ANZCTR search results

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

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31435 results sorted by trial registration date.
  • ReCITE (Remote Constraint Induced Therapy of the upper Extremity): An implementation study of remotely delivered constraint induced movement therapy for stroke survivors

    Constraint-induced movement therapy (CIMT) is an effective intervention for arm recovery after stroke. CIMT is recommended in national guidelines, yet only 11% of eligible stroke survivors receive CIMT. Telehealth provides opportunities to deliver CIMT to stroke survivors who live regionally or without transport. Early studies have achieved similar outcomes delivering CIMT via telehealth or online compared to face-to-face. However, implementation support was not provided in any study to embed TeleCIMT into practice. The TeleCIMT International DEvelopment group of occupational therapists, physiotherapists and researchers from Australia, United Kingdom and New Zealand have developed resources to support CIMT implementation and delivery by telehealth (TeleCIMT) in response to the COVID-19 pandemic. This prospective, single-group implementation study will evaluate the feasibility of TeleCIMT using TIDE resources, and explore therapists’ experiences and use of online implementation resources to support TeleCIMT delivery.

  • Electroacupuncture for taxane-induced peripheral neuropathy in patients with Breast Cancer during treatment

    This study will be investigating the effectiveness of electroacupuncture in treating chemotherapy-induced peripheral neuropathy (CIPN) during paclitaxel chemotherapy for breast cancer patients. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with stage I-III breast cancer and have been scheduled to receive weekly adjuvant or neoadjuvant paclitaxel treatments Study details Participants will be randomly allocated to receive 10 weekly sessions of either electroacupuncture or sham electroacupuncture. Feasibility and acceptability of the intervention, as well as any changes in CIPN symptoms, will be assessed over the course of the study. It is hoped that information from this study will inform researchers of any potential benefits that electroacupuncture has for treatment of CIPN.

  • A study to evaluate multi-parametric MRI imaging in active surveillance cohort for low risk Prostate Cancer

    The purpose of this study is to assess the accuracy and utility of MRI imaging in patients who are in active surveillance. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with low risk prostate cancer and your urologist has put you in active surveillance. All participants will be asked to undertake an MRI scan, have their blood test for PSA test result and have the urologist conduct a direct rectal exam within (6 months prior to your biopsy, 1 yr, 2 yrs and 3yrs). Follow-up will be as per standard of care with the urologist

  • Exercise and peritoneal dialysis, is it safe?

    Exercise has the potential to enhance the quality of life for people receiving peritoneal dialysis, however, there is concern regarding risk. It is vital to understand risks associated with exercise and physical activity for people receiving peritoneal dialysis. Thus, the aim of this survey is to address this knowledge gap by exploring the characteristics and frequency of adverse health events reported by people receiving peritoneal dialysis related to exercise or physical activity. Participants will anonymously complete a survey that takes them through a list of adverse events asking if they have experienced the respective event either during, or soon after participation in physical activity or exercise. Identification of these events will provide increased understanding of the safety of exercise or physical activity for this population. This will enhance the ability of patients and clinicians to make evidence informed decisions regarding possible risks while awaiting the necessary rigorous intervention and adverse event data.

  • Point of Care Peritoneal Dialysis System Early Evaluation Study

    The Point of Care Peritoneal Dialysis System Early Evaluation Study (POC-PDEE) will utilise different methodologies to establish the safety, efficacy and usability of the Ellen Medical - Point of Care (EM-POC) peritoneal dialysis system with Australian dialysis patients as a key step in the system evaluation. This study comprises three inter-linked components: (1) a series of human factors usability assessments, (2) a shadow study testing the reliability of the chemical composition and sterility of PD fluid produced by the EM-POC system when used by dialysis patients or their carers independently at the point-of-care and (3) patient perspectives regarding the EM-POC system, it’s usability and the training provided prior to using the EM-POC system will be sought through semi-structured interviews.

  • Effectiveness of the Groups 4 Health program for People with Social Anxiety

    Social anxiety is a prevalent mental health condition, with 4.2% of the population meeting the criteria for social anxiety disorder within a 12-month period (McEvoy et al., 2011). Current treatments for social anxiety tend to focus solely on individual psychological factors (e.g., a person’s negative thoughts) while ignoring the influence of social factors. Groups 4 Health (G4H) has strong potential to address social anxiety symptoms because it focuses on these social factors and how they influence health. G4H is a manualised group therapy program that seeks to increase social connectedness by building group-based connections over five sessions. Its effectiveness for depression and loneliness has already been demonstrated in three trials (i.e., Cruwys et al., 2021; Haslam et al., 2016; 2019), however, it has not yet been tested in people with elevated social anxiety symptoms. Our study is a pilot test of G4H for people with social anxiety. We aim to recruit 80 people with elevated social anxiety symptoms. The primary outcomes we will use to assess whether the intervention is effective are social anxiety and loneliness. Our secondary outcomes include participants’ social connection to their therapy group, depression, multiple group memberships, social isolation, self-focused attention (which has been linked to social anxiety), and wellbeing. We are also interested in what therapist behaviours help foster a sense of connectedness in the therapy group and thus other secondary outcomes include therapists’ identity leadership (a leadership style that aims to build group connectedness) and social support. We hypothesise there will be reductions in social anxiety, loneliness, depression, social isolation, and self-focused attention across the course of therapy, and increases in social connectedness to the therapy group, multiple group memberships, and wellbeing. We also expect that these outcomes will be better when therapists engage in more identity leadership and provide more social support.

  • iCareTracking: Optimising the appropriateness of glaucoma and diabetic eyecare delivery by Australian optometrists

    Glaucoma and diabetic retinopathy are leading causes of irreversible blindness in Australia which pose considerable public health concerns. Early detection and appropriate management is required to prevent vision loss and blindness. A gap between best practice recommendations and actual care provided for people with glaucoma and diabetic retinopathy exists. This project aims to test the feasibility and potential effectiveness of a quality improvement program for optometrists to improve the quality of care provided by optometrists to people with diabetes and with or at risk of glaucoma. The quality improvement program for optometrists consists of self-assessment with benchmarking, peer support, educational activities and resources.

  • Endoscopic ultrasound (EUS)-guided portal pressure measurement in assessing the effectiveness of suboptimal beta-blocker dosing in primary variceal prophylaxis

    This study is looking to assess whether alternative treatment to prevent variceal bleeding (variceal banding involving multiple endoscopic procedures) is required if you are on a suboptimal dose of a beta-blocker (Propranolol or Carvedilol); a medication that reduces your heart rate and blood pressure, with the aim of reducing the pressure gradient in the liver. Suboptimal dose suggests this is not the highest dose possible reaching the target of a heart rate less than 60. Reasons for being unable to increase the dose may include side effects such as low blood pressure. The aim of the medication is to reduce portal hypertension (portal vein pressure gradient in the liver, causing higher risk of varices and bleeding). If your portal pressure gradient measurement is adequate (<12mmHg) then you would not require alternative prophylaxis with variceal banding. The aim of this study is to assess the effectiveness of suboptimal doses of beta-blockers in patients unable to tolerate higher doses. Liver inflammation and pressure can be assessed through blood tests, ultrasound and liver elastography (fibroscan) as well as splenic elastography, all of which are non-invasive however these investigations do not measure portal pressure gradient. We are doing this study in the hope that we can optimise treatment management of patients with cirrhosis. Our overall hypothesis is that directly measuring portal pressure gradient via endoscopic ultrasound (EUS-PPG) can identify patients on suboptimal doses of beta-blockers who do or do not require variceal band ligation for primary prophylaxis.

  • Patient-Focused Prognostic Tool to Evaluate Willingness for Surgery in Total Knee Arthroplasty: A Randomised Controlled Trial (The Proto Knee Trial)

    1 in 5 patients after total knee arthroplasty (TKA) are left feeling unsatisfied. Therefore, patient selection prior to TKA is critical. We have developed a prognostic tool that can predict outcomes after TKA before the patient undergoes surgery. Our tool (PROTO-KNEE) uses machine learning algorithms to predict TKA outcome before patients undergo surgery. Patients can use the tool by inputting their age, gender, and pre-operative quality of life (using a validated questionnaire) and the tool will predict their likelihood for improvement or no improvement after TKA. The study will evaluate this tool on patients decision making. In particular, we are interested to understand how this predictive tool influences a patient's willingness for surgery. Our hypothesis is that use of this tool will better inform patient decision making through individualised outcome prediction early in the TKA journey.

  • First in Human Early Feasibility study of BD(TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries

    This study aims to conduct a first in human, single arm, multicenter trial of the BD(TM) Sirolimus Drug Coated Balloon Catheter for the treatment of femoropopliteal arterial disease to assess the need for future clinical research to evaluate performance and safety.

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