ANZCTR search results

Executive Summary – The symptom of vaginal laxity or looseness is a common problem effecting anywhere from 24% to 50% of parous women(1,2). It is frequently underreported(1,2). Till recently, the only treatment options for this condition have included physiotherapy or surgery. Both are known to have inconclusive results. Additionally, surgical treatment remains largely diverse in technique with no strong literature suggesting it is effective. Also, risks associated with surgery often don’t make it an amiable choice for younger women who are more likely to be affected by this symptom and potentially considering future pregnancy. Recently, monopolar radiofrequency devices have shown some promising impact on the symptom of vaginal laxity(3, 4). More importantly, they are a low risk option in comparison to surgery. Therefore, we propose to perform a single blinded, randomized sham controlled trial at the Townsville Hospital. The trial will compare treatment with The Thermiva to sham treatment. The study will take place over a period of 24 months. Patients in the treatment and sham group will undergo the same study protocol. There will be an enrolment visit followed by three treatments at one month apart. Follow-up will be at the third treatment and at six and twelve months’ post treatment. According to our sample size calculation we need to recruit 168 patients (84 in the treatment and 84 in the sham group). We will be using the Thermiva monopolar radiofrequency device which is TGA approved and currently being used in Australia for the management of symptoms of vaginal laxity. We will be using the same Thermiva probe for the sham treatments however, will be operating it at sub therapeutic temperatures (at or below 30 degrees Celsius). The temperature suggested to optimal treatment is 47 degrees Celsius. For the Sham will be use 20 degrees Celsius. We will be obtaining HREC approval from The Townsville Hospital prior to commencement of the study. 1. Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, Yacoubian A, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. The Journal of Sexual Medicine. Elsevier; 2017 Feb;14(2):215–25. 2. Dietz HP, Stankiewicz M, Atan IK, Ferreira CW, Socha M. Vaginal laxity: what does this symptom mean? International Urogynecology Journal. Springer London; 2017 Jul 31;23(5):1435–6. 3. Magon N, Alinsod R. ThermiVa: The Revolutionary Technology for Vulvovaginal Rejuvenation and Noninvasive Management of Female SUI. J Obstet Gynaecol India. Springer India; 2016 Aug;66(4):300–2. 4. MD MK, PhD CGR, C BBAMPF, PhD LD, MPH SD, BSc AY, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. The Journal of Sexual Medicine. Elsevier Inc; 2017 Feb 1;14(2):215–25.

Regular consumption of traditionally allergenic foods, like egg and peanut, in solid foods can reduce food allergies, however this is too late for some infants. We have discovered that infant immune responses to egg can be beneficially enhanced during the first six weeks of breastfeeding when mothers eat more eggs. We now propose to investigate the effects of breastfeeding mothers eating higher dietary intakes of both egg and peanut for an extended period of the first six months of life. The key translatable message from this project will be to answer the question of whether higher maternal dietary intakes of eggs and peanuts during breastfeeding are needed to reduce the risk of food allergy development.

Cycling-related injuries, including minor injuries that are largely hidden from other reporting methods, are over-represented in emergency departments. This opens up opportunity for more focused & inclusive analysis of this population of patients. The Bicycle Injuries Study (BIS) aims to identify, describe and quantify the patterns of cause, type and severity of cycling crash injuries, within the adult population, as they present to the Emergency Department of Royal North Shore Hospital in NSW; the trial will be based on extraction and analysis of emergency department medical record data relating to the crash circumstances, resulting injuries & treatment. Collecting data from emergency department records in this way will allow for the creation of an integrated database that grounds cycling injuries in the context of our current road environments, potentially revealing new targets for injury prevention.

Synthetic colloid fluids are frequently used for blood volume expansion in critically ill patients. Starch-based synthetic colloid fluids have been associated with increased risk of acute kidney injury. There is some evidence that gelatine-based colloid fluids may also pose a similar risk. This randomised open-label controlled pilot trial will assess the effects of 4% succinylated gelatine fluid on urinary biomarkers of acute kidney injury in Intensive Care Unit (ICU) patients. This study will also assess clinical outcomes, as secondary endpoints, including change in AKI stage, need for renal replacement therapy (RRT), ICU length of stay and mortality.

The study aims to investigate the links between the parent-adolescent relationship and adolescent mental health and functioning, and how these variables may be mediated by participation in a brief parenting intervention. One hundred and fourteen (114) parent-adolescent dyads will be recruited. Adolescents will be aged 11 to 17 years and will meet diagnostic criteria for i) an Anxiety Disorder, ii) Conduct Disorder or iii) no psychiatric disorder (No Disorder). The goal is to recruit equal numbers of parent-adolescent dyads within each diagnostic category. The main objectives are: 1) to evaluate the influence of differential aspects of the parent-adolescent relationship, particularly connectedness and hostility, on adolescent mental health; and 2) to assess the effectiveness of the parenting group for promoting supportive parenting, improved parent-adolescent relationships (i.e., increased connectedness and reduced hostility), and improved adolescent functioning. Parent-adolescent dyads will take part in two face-to-face multi-method assessment sessions, approximately six to eight weeks apart. Following the first assessment session (pre-intervention, Time 1), parents will participate a brief, stand-alone 2-hour parenting intervention, the Triple P-Positive Parenting Program discussion group: ‘Coping with Teenagers’ Emotions’. The intervention aims to enhance parenting skills and knowledge and introduce strategies to help parents encourage their teenager to better manage their own emotions. The second assessment session (post-intervention, Time 2) will be held approximately two to four weeks following parent attendance at the parenting group. Parent-adolescent dyads will be followed up via online questionnaires six months after completing the second assessment session (6-month follow-up, Time 3).

Aims: The aim of the proposed study is to determine feasibility and efficacy of a strategy where BP targets during management of shock in ICU are individualized for each patient based on his/her basal-BP. Primary objective: To demonstrate that compared to the standard care of patients with shock in ICU, a strategy of targeting patients’ basal-BP would minimize the degree of untreated relative hypotension (BP-deficit) during vasopressor therapy by at least 75%. Secondary objectives: To determine whether in this study design, the interventional phase, as compared to conventional care, can (a) enrol at least one patient per week (b) complete follow up for all patients with >90% of data collection (c) reduce the incidence of significant AKI (at least two AKI-stage increase) during the first 14 study days, (d) reduce the peak increase in serum creatinine during the first 7 days among patients not on renal replacement therapy (RRT), (e) reduce percentage of time-points spent with >20% BP-deficit by at least 75%, and (f) be implemented without any appreciable increase in new-onset arrhythmias or serious adverse events. Methods: This is a prospective before-and-after pilot study at multidisciplinary academic ICUs. The study will be conducted over eight consecutive months- first four months of conventional care, followed by the last four months of individualized BP targets. All consecutive eligible patients screened during the two periods will be enrolled in the study. Besides demographics, severity score and clinical outcomes, the study will collect four hourly data on the difference between basal-BP and achieved-BP during the first five days of vasopressor therapy.

The aim of this pilot study in premature infants who are on nasal continuous positive airway pressure (nCPAP) is to determine if surfactant given by aerosol is safe, tolerable, and able to reduce the need for mechanical ventilation and use of instilled surfactant administered using an endotracheal tube.

Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN2246 in healthy volunteers. Participants in Part A of the study will receive a single dose of PRN2246. Participants in Part B of the study will receive one dose of PRN2246 per day for up to 10 days

Once a woman with gestational diabetes mellitus (GDM) gives birth and her GDM resolves, Little attention is paid to her future risk of developing type 2 diabetes mellitus (T2DM). Women with GDM have up to a 7 times greater risk of developing T2DM than women without GDM. Despite this increased risk, ongoing care or support programs tailored to the unique characteristics on this group are not currently available nor easily accessible. This study proposes to address this gap. We will evaluate the impact of a tailored, self-administered Internet program, with or without individualised video coaching to empower women with a history of GDM to improve their nutrition and physical activity behaviours and reduce their T2DM risk.

Soluble fibre is a source of plasma short chain fatty acids (SCFA), which are known to have antiinflammatory properties. This study will investigate the plasma short chain fatty acid (SCFA) yield over 10 hours following consumption of four different soluble fibre supplements in healthy adult males and females. This will provide a proxy for rating the antiinflammatory potential of each type of soluble fibre. This information will be used in the design of future clinical intervention trials.