ANZCTR search results

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

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30819 results sorted by trial registration date.
  • Effectiveness of an Online Group Memory Intervention for Neurocognitive Disorders: Pilot Study

    This a pilot study aiming to determine how appropriate and helpful is a telehealth program aimed to improving memory functioning in people who have a condition affecting their cognitive abilities (e.g., memory, attention, etc.). In other words, will this telehealth memory intervention lead to improvements in memory problems and other psychological factors (e.g., satisfaction with participation in social roles). The structured group rehabilitation program consists of six weekly two-hour sessions, covering psychoeducation about the impact of neurological conditions on memory, training in compensatory memory strategies, and education on the influence of lifestyle factors like diet, exercise, and sleep. The sessions involve interactive activities and homework tasks to practice and apply the learned skills in daily life.

  • Effectiveness of an Online Group Memory Intervention for Neurocognitive Disorders: Randomised Controlled Trial with a Waitlist Control

    This is a randomised controlled trial comparing the effectiveness of an online telehealth program aimed to improving memory functioning in people who have a condition affecting their cognitive abilities (e.g., memory, attention, etc.) with a waitlist control. In other words, will this telehealth memory intervention lead to improvements in memory problems and other psychological factors (e.g., satisfaction with participation in social roles). The structured group rehabilitation program consists of six weekly two-hour sessions, covering psychoeducation about the impact of neurological conditions on memory, training in compensatory memory strategies, and education on the influence of lifestyle factors like diet, exercise, and sleep. The sessions involve interactive activities and homework tasks to practice and apply the learned skills in daily life.

  • Effectiveness of Telehealth vs Face-to-Face Group Memory Intervention for Neurocognitive Disorders

    This is a semi-randomised controlled trial that compares the effectiveness of an online telehealth versus face-to-face program aimed to improve memory functioning in people who have a condition affecting their cognitive abilities (e.g., memory, attention, etc.). In other words, will this telehealth memory intervention lead to improvements in memory problems and other psychological factors (e.g., satisfaction with participation in social roles). Participants will have the option to either elect do the program over telehealth only, or telehealth/face-to-face at Westmead Hospital. The structured group rehabilitation program consists of six weekly two-hour sessions, covering psychoeducation about the impact of neurological conditions on memory, training in compensatory memory strategies, and education on the influence of lifestyle factors like diet, exercise, and sleep. The sessions involve interactive activities and homework tasks to practice and apply the learned skills in daily life.

  • Safety and Feasibility of Allogeneic Cord Blood-Derived Cell Therapy in Preterm Infants with Severe Brain Injury (ALLO Trial)

    This trial aims to assess the safety and feasibility of using allogeneic UCBCs in preterm infants with severe brain injury. The primary objectives include evaluating the availability of at least 4/6 HLA-matched allogeneic UCBCs for more than 60% of eligible infants and assessing the safety of UCBCs administration by monitoring adverse events and the absence of graft versus host disease (GVHD). Secondary objectives involve evaluating the impact of UCBC administration on short and long-term clinical outcomes, such as death, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, sepsis, developmental delay, cerebral palsy, blindness, and deafness. Additionally, the trial aims to assess the effect of UCBCs on immune responses by measuring cytokine levels. The study will enroll 20 preterm infants with severe brain injury, divided into two strata based on gestational age. The infants will receive one intravenous infusion of 4/6 or higher HLA-matched allogeneic UCBCs obtained from the BMDI Cord Blood Bank at a dose of 50 million cells per kg. The trial will span 3-5 years, including a 24-month post-intervention follow-up period. The recruitment will be limited to Monash Children's Hospital.

  • Weight bias in Australian healthcare students: Examining the effectiveness of an empathy vs science approach to stigma response

    The negative attitudes and beliefs towards people living with overweight or obesity exhibited by healthcare students have the potential to impact the care they provide to this population in future practice. Therefore, it becomes increasingly important to develop interventions that aim to reduce weight bias in healthcare students. This study aims to investigate whether evoking empathy towards people living with overweight or obesity or providing education about the multifactorial causes of obesity will be the most effective in reducing Australian healthcare students' explicit weight bias. Students will view one of 3 videos (about empathy evoking, multifactorial causes of obesity, and smoking) and answer several questionnaires. It is hypothesised that the empathy evoking video and the video about the multifactorial causes of obesity will be more effective in reducing students' explicit weight bias compared to the smoking video. We will also explore whether one of the two main videos (empathy evoking and multifactorial causes of obesity) is more effective in reducing students' explicit weight bias.

  • Use of Acellular Human Dermal Allograft Patch for Augmentation of Rotator Cuff Repair - A Randomised Controlled Trial

    To compare whether use of a dermal allopatch graft in rotator cuff repair leads to improved functional and structural outcomes over a 2-year period compared to no graft. It is expected the use of these grafts will improve functional shoulder outcomes and reduce the re-tear rate following surgery. If successful these grafts can be potentially considered a gold standard of care moving forward. We will also be monitoring for any changes in adverse event profile.

  • Assessing ginger (6-Shogaol) in improving blood markers (cytopenias) of patients with lower risk Myelodysplastic Syndromes – a pilot clinical trial

    Shogaols are biologically active constituents of ginger which have a chemical structure similar to gingerols. The most common constituent is 6-Shogaol which has been shown to be a promising anti-cancer and anti-inflammatory agent that also possesses strong hepatoprotective effects (Zhang et al., 2019). In a small investigative study among six early-stage, transfusion-independent patients with MDS, Golombick et al. (2017) found that 6-Shogaol caused a decrease in the serum ferritin (SF) levels of three patients who had elevated SF at baseline. Upregulation of hepcidin levels was observed in two of these three patients, possibly through an improvement in liver function with 6-Shogaol supplementation. Hence, 6-Shogaol, a natural food derivative, may lower the iron overload by decreasing iron absorption. Such promising findings call for a more extensive study to confirm the potential beneficial effect of 6-Shogaol in low-risk MDS patients with SF levels greater than or equal to 100ug/L due to ineffective erythropoiesis. Furthermore, whether the lowering of SF levels in this group of patients can translate into improvements in cytopenias and QoL also requires investigating.

  • Analgesia for patients undergoing minimally invasive major abdominal surgery using Intrathecal Morphine with local anaesthetic. The AIM Study.

    This multicentre, randomised trial aims to determine whether a single preoperative dose of intrathecal morphine with local anaesthetic in patients undergoing elective minimally invasive major abdominal surgery improves quality of recovery as measured by the QoR-15 score on post operative day 1 where a difference of 6 is deemed clinically important. Patients will be randomised into the intervention group (preoperative injection of intrathecal morphine 200 mcg with local anaesthetic + multimodal analgesia) or the control group (multimodal analgesia). A dose increase of intrathecal morphine to 300mcg will occur after recruiting the first 100 patients and following review of safety data. Secondary outcomes of interest include cumulative opioid consumption over the first 3 postoperative days, dynamic and rest pain scores, return of bowel function, opioid related adverse events, hospital length of stay, persistent opioid use and pain at day 90.

  • Can we train maternity staff in Healthy Conversation Skills to support them to provide care for pregnancy weight gain?

    This study aims to determine if we can train maternity staff in Healthy Conversation Skills to support them to provide pregnancy weight gain care to pregnant women. We hypothesise that after receiving the Healthy Conversation Skills intervention, antenatal care providers will have higher competence and confidence, and report less barriers, to having behaviour change conversations about weight gain with pregnant women. This study will be conducted as a single-arm, pre-post study with staggered implementation of the 2-month Healthy Conversation Skills intervention in three health sectors within the Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidenced-based strategies including leadership support, service champions, community of practice meetings, clinician training, educational materials and prompts and reminders. Study outcomes include changes in antenatal care provider’s competence, confidence and barriers to having behaviour change conversations with patients, and adoption of Healthy Conversation Skills. Implementation processes of fidelity, reach, acceptability and appropriateness of the intervention will also be measured. A cost analysis will be undertaken to assess the cost of the Healthy Conversation Skills intervention.

  • Evaluation of the effectiveness of the Enhanced Management of home-Based Elders with Depression (EMBED) program in reducing depression among older adults receiving in-home aged care.

    Older adults who receive aged care services within their own home commonly experience depression. Physical health is often prioritised in this population and mental health concerns can remain overlooked and undertreated. A new mental health model of care, Enhanced Management of home-Based Elders with Depression (EMBED) has been developed to meet the growing need for accessible and tailored psychological care for home aged care recipients. This study aims to evaluate the effectiveness of the EMBED intervention, as well as the costs and benefits of this approach.

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