a 2 day washout period. This is a phase 1 trial in 16 young healthy males aged 18 to 55 years. While comparing the two delivery methods, this study will also investigate the safety and tolerability of Rivastigmine nasal spray.

Australian women receive 0.15-0.2 mg/d of folic acid from food containing fortified bread flour. In addition, >80% of Australian women take a multivitamin during pregnancy, with one of the most popular brands containing double the amount of folic acid recommended for pregnant women until 3 months gestation. (0.8 mg/d). There is no question that taking folic acid in early pregnancy is important to prevent neural tube defects. However, there is no proven benefit and potential harm from taking folic acid after neural tube closure at approximately 28 days post conception. We aim to determine if removing folic acid from prenatal supplements after 12 weeks of gestation results in lower blood concentrations of unmetabolised folic acid, a biomarker of excess folic acid, at 36 weeks’ gestation. We will also determine if removing folic acid from prenatal supplements after 12 weeks’ gestation allows women to maintain red blood cell folate concentrations >905 nmol/L at 36 weeks’ gestation.