ANZCTR search results

The purpose of this study is to evaluate whether clomiphene improves sperm quantity and quality in men with unexplained infertility and low sperm counts. Eligible men recruited from fertility clinics will be randomised to either clomiphene or placebo for 6 months. Both clomiphene and placebo will be taken as a once daily oral capsule. Both groups of men will also receive a men’s fertility multivitamin (Menevit). We hypothesise that clomiphene will increase sperm production compared to placebo.

The supplier of a new peripheral intravenous catheter (PIVC), BBraun, have engineered a new type of catheter called the ‘Introcan Safety 3’ that contains a new type of stabilisation technology. The investigators would like to test this device against BBraun’s existing device (Introcan Safety) to determine if there is an improvement in devices’ stability and whether this reduces blood clot formation and improves how long the devices work for. We propose to use bilateral cannulation (i.e., cannulate both your left and right lower arms) and allow these PIVCs to stay within your arms for up to 72-hours to determine whether any advantage exists when using the different catheter types. This study will be performed in human participants that meet the study screening criteria. The position and motion of the two catheter types will be monitored using ultrasound, as well as standard observations to document whether the devices are working, whether blood clots, local swelling, redness/pain, and device motion is observed. Participants will also record their experiences with the devices to determine whether using either catheter is associated with improved patient comfort.

This study evaluates teledentistry and artificial intelligence (AI) in the screening of new orthodontic referrals as well as during braces treatment in Australian adolescents and adults. Its goal is to improve access to public orthodontic services. Participants will submit photos using a smartphone-compatible platform called Dental Monitoring (DM). . 30 participants treated with braces will be recalled every 6 weeks and another 3o will be recalled when DM recommends it. Groups will be compared by number of appointments needed to complete the levelling and alignment stage of treatment . Patient satisfaction, reduction in waiting lists and the costeffectiveness will also be assessed.

The study aims to test the acceptability, engagement and physical activity changes of a web-based physical activity program utilizing social support to promote active ageing. The study will be a pre-post trial of a 10,000 steps tournament in older adults. The 10,000 steps team tournament will involve community group team members syncing their tracker recorded steps on the 10,000 steps website to compete with other community groups on average team steps over a 6-week period. Each team will be coordinated throughout the tournament by the project staff who will send tournament updates weekly (e.g. leaderboard updates and time left in tournament). Physical activity information (e.g. physical activity guidelines for older adults) and behavior change information (benefits and barriers, goal setting, environment, habit formation) will also be emailed weekly and participants will be encouraged to engage in a moderated online social networking group specific to their tournament. Local community groups with members predominantly 55+ years will be recruited. Individuals will sign up to their local groups' team. At baseline the trial participants will be asked to start recording their steps through an activity tracker, then complete a brief online baseline survey to assess participant demographics, self-reported physical activity and social support. Participants will complete a brief post-intervention online survey in week 7 to assess intervention acceptability (intervention group only) and reassess physical activity and social support. Participants will compete a follow up online survey in week 14 to reassess physical activity and social support. Intervention engagement (e.g. log ins, days steps synced, time on website) will be recorded via the 10,000 steps website throughout the 14-week trial. The primary outcome will be physical activity changes between baseline, post-intervention, and follow up.

Early childhood dental caries remains a complex childhood problem that affects more than 600 million children worldwide. Our research group has previously found that in NSW currently, one in every 250 children require hospitalisation each year, with a 9% repeat admission rate within a two-year period2 for dental caries. Most of these children attend the safety-net service offered by the public health system. Improving the oral health literacy of parents remains a strong predictor that can shift the barriers to improved oral health outcomes for the child across the lifespan. The latest WHO definition on health literacy is more comprehensive and represents the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. When applied to the prevention of tooth decay this definition moves beyond providing a pamphlet and includes elements of motivation and empowerment related to the skills (tooth brushing) and self-efficacy required to maintain sustained preventive behaviours. Whilst, previous oral health literacy tools have focused on word recognition and understanding appointment visitations, our study will directly measure oral health literacy for behaviour change. We hypothesise that co-designed text message interventions will improve oral health literacy, self-efficacy, and behaviours (tooth brushing) of parents with children waiting for a hospital admission for dental caries more effectively than usual care. This randomised control trial, aims to co-design, assess the effectiveness, and evaluate a text message program to support oral health behaviours, increase the oral health literacy and self-efficacy of parents, compared to usual care. We also aim to evaluate fidelity, barriers, and enablers which will inform potential scale-up of the intervention.

Australia is the thirteenth largest contributor of household waste per capita in the world (Organisation for Economic Co-operation and Development, 2022), spending over $10.5 billion annually on goods and services that are never or rarely used (Australia Institute, 2005). This wasteful behaviour contributes to costly landfills, environmental degradation, and rising household debt. Given society’s overconsumption, a handful of commercial programs currently exist to help people strive for minimalism and to declutter their homes. To the best of our knowledge, none of these commercial programs have been scientifically evaluated to see if they actually work, although many testimonials regarding their effectiveness can be found on the Internet. Thus, there is a clear need to develop an evidence base for such interventions. The purpose of this study is to investigate the effectiveness of a new online educational course that was developed to help people buy and save fewer possession in order to save money, reduce clutter, and safeguard the planet. This new course, Breaking up with Belongings, is based on scientific research regarding object attachment, possession ownership, and behaviour change. The course is self-paced and comprised of 6 hours of content (videos plus workbook activities). Eligible participants will be randomly assigned to receive this program immediately or after a three month delay. We ask that participants complete the course within 7 weeks of receiving it, so that they can spend the rest of their time working toward reaching the goal(s) they set during the course. Participants are assessed at baseline and three months later. We expect that those who recieve the Breaking up with Belongings course immediately will report greater improvements than those who receive access to it after a three month delay.

The research project aims to (1) to determine the effectiveness of the ‘Tailored iSupport’ intervention for carers and people with dementia; and (2) to evaluate the effectiveness of the implementation strategies applied to embed the ‘Usual support’ and the ‘Tailored iSupport’ into the routine services of aged care organisations in real-world settings. The study will also explore the experiences of carers, frontline staff and facilitators in the project. The hypotheses tested in the study are described in the following: 1. Carers receiving the ‘Tailored iSupport’ will report 1) a higher level of QoL; 2) a higher level of Self-Efficacy; 3) a significantly higher level of QoL for the person they care for via a proxy rating; 4) fewer unplanned hospital admissions, less emergency department use and a lower level of permanent admission into residential aged care by the person they care for; 5) better quality care experiences of persons with dementia via proxy ratings, compared to those in the ‘Usual iSupport group’.

Abdominoplasty is one of the most common plastic surgery procedures performed in Australia. A common complication of abdominoplasty is the formation of post operative seroma, which is thought to be influenced by dissection technique utilised by the surgeon. We propose to conduct a study of patients undergoing abdominoplasty, comparing seroma rates with three different diathermy settings. The proposal will be a prospective, randomised, study of consecutive patients undergoing abdominoplasty, with no exclusion criteria. Only patients consenting to involvement will be included. For excision of tissue and dissection of flaps, a monopolar coagulation diathermy with power setting of 20W will be used for one group, a monopolar coagulation diathermy with power setting of 35W will be used in the second group, and a monopolar cutting diathermy with power setting of 35W will be used for the third group. All three diathermy settings are well within usual range of setting used for diathermy and pose negligible additional risk to patients in either group. We hypothesize that the lower diathermy and cutting settings will result in lower seroma rates, due to less soft tissue damage during dissection. The general surgical technique involves scalpel skin incision, monopolar dissection, liposuction, rectus divarification repair where indicated, and layered soft tissue closure. Compression garment’s will be placed at the conclusion of surgery and continued fulltime for 6 weeks. Patient demographic factors and surgical technique baseline characteristics will be compared. Drains will be emptied at midnight daily by ward nurses who are blinded to the study, with outputs documented at 24-hour intervals. Postoperative mobilisation commences on day 1, with a physiotherapist. Drains will be removed when they were <30ml/d for 2 consecutive days. Data collected will include: baseline demographics, surgical technique, daily drain outputs, time to removal of drains, development of postoperative complications. If complications include seroma or haematoma, the size, location and subsequent management will be noted. Follow up period for the purpose of this study will be 6 weeks post operatively.

The DAB study (ACTRN12613000316707) was a pragmatic, randomised study of corticosteroids and nebulised adrenaline in children with bronchiolitis admitted to intensive care. It showed that, compared to standard care alone, the combination of steroids and nebulised adrenaline reduced the duration of positive pressure respiratory support (PPS). The evidence was particularly strong in the sickest children requiring, continuous positive airway pressure (CPAP) and mechanical ventilation (MV), and those who had Respiratory Syncytial Virus (RSV) infection. Chest hyperinflation is a common clinical sign in children with severe bronchiolitis. It occurs because of lower airway obstruction during expiration and subsequent gas trapping in the lung. Chest hyperinflation can be identified clinically but it is also a chest x-ray finding with varying severity. Chest x-ray findings include, flattened hemidiaphragms, an increased number of rib markings and widened intercostal spaces. Children with bronchiolitis and hyperinflation may be more responsive to the bronchodilator effects of combination corticosteroid and adrenaline therapy compared to those without hyperinflation. Moreover, hyperinflation may be associated with RSV infection, and the presence of hyperinflation in this group may explain the strong effect of steroids and adrenaline. We hypothesise that the degree of hyperinflation predicts the response to steroids and adrenaline on duration of PPS in children with bronchiolitis. We also hypothesise that hyperinflation is associated with the presence of RSV infection. The primary aim of this study is to investigate whether chest hyperinflation, based on x-ray findings, predicts the response to corticosteroids and inhaled adrenaline on the duration of positive pressure support in children enrolled in the DAB study. The secondary aims are to investigate whether chest hyperinflation predicts the presence of RSV and human metapneumovirus or other viruses, and to assess the concordance between radiologists of their assessment of the degree of hyperinflation.

Contemporary treatment of early oesophageal (food pipe) cancer, involves minimally invasive endoscopic procedures; while surgery is reserved only for cases with the highest-risk of the cancer spreading into the surrounding tissues. The risk of cancer spread is determined by samples removed at endoscopy, in which a pathologist is looking to see the depth of cancer spread into the wall of the oesophagus or for abnormal characteristics of the cancer. The purpose of this study is to try and identify patients who are considered higher risk by conventional practice, who are actually at low risk for cancer spread; and, thus can forgo the need for a major operation with poor post-operative outcomes with respect to quality of life, morbidity and mortality. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a high risk oesophageal cancer removed at endoscopy. Study details This observational study will be reviewing the medical records of patients who meet the inclusion criteria only. Participants who meet the inclusion criteria will not be required to attend any additional clinic visits or complete assessments; all relevant information will be extracted from medical records directly. It is hoped this research will determine which patients, with lower risk of cancer spread would be considered candidates for non-surgical management, to avoid an unnecessary (major) oesophageal operation.