ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

You can narrow down the results using the filters

32712 results sorted by trial registration date.
  • Pelvic floor assessment in post-partum women

    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: Help us beat rural suicide

    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.

  • Written information delivery to improve patient understanding and anxiety at Flexible cystoscopy

    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.

  • Do omega-3 polyunsaturated fatty acids have a gender-specific effect on insulin resistance?

    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

  • Exploring pacing to increase physical activity: Is active video gaming a feasible and acceptable strategy for adults with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)?

    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

  • Exercise to prevent muscle loss during androgen deprivation

    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.

  • The effect of healthy lifestyle changes on stroke risk in adults with cardiovascular disease

    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.

  • Parent-Child Interaction Therapy for Treating Preschool Conduct Problems

    Conduct problems are the most common reason children are referred for mental health treatment, and each child with conduct problems incurs a lifetime public service cost more than eight times greater than that for a healthy child. The presence of callous-unemotional (CU) traits (e.g., lack of empathy/guilt, uncaring attitudes) designates an important subgroup of children whose severe, stable, and aggressive conduct problems are developmental precursors to psychopathy and antisocial behaviour in adulthood. Consequently, CU traits were added as a specifier (called ‘with limited prosocial emotions’) to the diagnosis of conduct disorder in the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders. Between 50-70% of Australian children with diagnosable conduct problems show clinically significant levels of CU traits ('CP+CU children’). Given that treatment for adult psychopathy does not significantly reduce crime and violence, early intervention with at-risk children is vital. However, the conduct problems of CP+CU children are resistant to many traditional evidence-based behavioural interventions that are effective for children without CU traits (‘CP only children’). The reason for this resistance to treatment appears to be that the conduct problems of children with CU traits arise from distinct factors from those typically targeted in traditional interventions. While the field has developed a better understanding of the unique deficits and needs of CP+CU children, interventions that comprehensively target them have not yet been systematically developed and tested. In order to improve the clinical outcomes of these particularly high risk (CP+CU) children, a major shift in clinical practice paradigms is needed. We propose testing the efficacy of a novel intervention to improve emotional and behavioural outcomes in young CP+CU children. Through pilot testing, an adaptation of Parent-Child Interaction Therapy (PCIT), a traditional evidence-based model of parent management training (PMT) intervention, has developed and refined. PCIT-CU, as it is known, addresses the distinct temperamental deficits of CP+CU children—reward dominance, and insensitivity to distress cues and punishment. PCIT-CU differs from standard PCIT in three key ways: it (a) trains parents to engage in warm, emotionally responsive parenting that improves conscience development among temperamentally fearless children, (b) systematically supplements punishment-based parenting strategies (i.e., time out) with reward-based techniques shown to improve treatment outcomes for reward-dominant CP+CU children, and (c) delivers emotional skill-building instruction to CP+CU children to target their distinct emotional deficits. Given the significant societal burden of this seriously impaired and treatment-resistant subpopulation of children, outcomes associated with the project have the potential to yield impactful and far-reaching clinical and public health benefits.

  • Use of intravenous fat emulsion an alternative method of preparing patients for positron emission tomography (PET) imaging of the heart

    This research project aims to help improve detection methods for heart disease. The purpose of this research project is to investigate whether it is possible to prepare patients faster and whether it is possible to improve imaging of the heart for cardiac PET imaging. Usual practice is to have patients on a high fat, low carbohydrate diet from the evening beforehand and then to have them fasting for 4-6 hours immediately prior to the scan. The new method is called intravenous fat emulsion (trade name Intralipid), which should be able to be administered rapidly. This will be tested to see if it is an effective preparation for positron emission tomography using a sugar-based radionuclide as an alternative method of preparation.

  • Pathophysiology and Prevention of Early Bile Duct Injury in Liver Transplantation: The role of the additional In-Situ Bile Duct Flush

    Biliary complications are significant cause of graft failure and morbidity in Liver Transplantation. Cellular injury has been shown in the literature to contribute to the development of biliary complications. A growing body of evidence demonstrate that bile duct injury occurs early after organ retrieval. Bile salt toxicity is a vector of injury to bile ducts which may be preventable. Experimental animal studies on pigs have indicated that flush the bile duct with hydrophobic bile salts and preservation solution can induce injury to the biliary epithelium during cold ischaemia. In addition, there have been studies demonstrating the importance of adequate biliary flush out before cold storage in liver transplantation, however this would typically occur at the backtable procedure in the donor surgery, which may be up to 20minutes from cross clamping. Our hypothesis is that an intraoperative bile duct flush (IBF) before cross clamping, will decrease exposure of hydrophobic bile salts to bile duct and reduce bile salt toxicity. The reduced bile salt toxicity should decrease injury to the bile duct which has been associated with the development of biliary strictures and biliary complications and highlights the expected benefit of the intervention.

Tags:
  • Finding clinical trials