ANZCTR search results

Biliary fully-covered self-expanding metal stents are increasingly used over plastic or uncovered self-expanding metal stents due to their long-term patency and removability. However, there is concern that their placement across the papilla may lead to post-ERCP pancreatitis. Thus, this study aimed to assess the rates of post-ERCP pancreatitis with and without the use of fully-covered self-expanding metal stents for both benign and malignant indications. Our hypothesis for this study was that the use of fully-covered self-expanding metal stents would be associated with a higher risk of post-ERCP pancreatitis. This is a retrospective study involving three Australian tertiary referral centers. Consecutive adults who underwent ERCP for biliary indications between October 2016-October 2019 were included. We analysed the rate of post-ERCP pancreatitis, severity of pancreatitis, other procedure- and stent-related adverse events occurring within 90 days.

Currently, patient reported outcome measures (PROMs) such as the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) are the standard method to assess improvement after spine surgery. However, these measures are subjective and do not provide an objective measure of physical capacity. To provide patients with an accurate representation of their function, it seems most beneficial to provide patients with a standardised objective tool which reflects the requirements of daily living. However, the necessary equipment needed to conduct some of these tests may not be accessible for some clinicians. Therefore, the aim of this study is to develop a tool which can be easily and reliably administered within clinical practice. The hypothesis of this study is that test scores are responsive to changes over time, more so than the standard measures of pain (VAS) and disability (ODI). The secondary hypothesis is that changes in clinical tests (e.g. the fingertip to floor) will correlate with the changes seen in their objective counterparts (e.g. the DorsaVi wearable sensors).

This is a parallel, randomized, placebo-controlled, two-part, Phase 1, Investigator- and participant blinded, first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity of single (SAD17442) and multiple (MAD17443) ascending, subcutaneous doses of SAR444559 in male and female healthy participants aged 18 to 55 years. Part 1 – SAD17442: - The study duration per participant will be up to 12 weeks, including screening period. - The treatment duration will be 7 weeks including a 4-day in-house institutionalization period after single dose administration and a follow-up period up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and one 4-day in-house period, and 4 to 5 ambulatory visits to the ophthalmologist. Part 2 – MAD17443: - The study duration per participant will be approximately 16 weeks, including screening period and treatment period of 11 weeks. - The treatment duration will be approximately 11 weeks including 4-day in-house institutionalization periods after each dose administration (3 total doses) and follow-up periods between and after each of the three institutionalizations up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and three 4-day in-house periods, and 4 to 5 ambulatory visits to the ophthalmologist.

RoboSTER is a prospective cohort trial designed to evaluate the outcomes following robotic removal of pelvic tumours and attached organs during multivisceral complete soft tissue extended resections (STER). The procedure is split into three parts, Firstly, there is removal of the bowel, then removal of the bladder, +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The third part involves construction of a faecal diversion, ileostomoy/colostomy, using a section in the bowel to drain faecal matter produced in the intestines. The main objective is to investigate whether performing the operation inside the body (via a "keyhole surgery approach") with robotic assistance (using the da Vinci Xi surgical robot) is safe and feasible. Who is it for? You may be eligible for this study if you are aged over 18 years, and are undergoing an elective robotic multivisceral complete soft tissue extended resections for pelvic cancers. Study details All participants will undergo a multivisceral complete soft tissue extended resection using robotic surgical techniques. This will involve using the robotic equipment to perform the resection, and is anticipated to take approximately 13 hours to complete. For all participants conversion to traditional approach rates, quality of life measures, morbidity data and other clinical data (ie: blood loss, oncological outcomes etc) will be recorded to test the safety and feasibility of the approach. It is hoped that this study may demonstrate that intracorporeal pelvic tumour removal following robotic multivisceral complete STER is a safe and feasible approach and may result in better patient outcomes.

Existing therapeutic writing studies are largely based on Expressive Writing, a short-term intervention based on a single writing-task instruction. They have demonstrated the emotional and physical health benefits in various populations; however, the feasibility and potential effectiveness of a longitudinal therapeutic writing program utilising creative writing undertaken in a therapeutic setting to improve emotional wellbeing and adaptation to grief is unknown. The premise underlying this longitudinal study was that more and longer-lasting health benefits might be achieved than the short-term Expressive Writing intervention in the context of grieving if the writing intervention was extended, if writing prompts were more varied and if the intervention was undertaken in a therapeutic setting. This quantitative and qualitative Writing-for-wellbeing pilot study assessed the feasibility, acceptability, and potential efficacy of a longitudinal writing intervention in helping participants to work through their grief to facilitate adaptation, meaning-making, and emotional wellbeing. The study was designed to test a 6-session writing intervention with two groups of 10 adult participants each. The first comprised bereaved participants. The participants in the second group had experienced living losses, which included life-threatening illness, divorce, infertility, severe long-term menopause, caring for an elderly parent with dementia, loss of family connection, and caring for a disabled child. Groups were small to facilitate a safe environment and an intimate space for sharing. To assess potential efficacy, participants completed a series of measures at pre-test (immediately before session 1) and post-test (at the conclusion of session 6). Participants completed measures of prolonged grief, adaptive coping, anxiety and depression, meaning reconstruction, and a satisfaction questionnaire.

Anxiety disorders are highly prevalent among children, are often highly comorbid with problematic sleep. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., anxiety OR sleep). Children are therefore routinely provided with a digital mental health program targeting their primary presenting problem (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means anxiety is routinely treated, but sleep is not. This randomised controlled trial will target children with primary anxiety, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH of anxiety and sleep problems, with one that will target ONLY anxiety. We expect that compared to the programs targeting ONLY anxiety, programs directly targeting comorbidity of anxiety and sleep will lead to better and longer-lasting mental health outcomes not only for anxiety problems, but also for comorbid sleep problems.

Depressive disorders are highly prevalent among adolescents, are often highly comorbid with problematic sleep. In fact, problematic sleep is one of nine possible criterions of a major depressive disorder diagnosis. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child and adolescent mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., depression OR sleep). Youth are therefore routinely provided with a digital mental health program targeting their primary presenting problem only (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means depression is routinely treated, but sleep is not. This RCT will target adolescents with primary depression, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH depression and sleep, with one that will target only the primary presenting problem of depression. We expect that compared to the program targeting ONLY depression, the program directly targeting BOTH depression and sleep will lead to better and longer-lasting mental health outcomes not only for the depression, but also for the comorbid sleep problem.

Anxiety and depressive disorders are highly prevalent among children and adolescents, are highly comorbid with each other, are chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child and adolescent mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., anxiety OR depression). Youth are therefore routinely provided with a digital mental health program targeting their primary presenting problem (i.e., the problem that is causing them the most distress or is most interfering with their functioning). This randomised controlled trial will target adolescents with both anxiety and depression, comparing an online program targeting BOTH anxiety and depression, with one that will target only the PRIMARY presenting problem (i.e., either anxiety OR depression). We expect that compared to the program targeting ONLY the primary presenting problem, the program directly targeting BOTH anxiety and depression will lead to better and longer-lasting mental health outcomes not only for the primary presenting problem, but also for the comorbid problem.

Ambroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study aims to investigate if ambroxol in high doses is effective in treating ALS. This study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where newly diagnosed ALS patients will be asked to participate. Participation will be over a 32-week period, where they will come in for a 4-week screening, 24-week treatment, and 4-week end of study safety follow-up period. The participants will receive either the placebo or drug solution that they will take three times a day, up dosing each week till they reach the maximum dose or highest dose they can tolerate. Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.

This pragmatic effectiveness-implementation hybrid type-1 cluster randomised controlled trial in general practice will determine effectiveness and cost-effectiveness of two multi-strategy interventions, RELEASE and RELEASE+, in supporting safe cessation of long-term antidepressants when there is no clinical indication for continued use. Implementation strategies will be evaluated and assessed for scale up to improve primary health care and outcomes for patients. All prescribing decisions are made as usual by patient and GP together.