ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Group cognitive rehabilitation via telehealth for brain cancer

    This study aims to investigate the feasibility, applicability and reach of an online group program targeting management of everyday memory and thinking problems of brain cancer survivors. Who is it for? You may be eligible for this study if you are an adult survivor of brain cancer over the age of 18 years old at least three months post-diagnosis and have not undergone radiation therapy in the past month. Study details Participants will attend six weekly 2-hour memory-focused group sessions via Zoom, with a booster session scheduled 6 weeks thereafter. Data will be collected on participants' perception of their memory and cognitive abilities, as well as emotional wellbeing and quality of life. It is hoped that this study will help inform future programs aiding brain cancer survivors manage their cognitive function.

  • Prospective cross-sectional study of 68Ga-PSMA PET/CT in addition to mpMRI in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer

    A multicentre clinical trial evaluating the additive value of a novel diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been newly diagnosed prostate cancer deemed suitable for active surveillance by treating urologist and not yet had a 12-month confirmatory biopsy on active surveillance Study details All participants in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 3 months prior to their 12-month (range 6-18-months) confirmatory biopsy. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and saturation transperineal confirmatory biopsy. Although recent studies have demonstrated the value of mpMRI as a surveillance tool, it has a propensity to miss a small proportion of clinically significant PCa which has limited its ability to safely replace surveillance biopsies. To date, the additive value of PSMA PET in AS has not been evaluated. Given its promising performance in the detection of both metastatic PCa in a BCR setting and the primary diagnosis of intraprostatic PCa, we propose the evaluation of its use in AS.

  • A manualised group program targeted towards internalised stigma.

    This study aims to determine the efficacy of the Narrative Enhancement Cognitive Therapy (NECT) program in reducing SS in Australian youth (16 to 24 years) treated for mental illness and moderate to severe SS. This quantitative project will involve a randomised controlled trial (RCT) assessing the effectiveness of the manualised group program, which has been designed to reduce SS in youth with a mental illness and will be further adapted to the Australian context. A total of 110 youth will be required at baseline of the RCT. It is hypothesised that the NECT program will improve SS, overall mental and physical health, and wellbeing in this vulnerable population.

  • Beyond Now: Evaluating the effectiveness of a self-guided suicide safety planning app for people at risk of suicide

    This study will examine whether app-based suicide safety planning is effective over a 3-month period in increasing suicide-related coping, reducing suicidal ideation, and supporting the basic psychological needs of self-determination (autonomy, competence, relatedness). It is hypothesised that (i) overall, participants will experience significant increases in suicide-related coping and self-determination, and significant decreases in suicidal ideation, and (ii) these outcomes will be superior for participants who made a safety plan in collaboration with a clinician, made plans of higher quality, had higher distress tolerance, and had higher autonomous causality orientations.

  • THE IC3 TRIAL: Identifying Cirrhosis and liver Cancer in primary Care

    This study aims to evaluate the effectiveness of a healthcare model for detecting and monitoring liver disease and liver cancer. Who is it for? You may be eligible to participate in this trial if you are between 45-75 years, and are at risk of chronic liver disease and are under the care of a participating general practitioner (GP). Study details Participants will be randomised to one of two groups. Both groups will receive information and a discussion about liver health (approx. 5 mins). One group will receive usual care provided by their GP. The other group will undergo a blood test. Based on their blood test results, participants may then be offered a special liver ultrasound. Based on their special liver ultrasound results, participants may then be entered into a liver cancer surveillance program which involves liver ultrasounds with or without blood tests every 6 months. It is hoped that this research will demonstrate if this healthcare model is effective in improving detection of liver disease and liver cancer, thus improving patient outcomes.

  • E-learning for early diagnosis of cerebral palsy: a randomised controlled trial evaluating the effectiveness of physician e-learning interventions on cerebral palsy diagnostic skills, behaviours and practice

    This study aims to close an identified research-practice gap and increase accurate cerebral palsy diagnosis (CP) under six months of age in Australia through tailored e-learning for physicians. This trial will determine whether adaptive e-learning using virtual patients, targeting CP diagnostic behaviours and skills, effectively changes physician behaviour and practice compared to non-adaptive e-learning instructional design or control. Our hypothesis is that physicians who complete adaptive e-learning will perform better on an examination of CP diagnostic skills, and self-report of real-world behaviours and practice compared to physicians that receive the non-adaptive e-learning or a control group who don’t receive an intervention. We also hypothesise that physicians who complete either type of e-learning will be more effective at clinically diagnosing and applying for National Disability Insurance Scheme funding for infants with a diagnosis of CP under six months of age compared to a control who don’t receive an intervention.

  • Does the inclusion of transcranial direct current stimulation of the brains motor cortex improve outcomes when combined with rehabilitation following Anterior Cruciate Ligament (ACL) reconstruction.

    People with musculoskeletal pain and injury exhibit higher than expected cortical inhibition, which means that the brain actively inhibits the recruitment of motor units and hence impairs motor function. Specifically, following ACLR and a rehabilitation program targeting lower limb strength, decreased quadriceps strength has been associated with abnormal cortical inhibition, with higher than expected corticospinal inhibition present even at the stage athletes return to running. One intervention proposed to assist in the reduction of cortical inhibition and improve motor drive is transcranial direct current stimulation (tDCS). tDCS can be applied to the motor cortex using a direct current via electrodes placed on the head when performing exercise. tDCS has been shown to improve muscle strength and assist in motor learning making it feasible that applying tDCS to a cohort of ACLR patients may improve functional outcomes. Specifically, anodal tDCS to the primary motor cortex has been shown to reduce intracortical inhibition, potentially addressing the identified deficits following ACLR. Objectives 1. Determine if the addition of tDCS is superior to sham tDCS for improvements in knee muscle strength and motor control following ACL-R in the short and long-term. 2. Determine if the addition of tDCS results in a reduced timeline to pass a return to play testing battery compared to sham tDCS.

  • The feasibility of a personalized approach to venous thromboembolism prophylaxis in heavier critically ill patients.

    Our study will establish whether weight-based dosing of enoxaparin (for venous thromboembolism prevention) is feasible. Feasibility will be determined by the observation of peak levels of a biomarker outcome (anti-Xa) within the target ranges for VTE prophylaxis recommended for ICU patients. On completion of the study we expect to inform a future (larger, multi-centre) trial for one of the most common treatments in ICU, VTE prophylaxis in critically ill patients weighing greater than or equal to 100kg. We will also gain valuable insights into how the electronic medical record can be utilized for research on campus. Patients assigned to usual care (control) will receive enoxaparin 40mg subcutaneously twice daily. Patients assigned to the intervention arm will receive enoxaparin according to a personalized algorithm. We have reviewed the literature and based on existing data, a weight-based dosing regimen with dynamic adjustment (personalized approach) is recommended when the pharmacodynamics and pharmacokinetics of enoxaparin become unpredictable. Patients with increased body weight during critical illness represents the archetypal condition that would benefit from such an approach; it has the greatest potential to improve VTE prevention in this cohort.

  • Randomised Controlled Trial (RCT) of Managing Emotion in First Year University Students: An Online Emotion Regulation Skills Program for University Students

    The present study seeks to evaluate a brief online intervention, Managing Emotion, which has been developed by the present investigators for the purpose of supporting the psychological and emotional well-being of university students. Participants will be recruited for the trial through the Curtin Wellbeing Survey, a mental health screening and stepped referral care program offered to all first year students at Curtin University in Western Australia. Students identified as being at low suicide risk will be invited to participate in the Managing Emotion RCT (Students at moderate to high risk suicide risk receive safety planning or personalised referral options, and are excluded from invitation to the Managing Emotion RCT). Participants will be randomly assigned to either the Managing Emotion intervention or treatment as usual (provision of list of general mental health resources). The intervention content seeks to increase understanding of the relationship between thoughts, emotions, and behaviour, and discusses a number of evidence-based strategies for managing one’s emotions, particularly during times of stress. The intervention content is divided into five self-paced modules, to be completed over the course of one week. Each module includes a number of brief engaging videos, light reading material, and take-home activities. A set of questionnaire measures will be administered immediately before and after completion of the Managing Emotion program, and at 1 month follow-up, to provide an evaluation of the efficacy, acceptability and feasibility of this intervention. We predict that completion of the Managing Emotion program will be associated with an increase in participants' ability to regulate their own emotions, an increase in participants' perceived self-efficacy and resilience, reductions in reported depressed mood, anxiety and stress, and their overall adaptation to university.

  • Survival and Patterns of Care in the Era of Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel (FLOT)-based Chemotherapy for Gastric and Gastroesophageal Adenocarcinoma (SPACE-FLOT): An international multicentre cohort study

    Gastric and gastroesophageal cancers are common and carry exceedingly high mortality rates. Of those patients treated with curative intent, the majority have locally advanced disease, and require chemotherapy before and after radical surgery. Since 2017, 5-fluorouracil, leucovorin, oxaliplatin and paclitaxel (FLOT)-based chemotherapy has become the most commonly used perioperative regimen. This study aims to assess the survival patterns of patients receiving this chemotherapy regimen, and to assess whether receiving FLOT-based chemotherapy both before and after surgical management affects survival compared to those who received only pre-operative FLOT-based chemotherapy. Who is it for? You may be eligible for this study if you are aged 18 years and over, have been diagnosed with gastric or gastroesophageal cancer, and received preoperative FLOT-based chemotherapy and surgical resection between 01/01/2017 to 31/12/2021. Study details For all participants, information regarding survival and disease progression (identified clinically, biochemically, and/or radiologically) will be obtained from your electronic medical record, with no study visits or additional testing required. This data will be used to compare the survival and disease progression between those who did and did not receive post-operative FLOT-based chemotherapy. It is hoped that this research may identify whether there is any further survival benefit from providing post-operative FLOT-based chemotherapy, which may help to dictate future management of patients with gastric or gastroesophageal cancer.

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