ANZCTR search results

This is a Phase I study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with atopic dermatitis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist, developed by Akaal Pharma PTY LTD. AKP-11 targets the immune activity, inhibits the over-expression of pro-inflammatory cytokines and factors including the inflammation. AKP-11 has been tested in several immune/ inflammatory diseases including psoriasis patients in order to establish its efficacy. The twice daily topical application of 1 g ointment containing 30 mg AKP-11 or matching placebo in up to 21 participants. Participants will be randomized as groups of 2 (AKP-11) and 1 (Placebo). The dosing is proposed for up to 28 days or one week post complete clearance, confirmed by the physician, whichever comes first.

This is a Phase II study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with mild to moderate psoriasis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist, developed by Akaal Pharma PTY LTD. AKP-11 targets the immune activity, inhibits the over-expression of pro-inflammatory cytokines and factors including the inflammation. AKP-11 has been tested in several immune/ inflammatory diseases including psoriasis patients (Phase I) in order to establish its efficacy. The twice daily topical application of 0.5 g of 3% ointment containing 15 mg AKP-11 or matching placebo in up to 65 participants for 41 days. Participants will be randomized 1 to 1 into 3% AKP-11 and Placebo groups respectively.

Emergency Department Procedural Sedation is performed many times each day in Emergency Departments around the country. It is becoming an increasingly important skill in the practice of Emergency Medicine. It allows the performance of procedures (including reduction of fractures and dislocations, suturing of wounds, draining of abscesses etc) which in the absence of sedation would be painful and distressing for patients and or technically more difficult or impossible for Doctors. This sedation is increasingly valuable in health systems which demand more efficient use of resources. Effective, safe procedural sedation offers this by saving operating theatres (which are resource intensive) for more complicated procedures. This study aims to add to the current knowledge base by ongoing data collection on procedural sedation done in the Emergency Department. The actual procedural sedation for the patients in the study period will not be influenced by this study. This study will simply document techniques and outcomes of sedation which is done in the normal practice of Emergency Medicine at our Hospital. Complications of the sedation and the procedure will be recorded.

Obstetric anal sphincter injury syndrome (OASIS) is a common occurrence in females after childbirth, and is an established risk factor for faecal incontinence (FI). Risk factors for OASIS include increased maternal age, high birth-weight and co-morbidities such as diabetes. As each of these elements is on the rise, the likelihood is that the frequency of OASIS will increase, and along with it, the possible increased burden FI. However, its association with the development of FI remains poorly understood and the obstetrics recommendation following OASIS (C-section vs vaginal delivery) on subsequent pregnancies is highly variable and debated in the literature. We aim to assess the anorectal physiology effect of OASIS, as well as its impact on the patient (Sexual health, quality of life, urinary and faecal incontinence) to first obtain a better understanding of OASIS. We will then compare the data of patients who develop FI (symptomatic) to those who do not (asymptomatic) in an effort to better understand OASIS and its link to FI. Lastly, we aim to collect long term follow up data on patients in order to assess for the subsequent development of FI and other pelvic floor problems. This will enable us to build a prediction model to assist in clarifying the obstetrician’s practice and recommendations for future pregnancies in women with OASIS and/or FI.

The Ripple Effect (RE) is a digital intervention that will be evaluated using nationally comparable scales—the SOSS (adapted to assess self-stigma and perceived-stigma) and the LOSS—administered at baseline and on completion of the intervention. The RE is based around the design and evaluation of a highly responsive and flexible website providing: 1. Opportunity to anonymously share experiences in a peer-supported environment. 2. Opportunity to increase knowledge and literacy about the personal experience of suicide (challenging suicide myths and framing experience in a contextual way, facilitating help-seeking where required). 3. Encouragement for a positive cycle by which the disruption of the negative feedback of self-stigma and perceived-stigma will also reduce stigma in others. The RE aims to: (1) Identify the effect of a digital intervention to reduce stigma experienced by rural community members with a personal experience of suicide—bereaved by suicide, attempted suicide, cared for someone who attempted suicide, had thoughts of suicide or touched by suicide in another way—as shown by changes in the Stigma of Suicide Scale (SOSS). (2) Increase suicide literacy in the rural community and explore the relationship between change in stigma, suicide literacy—as shown by the Literacy of Suicide Scale (LOSS)—the nature of lived experience of suicide, age and health behaviour measures. The RE is designed to reach as many isolated rural community members (both geographically and psychologically) as possible—irrespective of age of technology or internet quality. The project is developed around a responsive, flexible website that will work across multiple platforms (e.g. PC, smart device) and allow for delivery of both staged and scheduled content. It is available as a highly accessible, non-linear, self-paced experience—focusing on suicide stigma topics and addressing knowledge, motivation, beliefs/attitudes, and building skills and behaviours. A Steering Group, comprising farmers with a lived experience of suicide, stigma experts, academics, health professionals and digital experts, will determine content. Each session will include a digital story about the experience of suicide, describing the stigma experienced, whether this was overcome, and how this was achieved. Hard copy and digital postcards will allow men to share experiences and read about other’s experiences. Complementing this is education about suicide and stigma; techniques to reduce stigma; and, links to available resources and support services. Participants are requested to set personal challenges (designed to reduce stigma) during the intervention. Achievement of these will be self-evaluated.

Background and rationale: Patients undergoing procedures such as flexible cystoscopy are usually given information regarding the findings from the procedure, and further treatment plans. This may be done verbally (as is usual at Austin Health) or in writing (as is done in some centres). We hypothesise that the provision of written information will aid patient understanding and retention, and thereby reduce anxiety. Methodology: Patients undergoing flexible cystoscopy will be invited to participate, with the main exclusion being those with language, psychological or cognitive barriers to participation. Patients will be given a plain (English) language statement, and will sign the study consent form, and complete the pre-procedure questionnaire. They will then have their flexible cystoscopy as is usual practice. The findings from the cystoscopy as well as the plan of management will be communicated to them either verbally only or on a standardized written template in addition, according to a random allocation. At the conclusion of the procedure, the patient will be invited to complete the post-procedure questionnaire. Data collection and analysis: The questionnaires and limited clinical and demographic data will be collected in blinded fashion by members of the research team other than the proceduralists (p). Data from the medical record to be collected in de-identified fashion includes age, sex, diagnosis (ie bladder cancer, other pathology or normal), prior cystoscopies (& number) and need for further intervention (after cystoscopy). Endpoints: The patient’s understanding of the findings at cystoscopy and the subsequent plan will be coded as follows: *Good: patient’s response matches documentation from proceduralist *Fair: patient’s response is close to documentation from proceduralist, but with minor errors / discrepancies *Poor: No response or response completely erroneous The patients’ self-assessed impression of being well informed and worried will be scored on a standard 5-point scale. The above measures will be compared between the two groups receiving verbal vs written information, with assessment of associations with other variables (i.e. age, sex, diagnosis, prior cystoscopies and need for subsequent procedures) Significance: On the basis of this study, we will determine the preferred method for communicating with patients after flexible cystoscopy. The findings may have relevance for patient communication after day-case surgical procedures in general.

Development of type 2 diabetes is closely linked with overweight and obesity. Due to the increasing prevalence of obesity in Australia, combined with an increasingly aged population, type 2 diabetes and associated health complications will become an increasingly burdensome public health problem in the near future. Epidemiological studies, as well as animal studies, suggest that a higher omega-3 status might be protective against obesity-related insulin resistance, however, intervention trials have had equivocal results. Recent evidence suggests that the effect of omega-3 polyunsaturated fatty acids on insulin resistance might be sex dependent. Therefore the aim of the current study is to determine whether there is a sex-dependent response on measures of insulin resistance to an omega-3PUFA intervention

There is much confusion in the community regarding the difference between using a Graded Exercise Therapy (GET) protocol to increase activity and a pacing protocol to increase activity. This project is using a pacing protocol to increase activity – a concept not well investigated in the literature. Aims 1. To determine the feasibility and acceptability of pacing plus active video gaming as a management strategy to increase physical activity levels in adults with CFS/ME 2. To explore if pacing plus active video gaming is an effective management strategy to increase physical activity for people with ME/CFS 3 To explore whether pacing plus conventional physical activity differs in effectiveness to pacing plus active video gaming compared to pacing alone 4. To explore the relationship between allostatic load and physical activity in people with CFS/ME

This study aims to investigate the effects of a targeted exercise program on muscle function in men with non-metastatic prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you are a male aged 50-80 years with non-localised non-metastatic prostate cancer, and are about to commence androgen deprivation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive routine recommendations for healthy lifestyle. Participants in the other group will undertake an exercise program which will be home-based and administered by an exercise physiologist The exercise physiologist will design a program tailored to each participant to strengthen lower limb muscles.. After 12 months all participants will undertake physical testing to evaluate any effects of the exercise program. They will also be asked to complete a questionnaire evaluating quality of life. It is hoped that the exercise program will help to prevent muscle loss, which is a major adverse effect of ADT.

Our aims of the study are: 1. Increase awareness and adoption of healthy lifestyle factors for people with cardiovascular risk factors, to prevent cardiovascular morbidity and mortality 2. To conduct a feasibility study in the primary care setting to promote the Life's Simple 7 approach, developed by the American Heart Association, for people at risk of stroke 3. To implement a 6 month study to confirm the feasibility, and to provide preliminary data on effectiveness of such an approach. 1. Our overarching hypothesis is that targeted and individualised, longterm support will result in significantly reduced rate of, and risk factors for, morbidity and mortality from stroke and other causes, compared to current practice 2. The 6 month intervention, based on the Life's Simple 7 (LSS) approach, will result in a reduction in stroke risk, measured using the LSS score 3. We hypothesise that the intervention will be feasible, acceptable for participants and we will also collect cost data to determine if the approach is cost effective.