ANZCTR search results

The aim of this research project is to compare Glucagon with Diazoxide for the maintenance of normal blood sugar levels in babies of mothers with diabetes who have low blood sugar levels. The routine nursery treatment differs with each baby but includes use of high concentration sugar infusion (drip) given through an IV line placed in a large vein, intravenous Glucagon and oral Diazoxide. We aim to determine which of these medications, Glucagon or Diazoxide, is better at maintaining blood sugar and which is easier to use

The REAL Treatment project will investigate the inter-play between evidenced-based interventions that improve the child caregiving context, childhood behavioural outcomes, and, changes in DNA methylation of the major neurodevelopmental genes. 400 Children aged 2 to 8 years and their families will be recruited through the Sydney Child Behaviour Research Clinic over a 4 year period to participate in the REAL Treatment Study: A parenting Intervention for Child Conduct Problems. Families and the research team will form a supportive partnership to assess and monitor a child’s behavioural, emotional and neurodevelopmental progress, as well as parenting progress and family environment over the course of a 6 to 10 week tailored, evidenced-based parenting intervention to address child conduct problems. Assessments will be taken prior to and directly after receipt of the intervention as well as at a three month follow-up review assessment. Assessment will cover areas including: Child adjustment and diagnostic status, caregiver/parent adjustment, family environment, engagement with and dose of intervention received, epigenetic assessment (buccal cell collection for methylation assessment) and neurodevelopmental assessment (examining processes of emotional attention and responsiveness to stimuli). Preliminary assessments will also be conducted with a sub-sample of participants who are expected to be on the wait-list for 3 months or more before commencing treatment. A multi-informant assessment method will be applied throughout the research protocol that includes gathering data from: parents/caregivers; clinical interviews; the use of standardized questionnaire and psychometric assessments; coding of observational data of child and family interaction activities; and, teacher/educator reports and completion of questionnaires. We aim to a) confirm an emerging model of how epigenetic regulation of the major neurodevelopmental systems maps onto individual differences in comorbid symptom profiles before and after intervention; b) to examine how this regulation and mapping predicts individual differences in responsiveness of children to intervention that produces standardised and measurable improvements in the child caregiving environment; c) to examine how early intervention alters epigenetic regulation of the major neurodevelopmental systems and REAL (responsiveness, emotional attention and learning) phenomena, thus modifying risk versus protection for future development.

This study aims to investigate an alternative method of administration, an auto-injector device containing ACP-011 compared to the usual needle and syringe. This research project is testing and comparing the safety, tolerability, pharmacokinetics (the amount of study drug and it’s breakdown products in your blood), pharmacodynamics (how your body is affected by the study drug) and immunogenicity (how your immune system is affected by the study drug) of ACP-011. Approximately 26 healthy male participants will be enrolled across 2 cohorts (groups). Each cohort will consist of 13 participants. The study medication will be administered through two methods over two periods, Particpants will receive both treatment methods in a particular sequence. The dose of study drug will be the same for each method. Participants will not have a choice as to which method or treatment sequence assigned, this will random (like flipping a coin). After the first treatment period, there will be a 14 day period where there will not be any study medication given. This period is known as a wash-out period. Treatment A: consists of a single subcutaneous (SC) (just under the skin) injection to the abdomen administered via syringe and needle. Treatment B: consists of a single SC injection administered via the auto-injector to the same quadrant of the abdomen as the previous injection (depending on sequence). Total participation in the study consists of 45 days which is broken up into 3 phases: - Screening Phase: During which participants will undergo suitability assessments - Treatment Phase: During which participants will be required to stay overnight in the unit for 8 consecutive nights on two separate occasions. Following this participants will be required to attend the study centre on 3 separate occasions - Washout Phase: in between the inpatient stays, where no study visits are required.

Current treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This trial will examine the safety, tolerability and preliminary efficacy of DEN-181 in Rheumatoid arthritis patients.

The purpose of this study is to compare the effects of an immunotherapy combination of both durvalumab plus tremelimumab with or without chemotherapy on you and your lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have histologically and/or cytologically confirmed diagnosis of metastatic squamous or non-squamous, non-small cell carcinoma of the lung. Study details Participants will be allocated by chance to one of two treatment groups. Participant in both groups will receive durvalumab and tremelimumab every 28 days for 4 cycles followed by durvalumab every 28 days until disease progression. Participants in one group only will also receive additional chemotherapy during the first stage which will be dependent on Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC). Squamous Cell treatment will include gemcitabine and cisplatin or carboplatin while Non-Squamous Cell treatment will include pemetrexed and cisplatin or carboplatin. Immunotherapy with immune checkpoint inhibitors has demonstrated superior efficacy compared to chemotherapy and has a favourable side effect profile in the treatment of a subset of patients with NSCLC. Combining immunotherapies in the second-line setting has resulted in higher anti-cancer activity, but increases risk of immune-related side effects. Combining immunotherapy with chemotherapy is a promising new approach, with early results indicating much higher anti-cancer activity then would be expected with either treatment alone with no additional toxicity. The combination of two immunotherapy agents, with or without chemotherapy may be the best way to balance the chances of prolonged anticancer responses seen with immunotherapy against the risk of side-effects associated with treatment.

The purpose of this study is to, 1. Assess the effect of MWM on fibular positional fault in CAI 2. Evaluate the effectiveness of MWM on clinically relevant outcomes (dorsiflexion range, pressure pain threshold, pain intensity, function, static and dynamic balance) Participants aged over 18 years will be recruited from the general community in the Newcastle area of New South Wales, Australia and volunteers with CAI will be accepted into the study if they satisfy the inclusion and exclusion criteria as endorsed by the International Ankle Consortium. They will also be excluded if they have conditions for which manual therapy, taping or radiographs are contraindicated. All physiotherapy undergraduates, except first year students also be excluded. The initial screening will be performed over the telephone after the potential participant contacts the research team. The screening questions are based on injury history. If a potential participant appears eligible following the telephone interview, further screening will be performed using Qualtrics survey tool. Survey link with two questionnaires: the Foot and Ankle Ability Measure (FAAM) and the Cumberland Ankle Instability Tool (CAIT), will be sent, along with the participant information statement and the consent form, through an email. Once the eligibility decided, (CAIT less than or equal to 24, FAAM: ADL < 90%, FAAM: Sports <80 %), the participant will be contacted to schedule an appointment for data collection. Consenting participants will be randomised into two groups: an experimental group (MWM), and a placebo group (detuned laser). All of the participants will be assessed for general joint hypermobility using the Beighton score. Mechanical ankle instability will be tested using two X-rays taken while performing an anterior drawer stress test. The clinically important outcome measures will include; radiological imaging of fibular position, dorsiflexion range of motion, pressure pain threshold, pain intensity, function, static balance and dynamic balance. Researcher who collect the measurements, and the radiographer will be blinded to the treatment allocation. Due to the nature of the intervention, treating physiotherapist cannot be blinded. Further, the participant does not know which treatment is the active intervention. Then according to the random allocation; the participant will receive a MWM or a placebo intervention. Participants will receive between 2- 8 intervention sessions over 4 weeks, depend on the clinical judgement of the treating therapist on individual response. The same measures will be repeated at the fourth week after enrolment. Follow up data collection will be carried out after twelfth week, and after twelfth month of the intervention. Telephone interviews will be conducted in every 4 weeks after enrolment up to one year. These will be made to record new injuries, any treatment co-interventions and the level of engagements in sports and other activities

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.