ANZCTR search results

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.

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.